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Program-Specific Guidance About Fixed
Gauge Licenses - Final Report (NUREG-1556, Vol. 4)
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Table of Contents
Publication Information
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Manuscript Completed: October 1998
Date Published: October 1998
Prepared by
P.J. Henderson, A.S. Kirkwood, S.H. Lewis, W.H. Radcliffe, G.M. Watson
Division of Industrial and Medical Nuclear Safety
Office of Nuclear Material Safety and Safeguards
U.S. Nuclear Regulatory Commission
Washington, DC 20555-0001
Availablity
Notice
Abstract
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As part of its redesign of the materials licensing process, the Nuclear
Regulatory Commission (NRC) is consolidating and updating numerous guidance
documents into a single comprehensive repository as described in NUREG-1539,
"Methodology and Findings of the NRC's Materials Licensing Process Redesign,"
dated April 1996, and draft NUREG-1541, "Process and Design for Consolidating
and Updating Materials Licensing Guidance," dated April 1996. NUREG-1556,
Vol. 4, "Consolidated Guidance about Materials Licenses: Program-Specific
Guidance about Fixed Gauges Licenses," dated October 1998, is the fourth
program-specific guidance developed for the new process and is intended
for use by applicants, licensees, and NRC staff and will also be available
to Agreement States. This document supersedes the guidance found in Draft
Regulatory Guide and Value/Impact Statement, FC 404-4, "Guide for the
Preparation of Applications for Licenses for the Use of Sealed Sources
and Nonportable Gauging Devices," dated January 1985, in NMSS Policy and
Guidance Directive (P&GD), FC 85-4, "Standard Review Plan for Applications
for Use of Sealed Sources and Nonportable Gauging Devices," dated February
6, 1985, and in NMSS P&GD, FC 85-8, Revision (Rev.) 1, "Licensing
of Fixed Gauges and Similar Devices," dated June 29, 1988. This final
report takes a more risk-informed, performance-based approach to licensing
fixed gauges, and reduces the information (amount and level of detail)
needed to support an application to use these devices. It incorporates
many suggestions received during the comment period on draft NUREG-1556,
Vol. 4. When published, this final report should be used in preparing
fixed gauge license applications. NRC staff will use this final report
in reviewing these applications.
Figures
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1.1 Fixed Gauge Basic Design Features.
1.2 Where is the Radioactive Source?
2.1 U.S. Map. Location of NRC Offices and Agreement
States.
8.1 Examples of Several Different Types of Fixed
Gauges.
8.2 RSO Responsibilities. Typical duties and responsibilities
of RSOs.
8.3 Material Receipt and Accountability. Licensees
must maintain records of receipt, transfer, and disposal and conduct semiannual
physical inventories.
8.4 Annual Dose Limits for Occupationally Exposed
Adults.
8.5 Limiting Public Dose.
8.6 Proper Handling of Incident.
8.7 Lock-out Procedures.
8.8 Leak Test Sample.
8.9 Maintenance.
8.10 Transportation.
8.11 Proper Handling of Incident.
8.12 Examples of Uses for Fixed Gauges at Temporary
Job Sites.
8.13 DOT Transportation Requirements.
8.14 Security.
8.15 Installation of Fixed Gauges at Temporary
Job Sites.
8.16 Security.
Appendix E 1: Functional Sketch of the Model
Appendix E 2: Model
Appendix E 3: Label on Outer Housing
Appendix E 4: Side Cut View & Top View
Appendix E 5: Bottom Plate View & Side View
90° Rotation
Appendix K 1: Diagram of Bottling Line and Fixed
Gauges
Appendix Q 1: 1 of 6 Material Licensee
Appendix Q 2: 2 of 6 Materials License (Supplementary
Sheet)
Appendix Q 3: 3 of 6 Materials License (Supplementary
Sheet)
Appendix Q 4: 4 of 6 Materials License (Supplementary
Sheet)
Appendix Q 5: 5 of 6 Materials License (Supplementary
Sheet)
Appendix Q 6: 6 of 6 Materials License (Supplementary
Sheet)
Foreword
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The United States Nuclear Regulatory Commission (NRC) is using Business
Process Redesign (BPR) techniques to redesign its materials licensing
process. This effort is described in NUREG-1539, "Methodology and Findings
of the NRC's Materials Licensing Process Redesign," dated April 1996.
A critical element of the new process is consolidating and updating numerous
guidance documents into a NUREG-series of reports. Below is a listing
of volumes currently included in the NUREG-1556 series: "Consolidated
Guidance About Materials Licenses":
Vol. No. |
Volume Title |
Status |
1 |
Program-Specific Guidance About Portable Gauge Licenses |
Final Report |
2 |
Program-Specific Guidance About Industrial Radiography Licenses |
Final Report |
3 |
Applications for Sealed Source and Device Evaluation and Registration |
Final Report |
4 |
Program-Specific Guidance About Fixed Gauge Licenses |
Final Report |
5 |
Program-Specific Guidance about Self-Shielded Irradiator Licenses |
Draft for Comment |
6 |
Program-Specific Guidance about 10 CFR Part 36 Irradiators |
Draft for Comment |
7 |
Program-Specific Guidance about Academic, Research and Development,
and Other Licenses of Limited Scope |
Draft for Comment |
8 |
Program-Specific Guidance about Licenses for Exempt Distribution |
Final Report |
9 |
Program-Specific Guidance about Medical Use Licenses |
Draft for Comment |
10 |
Program-Specific Guidance about Master Materials Licenses |
Draft for Comment |
11 |
Program-Specific Guidance about Licenses of Broad Scope |
Draft for Comment |
The current document (NUREG-1556, Vol. 4, "Consolidated Guidance about
Materials Licenses: Program-Specific Guidance about Fixed Gauges," dated
October 1998) is the fourth program-specific guidance developed for the
new process. It is intended for use by applicants, licensees, NRC license
reviewers, and other NRC personnel. It supersedes the guidance for applicants
and licensees previously found in Draft Regulatory Guide and Value/Impact
Statement, FC 404-4, "Guide for the Preparation of Applications for Licenses
for the Use of Sealed Sources in Nonportable Gauging Devices," dated January
1985, and the guidance for licensing staff previously found in P&GD,
FC 85-4, "Standard Review Plan for Applications for the Use of Sealed
Sources in Nonportable Gauging Devices," dated February 6, 1985, P&GD,
FC 85-8, Rev. 1, "Licensing of Fixed Gauges and Similar Devices," dated
June 29, 1988, and the documents marked with an asterisk (*) in Appendix
Q. NUREG-1556, Vol. 4 incorporates suggestions submitted during the comment
period on draft NUREG-1556, Vol. 4. See the Addendum for summaries of
comments, staff responses, and other changes.
This report takes a risk-informed, performance-based approach to licensing
fixed gauges, i.e., it reduces the amount of information needed from an
applicant seeking to possess and use a relatively safe device. These fixed
gauges containing sealed sources of radioactive material incorporate features
engineered to enhance their safety. NRC's considerable experience with
these licensees indicates that radiation exposures to workers are generally
low, if workers follow basic safety procedures, and the gauges operate
as designed.
A team composed of NRC staff from headquarters and regional offices drafted
this document, drawing on their collective experience in radiation safety
in general and as specifically applied to fixed gauges. A representative
of NRC's Office of the General Counsel provided a legal perspective.
NUREG-1556, Vol. 4, "Consolidated Guidance about Materials Licenses:
Program-Specific Guidance about Fixed Gauges," dated October 1998, represents
a step in the transition from the current paper-based process to the new
electronic process. This document is available on the Internet at the
following uniform resource locator (URL): <http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v4/index.html>
The performance-based approach in NUREG-1556, Vol. 4, gives licensees
greater flexibility than previously permitted under licenses based on
applications prepared according to Draft Regulatory Guide and Value/Impact
Statement, FC 404-4, "Guide for the Preparation of Applications for Licenses
for the Use of Sealed Sources in Nonportable Gauging Devices," dated January
1985. This guidance document permits licensees to make more changes in
their radiation safety program without amending their licenses, thus reducing
the regulatory burden on licensees and the NRC staff. Accordingly, existing
fixed gauge licensees have the option of submitting a complete application
using NUREG-1556, Vol. 4, at the time that they file an amendment request.
Licensees choosing this option should incorporate the requested change
into the complete application, submit it with the appropriate amendment
fee, and indicate that the complete revision is an amendment request to
take advantage of the new guidance. When the staff has reviewed the request
and resolved any outstanding issues, the staff will amend the license
without changing the expiration date.
Licensees wishing to renew their licenses should submit a complete application
according to NUREG-1556, Vol. 4. The staff's action will be similar to
that described for amendments, but will include an extension of the license's
expiration date. By following this procedure, the staff expects all existing
fixed gauge licenses to be converted to the more performance-based format
within a few years.
This report describes and makes available to the public information on:
methods acceptable to the NRC staff for implementing specific parts of
the Commission's regulations; techniques the staff uses in evaluating
applications, including specific problems or postulated accidents; and
data the NRC staff needs to review applications for licenses. NUREG-1556,
Vol. 4, "Consolidated Guidance about Materials Licenses: Program-Specific
Guidance about Fixed Gauges," dated October 1998, is not a substitute
for NRC regulations, and compliance is not required. The approaches and
methods described in this report are provided for information only. Methods
and solutions different from those described in this report will be acceptable
if they provide a basis for the staff to make the determinations needed
to issue or continue a license.
__________________________________
Frederick C. Combs, Acting Director
Division of Industrial and Medical Nuclear Safety
Office of Nuclear Material Safety and Safeguards
Acknowledgments
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The writing team thanks the individuals listed below for assisting in
the development and review of both the draft and final reports. All participants
provided valuable insights, observations, and recommendations.
The team also thanks Kay Avery, Kathryn M. LaViolette, D. W. Benedict
Llewellyn, Alyce J. Martin, Carla T. Purvis, Steven W. Schawaroch, and
Gina G. Thompson of Computer Sciences Corporation and Angela S. Case of
Total Systems Solutions, Inc.
The Participants
Blough, A. Randolph
Camper, Larry W.
Caniano, Roy J.
Combs, Frederick C.
Cool, Donald A.
Henderson, Pamela J.
Johansen, Jenny M.
Jones, Cynthia G.
Kirkwood, Anthony S.
Lewis, Stephen H.
Merchant, Sally L.
Piccone, Josephine M.
Radcliffe, William R.
Roe, Mary Louise
Schwartz, Maria E.
Treby, Stuart A.
Vacca, Patricia C.
Watson, Gidget M.
Abbreviations
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ALARA |
as low as is reasonably achievable |
Am-241 |
americium-241 |
ANSI |
American National Standards Institute |
AU |
authorized user |
bkg |
background |
BPR |
business process redesign |
Bq |
Becquerel |
CaF2 |
calcium fluoride |
Cf-252 |
californium-252 |
CDE |
committed dose equivalent |
CEDE |
committed effective dose equivalent |
CFR |
Code of Federal Regulations |
Ci |
Curie |
C/kg |
coulomb per kilogram |
Co-60 |
cobalt-60 |
cpm |
counts per minute |
Cs-137 |
cesium-137 |
d |
day |
DOE |
United States Department of Energy |
DOT |
United States Department of Transportation |
EDE |
effective dose equivalent |
FDA |
United States Food and Drug Administration |
ft |
foot |
GBq |
gigabecquerel |
G-M |
Geiger-Mueller |
GPO |
Government Printing Office |
hr |
hour |
IN |
Information Notice |
IP |
Inspection Procedure |
kg |
kilogram |
Kr-85 |
krypton-85 |
LiF |
lithium fluoride |
m |
meter |
mCi |
millicurie |
mo |
month |
MOU |
memorandum of understanding |
mR |
milliroentgen |
mrem |
millirem |
mSv |
millisievert |
NCRP |
National Council on Radiation Protection and Measurements |
NIST |
National Institute of Standards and Technology |
NMSS |
Office of Nuclear Material Safety and Safeguards |
NRC |
United States Nuclear Regulatory Commission |
NVLAP |
National Voluntary Laboratory Accreditation Program |
OSP |
Office of State Programs |
P&GD |
Policy and Guidance Directive |
Q |
Quality Factor |
R |
Roentgen |
Rev. |
revision |
RG |
Regulatory Guide |
RQ |
reportable quantities |
RSO |
radiation safety officer |
SDE |
shallow-dose equivalent |
Sr-90 |
strontium-90 |
SI |
SI International System of Units (abbreviated SI from the French Système International d'Unités) |
SSD |
sealed source and device |
std |
standard |
Sv |
Sievert |
TAR |
technical assistance request |
TEDE |
total effective dose equivalent |
TI |
transportation index |
TLD |
thermoluminescent dosimeters |
URL |
uniform resource locator |
wk |
week |
yr |
year |
1 Purpose of Report
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This report provides guidance to an applicant in preparing a fixed gauge
license application as well as NRC criteria for evaluating a fixed gauge
license application. It is not intended to address the research and development
of fixed gauges or the commercial aspects of manufacturing, distribution,
and service of such devices. Within this document, the phrases or terms,
"fixed gauge," "gauging devices," or "gauges" are used interchangeably.
This report addresses a variety of radiation safety issues associated
with fixed gauges of many designs. Figure 1.1 is a cutaway diagram of
a typical fixed gauge showing basic design features. Figure 1.2 illustrates
various designs of fixed gauges based, in part, on their intended use
and the location of the radioactive source within the gauges. Typically
gauges are used for process control (e.g., to measure the thickness of
paper, the density of coal, the level of material in vessels and tanks,
and volumetric flow rate). Because of differences in design, manufacturers
provide appropriate instructions and recommendations for proper operation
and maintenance. In addition, with gauges of varying designs, the sealed
sources may be oriented in different locations within the devices, resulting
in different radiation safety problems.
Figure 1.1 Fixed Gauge Basic Design Features.
Cutaway of a typical fixed gauge diagraming the basic design features:
the source, source holder, detector, shutter, shutter control or on-off
mechanism, and shielding.
Figure 1.2 Where is the Radioactive Source?
The wide variety of fixed gauge designs results in different radiation
safety considerations.
This report identifies the information needed to complete NRC Form 313
(Appendix A), "Application for Material License," for the use of sealed
sources in fixed gauges. The information collection requirements in Title
10, Code of Federal Regulations, Part 30 (10 CFR Part 30) and NRC Form
313 have been approved under the Office of Management and Budget (OMB)
Clearance Nos. 3150-0017 and 3150-0120, respectively.
The format within this document for each item of technical information
is as follows:
- Regulations -- references the regulations applicable to the item;
- Criteria -- outlines the criteria used to judge the adequacy of the
applicant's response;
- Discussion -- provides additional information on the topic sufficient
to meet the needs of most readers; and
- Response from Applicant -- provides suggested response(s), offers
the option of an alternative reply, or indicates that no response is
needed on that topic during the licensing process.
Notes and References are self-explanatory and may not be found for each
item on NRC Form 313.
Appendix B provides a convenient format to respond to items 5 through
11 on NRC Form 313 (Appendix A) since the form does not have sufficient
space for applicants to provide full responses to these items. For streamlined
handling of fixed gauge applications in the new materials licensing process,
use Appendix B to provide supporting information, attach it to NRC Form
313, and submit them to NRC. Otherwise, as indicated on NRC Form 313,
the answers to items 5 through 11 are to be provided on separate sheets
of paper and submitted with the completed NRC Form 313.
Appendix C contains information needed for transfer of control. Appendix
D is a checklist that NRC staff uses to review applications and applicants
can use to check for completeness. Appendix E contains a sample SSD Registration
Certificate. Appendixes F through P contain additional information on
various radiation safety topics. Appendix Q is a sample fixed gauge license;
it contains the conditions most often found on these licenses, although
not all licenses will have all conditions. Appendix R contains a list
of all documents used to develop this NUREG (NUREG-1556, Vol. 4). The
Addendum contains the comments received on draft NUREG-1556, Vol. 4 and
NRC staff's response to each comment.
In this document, dose or radiation dose means absorbed dose, dose equivalent,
effective dose equivalent (EDE), committed dose equivalent (CDE), committed
effective dose equivalent (CEDE), or total effective dose equivalent (TEDE).
These terms are defined in 10 CFR Part 20. Rem, and its SI equivalent
Sievert (1 rem = 0.01 Sievert (Sv)), are used to describe units of radiation
exposure or dose. This is done because 10 CFR Part 20 sets dose limits
in terms of rem, not rad or roentgen (R). When the sealed sources used
in gauges emit beta and gamma rays, for practical reasons, we are assuming
that 1 R = 1 rad = 1 rem. Less common are sealed sources used in gauges
that emit neutrons or alpha particles. For neutron and alpha emitting
sealed sources, 1 rad is not equal to 1 rem. Determination of dose equivalent
(rem) from absorbed dose (rad) from neutrons and alpha particles requires
the use of an appropriate quality factor (Q) value. Q values are used
to convert absorbed dose (rad) to dose equivalent (rem). Q values for
neutrons and alpha particles are addressed in the Tables 1004(b).1 and
2 in 10 CFR §20.1004.
2 Agreement States
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Certain states, called Agreement States (see Figure 2.1), have entered
into agreements with the NRC that give them the authority to license and
inspect byproduct, source, or special nuclear materials used or possessed
within their borders. A current list of Agreement States (including names,
addresses, and telephone numbers of responsible officials) may be obtained
upon request from NRC's Regional Offices. Any applicant other than a Federal
agency who wishes to possess or use licensed material in one of these
Agreement States needs to contact the responsible officials in that State
for guidance on preparing an application; file these applications with
State officials, not with the NRC.
In general, NRC's materials licensees who wish to conduct operations
at temporary job sites in an Agreement State should contact that State's
radiation control program office for information about State regulations.
To ensure compliance with Agreement State reciprocity requirements, a
licensee should request authorization well in advance of scheduled use.
In the special situation of work at Federally-controlled sites in Agreement
States, it is necessary to know the jurisdictional status of the land
in order to determine whether NRC or the Agreement State has regulatory
authority. NRC has regulatory authority over land determined to be "exclusive
Federal jurisdiction," while the Agreement State has jurisdiction over
non-exclusive Federal jurisdiction land. Licensees are responsible for
finding out, in advance, the jurisdictional status of the specific areas
where they plan to conduct licensed operations. NRC recommends that licensees
ask their local contact for the Federal agency controlling the site (e.g.,
contract officer, base environmental health officer, district office staff)
to help determine the jurisdictional status of the land and to provide
the information in writing, so that licensees can comply with NRC or Agreement
State regulatory requirements, as appropriate. Additional guidance on
determining jurisdictional status is found in All Agreement States Letter,
SP-96-022, dated February 16, 1996, which is available as indicated below.
Table 2-1 provides a quick way to check on which agency has regulatory
authority.
Table 2.1 Who Regulates the Activity?
Applicant and Proposed Location of Work |
Regulatory Agency |
Federal agency regardless of location (except that Department
of Energy [DOE] and, under most circumstances, its prime contractors
are exempt from licensing [10 CFR 30.12]) |
NRC |
Non-Federal entity in non-Agreement State, US territory
or possession |
NRC |
AGREEMENT STATES
Non-Federal entity in Agreement State at non-Federally controlled
site |
Agreement State |
Non-Federal entity in Agreement State at Federally-controlled
site NOT subject to exclusive Federal jurisdiction |
Agreement State |
Non-Federal entity in Agreement State at Federally-controlled
site subject to exclusive Federal jurisdiction |
NRC |
Figure 2.1 U.S. Map. Location of NRC Offices
and Agreement States.
References: A current list of Agreement States (including
names, addresses, and telephone numbers of responsible officials) is available
by choosing "Directories" on the NRC Office of State and Tribal Programs' (OSP)
Home Page <http://www.hsrd.ornl.gov/nrc/home.html>
As an alternative, request the list from NRCs Regional Offices.
All Agreement States Letter, SP-96-022, dated February 16, 1996, is available
on the OSP Home Page at
<http://www.hsrd.ornl.gov/nrc/home.html>
choose "NRC-State Communications," then choose "All of the Above" and
follow the directions for submitting a query for "SP96022." As an alternative,
request the list from OSP; call NRC's toll free number (800) 368-5642
and then ask for extension 415-3340.
3 Management Responsibility
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The NRC recognizes that effective radiation safety program management
is vital to achieving safe and compliant operations. NRC also believes
that consistent compliance with its regulations provides reasonable assurance
that licensed activities will be conducted safely. NRC also believes that
effective management will result in increased safety and compliance.
"Management" refers to the processes for conduct and control of
a radiation safety program and to the individuals who are responsible
for those processes and who have authority to provide necessary
resources to achieve regulatory compliance. |
To ensure adequate management involvement, a duly authorized management
representative must sign the submitted application acknowledging
management's commitments and responsibility for the following:
- Radiation safety, security and control of radioactive materials, and
compliance with regulations;
- Completeness and accuracy of the radiation safety records and all
information provided to NRC (10 CFR 30.9);
- Knowledge about the contents of the license and application;
- Compliance with current NRC and Department of Transportation (DOT)
regulations and the licensee's operating and emergency procedures;
- Commitment to provide adequate resources (including space, equipment,
personnel, time, and, if needed, contractors) to the radiation protection
program to ensure that public and workers are protected from radiation
hazards and meticulous compliance with regulations is maintained;
- Selection and assignment of a qualified individual to serve as the
Radiation Safety Officer (RSO) for their licensed activities;
- Prohibition against discrimination of employees engaged in protected
activities (10 CFR 30.7);
- Commitment to provide information to employees regarding the employee
protection and deliberate misconduct provisions in 10 CFR 30.7 and 10
CFR 30.10, respectively;
- Obtaining NRC's prior written consent before transferring control
of the license; and
- Notifying appropriate NRC regional administrator in writing, immediately
following filing of petition for voluntary or involuntary bankruptcy
(10 CFR 30.34(h)).
For information on NRC inspection, investigation, enforcement, and other
compliance programs, see the current version of "General Statement of
Policy and Procedures for NRC Enforcement Actions," NUREG-1600, and Inspection
Procedure (IP) 87110, Appendix A, "Industrial/Academic/Research Inspection
Field Notes." These documents are available electronically at <http://www.nrc.gov>. For hard copies of NUREG-1600 and IP
87110, see the Notice of Availability (on the inside front cover of this
report).
4 Applicable Regulations
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It is the applicant's or licensee's responsibility to have up-to-date
copies of applicable regulations, read them, and abide by each applicable
regulation.
The following Parts of 10 CFR Chapter I contain regulations applicable
to fixed gauges:
- 10 CFR Part 2, "Rules of Practice for Domestic Licensing Proceedings
and Issuance of Orders"
- 10 CFR Part 19, "Notices, Instructions and Reports to Workers: Inspection
and Investigations"
- 10 CFR Part 20, "Standards for Protection Against Radiation"
- 10 CFR Part 21, "Reporting of Defects and Noncompliance"
- 10 CFR Part 30, "Rules of General Applicability to Domestic Licensing
of Byproduct Material"
- 10 CFR Part 32, "Specific Domestic Licenses to Manufacture or Transfer
Certain Items Containing Byproduct Material"
- 10 CFR Part 71, "Packaging and Transportation of Radioactive Material"
Part 71 requires that licensees who transport licensed material
or who may offer such material to a carrier for transport must comply
with the applicable requirements of the United States Department of
Transportation (DOT) that are found in 49 CFR Parts 170 through 189.
Copies of DOT regulations can be ordered from the Government Printing
Office (GPO) whose address and telephone number are listed below. |
- 10 CFR Part 150, "Exemptions and Continued Regulatory Authority in
Agreement States and in Offshore Waters Under Section 274"
- 10 CFR Part 170, "Fees for Facilities, Materials, Import and Export
Licenses and Other Regulatory Services Under the Atomic Energy Act of
1954, as Amended"
- 10 CFR Part 171, "Annual Fees for Reactor Operating Licenses, and
Fuel Cycle Licenses and Materials Licenses, Including Holders of Certificates
of Compliance, Registrations, and Quality Assurance Program Approvals
and Government Agencies Licensed by NRC"
To request copies of the above documents, call GPO's order desk in Washington,
DC at (202) 512-1800. Order the two-volume bound version of Title 10,
Code of Federal Regulations, Parts 0-50 and 51-199 from the GPO, Superintendent
of Documents, Post Office Box 371954, Pittsburgh, Pennsylvania 15250-7954.
You may also contact the GPO electronically at <http://www.gpo.gov> .
Request single copies of the above documents from NRC's Regional Offices
(see Figure 2.1 for addresses and telephone numbers). Note that NRC and
all other Federal Agencies publish amendments to regulations in the Federal
Register .
5 How to File
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5.1 Paper Application
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Applicants for a materials license should do the following:
- Be sure to use the most recent guidance in preparing an application.
- Complete NRC Form 313 (Appendix A) Items 1 through 4, 12, and 13 on
the form itself.
- Complete NRC Form 313 Items 5 through 11 on supplementary pages or
use Appendix B.
- For each separate sheet, other than Appendix B, that is submitted
with the application, identify and key it to the item number on the
application or the topic to which it refers.
- Submit all documents on 8-1/2 x 11 inch paper.
- Avoid submitting proprietary information unless it is absolutely necessary.
- Submit an original application and one copy.
- Retain one copy of the license application for future reference. Applicants
for a materials license should do the following:
As required by 10 CFR 30.32 (c), applications must be signed by
a duly authorized representative; see section in this report entitled
"Certification." |
Using the suggested wording of responses and committing to using
the model procedures in this report will expedite NRC's review. |
All license applications will be available for review by the general
public in NRC's Public Document Rooms. If it is necessary to submit proprietary
information, follow the procedure in 10 CFR 2.790. Failure to follow this
procedure could result in disclosure of the proprietary information to
the public or substantial delays in processing the application. Employee
personal information, i.e., home address, home telephone number, social
security number, date of birth, radiation dose information, should not
be submitted unless specifically requested by NRC.
As explained in the Foreword to this document, NRC's new licensing process
will be faster and more efficient, in part, through acceptance and processing
of electronic applications at some future date. NRC will continue to accept
paper applications. However, these will be scanned and put through an
optical character reader to convert them to electronic format. To ensure
a smooth transition, applicants are requested to follow these suggestions:
- Submit printed or typewritten, not handwritten, text on smooth, crisp
paper that will feed easily into the scanner.
- Choose typeface designs that are sans serif, such as Arial, Futura,
Univers; the text of this document is in a serif font called Times
New Roman.
- Choose 12-point or larger font size.
- Avoid stylized characters such as script, italic, etc.
- Be sure the print is clear and sharp.
- Be sure there is high contrast between the ink and paper (black ink
on white paper is best).
5.2 Electronic Application
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As the electronic licensing process develops, it is anticipated that
NRC may provide mechanisms for filing applications via diskettes or CD-ROM,
and through the Internet. Additional filing instructions will be provided
as these new mechanisms become available. The existing paper process will
be used until the electronic process is available.
6 Where to File
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Applicants wishing to possess or use licensed material in any State or
U.S. territory or possession subject to NRC jurisdiction must file an
application with the NRC Regional Office for the locale in which the material
will be possessed and/or used. Figure 2.1 shows NRC's four Regional Offices
and their respective areas for licensing purposes and identifies Agreement
States.
In general, applicants wishing to possess or use licensed material in
Agreements States must file an application with the Agreement State, not
NRC. However, if work will be conducted at Federally controlled sites
in Agreement States, applicants must first determine the jurisdictional
status of the land in order to determine whether NRC or the Agreement
State has regulatory authority. See the section on "Agreement States"
for additional information.
7 License Fees
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Each application for which a fee is specified, including applications
for new licenses and license amendments, must be accompanied by the appropriate
fee. Refer to 10 CFR 170.31 to determine the amount of the fee. NRC will
not issue the new license prior to fee receipt. Once technical review
has begun, no fees will be refunded; application fees will be charged
regardless of the NRC's disposition of an application or the withdrawal
of an application.
Most NRC licensees are also subject to annual fees; refer to 10 CFR 171.16.
Consult 10 CFR 171.11 for additional information on exemptions from annual
fees and 10 CFR 171.16(c) on reduced annual fees for licensees that qualify
as "small entities."
Direct all questions about NRC's fees or completion of Item 12 of NRC
Form 313 (Appendix A) to the Office of the Chief Financial Officer at
NRC Headquarters in Rockville, Maryland, (301) 415-7554. You may also
call NRC's toll free number (800) 368-5642 and then ask for extension
415-7554.
8 Contents of an Application
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The following comments apply to the indicated items on NRC Form 313 (Appendix
A).
8.1 Item 1: License Action Type
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THIS IS AN APPLICATION FOR (Check appropriate item):
Type of Action |
License No. |
[ ] A. New License |
Not Applicable |
[ ] B. Amendment |
XX-XXXXX-XX |
[ ] C. Renewal |
XX-XXXXX-XX |
Check box A for a new license request.
Check box B for an amendment(1) to an
existing license, and provide license number.
Check box C for a renewal1 of an existing license, and provide
license number.
8.2 Item 2: Applicant's Name and Mailing Address
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List the legal name of the applicant's corporation or other legal entity
with direct control over use of the radioactive material; a division or
department within a legal entity may not be a licensee. An individual
may be designated as the applicant only if the individual is acting in
a private capacity and the use of the radioactive material is not connected
with employment in a corporation or other legal entity. Provide the mailing
address where correspondence should be sent. A post office box number
is an acceptable mailing address.
Notify NRC of changes in mailing address; these changes do not require
a fee.
Note: NRC must be notified before control of
the license is transferred or bankruptcy proceedings have been initiated;
see below for more details. NRC Information Notice (IN) 97-30, "Control
of Licensed Material during Reorganizations, Employee-Management Disagreements,
and Financial Crises," dated June 3, 1997, discusses the potential for
the security and control of licensed material to be compromised during
periods of organizational instability.
Timely Notification of Transfer of Control
Regulations: 10 CFR 30.34(b).
Criteria: Licensees must provide full information and
obtain NRC's prior written consent before transferring
control of the license, or, as some licensees call it, "transferring the
license."
Discussion: Transfer of control may be the result of
mergers, buyouts, or majority stock transfers. Although it is not NRC's
intent to interfere with the business decisions of licensees, it is necessary
for licensees to obtain prior NRC written consent before the transaction
is finalized.
This is to ensure the following:
- Radioactive materials are possessed, used, or controlled only by persons
who have valid NRC licenses;
- Materials are properly handled and secured;
- Persons using these materials are competent and committed to implementing
appropriate radiological controls;
- A clear chain of custody is established to identify who is responsible
for disposition of records and licensed material; and
- Public health and safety are not compromised by the use of such materials.
Response from Applicant: None from an applicant for
a new license; Appendix C, excerpted from IN 89-25, Revision
1, "Unauthorized Transfer of Ownership or Control of Licensed Activities,"
dated December 7, 1994, identifies the information to be provided about
transfers of control.
References: See Notice of Availability (on the inside
front cover of this report) to obtain copies of IN 89-25, Revision 1,
"Unauthorized Transfer of Ownership or Control of Licensed Activities,"
dated December 7, 1994, and IN 97-30, "Control of Licensed Material during
Reorganizations, Employee-Management Disagreements, and Financial Crises,"
dated June 3, 1997.
Notification of Bankruptcy Proceedings
Regulations: 10 CFR 30.34(h).
Criteria: Immediately following filing of voluntary
or involuntary petition for bankruptcy for or against a licensee, the
licensee must notify the appropriate NRC Regional Administrator, in writing,
identifying the bankruptcy court in which the petition was filed and the
date of filing.
Discussion: Even though a licensee may have filed for
bankruptcy, the licensee remains responsible for all regulatory requirements.
NRC needs to know when licensees are in bankruptcy proceedings in order
to determine whether all licensed material is accounted for and adequately
controlled and whether there are any public health and safety concerns
(e.g., contaminated facility). NRC shares the results of its determinations
with other involved entities (e.g., trustee) so that health and safety
issues can be resolved before bankruptcy actions are completed.
Response from Applicant: None at time of application
for a new license. Generally, licensees should notify NRC within 24 hours
of filing a bankruptcy petition.
References: INs are available in the "Reference Library"
on NRC's Home Page at <http://www.nrc.gov.> For
hard copies, see the Notice of Availability (on the inside front cover
of this report).
8.3 Item 3: Address(es) Where Licensed Material
Will Be Used or Possessed
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Specify the street address, city, and state or other descriptive address
(such as on Highway 10, 5 miles east of the intersection of Highway 10
and State Route 234, Anytown, State) for each facility. The descriptive
address should be sufficient to allow an NRC inspector to find the facility
location. A Post Office Box address is not acceptable.
An NRC license does not relieve a licensee from complying with other
applicable Federal, State, or local requirements (e.g., local zoning
requirements or local ordinances requiring registration of radioactive
material). |
An NRC-approved license amendment is required before locating a gauge
at an address not already listed on the license, whether that gauge
is an additional unit or a relocation of an existing unit.
For information on conducting operations at temporary job sites (i.e.,
locations where work is conducted for limited periods of time, refer to
the section in this report called "Fixed Gauges Used at Temporary Job
Sites." That section offers examples of operations where fixed gauges
might be used at temporary job sites and gives information which should
be provided to the NRC to support a request for these operations.
The applicant need not submit sketches or identify the specific
location of the fixed gauge within the facility with the application.
The acceptability of the gauge's location will be reviewed during
the inspection process. |
Note: As discussed later in the section "Financial
Assurance and Record Keeping for Decommissioning," licensees do need to
maintain permanent records on where licensed material was used or stored
while the license was in force. This is important for making future determinations
about the release of these locations for unrestricted use (e.g., before
the license is terminated). For fixed gauge licensees, acceptable records
are sketches or written descriptions of specific locations where each
gauge was used or stored and any information relevant to damaged devices
or leaking radioactive sources.
8.4 Item 4: Person to Be Contacted about this Application
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Identify the individual who can answer questions about the application
and include his or her telephone number. This is typically the proposed
radiation safety officer, unless the applicant has named a different person
as the contact. The NRC will contact this individual if there are questions
about the application.
Notify NRC if the contact person or his or her telephone number changes
so that NRC can contact the applicant or licensee in the future with questions,
concerns, or information. This notice is for "information only" and does
not require a license amendment or a fee.
As indicated on NRC Form 313 (Appendix A), Items 5 through 11 should
be submitted on separate sheets of paper. Applicants may use Appendix
B for this purpose and should note that using the suggested wording
of responses and committing to using the model procedures in this
report will expedite NRC's review. Appendix D provides examples of
the criteria that NRC license reviewers use to review submissions
of alternative procedures. |
8.5 Item 5: Radioactive Material
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8.5.1 Sealed Sources and Devices
Regulations: 10 CFR 30.32(g), 10 CFR 30.33(a)(2), 10
CFR 32.210.
Criteria: Applicants must provide the manufacturer's
or distributor's name and model number for each requested sealed source
and device. Licensees will be authorized to possess and use only those
sealed sources and devices specifically approved or registered by NRC
or an Agreement State.
Discussion: NRC or an Agreement State performs a safety
evaluation of fixed gauges before authorizing a manufacturer or distributor
to distribute the gauges to specific licensees. The safety evaluation
is documented in a Sealed Source and Device (SSD) Registration Certificate.
Before the SSD registration process was formalized, some older gauges
may not have been evaluated in a separate document, but were specifically
approved on a license. Licensees can continue to use these gauges that
are specifically listed on their licenses. Some examples of fixed gauges
are shown in Figure 8.1.
Figure 8.1 Examples of Several Different Types
of Fixed Gauges.
Consult with the proposed manufacturer or distributor to ensure that
requested sources and devices are compatible and conform to the sealed
source and device designations registered with NRC or an Agreement State.
Licensees may not make any changes to the sealed source, device, or source/device
combination that would alter the description or specifications from those
indicated in the respective registration certificates, without obtaining
NRC's prior permission in a license amendment. Such changes may necessitate
a custom registration review, increasing the time needed to process a
licensing action.
SSD Registration Certificates contain sections on "Conditions of Normal
Use" and "Limitation and Other Considerations of Use." These sections
may include limitations derived from conditions imposed by the manufacturer
or distributor, by particular conditions of use that would reduce radiation
safety of the device, or by circumstances unique to the sealed source
or device. For example, working life of the device or appropriate temperature
and other environmental conditions may be specified. Except as specifically
approved by NRC, licensees are required to use gauges according to their
respective SSD Registration Certificates. Accordingly, applicants may
want to obtain a copy of the certificate and review it with the manufacturer
or distributor or with NRC or the issuing Agreement State to ensure that
it correctly reflects the radiation safety properties of the source or
device. See Appendix E for an example of a fixed gauge SSD Registration
Certificate.
Response from Applicant:
- Identify each radionuclide that will be used in each source in the
gauging device(s).
- Identify the manufacturer or distributor and model number of each
type of sealed source and device requested.
- Confirm that each sealed source, device, and source/device combination
is registered as an approved sealed source or device by NRC or an Agreement
State.
- Confirm that the activity per source and maximum activity per device
will not exceed the maximum activity listed on the approved certificate
of registration issued by NRC or by an Agreement State.
Note: For information on SSD registration certificates,
contact the Registration Assistant by calling NRC's toll free number (800)
368-5642 and then asking for extension 415-7217. For more information
about the SSD registration process, see the current version of NUREG-1556,
Vol. 3, "Consolidated Guidance About Materials Licenses: Applications
for Sealed Source and Device Evaluation and Registration." It is available
electronically in the "Reference Library" at <http://www.nrc.gov>;
for a paper copy, see the Notice of Availability (on the inside front
cover of this report).
8.5.2 Financial Assurance and Recordkeeping for
Decommissioning
Regulations: 10 CFR 30.34(b), 10 CFR 30.35.
Criteria: Fixed gauge licensees authorized to possess
sealed sources containing radioactive material in excess of the limits
specified in 10 CFR 30.35(b) and (d) must provide evidence of financial
assurance for decommissioning.
Even if no financial assurance is required, licensees are required to
maintain, in an identified location, decommissioning records related to
structures and equipment where gauges are used or stored and to leaking
sources. Pursuant to 10 CFR 30.35(g), licensees must transfer these records
important to decommissioning to either of the following:
- The new licensee before licensed activities are transferred or assigned
according to 10 CFR 30.34(b).
The appropriate NRC regional office before the license is terminated.
Discussion: The requirements for financial assurance
are specific to the types and quantities of byproduct material authorized
on a license. Most fixed gauge applicants and licensees do not need to
take any action to comply with the financial assurance requirements because
their total inventory of licensed material does not exceed the thresholds
in 10 CFR 30.35(b) and (d). The thresholds for typical radionuclides used
for fixed gauge sealed sources are shown in Table 8.1.
Table 8.1 Examples of Minimum Inventory Quantities Requiring
Financial Assurance
Radionuclide (Sealed Sources) |
Activity in Gigabecquerels |
Activity in Curies |
Co-60 |
3.7 x 105 |
10,000 |
Kr-85 |
3.7 x 107 |
1,000,000 |
Sr-90 |
3.7 x 104 |
1,000 |
Cs-137 |
3.7 x 106 |
100,000 |
Am-241 |
3.7 x 103 |
100 |
Cf-252 |
3.7 x 103 |
100 |
A licensee would need to possess hundreds of gauges before the financial
assurance requirements would apply. Since the standard gauge license does
not specify the maximum number of gauges that a licensee may possess (allowing
flexibility in obtaining additional gauges specifically authorized by
the license as needed without amending its license), it contains a condition
requiring the licensee to limit its possession of fixed gauges to quantities
not requiring financial assurance. Applicants and licensees desiring to
possess gauges exceeding the threshold amounts must submit evidence of
financial assurance.
Applicants requesting more than one radionuclide may determine whether
financial assurance for decommissioning is required by calculating, for
each radionuclide possessed, the ratio between the activity possessed,
in curies, and the radionuclide's threshold activity requiring financial
assurance, in curies. If the sum of such ratios for all of the radionuclides
possessed exceeds "1" (i.e., "unity"), then applicants must submit evidence
of financial assurance for decommissioning.
The same regulation also requires that licensees maintain records important
to decommissioning in an identified location. All fixed gauge licensees
need to maintain records of structures and equipment where each gauge
was used or stored. As-built drawings with modifications of structures
and equipment shown as appropriate fulfill this requirement. If drawings
are not available, licensees shall substitute appropriate records (e.g.,
a sketch of the room or building or a narrative description of the area)
concerning the specific areas and locations. If no records exist regarding
structures and equipment where gauges were used or stored, licensees shall
make all reasonable efforts to create such records based upon historical
information (e.g. employee recollections). In addition, if fixed gauge
licensees have experienced unusual occurrences (e.g., leaking sources,
other incidents that involve spread of contamination), they also need
to maintain records about contamination that remains after cleanup or
that may have spread to inaccessible areas.
For fixed gauge licensees whose sources have never leaked, acceptable
records important to decommissioning are sketches or written descriptions
of the specific locations where each gauge was used or stored. |
Response from Applicant: No response is needed from
most applicants. If financial assurance is required, submit the documentation
required under 10 CFR 30.35. RG 3.66, "Standard Format and Content of
Financial Assurance Mechanisms Required for Decommissioning Under 10 CFR
Parts 30, 40, 70, and 72," dated June 1990, contains approved wording
for each of the mechanisms authorized by the regulation to guarantee or
secure funds except for the Statement of Intent for Government licensees.
Licensees must transfer records important to decommissioning either
to the new licensee before licensed activities are transferred or
assigned in accordance with 10 CFR 30.34(b) or to the appropriate
NRC regional office before the license is terminated. |
References: See Notice of Availability (on the inside
front cover of this report) to obtain copies of RG 3.66, "Standard Format
and Content of Financial Assurance Mechanisms Required for Decommissioning
Under 10 CFR Parts 30, 40, 70, and 72," dated June 1990, and P&GD
FC 90-2, Revision 1, "Standard Review Plan for Evaluating Compliance with
Decommissioning Requirements," dated April 30, 1991.
8.6 Item 6: Purpose(s) for Which Licensed Material
Will Be Used
Regulations: 10 CFR 30.33(a)(1).
Criteria: Proposed purpose is authorized by the Atomic
Energy Act of 1954, as amended. Gauges should be used only for the purposes
for which they were designed, according to the manufacturer's or distributor's
recommendations and instructions, as specified in an approved SSD Registration
Certificate, and as authorized on an NRC license.
Discussion: Uses other than those listed in the SSD
Registration Certificate require review and approval by the NRC or an
Agreement State. Requests to use fixed gauges for purposes not listed
in the SSD Registration Certificate will be reviewed on a case-by-case
basis. Applicants need to submit sufficient information to demonstrate
that the proposed use will not compromise the integrity of the source
or source shielding, or other radiation safety-critical components of
the device. NRC will evaluate the radiation safety program for each type
and use of gauge requested.
An NRC license does not relieve a licensee from complying with other
applicable Federal, State, or local regulations. |
Response from Applicant: Provide either of the following:
- If the fixed gauge(s) will be used for the purposes listed on the
SSD Registration Certificate, do the following:
- State that "The fixed gauge(s) will be used for the purposes described
on the SSD Registration Certificate(s)"
- Provide a specific description of use for each type of gauge requested,
e.g., "for use in measuring the thickness of paper, the bulk density
and weight of coal on a beltscale, etc."
OR
- If the fixed gauge will be used for purposes other than those listed
on the SSD Registration Certificate, specify these other purposes and
submit safety analyses (and procedures, if needed) to support safe use.
Note:
- Allowed uses of fixed gauges normally include process control methods
such as measuring the thickness of paper, the density of coal, the level
of material in vessels and tanks, etc.
- Unusual uses will be evaluated on a case-by-case basis and the authorized
use condition will reflect approved uses.
8.7 Item 7: Individual(s) Responsible for Radiation
Safety Program and Their Training Experience
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8.7.1 Radiation Safety Officer (RSO)
Regulations: 10 CFR 30.33(a)(3).
Criteria: Radiation Safety Officers (RSOs) must have
adequate training and experience. Successful completion of training of
one of the following is evidence of adequate training and experience.
- Fixed gauge manufacturer's or distributors course for users or for
RSOs
- Equivalent course that meets Appendix G criteria
Additional training is required for RSOs of programs that perform non-routine
operations. This includes repairs involving or potentially affecting components
related to the radiological safety of the gauge (e.g., the source, source
holder, source drive mechanism, shutter, shutter control, or shielding)
and any other activities during which personnel could receive radiation
doses exceeding NRC limits (e.g., installation, initial radiation survey,
gauge relocation, and removal of the gauge from service). See "Radiation
Safety Program - Maintenance" in this report and Appendix N, "Non Routine
Operations."
Discussion: The person responsible for the radiation
protection program is called the Radiation Safety Officer (RSO). The RSO
needs independent authority to stop operations that he or she considers
unsafe. He or she must have sufficient time and commitment from management
to fulfill certain duties and responsibilities to ensure that radioactive
materials are used in a safe manner. Typical RSO duties are illustrated
in Figure 8.2 and described in Appendix F. NRC requires the name of the
RSO on the license to ensure that licensee management has always identified
a responsible, qualified person and that the named individual knows of
his or her designation as RSO.
Figure 8.2 RSO Responsibilities. Typical
duties and responsibilities of RSOs.
Response from Applicant: Provide the following:
- Name of the proposed RSO;
AND EITHER
- Statement that "Before obtaining licensed materials, the proposed
RSO will have successfully completed the training described in Criteria
in the section entitled 'Radiation Safety Officer' in NUREG-1556, Vol.
4, 'Consolidated Guidance about Materials Licenses: Program-Specific
Guidance about Fixed Gauges Licenses,' dated October 1998"; and
- Statement that "Before being named as the RSO, future RSOs will have
successfully completed the training described in Criteria in the section
entitled 'Radiation Safety Officer' in NUREG-1556, Vol. 4, 'Consolidated
Guidance about Materials Licenses: Program-Specific Guidance about Fixed
Gauges Licenses,' dated October 1998. Within 30 days of naming a new
RSO, we will submit the new RSO's name to NRC to include in our license."
OR
- Alternative information demonstrating that the proposed RSO and any
future RSO are qualified by training and experience.
Note:
- It is important to notify NRC, as soon as possible, of changes in
the designation of the RSO; such notifications will be handled as administrative
amendments not requiring fees as long as the application contains the
commitment listed in the third bullet under "Response from Applicant."
- Alternative responses will be evaluated using the criteria listed
above.
8.7.2 Authorized Users
Regulations: 10 CFR 30.33(a)(3).
Criteria: Authorized users (AUs) must have adequate
training and experience. Successful completion of one of the following
is evidence of adequate training and experience:
- Fixed gauge manufacturer's or distributors course for users
- Equivalent course that meets Appendix G criteria
Applicants requesting to perform non-routine operations such as installation,
initial radiation survey, repair, and maintenance of components related
to the radiological safety of the gauge, gauge relocation, replacement
and disposal of sealed sources, alignment, or removal of a gauge from
service, must provide additional training. See the section in this report
titled "Radiation Safety Program - Maintenance" and Appendix N.
Discussion: An AU is a person whose training and experience
meet NRC criteria, who is named either explicitly or implicitly on the
license, and who uses or directly supervises the use of licensed material.
AUs must ensure the proper use, security, and routine maintenance of fixed
gauges containing licensed material. AUs must attend the training and
instruction given at the time of installation or receive equivalent training
and instruction.
An AU is considered to be supervising the use of licensed material when
he or she directs personnel in operations involving the material. Although
the AU may delegate specific tasks to supervised users (e.g., maintaining
records), he or she is still responsible for safe use of licensed material.
Response from Applicant: Provide either of the following:
- The statement "Before using licensed materials, authorized users
will have successfully completed one of the training courses described
in Criteria in the section entitled 'Authorized Users' in NUREG-1556,
Vol. 4, 'Consolidated Guidance about Materials Licenses: Program-Specific
Guidance about Fixed Gauge Licenses,' dated October 1998."
OR
- A description of the training and experience for proposed authorized
users.
Note: Alternative responses will be evaluated
using the criteria listed above.
8.8 Item 8: Training for Individuals Who in the
Course of Employment Are Likely to Receive Occupational Doses of Radiation
in Excess of 1 Msv (100 Mrem) in a Year (Occupationally Exposed Workers)
and Ancillary Personnel
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Regulations: 10 CFR 19.11, 10 CFR 19.12, 10 CFR 19.13,
10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 30.7, 10 CFR 30.9, 10 CFR 30.10,
10 CFR 30.33.
Criteria: Individuals who in the course of employment
are likely to receive occupational doses of radiation in excess of 1 mSv
(100 mrem) in a year must receive training according to 10 CFR 19.12.
The extent of this training must be commensurate with potential radiological
health protection problems present in the work place.
Discussion: Licensees need to perform a prospective
evaluation to determine radiation doses likely to be received by different
individuals or groups. AUs, and individuals performing installations,
relocations, non-routine maintenance, or repairs would be most likely
to receive doses in excess of 1 mSv (100 mrem) in a year. See the previous
section for a discussion of training and experience for Aus. Licensee
personnel who work in the vicinity of a fixed gauge but do not use gauges
(ancillary staff) are not required to have radiation safety training as
long as they are not likely to receive 1 mSv (100 mrem) in a year. However,
to minimize potential radiation exposure when ancillary staff are working
in the vicinity of a fixed gauge, it is prudent for them to work under
the supervision and in the physical presence of an AU or to be provided
some basic radiation safety training. Such ancillary staff should be informed
of the nature and location of the gauge and the meaning of the radiation
symbol, and should be instructed not to touch the gauge and to keep away
from it as much as their work permits.
Some ancillary staff, although not likely to receive doses over 1 mSv
(100 mrem), should receive training to ensure adequate security and control
of licensed material. Licensees may provide these individuals with training
commensurate with their assignments in the vicinity of the gauge, to ensure
the control and security of licensed material.
Response from Applicant: The applicant's training program,
for individuals who in the course of employment are likely to receive
occupational doses of radiation in excess of 1 mSv (100 mrem) in a year
(occupationally exposed workers) and ancillary personnel, will be examined
during inspections, but should not be submitted in the license application.
8.9 Item 9: Facilities and Equipment
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Regulations: 10 CFR 30.33(a)(2), 10 CFR 32.210.
Criteria: Facilities and equipment must be adequate
to protect health and to minimize danger to life or property. This may
be demonstrated by the following:
- The location of the gauge is compatible with the "Conditions of Normal
Use" and "Limitations and/or Other Considerations of Use" on the SSD
Registration Certificate
- The fixed gauge is secured to prevent unauthorized removal or access
(e.g., located in a locked room, permanently mounted, or chained and
locked to a storage rack).
Discussion: Fixed gauges incorporate many engineering
features to protect the user from unnecessary radiation exposure in a
wide variety of environments. Fixed gauges may be located in harsh environments
involving variables such as pressure, vibration, mounting height/method,
temperature, humidity, air quality, corrosive atmospheres, corrosive chemicals
including process materials and cleaning agents, possible impact or puncture
conditions, and fire, explosion, and flooding potentials. Applicants need
to consult the sections on the SSD Registration Certificate,
"Conditions of Normal Use" and "Limitations and/or Other Considerations
of Use" to determine the appropriate gauge for a location. In those instances
when a proposed location is not consistent with the SSD Registration Certificate,
the applicant may ask the source or device manufacturer or distributor
to request an amendment to modify the SSD Registration Certificate to
include the new conditions. If the manufacturer or distributor does not
request an amendment, the applicant must provide the NRC with specific
information demonstrating that the proposed new conditions will not impact
the safety or integrity of the source or device.
Response from Applicant: Provide one of the following:
- A statement that "We will ensure that the location of each fixed
gauge meets the criteria in the section entitled 'Facilities and Equipment'
in NUREG-1556, Vol. 4, 'Consolidated Guidance about Materials Licenses:
Program-Specific Guidance about Fixed Gauge Licenses,' dated October
1998."
OR
- Confirm that the fixed gauge is secured to prevent unauthorized removal
or access; and submit specific information demonstrating that the proposed
conditions will not impact the safety or integrity of the source or
device. Address any instances where the proposed conditions exceed any
conditions listed in the SSD Registration Certificate.
Note:
- Any deviations from an SSD Registration Certificate will require specific
NRC approval.
- Alternative responses will be evaluated using the criteria listed
above.
References: INs are available in the "Reference Library"
on NRC's Home Page at <http://www.nrc.gov>. For
hard copies, see the Notice of Availability (on the inside front cover
of this report).
8.10 Item 10: Radiation Safety Program
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8.10.1 Audit Program
Regulations: 10 CFR 20.1101, 10 CFR 20.2102.
Criteria: Licensees must review the content and implementation
of their radiation protection programs at intervals not to exceed 12 months
to ensure the following:
- Compliance with NRC and DOT regulations (as applicable), and the terms
and conditions of the license;
- Occupational doses and doses to members of the public are ALARA (10
CFR 20.1101); and
- Records of audits and other reviews of program content are maintained
for 3 years.
Discussion: Appendix H contains a suggested audit program
that is specific to the use of fixed gauges and is acceptable to NRC.
All areas indicated in Appendix H may not be applicable to every licensee
and all items may not need to be addressed during each audit. For example,
licensees do not need to address areas which do not apply to their activities,
and activities which have not occurred since the last audit need not be
reviewed at the next audit. Currently the NRC's emphasis in inspections
is to perform actual observations of work in progress. As a part of their
audit programs, applicants should consider performing unannounced audits
of fixed gauge users to determine if, for example, Operating and Emergency
Procedures are available and are being followed, etc.
It is essential that once identified, problems be corrected comprehensively
and in a timely manner; IN 96-28, "Suggested Guidance Relating to Development
and Implementation of Corrective Action," provides guidance on this subject.
The NRC will review the licensee's audit results and determine if corrective
actions are thorough, timely, and sufficient to prevent recurrence. If
violations are identified by the licensee and these steps are taken, the
NRC will normally exercise discretion and may elect not to cite a violation.
The NRC's goal is to encourage prompt identification and prompt, comprehensive
correction of violations and deficiencies. For additional information
on NRC's use of discretion on issuing violations, refer to the current
version of NUREG-1600, "General Statement of Policy and Procedures for
NRC Enforcement Actions." Licensees must maintain records of audits and
other reviews of program content and implementation for 3 years from the
date of the record. NRC has found audit records that contain the following
information to be acceptable: date of audit, name of person(s) who conducted
audit, persons contacted by the auditor(s), areas audited, audit findings,
corrective actions, and follow-up.
Response from Applicant: The applicant's program for
reviewing the content and implementation of its radiation protection program
will be examined during inspections, and should not be submitted in the
license application.
References: The current version of NUREG-1600 is available
electronically at
<http://www.nrc.gov/OE>. INs are available in the "Reference
Library" on NRC's Home Page at <http://www.nrc.gov>.
For hard copies of NUREG-1600, IN 96-28, and IP 87110, Appendix A, "Industrial/Academic/Research
Inspection Field Notes," see the Notice of Availability (on the inside
front cover of this report).
8.10.2 Instruments
Regulations: 10 CFR 20.1501, 10 CFR 20.2103(a), 10 CFR
30.33(a)(2).
Criteria: Licensees must possess, or have access to,
radiation monitoring instruments which are necessary to protect health
and minimize danger to life or property. Instruments used for quantitative
radiation measurements must be calibrated periodically for the radiation
measured.
Discussion: Usually it is not necessary for fixed gauge
licensees to possess a survey meter. However, surveys according to 10
CFR 20.1501 will be required if an applicant plans to conduct non-routine
operations. This includes installation, initial radiation surveys, relocation,
removal from service, dismantling, alignment, replacement, disposal of
the sealed source, and non-routine maintenance and repair of components
related to the radiological safety of the gauge. Because some of these
operations may increase the risk of radiation exposure, individuals performing
these operations should be carefully monitored with a survey meter. Such
survey meters should be properly calibrated. Proper calibration is particularly
important for initial surveys since the results can be used as a basis
for public dose estimates. For those licensees requesting authorization
to calibrate their own survey instruments, Appendix I contains calibration
procedures acceptable to the NRC. Licensees who perform surveys pursuant
to 10 CFR 20.1501 must possess a survey meter that
- Measures at least 0.3 through 1 through 200 mR per hour (50 microcoulombs
per kilogram)
- Is capable of measuring the radiation being emitted from the gauges
sealed source
- Is checked for functionality with a source of radiation at the beginning
of each day of use (e.g., with the gauge or a check source)
- Is calibrated
- At intervals not to exceed 12 months
- Using a source of radiation similar to those found in the gauges
- To ensure that exposure rates indicated by the meter do not vary
from the actual exposure rates by more than ± 20% on each scale
- After any servicing or repair (other than a simple battery exchange)
By the instrument manufacturer or person specifically authorized by the
NRC or an Agreement State Since many fixed gauge licensees are not required
to possess a survey meter, applicants should preplan how they will obtain
assistance in performing a radiation survey in the event of an emergency
(e.g., obtain a survey instrument from hospitals, universities, other
NRC or Agreement State licensees, or local emergency response organization).
It is important to determine as soon as possible after an incident, by
the use of a radiation survey meter, whether the shielding and source
are intact.
For those licensees using gauges containing only beta, neutron or alpha-emitting
radionuclides, specialized survey instruments may be required.
Response from Applicant: Provide one of the following:
- A statement that "Surveys according to 10 CFR 20.1501 will be performed
by a person specifically authorized by the NRC or an Agreement State
to perform these surveys."
OR
- A statement that "We will use survey instruments that meet the Criteria
in the section entitled 'Radiation Safety Program - Instruments' in
NUREG-1556, Vol. 4, 'Consolidated Guidance about Materials Licenses:
Program-Specific Guidance about Fixed Gauge Licenses,' dated October
1998"; and one of the following three choices:
- "Each survey meter will be calibrated by the manufacturer or other
person authorized by the NRC or an Agreement State to perform survey
meter calibrations."
OR
- "We will implement the model survey meter calibration program published
in Appendix I entitled 'Survey Instrument Calibration' in NUREG-1556,
Vol. 4, 'Consolidated Guidance about Materials Licenses: Program-Specific
Guidance about Fixed Gauge Licenses,' dated October 1998."
OR
- "We will submit alternative calibration procedures for NRC review."
OR, IN LIEU OF ALL OF THE ABOVE
- Submit a description of an alternative method to perform surveys according
to 10 CFR 20.1501.
Notes:
- Alternative responses will be reviewed against the criteria listed
above.
- The NRC license will state that survey meter calibrations will be
performed by the instrument manufacturer or a person specifically authorized
by the NRC or an Agreement State, unless the applicant specifically
requests this authorization. Applicants seeking authorization to perform
survey meter calibrations must submit additional information for review.
See Appendix I for more information.
- Regardless of whether an applicant is authorized to calibrate survey
meters or contracts an authorized firm to perform calibrations, the
licensee must retain calibration records for at least 3 years.
8.10.3 Material Receipt and Accountability
Regulations: 10 CFR 30.34(e), 10 CFR 30.41, 10 CFR 30.51,
10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 20.2201.
Criteria: Licensees must do the following:
- Maintain records of receipt, transfer, and disposal of fixed gauges
and
- Conduct physical inventories at intervals not to exceed 6 months,
or some other interval justified by the applicant and approved by NRC,
to account for all sealed sources.
Discussion: As illustrated in Figure 8.3, licensed materials
must be tracked from "cradle to grave" in order to ensure gauge accountability,
identify when gauges could be lost, stolen, or misplaced, and ensure that
possession limits listed on the license are not exceeded. Significant
problems can arise from failure to ensure the accountability of gauges.
See IN 88-02, "Lost or Stolen Gauges," dated February 2, 1988.
Figure 8.3 Material Receipt and Accountability.
Licensees must maintain records of receipt, transfer, and disposal and
conduct semiannual physical inventories.
Receipt, transfer, and disposal records must be maintained for the times
specified in Table 8-2. Typically, these records contain the following
types of information:
- Radionuclide and activity (in units of becquerels or curies) of byproduct
material in each sealed source
- Manufacturer's or distributor's name, model number, and serial number
(if appropriate) of each device containing byproduct material
- Location of each sealed source and device
- For materials transferred or disposed of, the date of the transfer
or disposal, name and license number of the recipient, description of
the affected radioactive material (e.g., radionuclide, activity, manufacturer's
or distributor's name and model number, serial number).
Table 8.2 Record Maintenance
Type of Record |
How Long Record Must Be Maintained |
Receipt |
For as long as the material is possessed until 3 years after transfer
or disposal |
Transfer |
For 3 years after transfer |
Disposal |
Until NRC terminates the license |
Important to Decommissioning* |
Until the site is released for unrestricted use |
* See the section "Financial Assurance and
Recordkeeping for Decommissioning." |
Response from Applicant: Provide either of the following:
- A statement that "Physical inventories will be conducted at least
every 6 months or at other intervals approved by the NRC, to account
for all sealed sources and devices received and possessed under the
license."
OR
- A description of the procedures for ensuring that no fixed gauge has
been lost, stolen, or misplaced and how often they will be conducted.
Note:
- Alternative responses will be evaluated using the criteria listed
above.
- Inventory records should be maintained and contain the following types
of information:
- Radionuclide and amount (in units of becquerels or curies) of byproduct
material in each sealed source
- Manufacturer's or distributors name, model number, and serial number
(if appropriate) of each device containing byproduct material
- Location of each sealed source and device
- Date of the inventory
- Signature of the individual conducting the inventory.
References: INs are available in the "Reference Library" on NRC's Home
Page at <http://www.nrc.gov>. For hard copies, see
the Notice of Availability (on the inside front cover of this report).
8.10.4 Occupational Dose
Regulations: 10 CFR 20.1502, 10 CFR 20.1201, 10 CFR
20.1207, 10 CFR 20.1208.
Criteria: Applicants must do either of the following:
- Perform a prospective evaluation demonstrating that unmonitored individuals
are not likely to receive, in one year, a radiation dose in excess of
10% of the allowable limits as shown in Figure 8.4
OR
- Provide dosimetry processed and evaluated by a National Voluntary
Laboratory Accreditation Program (NVLAP) approved processor that is
exchanged at a frequency recommended by the processor.
Figure 8.4 Annual Dose Limits for Occupationally
Exposed Adults.
Discussion: Under conditions of routine use, the typical
fixed gauge user does not require a personnel monitoring device (dosimetry).
A gauge user also does not require dosimetry when proper emergency procedures
are used. Appendix J provides guidance on performing a prospective evaluation
demonstrating that fixed gauge users are not likely to exceed 10% of the
limits as shown in Figure 8.4 and thus, are not required to have personnel
dosimetry.
Individuals who perform non-routine operations such as installation,
initial radiation survey, repair, and maintenance of components related
to the radiological safety of the gauge, gauge relocation, replacement,
and disposal of sealed sources, alignment, or removal of a gauge from
service are more likely to exceed 10% of the limits as shown in Figure
8.4. Applicants may be required to provide dosimetry (whole body and perhaps
extremity monitors) to individuals performing such services or must perform
a prospective evaluation demonstrating that unmonitored individuals performing
such non-routine operations are not likely to receive, in one year, a
radiation dose in excess of 10% of the allowable limits as shown in Figure
8.4.
When personnel monitoring is needed, most licensees use either film badges
or thermoluminescent dosimeters (TLDs) that are supplied by a NVLAP-approved
processor. The exchange frequency for film badges is usually monthly due
to technical concerns about film fading. The exchange frequency for TLDs
is usually quarterly. Applicants should verify that the processor is NVLAP-approved.
Consult the NVLAP-approved processor for its recommendations for exchange
frequency and proper use.
Response from Applicant: Provide one of the following:
- A statement that "We will perform a prospective evaluation demonstrating
that unmonitored individuals are not likely to receive, in one year,
a radiation dose in excess of 10% of the allowable limits in 10 CFR
Part 20 or we will provide dosimetry that meets the Criteria in the
section entitled 'Radiation Safety Program - Occupational Dosimetry'
in NUREG-1556, Vol. 4, 'Consolidated Guidance about Materials Licenses:
Program-Specific Guidance about Fixed Gauge Licenses,' dated October
1998"
OR
- A description of an alternative method for demonstrating compliance
with the referenced regulations.
Notes:
- Alternative responses will be evaluated using the criteria listed
above.
- Some licensees choose to provide personnel dosimetry to their workers
for reasons other than compliance with NRC requirements (e.g., to respond
to worker requests).
References: National Institute of Standards and Technology
(NIST) Publication 810, "National Voluntary Laboratory Accreditation Program
Directory," is published annually and is available electronically at <http://ts.nist.gov/nvlap> .
NIST Publication 810 can be purchased from GPO, whose URL is <http://www.gpo.gov> .
ANSI N322 may be ordered electronically at <http://www.ansi.org>
or by writing to ANSI, 1430 Broadway, New York, NY 10018.
8.10.5 Public Dose
Regulations: 10 CFR 20.1301, 10 CFR 20.1302, 10 CFR
20.1003, 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 20.2107.
Criteria: Licensees must do the following:
- Ensure that fixed gauges will be used, transported, and stored in
such a way that members of the public will not receive more than 1 mSv
[100 mrem] in one year, and the dose in any unrestricted area will not
exceed 0.02 mSv [2 mrem] in any one hour, from licensed operations.
- Prevent unauthorized access, removal, or use of fixed gauges.
Discussion: Public dose is defined in 10 CFR Part 20
as "the dose received by a member of the public from exposure to radiation
and/or radioactive material released by a licensee, or to any other source
of radiation under the control of a licensee." Public dose excludes doses
received from background radiation and from medical procedures. Whether
the dose to an individual is an occupational dose or a public dose depends
on the individual's assigned duties. It does not depend on the area (restricted,
controlled, or unrestricted) the individual is in when the dose is received.
In the case of fixed gauges, members of the public include persons who
live, work, or may be near locations where fixed gauges are used or stored
and employees whose assigned duties do not include the use of licensed
materials and who work in the vicinity where gauges are used or stored.
Since a fixed gauge presents a radiation field, the applicant must use
methods to limit the public dose such that the radiation level in an unrestricted
area (e.g., a nearby walkway or area near the gauge that requires frequent
maintenance) does not exceed 1 mSv (100 mrem) in a year or 0.02 mSv (2
mrem) in any one hour.
Because fixed gauges are generally permanently mounted (e.g., chained
and locked to a storage rack), they may not need to be in a locked area
to prevent loss, theft, or unauthorized removal. Operating and emergency
procedures regarding security and lock-out procedures specified in this
document should be sufficient to limit the exposure to the public during
use or storage and after accidents. IN 81-37, "Unnecessary Radiation Exposures
to the Public and Workers During Events Involving Thickness and Level
Measuring Devices," dated December 15, 1981, provides information about
two events that resulted or may have resulted in unnecessary radiation
exposure to members of the public and to maintenance workers. IN 88-02,
"Lost or Stolen Gauges," dated February 2, 1988, provides information
about several events where fixed gauges were lost or stolen.
Public dose is also affected by the location of the gauge. Use the concepts
of time, distance, and shielding when developing a method to limit public
dose. Decreasing the time spent near a gauge, increasing the distance
from the gauge, and using shielding will reduce the radiation exposure.
The most effective way to limit public dose is to prevent members of the
public from entering areas where gauges are used or stored. This may be
accomplished by administrative or engineering controls.
Administrative controls include training and warning signs. In cases
where gauges are located in hostile environments (e.g., high temperatures,
caustic chemicals, etc.), warning signs may be difficult to maintain so
mandatory training programs may be necessary to caution employees.
Engineering controls reduce radiation levels in areas that are accessible
to the public. Shielding the gauge with a protective barrier (e.g., using
brick, concrete, lead, or other solid walls) or placing the gauge within
an enclosure to prevent access to higher radiation levels are examples
of engineering controls. See Figure 8.5.
Figure 8.5 Limiting Public Dose. When dose
rates in an area are high enough that a member of the public could receive
a dose in excess of 0.02 mSv (2 mrem) in any one hour or 1 mSv (100 mrem)
in a year, licensees must take additional measures to prevent public access
to these higher dose rates, such as building enclosures around the gauges.
Public dose can be estimated in areas near the gauge by using radiation
levels determined during initial surveys and applying the "inverse square"
law to evaluate the effect of distance on radiation levels and occupancy
factors to account for the actual presence of members of the public. See
Appendix K for an example.
If, after making a public dose estimate, the conditions used to make
the evaluation change (e.g., changes the location of gauges, changes the
type or frequency of gauge use, adds gauges, changes the occupancy of
adjacent areas), then the licensee must perform a new evaluation to ensure
that the public dose limits are not exceeded and take corrective action,
as needed.
During NRC inspections, licensees must be able to provide documentation
demonstrating, by measurement or calculation, that the TEDE to the individual
likely to receive the highest dose from the licensed operation does not
exceed the annual limit for individual members of the public. See Appendix
K for examples of methods to demonstrate compliance.
Response from Applicant: No response is required from
the applicant during the licensing phase. Documentation demonstrating
compliance will be examined during inspection.
References: See the Notice of Availability (on the inside
front cover of this report) to obtain copies of IN 81-37, "Unnecessary
Radiation Exposures to the Public and Workers During Events Involving
Thickness and Level Measuring Devices," dated December 15, 1981, and IN
88-02, "Lost or Stolen Gauges," dated February 2, 1988.
8.10.6 Operating and Emergency Procedures
Regulations: 10 CFR 30.34(e), 10 CFR 20.1101, 10 CFR
20.1801, 10 CFR 20.1802, 10 CFR 20.2201-2203, 10 CFR 30.50, 10 CFR 21.21,
10 CFR 19.11(a)(3).
Criteria: Each applicant should do the following:
- Develop, implement, and maintain operating procedures containing the
following elements for each type of fixed gauge:
- Instructions for operating the gauge
- Instructions for performing routine cleaning and maintenance (e.g.,
calibration and lubrication) according to the manufacturer's or distributors
recommendations and instructions
- Instructions for testing each gauge for the proper operation of
the on-off mechanism (shutter) and indicator, if any, at intervals
not to exceed 6 months or as specified in the SSD certificate
- Instructions for lock-out procedures, if applicable, that are adequate
to assure that no individual or portion of an individual's body can
enter the radiation beam
- Instructions to prevent unauthorized access, removal, or use of
fixed gauges
- Steps to take to keep radiation exposures ALARA
- Steps to maintain accountability (i.e., inventory)
- Instructions to ensure that non-routine operations such as installation,
initial radiation survey, repair and maintenance of components related
to the radiological safety of the gauge, gauge relocation, replacement
and disposal of sealed sources, alignment, or removal of a gauge from
service are performed by the manufacturer, distributor or person specifically
authorized by the NRC or an Agreement State
- Steps to ensure that radiation warning signs are visible and legible.
- Develop, implement, and maintain emergency procedures for gauge malfunction
or damage containing the following elements for each type of fixed gauge:
- Stop use of the gauge.
- Restrict access to the area.
- Contact responsible individuals. (Telephone numbers for the RSO,
AUs, the gauge manufacturer or distributor, fire department or other
emergency response organization, as appropriate, and the NRC should
be posted or easily accessible.)
- Do not attempt repair or authorize others to attempt repair of the
gauge except as specifically authorized in a license issued by the
NRC or an Agreement State.
- Require timely reporting to NRC pursuant to 10 CFR 20.2201-20.2203,
10 CFR 30.50, and 10 CFR 21.21.
- Take additional steps, dependent on the specific situations.
- Provide copies of operating and emergency procedures to all gauge
users.
- Post copies of operating and emergency procedures at each location
of use or if posting procedures is not practicable, post a notice which
briefly describes the procedures and states where they may be examined.
Discussion: NRC will permit an applicant greater flexibility
when licensing certain types of gauges. For each gauge that is requested,
if one or more of the following safety conditions are met, the applicant
must develop, implement, maintain, and distribute operating and emergency
procedures but need not submit these procedures for NRC review:
- The air gap between the radiation source and detector of the device
is less than 45 cm (18 inches)
- The air gap of the device would not allow insertion of a 30 cm (12
inches) diameter sphere into the radiation beam of the device without
removal of a barrier
- The radiation dose rate in the radiation beam of the device at 45
cm (18 inches) from the radiation source with the device shutters, if
any, in the open position does not exceed 1 mSv/hour (0.1 rem/hour)
- Entry into vessels (e.g., bins, tanks, hoppers, or pipes) with a gauge
installed is not necessary under any foreseeable circumstances and is
prohibited.
Operating and emergency procedures should be developed, maintained, and
implemented to ensure that gauges are used only as they were designed
to be used, control and accountability are maintained, and radiation doses
received by occupational workers and members of the public are ALARA.
Copies of operating and emergency procedures should be provided to all
gauge users. In addition, licensees must post current copies of operating
and emergency procedures applicable to licensed activities at each site.
If posting of procedures is not practicable, the licensee may post a notice
which describes the documents and states where they may be examined.
Improper operation could lead to the damage or malfunction of a gauge
and elevated exposure rates in the gauge's immediate vicinity. A list
of specific items that should be addressed in operating and emergency
procedures is contained in Appendix L. Figure 8.6 illustrates proper response
to fire involving a fixed gauge. Emergency procedures should be developed
to address a spectrum of incidents (e.g., fire, explosion, mechanical
damage, flood, or earthquake).
Figure 8.6 Proper Handling of Incident. Licensee
personnel implement emergency procedures when a fire melts the lead shielding
of a gauge producing the potential for elevated exposure levels.
NRC considers security of licensed material extremely important and lack
of security is a significant violation for which licensees may be fined.
Although most fixed gauges are difficult to move, the licensee must prevent
unauthorized access, removal, or use of the gauge. Licensees are responsible
for ensuring that gauges are secure and accounted for at all times (e.g.,
during plant modifications, change in ownership, staffing changes, or
after termination of activities at a particular location).
The NRC must be notified when gauges are lost, stolen, or certain
other conditions occur.
The RSO must be proactive in evaluating whether NRC notification
is required. Refer to Appendix P and the regulations (10 CFR 20.2201-20.2203,
10 CFR 30.50, 10 CFR 21.21) for a description of when and where
notifications are required. |
Figure 8.7 Lock-out Procedures. Typical lock-out
procedures include locking the shutter into the "off" position and tagging
the shutter control mechanism to indicate the gauge is locked-out.
When the distance or air gap between the source and detector permits
entry of all or a portion of a person's body into the primary radiation
beam, licensees must develop lock out procedures. Lock-out procedures
encompass locking the on-off or shutter mechanism into the off position
or otherwise controlling the radiation beam or using any other means of
preventing an individual or a portion of an individual's body from entering
the radiation beam during maintenance, repairs, or work in, on, or around
the process line (e.g., bin, tank, hopper, pipe, or conveyor belt) where
the device is mounted. The on-off or shutter control mechanism should
be tagged to indicate that the gauge is locked out. A warning sign should
be posted at each entryway to an area where it is possible to be exposed
to the primary beam. In addition to providing a warning, the sign should
give safety instructions, e.g., "contact the RSO before entering this
vessel." Lock-out procedures should specify who is responsible for performing
them.
Response from Applicant: Provide either of the following:
- If the gauge meets one or more of the safety conditions specified
in "Discussion," provide either of the following:
- A statement that "Operating and emergency procedures will be developed,
implemented, maintained, and distributed, and will meet the Criteria
in the section entitled 'Radiation Safety Program - Operating and
Emergency Procedures' in NUREG-1556, Vol. 4, 'Consolidated Guidance
about Materials Licenses: Program-Specific Guidance about Fixed Gauge
Licenses,' dated October 1998";
OR
- Submit a description of alternative procedures.
- If the gauge does not meet one or more of the safety conditions specified
in "Discussion," provide your operating, emergency, and lock-out (if
applicable) procedures to NRC for review.
Note:
- Alternative procedures will be evaluated using the criteria listed
above.
- Incidents involving fixed gauges are described in IN 81-37, "Unnecessary
Radiation Exposures to the Public and Workers During Events Involving
Thickness and Level Measuring Devices," dated December 15, 1981; IN
86-31, "Unauthorized Transfer and Loss of Control of Industrial Nuclear
Gauges," dated May 5, 1986; IN 88-02, "Lost or Stolen Gauges," dated
February, 2, 1988; IN 88-90, "Unauthorized Removal of Industrial Nuclear
Gauges," dated November 22, 1988; and IN 94-15, "Radiation Exposures
during an Event Involving a Fixed Nuclear Gauge," dated March 2, 1994.
Applicants should consider the information contained in these documents
when developing operating and emergency procedures.
References: See the Notice of Availability (on the inside
front cover of this report) to obtain copies of IN 81-37, "Unnecessary
Radiation Exposures to the Public and Workers During Events Involving
Thickness and Level Measuring Devices," dated December 15, 1981; IN 86-31,
"Unauthorized Transfer and Loss of Control of Industrial Nuclear Gauges,"
dated May 5, 1986; IN 88-02, "Lost or Stolen Gauges," dated February 2,
1988; IN 88-90 "Unauthorized Removal of Industrial Nuclear Gauges," dated
November 22, 1988; and IN 94-15, "Radiation Exposures during an Event
Involving a Fixed Nuclear Gauge," dated March 2, 1994.
8.10.7 Leak Tests
Regulations: 10 CFR 30.53, 10 CFR 20.1501, 10 CFR 20.2103.
Criteria: NRC requires testing to determine whether
there is any radioactive leakage from the source in the fixed gauge. Records
of the test results must be maintained.
Discussion: When issued, a license will require performance
of leak tests at intervals approved by the NRC or an Agreement State and
specified in the SSD Registration Certificate. The measurement of the
leak test sample is a quantitative analysis requiring that instrumentation
used to analyze the sample be capable of detecting 185 Bq (0.005 microcurie)
of radioactivity.
Manufacturers, distributors, consultants, and other organizations may
be authorized by NRC or an Agreement State to either perform the entire
leak test sequence for other licensees or provide leak test kits to licensees.
In the latter case, the licensee is expected to take the leak test sample
according to the fixed gauge manufacturer's and the kit supplier's instructions
and return it to the kit supplier for evaluation and reporting results.
Leak test samples should be collected at the most accessible area where
contamination would accumulate if the sealed source were leaking. See
Figure 8.8 below. Licensees may also be authorized to conduct the entire
leak test sequence themselves. Appendix M contains information to support
a request to perform leak testing and sample analysis.
Figure 8.8 Leak Test Sample. A leak test sample
is collected according to the gauge manufacturer's and the leak test kit
supplier's instructions.
Response from Applicant: Provide one of the following
three alternatives:
A statement that "Leak tests will be performed at intervals approved
by the NRC or an Agreement State and specified in the Sealed Source and
Device Registration Certificate. Leak tests will be performed by an organization
authorized by NRC or an Agreement State to provide leak testing services
to other licensees or using a leak test kit supplied by an organization
authorized by NRC or an Agreement State to provide leak test kits to other
licensees and according to the kit supplier's instructions. Records of
leak test results will be maintained."
OR
A statement that "We will implement the model leak test program published
in Appendix M to NUREG-1556, Vol. 4, 'Consolidated Guidance about Materials
Licenses: Program-Specific Guidance about Fixed Gauge Licenses,' dated
October 1998."
OR
- A description of alternative equipment and/or procedures for determining
whether there is any radioactive leakage from sources contained in gauges.
Note: Requests for authorization to perform leak
testing and sample analysis will be reviewed and, if approved, NRC staff
will authorize via a license condition.
References: See the Notice of Availability (on the inside
front cover of this report) to obtain copies of Draft Regulatory Guide
FC 412-4, "Guide for the Preparation of Applications for the Use of Radioactive
Materials in Leak-Testing Services," dated June 1985.
8.10.8 Maintenance
Regulations: 10 CFR 20.1101, 10 CFR 30.34(e).
Criteria: Licensees must routinely clean and maintain
gauges according to the manufacturer's or distributor's written recommendations
and instructions. Individuals performing routine maintenance must have
adequate training and experience. Radiation safety procedures for routine
cleaning and maintenance (e.g., removal of exterior residues from the
gauge housing, external lubrication of shutter mechanism, calibration,
and electronic repairs) must consider ALARA and ensure that the gauge
functions as designed and source integrity is not compromised.
Non-routine maintenance or repair (beyond routine cleaning, lubrication,
calibration, and electronic repairs) means any maintenance or repair
that involves or potentially affects components, including electronics,
related to the radiological safety of the gauge (e.g., the source,
source holder, source drive mechanism, shutter, shutter control or
shielding) and any other activities during which personnel could receive
radiation doses exceeding NRC limits. |
Non-routine repair or maintenance must be performed by the fixed gauge
manufacturer or distributor or a person specifically authorized by NRC
or an Agreement State. Information to support requests for specific authorization
to perform non-routine maintenance or repair is addressed in Appendix
N.
Figure 8.9 Maintenance. Licensees need to perform
routine maintenance to ensure proper operation of the fixed gauge. For
non-routine maintenance, most licensees rely on the gauge manufacturer,
distributor or other service companies.
Discussion: NRC permits fixed gauge licensees to perform
routine maintenance of the gauges provided that they follow the gauge
manufacturer's or distributors written recommendations and instructions.
Generally, before any maintenance or repair work is done, licensees need
to determine (and assure themselves of the adequacy of) the following:
- The tasks to be performed
- The protocol or procedures to be followed
- The radiation safety procedures including possible need for compensatory
measures (e.g., steps taken to compensate for lack of or reduced shielding)
- ALARA considerations
- Training and experience of personnel performing the work
- The qualification of parts, components, other materials to be used
in the gauge
- The tests (to be performed before the gauge is returned to routine
use) to ensure that it functions as designed.
Although manufacturers or distributors may use different terms, "routine
maintenance" includes, but is not limited to, cleaning, lubrication, calibration,
and electronic repairs.
Routine maintenance does not include any activities
that involve:
- Components, including electronics, related to the radiological safety
of the gauge (e.g., the source, source holder, source drive mechanism,
shutter, shutter control or shielding)
- Installation, relocation, or alignment of the gauge
- Initial radiation surveys
- Replacement and disposal of sealed sources
- Removal of a gauge from service
- A potential for any portion of the body to come into contact with
the primary radiation beam
- Any other activity during which personnel could receive radiation
doses exceeding NRC limits
Mounting a gauge is unpacking or uncrating the gauge, and fastening,
hanging, or affixing the gauge into position before using. Mounting does
not include electrical connection, activation, or operation of the gauge.
Installing a gauge includes mounting, electrical connection, activation,
and first use of the device. Specific NRC or Agreement State authorization
is required to install a gauge. However, a licensee may initially mount
a gauge, without specific NRC or Agreement State authorization, if the
gauge's SSD Certificate explicitly permits it and under the following
guidelines:
- The gauge must be mounted according to written instructions provided
by the manufacturer or distributor
- The gauge must be mounted in a location compatible with the "Conditions
of Normal Use" and "Limitations and/or Other Considerations of Use"
in the certificate of registration issued by NRC or an Agreement State
- The on-off mechanism (shutter) must be locked in the off position,
if applicable, or the source must be otherwise fully shielded
- The gauge must be received in good condition (package was not damaged)
- The gauge must not require any modification to fit in the proposed
location.
The source must remain fully shielded and the gauge may not be used until
it is installed and made operational by a person specifically licensed
by the Commission or an Agreement State to perform such operations.
A condition in the NRC license will state that operations such as installation,
initial radiation survey, repair, and maintenance of components related
to the radiological safety of the gauge, gauge relocation, replacement,
and disposal of sealed sources, alignment, or removal of a gauge from
service shall be performed only by the manufacturer, distributor or other
persons specifically licensed by the Commission or an Agreement State
to perform such services. Most licensees do not perform non-routine operations.
Rather, these licensees rely upon persons specifically licensed by the
Commission or an Agreement State who have the specialized equipment and
technical expertise needed to perform these activities. Applicants seeking
authorization to perform non-routine operations must submit specific procedures
for review. See Appendix N for more information.
Response from Applicant:
Routine maintenance: Submit either of the following:
- A statement that "We will implement and maintain procedures for routine
maintenance of our gauges according to each manufacturer's or distributors
written recommendations and instructions."
OR
- Alternative procedures for NRC's review.
Non-routine operations: Submit either of the following:
- A statement that "The gauge manufacturer, distributor or other person
authorized by NRC or an Agreement State will perform non-routine operations
such as installation, initial radiation survey, repair, and maintenance
of components related to the radiological safety of the gauge, gauge
relocation, replacement, and disposal of sealed sources, alignment,
or removal of a gauge from service."
OR
- The information listed in Appendix N supporting a request to perform
this work "in-house."
Note:
- Alternative procedures for performing routine maintenance will be
evaluated using the criteria listed above.
- Information requested in Appendix N will be reviewed on a case-by-case
basis; if approved, the license will contain a condition authorizing
the licensee to perform non-routine operations.
8.10.9 Transportation
Regulations: 10 CFR 71.5, 49 CFR Parts 171-178, 10 CFR
20.1101.
Criteria: Applicants must either
- Arrange for transportation of a gauge by the manufacturer, distributor
or other person specifically licensed to transport gauges by the NRC
or Agreement State.
OR
- Develop, implement, and maintain safety procedures for off-site transport
of radioactive material to ensure compliance with DOT regulations.
Discussion: Some fixed gauge licensees have the manufacturer,
distributor or other person specifically licensed to transport gauges
by the NRC or Agreement State arrange for preparing and shipping licensed
material. If licensees decide to transport their own gauges, they are
responsible for compliance with DOT regulations which require, in part,
specific labeling and surveying of the package before shipping. To appropriately
survey the package the surveyor must use instruments that can measure
radiation exposure rates around the package and detect contamination on
the package. Appendix O lists major DOT regulations and provides an example
of a shipping paper. During an inspection, NRC uses the provisions of
10 CFR 71.5 and a Memorandum of Understanding (MOU) with DOT on the Transportation
of Radioactive Material (signed June 6, 1979) to examine and enforce transportation
requirements applicable to gauge licensees.
Figure 8.10 Transportation. Illustration of
a fixed gauge being disassembled and packaged for transport.
Response from Applicant: No response is needed from
applicants during the licensing process; this issue will be reviewed during
inspection.
References: "A Review of Department of Transportation
Regulations for Transportation of Radioactive Materials (1983 revision)"
can be obtained by calling DOT's Office of Hazardous Material Initiatives
and Training at (202) 366-4425. See the Notice of Availability (on the
inside front cover of this report) to obtain copies of the MOU with DOT
on the Transportation of Radioactive Material, signed June 6, 1979.
8.10.10 Fixed Gagues Used at Temporary Job Site
Regulations: 10 CFR 30.34(e), 10 CFR 20.1101, 10 CFR
20.1801, 10 CFR 20.1802, 10 CFR 20.2201-2203, 10 CFR 30.50.
Criteria: Each applicant requesting authorization to
perform work with fixed gauges at temporary job sites should do the following:
Develop, implement, maintain, and distribute operating and emergency
procedures containing the following elements:
- Instructions for transporting radioactive material to ensure compliance
with DOT regulations
- Instructions for using gauges at temporary job sites and performing
routine maintenance according to the manufacturer's or distributors
recommendations and instructions
- Instructions for maintaining security during storage and transportation
- Instructions to keep gauges under control and immediate surveillance
or secured to prevent unauthorized use or access.
- Steps to take to keep radiation exposures ALARA
- Steps to maintain accountability during use
- Steps to control access to a potentially damaged gauge (See Figure
8.11)
- Steps to take, and who to contact, when a gauge has been lost or damaged
(e.g., local officials, RSO, etc.) (See Figure 8.11)
- If gauges are to be installed at temporary job sites, the operating
and emergency procedures should contain instructions on using personal
dosimetry and survey instruments and conducting surveys
- Provide copies of operating and emergency procedures to all gauge
users and at each job site.
Figure 8.11 Proper Handling of Incident. Licensee
personnel implement emergency procedures when a traffic accident results
in a damaged gauge and potentially elevated exposure levels.
Discussion: A temporary job site is a location where
work with licensed materials is conducted for a limited period of time.
Temporary job sites are not specifically listed on a license. A gauge
user may be dispatched to work at several temporary job sites in one day.
A location is not considered a temporary job site if it is used to store
and dispatch licensed material. The NRC considers such a location
to be a field office. Licensees must apply for and receive a license amendment
specifically listing each field office location.
Figure 8.12 Examples of Uses for Fixed Gauges at
Temporary Job Sites.
There are two categories of fixed gauges used at temporary job sites:
Gauges that are permanently mounted to vehicles or trailers, and gauges
that are transported to plants or refineries and temporarily installed
on process equipment to conduct short-term QA/QC studies. See Figure 8.12.
Figure 8.13 DOT Transportation Requirements.
Applicants must develop, implement, and maintain safety procedures for
off-site transport of radioactive material to ensure compliance with DOT
regulations. Figure 8.13 illustrates some important DOT requirements for
gauge licensees. During an inspection, NRC uses the provisions of 10 CFR
71.5 and an MOU with DOT to examine and enforce transportation requirements
applicable to fixed gauge licensees. Appendix O lists major DOT regulations
and provides examples of shipping documents, placards, and labels.
Figure 8.14 Security. Examples of Methods used
to Secure Fixed Gauges at Temporary Job Sites.
When working at a temporary job site, licensees generally have to follow
the rules and procedures of the organization that owns or controls the
site. Thus, licensees may not be able restrict access to areas in the
same manner that they could at their own facilities. Furthermore, non-licensee
personnel may not be familiar with fixed gauges or radioactive material.
Therefore, to avoid lost or stolen gauges and to prevent unnecessary radiation
exposures to members of the public, licensees must keep gauges under constant
surveillance, or secured against unauthorized use or removal. See Figure
8.14.
Figure 8.15 Installation of Fixed Gauges at Temporary
Job Sites. Examples of the Additional Precautions Needed when Installing
Fixed Gauges at Temporary Job Sites.
While installing gauges, personnel could receive radiation doses exceeding
NRC limits if proper radiation safety principles are not followed. Licensee
personnel performing installations should be assigned and wear personal
dosimetry and use a survey meter to monitor radiological conditions. See
Figure 8.15.
After installing a gauge at a temporary job site, a radiation survey
should be conducted to ensure that dose rates in unrestricted areas will
not exceed 0.02 mSv (2 mrem) in any one hour or 1 mSv (100 mrem) in a
year. If surveys indicate that a member of the public (e.g., client personnel)
could receive a dose exceeding these limits, licensees would need to adopt
additional security measures to prevent public access such as maintaining
constant surveillance or erecting physical barriers. See Figure 8.16.
Figure 8.16 Security. Additional Security Measures
following Installation of Fixed Gauges at a Temporary Job Site.
Response from Applicant: Submit one of the following
three alternatives:
- A statement that "We will not use fixed gauges at temporary job sites."
OR
- A statement that "Procedures for use of fixed gauges at temporary
job sites will be developed, implemented, maintained, and distributed
and will meet the Criteria in the section entitled 'Radiation Safety
Program - Fixed Gauges Used at Temporary Job Sites,' in NUREG-1556,
Vol. 4, 'Consolidated Guidance about Materials Licenses: Program-Specific
Guidance about Fixed Gauge Licenses,' dated October 1998 and copies
of these procedures will be provided to all gauge users."
OR
- Alternative procedures for use of fixed gauges at temporary job sites.
Note: Alternative procedures will be evaluated
using the criteria listed above.
8.10.11 Minimization of Contamination
Regulations: 10 CFR 20.1406.
Criteria: Applicants for new licenses must describe
how facility design and procedures for operation will minimize, to the
extent practicable, contamination of the facility and the environment,
facilitate eventual decommissioning, and minimize, to the extent practicable,
the generation of radioactive waste.
Discussion: All applicants for new licenses need to
consider the importance of designing and operating their facilities so
as to minimize the amount of radioactive contamination generated at the
site during its operating lifetime and to minimize the generation of radioactive
waste during decontamination. In the case of fixed gauge applicants, these
issues usually do not need to be addressed as a separate item, as they
are included in responses to other items of the application.
Sealed sources and devices that are approved by NRC or an Agreement State
and located and used according to the respective SS&D Registration
Certificate usually pose little risk of contamination. Leak tests performed
at the frequency specified in the SS&D Registration Certificate should
identify defective sources. Leaking sources must be immediately withdrawn
from use and decontaminated, repaired, or disposed of according to NRC
requirements. These steps minimize the spread of contamination and reduce
radioactive waste associated with decontamination efforts. Other efforts
to minimize radioactive waste do not apply to programs using only sealed
sources and devices that have not leaked.
Response from Applicant: The applicant does not need
to provide a response to this item under the following condition. NRC
will consider that the above criteria have been met if the applicant's
responses meet the criteria for the following sections: Radioactive Material
- Sealed Sources and Devices, Facilities and Equipment, Radiation Safety
Program - Operating and Emergency Procedures, Radiation Safety Program
- Leak Testing, and Waste Management -Gauge Transfer and Disposal.
8.11 Item 11: Waste Management
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8.11.1 Gauge Disposal and Transfer
Regulations: 10 CFR 20.2001, 10 CFR 30.41, 10 CFR 30.51,
10 CFR 30.36.
Criteria: Licensed materials must be disposed of in
accordance with NRC requirements by transfer to an authorized recipient.
Appropriate records must be maintained.
Discussion: When disposing of fixed gauges, licensees
must transfer them to an authorized recipient. Authorized recipients are
the original manufacturer or distributor of the device, a commercial firm
licensed by the NRC or an Agreement State to accept radioactive waste
from other persons, or another specific licensee authorized to possess
the licensed material (i.e., its license specifically authorizes the same
radionuclide, form, and use).
Before transferring radioactive material, a licensee must verify that
the recipient is properly authorized to receive it using one of the methods
described in 10 CFR 30.41. In addition, all packages containing radioactive
sources must be prepared and shipped in accordance with NRC and DOT regulations.
Records of the transfer must be maintained as required by 10 CFR 30.51.
Response from Applicant: The applicant does not need
to provide a response to this item during the licensing process. However,
the licensee should establish and include waste disposal procedures in
its radiation safety program.
Because of the difficulties and costs associated with disposal of
sealed sources, applicants should preplan the disposal. Applicants
may want to consider contractual arrangements with the source supplier
as part of a purchase agreement. Significant problems can arise from
improper gauge transfer or failure to dispose of gauges in a proper
and timely manner. See IN 86-31, "Unauthorized Transfer and Loss of
Control of Industrial Nuclear Gauges," dated May 5, 1986, and IN 88-02,
"Lost or Stolen Gauges," dated February 2, 1988. |
References: See the Notice of Availability (on the
inside front cover of this report) to obtain copies of IN 86-31, "Unauthorized
Transfer and Loss of Control of Industrial Nuclear Gauges," dated May
5, 1986 and IN 88-02, "Lost or Stolen Gauges," dated February, 2, 1988.
Items 12 and 13, discussed below, are to be completed on the
form itself (NRC Form 313).
8.12 Item 12: Fees
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On NRC Form 313, enter the appropriate fee category from 10 CFR 170.31
and the amount of the fee enclosed with the application.
Direct all questions about NRC's fees or completion of Item 12 of NRC
Form 313 (Appendix A) to the Office of the Chief Financial Officer at
NRC Headquarters in Rockville, MD, (301) 415-7554. You may also call NRC's
toll free number, 800-368-5642, and ask for extension 415-7554.
8.13 Item 13: Certification
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Individuals acting in a private capacity are required to date and sign
NRC Form 313. Otherwise, representatives of the corporation or legal entity
filing the application should date and sign NRC Form 313. Representatives
signing an application must be authorized to make binding commitments
and to sign official documents on behalf of the applicant. As discussed
previously in "Management Responsibility," signing the application acknowledges
management's commitment and responsibilities for the radiation protection
program. NRC will return all unsigned applications for proper signature.
Note:
- It is a criminal offense to make a willful false statement or representation
on applications or correspondence (18 U.S.C. 1001).
- When the application references commitments, those items become part
of the licensing conditions and regulatory requirements.
9 Amendments and Renewals to a License
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It is the licensee's obligation to keep the license current. If any of
the information provided in the original application is to be modified
or changed, the licensee must submit an application for a license amendment
before the change takes place. Also, to continue the license after its
expiration date, the licensee must submit an application for a license
renewal at least 30 days before the expiration date (10 CFR 2.109, 10
CFR 30.36(a)).
Applications for license amendment, in addition to the following, must
provide the appropriate fee. For renewal and amendment requests applicants
must do the following:
- Be sure to use the most recent guidance in preparing an amendment
or renewal request.
- Submit in duplicate, either an NRC Form 313 or a letter requesting
amendment or renewal.
- Provide the license number.
- For renewals, provide a complete and up-to-date application if many
outdated documents are referenced or there have been significant changes
in regulatory requirements, NRC's guidance, the licensee's organization,
or radiation protection program. Alternately, describe clearly the exact
nature of the changes, additions, and deletions.
Using the suggested wording of responses and committing to using
the model procedures in this report will expedite NRC's review. |
10 Applications for Exemptions
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Various sections of NRC's regulations address requests for exemptions
(e.g., 10 CFR 19.31, 10 CFR 20.2301, 10 CFR 30.11(a), 10 CFR 71.8). These
regulations state that NRC may grant an exemption, acting on its own initiative
or on an application from an interested person. Key considerations are
whether the exemption is authorized by law, will endanger life or property
or the common defense and security, and is otherwise in the public interest.
Until NRC has granted an exemption in writing, NRC expects strict
compliance with all applicable regulations. |
Exemptions are not intended to revise regulations, are not intended for
large classes of licenses, and are generally limited to unique situations.
Exemption requests must be accompanied by descriptions of the following:
- Exemption and why it is needed
- Proposed compensatory safety measures intended to provide a level
of health and safety equivalent to the regulation for which the exemption
is being requested
- Alternative methods for complying with the regulation and why they
are not feasible.
11 Termination of Activities
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Regulations: 10 CFR 20.1402, 10 CFR 20.1403, 10 CFR
30.34(b), 10 CFR 30.35(g), 10 FR 0.36(d), 10 CFR 30.36(g), 10 CFR 30.36(h),
10 CFR 30.36(j), 10 CFR 30.51(f)
Criteria: The licensee must do the following:
- Notify NRC, in writing, within 60 days of
- the expiration of its license
- a decision to permanently cease licensed activities at the entire
site (regardless of contamination levels)
- a decision to permanently cease licensed activities in any separate
building or outdoor area, if they contain residual radioactivity
making them unsuitable for release according to NRC requirements.
- no principal activities having been conducted at the entire site
under the license for a period of 24 months
- no principal activities having been conducted for a period of 24
months in any separate building or outdoor area, if they contain
residual radioactivity making them unsuitable for release according
to NRC requirements.
- Submit decommissioning plan, if required by 10 CFR 30.36(g).
- Conduct decommissioning, as required by 10 CFR 30.36(h) and 10 CFR
30.36(j).
- Submit, to the appropriate NRC regional office, completed NRC Form
314, "Certificate of Disposition of Materials" (or equivalent information)
and a demonstration that the premises are suitable for release for unrestricted
use (e.g., results of final survey).
- Before a license is terminated, send the records important to decommissioning
to the appropriate NRC regional office. If licensed activities are transferred
or assigned in accordance with 10 CFR 30.34(b), transfer records important
to decommissioning to the new licensee.
Discussion: As noted in several instances discussed
in "Criteria," before a licensee can decide whether it must notify NRC,
the licensee must determine whether residual radioactivity is present
and if so, whether the levels make the building or outdoor area unsuitable
for release according to NRC requirements. A licensee's determination
that a facility is not contaminated is subject to verification by NRC
inspection.
For guidance on the disposition of licensed material, see the section
on "Waste Management -Gauge Disposal or Transfer." For guidance on decommissioning
records, see the section on "Radioactive Materials - Financial Assurance
and Record Keeping for Decommissioning."
Response from Applicant: The applicant is not required
to submit a response to the NRC during the initial application. However,
when the license expires or at the time the licensee ceases operations,
then any necessary decommissioning activities must be undertaken and NRC
Form 314 or equivalent information must be submitted, and other actions
must be taken as summarized in criteria above.
References: Copies of NRC Form 314, "Certificate of
Disposition of Materials," are available upon request from NRC's Regional
Offices. See Figure 2.1 for addresses and telephone numbers.
Appendix A: NRC Form 313
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NRC
Form 313
Appendix B: Suggested Format for Providing Information
Requested in Items 5 Through 11 of NRC Form 313
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Suggested Format for Providing Information Requested in Items
5 Through 11 of NRC Form 313
Table B.1 Items 5 & 6: Materials To Be Possessed and Proposed
Uses
Yes |
No |
Radioisotope |
Manufacturer or Distributor Model No. |
Quantity |
Use As Listed on SSD Certificate |
Specify Other Uses Not Listed on SSD Certificate |
|
|
Cobalt-60 |
Sealed source manufacturer or distributor and model number:
_____________
Device manufacturer or distributor and model number:
_____________ |
Not to exceed either the maximum activity per source or maximum
activity per device as specified in Sealed Source and Device Registration
Certificate |
Yes [ ]
Specific description of the gauge use:
_____________
_____________
_____________
_____________ |
[ ] Not applicable
_____________
[ ] Uses are:
_____________
(Submit safety analysis supporting safe use) |
|
|
Krypton-85 |
Sealed source manufacturer or distributor and model number:
_____________
Device manufacturer or distributor and model number:
_____________ |
Not to exceed either the maximum activity per source or maximum
activity per device as specified in Sealed Source and Device Registration
Certificate |
Yes [ ]
Specific description of the gauge use:
_____________
_____________
_____________
_____________ |
[ ] Not applicable
_____________
[ ] Uses are:
_____________
(Submit safety analysis supporting safe use) |
|
|
Strontium-90 |
Sealed source manufacturer or distributor and model number:
_____________
Device manufacturer or distributor and model number:
_____________ |
Not to exceed either the maximum activity per source or maximum
activity per device as specified in Sealed Source and Device Registration
Certificate |
Yes [ ]
Specific description of the gauge use:
_____________
_____________
_____________
_____________ |
[ ] Not applicable
_____________
[ ] Uses are:
_____________
(Submit safety analysis supporting safe use) |
|
|
Cesium-137 |
Sealed source manufacturer or distributor and model number:
_____________
Device manufacturer or distributor and model number: |
Not to exceed either the maximum activity per source or maximum
activity per device as specified in Sealed Source and Device Registration
Certificate |
Yes [ ]
Specific description of the gauge use:
_____________
_____________
_____________
_____________ |
[ ] Not applicable
_____________
[ ] Uses are:
_____________
(Submit safety analysis supporting safe use) |
|
|
Americium-241 |
Sealed source manufacturer or distributor and model number:
_____________
Device manufacturer or distributor and model number: |
Not to exceed either the maximum activity per source or maximum
activity per device as specified in Sealed Source and Device Registration
Certificate |
Yes [ ]
Specific description of the gauge use: |
[ ] Not applicable
_____________
[ ] Uses are:
_____________
(Submit safety analysis supporting safe use) |
|
|
Other Isotope (Specify): |
Sealed source manufacturer or distributor and model number:
_____________
Device manufacturer or distributor and model number: |
Not to exceed either the maximum activity per source or maximum
activity per device as specified in Sealed Source and Device Registration
Certificate |
Yes [ ]
Specific description of the gauge use:
_____________
_____________
_____________
_____________ |
[ ] Not applicable
_____________
[ ] Uses are:
_____________
(Submit safety analysis supporting safe use) |
Financial Assurance Required and
Evidence of Financial Assurance Provided |
Table B.2 Items 7 Through 11: Training and Experience, Facilities
and Equipment, Radiation Safety Program, and Waste Disposal
Item No. and Title |
Suggested Response |
Yes |
Alternative Procedures Attached |
7. Individual(s) Responsible for Radiation Safety Program
and Their Training and Experience
7.1 Radiation Safety Officer
Name: ______________ |
Before obtaining licensed materials, the proposed RSO will have
successfully completed the training described in Criteria in the section
"Individual(s) Responsible for Radiation Safety Program and
Their Training and Experience - Radiation Safety Officer" in NUREG-1556,
Vol. 4, dated October 1998.
AND
Before being named as the RSO, future RSOs will have successfully completed the
training described in Criteria in the section "Individual(s)
Responsible for Radiation Safety Program and Their Training and
Experience - Radiation Safety Officer" in NUREG-1556, Vol. 4, dated
October 1998. Within 30 days of naming a new RSO, we will submit
the new RSO's name to NRC to include in our license. |
[ ] |
[ ] |
7. Individual(s) Responsible for Radiation Safety Program
and Their Training and Experience
7.2 Authorized Users |
PROPOSED AUTHORIZED USERS:
Before using licensed materials, authorized users will have successfully
completed the training described in Criteria in the section "Authorized Users" in NUREG-1556, Vol. 4, dated October 1998. |
[ ] |
[ ] |
8. Training for Individuals Who in the Course of Employment
are Likely to Receive Occupational Doses of Radiation in Excess of
1 mSv (100 mrem) in a Year (Occupationally Exposed Workers) and Ancillary
Personnel |
The applicant is not required to, and should not, submit is training
program, for individuals who in the course of employment are likely
to receive occupational doses of radiation in excess of 1 mSv (100
mrem) in a year (occupationally exposed workers) and ancillary personnel,
to the NRC for review during the licensing phase. |
Need Not Be Submitted with Application |
9. Facilities and Equipment |
We will ensure that the location of each fixed gauge meets the Criteria
in the section entitled "Facilities and Equipment" in NUREG-1556,
Vol. 4, dated October 1998. |
[ ] |
[ ] |
10. Radiation Safety Program - Audit Program |
The applicant is not required to, and should not, submit its audit
program to the NRC for review during the licensing phase. |
Need Not Be Submitted with Application |
10. Radiation Safety Program - Survey Instruments |
Surveys pursuant to 10 CFR 20.1501 will be performed by a person
specifically authorized by the NRC or an Agreement State to perform
these surveys. OR We will use instruments that meet
the Criteria in the section entitled "Radiation Safety Program -
Instruments," in NUREG-1556, Vol. 4, dated October 1998, and one
of the following:
Each survey meter will be calibrated by the manufacturer or other
person authorized by the NRC or an Agreement State to perform survey
meter calibrations.
OR
We will implement the model survey instrument calibration program
in Appendix I to NUREG-1556, Vol. 4, dated October 1998. |
[ ] |
[ ] |
10. Radiation Safety Program - Material Receipt and
Accountability |
Physical inventories will be conducted at intervals not to exceed
6 months or at other intervals approved by the NRC, to account for
all sealed sources and devices received and possessed under the license. |
[ ] |
[ ] |
10. Radiation Safety Program - Occupational Dosimetry |
We will perform a prospective evaluation demonstrating that unmonitored
individuals are not likely to receive, in one year, a radiation dose
in excess of 10% of the allowable limits in 10 CFR Part 20 or we will
provide dosimetry that meets the Criteria in the section entitled
"Radiation Safety Program - Occupational Dosimetry," in NUREG-1556,
Vol. 4, dated October 1998. |
[ ] |
[ ] |
10. Radiation Safety Program - Public Dose |
The applicant is not required to submit a response to the public
dose section during the licensing phase. However, during NRC inspections,
licensees must be able to provide documentation demonstrating, by
measurement or calculation, that the total effective dose equivalent
to the individual likely to receive the highest dose from the licensed
operation does not exceed the annual limit for individual members
of the public. |
Need Not Be Submitted with Application |
10. Radiation Safety Program - Operating
and Emergency Procedures |
If the gauge meets one or more of the safety conditions specified
in "Discussion,"in the section entitled "Radiation Safety Program-Operating
Emergency Procedures," in NUREG-1556, Vol. 4, dated October 1998 state
the following: |
[ ] |
[ ] |
Operating and emergency procedures will be developed, implemented,
maintained, and distributed, and will meet the Criteria in the section
entitled "Radiation Safety Program - Operating and Emergency Procedures,"
in NUREG-1556, Vol. 4, dated October 1998. |
|
For each gauge requested that does not meet one or more of the safety
conditions specified in "Discussion," in the section entitled "Radiation
Safety Program-Operating Emergency Procedures," in NUREG 1556, Vol.
4, dated October 1998 provide your operating, emergency and lock-out
(if applicable) procedures to NRC for review. |
[ ] Procedures Attached |
10. Radiation Safety Program - Leak Test |
Leak tests will be performed at intervals approved by the NRC or
an Agreement State and specified in the Sealed Source and Device Registration
Certificate. Leak tests will be performed by an organization authorized
by NRC or an Agreement State to provide leak testing services for
other licensees or using a leak test kit supplied by an organization
authorized by NRC or an Agreement State to provide leak test kits
to other licensees and according to the kit supplier's instructions. |
[ ] |
[ ] |
OR |
|
We will implement the model leak test program published in Appendix
M to NUREG-1556, Vol. 4, dated October 1998. |
[ ] |
10. Radiation Safety Program - Maintenance |
ROUTINE MAINTENANCE We will implement and maintain procedures
for routine maintenance of our fixed gauges according to each manufacturer's
or distributor's written recommendations and instructions. |
|
[ ] |
NON-ROUTINE MAINTENANCE OPERATIONS The gauge manufacturer,
distributor or other person authorized by NRC or an Agreement State
will perform non-routine operations such as installation, initial
radiation survey, repair, and maintenance of components related
to the radiological safety of the gauge, gauge relocation, replacement,
and disposal of sealed sources, alignment, or removal of a gauge
from service. |
[ ] |
[ ] The information listed in Appendix N supporting
a request to perform non-routing operations in-house is attached |
10. Radiation Safety Program - Transportation |
The applicant is not required to submit its response to transportation
during the licensing process; this issue will be reviewed during inspection.
However, the licensee should develop, implement, and maintain transportation
procedures according to NRC and DOT regulations. |
Need Not Be Submitted with Application |
10. Radiation Safety Program - Fixed Gauges
Used at Temporary Job Sites |
This is not applicable to our program. We will not use fixed gauges
at temporary job sites. |
[ ] Not Applicable |
[ ] |
OR |
|
We will develop, implement, maintain and distribute procedures that
meet the Criteria in the section entitled "Radiation Safety Program
- Fixed Gauges Used at Temporary Job Sites" in NUREG-1556, Vol. 4,
dated October 1998. |
[ ] |
10. Radiation Safety Program - Minimization of Contamination |
The applicant is not required to submit a response to minimization
of contamination if the applicant's responses meet the criteria for
the following sections: Radioactive Material - Sealed Sources and
Devices, Facilities and Equipment, Radiation Safety Program - Operating
and Emergency Procedures, Radiation Safety Program - Leak Testing,
and Waste Management - Gauge Transfer and Disposal. |
Need Not Be Submitted with Application |
11. Waste Management - Gauge Disposal & Transfer |
The applicant is not required to submit a response to waste management
during the licensing process. However, the licensee should develop,
implement, and maintain gauge transfer and disposal procedures in
its radiation protection program. |
Need Not Be Submitted with Application |
Appendix C: Information Needed for Transfer of Control
Application
[ Prev | Next
| Top of file ]
Information Needed for Transfer of Control Application
Licensees must provide full information and obtain NRC's prior written
consent before transferring control of the license; some licensees
refer to this as "transferring the license." Provide the following information
concerning changes of control by the applicant (transferor and/or transferee,
as appropriate). If any items are not applicable, so state.
1. |
The new name of the licensed organization. If there is no change,
the licensee should so state. |
2. |
The new licensee contact and telephone number(s) to facilitate communications. |
3. |
Any changes in personnel having control over licensed activities
(e.g., officers of a corporation) and any changes in personnel named
in the license such as radiation safety officer, authorized users,
or any other persons identified in previous license applications as
responsible for radiation safety or use of licensed material. The
licensee should include information concerning the qualifications,
training, and responsibilities of new individuals. |
4. |
An indication of whether the transferor will remain in non-licensed
business without the license. |
5. |
A complete, clear description of the transaction, including any
transfer of stocks or assets, mergers, etc., so that legal counsel
is able, when necessary, to differentiate between name changes and
transferring control. |
6. |
A complete description of any planned changes in organization, location,
facility, equipment, or procedures (i.e., changes in operating or
emergency procedures). |
7. |
A detailed description of any changes in the use, possession, location,
or storage of the licensed materials. |
8. |
Any changes in organization, location, facilities, equipment, procedures,
or personnel that would require a license amendment even without transferring
control. |
9. |
An indication of whether all surveillance items and records (e.g.,
calibrations, leak tests, surveys, inventories, and accountability
requirements) will be current at the time of transfer. Provide a description
of the status of all surveillance requirements and records. |
10. |
Confirmation that all records concerning the safe and effective
decommissioning of the facility, pursuant to 10 CFR 30.35(g), 40.36(f),
70.25(g), and 72.30(d); public dose; and waste disposal by release
to sewers, incineration, radioactive material spills, and on-site
burials, have been transferred to the new licensee, if licensed activities
will continue at the same location, or to the NRC for license terminations. |
11. |
A description of the status of the facility. Specifically, the presence
or absence of contamination should be documented. If contamination
is present, will decontamination occur before transfer? If not, does
the successor company agree to assume full liability for the decontamination
of the facility or site? |
12. |
A description of any decontamination plans, including financial
assurance arrangements of the transferee, as specified in 10 CFR 30.35,
40.36, and 70.25. Include information about how the transferee and
transferor propose to divide the transferor's assets, and responsibility
for any cleanup needed at the time of transfer. |
13. |
Confirmation that the transferee agrees to abide by all commitments
and representations previously made to NRC by the transferor. These
include, but are not limited to: maintaining decommissioning records
required by 10 CFR 30.35(g); implementing decontamination activities
and decommissioning of the site; and completing corrective actions
for open inspection items and enforcement actions.
With regard to contamination of facilities and equipment, the transferee
should confirm, in writing, that it accepts full liability for the
site, and should provide evidence of adequate resources to fund
decommissioning; or the transferor should provide a commitment to
decontaminate the facility before transferring control.
With regard to open inspection items, etc., the transferee should
confirm, in writing, that it accepts full responsibility for open
inspection items and/or any resulting enforcement actions; or the
transferee proposes alternative measures for meeting the requirements;
or the transferor provides a commitment to close out all such actions
with NRC before license transfer. |
14. |
Documentation that the transferor and transferee agree to transfer
control of the licensed material and activity, and the conditions
of transfer; and the transferee is made aware of all open inspection
items and its responsibility for possible resulting enforcement actions. |
15. |
A commitment by the transferee to abide by all constraints, conditions,
requirements, representations, and commitments identified in the existing
license. If not, the transferee must provide a description of its
program, to ensure compliance with the license and regulations. |
References: The information above is contained in IN
89-25, Revision 1, "Unauthorized Transfer of Ownership or Control of Licensed
Activities." See the Notice of Availability (on the inside front cover
of this report) to obtain copies.
Appendix D: Reviewer Checklist for Fixed Gauge Application
[ Prev | Next
| Top of file ]
Reviewer Checklist for Fixed Gauge Application
ITEM 1: ACTION TYPE
ACTION TYPE: [ ] New
[ ] Amendment
[ ] Renewal |
ADMINISTRATIVE REVIEW: [ ] Current Guidance
Used
[ ] References in Application Based On Current Regulations
[ ] All Attachments Referenced Included
[ ] Signature on Application |
ITEM 2: LEGAL IDENTITY
ITEMS 2 & 3: ADDRESS
LOCATION OF USE/STORAGE ADDRESS: |
MAILING ADDRESS: |
ITEM 4: PERSON TO BE CONTACTED ABOUT THIS APPLICATION
CONTACT PERSON: |
|
TELEPHONE NUMBER: |
|
Table D.1 Items 5 and 6: Materials to Be Possessed and Uses
Yes |
No |
Radioisotope |
Model No. |
Quantity |
Use as Listed on SSD Certificate |
Specify Other Uses Not Listed on SSD Certificate |
|
|
Cobalt-60 |
Sealed source manufacturer or distributor and model number: __________________________
Device manufacturer or distributor and model number: __________________________
|
Not to exceed either the maximum activity per source or maximum
activity per device as specified in Sealed Source and Device Registration
Certificate |
Yes [ ]
Specific description of the gauge use:
_____________
_____________
_____________
_____________
_____________
_____________
_____________ |
[ ] Not
applicable
_____________
[ ] Uses are:
_____________ |
|
|
Krypton-85 |
Sealed source manufacturer or distributor and model number:
__________________________
Device manufacturer or distributor and model number : __________________________
|
Not to exceed either the maximum activity per source or maximum
activity per device as specified in Sealed Source and Device Registration
Certificate |
Yes [ ]
Specific description of the gauge use:
_____________
_____________
_____________
_____________
_____________
_____________
_____________ |
[ ] Not applicable _____________
[ ] Uses are: _____________ |
|
|
Strontium-90 |
Sealed source manufacturer or distributor and model number:
__________________________
Device manufacturer or distributor and model number: __________________________
|
Not to exceed either the maximum activity per source or maximum
activity per device as specified in Sealed Source and Device Registration
Certificate |
Yes [ ]
Specific description of the gauge use:
_____________
_____________
_____________
_____________
_____________
_____________
_____________ |
[ ] Not applicable _____________
[ ] Uses are: _____________ |
|
|
Cesium-137 |
Sealed source manufacturer or distributor and model number:
__________________________
Device manufacturer or distributor and model number: __________________________
|
Not to exceed either the maximum activity per source or maximum
activity per device as specified in Sealed Source and Device Registration
Certificate |
Yes [ ]
Specific description of the gauge use:
_____________
_____________
_____________
_____________
_____________
_____________
_____________ |
[ ] Not applicable _____________
[ ] Uses are: _____________ |
|
|
Americium-241 |
Sealed source manufacturer or distributor and model number: __________________________
Device manufacturer or distributor and model number:
__________________________ |
Not to exceed either the maximum activity per source or maximum
activity per device as specified in Sealed Source and Device Registration
Certificate |
Yes [ ]
Specific description of the gauge use:
_____________
_____________
_____________
_____________
_____________
_____________
_____________ |
[ ] Not applicable _____________
[ ] Uses are: _____________ |
|
|
Other Isotope (Specify): |
Sealed source manufacturer or distributor and model number: __________________________
Device manufacturer or distributor and model number: __________________________
|
Not to exceed either the maximum activity per source or maximum
activity per device as specified in Sealed Source and Device Registration
Certificate |
Yes [ ]
Specific description of the gauge use:
_____________
_____________
_____________
_____________
_____________
_____________
_____________ |
[ ] Not applicable _____________
[ ] Uses are: _____________ |
|
|
Financial Assurance Required and
Evidence of Financial Assurance Provided |
Table D.2 Items 7 Through 11: Training and Experience, Facilities
and Equipment, Radiation Safety Program, and Waste Management
Item Number and Title |
Suggested Response |
Applicant's Response |
Yes |
No |
Other |
Yes |
No |
7. Individual(s) Responsible for Radiation Safety
Program and their Training and Experience 7.1
Radiation Safety Officer (RSO)
Name: _______________ |
Before obtaining licensed materials, the proposed RSO will have
successfully completed the training described in Criteria in the section
entitled "Radiation Safety Officer," in NUREG-1556, Vol. 4 dated August
1998. AND
Before being named as the RSO, future RSOs will have successfully
completed the training described in Criteria in the section entitled
"Radiation Safety Officer," in NUREG-1556, Vol. 4, dated August
1998. Within 30 days of naming a new RSO, we will submit the new
RSO's name to NRC to include in our license. |
|
|
|
|
7. Individual(s) Responsible for Radiation Safety
Program and their Training and Experience 7.1
Radiation Safety Officer (RSO)
(Cont'd) |
Optional Response Criteria for Acceptable
Training Course for Radiation Safety Officer
Classroom Training:
- Radiation Safety
- Radiation vs. contamination
- Internal vs. external exposure
- Biological effects of radiation
- Types and relative hazards of radioactive material possessed
- ALARA concept
- Use of time, distance, and shielding to minimize exposure
- Locations of sealed source within the gauge
- Use of survey meters and personal dosimetry, when required
- Regulatory Requirements
- Applicable regulations
- License conditions, amendments, renewals
- Locations of use and storage of radioactive
- Material control and accountability
- Annual audit of radiation safety program
- Transfer and disposal
- Recordkeeping
- Prior events involving fixed gauges.
- Handling incidents
- Recognizing and ensuring that radiation warning signs are visible
and legible
- Licensing and inspection by regulatory agency
- Need for complete and accurate information
- Employee protection
- Deliberate misconduct
- Practical Explanation of the Theory and Operation for Each Gauge
Possessed by the Licensee
- Operating and emergency procedures
- Routine vs. non-routine maintenance
- Lock-out procedures
- Supervised "Hands-On" Experience performing
- Operating procedures
- Test runs of emergency procedures
- Routine maintenance
- Lock-out procedures
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7 Individual(s) Responsible for Radiation Safety
Program and their Training and Experience 7.2
Authorized Users |
Training Assessment Course Instructor Qualifications:
- Bachelor's degree in a physical or life science or engineering
with successful completion of both a fixed gauge manufacturer's
or distributor's course for users and an 8 hour radiation safety
course and 8 hours hands-on experience with fixed gauges
OR
- Successful completion of a fixed gauge manufacturer's or distributor's
course for users
- Successful completion of 40 hour radiation safety course
- 30 hours of hands-on experience with fixed gauges.
Note: Additional training is required for
those applicants intending to perform non-routine operations. |
|
|
|
|
7 Individual(s) Responsible for Radiation Safety
Program and their Training and Experience 7.2
Authorized Users |
Proposed Authorized Users Before using licensed
materials, authorized users will have successfully completed the
training described in Criteria in the section "Authorized
Users," in NUREG-1556, Vol. 4, dated August 1998. |
|
|
|
|
7 Individual(s) Responsible for Radiation Safety
Program and their Training and Experience 7.2
Authorized Users(Cont'd) |
Optional Response Classroom Training:
- Radiation Safety
- Radiation vs. contamination
- Internal vs. external exposure
- Biological effects of radiation
- Types and relative hazards of radioactive material possessed
- ALARA concept
- Use of time, distance, and shielding to minimize exposure
- Location of sealed source within the gauge
- Use of survey meters and personal dosimetry, when required
|
|
|
|
|
|
- Regulatory Requirements
- Applicable regulations
- License conditions, amendments, renewals
- Locations of use and storage of radioactive materials
- Material control and accountability
- Annual audit of radiation safety program
- Transfer and disposal
- Recordkeeping
- Prior events involving fixed gauges
- Handling incidents
- Recognizing and ensuring that radiation warning signs are visible
and legible
- Licensing and inspection by regulatory agency
- Need for complete and accurate information
- Employee protection
- Deliberate misconduct
|
|
|
|
|
|
- Practical Explanation of the Theory and Operation for Each Type
of Gauge that may be used by the Authorized User
- Operating and emergency procedures
- Routine vs. non-routine maintenance
- Lock-out procedures
|
|
|
|
|
|
- Supervised Hands-on Experience Performing
- Operating procedures
- Test runs of emergency procedures
- Routine maintenance
- Lock-out procedures
|
|
|
|
|
7 Individual(s) Responsible for Radiation Safety
Program and their Training and Experience 7.2
Authorized Users(Cont'd) |
Training Assessment Course Instructor Qualifications:
- Bachelor's degree in a physical or life science or engineering
with successful completion of both a fixed gauge manufacturer's
or distributor's course for users and an 8 hour radiation safety
course and 8 hours hands-on experience with fixed gauges
OR
- Successful completion of a fixed gauge manufacturer's or distributor's
course for users
- Successful completion of 40 hour radiation safety course
- 30 hours of hands-on experience with fixed gauges
|
|
|
|
|
|
Note:
- Individuals who in the course of employment are likely to receive
occupational doses of radiation in excess of 1 mSv (100 mrem)
in a year must receive training pursuant to 10 CFR 19.12.
- Additional training is required for those applicants requesting
to perform non-routine operations.
|
|
|
|
|
8 Training for Individuals Who in the Course
of Employment Are Likely to Receive Occupational Doses of Radiation
in Excess of 1 mSv (100 mrem) in a Year (Occupationally Exposed Workers)
and Ancillary Personnel |
The applicant is not required to, and should not, submit its training
program, for individuals who in the course of employment are likely
to receive occupational doses of radiation in excess of 1 mSv (100
mrem) in a year (occupationally exposed workers) and ancillary personnel,
to the NRC for review during the licensing phase. |
Need Not Be Submitted with Application |
9 Facilities and Equipment |
We will ensure that the location of each fixed gauge meets the Criteria
in section "Facilities and Equipment," in NUREG-1556, Vol.
4, dated August 1998.
OR
Confirm that the fixed gauge is secured to prevent unauthorized
removal or access; and submit specific information supporting the
new conditions demonstrating that they will not impact the safety
or integrity of the source or device. Address any instances where
the proposed conditions exceed any conditions listed in the SSD
Registration Certificate |
|
|
|
|
|
Optional Response
- The area corresponds to the "Conditions of Normal Use" and "Limitations
and/or Other Considerations of Use" on the SSD Registration Certificate
- The fixed gauge is secured to prevent unauthorized removal (e.g.,
located in a locked room, permanently mounted, or chained and
locked to a storage rack)
|
|
|
|
|
10 Radiation Safety Program - Audit Program |
The applicant is not required to, and should not, submit its audit
program to the NRC for review during the licensing phase. |
Need Not Be Submitted with Application |
10 Radiation Safety Program - Instruments |
Surveys pursuant to 10 CFR 20.1501 will be performed by a person
specifically authorized by the NRC or an Agreement State to perform
these surveys." OR
We will use instruments that meet the Criteria in the section "Radiation Safety Program - Instruments," in NUREG-1556, Vol. 4,
dated August 1998, and one of the following:
- Each survey meter will be calibrated by the manufacturer or
other person authorized by the NRC or an Agreement State to perform
survey meter calibrations.
OR
- We will follow the model survey instrument calibration program
in Appendix I to NUREG-1556, Vol. 4, dated August 1998.
|
|
|
|
|
|
Optional Response The applicant may provide
a description of an alternate method to perform surveys pursuant
to 10 CFR 20.1501. |
|
|
|
|
10 Radiation Safety Program - Instrument Calibration |
If required to do surveys pursuant to 10 CFR 20.1501, and requesting
to calibrate their own survey meters:
We will implement the model survey instrument calibration program
published in Appendix I to NUREG-1556, Vol. 4, dated October 1998.
|
|
|
|
|
10 Radiation Safety Program - Instrument Calibration
(Cont'd) |
Optional Response
- Training and experience of individual performing calibration.
- Description of facilities, equipment
- Specify calibration source radionuclide, activity, traceability
(source activity sufficient to provide a dose rate of at least
30 mR/hr at 100 cm, similar in energy to gauge sources. NIST traceable)
- Specific procedures for calibration
- Calibration report
- Calibration tag, sticker:
- source
- for each scale or decade not calibrated, indication checked
for function only or scale not operative
- calibration date
- due date
- exposure rate from check source if used
- Maintain calibration records for 3 years
|
|
|
|
|
10 Radiation Safety Program - Material Receipt
and Accountability |
Physical inventories will be conducted at intervals not to exceed
6 months or at other intervals as approved by the NRC, to account
for all sealed sources and devices received and possessed under the
license.
Optional Response
A description of the procedures for ensuring that no fixed gauge
has been lost, stolen, or misplaced and how often they will be conducted.
|
|
|
|
|
10 Radiation Safety Program - Occupational Dosimetry |
We will perform a prospective evaluation demonstrating that unmonitored
individuals are not likely to receive, in one year, a radiation dose
in excess of 10% of the allowable limits in 10 CFR Part 20 or we will
provide dosimetry that meets the Criteria in the section "Radiation Safety Program - Occupational Dosimetry," in NUREG-1556,
Vol. 4, dated October 1998.
Optional Response
Alternative response demonstrates compliance with 10 CFR Part 20
requirements. |
|
|
|
|
10 Radiation Safety Program - Public Dose |
The applicant is not required to submit a response to public dose
section during the licensing phase. Documentation demonstrating compliance
will be examined during inspection. |
Need Not Be Submitted with Application |
10 Radiation Safety Program - Operating &
Emergency Procedures |
If the gauge meets one or more of the safety conditions specified
in "Discussion," in the section "Radiation Safety Program
- Operating Emergency Procedures," in NUREG 1556, Vol. 4, dated October
1998 state the following:
Operating and emergency procedures will be developed, implemented
and maintained and will meet the Criteria in the section
"Radiation Safety Program - Operating and Emergency Procedures,"
in NUREG-1556, Vol. 4, dated October 1998.
For each gauge requested that does not meet one or more of the
safety conditions specified in "Discussion," in the section
"Radiation Safety Program - Operating Emergency Procedures," in
NUREG 1556, Vol. 4, dated October 1998 provide your operating, emergency
and lock-out (if applicable) procedures to NRC for review. |
|
|
|
|
10 Radiation Safety Program - Operating &
Emergency Procedures (Cont'd)
|
Optional Response For each type of gauge:
- Operating Procedures
- Instructions for operating the gauge
- Instructions for performing routine cleaning and
maintenance according to the manufacturers' or distributors' recommendations
and instructions
- Instructions for testing each gauge for the proper operation
of the on/off mechanism (shutter) and indicator, if any, at intervals
not to exceed 6 months or as specified in the SSD certificate
- Instructions for lock-out procedures, if applicable, that are
adequate to ensure that no individual or portion of an individual's
body can enter the radiation beam.
- Instructions to prevent unauthorized access, removal, or use
of fixed gauges
- Steps to take to keep radiation exposures ALARA
- Steps to maintain accountability (i.e., physical inventory)
- Instructions to ensure that non-routine operations such as installation,
initial radiation survey, repair, and maintenance of components
related to the radiological safety of the gauge, gauge relocation,
replacement and disposal of sealed sources, alignment, or removal
of a gauge from service, alignment, or removal of a gauge form
service are performed by the manufacturer, distributor or person
specifically authorized by the NRC or an Agreement State.
- Steps to ensure that radiation warning signs are present, visible,
and legible
|
|
|
|
|
10 Radiation Safety Program - Operating &
Emergency Procedures(Cont'd) |
Emergency Procedures:
- Restrict access to the area
- Contact responsible and individuals (Telephone numbers for the
RSO, authorized users, the gauge manufacturer or distributor,
fire department, or other emergency response organization, as
appropriate, and the NRC should be posted or easily accessible)
- Do not attempt repair or authorize others to attempt repair
of the gauge except as specifically authorized in a license issued
by the NRC or an Agreement State
- Require reporting to NRC pursuant to 10 CFR 20.2201-20.2203,
10 CFR 30.50, and 10 CFR 21.21
- Take additional steps, dependent on the specific situations.
Note:
- Copies of operating and emergency procedures provided to all
gauge users
- Post copies of operating and emergency procedures at each location
of use or post a notice describing where procedure may be examined.
|
|
|
|
|
10 Radiation Safety Program - Leak Tests |
- Leak tests will be performed at intervals approved by the NRC
or an Agreement State and Specified in the SSD Registration Certificate.
Leak tests will be performed by an organization authorized by
NRC or an Agreement State to provide leak testing services for
other licensees or using a leak test kit supplied by an organization
authorized by NRC or an Agreement State to provide leak test kits
to other licensees and according to the kit supplier's instructions.
Records of leak test results will be maintained.
OR
- We will implement the model leak test program published in Appendix
M to NUREG-1556, Vol. 4, dated October 1998.
|
|
|
|
|
10 Radiation Safety Program - Leak Tests |
Optional Response
- Identify the individual who will make the analysis; their training
and experience
- Leak test frequency as specified in the appropriate Sealed Source
and Device Registration Certificate.
- How and where test samples taken; materials to be used; methods
of handling samples to prevent or minimize exposure to personnel.
- Type of instrument(s) used, counting efficiency, and minimum
levels of detection for each radionuclide
Note: An instrument capable of making quantitative
measurements should be used; hand-held survey meters will not normally
be considered adequate for measurements.
- Specify the standard calibration sources including for each:
the radionuclide, quantity, accuracy, and traceability to primary
radiation standards
Note: Accuracy of standards should be within
+ 5% of the stated value and traceable to a primary radiation
standard such as those maintained by the National Institutes of
Standards and Technology (NIST).
- Sample calculation to convert measurement data to becquerels
(or microcuries)
- Instructions on actions, notifications regarding leaking source
- Maintain record of leak test results
|
|
|
|
|
10 Radiation Safety Program - Maintenance |
Routine Maintenance We will implement and maintain
procedures for routine maintenance of our gauges according to each
manufacturer's or distributor's written recommendations and instructions.
|
|
|
|
|
|
Optional Response
- Adequate training, experience
- Manufacturer's or distributor's written instructions
- Considers ALARA
- Ensures gauge functions as designed
- Ensures source integrity not compromised
|
|
|
|
|
10 Radiation Safety Program - Maintenance(Cont'd) |
Non-Routine Operations The gauge manufacturer,
distributor or other person authorized by NRC or an Agreement State
will perform non-routine operations such as installation, initial
radiation survey, repair, and maintenance of components related
to the radiological safety of the gauge, gauge relocation, replacement,
and disposal of sealed sources, alignment, or removal of a gauge
from service. |
|
|
|
|
|
Optional Response Provide the information listed
in Appendix N supporting a request to perform non-routine operations
in-house.
- Types of work to be performed
- Identify the individual who will perform non-routine operations,
their training and experience
- Procedures to ensure:
- doses to public, personnel are ALARA and within regulatory limits
- security
- posting
- manufacturers or distributors instructions and recommendations
are followed
- non-manufacturer/non-distributor supplied replacement components
or parts, or the use of materials (e.g., lubricants) other than
those specified or recommended by the manufacturer or distributor
are evaluated to ensure that they do not degrade the engineering
safety analysis
- before being returned to routine use, the gauge is tested to
verify that it functions as designed and source integrity is not
compromised
- Use of whole body and extremity monitoring if required
- Possess survey instrument calibrated by NRC/Agreement State
licensee; or as defined in Appendix I; checked before use
- 10 CFR 20.1301 surveys
- when and where surveys performed
- survey records maintained for 3 years
|
|
|
|
|
10 Radiation Safety Program - Transportation |
The applicant is not required to submit a response to transportation
section during the licensing process; this issue will be reviewed
during inspection. |
Need Not Be Submitted with Application |
10 Radiation Safety Program - Fixed
Gauges Used at Temporary Job Sites |
This is not applicable to the applicant's program. Applicant will
not use fixed gauges at temporary job sites. |
[ ] N/A |
|
|
|
OR |
|
|
Procedures will be developed, implemented, maintained and distributed
and will meet the Criteria in the section "Radiation Safety
Program - Fixed Gauges Used at Temporary Job Sites," in NUREG-1556,
Vol. 4, dated October 1998. |
[ ] |
[ ] |
10 Radiation Safety Program - Fixed Gauges Used
at Temporary Job Sites (Cont'd) |
Optional Response
- Develop, implement, maintain, and distribute operating and emergency
procedures containing the following elements:
- Instructions for transporting radioactive material to ensure
compliance with DOT regulations
- Instructions for using gauges at temporary job sites and performing
routine maintenance according to the manufacturer's or distributor's
recommendations and instructions
- Instructions for maintaining security during storage and transportation
- Instructions to keep gauges under control and immediate surveillance
or secured to prevent unauthorized use or access
- Steps to take to keep radiation exposures ALARA
- Steps to maintain accountability during use
- Steps to control access to a potentially damaged gauge
- Steps to take, and whom to contact, when a gauge has been lost
or damaged.
- If gauges are to be installed at temporary job sites, the operating
and emergency procedures should contain instructions on the use
of personal dosimetry, and survey instruments and conducting surveys.
- Provide copies of operating and emergency procedures to all
gauge users and maintain copies at each job site.
|
|
|
|
|
10 Radiation Safety Program - Minimization of
Contamination |
The applicant does not need to provide a response to this item under
the following condition. NRC will consider that the above criteria
have been met if the applicant's responses meet the criteria for the
following sections: Radioactive Material - Sealed Sources and Devices,
Facilities and Equipment, Radiation Safety Program - Operating and
Emergency Procedures, Radiation Safety Program - Leak Testing, and
Waste Management - Gauge Transfer and Disposal. |
Need Not Be Submitted with Application |
11 Waste Disposal - Fixed Gauge Disposal and
Transfer |
The applicant is not required to submit a response to waste management
section during the licensing process; however, the licensee should
develop, implement, and maintain fixed gauge transfer and disposal
procedures in its radiation safety program. |
Need Not Be Submitted with Application |
Appendix E: Sample SSD Registration Certificate
[ Prev | Next
| Top of file ]
Sample SSD Registration Certificate
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF DEVICE |
AMENDED IN ENTIRETY |
NO: |
DATE: |
PAGE 1 OF 7 |
DEVICE TYPE: Pipe Wall Thickness Caliper
MODEL: Tube Wall Caliper
MANUFACTURER/DISTRIBUTOR:
SEALED SOURCE MODEL DESIGNATION: |
1. 3M Model 4f6s or 4F6H |
|
2. Gulf Nuclear Model CSV |
|
3. Amersham Model CDC 711m |
ISOTOPE: |
1. cesium-137 |
MAXIMUM ACTIVITY: |
1. 1.5 curies |
|
2. cesium-137 |
|
2. 1.5 curies |
|
3. cesium-137 |
|
3. 1.5 curies |
LEAK TEST FREQUENCY: 6 Months
PRINCIPAL USE: Gamma Gauges (D)
CUSTOM DEVICE: ___YES X NO
CUSTOM USER:
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF DEVICE |
AMENDED IN ENTIRETY |
NO: |
DATE |
PAGE 2 OF 7 |
DEVICE TYPE: Pipe Wall Thickness Caliper
DESCRIPTION: This device has an exterior housing that is doughnut
shaped with a center hole that will accommodate pipe sizes from 1 inch
to 17 inches OD, but be increased by enlargement of the cylinder through
which the pipe passes. The housing is mounted on its edge so the pipe
can pass through its center. The device can be used as a stationary or
rotating unit at either a fixed location or in a mobile van.
Inside the housing, a tungsten source holder emits a collimated beam
of radiation through the pipe to be inspected to a detected to a detector
on the other side of the housing which has a beam stop behind it. The
source holder and detector are oppositely mounted on a frame inside the
housing which rotates about the pipe as the pipe is conveyed through the
device. Flaws in this section of pipe are detected by the variation in
beam attenuation.
Appendix E Figure 1: Functional Sketch of the Model
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF DEVICE |
DEVICE TYPE: Pipe Wall Thickness Caliper
DESCRIPTION (Continued): The source holder is made of a solid
tungsten body with a tungsten slide shutter which aligns a beam collimation
hold with the source when in operation. The shutter can be locked in either
the "ON" or "OFF" position. When in the "ON" position, red is visible
on the back cover, while in the "OFF" position black is indicated. The
source is inaccessible to the user and cannot be removed unless four security
wire seals are broken and the respective cover lugs removed.
LABELING: The outer housing and the source holder are both labeled
with the conventional radioactive symbol. Another source holder label
also includes isotope, number of curie, date and serial number as seen
below.
Appendix E 2: Model
Appendix E 3: Label on Outer Housing
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF DEVICE |
AMENDED IN ENTIRETY |
NO: |
DATE: |
PAGE 4 OF 7 |
DEVICE TYPE: Pipe Wall Thickness Caliper
CONDITIONS OF NORMAL USE: The Model________ is designed to provide
wall thickness measurements of oilfield pipe either from a portable platform
as part of a fixed facility in a pipe yard.
It is designed to be used in environmental conditions compatible with
man. Because of its construction, the source holder will withstand the
extreme conditions present during a fire and/or explosion.
PROTOTYPE TESTING: his device is a modification tungsten shielding
to replace the more crumbersome lead shielding of the Model ___________
This device, also, has been in operation for more than 17 years. During
this time three pipe inspection units containing the Model __________
tube wall caliper. Two units were destroyed by fire and one unit was destroyed
in a vehicle accident. All three source holders were removed, cleaned
and reinstalled in new pipe inspection units with no loss of integrity.
EXTERNAL RADIATION LEVELS: Maximum surface readings are approximately
70 mR/hr on the side of the source holder. Rigid quality control of
all components is maintained throughout the manufacturing process.
When construction of the source holder is complete, it is sent to
another sub-contractor for source installation and inspected once
again before installation into the pipe inspection unit. |
QUALITY ASSURANCE AND CONTROL: ____________ sub-contracts
all construction of component parts of the source holder. Rigid quality
control of all components is maintained throughout the manufacturing
process. When construction of the source holder is complete, it is
sent to another sub-contractor for source installation and inspected
once again before installation into the pipe inspection unit. |
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
- Installation, dismantling, relocation, repair or testing must be performed
only by persons specifically licensed to perform such operations.
- Leak testing of the source must be performed at intervals not to exceed
6 months
- Operation of this device must be performed only by persons who have
received radiation safety training by the manufacturer or another person
specifically authorized by the Commission, an Agreement State or a Licensing
State to present such training.
- Routine maintenance on the electronics of this device may be performed
by the licensee. Routine maintenance on the source holder by the licensee
may be authorized if adequate procedures for securing the shutter mechanism
are provided.
SAFETY ANALYSIS SUMMARY: Although radiation fields at the
surface on the side of the source holder are relatively high, the
metal housing of the device used to protect the operator form the
moving parts will also prevent the operator from excessive exposures. |
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF DEVICE |
AMENDED IN ENTIRETY |
NO: |
DATE: |
PAGE 5 OF 7 |
DEVICE TYPE: |
Pipe Wall Thickness Caliper |
SUMMARY: Review of the information provided by ____________
indicates theat the design and construction exceeds the ANSI classification
for industrial gauging devices. Because these devices were intended
for use in an environment compatible with man, the source and source
holder will maintain their integrity during all applicable accident
conditions. |
REFERENCES: This summary was prepared with the aid of ______________
letters dated associated drawings, documents and procedures. |
DATE: ___________________________ |
REVIEWED BY: _________________________ |
DATE: ___________________________ |
REVIEWED BY: _________________________ |
ISSUING AGENCY:
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF DEVICE |
AMENDED IN ENTIRETY |
NO: |
DATE: |
PAGE 6 OF 7 |
DEVICE TYPE: |
Pipe Wall Thickness Caliper |
Appendix E 4: Side Cut View & Top View
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF DEVICE |
AMENDED IN ENTIRETY |
NO: |
DATE: |
PAGE 7 OF 7 |
DEVICE TYPE: |
Pipe Wall Thickness Caliper |
Appendix E 5: Bottom Plate View & Side View,
90° Rotation
Appendix F: Typical Duties and Responsibilities
of the Radiation Safety Officer
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Typical Duties and Responsibilities of the Radiation Safety Officer
The RSO's duties and responsibilities include ensuring radiological safety
and compliance with both NRC regulations and the conditions of the license.
(See Figure 8.2.) Typically, the RSO's duties and responsibilities include
ensuring the following:
- Activities involving licensed material that the RSO considers unsafe
are stopped
- Radiation exposures are ALARA
- Development, maintenance, distribution, and implementation of up-to-date
operating and emergency procedures
- Individuals that use fixed gauges are properly trained
- Possession, installation, relocation, use, storage, routine maintenance
and non-routine operations of fixed gauges are consistent with the limitations
in the license, the SSD Registration Certificate(s), manufacturer's
or distributors recommendations and instructions
- Safety consequences of non-routine operations are analyzed before
conducting any such activities that have not been previously analyzed
- Non-routine operations are performed by the manufacturer, distributor
or person specifically authorized by the NRC or an Agreement State
- Prospective evaluations are performed demonstrating that unmonitored
individuals are not likely to receive, in one year, a radiation dose
in excess of 10% of the allowable limits or personnel monitoring devices
are provided
- Personnel monitoring devices, if required, are used and exchanged
at the proper intervals, and records of the results of such monitoring
are maintained
- Documentation is maintained to demonstrate, by measurement or calculation,
that the TEDE to the individual member of the public likely to receive
the highest dose from the licensed operation does not exceed the annual
limit in 10 CFR 20.1301
- Fixed gauges are properly secured
- Notification of proper authorities of incidents such as damage to
or malfunction of fixed gauges, fire, loss, or theft
- Investigation of unusual occurrences involving the fixed gauge (e.g.,
malfunctions or damage), identification of cause(s), implement of appropriate
and timely corrective action(s)
- Radiation safety program audits are performed at intervals not to
exceed 12 months and development, implement, and documentation of timely
corrective actions
- When the licensee identifies violations of regulations or license
conditions or program weaknesses, corrective actions are developed,
implemented, and documented
- Licensed material is transported according to all applicable DOT requirements
- Licensed material is disposed of properly
- Appropriate records are maintained
- An up-to-date license is maintained and amendment and renewal requests
are submitted in a timely manner
- Posting of documents required by 10 CFR 19.11 (Parts 19 and 20, license
documents, operating procedures, NRC Form 3 "Notice to Employees"),
and 10 CFR 21.6 (Part 21, Section 206 of Energy Reorganization Act of
1974, procedures adopted pursuant to Part 21) or posting a notice indicating
where these documents can be examined
Appendix G: Criteria for Acceptable Training
for Authorized Users and Radiation Safety Officers
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Criteria for Acceptable Training for Authorized Users and Radiation
Safety Officers
Course Content
Classroom training may be in the form of lecture, videotape, or self-study
emphasizing practical subjects important to safe use of the gauge:
Radiation Safety:
- Radiation vs. contamination
- Internal vs. external exposure
- Biological effects of radiation
- Types and relative hazards of radioactive material possessed
- ALARA concept
- Use of time, distance, and shielding to minimize exposure
- Location of sealed source within the gauge
Regulatory Requirements:
- Applicable regulations
- License conditions, amendments, renewals
- Locations of use and storage of radioactive materials
- Material control and accountability
- Annual audit of radiation safety program
- Transfer and disposal
- Recordkeeping
- Prior events involving fixed gauges
- Handling incidents
- Recognizing and ensuring that radiation warning signs are visible
and legible
- Licensing and inspection by regulatory agency
- Need for complete and accurate information
- Employee protection
- Deliberate misconduct
Practical Explanation of the Theory and Operation for Each Gauge Possessed
by the Licensee:
- Operating and emergency procedures
- Routine vs. non-routine maintenance
- Lock-out procedures
On-the-job training must be done under the supervision of an AU or RSO:
- Supervised Hands-On Experience Performing
- Operating procedures
- Test runs of emergency procedures
- Routine maintenance
- Lock-out procedures
Training Assessment
Management will ensure that proposed AUs are qualified to work independently
with each type of gauge with which they may work. Management will ensure
that proposed RSOs are qualified to work independently with and are knowledgeable
of the radiation safety aspects of all types of gauges to be possessed
by the applicant. This may be demonstrated by written or oral examination
or by observation.
Course Instructor Qualifications
Instructor should have:
- Bachelor's degree in a physical or life science or engineering
- Successful completion of a fixed gauge manufacturer's or distributor's
course for users (or equivalent)
- Successful completion of an 8 hour radiation safety course; and
- 8 hours hands-on experience with fixed gauges
OR
- Successful completion of a fixed gauge manufacturer's or distributor's
course for users (or equivalent)
- Successful completion of 40 hour radiation safety course; and
- 30 hours of hands-on experience with fixed gauges.
OR
- The applicant may submit a description of alternative training and
experience for the course instructor.
Note: Additional training is required for those
applicants intending to perform non-routine operations such as installation,
initial radiation survey, repair, and maintenance of components related
to the radiological safety of the gauge, gauge relocation, replacement,
and disposal of sealed sources, alignment, or removal of a gauge from
service. See Appendix N - "Non-Routine Operations."
Appendix H: Suggested Fixed Gauge Audit
Checklist
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Suggested Fixed Gauge Audit Checklist
Note: All areas indicated in audit notes may
not be applicable to every license and may not need to be addressed during
each audit. For example, licensees do not need to address areas which
do not apply to their activities and activities which have not occurred
since the last audit need not be reviewed at the next audit.
Licensee's name _________________ |
License No. _________________ |
Date of This Audit ________________ |
Date of Last Audit _______________ |
(Auditor Signature) |
Date ___________________ |
________________________
(Management Signature) |
Date ___________________ |
Audit History
A. |
Last audit of this location conducted on (date) _______________________
|
B. |
Were previous audits conducted at intervals not to exceed 12 months?
[10 CFR 20.1101] |
C. |
Were records of previous audits maintained? [10 CFR 20.2102] |
D. |
Were any deficiencies identified during last two audits or two years,
whichever is longer? |
E. |
Were corrective actions taken? (Look for repeated deficiencies). |
Organization and Scope of Program
A. |
If the mailing address or places of use changed, was
the license amended? |
B. |
If ownership changed or bankruptcy filed, was NRC prior
consent obtained or was NRC notified? |
C. |
Radiation Safety Officer |
|
1. |
If the RSO was changed, was license amended? |
|
2. |
Does new RSO meet NRC training requirements? |
|
3. |
Is RSO fulfilling his/her duties? |
|
4. |
To whom does RSO report? |
D. |
If the designated contact person for NRC changed, was
NRC notified? |
E. |
Sealed Sources and Devices |
|
1. |
Does the license authorize all of the NRC regulated radionuclides
contained in gauges? |
|
2. |
Are the gauges as described in the Sealed Source and Device (SSD)
Registration Certificate? |
|
3. |
Have copies of (or access to) SSD Certificates? |
|
4. |
Have manufacturers' or distributors manuals for operation and maintenance?
[10 CFR 32.210] |
|
5. |
Are the actual uses of gauges consistent with the authorized uses
listed on the license? |
|
6. |
Are the location of the gauges compatible with the "Conditions of
Normal Use" and "Limitations and/or Other Considerations of Use" on
the SSD Registration Certificates? |
Training and Instructions to Workers
A. |
Were all workers who are likely to exceed 1 mSv (100 mrem) in a
year instructed per 10 CFR 19.12? Refresher training provided, as
needed? [10 CFR 19.12] Records maintained? |
B. |
Did each AU receive training and instruction given at the time of
gauge installation or equivalent training and instruction before using
gauges? |
C. |
Are training records maintained for each AU? |
D. |
Did individuals who perform non-routine operations receive training
before performing these operations? |
E. |
Did interviews with AUs reveal that they know the emergency procedures? |
F. |
Did this audit include observations of AUs using the gauge? |
G. |
Did this audit include observations of workers performing routine
cleaning and lubrication on the gauge? |
H. |
HAZMAT training provided, if required? [49 CFR 172.700, 172.701,
172.702, 172.703, 172.704] |
Radiation Survey Instruments
A. |
If the licensee is required to possess a survey meter, does it meet
the NRC's criteria? [10 CFR 20.1501] |
B. |
Are calibration records maintained? [10 CFR 20.2103(a)] |
Gauge Inventory
A. |
Is a record kept showing the receipt of each gauge? [10 CFR 30.51(a)(1)] |
B. |
Are all gauges physically inventoried every 6 months? |
C. |
Are records of inventory results with appropriate information maintained? |
Personnel Radiation Protection
A. |
Are ALARA considerations incorporated into the radiation
protection program? [10 CFR 20.1101(b)] |
B. |
Were prospective evaluations performed showing that
unmonitored individuals receive 10% of limit? [10 CFR 20.1502(a)] |
C. |
Did unmonitored individuals' activities change during
the year that could put them over 10% of limit? |
D. |
If yes to C. above, was a new evaluation performed? |
E. |
Is external dosimetry required (individuals likely to
receive >10% of limit)? And is dosimetry provided to these individuals? |
|
1. |
Is the dosimetry supplier NVLAP approved? [10 CFR 20.1501(c)] |
|
2. |
Are the dosimeters exchanged monthly for film badges
and quarterly for TLDs? |
|
3. |
Are dosimetry reports reviewed by the RSO when they
are received? |
|
4. |
Are the records NRC Forms or equivalent? [10 CFR 20.2104(d),
20.2106(c)] |
|
|
a. |
NRC Form 4 "Cumulative Occupational Exposure History" completed? |
|
|
b. |
NRC Form 5 "Occupational Exposure Record for a Monitoring Period"
completed? |
|
5. |
Declared pregnant worker/embryo/fetus |
|
|
a. |
If a worker declared her pregnancy, did licensee comply with 10
CFR 20.1208? |
|
|
b. |
Were records kept of embryo/fetus dose per 10 CFR 20.2106(e)? |
F. |
Are records of exposures, surveys, monitoring, and evaluations
maintained? [10 CFR 20.2102, 20.2103, 20.2106] |
Public Dose
A. |
Is public access to gauges controlled in a manner to keep doses
below 1 mSv (100 mrem) in a year? [10 CFR 20.1301(a)(1)] |
B. |
Has a survey or evaluation been performed per 10 CFR 20.1501(a)?
Have there been any additions or changes to the storage, security,
or use of surrounding areas that would necessitate a new survey or
evaluation? |
C. |
Do unrestricted area radiation levels exceed 0.02 mSv (2 mrem) in
any one hour? [10 CFR 20.1301(a)(2)] |
D. |
Is gauge access controlled in a manner that would prevent unauthorized
use or removal? [10 CFR 20.1801] |
E. |
Records maintained? [10 CFR 20.2103, 20.2107] |
Operating and Emergency Procedures
A. |
Have operating and emergency procedures been developed? |
B. |
Do they contain the required elements? |
C. |
Does each individual working with the gauges have a
current copy of the operating and emergency procedures (including
lock-out procedures and emergency telephone numbers)? |
D. |
Is a lock-out warning sign posted at each entryway to
an area where it is possible to be exposed to the beam? |
E. |
Did any emergencies occur? |
|
1. |
If so, were they handled properly? |
|
2. |
Were appropriate corrective actions taken? |
|
3. |
Was NRC notification or reporting required? [10 CFR 20.2201, 20.2202,
20.2203] |
Leak Tests
A. |
Was each sealed source leak tested every 6 months or at other prescribed
intervals? |
B. |
Was the leak test performed according to the license? |
C. |
Are records of results retained with the appropriate information
included? |
D. |
Were any sources found leaking and if yes, was NRC notified? |
Maintenance of Gauges
A. |
Are manufacturer's or distributors procedures followed for routine
cleaning and lubrication of gauge? |
B. |
Was each on-off mechanism tested for proper operation every 6 months
or at other prescribed intervals? |
C. |
Are repair and maintenance of components related to the radiological
safety of the gauge performed by the manufacturer, distributor or
person specifically authorized by the NRC or an Agreement State and
according to license requirements (e.g., extent of work, procedures,
dosimetry, survey instrument, compliance with 10 CFR 20.1301 limits)? |
D. |
Are labels, signs, and postings identifying gauges containing radioactive
material, radiation areas, and lock-out procedures/warnings clean
and legible? |
Transportation
(Note: This section will not apply if you have not transported gauges
during the period covered by this audit.)
A. |
DOT-7A or other authorized packages used? [49 CFR 173.415, 173.416(b)] |
B. |
Package performance test records on file? |
C. |
Special form sources documentation? [49 CFR 173.476(a)] |
D. |
Package has two labels (ex. Yellow-II) with TI, Nuclide, Activity,
and Hazard Class? [49 CFR 172.403, 173.441] |
E. |
Package properly marked? [49 CFR 172.301, 172.304, 172.310, 172.324] |
F. |
Package closed and sealed during transport? [49 CFR 173.475(f)] |
G. |
Shipping papers prepared and used? [49 CFR 172.200(a)] |
H. |
Shipping papers contain proper entries? (Shipping name, Hazard Class,
Identification Number [UN Number], Total Quantity, Package Type, Nuclide,
RQ, Radioactive Material, Physical and Chemical Form, Activity [SI
units required], category of label, TI, Shipper's Name, Certification
and Signature, Emergency Response Phone Number, Cargo Aircraft Only
[if applicable]) [49 CFR 172.200, 172.201, 172.202, 172.203, 172.204,
172.604] |
I. |
Shipping papers within drivers reach and readily accessible during
transport? [49 CFR 177.817(e)]. |
J. |
Package secured against movement? [49 CFR 177.834] |
K. |
Placards on vehicle, if needed? [49 CFR 172.504] |
L. |
Proper overpacks, if used? [49 CFR 173.25] |
M. |
Any incidents reported to DOT? [49 CFR 171.15, 171.16] |
Auditor's Independent Survey Measurements (If Made)
A. |
Describe the type, location, and results of measurements. Does any
radiation level exceed regulatory limits? [10 CFR 20.1501(a) &
20.1502(a)] |
Notification and Reports
A. |
Was any radioactive material lost or stolen? Were reports made?
[10 CFR 20.2201, 30.50] |
B. |
Did any reportable incidents occur? Were reports made? [10 CFR 20.2202,
21.21, 30.34, 30.36, 30.50] |
C. |
Did any overexposures and high radiation levels occur? Reported?
[10 CFR 20.2203, 30.50] |
D. |
If any events (as described in items A through C above) did occur,
what was root cause? Were corrective actions appropriate? |
E. |
Is the management/RSO/shift foreman licensee aware of telephone
number for NRC Emergency Operations Center? [(301) 816-5100] |
Posting and Labeling
A. |
NRC Form 3 "Notice to Employees" posted? [10 CFR 19.11] |
B. |
NRC regulations, license documents posted or a notice posted? [10
CFR 19.11, 21.6] |
C. |
Other posting and labeling? [10 CFR 20.1902, 20.1904] |
Record Keeping for Decommissioning
A. |
Records kept of information important to decommissioning? [10 CFR
30.35(g)] |
B. |
Records include all information outlined in 10 CFR 30.35(g)? |
Bulletins and Information Notices
A. |
NRC Bulletins, NRC Information Notices, NMSS Newsletters, received? |
B. |
Appropriate training and action taken in response? |
Special License Conditions or Issues
A. |
Did auditor review special license conditions or other issues (e.g.,
non-routine operations)? |
Deficiencies Identified in Audit; Corrective Actions
A. |
Summarize problems/deficiencies identified during audit. |
B. |
If problems/deficiencies identified in this audit, describe corrective
actions planned or taken. Are corrective actions planned or taken
at ALL licensed locations (not just location audited)? Include date(s)
when corrective actions are implemented. |
C. |
Provide any other recommendations for improvement. |
Evaluation of Other Factors
A. |
Senior licensee management is appropriately involved with the radiation
protection program and/or RSO oversight? |
B. |
RSO has sufficient time to perform his/her radiation safety duties? |
C. |
Licensee has sufficient staff to support the radiation protection
program? |
Appendix I: Model Survey Instrument Calibration
Program
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Model Survey Instrument Calibration Program
Training
Before independently calibrating survey instruments, an individual should
complete both classroom and on-the-job training as follows:
- Classroom training may be in the form of lecture, videotape, or self-study
and will cover the following subject areas:
- Principles and practices of radiation protection
- Radioactivity measurements, monitoring techniques, and the use of
instruments
- Mathematics and calculations basic to using and measuring radioactivity
- Biological effects of radiation.
- On-the-job training will be considered complete if the individual
has:
- Observed authorized personnel performing survey instrument calibration;
and
- Conducted survey meter calibrations under the supervision, and in
the physical presence of an individual already authorized to perform
calibrations.
Facilities and Equipment
- To reduce doses received by individuals not calibrating instruments,
calibrations will be conducted in an isolated area of the facility or
at times when no one else is present
- Individuals conducting calibrations will wear assigned dosimetry
- Individuals conducting calibrations will use a calibrated and operable
survey instrument to ensure that unexpected changes in exposure rates
are identified and corrected.
Model Procedure for Calibrating Survey Instruments
- A radioactive sealed source(s) will be used for calibrating survey
instruments, and this source will:
- Approximate a point source
- Have its apparent source activity or the exposure rate at a given
distance traceable by documented measurements to a standard certified
to be within ± 5% accuracy by National Institutes of Standards and
Technology (NIST)
- Contain a radionuclide which emits radiation of identical or similar
type and energy as the sealed sources that the instrument will measure
- Be strong enough to emit a radiation field that is representative
of the field being emitted by the gauge. For calibration of instruments
intended to measure gamma radiation, the exposure rate should be at
least 30 mR/hour (7.7 microcoulomb/kilogram per hour) at 100
cm (e.g., 3.1 gigabecquerels [85 millicuries] of Cs-137 or 780 megabecquerels
[21 millicuries] of Co-60).
- Inverse square and radioactive decay laws must be used to correct
changes in exposure rate due to changes in distance or source decay.
- record must be made of each survey meter calibration.
- A single point on a survey meter scale may be considered satisfactorily
calibrated if the indicated exposure rate differs from the calculated
exposure rate by less than ±20%.
- There are three kinds of scales frequently used on radiation survey
meters. They are calibrated either as described in ANSI N323A-1996,
"American National Standard Radiation Protection Instrumentation Test
and Calibration - Portable Survey Instruments," or as follows:
- Meters on which the user selects a linear scale must be calibrated
at not fewer that two points on each scale. The points will be at
approximately 1/3 and 2/3 of the decade.
- Meters that have a multidecade logarithmic scale must be calibrated
at one point (at the least) on each decade and not fewer than two
points on one of the decades. Those points will be approximately 1/3
and 2/3 of the decade.
- Meters that have an automatically ranging digital display device
for indicating exposure rates must be calibrated at one point (at
the least) on each decade and at no fewer than two points on one of
the decades. Those points should be at approximately 1/3 and 2/3 of
the decade.
- Readings above 200 mR/hour (50 microcoulomb/kilogram per hour) need
not be calibrated. However, higher scales should be checked for operation
and approximately correct response.
- Survey meter calibration reports will indicate the procedure used
and the results of the calibration. The reports will include:
- The owner or user of the instrument
- A description of the instrument that includes the manufacturer's
name, model number, serial number, and type of detector
- A description of the calibration source, including the exposure
rate at a specified distance on a specified date, and the calibration
procedure
- For each calibration point, the calculated exposure rate, the indicated
exposure rate, the deduced correction factor (the calculated exposure
rate divided by the indicated exposure rate), and the scale selected
on the instrument
- The exposure reading indicated with the instrument in the "battery
check" mode (if available on the instrument)
- For instruments with external detectors, the angle between the radiation
flux field and the detector (i.e., parallel or perpendicular)
- For instruments with internal detectors, the angle between radiation
flux field and a specified surface of the instrument
- For detectors with removable shielding, an indication whether the
shielding was in place or removed during the calibration procedure
- The exposure rate from a check source, if used
- The signature of the individual who performed the calibration and
the date on which the calibration was performed.
- The following information will be attached to the instrument as a
calibration sticker or tag:
- The source that was used to calibrate the instrument
- The proper deflection in the battery check mode (unless this is
clearly indicated on the instrument)
- For each scale or decade not calibrated, an indication that the
scale or decade was checked only for function but not calibrated
- The date of calibration and the next calibration due date
- The apparent exposure rate from the check source, if used.
References: Detailed information about survey instrument calibration
may be obtained by referring to ANSI N323A-1996, "American National Standard
Radiation Protection Instrumentation Test and Calibration -Portable Survey
Instruments." Copies may be ordered electronically at <http://www.ansi.org>
or by writing to ANSI, 1430 Broadway, New York, NY 10018.
See the Notice of Availability (on the inside front cover of this report)
to obtain copies of Draft RG FC 413-4, "Guide for the Preparation of Applications
for Licenses for the Use of Radioactive Materials in Calibrating Radiation
Survey and Monitoring Instruments," dated June 1985.
Appendix J: Guidance for Demonstrating
That Unmonitored Individuals Are Not Likely to Exceed 10 Percent of the
Allowable Limits
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Guidance for Demonstrating That Unmonitored Individuals Are Not
Likely to Exceed 10 Percent of the Allowable Limits
Dosimetry is required for individuals likely to receive, in 1 year from
sources external to the body, a dose in excess of 10% of the applicable
regulatory limits in 10 CFR 20.1201. To demonstrate that dosimetry is
not required, a licensee needs to perform a prospective evaluation to
demonstrate that its workers are not likely to exceed 10% of the applicable
annual limits.
The most common way that individuals might exceed 10% of the applicable
limits is by performing frequent routine maintenance on the gauge. However,
for most gauges even these activities result in the individual receiving
minimal doses. Before allowing workers to perform these tasks, a licensee
will need to evaluate the doses which its workers might receive to assess
whether dosimetry is required; this is a prospective evaluation.
Example
One gauge manufacturer has estimated the doses to the extremities and
whole body of a person replacing the assay plate on one of its series
of gauges. Each gauge in the series is authorized to contain up to 7.4
gigabecquerels (200 millicuries) of Cs-137. The manufacturer based its
estimate on observations of individuals performing the recommended procedure
according to good radiation safety practices. The manufacturer had the
following types of information:
- Time needed to perform the entire procedure (e.g., 15 minutes)
- Expected dose rate received by the whole body of the individual, associated
with the shielded source and determined using measured or manufacturer-determined
data (e.g., 0.02 mSv/hr [2 mrem/hr] at 46 cm [18.1 in] from the
shield)
- Time the hands were exposed to the shielded source (e.g., 6 min)
- Expected dose rate received by the extremities of the individual,
associated with the shielded source and determined using measured or
manufacturer-determined data on contact with the shield (e.g., 0.15
mSv/hr [15 mrem/hr])
From this information, the manufacturer estimated that the individual
performing each routine cleaning and lubrication could receive the following:
- Less than 0.005 mSv (0.5 mrem) TEDE (whole body) and
- 0.015 mSv (1.5 mrem) to the hands.
The applicable TEDE (whole body) limit is 50 mSv (5 rems) per year and
10% of that value is 5 mSv (500 millirems) per year. If one of these procedures
delivers 0.005 mSv (0.5 mrem), then an individual could perform 1,000
of these procedures each year and remain within 10% of the applicable
limit.
The applicable shallow-dose equivalent (SDE) (extremities) is 500 mSv
(50 rems) is 500 mSv (50 rems) per year and 10% of that value is 50 mSv
(5 rems or 5000 millirems) per year. If one of these procedures delivers
0.015 mSv (1.5 mrem), then an individual could perform 3,333 of these
procedures each year and remain within 10% of the applicable limit.
Based on the above specific situation, no dosimetry is required if a
worker performs fewer than 1,000 routine maintenance procedures per year.
Guidance to Licensees
Licensees who wish to demonstrate that they are not required to provide
dosimetry to their workers need to perform prospective evaluations similar
to that shown in the example above. The expected dose rates, times, and
distances used in the above example may not be appropriate to individual
licensee situations. In their evaluations, licensees need to use information
appropriate to the type(s) of gauge(s) they intend to use; this information
is generally available from the gauge manufacturer or the SSD Registration
Certificate maintained by the NRC and Agreement States.
Table J.1 may be helpful in performing a prospective evaluation.
Licensees should review evaluations periodically and revise them as needed.
Licensees need to check assumptions used in their evaluations to ensure
that they continue to be up-to-date and accurate. For example, if workers
become lax in following good radiation safety practices, perform the task
more slowly than estimated, work with new gauges containing sources of
different activities or radionuclides, or use modified procedures, the
licensee would need to conduct a new evaluation.
Table J.1 Dosimetry Evaluation
Dosimetry Evaluation for __________ |
Model __________ |
Gauge __________ |
A. |
Time needed to perform the entire routine maintenance
procedure. |
______________ minutes/60 |
_____ hour |
B. |
Expected whole body dose rate received by the individual,
determined using exposure rates measured on contact with the gauge
while the sealed source is in the shielded position. |
______________ mrem/hr |
C. |
Time the hands were exposed to the shielded source. |
______________ minutes/60 |
_____ hour |
D. |
Expected extremity dose rate received by the individual,
determined using measured or manufacturer-provided data for the shielded
source at the typical distance from the hands to the shielded source. |
______________ mrem/hr |
Formula: ( _____ # hours in Row A) x ( _____ mrem/hr
in Row B) = ( _____ mrem per routine procedure) x ( _____ # of routine
maintenance procedures each year) = _____ mrem *Whole Body Dose |
Formula: ( _____ # hours in Row C) x ( _____ mrem/hr
in Row D) = ( _____ mrem per routine procedure) x ( _____ # of routine
maintenance procedures each year) = _____ mrem **Extremity Dose |
* Expected Whole Body Doses less than 500 mrem requires
no dosimetry
** Expected Extremity Doses less than 5000 mrem requires no dosimetry |
Appendix K: Guidance for Demonstrating
That Individual Members of the Public Will Not Receive Doses Exceeding
the Allowable Limits
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Guidance for Demonstrating That Individual Members of the Public
Will Not Receive Doses Exceeding the Allowable Limits
Licensees must ensure that
- The radiation dose received by individual members of the public does
not exceed 1 millisievert (1 mSv) [100 millirems (100 mrem)] in one
calendar year resulting from the licensee's possession and/or use of
licensed materials.
Members of the public include persons who live, work, or may be
near locations where fixed gauges are used or stored and employees
whose assigned duties do not include the use of licensed materials
and who work in the vicinity where gauges are used or stored. |
The radiation dose in unrestricted areas does not exceed 0.02 mSv (2
mrem) in any one hour.
Typical unrestricted areas may include offices, shops, laboratories,
a nearby walkway, an area near the gauge that requires frequent maintenance,
areas outside buildings, and nonradioactive equipment storage areas.
The licensee does not control access to these areas for purposes of
controlling exposure to radiation or radioactive materials. However,
the licensee may control access to these areas for other reasons such
as security. |
Licensees must show compliance with both portions of the regulation.
Calculations or a combination of calculations and measurements (e.g.,
using an environmental TLD) are often used to prove compliance.
Calculational Method
For ease of use by most fixed gauge licensees, the examples in this Appendix
use conventional units. The conversions to SI units are as follows: 1
ft = 0.305 m; 1 mrem = 0.01 mSv.
The calculational method takes a tiered approach, going through a three-part
process starting with a worst case situation and moving toward more realistic
situations. It makes the following simplifications:
- each gauge is a point source;
- typical radiation levels encountered when the source is in the shielded
position are taken from either the Sealed Source and Device (SSD)
Registration Certificate or the manufacturer's literature; and
- no credit is taken for any shielding found between the gauges and
the unrestricted areas.
Part 1 of the calculational method is simple but conservative. It assumes
that an affected member of the public is present 24 hours a day and uses
only the inverse square law to determine if the distance between the gauge
and the affected member of the public is sufficient to show compliance
with the public dose limits. Part 2 considers not only distance, but also
the time that the affected member of the public is actually in the area
under consideration. Part 3 considers distance and the portion of time
that both the gauge and the affected member of the public are present.
Using this approach, licensees make only those calculations that are needed
to demonstrate compliance. In many cases licensees will need to use the
calculational method through Part 1 or Part 2. The results of these calculations
typically result in higher radiation levels than would exist at typical
facilities, but provide a method for estimating conservative doses which
could be received.
Example 1
To better understand the calculational method, we will look at ABC Bottling,
Inc., a fixed gauge licensee. Yesterday, while on a walk-through during
product changeover, the company's president noted that three new gauges
will be very close to a bottling control panel where a quality control
supervisor, a worker who does not work with fixed gauges, works. The company's
president asked Joe, the Radiation Safety Officer (RSO), to determine
if the company is complying with NRC's regulations.
Joe measures the distances from each gauge to the bottling control panel
and looks up in the manufacturer's literature the radiation levels individuals
would encounter for each gauge. Figure K.1 is Joe's sketch of the areas
in question, and Table K-1 summarizes the information Joe has on each
gauge.
Figure K.1 Diagram of Bottling Line and Fixed Gauges.
This sketch shows the areas described in Examples 1 and 2.
Table K.1 Information Known About Each Gauge
Description of Known Information |
Gauge 1 |
Gauge 2 |
Gauge 3 |
Where gauge is located |
Gauge on bottling line |
Gauge on main feed line |
Gauge on tank |
Dose rate in mrem/hr encountered at specified distance
from the gauge (from manufacturers literature) |
2 mrem/hr at 1 ft |
8 mrem/hr at 1 ft |
2 mrem/hr at 3 ft |
Distance in ft to bottling control panel |
8 ft |
12 ft |
15 ft |
Example 1: Part 1
Joe's first thought is that the distance between the gauges and the bottling
control panel may be sufficient to show compliance with the regulation
in 10 CFR 20.1301. So, taking a worst case approach, he assumes (1) the
gauges are constantly present (i.e., 24 hr/d), (2) all three gauges are
on (i.e., shutters are open), and (3) a quality control (QC) supervisor,
a worker who does not work with the fixed gauges, is constantly sitting
at the control panel (i.e., 24 hr/d). Joe proceeds to calculate the dose
the QC supervisor might receive hourly and yearly from each gauge as shown
in Tables K-2, K-3, and K-4 below.
Table K.2 Calculational Method, Part 1: Hourly and Annual Dose
Received from Gauge 1
|
Gauge 1 |
Step No. |
Description |
Input Data |
Results |
1 |
Dose received in an hour at known distance from gauge (e.g., from
manufacturer's data), in mrem/hr |
2 |
2 |
2 |
Square of the distance (ft) at which the Step 1 rate was measured,
in ft2 |
(1)2 |
1 |
3 |
Square of the distance (ft) from the gauge to the bottling control
panel in an unrestricted area, in ft2 |
(8)2 |
64 |
4 |
Multiply the results of Step 1 by the results of Step 2 (this is
an intermediate result) |
2 x 1 =2 |
5 |
Divide the result of Step 4 by the result of Step 3 to calculate
the dose received by the worker at the bottling control panel, HOURLY
DOSE RECEIVED FROM GAUGE 1, in mrem in an hour. |
2/64 = 0.031 |
6 |
Multiply the result of Step 5 by 24 hr/d x 365 d/yr = MAXIMUM ANNUAL
DOSE RECEIVED FROM GAUGE 1, in mrem in a year. |
0.031 x 24 x 365 = 0.031 x 8760 = 272 |
Table K.3 Calculational Method, Part 1: Hourly and Annual Dose
Received from Gauge 2
|
Gauge 2 |
Step No. |
Description |
Input Data |
Results |
1 |
Dose received in an hour at known distance from gauge (e.g., from
manufacturer's data), in mrem/hr |
8 |
8 |
2 |
Square of the distance (ft) at which the Step 1 rate was measured,
in ft2 |
(1) 2 |
1 |
3 |
Square of the distance (ft) from the gauge to the bottling control
panel in an unrestricted area, in ft2 |
(12) 2 |
144 |
4 |
Multiply the results of Step 1 by the results of Step 2 (this is
an intermediate result) |
8 x 1 = 8 |
5 |
Divide the result of Step 4 by the result of Step 3 to calculate
dose received in an hour by the worker at the bottling control panel,
HOURLY DOSE RECEIVED FROM GAUGE 2, in mrem in an hour |
8/144 = .056 |
6 |
Multiply the result of Step 5 by 24 hr/d x 365 d/yr = MAXIMUM ANNUAL
DOSE RECEIVED FROM GAUGE 2, in mrem in a year |
0.056 x 24 x 365 = 0.056 x 8760 = 491 |
Table K.4 Calculational Method, Part 1: Hourly and Annual Dose Received
from Gauge 3
|
Gauge 3 |
Step No. |
Description |
Input Data |
Results |
1 |
Dose received in an hour at known distance from gauge (e.g., from
manufacturer's data), in mrem/hr |
|
2 |
2 |
Square of the distance (ft) at which the Step 1 rate was measured,
in ft2 |
(3)2 |
9 |
3 |
Square of the distance (ft) from the gauge to bottling control panel
in an unrestricted area, in ft2 |
(15)2 |
225 |
4 |
Multiply the results of Step 1 by the results of Step 2 (this is
an intermediate result) |
2 x 9 =18 |
5 |
Divide the result of Step 4 by the result of Step 3 to calculate
dose received by the worker at the bottling control panel, HOURLY
DOSE RECEIVED FROM GAUGE 3, in mrem in an hour |
18/225 = 0.08 |
6 |
Multiply the result of Step 5 by 24 hr/d x 365 d/yr = MAXIMUM ANNUAL
DOSE RECEIVED FROM GAUGE 3, in mrem in a year |
0.08 x 24 x 365 = 0.08 x 8760 = 701 |
To determine the total hourly and total annual dose received, Joe adds
the pertinent data from the preceding tables.
Table K.5 Calculational Method, Part 1: Total Hourly and Annual
Dose Received from Gauges 1, 2, and 3
Step No. |
Description |
Gauge 1 |
Gauge 2 |
Gauge 3 |
Sum |
7 |
TOTAL HOURLY DOSE RECEIVED from Step 5 of Tables
K-2, K-3, and K-4, in mrem in an hour |
0.031 |
0.056 |
0.08 |
0.031 + 0.056 + 0.08 = 0.167 |
8 |
TOTAL ANNUAL DOSE RECEIVED from Step 6 of Tables
K-2, K-3, and K-4, in mrem in a year |
272 |
491 |
701 |
272 + 491 + 701 = 1464 |
Note: The Sum in Step 7 demonstrates
compliance with the 2 mrem in any one hour limit. Reevaluate if assumptions
change. If the Sum in Step 8 exceeds 100 mrem/yr, proceed to Part
2 of the calculational method. |
At this point, Joe is pleased to see that the total dose that an individual
could receive in any one hour is only 0.167 mrem, but notes that an individual
could receive a dose of 1,464 mrem in a year, much higher than the 100
mrem limit.
Example 1: Part 2
Joe reviews his assumptions and recognizes that the QC supervisor is
not at the bottling control panel 24 hr/d. He decides to make a realistic
estimate of the number of hours the QC supervisor would be present at
the bottling control panel, keeping his other assumptions constant (i.e.,
the gauges are constantly present [i.e., 24 hr/d], all three gauges remain
on [i.e., shutter is open]). He then recalculates the annual dose received.
Table K.6 Calculational Method, Part 2: Annual Dose Received
from Gauges 1, 2, and 3
Step No. |
Description |
Results |
9 |
A. Average number of hours per day that individual spends in area
of concern (e.g., worker present at bottling control panel 5 hr/day;
the remainder of the day the worker is away from the area performing
other duties that are not in the vicinity of gauges)
B. Average number of days per week in area (e.g., worker is part
time and works 3 days/week)
C. Average number of weeks per year in area (e.g., worker works
all year ) |
5
3
52 |
10 |
Multiply the results of Step 9.A. by the results of Step 9.B. by
the results of Step 9.C. = AVERAGE NUMBER OF HOURS IN AREA
OF CONCERN PER YEAR |
5 x 3 x 52 = 780 |
11 |
Multiply the sum in Step 7 by the results of Step 10 = ANNUAL
DOSE RECEIVED FROM GAUGES CONSIDERING REALISTIC ESTIMATE OF TIME SPENT
IN AREA OF CONCERN, in mrem in a year |
0.167 x 780 = 130 |
Note: If Step 11 exceeds 100
mrem in a year, proceed to Part 3 of the calculational method. |
Although Joe is pleased to note that the calculated annual dose received
is significantly lower, he realizes it still exceeds the 100 mrem in a
year limit.
Example 1, Part 3
Again Joe reviews his assumptions and recognizes that Gauge 3 will only
be used on the process line during product changeovers and Gauge 2 has
different radiation levels depending on whether the gauge is in the on
or off position (i.e., shutter is open or closed). As he examines the
situation, he realizes he must consider each gauge individually.
Table K.7 Calculational Method, Part 3: Summary of Information
INFORMATION ON GAUGES:
- Gauge 1 operates continuously (24 hrs/day)
on the bottling line.
- Gauge 2 operates (in the "on" position) while
the tank is being filled, approximately 1 hour during the time
the worker is present. When the pipe is not filling the tank,
the gauge is in the "off" position. While in the "off" position,
the radiation level around the gauge drops to 2 mrem/hr at 1ft,
one-fourth of the radiation level as when the gauge is in the
"on" position.
- Gauge 3 is only used on the process line during
product changeovers, 4 weeks per year. While affixed, it operates
continuously (24 hrs/day).
INFORMATION FROM EXAMPLE 1, PART 2, ON WHEN THE WORKER
IS PRESENT AT THE BOTTLING CONTROL PANEL:
|
Table K.8 Calculational Method, Part 3: Annual Dose Received from Gauges
1, 2, and 3
Step No. |
Description |
Gauge 1 |
Gauge 2 "On" |
Gauge 2 "Off" |
Gauge 3 |
12 |
Average number of hours per day gauge operates when worker is present
at the bottling control panel |
5 |
1 |
4 |
5 |
13 |
Average number of days per week gauge operates when worker is present
at the bottling control panel |
3 |
3 |
3 |
3 |
14 |
Average number of weeks per year gauge operates when worker is present
at the bottling control panel |
52 |
52 |
52 |
4 |
15 |
Multiply the results of Step 12 by the results of Step 13 by the
results of Step 14 = TOTAL HOURS EACH GAUGE OPERATED PER YEAR WHILE
WORKER IS PRESENT AT BOTTLING CONTROL PANEL |
5 x 3 x 52 = 780 |
1 x 3 x 52 = 156 |
4 x 3 x 52 = 624 |
5 x 3 x 4 = 60 |
16 |
Multiply the results of Step 15 by the results of Step 7 (for Gauge
2 in the "off" position, the radiation level drops to 1/4th, so divide
the results of Step 7 by 4) = ANNUAL DOSE RECEIVED FROM EACH GAUGE,
in mrem in a year |
780 x 0.031 = 24 |
156 x 0.056 = 8.7 |
624 x (0.056/4) = 8.7 |
60 x 0.08 = 4.8 in mrem in a year |
17 |
Sum the results of Step 16 for each gauge = TOTAL ANNUAL DOSE RECEIVED
CONSIDERING REALISTIC ESTIMATE OF TIME SPENT IN AREA OF CONCERN AND
TIME GAUGE OPERATES, in mrem in a year |
24 + 8.7 + 8.7 + 4.8 = 46.2 |
Note: If the result in Step 17 is greater than 100 mrem/yr,
the licensee must take corrective actions. |
Joe is pleased that the result in Step 17 shows compliance with the 100
mrem/yr limit. Had the result in Step 17 been higher than 100 mrem/yr,
then Joe could have done one or more of the following:
- Consider whether the assumptions used to determine occupancy and the
time each gauge operates are accurate, revise the assumptions as needed,
and recalculate using the new assumptions
- Calculate the effect of any shielding located between the gauges and
the bottling control panel -- such calculation is beyond the
scope of this Appendix
- Take corrective action (e.g., add shielding, move the bottling control
panel) and perform new calculations to demonstrate compliance
- Train the QC supervisor as required by 10 CFR 19.12.
Note that in the example, Joe evaluated the unrestricted area at the
bottling control panel. Licensees also need to make similar evaluations
for other unrestricted areas and to keep in mind the ALARA principle,
taking reasonable steps to keep radiation dose received below regulatory
requirements. In addition, licensees need to be alert to changes in situations
(e.g., adding a gauge to the process line, changing the QC supervisor's
schedule, or changing the estimate of the portion of time spent at the
bottling control panel) and to perform additional evaluations, as needed.
RECORD KEEPING: 10 CFR 20.2107 requires licensees to maintain records
demonstrating compliance with the dose limits for individual members
of the public. |
Combination Measurement - Calculational Method
This method, which allows the licensee to take credit for shielding between
the gauge and the area in question, begins by measuring radiation levels
in the areas, as opposed to using manufacturer-supplied rates at a specified
distance from each gauge. These measurements must be made with calibrated
survey meters sufficiently sensitive to measure background levels of radiation.
A maximum dose of 1 mSv (100 mrem) received by an individual over a period
of 2080 hours (i.e., a work year of 40 hr/wk for 52 wk/yr) is equal to
less than 0.5 microsievert (0.05 mrem) per hour.
This rate is well below the minimum sensitivity of most commonly
available G-M survey instruments. |
Instruments used to make measurements for calculations must be sufficiently
sensitive. An instrument equipped with a scintillation-type detector (e.g.,
NaI(Tl)) or a micro-R meter used in making very low gamma radiation measurements
should be adequate.
Licensees may also choose to use environmental TLDs. TLDs used for personnel
monitoring (e.g., LiF) may not have sufficient sensitivity for this purpose.
Generally, the minimum reportable dose received is 0.1 mSv (10 mrem).
Suppose a TLD monitors dose received and is changed once a month. If the
measurements are at the minimum reportable level, the annual dose received
could have been about 1.2 mSv (120 mrem), a value in excess of the 1 mSv/yr
(100 rem/yr) limit. If licensees use TLDs to evaluate compliance with
the public dose limits, they should consult with their TLD supplier and
choose more sensitive TLDs, such as those containing CaF2 that are used
for environmental monitoring. This direct measurement method would provide
a definitive measurement of actual radiation levels in unrestricted areas
without any restrictive assumptions. Records of these measurements can
then be evaluated to ensure that rates in unrestricted areas do not exceed
the 1 mSv/yr (100 mrem/yr) limit.
Example 2
As in Example 1, Joe is the RSO for ABC Bottling, Inc., a fixed gauge
licensee. The company has three gauges located near a bottling control
panel which is operated by a worker who does not work with the fixed gauges.
See Figure K.1 and Table K-1 for information. Joe wants to see if the
company complies with the public dose limits at the bottling control panel.
Joe placed an environmental TLD badge at the bottling control panel for
30 days. The TLD processor sent Joe a report indicating the TLD received
100 mrem.
Table K.9 Combination Measurement - Calculational Method
Step No. |
Description |
Input Data and Results |
Part 1 |
1 |
Dose received by TLD, in mrem |
100 |
2 |
Total hours TLD exposed |
24 hr/d x 30 d/mo = 720 |
3 |
Divide the results of Step 1 by the results of Step 2 to determine
HOURLY DOSE RECEIVED, in mrem in 1 hour |
0.14 |
4 |
Multiply the results of Step 3 by 365 d/yr x 24 hr/d = 8760 hours
in one year = MAXIMUM ANNUAL DOSE RECEIVED FROM GAUGES, in mrem in
1 year |
365 x 24 x 0.14 = 8760 x 0.14 = 1226 |
Note: For the conditions described above, Step 3 indicates
that the dose received in any one hour is less than the 2 mrem in
any 1 hour limit. However, if there are any changes, then the licensee
would need to reevaluate the potential doses which could be received
in any one hour. Step 4 indicates that the annual dose received would
be much greater than the 100 mrem in a year allowed by the regulations. |
Part 2 |
At this point Joe can adjust for a realistic estimate
of the time the worker spends at the bottling control panel as he
did in Part 2 of Example 1. |
Part 3 |
If the results of Joe's evaluation in Part 2 show that
the annual dose received in a year exceeds 100 mrem, then he can make
adjustments for realistic estimates of the time spent in the area
of concern as in Part 3 of Example 1. (Recall that the TLD measurement
was made while all the gauges were operating: i.e., 24 hr/d for the
30 days that the TLD was in place.) |
Appendix L: Operating and Emergency Procedures
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Operating and Emergency Procedures
Operating Procedures:
- If personnel dosimetry is provided:
- Always wear your assigned thermoluminescent dosimeter (TLD) or film
badge when using the gauge.
- Never wear another person's TLD or film badge.
- Never store your TLD or film badge near the gauge.
- Use the gauge according to the manufacturer's or distributors instructions
and recommendations. Perform routine cleaning and maintenance according
to the manufacturer's or distributors instructions and recommendations.
- Test each gauge for the proper operation of the on-off mechanism (shutter)
and indicator, if any, at intervals not to exceed 6 months or as specified
in the SSD certificate.
- Do not touch the unshielded source with your fingers, hands, or any
part of your body.
- Do not place hands, fingers, feet, or other body parts in the radiation
field from an unshielded source.
- Post a radiation warning sign at each entryway to an area where it
is possible to be exposed to the beam.
- Prevent employees from entering the radiation beam during maintenance,
repairs, or work in, on, or around the bin, tank, or hopper on which
the device is mounted by developing lock-out procedures. These procedures
should specify who will be responsible for ensuring that the lock-out
procedures are followed.
- Prevent unauthorized access, removal, or use of the gauge.
- After making changes affecting the gauge (e.g., changing the location
of gauges , removing shielding, adding gauges, changing the occupancy
of adjacent areas), reevaluate compliance with public dose limits
and ensure proper security of gauges.
- Conduct a physical inventory every 6 months to account for all sealed
sources and devices.
Emergency Procedures:
- If the gauge becomes damaged or if any other emergency or unusual
situation arises:
- Stop use of the gauge.
- Immediately secure the area and keep people away from the gauge
until the situation is assessed and radiation levels are known. However,
perform first aid for any injured individuals and remove them from
the area only when medically safe to do so.
- If any equipment is involved, isolate the equipment until it is
determined there is no contamination present.
- Gauge users and other potentially contaminated individuals should
not leave the scene until emergency assistance arrives.
- Notify the persons in the order listed below of the situation:
NAME (2) |
WORK PHONE NUMBER 2 |
HOME PHONE NUMBER 2 |
__________________ |
__________________ |
__________________ |
__________________ |
__________________ |
__________________ |
__________________ |
__________________ |
__________________ |
- Follow the directions provided by the person contacted above.
RSO and Licensee Management:
- Arrange for a radiation survey to be conducted as soon as possible
by a knowledgeable person using appropriate radiation detection instrumentation.
This person could be a licensee employee using a survey meter, a local
emergency responder or a consultant. To accurately assess the radiation
danger, it is essential that the person performing the survey be competent
in the use of the survey meter.
- Make necessary notifications to local authorities as well as the NRC
as required. Appendix P contains typical NRC incident notifications
required for fixed gauge licensees. (Even if not required to do so,
you may report ANY incident to NRC by calling NRC's Operations Center
at 301-816-5100 or 301-951-0550, which is staffed 24 hours a day and
accepts collect calls.) NRC notification is required when gauges containing
licensed material are lost or stolen and when gauges are damaged or
involved in incidents that result in doses in excess of 10 CFR 20.2203
limits. Reporting requirements are found in 10 CFR 20.2201-2203 and
10 CFR 30.50.
Copies of operating and emergency procedures must be posted at each
location of use or if posting procedures is not practicable, a notice
which briefly describes the procedures and states where they may be
examined may be posted instead. |
Copies of operating and emergency procedures should be provided
to all gauge users. |
Appendix M: Model Leak Test Program
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Model Leak Test Program
Training
Before allowing an individual to perform leak testing, the RSO will ensure
that he or she has sufficient classroom and on-the-job training to show
competency in performing leak tests independently.
Classroom training may be in the form of lecture, videotape, or self-study
and will cover the following subject areas:
- Principles and practices of radiation protection
- Radioactivity measurements, monitoring techniques, and the use of
instruments
- Mathematics and calculations basic to the use and measurement of radioactivity
- Biological effects of radiation.
Appropriate on-the-job-training consists of
- Observing authorized personnel collecting and analyzing leak test
samples
- Collecting and analyzing leak test samples under the supervision and
in the physical presence of an individual authorized to perform leak
tests.
Facilities and Equipment
- To ensure achieving the required sensitivity of measurements, leak
tests will be analyzed in a low-background area.
- Individuals conducting leak tests will use a calibrated and operable
survey instrument to check leak test samples for gross contamination
before they are analyzed.
- A NaI(Tl) well counter system with a single or multichannel analyzer
will be used to count samples from gauges containing gamma-emitters
(e.g., Cs-137, Co-60).
- A liquid scintillation or gas-flow proportional counting system will
be used to count samples from gauges containing beta-emitters (e.g.,
Sr-90) or alpha emitters (e.g., Am-241).
Frequency for Conducting Leak Tests of Sealed Sources
- Leak tests will be conducted at the frequency specified in the respective
SSD Registration Certificate.
Procedure for Performing Leak Testing and Analysis
- For each source to be tested, list identifying information such as
gauge serial number, radionuclide, activity.
- If available, use a survey meter to monitor exposure.
- Prepare a separate wipe sample (e.g., cotton swab or filter paper)
for each source.
- Number each wipe to correlate with identifying information for each
source.
- Wipe the most accessible area where contamination would accumulate
if the sealed source were leaking.
- Select an instrument that is sensitive enough to detect 185 Bq (0.005
microcurie) of the radionuclide contained in the gauge.
- Using the selected instrument count and record background count rate.
- Check the instrument's counting efficiency using standard source of
the same radionuclide as the source being tested or one with similar
energy characteristics. Accuracy of standards should be within ±5%
of the stated value and traceable to a primary radiation standard such
as those maintained by the National Institutes of Standards and Technology
(NIST).
- Calculate efficiency.
For example:
[(cpm from std) - (cpm from bkg)] = efficiency in cpm/Bq
activity of std in Bq |
|
where: |
cpm = counts per minute
std = standard
bkg = background
Bq = Becquerel |
|
- Count each wipe sample; determine net count rate.
- For each sample, calculate and record estimated activity in Bq (or
microcuries).
For example:
[(cpm from wipe sample) - (cpm from bkg)] = Bq on wipe sample
efficiency in
cpm/Bq |
|
- Sign and date the list of sources, data and calculations. Retain records
for 3 years.
- If the wipe test activity is 185 Bq (0.005 microcurie) or greater,
notify the RSO, so that the source can be withdrawn from use and disposed
of properly. Also notify NRC.
Reference: See the Notice of Availability (on the inside front cover
of this report) to obtain a copy of Draft RG FC 412-4, "Guide for the
Preparation of Applications for Licenses for the Use of Radioactive Materials
in Leak-Testing Services," dated June 1985.
Appendix N: Information Needed to Support
Applicant's Request to Perform Non-Routine Operations
[ Prev | Next
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Information Needed to Support Applicant's Request to Perform
Non-Routine Operations
Applicants should review the section in this document on "Maintenance,"
which discusses, in general, licensee responsibilities before any maintenance
or repair is performed.
Non-routine operations include installation of the gauge, initial radiation
survey, repair or maintenance involving or potentially affecting components,
including electronics, related to the radiological safety of the gauge
(e.g., the source, source holder, source drive mechanism, shutter, shutter
control, or shielding), gauge relocation, replacement, and disposal of
sealed sources, alignment, removal of a gauge from service, and any other
activities during which personnel could receive radiation doses exceeding
NRC limits. See Figure 8.9.
Any non-manufacturer/non-distributor supplied replacement components
or parts, or the use of materials (e.g., lubricants) other than those
specified or recommended by the manufacturer or distributor need to be
evaluated to ensure that they do not degrade the engineering safety analysis
performed and accepted as part of the device registration. Licensees also
need to ensure that, after maintenance or repair is completed, the gauge
is tested and functions as designed, before the unit is returned to routine
use.
If non-routine operations are not performed properly with attention to
good radiation safety principles, the gauge may not operate as designed
and personnel performing these tasks could receive radiation doses exceeding
NRC limits. Radionuclides and activities in fixed gauges vary widely.
For illustrative purposes in less than one minute, an unshielded cesium-137
source with an activity of 100 millicuries can deliver 0.05 Sv (5 rems)
to a worker's hands or fingers (i.e., extremities), assuming the extremities
are 1 centimeter from the source. However, gauges can contain sources
of even higher activities with correspondingly higher dose rates. The
threshold for extremity monitoring is 0.05 Sv (5 rems) per year.
Thus, applicants wishing to perform non-routine operations must use personnel
with special training and follow appropriate procedures consistent with
the manufacturer's or distributors instructions and recommendations that
address radiation safety concerns (e.g., use of radiation survey meter,
shielded container for the source, and personnel dosimetry (if required)).
Accordingly, provide the following information:
Describe the types of work, maintenance, cleaning, repair that involve
- Installation, relocation, or alignment of the gauge
- Components, including electronics, related to the radiological safety
of the gauge (e.g., the source, source holder, source drive mechanism,
shutter, shutter control, or shielding)
- Replacement and disposal of sealed sources
- Removal of a gauge from service
- A potential for any portion of the body to come into contact with
the primary radiation
beam; or
- Any other activity during which personnel could receive radiation
doses exceeding NRC limits.
The principal reason for obtaining this information is to assist in the
evaluation of the qualifications of individuals who will conduct the work
and the radiation safety procedures they will follow.
A licensee may initially mount a gauge, without specific NRC or
Agreement State authorization, if the gauge's SSD Certificate explicitly
permits mounting of gauges by users and under the following conditions:
- The gauge must be mounted according to written instructions
provided by the manufacturer or distributor;
- The gauge must be mounted in a location compatible with the
"Conditions of Normal Use" and "Limitations and/or Other Considerations
of Use" in the certificate of registration issued by NRC or an
Agreement State;
- The on-off mechanism (shutter) must be locked in the off position,
if applicable, or the source must be otherwise fully shielded;
- The gauge must be received in good condition (package was not
damaged); and
- The gauge must not require any modification to fit in the proposed
location.
Mounting does not include electrical connection, activation, or
operation of the gauge. The source must remain fully shielded and
the gauge may not be used until it is installed and made operational
by a person specifically licensed by the Commission or an Agreement
State to perform such operations. |
- Identify who will perform non-routine operations and their training
and experience. Acceptable training would include manufacturer's or
distributors courses for non-routine operations or equivalent.
- Submit procedures for non-routine operations. These procedures should
ensure the following:
- doses to personnel and members of the public are within regulatory
limits and ALARA (e.g., use of shielded containers or shielding);
- the source is secured against unauthorized removal or access or
under constant surveillance;
- appropriate labels and signs are used;
- manufacturer's or distributors instructions and recommendations
are followed;
- any non-manufacturer/non-distributor supplied replacement components
or parts, or the use of materials (e.g., lubricants) other than those
specified or recommended by the manufacturer or distributor are evaluated
to ensure that they do not degrade the engineering safety analysis
performed and accepted as part of the device registration; and
- before being returned to routine use, the gauge is tested to verify
that it functions as designed and source integrity is not compromised.
- Confirm that individuals performing non-routine operations on gauges
will wear both whole body and extremity monitoring devices or perform
a prospective evaluation demonstrating that unmonitored individuals
performing non-routine operations are not likely to receive, in one
year, a radiation dose in excess of 10% of the allowable limits.
- Verify possession of at least one survey instrument that meets the
criteria in "Radiation Safety Program - Instruments in NUREG-1556, Vol.
4, 'Consolidated Guidance about Materials Licenses: Program-Specific
Guidance About Fixed Gauges Licenses,' dated October 1998."
- Describe steps to be taken to ensure that radiation levels in areas
where non-routine operations will take place do not exceed 10 CFR 20.1301
limits. For example, applicants can do the following:
- commit to performing surveys with a survey instrument (as described
above);
- specify where and when surveys will be conducted during non-routine
operations; and
- commit to maintaining, for 3 years from the date of the survey,
records of the survey (e.g., who performed the survey, date of the
survey, instrument used, measured radiation levels correlated to location
of those measurements), as required by 10 CFR 20.2103.
Appendix O: Major DOT Regulations; Sample
Shipping Documents, Placards and Labels
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| Top of file ]
Major DOT Regulations; Sample Shipping Documents, Placards and
Labels
The major areas in the DOT regulations that are most relevant for transportation
of typical fixed gauges that are shipped as Type A quantities are as follows:
- Hazardous Materials Table, 49 CFR 172.101, Appendix A, list of hazardous
substances and reportable quantities (RQ), Table 2: radionuclides
- Shipping Papers 49 CFR 172.200, 172.201, 172.202, 172.203, 172.204:
general entries, description, additional description requirements, shipper's
certification
- Package Markings 49 CFR 172.300, 172.301, 172.303, 172.304, 172.310,
172.324: General marking requirements for non-bulk packagings, prohibited
marking, marking requirements, radioactive material, hazardous substances
in non-bulk packaging
- Package Labeling 49 CFR 172.400, 172.401, 172.403, 172.406, 172.407,
172.436, 172.438, 172.440: General labeling requirements, prohibited
labeling, radioactive materials, placement of labels, specifications
for radioactive labels
- Placarding of Vehicles 49 CFR 172.500, 172.502, 172.504, 172.506,
172.516, 172.519, 172.556: Applicability, prohibited and permissive
placarding, general placarding requirements, providing and affixing
placards: highway, visibility and display of placards, specifications
for RADIOACTIVE placards
- Emergency Response Information, Subpart G, 49 CFR 172.600, 172.602,
172.604: Applicability and general requirements, emergency response
information, emergency response telephone number
- Training, Subpart H, 49 CFR 172.702, 172.704: Applicability and responsibility
for training and testing, training requirements
- Radiation Protection Program for Shippers and Carriers, Subpart I,
49 CFR 172.801, 172.803, 172.805: Applicability of the radiation protection
program, radiation protection program, recordkeeping, and notifications
- Shippers - General Requirements for Shipments and Packaging, Subpart
I, 49 CFR 173.403, 173.410, 173.412, 173.415, 173.431, 173.433, 173.435,
173.441, 173.443, 173.448, 173.475, 173.476: Definitions, general design
requirements, additional design requirements for Type A packages, authorized
Type A packages, activity limits for Type A… packages, requirements
for determining A1 and A2…, table of A1 and A2 values for radionuclides,
radiation level limitations, contamination control, general transportation
requirements, quality control requirements prior to each shipment, approval
of special form radioactive materials
- Carriage by Public Highway - General Information and Regulations,
Subpart A, 49 CFR 177.816, 177.817, 177.834(a), 177.842: Driver
training, shipping paper, general requirements (secured against movement),
Class 7 (radioactive) material.
Note: Type B shipping packages transport quantities
of radionuclides greater than Type A allowable quantities. Requirements
for Type B packages are in 10 CFR Part 71.
Hazard Communications
for Class 7 (Radioactive) Materials Marking
Packages (49 CFR 172.300-338)
Note: IAEA, ICAO, and IMO may require additional hazard communication
information for international shipments.
This table must not be used as a substitute for the DOT and NRC
regulations on the transportation of radioactive materials. |
Markings Always Required
Unless Excepted |
Additional Markings
Sometimes Required |
Optional Markings |
Non-Bulk Packages
- U.N. identification number
- Name and address of consignor or consignee, unless:
- highway only and no motor carrier transfers, or
- part of carload or truckload lot or freight container load, and
entire contents of railcar, truck, or freight container are shipped
from one consignor to one consignee [see § 172.301(d)]
|
Materials-Based Requirements
- If in excess of 110 lbs (50 kg), gross weight
- If non-bulk liquid package, underlined double arrows
indicating upright orientation (two opposite sides) [ISO Std 780-1985
marking]
- If a Hazardous substance in non-bulk package, the letters "RQ"
in association with the proper shipping name
Package-Based Requirements
- The package type if Type A or Type B (½" or greater letters)
- The specification-required markings [e.g., for Spec. 7A packages:
"DOT 7A Type A" and "Radioactive Material" (see § 178.350-353)]
- For approved packages, the certificate ID number (e.g., USA/9166/B(U), USA/9150/B(U)-85, etc.)
- If Type B, the trefoil (radiation) symbol per Part 172 App.
B [size: outer radius > 20 mm (0.8 in)]
- For NRC certified packages, the model number, gross weight,
and package ID number (10 CFR 71.85)
Administrative-Based Requirements
- If a DOT exemption is being used, "DOT-E" followed by the exemption
number
- If an export shipment, "USA" in conjunction with the specification
markings or certificate markings
|
- "IP-1," "IP-2," or "IP-3" on industrial packaging is recommended
- Both the name and address of consignor and consignee are recommended
- Other markings (e.g., advertising) are permitted, but must be
sufficiently away from required markings and labeling
|
Bulk Packages (i.e., net capacity greater than 119 gallons
as a receptacle for liquid or 119 gallons and 882 pounds as a receptacle
for solid, or water capacity greater than 1000 lbs, with no consideration
of intermediate forms of containment)
- U.N. identification number, on orange, rectangular panel (see
§ 172.332) -- some exceptions exist
|
Some Special
Considerations/Exceptions for Marking Requirements |
- Marking is required to be (1) durable, (2) printed on a package,
label, tag, or sign, (3) unobscured by labels or attachments,
(4) isolated from other marks, and (5) representative of the
hazmat contents of the package.
- Limited Quantity (§ 173.421) packages and Articles Containing
Natural Uranium and Thorium (§ 173.426) must bear the marking "radioactive"
on the outside of the inner package or the outer package itself,
and are excepted from other marking. The excepted packages shipped
under U.N. 2910 must also have the accompanying statement that is
required by § 173.422.
- Empty (§ 173.428) and Radioactive Instrument and Article (§ 173.424)
packages are excepted from marking.
- Shipment of LSA or SCO required by § 173.427 to be consigned
as exclusive use are excepted from marking except that the exterior
of each nonbulk package must be marked "Radioactive-LSA"
or "Radioactive-SCO," as appropriate. Examples
of this category are domestic, strong-tight containers with less
than an A2 quantity and domestic NRC certified
LSA/SCO packages using 10 CFR 71.52.
- For bulk packages, marking may be required on more than one
side of the package (see 49 CFR 172.302(a)).
|
Hazard Communications
for Class 7 (Radioactive) Materials DOT Shipping
Papers (49 CFR 172.200-205)
Note: IAEA, ICAO, and IMO may require additional hazard communication
information for international shipments.
This table must not be used as a substitute for the DOT and NRC
regulations on the transportation of radioactive materials. |
Entries Always Required
Unless Excepted |
Additional Entries Sometimes
Required |
Optional Entries |
- The basic description, in sequence:
Proper Shipping Name,
Hazard Class (7),
U.N. Identification Number
- 24 hour emergency response telephone number
- Proper page numbering
(e.g., Page 1 of 4)
- Except for empty and bulk packages, the total quantity
(mass, or volume for liquid), in appropriate units (lbs, mL....)
- If not special form, chemical and physical form
- The name of each radionuclide (95% rule) and
total package activity. The activity must be in SI units (e.g.,
Bq, TBq), or both SI units and customary units (e.g., Ci, mCi).
However, for domestic shipments, the activity may be
expressed in terms of customary units only, until April , 191/97.
- For each labeled package:
- The category of label used;
- The transport index of each package with
a Yellow-II or Yellow-III label
- Shipper's certification (not required of private
carriers)
|
Materials-Based Requirements
- If hazardous substance, "RQ" as part of the basic description
- The LSA or SCO group (e.g., LSA-II)
- "Highway Route Controlled Quantity" as part of the basic description
, if HRCQ
- Fissile material information (e.g., "Fissile Exempt," controlled
shipment statement [see § 172.203(d)(7)])
- If the material is considered hazardous waste and the word waste
does not appear in the shipping name, then "waste" must precede
the shipping name (e.g., Waste Radioactive Material, nos., UN2982)
- "Radioactive Material" if not in proper shipping name
Package-Based Requirements:
- Package identification for DOT Type B or NRC certified packages
- IAEA CoC ID number for export shipments or shipments using foreign-made
packaging (see § 173.473)
Administrative-Based Requirements:
- Instructions for maintenance of exclusive use-shipment controls
for LSA/SCO strong-tight or NRC certified LSA (§ 173.427)
- If a DOT exemption is being used, "DOT-E" followed by the exemption
number
|
- The type of packaging (e.g., Type A, Type B, IP-1, ....)
- The Technical/chemical name may be in included (if listed in
§ 172.203(k), in parentheses between the proper shipping name and
hazard class; otherwise inserted in parenthesis after the basic
description)
- Other information is permitted (e.g., functional description
of the product), provided it does not confuse or detract from
the proper shipping name or other required information
- For fissile radionuclides, except Pu-238, Pu-239, and Pu-241,
the weight in grams or kilograms may be used in place of
activity units. For Pu-238, Pu-239, and Pu-241, the weight in
grams or kilograms may optionally be entered in addition to
activity units [see § 172.203(d)(4)]
- Emergency response hazards and guidance information (§§ 172.600-604)
may be entered on the shipping papers, or may be carried with
the shipping papers [§72.602(b)]
|
Some Special
Considerations/Exceptions for Shipping Paper Requirements |
- Shipments of Radioactive Material, excepted packages, under
UN2910 (e.g., Limited Quantity, Empty packages, and Radioactive
Instrument and Article), are excepted from shipping papers. For
limited quantities (§ 173.421), this is only true if the limited
quanttiy is not a hazardous substance (RQ) or hazardous waste
(40 CFR 262)
- Shipping papers must be in the pocket on the left door, or readily
visible to person entering driver's compartment and within arm's
reach of the driver
- For shipments of multiple cargo types, any HAZMAT entries must
appear as the first entries on the shipping papers, be designated
by an "X" (or "RQ") in the hazardous material column, or
be highlighted in a contrasting color
|
NRC Contacts: John Cook, (301) 415-8521 Earl Easton, (301)
415-8520
Hazard Communications
for Class 7 (Radioactive) Materials Labeling Packages
(49 CFR 172.400-450)
Note: IAEA, ICAO, and IMO may require additional hazard communication
information for international shipments
This table must not be used as a substitute for the DOT and NRC
regulations on the transportation of radioactive materials |
Placement of
Radioactive Labels |
- Labeling is required to be: (1) placed near the required marking
of the proper shipping name, (2) printed or affixed to the package
surface (not the bottom), (3) in contrast with its background,
(4) unobscured by markings or attachments, (5) within color,
design, and size tolerance, and (6) representative of the HAZMAT
contents of the package
- For labeling of radioactive materials packages, two labels are
required on opposite sides excluding the bottom
|
Determination
of Required Label |
Size: Sides:
> 100 mm (3.9 in.)
Border:
5-6.3 mm
(0.2-0.25 in.) |
49 CFR 172.436 |
49 CFR 172.438 |
49 CFR 172.440 |
|
49 CFR 172.450 |
Label |
WHITE-I |
YELLOW-II |
YELLOW-III |
EMPTY LABEL |
Required when: |
Surface radiation level
< 0.005 mSv/hr (0.5 mrem/hr) |
0.005 mSv/hr (0.5 mrem/hr) < surface radiation level <
0.5 mSv/hr (50 mrem/hr) |
0.5 mSv/hr (50 mrem/hr)
< surface radiation level < 2 mSv/hr (200
mrem/h) [Note: 10 mSv/hr (1000 mrem/hr) for exclusive-use closed
vehicle (§ 173.441(b)] |
The EMPTY label is required for shipments of empty Class
7 (radioactive) packages made pursuant to § 173.428.
It must cover any previous labels, or they must be removed or obliterated. |
Or: |
TI = 0 [1 meter dose rate < 0.0005 mSv/hr (0.05
mrem/hr)] |
TI < 1 [1 meter dose rate < 0.01 mSv/hr
(1 mrem/hr)] |
TI < 10 [1 meter dose rate < 0.1 mSv/hr
(10 mrem/hr)]
[Note: There is no package TI limit for exclusive-use] |
Notes: |
- Any package containing a Highway Route Controlled Quantity (HRCQ)
must bear YELLOW-III label
- Although radiation level transport indices (TIs) are shown above,
for fissile material, the TI is typically determined
on the basis of criticality control
|
Content on
Radioactive Labels |
- RADIOACTIVE Label must contain (entered using a durable, weather-resistant
means):
(1) The radionuclides in the package (with consideration of available
space). Symbols (e.g., Co-60) are acceptable
(2) The activity in SI units (e.g., Bq, TBq), or both SI units
with customary units (e.g., Ci, mCi) in parenthesis. However, for
domestic shipments, the activity may be expressed in terms
of customary units only, until 4/1/97.
(3) The Transport Index (TI) in the supplied box. The TI is entered
only on YELLOW-II and YELLOW-III labels |
Some Special Considerations/Exceptions for Labeling
Requirements |
- For materials meeting the definition of another hazard class,
labels for each secondary hazard class need to be affixed to the
package. The subsidiary label may not be required on
opposite sides, and must not display the hazard class number
- Radioactive Material, excepted packages, under UN2910 (e.g.,
Limited Quantity, Empty packages, and Radioactive Instrument and
Article), are excepted from labeling. However, if the excepted
quantity meets the definition for another hazard class, it is
re-classed for that hazard. Hazard communication requirements
for the other class are required
- Labeling exceptions exist for shipment of LSA or SCO required
by § 173.427 to be consigned as exclusive use
- The "Cargo Aircraft Only" label is typically required for radioactive
materials packages shipped by air [§72.402(c)]
|
Hazard Communications
for Class 7 (Radioactive) Materials Placarding
Vehicles (49 CFR 172.500-560)
Note: IAEA, ICAO, and IMO may require additional hazard communication
information for international shipments
This table must not be used as a substitute for the DOT and NRC
regulations on the transportation of radioactive materials |
Visibility
and Display of Radioactive Placard |
Placards are required to be displayed
- on four sides of the vehicle
- visible from the direction they face (for the front side of
trucks, tractor-front, trailer, or both are authorized)
- clear of appurtenances and devices (e.g., ladders, pipes, tarpaulins)
- at least 3 inches from any markings (such as advertisements)
that may reduce placard's effectiveness
- upright and on-point such that the words read horizontally
- in contrast with the background or have a lined-border which
contrasts with the background
- such that dirt or water from the transport vehicle's wheels
will not strike them
- securely attached or affixed to the vehicle or in a holder.
Placard must be maintained by carrier to keep color, legibility,
and visibility. |
Conditions
Requiring Placarding |
- Placards are required for any vehicle containing package with
a RADIOACTIVE Yellow-III label
- Placards are required for shipment of LSA or SCO required by
§ 173.427 to be consigned as exclusive use. Examples of this category
are domestic, strong-tight containers with less than an A2
quantity, and domestic NRC certified LSA/SCO packages using 10
CFR 71.52. Also, for bulk packages of these materials, the orange
panel marking with the UN Identification number is not
required.
- Placards are required any vehicle containing package with a
Highway Route Controlled Quantity (HRCQ). In
this case, the placard must be placed in a square background as
shown below (see § 173.507(a))
|
Radioactive
Placard |
Size Specs: Sides:
> 273 mm (10.8 in.)
Solid line Inner border:
About 12.7 mm (0.5 in.) from edges
Lettering: > 41 mm (1.6 in.)
Square for HRCQ: 387mm (15.25 in.) outside length by 25.4
mm (1 in.) thick |
49 CFR 172.556 |
IAEA SS 6 (1985) paras. 443-444 |
See 49 CFR 172.527 AND 556 |
RADIOACTIVE PLACARD (Domestic)
Base of yellow solid area:
29 + 5 mm (1.1 + 0.2 in.) above horizontal centerline |
RADIOACTIVE PLACARD (International) |
RADIOACTIVE PLACARD FOR HIGHWAY ROUTE CONTROLLED
QUANTITY
(either domestic or international placard could be in middle) |
Some Special
Considerations/Exceptions for Placarding Requirements |
- Domestically, substitution of the UN ID number for the word
"RADIOACTIVE" on the placard is prohibited for Class 7 materials.
However, some import shipments may have this substitution in accordance
with international regulations.
- Bulk packages require the orange, rectangular panel marking
containing the UN ID number, which must be placed adjacent to
the placard (see § 172.332) [NOTE: except for LSA/ SCO exclusive
use under § 173.427, as above]
- If placarding for more than one hazard class, subsidiary placards
must not display the hazard class number. Uranium Hexaflouride
(UF6) shipments > 454 kg (1001
lbs) require both RADIOACTIVE and CORROSIVE (Class 8) placarding
- For shipments of radiography cameras in convenience overpacks,
if the overpack does not require a RADIOACTIVE - YELLOW III label,
vehicle placarding is not required (regardless of the label which
must be placed on the camera)
|
Minimum
Required Packaging For Class 7 (Radioactive) Materials
This table must not be used as a substitute
for the DOT and NRC regulations on the transportation of radioactive
materials |
Quantity: < 70 Bq/g Limited Quantity
A1/A2 value 1 rem/hr at
3 m, unshielded
(< 0.002 :Ci/g) (§ 173.421) (§ 173.435) (§ 173.427) |
Non-LSA/SCO: |
Excepted |
Type A |
Type
B 3 |
Domestic or International LSA/SCO: LSA-I solid,
(liquid)1
SCO-I |
Excepted |
IP-I |
Type B
3 |
LSA-I Liquid
LSA-II Solid, (liquid or gas)1
(LSA-III)1
SCO-II |
IP-II |
Type B
3 |
LSA-II Liquid or Gas LSA-III |
IP-III |
Type B
3 |
Domestic (only) LSA/SCO: LSA-I,
II, III; SCO-I, II |
Excepted |
Strong-tight
2 |
DOT
Spec. 7A Type A |
Type B
3 |
NRC Type
A LSA 3,4 |
1. |
For entries in parentheses, exclusive use is required for shipment
in an IP (e.g., shipment of LSA-I liquid in an IP-I packaging would
require exclusive use consignment) |
2. |
Exclusive use required for strong-tight container shipments made
pursuant to § 173.427(b)(2) |
3. |
Subject to conditions in Certificate, if NRC package |
4. |
Exclusive use required, see § 173.427(b)(4). Use of these packages
expires on 4/1/99 (10 CFR 71.52) |
Package and Vehicle Radiation Level
Limits (49 CFR 173.441)A This table must not be used
as a substitute for the DOT and NRC regulations on the transportation
of radioactive materials |
Transport Vehicle Use: |
Non-Exclusive |
Exclusive |
Transport Vehicle Type: |
Open or Closed |
Open (flat-bed) |
Open w/EnclosureB |
Closed |
Package (or freight
container) Limits: |
External Surface |
2 mSv/hr
(200 mrem/hr) |
2 mSv/hr
(200 mrem/hr) |
10 mSv/hr
(1000 mrem/hr) |
10 mSv/hr
(1000 mrem/hr) |
Transport Index (TI)C |
10 |
no limit |
Roadway or Railway Vehicle
(or freight container) Limits: |
Any point on the outer surface |
N/A |
N/A |
N/A |
2 mSv/hr (200 mrem/hr) |
Vertical planes projected from outer edges |
2 mSv/hr (200 mrem/hr) |
2 mSv/hr (200 mrem/hr) |
N/A |
Top of . . . |
load: (200 mrem/hr) |
enclosure: 2 mSv/hr (200 mrem/hr) |
vehicle: 2 mSv/hr (200 mrem/hr) |
2 meters from. . . |
|
vertical planes:
0.1 mSv/hr (10 mrem/hr) |
vertical planes:
0.1 mSv/hr (10 mrem/hr) |
outer lateral surfaces:
0.1 mSv/hr (10 mrem/hr) |
Underside |
|
2 mSv/hr (200 mrem/hr) |
Occupied position |
N/AD |
0.02 mSv/hr (2 mrem/hr)E |
Sum of package TIs |
50 |
no limit F |
A. |
The limits in this table do not apply to excepted packages - see
49 CFR 173.421-426 |
B. |
Securely attached (to vehicle), access-limiting enclosure; package
personnel barriers are considered as enclosures |
C. |
For nonfissile radioactive materials packages, the dimensionless
number equivalent to maximum radiation level at 1 m (3.3 feet) from
the exterior package surface, in millirem/hour |
D. |
No dose limit is specified, but separation distances apply to Radioactive
Yellow-II or Radioactive Yellow-III labeled packages |
E. |
Does not apply to private carrier wearing dosimetry if under radiation
protection program satisfying 10 CFR 20 or 49 CFR 172 Subpart I |
F. |
Some fissile shipments may have combined conveyance TI limit of
100 - see 10 CFR 71.59 and 49 CFR 173.457 |
Package
and Vehicle Contamination Limits (49 CFR 173.443)
This table must not be used as a substitute for the DOT and NRC
regulations on the transportation of radioactive materials |
NOTE: All values for contamination in DOT rules are
to be averaged over each 300 cm2
Sufficient measurements must be taken in the appropriate locations
to yield representative assessments
means the sum of beta emitters, gamma emitters, and low-toxicity
alpha emitters
" means the sum of all other alpha emitters (i.e., other than low-toxicity
alpha emitters) |
The
Basic Contamination Limits for All Packages: 49
CFR 173.443(a), Table 11 |
General Requirement:
Non-fixed (removable) contamination must be kept aslow as reasonably
achievable (ALARA) |
0.4 Bq/cm2
= 40 Bq/100 cm2 = 1x10-5 >:Ci/cm2
= 2200 dpm/100 cm2 |
0.04 Bq/cm2
= 4 Bq/100 cm2 = 1x10-6: Ci/cm2 =
220 dpm/100 cm2 |
The following exceptions
and deviations from the above basic limits exist: |
Deviation from Basic Limits |
Regulation 49 CFR §§ |
Applicable Location and Conditions
That Must Be Met: |
10 times the basic limits |
173.443(b)
and 173.443(c)
Also see 177.843 (highway) |
On any external surface of a package in an exclusive
use shipment, during transport including end of transport.
Conditions include:
(1) Contamination levels at beginning of transport must be below
the basic limits.
(2) Vehicle must not be returned to service until radiation level
is shown to be < 0.005 mSv/hr (0.5 mrem/hr) at any accessible
surface, and there is no significant removable (non-fixed) contamination. |
10 times the basic limits |
173.443(d)
Also see 177.843
(highway) |
On any external surface of a package, at the beginning
or end of transport, if a closed transport vehicle is used, solely
for transporting radioactive materials packages. Conditions include:
(1) A survey of the interior surfaces of the empty vehicle must
show that the radiation level at any point does not exceed 0.1 mSv/hr
(10 mrem/hr) at the surface, or 0.02 mSv/hr (2 mrem/hr) at 1 meter
(3.3 ft).
(2) Exterior of vehicle must be conspicuously stenciled, "For
Radioactive Materials Use Only" in letters at least 76
mm (3 inches) high, on both sides.
(3) Vehicle must be kept closed except when loading and unloading.
|
100 times the basic limits |
173.428 |
Internal contamination limit
for excepted package-empty packaging, Class 7 (Radioactive)
Material, shipped in accordance with 49 CFR 173.428. Conditions include:
(1) The basic contamination limits (above) apply to external
surfaces of package.
(2) Radiation level must be < 0.005 mSv/hr (0.5 mrem/hr)
at any external surface.
(3) Notice in § 173.422(a)(4) must accompany shipment.
(4) Package is in unimpaired condition & securely closed to
prevent leakage.
(5) Labels are removed, obliterated, or covered, and the "empty"
label (§ 172.450) is affixed to the package. |
In addition, after any incident involving
spillage, breakage, or suspected contamination, the modal-specific
DOT regulations (§ 177.861(a), highway; § 174.750(a), railway; and § 175.700(b),
air) specify that vehicles, buildings, areas, or equipment have "no
significant removable surface contamination," before being returned
to service or routinely occupied. The carrier must also notify offeror
at the earliest practicable moment after incident. |
Appendix P: NRC Incident Notifications
[ Prev | Next
| Top of file ]
NRC Incident Notifications
Table P.1 Typical NRC Incident Notifications Required for Fixed
Gauge Licensees
Event |
Telephone
Notification |
Written
Report |
Regulatory Requirement |
Theft or loss of material |
immediate |
30 days |
10 CFR 20.2201(a)(1)(i) |
Whole body dose greater than 0.25 Sv (25 rems) |
immediate |
30 days |
10 CFR 20.2202(a)(1)(i) |
Extremity dose greater than 2.5 Sv (250 rems) |
immediate |
30 days |
10 CFR 20.2202(a)(1)(iii) |
Whole body dose greater than 0.05 Sv (5 rems) in 24
hours |
24 hours |
30 days |
10 CFR 20.2202(b)(1)(i) |
Extremity dose greater than 0.5 Sv (50 rems) in 24 hours |
24 hours |
30 days |
10 CFR 20.2202(b)(1)(iii) |
Whole body dose greater than 0.05 Sv (5 rems) |
none |
30 days |
10 CFR 20.2203(a)(2)(i) |
Dose to individual member of public greater than 1 mSv
(100 mrems) |
none |
30 days |
10 CFR 20.2203(a)(2)(iv) |
Defect in equipment that could create a substantial
safety hazard |
2 days |
30 days |
10 CFR 21.21(d)(3)(i) |
|
Filing petition for bankruptcy under 11 U.S.C.
none |
immediately after filing petition |
10 CFR 30.34(h) |
Expiration of license |
none |
60 days |
10 CFR 30.36(d) |
Decision to permanently cease licensed activities at
entire site |
none |
60 days |
10 CFR 30.36(d) |
Decision to permanently cease licensed activities in
any separate building or outdoor area that is unsuitable for release
for unrestricted use |
none |
60 days |
10 CFR 30.36(d) |
No principal activities conducted for 24 months at the
entire site |
none |
60 days |
10 CFR 30.36(d) |
No principal activities conducted for 24 months in any
separate building or outdoor area that is unsuitable for release for
unrestricted use |
none |
60 days |
10 CFR 30.36(d) |
Event that prevents immediate protective actions necessary
to avoid exposure to radioactive materials that could exceed regulatory
limits |
immediate |
30 days |
10 CFR 30.50(a) |
Equipment is disabled or fails to function as designed
when required to prevent radiation exposure in excess of regulatory
limits |
24 hours |
30 days |
10 CFR 30.50(b)(2) |
Unplanned fire or explosion that affects the integrity
of any licensed material or device, container, or equipment with licensed
material |
24 hours |
30 days |
10 CFR 30.50(b)(4) |
Note: Telephone notifications shall be made
to the NRC Operations Center at 301-816-5100 or 301-951-0550.
Appendix Q: Sample Fixed Gauge License
[ Prev | Next
| Top of file ]
Sample Fixed Gauge License
A sample Fixed Gauge License appears on the following pages.
Appendix R: List of Documents Considered
in Development of this NUREG
[ Prev | Next
| Top of file ]
List of Documents Considered in Development of this NUREG
Draft Regulatory Guides (DRGs) and Policy and Guidance Directives
(P&GDs)
*FC 404-4 |
Guide for the Preparation of Applications for Licenses for the Use
Sealed Sources in Fixed Gauging Devices |
01/85 |
*FC 85-4 |
Standard Review Plan for Applications for the Use of Sealed Sources
in Nonportable Gauging Devices |
31083 |
*FC 85-8 |
Revision 1; Licensing of Fixed Gauges and Similar Devices |
32322 |
Information Notices (INs)
IN 81-37 |
Unnecessary Radiation Exposures to the Public and Workers During
Events Involving Thickness and Level Measuring Devices |
29934 |
IN 86-31 |
Unauthorized Transfer and Loss of Control of Industrial Nuclear
Gauges |
31536 |
IN 88-02 |
Lost or Stolen Gauges |
32174 |
IN 88-90 |
Unauthorized Removal of Industrial Nuclear Gauges |
32468 |
IN 89-25 |
Revision 1, Unauthorized Transfer of Ownership or Control of Licensed
Activities |
34674 |
IN 94-15 |
Radiation Exposures During an Event Involving a Fixed Nuclear Gauge |
34394 |
IN 96-28 |
Suggested Guidance Related to Development and Implemetation of Corrective
Action |
35185 |
IN 97-30 |
Control of Licensed Material During Reorganizations, Employee-Management
Disagreements, and Financial Crises |
35583 |
Technical Assistance Requests (TARs)
1. |
*TN Technologies, Inc. - Fixed Gauge Manufacturer Request to Allow
Customers to Install Fixed Gauges |
33034 |
2. |
U.S. Air Force - Multiple Questions on Moving Generally Licensed
Fixed Gauges from One Use Location to Another |
33386 |
3. |
Oceantrawl - Licensee Request to Convert Specifically Licensed Gauge
to a General License |
33884 |
4. |
Sharon Steel - Request for Review of the Adequacy of a Fixed Gauge
Training Program |
33982 |
5. |
Pennsylvania Power and Light Company - Request for Relief from Six-Month
Requirement to Check on/off Mechanism |
33965 |
6. |
Ram Services, Inc. - Request for Authorization to Collect and Analyze
Sealed Source Leak Tests |
34870 |
7. |
Philip Morris, USA - Request for Clarification of Regulatory Requirements
for Possession and Use of Gauging Devices Initial Distributed under
the Provision of 10 CFR 31.5 and 32.51 |
35143 |
Other Documents
1. |
*Memorandum from W. L. Axelson to Vandy L. Miller Re: Requiring
Shutter Operability Tests for Specifically Licensed Fixed Gauges |
31601 |
2. |
*Memorandum from John Glenn to Nuclear Materials Branch Chiefs,
Re: Installation of Fixed Gauges |
33129 |
3. |
*Memorandum from John W. Hickey Re: Implementation of 10 CFR 30.36(d) |
35653 |
(*) Marked items have been incorporated by this NUREG and are
superseded.
Appendix S: Addendum: Responses to Comments
on Draft NUREG-1556, Vol. 4, Dated October 1997
[ Prev | Top
of file ]
Table S.1 Homestake Mining Company Comment, Dated January 12,
1998
Location |
Subject
| Comment |
Appendix N |
Dosimetry for non-routine operations |
Our facility uses density gauges which are mounted on pipe lines.
We have permission to perform non-routine maintenance which initially
meant installation and today we are concerned with relocation. Our
procedures are in place and a survey meter has always been used to
ensure the safety of the person responsible for handling the gauge.
We have never used whole body or extremity monitoring devices when
performing these activities and feel the requirement is unnecessary
to ensure the safety of people. If the gauge shutter is locked out,
surveyed, and the task is monitored and documented as stated in Appendix
J, there should be no reason for mandatory dosimetry. Granted, maintenance
activities involving components related to the radiological safety
of the gauge is a separate issue. We are only concerned with the relocation
which may be necessary if a pipe must be changed and the gauge must
be unbolted, removed, and then rebolted to the new pipe. We would
hope that at a minimum, the NRC would accept a well documented procedure
to suffice when the necessity to change a pipe is unpredictable and
unplanned. If the NRC is adamant in enforcing mandatory dosimetry
during relocation, we could agree with dosimetry when process/pipe
changes are pre-planned. However, we urge you to consider the circumstances
surrounding emergency process disruptions requiring relocation. |
NRC Staff Response:
- 10 CFR 20.1502 requires each licensee to monitor occupational
exposure to radiation and supply and require the use of individual
monitoring devices by adults likely to receive, in 1 year, from
sources external to the body, a dose in excess of 10% of the limits
in 10 CFR 20.1201(a). A licensee need not monitor an individual's
occupational exposure or supply and require the use of individual
monitoring devices if the licensee can demonstrate that an individual
is not likely to receive, in one year, a radiation dose in excess
of 10% of the allowable limits.
- The 2nd paragraph in the "Discussion" section
of chapter 8.14 (8.10.4 in final NUREG), item 10, addressing occupational
dosimetry for non-routine operations has been revised as follows:
"Individuals who perform non-routine operations such as installation,
initial radiation survey, repair, and maintenance of components
related to the radiological safety of the gauge, gauge relocation,
replacement, and disposal of sealed sources, alignment, or removal
of a gauge from service are more likely to exceed 10% of the limits
as shown in Figure 8.4. Applicants may be required to provide
dosimetry (whole body and perhaps extremity monitors) to individuals
performing such services and must perform a prospective evaluation
demonstrating that unmonitored individuals performing such non-routine
operations are not likely to receive, in one year, a radiation
dose in excess of 10% of the allowable limits as shown in Figure
8.4."
- Appendix N was revised as follows:
- The 4th paragraph was changed to read: "Thus, applicants wishing
to perform non-routine operations must use personnel with special
training and follow appropriate procedures consistent with the
manufacturer's instructions and recommendations that address
radiation safety concerns (e.g., use of radiation survey meter,
shielded container for the source, and personnel dosimetry (if
required))."
- Under the section for submission of procedures for non-routine
operations, the 7th bullet was changed to read: "Confirm that
individuals performing non-routine operations on gauges will
wear both whole body and extremity monitoring devices or perform
a prospective evaluation demonstrating that unmonitored individuals
performing such non-routine operations are not likely to receive,
in one year, a radiation dose in excess of 10% of the allowable
limits."
|
Note: Unless otherwise noted, page numbers
and section numbers correspond to those in Draft NUREG-1556, Vol. 4,
dated October 1997
Table S.2 J. C. Van Horn and Associates, Inc. Comments, Received
on February 6, 1998
Page |
Subject |
Comment |
xi |
Abbreviations |
The Roentgen is no longer an accepted unit and should not be used
in this document. This includes the abbreviations R and mR.
LDE (Lens Dose Equivalent) and DDE (Deep Dose Equivalent) need
to be addressed as they are certainly exposure possibilities that
may have to be considered.
CEDE (Committed Effective Dose Equivalent) and CDE (Committed Dose
Equivalent) need to be addressed due to the potential for ingestion,
inhalation or injection m accident conditions. Note that these are
referenced on page 1-3 without definitions. |
NRC Staff Response:
- Fixed gauges are not typically the primary activity for the
vast majority of fixed gauge licensees in the U.S. Being up-to-date
on changes in health physics nomenclature would place an unreasonable
burden on these licensees and would be inconsistent with the NRC's
final metrication policy that requires NRC to use "...the system
of units employed by the licensee" (see 61 FR 31169, June 19,
1996). NRC made a conscious decision to use the Roentgen unit
in NUREG-1556, Vol. 4 to make the guide more efficient and useable
for the vast majority of gauge users.
- Although Lens Dose Equivalent (LDE) and Deep Dose Equivalent
(DDE) are exposure possibilities, it was decided not to address
them in NUREG-1556, Vol. 4.
- Reference to Committed Effective Dose Equivalent (CEDE) and
Committed Dose Equivalent (CDE) is made on page 1-3 of Draft NUREG-1556,
Vol. 4. It specifically refers the reader to 10 CFR Part 20 for
definitions. It states, "In this document, dose or radiation dose
means absorbed dose, dose equivalent, effective dose equivalent
(EDE), committed dose equivalent (CDE), committed effective dose
equivalent (CEDE), or total effective dose equivalent (TEDE).
These terms are defined in 10 CFR Part 20."
|
35797 |
Paragraph #4 sentence 1 |
Dose units mentioned do not include LDE and DDE and do include CEDE
and CDE which are not previously defined |
NRC Staff Response: See response to 2nd and 3rd bullets
in previous comment. |
35797 |
Paragraph #4 sentence 2 |
Are we sure people have access to 10CFR? |
NRC Staff Response: 10 CFR Parts are readily available
to license applicants and licensees. Individual copies of Parts may
be obtained, by request, free of charge from the NRC and may also
be "downloaded" from the NRC's Home Page on the Internet. 10 CFR Parts
are also available from the Public Document Room. When an individual
requests application materials from the NRC, appropriate documents
including applicable 10 CFR Parts are sent to the applicant. Licensees
are required by 10 CFR 19.11 to post (and thus possess) copies of
Parts 19 and 20. |
35797 |
Paragraph #4 sentence 3 |
Not all sealed sources only emit beta & gamma. There are also
neutron and alpha sources |
NRC Staff Response: The last paragraph of Chapter 1
has been revised. It now addresses neutrons and alpha particles. Please
see the revised paragraph in the response to the next comment. |
35797 |
Paragraph #4 sentence 4 |
Because of the use of neutron and alpha (as well as beta) sources,
the assumption that 1 Roentgen = 1 rad= 1 rem is NOT true for many
gauges due to the Quality Factors which can range up to 20. |
NRC Staff Response: The last paragraph of Chapter 1
has been revised to address neutrons, alpha particles and their respective
quality factors (Q). It now reads:
In this document, dose or radiation dose means absorbed dose, dose
equivalent, effective dose equivalent (EDE), committed dose equivalent
(CDE), committed effective dose equivalent (CEDE), or total effective
dose equivalent (TEDE). These terms are defined in 10 CFR Part 20.
Rem, and its SI equivalent Sievert (1 rem = 0.01 Sievert (Sv)),
are used to describe units of radiation exposure or dose. This is
done because 10 CFR Part 20 sets dose limits in terms of rem, not
rad or roentgen (R). When the sealed sources used in gauges emit
beta and gamma rays, for practical reasons, we are assuming that
1 R = 1 rad = 1 rem. Less common are sealed sources used in gauges
that emit neutrons or alpha particles. For neutron and alpha emitting
sealed sources, 1 rad is not equal to 1 rem. Determination
of dose equivalent (rem) from absorbed dose (rad) from neutrons
and alpha particles requires the use of an appropriate quality factor
(Q) value. Q values are used to convert absorbed dose (rad) to dose
equivalent (rem). Q values for neutrons and alpha particles are
addressed in the Tables 1004(b)(1) and (2) in 10 CFR §20.1004. |
35797 |
Paragraph #4, sentence 4 |
Note that quality factor is also not defined in this document. |
NRC Staff Response: The last paragraph of Chapter 1
has been revised. It now states that quality factor values for neutrons
and alpha particles are addressed in Tables 1004(b)(1) and (2) in
10 CFR 20.1004. In addition, the abbreviation "Q" has been added to
the list of abbreviations in NUREG-1556, Vol. 4. |
1-3 |
Paragraph #4, sentence 4 |
The above comments on page 1-3 imply that this document's fundamental
underlying assumptions may be incorrect. If this is true, then the
entire document needs to be dealt with. |
NRC Staff Response: See previous responses for comments
on page 1-3. |
3-1 |
Paragraph #2, bullet 4 |
The regulations are not specified here or prior to this point. |
NRC Staff Response: NRC staff have decided to specify
applicable regulations in Chapter 4 of NUREG-1556, Vol. 4. In addition,
each section of the document which address the contents of the application
begins by stating regulations applicable to the respective section. |
3-1 |
Paragraph #2 |
There is no reference to management's responsibility to ensure employees
who may be exposed to radiation are properly trained in radiation
hazards (10 CFR 19). As well as management responsibilities to ensure
gauge users are properly trained in their use and the radiological
hazards involved (10 CFR 20). |
NRC Staff Response:
- See "Training Assessment" in Appendix G of the document. In
draft NUREG-1556, Vol. 4 this section stated: "Management will
ensure that potential RSOs and AUs are qualified to work independently
with each type of gauge possessed." The final NUREG-1556, Vol. 4
states, "Management will ensure that proposed AUs are qualified
to work independently with each type of gauge with which they
may work. Management will ensure that proposed RSO's are qualified
to work independently with and are knowledgeable of the radiation
safety aspects of all types of gauges to be possessed by the applicant.
- The draft NUREG-1556, Vol. 4 had a chapter that was entitled
"Training for Authorized Users and Individuals who in the Course
of Employment are Likely to Receive Occupational Doses of Radiation
in Excess of 1 mSv (100 mrem) in a Year." The final NUREG-1556,
Vol. 4 will clarify training by dividing that chapter into two
chapters: One chapter entitled, "Training for Individuals Who
in the Course of Employment are Likely to Receive Occupational
Doses of Radiation in Excess of 1 mSv (100 mrem) in a Year (Occupationally
Exposed Workers) and Ancillary Personnel," specifically addresses
training for employees who may be exposed to radiation. The other
chapter entitled, "Authorized Users," specifically addresses training
for gauge uses.
- The list of responsibilities (bullets) in the section of the
document entitled "Management Responsibility" is not meant to
provide detailed responsibilities. Rather it is meant to provide
an overview of responsibilities. The responsibilities in the first
bullet encompass management's responsibility to ensure that workers
are properly trained. (Radiation safety, security and control
of radioactive materials, and compliance with regulations.)
|
4-1 |
Entire section |
This section should be inserted in this document prior to any references
to applicable regulations. |
NRC Staff Response: NRC staff have decided to specify
applicable regulations in Chapter 4 of NUREG-1556, Vol. 4. |
8-6 |
Table 8.1 |
This table is missing other isotopes which are in use in some gauges. |
NRC Staff Response:
- The "Discussion" section of chapter 8.6, item 5, just prior
to the table states, "The thresholds for typical radionuclides
used for fixed gauge sealed sources are shown in Table 8.1." The
NUREG does not seek to address all radionuclides that may be used
in sealed sources for fixed gauges. As the sentence "Discussion"
states, the table provides information for typical radionuclides.
- The table has been retitled: Examples of Minimum Inventory Quantity
Requiring Financial Assurance.
|
8-6 |
Paragraph #3 |
This paragraph, as constituted, presents a problem for gauge holders
who have been long-term users of radioisotopes. It is very possible
that buildings and set-ups within process lines have been removed,
renovated many years prior to the institution of this regulation.
If there is no way to reconstruct the make up of the area. What provisions
are allowed? What will be done for these situations that is reasonable? |
NRC Staff Response: The last sentence of 10 CFR 30.35(g)(2)
states, "If drawings are not available, the licensee shall substitute
appropriate records of available information concerning these areas
and locations." The regulation specifically stipulates "available"
information. The regulation only requires that the licensee retain
information that is available. To make this clearer, the following
changes have been made:
- The 4th sentence in Paragraph #3 on page 8-6 of draft NUREG-1556,
Vol. 4 has been changed to read: "If drawings are not available,
licensees shall substitute appropriate records (e.g., a sketch
of the room or building or a narrative description of the area)
concerning the specific areas and locations. If no records exist
regarding structures and equipment where gauges were used or stored,
licensees shall make all reasonable efforts to create such records
based upon historical information (e.g. employee recollections)."
|
36014 |
8.8 Item 7 paragraph 1 bullet 1 & 2 |
We have serious concerns about this provision and similar provisions
throughout this document.
- First, this provision ignores the Health Physics Profession
and could even be seen as attacking it by removing the capability
of Health Physicists to supervise radiological materials based
on their standards of training.
- Second, this provision improperly disqualifies personnel who
are the best trained in radiation safety (HPs, Medical Physicists,
and Radiation Protection Technicians).
- Third, we find that this could be interpreted to disqualify
even NRC HPs who might inspect these gauges. After all, if an
HP isn't qualified to be an RSO, how can they inspect for radiological
safety?
- Fourth, this provision eliminates all other RSO Training courses.
It gives a monopoly to Fixed Gauge Manufacturers in an area where
they are, by far, NOT the most experienced personnel in dealing
with Radiation Safety.
|
NRC Staff Response:
- The "Criteria" section of chapter 8.8, item 7, in the second
bullet, states, in part, that an, equivalent course that meets
Appendix G criteria would provide evidence of adequate training
and experience for an RSO. Any individual, including health physicists,
who provides evidence of training and experience that meets Appendix
G criteria would qualify as an RSO for a fixed gauge licensee.
- The "Criteria" section of chapter 8.8, item 7, disqualifies
only those individuals who do not have sufficient training and
experience to serve as an RSO for a fixed gauge licensee.
- Chapter 8.8, item 7 describes training and experience for RSOs
for fixed gauge licensees. NRC inspectors must complete certain
training and experience to qualify as inspectors. Such training
is independent of that required for qualification as an RSO for
a fixed gauge licensee.
- Although the first bullet in the "Criteria" section of chapter
8.8, item 7, states that a fixed gauge manufacturer's course for
users or for RSO would provide evidence of adequate training and
experience for an RSO, it is only one of the methods an applicant
may use to demonstrate evidence of adequate training and experience.
The second bullet provides another method, stating, in part, that
an, equivalent course that meets Appendix G criteria would also
provide evidence of adequate training and experience for an RSO.
In addition, the "Response from Applicant" section of chapter
8.8, item 7, states that "alternative information demonstrating
that the proposed RSO and any future RSO are qualified by training
and experience" will be accepted for review and evaluated using
the criteria stated in the chapter.
|
8-10 |
8.9 Item 8 Paragraph #l bullets 1 & 2 |
- Much research indicates that there are no such courses.
- Also there are no requirements for the personnel operating the
gauges to be able to take surveys and protect themselves from
the radiation hazard. This MAY contradict 10 CFR 20 requirements.
|
NRC Staff Response:
- Many fixed gauge manufacturers and distributors provide training
for users.
- As stated in the "Discussion" section of chapter
8.13, item 10, "Usually it is not necessary for fixed gauge licensees
to possess a survey meter." The chapter also discusses specific
circumstances when surveys are required. If a survey pursuant
to 10 CFR 20.1501 is required, the licensee must comply.
The survey may not be adequate if the individual performing the
survey is not properly trained on the use of survey meters and
is thus unable to operate it properly. It is not within the scope
of this document to address specific training on the use of survey
instruments. However, Appendix G, "Criteria for Acceptable Training
Courses for Authorized Users and Radiation Safety Officers" has
been modified to add training on:
- Use of survey meters and personal dosimetry, when required
|
8-11 |
Paragraph #1 |
This paragraph should be more closely compared to 10 CFR 19 requirements.
"To minimize the potential" sets up the licensee for both regulatory
and legal problems. e.g. "Do I or don't I train on the Rad Symbol?"
''What about posting and area control?" etc. |
NRC Staff Response:
- There is no specific requirement to provide training to individuals
who in the course of employment are not likely
to receive in a year an occupational dose in excess of 100 mrem
(this includes the majority of gauge users). Posting requirements
are addressed in 10 CFR 19.11 and 20.1902. Control of exposure
from external sources in restricted areas is addressed by 10 CFR
20.1601. Storage and control of licensed material is addressed
by 10 CFR 20.1801 and 20.1802. A licensee may determine that
it is necessary to provide some training to individuals, even
if they are not likely to receive a dose in excess of 100 mrem,
to meet the requirements of 10 CFR 19.11, 20.1902, 20.1601, 20.1801
and 20.1802.
- Some modification to the "Discussion" section of 8.9 Item 8:
"Training for Individuals Who in the Course of Employment Are
Likely to Receive Occupational Doses of Radiation in Excess of
1 mSv (100 mrem) in a Year (Occupationally Exposed Workers) and
Ancillary Personnel," was made to clarify this issue.
|
36019 |
8.13 Item 10 Paragraph 2 bullets 1.2 & 3 |
- Use of mR vs. mrem (mR & R undefined in 10 CFR 20)
- An instrument capable of measuring gamma radiation isn't going
to be much use with neutron or alpha radiation, and some gamma-sensitive
instruments won't be useful for beta
- This requires source checks, how about the other operational
checks? - physical condition, battery check etc.?
|
NRC Staff Response:
- Bullet 1 - The vast majority of exposure rate survey instruments
measure in mR and R units. The bullet does provides the alternative
unit (C/kg). The last paragraph in chapter 1 states that
"10 CFR Part 20 sets dose limits in terms of rem, not rad or roentgen
(R)." This implies that the R is undefined in 10 CFR Part 20.
The last paragraph in chapter 1 has also been modified to address
mR vs. mrad vs. mrem.
- Bullet 2 - This bullet has been modified to address this comment.
It now reads "Is capable of measuring the radiation being emitted
from the gauge's sealed source."
- Bullet 3 - A functionality check should indicate if the battery
is not functioning. Other operational checks are addressed during
calibration - see bullet 4.
|
8-14 & 15 |
All |
No training on how to use these instruments is required. |
NRC Staff Response: Appendix G, "Criteria
for Acceptable Training Courses for Authorized Users and Radiation
Safety Officers" has been modified to add training on
- Use of survey meters and personal dosimetry, when required
|
8-18 |
Figure 8.4 |
- Note LDE (although not named as such) is included here, but
not referenced elsewhere.
- Missing Internal dose (CEDE & CDE)
|
NRC Staff Response: See previous NRC
Staff responses on these dose equivalent comments. |
8-18 |
Paragraphs #1, 2, 3 |
- What is the basis for the assumption that dosimetry will not
be required?
- If dosimetry is required, there is no requirement for training
in its use.
|
NRC Staff Response:
- In the "Discussion" section of chapter 8.14
(8.10.4 in final NUREG), item 10, it states, "Under conditions
of routine use, the typical fixed gauge user does not require
a personnel monitoring device (dosimetry)." The basis for the
statement is NRC inspection experience which indicates that under
conditions of routine use, the typical fixed gauge user is not
likely to receive, in one year, a radiation dose in excess of
10% of the allowable limits specified in 10 CFR 20.1201(a). 10
CFR 20.1502 requires each licensee to monitor occupational exposure
to radiation and supply and require the use of individual monitoring
devices by adults likely to receive, in 1 year, from sources external
to the body, a dose in excess of 10% of the limits in 10 CFR 20.1201(a).
- It is not within the scope of this document to address specific
training on the use of personal monitoring devices. However, Appendix
G, "Criteria for Acceptable Training Courses for Authorized Users
and Radiation Safety Officers" has been modified to add training
on:
- Use of survey meters and personal dosimetry, when required
|
8-22 |
Routine Procedures bullet 8 |
- How does an individual become "authorized" by the NRC to do
non-routine repair & maintenance on a gauge?
- What are the qualifications, training and experience requirements.
- Is professional Radiation Protection Training and/or experience
necessary?
|
NRC Staff Response:
- Chapter 8.18 (8.10.8 in final NUREG), Radiation Safety Program
- Maintenance, in the "Criteria" sections, states,
"Information to support request for specific authorization to
perform non-routine maintenance or repair is addressed in Appendix
N." This information will be reviewed on a case-by-case basis;
if approved, the license will contain a condition authorizing
the licensee to perform non-routine operations.
- Appendix N, asks the applicant to, "Identify who will perform
non-routine operations and their training and experience. Acceptable
training would include manufacturer's or distributor's courses
for non-routine operations or equivalent." Submissions will be
reviewed by NRC license reviewers on a case-by-case basis.
- Appendix N, states, "Acceptable training would include manufacturer's
courses for non-routine operations or equivalent." Submissions
will be reviewed by NRC license reviewers on a case-by-case basis.
|
8-22 |
Emergency Procedures bullet |
Need to require control of potentially contaminated personnel and
objects. |
NRC Staff Response: A detailed consideration
of every possible emergency situation involving a fixed gauge that
could occur is beyond the intended scope of chapter 8.16 (8.10.6 in
final NUREG), item 10. One of the bullets under emergency procedures,
in the "Criteria" section states, "Take additional
steps, dependent on the specific situations." |
8-24 |
Figure 8.6 |
Why do you talk about trained radiological personnel here and ignore
their existence and qualifications elsewhere? |
NRC Staff Response: The last illustration
(#8) in Figure 8.6, has a caption which states, "Trained Radiological
Professional Handle Gauge Recovery and Clean-up." Use of fixed gauges
is not typically the primary activity for the vast majority of fixed
gauge licensees. Fixed gauge licensees be capable of responding to
an emergency situation involving a fixed gauge. This caption is meant
to imply that a typical fixed gauge user or RSO may not have the resources
or the training and experience to handle the aftermath of a incident
where a gauge is damaged, the sealed source may be exposed, and contamination
is a possibility. More experienced individuals may need to be consulted
to ensure that recovery and clean-up is performed safely. |
36035 |
Figure 8.9 |
- Why does this picture/diagram suggest that NRC authorization
is necessary to do non-routine maintenance on the gauge?
- We guess that its intent is to indicate that the person doing
the maintenance is authorized by the NRC to do so, but again,
how does one obtain this authorization?
|
NRC Staff Response:
- The non-routine maintenance portion of the "Response
from Applicant" section of chapter 8.18 (8.10.8 in final
NUREG), item 10, states, in part, that the applicant must commit
that either the gauge manufacturer or other person authorized
by the NRC or an Agreement State will perform non-routine maintenance,
or the applicant must submit the information in Appendix N of
NUREG-1556, Vol. 4 for NRC review.
- The applicant may obtain NRC authorization to perform non-routine
maintenance by submitting the information listed in Appendix N
for NRC review and receiving an amendment authorizing the licensee
to perform non-routine maintenance.
|
8-28 & 29 |
Item in box on 8-28 and 8 bullets discussion on 8-29 |
These two are repetitious and one should be eliminated with any
"missing elements" incorporated into the one which is retained. |
NRC Staff Response: NRC Staff believe
that the information in the box in the "Criteria"
section of chapter 8.18 (8.10.8 in final NUREG), item 10 and the bullets
in the "Discussion" section of the same chapter are
both necessary to the document's content and should be retained. |
8-33 |
Figure 8-11 |
Need to deal with contamination control measures as referenced before. |
NRC Staff Response:
- A detailed consideration of every possible emergency situation
involving a fixed gauge that could occur is beyond the intended
scope of chapter 8.16 (8.10.6 in final NUREG), item 10. The 3rd
bullet under emergency procedures, in the "Criteria"
section states, "Contact responsible individuals…" The last bullet
states, "Take addition steps, dependent on the specific situations."
- Appendix L, under emergency procedures, does address contamination
control measures.
|
8-39 |
8.21 Item 10 |
Needs to address contamination control in emergency or accident
situations. |
NRC Staff Response:
- A detailed consideration of every possible emergency situation
involving a fixed gauge that could occur is beyond the intended
scope of chapter 8.16 (8.10.6 in final NUREG), item 10. The 3rd
bullet under emergency procedures, in the "Criteria"
section states, "Contact responsible individuals…" The last bullet
states, "Take addition steps, dependent on the specific situations."
- Appendix L, under emergency procedures, does address contamination
control measures.
|
B-3 |
Item 8 |
An item entitled "Training for Potentially Exposed Personnel" needs
to be added. This should include the items previously discussed in
these comments and in the document. |
NRC Staff Response: The draft NUREG-1556,
Vol. 4 had a chapter that was entitled "Training for Authorized Users
and Individuals who in the Course of Employment are Likely to Receive
Occupational Doses of Radiation in Excess of 1 mSv (100 mrem) in a
Year." The final NUREG-1556, Vol. 4 will clarify training by dividing
that chapter into two chapters: One chapter entitled, "Training for
Individuals Who in the Course of Employment are Likely to Receive
Occupational Doses of Radiation in Excess of 1 mSv (100 mrem) in a
Year (Occupationally Exposed Workers) and Ancillary Personnel," specifically
addresses training for employees who may be exposed to radiation.
The other chapter entitled, "Authorized Users," specifically addresses
training for gauge uses. Appendix B in the final NUREG-1556, Vol.
4 has been appropriately modified to reflect the changes in the text
of these two new chapters. |
B-4 |
Item 10 Survey
Instruments |
Need to add an item entitled "Training For Personnel
Who Use Survey Instruments".
This training should include the standard instrument use training
such as enter the area with device on lowest setting, source check
the instrument, operationally check the instrument (battery check
etc.), proper survey techniques, etc. |
NRC Staff Response: It is not within
the scope of this document to address specific training on the use
of survey instruments. However, Appendix G, "Criteria for Acceptable
Training Courses for Authorized Users and Radiation Safety Officers"
has been modified to add training on:
- Use of survey meters and personal dosimetry, when required
|
B-4 |
Item 10 Dosimetry |
- Need to add an item about training on proper use of dosimetry.
This should include care, positioning, precautions etc.
- Note that the numbering system could be confusing.
|
NRC Staff Response: It is not within
the scope of this document to address specific training on the use
of personal monitoring devices. However, Appendix G, "Criteria for
Acceptable Training Courses for Authorized Users and Radiation Safety
Officers" has been modified to add training on
- Use of survey meters and personal dosimetry, when required
- The numbering system is meant to correspond to information requested
in NRC Form 313 in Appendix A of NUREG-1556, Vol. 4.
|
D-2 & D-3 |
Materials Possessed |
Should provide for more isotopes. |
NRC Staff Response: There is a row
in items 5 and 6 that states "Other isotope (specify):" Isotopes not
specifically listed in items 5 and 6 may be added in this row. |
D-4 |
RSO Qualifications |
What about Health Physicists? Also what about retraining frequency
& content requirements? etc.? |
NRC Staff Response:
- Health Physicists are not precluded from providing their training
and experience in support of a request to name an RSO. Item 7
of the reviewer checklist, Appendix D, reflects information covered
in chapter 8.8, item 7 which describes training and experience
for RSOs for fixed gauge licensees. There are several methods
that provide evidence of adequate training and experience for
an RSO. Completion of a fixed gauge manufacturer's course for
users or for RSOs or an equivalent course that
meets Appendix G criteria would each provide evidence of adequate
training and experience for an RSO. In addition, the checklist
allows an applicant to check the "Other- Yes" column and submit
alternative information demonstrating that the proposed RSO and
any future RSO are qualified by training and experience. Alternative
information will be accepted for review and evaluated using the
criteria stated in chapter 8.8, item 7.
- 10 CFR 19.12(a)(1) states that, "All individuals who in the
course of employment are likely to receive in a year an occupational
dose in excess of 100 mrem (1 mSv) shall be -- kept informed
of the storage, transfer, or use of radiation and/or radioactive
material. The phrasing "kept informed" may necessitate periodic
retraining for this group of individuals. Other retraining may
be necessary in order for licensees to ensure that their workers
have the skills to meet the requirements of NRC regulations (e.g.,
security and control of materials, surveys, posting).
|
D-5 |
Individual responsible for training |
- These qualifications are inaccurate and inadequate. They don't
reflect the capabilities of Health Physicists and other Radiation
Protection Trained personnel.
- Note that the operation of such a gauge is NOT DIFFICULT,
thus the Radiation Safety aspects of this issue are paramount.
- Note that a "Physical Science or Engineering Degree" could include
Astronomy, Geology, Paleontology.
- What about Health Science Degrees such as X-Ray Technician?
They have far more radiation safety training than a geologist!
- What happened to the "Or Equivalent" clause?
|
NRC Staff Response:
- The NRC Staff believe the qualifications for course instructors
are adequate. Alternative qualifications may be submitted. NRC
license reviewers will review alternative qualifications on a
case-by-case basis.
- The NRC Staff's concern is with radiation safety of the gauge.
The NRC Staff note that the operation of many gauges is not difficult.
- A physical science or engineering degree could include astronomy,
geology or paleontology. However, "Course Instructor Qualifications"
for individual's with a Bachelor's degree in a physical or life
science also suggests successful completion of both a fixed gauge
manufacturer's course for users, an 8 hour radiation safety course
and 8 hours of hands-on experience with fixed gauges.
- If individuals with health sciences degrees such as X-ray technicians
meet one of the training options stated in Item 7 "Individual(s)
Responsible for Radiation Safety Program and Their Training and
Experience - Radiation Safety Officer" of Appendix D, then they
may qualify to be an RSO.
- In the "Purpose of the Report" Chapter there is a bullet which
instructs:
- Response from Applicant -- provides suggested response(s), offers
the option of an alternative reply, or indicates that no response
is needed on that topic during the licensing process.
The last two columns in the checklist state "Other - Yes or No."
If the licensee checks "Yes" in the "Other" column, they may attach
an alternative reply to the application. NRC license reviewers will
review alternative replies on a case-by-case basis. |
D-6 D-7 |
RSO
Training for Authorized Users |
Again, what about Health Physics Qualifications? Does the item for
"Annual audit of radiation safety program" and its sub-bullets really
make sense here? This is an RSO Responsibility, not an "Authorized
User's" |
NRC Staff Response:
- Health Physicists qualifications will be reviewed against the
criteria stated in NUREG-1556 Vol. 4 or the applicant may elect
to submit the qualifications of a health physicist as an alternative
reply.
- The NRC Staff believes that authorized users should be aware
of the requirement for an annual audit of the program.
|
D-8 |
Training for Authorized Users |
- Bullet 4 - how about "Each gauge the Authorized User" will use?
some licensees possess several gauges that an individual will
never use due to their job description & location.
- What about training on the use of survey meters?
- What about retraining frequency and content requirements?
- Course Instructor qualifications are faulty as previously described.
These HAVE to be addressed.
|
NRC Staff Response:
- Bullet 4 has been changed to read "Practical Explanation of
the Theory and Operation for Each Type of Gauge that may be used
by the Authorized User"
- It is not within the scope of this document to address specific
training on the use of survey instruments. However, Appendix G,
"Criteria for Acceptable Training Courses for Authorized Users
and Radiation Safety Officers" has been modified to add training
on:
- Use of survey meters and personal dosimetry, when required
- 10 CFR 19.12(a)(1) states that, "All individuals who in the
course of employment are likely to receive in a year an occupational
dose in excess of 100 mrem (1 mSv) shall be -- kept informed
of the storage, transfer, or use of radiation and/or radioactive
material. The phrasing "kept informed" may necessitate periodic
retraining for this group of individuals. Other retraining may
be necessary in order for licensees to ensure that their workers
have the skills to meet the requirements of NRC regulations (e.g.,
security and control of materials, surveys, posting).
- The NRC Staff believe the qualifications for course instructors
are adequate. Alternative qualifications may be submitted. NRC
license reviewers will review alternative qualifications on a
case-by-case basis.
|
D-10 |
Instruments Optional Response |
- Instruction is unclear in its intent.
- Incorrect Units mR not mrem.
- Measuring Gamma radiation - What happened to alpha, beta and
neutron?
|
NRC Staff Response:
- The "criteria" section of chapter 8.13 item 10: "Radiation safety
Program - Instruments" provides a description of intent with regard
to instruments.
- See previous response regarding use of the Roentgen.
- NRC's final metrication policy that requires NRC to use "…the
system of units employed by the licensee" (see 61 FR
31169, June 19, 1996). NRC made a conscious decision to use the
Roentgen unit in NUREG-1556, Vol. 4 to make the guide more efficient
and useable for the vast majority of gauge users.
- 50 C/kg per hour is stated in the first bullet under optional
response in the instrument section of Appendix D.
- See also the "Criteria" section of chapter 8.13 item 10: "Radiation
Safety
Program - Instruments" which refers to 50 C/kg.
- The second bullet in the criteria" section of chapter 8.13 item
10: "Radiation Safety
Program - Instruments" has been changed to read, "Is capable of
measuring the radiation being emitted from the gauge's sealed
source."
|
D-13 |
Operating & Emergency Procedures |
Why is there no requirement for surveying the gauge/work area? This
is a simple, basic safety precaution. Every RG Technician at a DOE
Facility or a Nuclear Power Plant would wince at the lack of this
& issue a "stop work order." |
NRC Staff Response:
- 10 CFR 20.1501 requires each licensee to make or cause to be
made, surveys that may be necessary for the licensee to comply
with the regulations in this part; and are reasonable under the
circumstances to evaluate the extent of radiation levels; and
concentrations or quantities of radioactive material; and the
potential radiological hazards that could be present. Some of
the bullets listed in Appendix D - Operating and Emergency procedures,
depending upon circumstances, may require that a survey of the
gauge/work area be made.
- Chapter 8.13 item 10: "Radiation safety Program - Instruments"
discusses surveys and instruments.
- Appendix G, "Criteria for Acceptable Training Courses for Authorized
Users and Radiation Safety Officers" has been modified to add
training on:
- Use of survey meters and personal dosimetry, when required
|
D-15 |
Emergency procedures |
What about Contamination Control and control of contaminated personnel? |
NRC Staff Response: A detailed consideration
of every possible emergency situation involving a fixed gauge that
could occur is beyond the intended scope of the applicant's response.
The 3rd bullet under emergency procedures, states, "Contact responsible
individuals…" The last bullet states, "Take additional steps, dependent
on the specific situations." Appendix L, under emergency procedures,
does address contamination control measures. |
D-17 |
Routine Safety Program Maintenance |
- Potential Problem: manufacturer's recommendations may NOT include
good radiation safety precautions.
- Is each "Optional Response" a completely separate Option?
|
NRC Staff Response:
- Licensee's must comply with NRC regulations in addition to the
manufacturer's recommendations.
- The applicant may supply an optional response for any of the
items requested in the application.
|
F-1 |
Bullet 4 - Training |
Should have the RSO "supervise" the proper training. |
NRC Staff Response: There is no requirement
for the RSO to supervise training. |
G-1 |
Radiation Safety |
Include proper survey techniques and response to unusual readings. |
NRC Staff Response: It is not within
the scope of this document to address specific training on the use
of survey instruments. However, Appendix G, "Criteria for Acceptable
Training Courses for Authorized Users and Radiation Safety Officers"
has been modified to add training on:
- Use of survey meters and personal dosimetry, when required
|
G-1 |
Theory of the Gauge & lock out procedures |
Is this the "manufacturer's course (which doesn't exist)? Is normal
lock-out, tag-out training sufficient? |
NRC Staff Response: "Normal lock-out,
tag-out training" is sufficient if it is equivalent to the manufacturer's
training or equivalent. If the manufacturer or distributor does not
provide such training the licensee should submit alternative training.
NRC license reviewers will determine on a case-by-case basis if training
is adequate. |
G-2 |
OUT |
- Missing requirement for surveys for radiological safety.
- Supervision requirement should allow an HP or the RSO to do
this.
- How do you qualify an "authorized user" if no one has had the
training?
|
NRC Staff Response:
- As stated in the "Discussion" section of chapter
8.13, item 10, "Usually it is not necessary for fixed gauge licensees
to possess a survey meter." This chapter also discusses specific
circumstances when surveys are required. If a survey pursuant
to 10 CFR 20.1501 is required, the licensee must comply.
- The training and experience criteria for RSOs qualify them as
authorized users. Thus on-the-job training could also be done
under the supervision of an RSO. Wording of the sentence will
be changed to add "or RSO." If the health physicist's training
and experience meet those for an authorized user, the health physicist
may supervise on-the-job training.
- The proposed authorized user should be able to obtain training
from the manufacturer or distributor of the fixed gauge. If this
is not possible, the applicant should submit an alternative response
for training. NRC license reviewers will review alternative responses
on a case-by-case basis.
|
G-2 |
Training Assessment |
- Each type of gauge possessed is not practical for some users.
Use "Each type of gauge an Authorized User will work with."
- Qualifications need some form of formal documentation.
|
NRC Staff Response:
- The proposed wording in Appendix G, under "Training Assessment,"
for the final NUREG-1556, Vol. 4 states, "Management will ensure
that proposed AUs and RSOs are
qualified to work independently with each type of gauge with
which they may work. Management will ensure that proposed RSOs
are qualified to work independently with, and are knowledgeable
of the radiation safety aspects of, all types of gauges to be
possessed by the applicant.
- Course instructor qualifications need not be submitted with
the application. Evidence of training (e.g. documentation) may
be reviewed at time of inspection.
|
G-2 |
Instructor Qualifications |
- Inconsistent with previous requirements
- No specification of the hours of hands on experience.
- Why is this "hours of hands-on" a requirement? These gauges
are NOT "rocket science." The concern here is
for radiological safety. An 8 hour course in the subject is woefully
inadequate.
- Bachelor's degree requirements have the same problem as before,
I wouldn't want to have my radiological safety "guaranteed" by
a paleontologist.
- Is a Health Physics Degree or certification or "X" years (I
suggest 5 years) of Health Physics Experience equivalent?
- The 40 hr radiation safety course here is NOT??? the manufacturer's
course? - Inconsistent!! (But it makes more sense.)
|
NRC Staff Response:
- There are no specific requirements for course instructor qualifications.
The guidance in draft NUREG-1556, Vol. 4 combined and updated
previous guidance. Thus, course instructor qualifications in NUREG-1556,
Vol. 4 may be inconsistent with some previous guidance.
- Specification of eight hours of hands-on experience with fixed
gauges was inadvertently omitted from the draft document.
- Alternative training and experience for course instructors may
be submitted for NRC review. Appendix G has been revised to clearly
state that alternative qualifications may be submitted for NRC
review as follows: "The applicant may submit a description of
alternative training and experience for the course instructor."
- Course instructors should have radiation safety training in
addition to that provided by the manufacturer. Course instructors
who do not possess an appropriate undergraduate degree may require
more radiation safety training as they may not have the training
background to assimilate radiation safety principles as quickly
as an individual with a bachelor's degree in a physical or life
science or engineering. As stated above, the applicant may submit
a description of alternative training and experience for the course
instructor.
|
H-2 |
Training & Instructions |
Lots of questions in this section that no guidance is provided for
before this e.g.: a, b, d, h, i. |
NRC Staff Response: Appendix H is the
Suggested Fixed Gauge Audit Checklist. It is not the intent of the
document to specifically address each NRC regulation with regard to
fixed gauge licensees. Appendix H attempts to provide a fairly comprehensive
list of areas that the licensee should address during an audit. Appendix
H may address requirements that are not addressed elsewhere in the
document.
- a is addressed in 8.9, item 8.
- b is addressed in 8.8, item 7.2.
- d is addressed in Appendix N.
- h is addressed in 8.8 item 7.2 and 8.19 (8.10.9 in final NUREG)
item 10.
- i is addressed in 8.19 (8.10.9 in final NUREG), item 10, 8.20
(8.10.10 in final NUREG), item 10 and in Appendix O by reference
to 49 CFR.
|
H-2 & 3 |
Personnel Radiation Protection |
- ALARA is required in 10CFR20 why is the emphasis not existent
through the rest of the document (e.g., Survey requirements etc.)?
- e. Nowhere prior to this is any "warning" of the DPW concerns
given.
|
NRC Staff Response:
- Appendix H is the Suggested Fixed Gauge Audit Checklist. It
is not the intent of the document to specifically address each
NRC regulation with regard to fixed gauge licensees. Appendix
H attempts to provide a fairly comprehensive list of areas that
the licensee should address during an audit. Appendix H may address
requirements that are not specifically addressed elsewhere in
the document.
- 10 CFR 20.1101(b) states the ALARA requirement and applies
to all licensees. It requires that licensees use to the extent
practicable, procedures and engineering controls based upon
sound radiation protection principles to achieve occupational
doses and doses to members of the public that are as low as
reasonably achievable. Thus, ALARA applies to every aspect of
the licensee's entire Radiation Protection Program. ALARA is
addressed in the audit checklist for overall evaluation of the
Radiation Protection Program. ALARA is addressed throughout
the document. ALARA is defined in abbreviations and is discussed
in many chapters of the document including chapters 8.11 Item
10: Audit Program; 8.16 (8.10.6 in final NUREG) Item 10: Operating
and Emergency Procedures; 8.18 (8.10.8 in final NUREG) Item 10:
Maintenance; and 8.20 (8.10.10 in final NUREG) Item 10: Fixed
Gauges Used at Temporary Job Sites.
- Chapter 8.13, item 10, discusses specific circumstances when
surveys are required. If a survey pursuant to 10 FR 0.1501 is
required, the licensee must comply.
- 10 CFR 20.1208 addresses declared pregnant woman (DPW) and applies
to all licensees. If a woman declares pregnancy, the licensee
would need to ensure that all of the requirements of 20.1208 are
met. This regulation is addressed in the audit checklist to advise
licensees to the possibility of a DPW in their program.
|
H-5 |
Posting & Labeling |
How about "is the Radiological Hazard properly posted"? |
NRC Staff Response: The requirements
for posting radiological hazards are specified in 10 CFR 20.1902
and 20.1904. These regulations are stated in parenthesis following
item 14-c on page H-5 of draft NUREG-1556, Vol. 4. |
I-l |
OJT |
How is the OJT documented? |
NRC Staff Response: A specific method
of documenting on-the-job training (OJT) is not stipulated. OJT
may be documented by the applicant in numerous ways and will be
verified at time of inspection. |
I-2 |
Survey meter |
- Must be able to detect the appropriate type of radiation emitted
by the source.
- Calibration must be made for this type of radiation at the correct
energy.
|
NRC Staff Response: The third and
fourth bullet of section 1 of Appendix I have been changed to read:
- Contain a radionuclide which emits radiation of identical or
similar type and energy as the sealed sources that the instrument
will measure
- Be strong enough to emit a radiation field that is representative
of the field being emitted by the gauge. For calibration of instruments
intended to measure gamma radiation, the exposure rate should
be at least 30 mR/hour (7.7 microcoulomb/kilogram per hour) at
100 cm [e.g., 3.1 gigabecquerels (85 millicuries) of Cs-137 or
780 megabecquerels (21 millicuries) of Co-60].
|
J-1 |
Example |
Should scatter be considered? |
NRC Staff Response: Consideration of
scattered radiation is beyond the intended scope of the example provided
in Appendix J. |
L-1 |
Operating Procedures |
Survey of area? It should be required periodically. |
NRC Staff Response: Chapter 8.13, item
10, discusses specific circumstances when surveys are required. If
a survey pursuant to 10 CFR 20.1501 is required, the licensee must
comply. |
L-2 |
Emergency Procedures |
How about control of contaminated objects and personnel? |
NRC Staff Response: Detailed consideration
of control of contaminated objects and personnel is beyond the intended
scope of the emergency procedures provided in Appendix L. However,
some consideration is given to contamination control in Appendix L
in the 2nd and 3rd bullets under Emergency Procedures. See also response
to comments regarding figure 8.6 on page 8-24. |
N-2 |
Identify who will perform non-routine maintenance |
What is equivalent training? Especially if the manufacturer's courses
don't exist? |
NRC Staff Response: The applicant is
instructed that acceptable training includes the manufacturer's courses
on non-routine operations or equivalent training. NRC license reviewers
will determine on a case-by-case basis if training on non-routine
operations other than that provided by a manufacturer is adequate. |
[ Top of file
]
1. See "Amendments and Renewals to a License" later
in this document. Licensees may request an amendment to an existing license
to add authorization for a fixed gauge.
2. Fill in with (and update, as needed) the names
and telephone numbers of appropriate personnel (e.g., the RSO, Aus, or
other knowledgeable licensee staff, licensee's consultant, gauge manufacturer,
distributor or representative, fire department, or other emergency response
organization, as appropriate, and the NRC) to be contacted in case of
emergency. |