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Program-Specific Guidance About Commercial
Radiopharmacy Licenses - Final Report (NUREG-1556, Vol. 13)
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Table of Contents
Publication Information
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Manuscript Completed: September 1999
Date Published: September 1999
Prepared by
J. Cameron, P. Henderson, D. Howe, J. Montgomery
Division of Industrial and Medical Nuclear Safety
Office of Nuclear Material Safety and Safeguards
U.S. Nuclear Regulatory Commission
Washington, DC 20555-0001
Availability
Notice
Abstract
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As part of its redesign of the materials licensing process, 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. 13, "Consolidated Guidance about Materials
Licenses: Program-Specific Guidance About Commercial Radiopharmacy Licenses,"
dated September 1999, is the thirteenth 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
combines and supersedes the guidance found in "Draft Regulatory Guide
DG-0006" (previously issued as FC 410-4), "Guide for the Preparation
of Applications for Commercial Nuclear Pharmacy Licenses" (March 1997),
and Standard Review Plan 85-14, "Standard Review Plan for Applications
for Nuclear Pharmacy Licenses." This report takes a more risk-informed,
performance-based approach to licensing commercial radiopharmacies and
reduces the information (amount and level of detail) needed to support
an application for these activities.
Figures
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Figure K.1 Calculating Public Dose 8-87
Figure 2.1 U.S. Map
Figure 8.1 Location of Use
Figure 8.2 Purpose Wheel
Figure 8.3 Typical Facility Diagram
Figure 8.5 Examples of Portable and Stationary
Survey Instruments Used by Radiopharmacies
Figure 8.6 Accountability
Figure 8.7 Annual Dose Limits for Occupationally
Exposed Adults
Figure 8.8 Use of Appropriate Shielding
Figure 8.9 Types of Surveys
Figure 8.10 Personnel Surveys
Figure 8.11 Typical Surveys at Radiopharmacy
Figure 8.12 Returned Waste
Figure H.1 Typical Duties and Responsibilities
of the RSO
Figure K.1 Calculating Public Dose
Figure Q.1 Storage of Food and Drink
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 list of
volumes currently included in the NUREG-1556 series:
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 |
Final Report |
6 |
Program-Specific Guidance About 10 CFR Part 36 Irradiator Licenses |
Final Report |
7 |
Program-Specific Guidance About Academic, Research and Development,
and Other Licenses of Limited Scope |
Draft for Comment |
8 |
Program-Specific Guidance About Exempt Distribution Licenses |
Final Report |
9 |
Program-Specific Guidance About Medical Use Licenses |
Draft for Comment |
10 |
Program-Specific Guidance About Master Material Licenses |
Draft for Comment |
11 |
Program-Specific Guidance About Licenses of Broad Scope |
Final Report |
12 |
Program-Specific Guidance About Possession Licenses for Manufacturing
and Distribution |
Draft for Comment |
13 |
Program-Specific Guidance About Commercial Radiopharmacy Licenses |
Final Report |
14 |
Program-Specific Guidance About Well Logging, Tracer, and Field
Flood Study Licenses |
Draft for Comment |
15 |
Guidance About Changes of Control and About Bankruptcy Involving
Byproduct, Source, or Special Nuclear Material Licenses |
Draft for Comment |
16 |
Program-Specific Guidance About Licenses Authorizing Distribution
To General Licensees |
Draft for Comment |
The current document, NUREG-1556, Vol. 13, "Consolidated Guidance about
Materials Licenses: Program-Specific Guidance about Commercial Radiopharmacies,"
dated September 1999, is the thirteenth program-specific guidance developed
for the new process. It is intended for use by applicants, licensees,
NRC license reviewers, and other NRC personnel. It combines and supersedes
the guidance for applicants and licensees previously found in "Draft Regulatory
Guide DG-0006" (previously issued as FC 410-4) "Guide for the Preparation
of Applications for Commercial Nuclear Pharmacy Licenses" (March 1997)
and Draft Standard Review Plan 85-14, "Standard Review Plan for Applications
for Nuclear Pharmacy Licenses." In addition, this report also contains
pertinent information found in Technical Assistance Requests and Information
Notices, as listed in Appendix B.
This report takes a risk-informed, performance-based approach to licensing
commercial radiopharmacies. It identifies the information needed from
an applicant seeking to possess and use byproduct materials during the
preparation and distribution of radioactive drugs and in the distribution
of radiochemicals, sealed sources, and in-vitro test kits.
A team composed of NRC staff from headquarters and regional offices prepared
this document, drawing on their collective experience in radiation safety
in general and as specifically applied to commercial radiopharmacy. A
representative of NRC's Office of the General Counsel provided a legal
perspective.
This report 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 address: <http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/SR1556/V13/index.html>.
NUREG-1556, Vol. 13, "Consolidated Guidance about Materials Licenses:
Program-Specific Guidance about Commercial Radiopharmacy Licenses," 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 determination
needed to issue or continue a license.
_________________________________________
Donald A. Cool, 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 the report. All participants provided valuable
insights, observations, and recommendations.
The team also thanks Kay Avery, Judy Boykin, Randy Glantz, Rolonda Jackson,
D.W. Benedict Llewellyn, Steven W. Schawaroch, Agi Seaton,
and Gina G. Thompson of Computer Sciences Corporation.
The Participants
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Cameron, Jamnes L.
Camper, Larry W.
Cool, Donald A.
Henderson, Pamela J.
Hickey, John W.
Hosey, Charles M.
Howe, Donna-Beth
Howell, Linda L.
Kinneman, John D.
Merchant, Sally L.
Montgomery, James L.
Piccone, Josephine M.
Phillips, Monte P.
Roe, Mary Louise
Schwartz, Maria E.
Treby, Stuart A.
Abbreviations
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ALARA |
as low as is reasonably achievable |
ALI |
annual limit on intake |
ANP |
authorized nuclear pharmacist |
ANSI |
American National Standards Institute |
AU |
authorized user |
bkg |
background |
BPR |
business process redesign |
Bq |
becquerel |
CDE |
committed dose equivalent |
CEDE |
committed effective dose equivalent |
CFR |
Code of Federal Regulations |
Ci |
curie |
cm |
centimeter |
cpm |
counts per minute |
DAC |
derived air concentration |
DDE |
deep-dose equivalent |
DFP |
decommissioning funding plan |
DIS |
decay in storage |
DOE |
United States Department of Energy |
DOT |
United States Department of Transportation |
dpm |
disintegrations per minute |
dpm/cm2 |
disintegrations per minute per square centimeter |
EDE |
effective dose equivalent |
FA |
financial assurance |
FDA |
United States Food and Drug Administration |
G-M |
Geiger-Mueller |
GPO |
Government Printing Office |
IN |
Information Notice |
IP |
inspection procedure |
mGy |
milliGray |
MDA |
minimum detectable activity |
MOU |
Memorandum of Understanding |
mR |
milliroentgen |
mrem |
millirem |
mrem/hr |
millirem per hour |
mSv |
millisievert |
mSv/hr |
millisievert per hour |
NCRP |
National Council on Radiation Protection and Measurements |
NIST |
National Institute of Standards and Technology |
NMSS |
Office of Nuclear Materials Safety and Safeguards |
NRC |
Nuclear Regulatory Commission |
NVLAP |
National Voluntary Laboratory Accreditation Program |
OMB |
Office of Management and Budget |
P&GD |
Policy and Guidance Directive |
QA |
quality assurance |
R |
roentgen |
RG |
Regulatory Guide |
RQ |
reportable quantity |
RSO |
radiation safety officer |
SDE |
shallow-dose equivalent |
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 |
USDA |
United States Department of Agriculture |
1 Purpose of Report
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This report provides guidance to an applicant applying for a commercial
radiopharmacy license, as well as providing NRC with the appropriate criteria
for evaluating such applications. Within this document, the terms "byproduct
material," "licensed material," and "radioactive material," are used interchangeably.
In addition, the phrases or terms, "commercial radiopharmacy," "radiopharmacy,"
"nuclear pharmacy," and "pharmacy" are used interchangeably.
Commercial radiopharmacy licenses are those licenses issued by the Commission,
pursuant to 10 CFR Part 30 and 10 CFR 32.72, for the possession and
use of radioactive materials for the manufacture, preparation, or transfer
for commercial distribution of radioactive drugs containing byproduct
material for medical use under Part 35. Within this document, preparation
includes the making of radiopharmaceuticals from reagent kits (i.e., technetium-99m
MAA (macroaggregated albumin)), and from raw materials (i.e., the compounding
of radioiodine capsules for diagnostic and therapeutic medical use). Commercial
radiopharmacies may also be authorized to transfer for commercial distribution
in vitro test kits described in 10 CFR 31.11, radiopharmaceuticals
to licensees authorized to possess them for other than human medical use
(i.e., veterinary medicine and research licensees), and radiochemicals
to those licensees authorized to possess them, pursuant to 10 CFR Part
30. In addition, 10 CFR Part 30 authorizes radiopharmacies to redistribute
(transfer) sealed sources for calibration and medical use initially distributed
by a manufacturer licensed pursuant to 10 CFR 32.74.
Specific guidance for applicants requesting to manufacture and initially
distribute molybdenum-99/technetium-99m generators, in vitro
kits, radiochemicals and sealed sources is included in NUREG 1556, Vol
12, "Consolidated Guidance about Materials Licenses: Program-Specific
Guidance about Manufacturing and Distribution Licenses," and is not within
the scope of this guidance for commercial radiopharmacies. These activities
require specific NRC or Agreement State authorization and must be included
on a specific license.
Furthermore, specific guidance for applicants requesting authorization
to manufacture, distribute, and redistribute radioactive drugs to persons
exempt from licensing (i.e., carbon-14 tagged urea) is included in NUREG
- 1556, Vol. 8, "Consolidated Guidance about Materials Licenses: Program-Specific
Guidance about Exempt Distribution Licenses," and also is not within the
scope of this guidance. These activities require specific NRC authorization
and require the issuance of a separate license for exempt distribution.
This report identifies the information needed to complete NRC Form 313
(Appendix A), "Application for Material License," for the use of byproduct
materials in commercial radiopharmacies. The information collection requirements
in 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. Specific NRC references used in the development
of this guidance document are included in Appendix B.
NRC Form 313 does not have sufficient space for applicants to provide
full responses to Items 5 through 11; as indicated on the form, the answers
to those items are to be provided on separate sheets of paper and submitted
with the completed NRC Form 313. For the convenience of applicants and
for streamlined handling of applications for commercial radiopharmacy
licenses in the new materials licensing process, use Appendix C to provide
supporting information, attach it to NRC Form 313, and submit it to NRC.
Appendix D is a checklist that NRC staff uses to review applications
and that applicants may use to check for completeness. Appendix E is a
sample commercial radiopharmacy license, containing the conditions most
often found on these licenses, although not all licenses will have all
conditions. Appendices F through S contain additional information on various
radiation safety topics, including model procedures. Appendix T includes
a table of NRC incident notification and reporting requirements applicable
to commercial radiopharmacies.
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 radioactive material
emits beta and gamma rays, for practical reasons, we assume that 1 R =
1 rad = 1 rem. For alpha emitting radioactive material, 1 rad is
not equal to 1 rem. Determination of dose equivalent (rem) from absorbed
dose (rad) from 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 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. 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 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 from NRC upon request.
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 |
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.
Reference: 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 Programs' (OSP's)
Home Page <http://www.hsrd.ornl.gov/nrc/home.html>.
As an alternative, request the list from NRC's Regional Offices.
All Agreement States Letter, SP-96-022, dated February 16, 1996, is available
on OSP's Home Page <http://www.hsrd.ornl.gov/nrc/home.html>;
choose "NRC-State Letters," then choose "All of the Above," and follow
the directions for submitting a query for "SP96022." As an alternative,
request the letter 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 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) 87117, "Radiopharmacy Programs." These documents
are available electronically at <http://www.nrc.gov>.
For hard copies of NUREG-1600 and IP 87117, 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 obtain up-to-date
copies of applicable regulations, read and understand the requirements
of each of these regulations, and comply with each applicable regulation.
The following Parts of 10 CFR Chapter I contain regulations applicable
to commercial radiopharmacies:
- 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";
Part 32 allows licensees to prepare radioactive drugs for medical
use, provided that the radioactive drug is prepared by either an authorized
nuclear pharmacist (ANP) or an individual under the supervision of
an ANP as specified in 10 CFR 35.25. In addition, Part 35 specifies
the definition of an ANP and medical use in 35.2, and the qualifications
of an ANP, in 10 CFR 35.980(b) and 35.972; however, the
remaining sections of Part 35 do not apply to commercial radiopharmacy
licensees. |
- 10 CFR Part 71, "Packaging and Transportation of Radioactive Material";
Part 71 requires that licensees or applicants who transport licensed
material or who may offer such material to a carrier for transport
must comply with the applicable requirements of the 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 170, "Fees for Facilities, Materials, Import and Export
Licenses and Other Regulatory Services Under the Atomic Energy Act of
1954, as Amended"; and
- 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>.
Single copies of the above documents may be requested from NRC's Regional
Offices (see Figure 2.1 for addresses and telephone numbers). In addition,
10 CFR Parts O-199 can be found on the NRC's website at <www.nrc.gov/nrc/cfr/index/html>.
Note that NRC and all other Federal Agencies publish amendments to their
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 C;
- For each separate sheet, other than Appendix C, 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;
and
- Submit an original, signed application and one copy.
Retain one copy of the license application for future reference.
As required by 10 CFR 30.32(c), applications must be signed
by duly authorized representative; see section on "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, e.g., home address, home telephone number, Social
Security Number, date of birth, or radiation dose information, should
not be submitted unless specifically requested by NRC.
As explained in the "Foreword," 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, Helvetica,
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
(compact disc-read only memory), and through the Internet. Additional
filing instructions will be provided as these new mechanisms become 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
Agreement 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, 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 licensing action prior to fee receipt.
Consult 10 CFR 170.11 for information on exemptions from these fees. 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 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 B) to the Office of the Chief Financial Officer (OCFO)
at NRC Headquarters in Rockville, Maryland, (301) 415-7554. Information
about fees may also be obtained by calling NRC's toll free number (800)
368-5642, extension 415-7554. The e-mail address is fees@nrc.gov.
8 Contents of an Application
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The following comments apply to the indicated items on NRC Form 313 (Appendix
A).
All items in the application should be completed in enough detail for
the NRC to determine that the proposed equipment, facilities, training
and experience, and radiation safety program satisfy regulatory requirements
and are adequate to protect health and minimize danger to life and property.
Consideration shall be given, when developing your application, to the
concepts of ALARA and the minimization of contamination.
Regarding ALARA, 10 CFR 20.1101(b) states that "The licensee shall
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 is reasonably achievable
(ALARA)." ALARA concepts and philosophy are discussed in Regulatory Guide
8.10, "Operating Philosophy for Maintaining Occupational Radiation Exposures
As Low As Is Reasonably Achievable." Applications for commercial radiopharmacy
licenses must address ALARA considerations in all aspects of their programs,
e.g., monitoring and controlling external and internal personnel exposure,
monitoring and controlling air and liquid effluents. ALARA considerations,
including establishing administrative action levels and monitoring programs,
need to be documented in the application.
10 CFR 20.1406 requires that license applicants 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. Like ALARA, the applicant must address these concerns
in all aspects of their programs.
All information submitted to NRC during the licensing process will be
incorporated as part of the license and will be subject to review during
inspection.
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; provide license number.
Check box C for a renewal1 of an existing license; 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 when 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: Transferring 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. 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 F, excerpted from IN 89-25 (Rev. 1), "Unauthorized
Transfer of Ownership or Control of Licensed Activities," dated December
7, 1994, identifies the information to be provided about transferring
control.
Reference: See the Notice of Availability (on the inside
front cover of this report) to obtain copies of IN 89-25 (Rev. 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. Information Notices are available on NRC's website at <www.nrc.gov/nrc/reference.html>
Notification of Bankruptcy Proceedings
Regulation: 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. Licensees must immediately notify NRC following the
filing of a voluntary or involuntary petition for bankruptcy for or against
the licensee.
Reference: See the Notice of Availability (on the inside
front cover of this report) to obtain copies of Policy and Guidance Directive
PG 8-11, "NMSS Procedures for Reviewing Declarations of Bankruptcy," dated
September 8, 1996, and NRC Inspection Manual, Inspection Procedure 87103,
"Inspection of Material Licensees Involved in an Incident or Bankruptcy
Filing."
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
(e.g., 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. Sketches or street maps indicating the location of the proposed
facility would be helpful but are not required. A Post Office Box address
is not acceptable.
Figure 8.1 Location of Use.
An acceptable location of use specifies street address, city, state,
and zip code and does not include a post office box number.
An NRC-approved license amendment is required before receiving, using
and storing licensed material at an address or location not listed on
the license.
Being granted an NRC license does not relieve a licensee from complying
with other applicable Federal, State, or local regulations (e.g.,
local zoning requirements). |
Note: As discussed later under "Financial Assurance
and Record Keeping for Decommissioning," licensees must maintain permanent
records describing 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). Acceptable records are sketches, written descriptions
of the specific locations or room numbers where licensed material is used
or stored, and any records of spills or other unusual occurrences involving
the spread of contamination in or around the licensee's facilities.
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 individual, usually the
Radiation Safety Officer, will serve as the point of contact during the
review of the application and during the period of the license. If this
individual is not a full-time employee of the licensed entity, his or
her position and relationship should be specified. No individual other
than the duly authorized applicant may, for any licensing matter, act
on behalf of the applicant or provide information without the applicant's
written authorization. The NRC should be notified if the person assigned
to this function changes or if their telephone number changes. Notification
of a contact change is for information only and would not be considered
an application for license amendment, unless the notification involves
a change in the contact person who is also the Radiation Safety Officer.
As indicated on NRC Form 313 (Appendix A), Items 5 through 11 should
be submitted on separate sheets of paper. Applicants may use Appendix
C 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. |
8.5 Item 5: Radioactive Material
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8.5.1 Unsealed And/or Sealed Byproduct Material
Regulations: 10 CFR 30.33, 10 CFR 32.72(a)(3), 10 CFR
30.32(g), 10 CFR 32.210, 10 CFR 30.32(i).
Criteria: Applicants must submit information specifying
each radionuclide requested; the form; and the maximum activity to be
possessed at any one time. For sealed sources, the applicant must also
submit the manufacturer and model number of each requested sealed source.
Discussion: Each authorized radioisotope is listed on
an NRC license by its element name, form, and the maximum amount the licensee
may possess at any one time (maximum possession limit), as shown in items
6, 7, and 8 of the sample license in Appendix E.
Requests to license naturally-occurring radioactive material (NORM) and
accelerator-produced radioactive material should be made to the appropriate
State regulatory agency. NRC does not regulate NORM or accelerator-produced
radioactive material.
The applicant should list each requested radioisotope by its element
name and its mass number (e.g., technetium-99m) in item 5. Note in the
sample license in Appendix E that the NRC provides broad authorization
to permit radiopharmacy licensees flexibility to prepare and distribute
a range of radioisotopes as new radioactive drugs are developed. It is
necessary to specify whether the material will be acquired and used in
unsealed or sealed form. The name of the specific chemical compound that
contains the radioisotope is not generally required.
For unsealed radioactive material, it is also necessary to specify whether
requested radioisotopes will be handled in volatile or non-volatile form,
since additional safety precautions are required when handling and using
material in a volatile form. For example, when requesting authorization
to possess and distribute iodine-131, the applicant must specify whether
the material will be manipulated at the radiopharmacy in a volatile form
(e.g., compounding of iodine-131 capsules) or received in the form in
which it will be distributed (e.g., redistribution of sealed, unopened
vials of iodine-131). Applicants requesting authorization to manipulate
volatile radioactive material must describe appropriate facilities and
engineering controls in response to Section 8.9, "Facilities and Equipment,"
and radiation safety procedures for handling of such material in specific
responses to Section 8.10.4, "Occupational Dose;" Section 8.10.5, "Public
Dose;" Section 8.10.6, "Safe Use of Radionuclides and Emergency Procedures;"
and Section 8.10.7, "Surveys."
The anticipated possession limit in becquerels (Bq) or curies (Ci) for
each radioisotope should also be specified. Possession limits must include
the total anticipated inventory, including licensed material in storage
and waste, and should be commensurate with the applicant's needs and facilities
for safe handling. Applicants should review the requirements for submitting
a certification for financial assurance for decommissioning before specifying
possession limits of any radioisotope with a half life greater than 120
days. These requirements are discussed in the Section on Financial Assurance
and Decommissioning.
Applicants will be authorized to possess and use only those sealed sources,
such as calibration and reference sources, that are specifically approved
or registered by the NRC or an Agreement State. A safety evaluation of
sealed sources and devices is performed by the NRC or an Agreement State
before authorizing a manufacturer (or distributor) to distribute them
to specific licensees. The safety evaluation is documented in a Sealed
Source and Device (SSD) Registration Certificate. Information on SSD registration
certificates may be obtained by contacting the Registration Assistant
by calling NRC's toll-free number, (800) 368-5642, extension 415-7231.
Applicants must provide the manufacturer's name and model number for each
requested sealed source and device, so that NRC can verify that they have
been evaluated in an SSD Registration Certificate or specifically approved
on a license.
Consult with the proposed supplier, manufacturer, or distributor to ensure
that requested sources and devices are compatible with 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. To ensure that
applicants use sources and devices according to the registration certificates,
they may want to get a copy of the certificate and review it or discuss
it with the manufacturer.
A safety evaluation of sealed sources and devices is performed by
NRC or an Agreement State before authorizing a manufacturer (or distributor)
to distribute them to specific licensees. The safety evaluation is
documented in an SSD Registration Certificate. Information on SSD
registration certificates is available on the NRC's web site at <http://www.hsrd.ornl.gov/nrc/ssdrform.htm>
and may also be obtained by contacting the Registration Assistant
by calling NRC's toll free number, (800) 368-5642, Extension 415-7231.
For additional guidance relating to sealed sources and devices, see
also NUREG-1556, Vol. 3., "Applications for Sealed Source and Device
Evaluation and Registration." |
The applicant must also request authorization to possess depleted uranium
if it will be used for shielding of molybdenum-99/technetium-99m generators.
Depleted uranium is frequently used as shielding for generators when the
molybdenum-99 activity is greater than 148 gigabecquerels (4 curies).
10 CFR 40.13(c)(6) exempts depleted uranium from the requirements for
a license to the extent that the material is used as a shipping container,
such as when molybdenum-99/technetium-99m generators are in transit from
their manufacturer to the pharmacy; however, a specific license or authorization
from the NRC is needed to possess and use the depleted uranium as a shield
during the time that the pharmacy uses or stores the generator at its
facility. The applicant must specify the total amount of depleted uranium,
in kilograms, that will be needed.
If an applicant requests quantities of licensed material in excess of
10 CFR 30.72, "Schedule C - Quantities of Radioactive Materials Requiring
Consideration of the Need for an Emergency Plan for Responding to a Release,"
the applicant must either submit an emergency plan for responding to a
release of radioactive materials or perform an evaluation showing that
the maximum dose to a person offsite due to a release of radioactive materials
would not exceed 10 millisieverts (mSv) (1 rem) effective dose equivalent
or 50 mSv (5 rems) to the thyroid. For radiopharmacies, iodine-131 is
the radionuclide most likely to trigger the need for a emergency plan
due to its Schedule C quantity of 10 curies.
Licensees must submit a license amendment and receive NRC authorization
before they may make changes in the types, forms, and quantities of materials
possessed.
Response from Applicant:
- --Identify each radionuclide (element name and mass number) that will
be used, the form, and the maximum requested possession limit.
AND
- For potentially volatile materials (e.g., iodine-131):
- --Specify whether open containers of the materials will be manipulated
at the radiopharmacy.
- --Identify each radionuclide (element name and mass number) that will
be used in each source;
- --Provide the manufacturer's (distributor's) name and model number
for each 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; and
- --Confirm that the activity per source and maximum activity in each
device will not exceed the maximum activity listed on the approved certificate
of registration issued by NRC or by an Agreement State.
- For depleted uranium, specify the total amount (in kilograms).
8.5.2 Financial Assurance and Recordkeeping for
Decommissioning
Regulations: 10 CFR 30.35, 10 CFR 30.34(b).
Criteria: A licensee authorized to possess radioactive
material in excess of the limits specified in 10 CFR 30.35 must submit
a decommissioning funding plan (DFP) or provide a certification of financial
assurance (FA) for decommissioning. Even if a DFP or FA is not required,
licensees are required to maintain, in an identified location, decommissioning
records related to structures and equipment where radioactive materials
are used or stored and related to leaking sources. Pursuant to 10 CFR
30.35(g), licensees must transfer 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); or
- 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 commercial radiopharmacy applicants and licensees do
not need to take any action to comply with the financial assurance requirements,
because the vast majority of radioactive materials they possess and redistribute
do not have half-lives greater than 120 days and the total inventory of
licensed materials with half-lives greater than 120 days do not exceed
the thresholds in 10 CFR 30.35(b) and (d).
Applicants requesting more than one radionuclide may determine whether
financial assurance for decommissioning is required by calculating, for
each radionuclide with a half-life greater than 120 days 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 commercial nuclear pharmacy
licensees need to maintain records of structures and equipment where radioactive
material 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 radioactive materials 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 radiopharmacy licensees have experienced unusual occurrences (e.g.,
incidents that involve spread of contamination, leaking sources), they
also need to maintain records about contamination that remains after cleanup
or that may have spread to inaccessible areas.
For radiopharmacy licensees whose contamination incidents did not
involve radioactive materials with half-lives exceeding 120 days and
whose sealed sources have never leaked, acceptable records important
to decommissioning are sketches or written descriptions of the specific
locations where radioactive material 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. Regulatory Guide (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 Policy &
Guidance Directive (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
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Figure 8.2 Purpose Wheel.
The distribution of radioactive materials by commercial radiopharmacies
is authorized by several distinct regulations. The appropriate regulation
to refer to depends on the nature of the material, the purpose(s) for
which it will be used, and to whom it is sent.
8.6.1 Distribution and Redistribution of Sealed
and Unsealed Materials
Regulations: 10 CFR 30.41; 10 CFR 32.71; 10 CFR 32.72;
and 10 CFR 32.74.
Criteria: The applicant must specify the radioactive
material it intends to distribute and redistribute.
Discussion: Radiochemicals are those materials that
either require further manipulation to be suitable for human use or are
not intended for human use. Examples include raw materials received from
a non-10 CFR 32.72 supplier (chemical grade materials). Radioactive drugs
are those materials suitable for human use and include radiobiologics
(e.g., monoclonal antibodies and technetium-99m-tagged red blood cells)
and radiopharmaceuticals. However, the terms, "radiopharmaceutical" and
"radioactive drug" will be used interchangeably in this guidance document,
and reference to one is not meant to exclude the other.
Distribution activities are normally classified as either "distribution"
or "redistribution." "Distribution" applies to those radioactive drugs
and radiochemicals initially prepared by the pharmacy. "Redistribution"
refers to those materials received from another person, authorized pursuant
to either 10 CFR 32.71, 10 CFR 32.72, or 10 CFR 32.74, depending on the
product distributed, i.e., in vitro kits, other radiopharmaceuticals,
or sealed sources for medical use, respectively.The distribution of radioactive
materials to other persons requires specific approval from the NRC, either
by NRC regulation or by a license authorizing the activity. The initial
distribution of radioactive drugs for medical use must be prepared by
a person licensed pursuant to 10 CFR 32.72. The redistribution
of in vitro kits and sealed sources containing byproduct material
for medical use is authorized pursuant to 10 CFR 32.71 and 32.74, respectively,
provided that the materials are not repackaged and the labels are not
altered. The in vitro kits and sealed sources for medical use
intended for redistribution must be initially distributed by a person
licensed pursuant to 10 CFR 32.71 or 10 CFR 32.74, respectively. The transfer
of radioactive materials for non-medical use, including radiochemicals,
and sealed calibration and reference sources, is authorized pursuant to
10 CFR 30.41.
All radioactive material listed above shall be distributed only to persons
authorized by an NRC or Agreement State license to receive such materials,
or by a general license (10 CFR 31.11, or equivalent Agreement State regulation)
to receive in vitro test materials.
Initial distribution of unsealed byproduct material in the form of radiopharmaceuticals
intended for human diagnostic and therapeutic use by medical licensees
comprises the bulk of virtually all radiopharmacy activities. Prior to
the transfer, distribution, or redistribution of any licensed material,
the radiopharmacy must verify that the transferee's license authorizes
the receipt of the type, form, and quantity of byproduct material to be
transferred. The pharmacy should verify that the address to which radioactive
materials are delivered is an authorized location of use listed on the
customer's license. 10 CFR 30.41(d) lists five methods that can be used
to meet the license verification requirement. The most common form of
verification is for the radiopharmacy to possess a valid copy of the customer's
NRC or Agreement State license or other applicable document (e.g. in
vitro registration certificate/NRC Form 483).
Response From Applicant: Provide the following, as applicable:
For radiopharmaceuticals:
Confirm that radiopharmaceuticals will be prepared under the supervision
of an ANP or will be obtained from a supplier authorized pursuant to 10
CFR 32.72, or under equivalent Agreement State requirements; and
Describe all licensed material to be distributed or redistributed.
For generators:
- Confirm that the generators will be obtained from a manufacturer licensed
pursuant to 10 CFR 32.72, or under equivalent Agreement State
requirements; and
- Confirm that unused generators will be redistributed without opening
or altering the manufacturer's packaging.
For redistribution of used generators:
- Describe the procedures and instructions for safely repackaging the
generators, including the use of the manufacturer's original packaging
and minimization of migration of radioactive fluids out of the generator
during transport;
- Confirm that the manufacturer's packaging and labeling will not be
altered;
- Confirm that the generator will not be distributed beyond the expiration
date shown on the generator label;
- Confirm that the redistributed generator will be accompanied by the
manufacturer-supplied leaflet or brochure that provides radiation safety
instructions for handling and using the generator; and
- Confirm that only generators used in accordance with the manufacturer's
instructions will be redistributed.
Note: Although redistribution of used generators
may be authorized by the NRC, NRC approval does not relieve the licensee
from complying with applicable FDA or other Federal and State requirements.
For redistribution of sealed sources -- for brachytherapy or diagnosis:
- Confirm that the sealed sources for brachytherapy or diagnosis to
be redistributed will be obtained from a manufacturer authorized to
distribute sealed sources for brachytherapy or diagnosis in accordance
with a specific license issued pursuant to 10 CFR 32.74, or under equivalent
Agreement State requirements; and
- Confirm that the manufacturer's packaging, labeling, and shielding
will not be altered and that redistributed sources will be accompanied
by the manufacturer-supplied package insert, leaflet, brochure, or other
document that provides radiation safety instructions for handling and
storing the sources.
For redistribution of calibration and reference sealed sources:
- Confirm that calibration and reference sealed sources to be redistributed
to medical use licensees will be obtained from a person licensed pursuant
to 10 CFR 32.74 or under equivalent Agreement State requirements, to
initially distribute such sources; and
- Confirm that the manufacturer's labeling and packaging will not be
altered and that redistributed sources will be accompanied by the manufacturer-supplied
calibration certificate and the leaflet, brochure, or other document
that provides radiation safety instructions for handling and storing
the sources.
For redistribution of prepackaged units for in vitro tests:
- Confirm that the prepackaged units for in vitro tests to
be redistributed will have been obtained from a manufacturer authorized
to distribute the prepackaged units for in vitro tests in accordance
with a specific license issued pursuant to 10 CFR 32.71, or under an
equivalent license of an Agreement State.
For redistribution to general licensees:
- Confirm that the manufacturer's packaging and labeling of the prepackaged
units for in vitro tests will not be altered in any way; and
- Confirm that each redistributed prepackaged unit for in vitro
tests will be accompanied by the manufacturer-supplied package insert,
leaflet, or brochure that provides radiation safety instructions for
general licensees.
For redistribution to specific licensees:
- Confirm that the labels, package insert, leaflet, brochure, or other
documents accompanying the redistributed prepackaged units for in
vitro tests will NOT reference general licenses, exempt quantities,
or NRC's regulations that authorize a general license (e.g., 10 CFR
31.11); and
- Confirm that the labeling on redistributed prepackaged units for in
vitro tests will conform to the requirements of 10 CFR 20.1901
and 20.1904.
8.6.2 Preparation of Radiopharmaceuticals
Regulation: 10 CFR 32.72(b).Criteria:
The preparation of radiopharmaceuticals for commercial distribution to
medical users requires specific authorization.
Discussion: The bulk of radiopharmacy activities involve
the preparation of radiopharmaceuticals for commercial distribution to
medical users.
Response From Applicant: The applicant should indicate
the types of radiopharmaceutical preparation activities it intends to
perform (e.g., compounding of iodine-131 capsules, radioiodination, and
technetium-99m kit preparation).
8.6.3 Sealed Sources for Calibration and Checks
and Possession of Depleted Uranium
Regulation: 10 CFR 30.33; 10 CFR 30.32(g); 10 CFR 32.210.
Criteria: The applicant must specify the uses for sealed
sources for reference and calibration and depleted uranium for shielding.
Discussion: The applicant should describe the intended
use of sealed sources. This will normally be for calibration and checks
performed only on the applicant's instruments and equipment. Any sources
intended for use in a specific instrument calibration device should be
identified, along with the manufacturer and model number of the device.
The use of depleted uranium for shielding, (e.g., incorporated into molybdenum-99/technetium-99m
generators) should also be specified, if appropriate.
Response from Applicant: Supply specific information
concerning the use of sealed sources for reference and calibration and
depleted uranium.
8.6.4 Service Activities
Regulation: 10 CFR 30.33(a)(1).
Criteria: The applicant must specify the radiation protection
services it intends to provide to other licensees (e.g., customers), if
the service involves the applicant's possession of licensed material (calibration
sources and leak test samples).
Discussion: If the applicant intends to provide radiation
protection services to customers, the services must be described. Typically
these services include instrument calibration and sealed source leak testing.
Specific guidance regarding requests to provide service activities is
included in Draft Regulatory Guides FC 412-4, "Guide for the Preparation
of Applications for Licenses for the Use of Radioactive Materials in Leak-Testing
Services," and FC 413-4, "Guide for the Preparation of Applications for
Licenses for the Use of Radioactive Materials in Calibrating Radiation
Survey and Monitoring Instruments."
Response from Applicant: Specify the customer radiation
protection services involving licensed material that will be provided.
The applicant must submit specific procedures for all service activities
that it intends to provide.
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 Licenses for the Use of Radioactive Materials in Leak-Testing Services";
and
- Draft Regulatory Guide FC 413-4, "Guide for the Preparation of Applications
for Licenses for the Use of Radioactive Materials in Calibrating Radiation
Survey and Monitoring Instruments"
8.7 Item 7: Individual(s) Responsible for Radiation
Safety Program and Their Training Experience
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Regulations: 10 CFR 30.33(a)(3).
Criteria: The Radiation Safety Officer (RSO), Authorized
Users (AUs), and Authorized Nuclear Pharmacists (ANPs) must have adequate
training and experience.
Discussion: Individuals responsible for the radiation
protection program are licensee senior management, the RSO, ANPs, and
AUs. NRC requires that an applicant be qualified by training and experience
to use licensed materials for the purposes requested in such a manner
as to protect health and minimize danger to life or property. Subpart
J of 10 CFR Part 35 and 10 CFR 32.72(b) give specific criteria
for acceptable training and experience for ANPs. The minimum training
and experience criteria for RSOs and AUs, though not specifically described
in NRC's regulations for radiopharmacy licensees, should include a bachelor's
degree in a physical science, or equivalent, and previous experience handling
and supervising similar activities. Applicants should note that a résumé
or a curriculum vitae does not usually supply all the information needed
to evaluate an individual's training and experience.
NRC holds the licensee responsible for the radiation protection program;
therefore, it is essential that strong management controls and oversight
exist to ensure that licensed activities are conducted properly. Management
responsibility and liability are sometimes underemphasized or not addressed
in applications and are often poorly understood by licensee employees
and managers. Senior management should delegate to the RSO, in writing,
sufficient authority, organizational freedom, and management prerogative
to communicate with and direct personnel regarding NRC regulations and
license provisions and to terminate unsafe activities involving byproduct
material. The licensee maintains the ultimate responsibility, nevertheless,
for the conduct of licensed activities.
Response from Applicant: Refer to the subsequent sections
specific to the individuals described above. Applicants should submit
an organizational chart describing the management structure, reporting
paths, and the flow of authority between executive management and the
RSO.
8.7.1 Radiation Safety Officer (RSO)
Regulations: 10 CFR 30.33(a)(3).
Criteria: Each licensee must appoint a qualified individual
to act as the Radiation Safety Officer (RSO). The RSO must have adequate
training and experience.
Discussion: NRC requires the name, training, and experience
of the proposed RSO to ensure that the applicant has identified a responsible,
qualified person to oversee the radiation safety program. When selecting
an RSO, the applicant should keep in mind the duties and responsibilities
of the position, and select an individual who is qualified and has the
time and resources to fulfill those duties and responsibilities. Typical
duties and responsibilities of a radiopharmacy RSO are included in Appendix
H.
The RSO needs a level of basic technical knowledge sufficient to understand
the work to be performed with byproduct materials at the radiopharmacy
and to be qualified by training and experience to perform the duties required
for that position. Any individual who has sufficient training and experience
to be named as an authorized nuclear pharmacist (ANP) is also considered
qualified to serve as the facility RSO. The same is true for an authorized
user (AU) who has had adequate training and experience in the radiation
safety aspects associated with the use of similar types of byproduct material.
The training and experience requirements for the RSO may be met by any
of the following:
- Qualification as an ANP;
- Identification as an AU on the license and experience in the use of
the types and quantities of licensed material for which the individual
has RSO responsibilities; and
- Didactic and work experience.
In order to demonstrate adequate training and experience, the RSO should
have (1) as a minimum, a college degree at the bachelor level, or equivalent
training and experience in physical, chemical, biological sciences, or
engineering; and (2) training and experience commensurate with the scope
of proposed activities. Training should include the following subjects:
- Radiation protection principles;
- Characteristics of ionizing radiation;
- Units of radiation dose and quantities;
- Radiation detection and measurement instrumentation;
- Biological hazards of exposure to radiation (appropriate to types
and forms of byproduct material to be used);
- NRC regulatory requirements and standards; and
- Hands-on use of radioactive materials commensurate with the uses proposed
by the applicant.
The length of training and experience will depend upon the type, form,
quantity, and proposed use of the licensed material requested. The proposed
RSO's training and experience should be sufficient to identify and control
the anticipated radiation hazards. The requisite training may be obtained
from formal courses consisting of lectures and laboratories designed for
RSOs presented by academic institutions, commercial radiation safety consulting
companies, or appropriate professional organizations. Each hour of training
may be counted only once and should be allocated to the most representative
topic.
On-the-job training may not be counted toward the hours documenting length
of training unless it was obtained as part of a formal training course.
A "formal" training course is one that incorporates the following elements:
- A detailed description of the content of the course is maintained
on file at the sponsoring institution and can be made available to the
NRC upon request;
- Evidence that the sponsoring institution has examined the student's
knowledge of the course content is maintained on file at the institution
and can be made available to NRC upon request. This evidence of the
student's overall competency in the course material should include a
final grade or percentile; and
- A permanent record that the student successfully completed the course
is kept at the institution.
Response from Applicant: Provide the following:
- Name of the proposed RSO;
AND
- A copy of the license (NRC or Agreement State) that authorized the
uses requested and on which the individual was specifically named as
the RSO, an ANP, or an AU;
OR
- Description of the training and experience demonstrating that the
proposed RSO is qualified by training and experience applicable to commercial
nuclear pharmacies.
Note: See Appendix G for convenient formats
to use for documenting hours of training in basic radioisotope handling
techniques and hours of experience using radioisotopes. Figures G-1 and
G-2 are specific to RSO training and experience.
8.7.2 Authorized Nuclear Pharmacist (ANP)
Regulations: 10 CFR 32.72 (b)(2) and (4); 10 CFR 35.2;
10 CFR 35.972; and 10 CFR 35.980.
Criteria: ANP must be a State-licensed or State-registered
pharmacist with adequate training and experience.
Discussion: Each commercial nuclear pharmacy must have
an authorized nuclear pharmacist to prepare or supervise the preparation
of radioactive drugs for medical use. Any individual who is not qualified
to be an authorized nuclear pharmacist may work under the supervision
of an authorized nuclear pharmacist.
The criteria for a pharmacist to work as an ANP at a commercial radiopharmacy
are described in 10 CFR 32.72 (b)(2) and (4). This section of the regulation
refers to the definition of an ANP in 10 CFR 35.2, "Definitions," the
training and experience criteria described in 10 CFR 35.980, "Training
for an Authorized Nuclear Pharmacist," and recentness criteria described
in 10 CFR 35.972, "Recentness of Training." Successful completion
of training as described in 10 CFR 35.980, within 7 years preceding
the date of the application, is evidence of adequate training and experience.
Additional training and experience may be necessary if the time interval
is greater than 7 years. Applicants may find it convenient to present
this documentation using a format similar to Figures G-3 and G-4 in Appendix
G. Each hour of training may be listed only once, (i.e., under the most
applicable category). The recentness of training requirements apply to
board certification as well as to other recognized training pathways.
On-the-job training may not be counted toward the hours listed above
unless it was obtained as part of a formal training course. A "formal"
training course is one that incorporates the following elements:
A detailed description of the content of the course is maintained on
file at the sponsoring institution and can be made available to the NRC
upon request;
- Evidence that the sponsoring institution has examined the student's
knowledge of the course content is maintained on file at the institution
and can be made available to NRC upon request. This evidence of the
student's overall competency in the course material should include a
final grade or percentile; and
- A permanent record that the student successfully completed the course
is kept at the institution.
Response from Applicant: For each proposed ANP, provide
the following:
AND
- A copy of the State pharmacy licensure or registration for the pharmacist;
AND
- A copy of the license (NRC or Agreement State) on which the individual
was specifically named as an ANP;
OR
- A copy of the permit maintained by a licensee of broad scope that
identifies the individual as ANP;
OR
- A copy of previous NRC license issued to a commercial radiopharmacy
prior to December 2, 1994, on which the pharmacist was specifically
named as an authorized user;
OR
- A copy of the pharmacist's certification(s) from the radiopharmacy
board(s) approved by the NRC;
OR
- Description of the training and experience demonstrating that the
proposed ANP is qualified by training and experience; and written certification,
signed by a preceptor ANP, that the above training and experience has
been satisfactorily completed and that the individual has achieved a
level of competency sufficient to independently operate a nuclear pharmacy;
AND
- Description of the recentness of training, if necessary.
Note: ANPs approved by corporate nuclear pharmacy
radiation safety committees are not recognized under the criteria under
10 CFR 32.72 (b). For these individuals, the applicant must provide a
description of their training and experience to the NRC for review.
8.7.3 Authorized Users (AU)
Regulations: 10 CFR 30.33(a)(3).
Criteria: Authorized users (AUs) must have adequate
training and experience with the types and quantities of licensed material
that they propose to use.
Discussion: If the applicant intends to perform functions
other than the preparation and distribution of radioactive drugs, the
applicant may request that an individual other than an ANP perform and/or
supervise those functions. This individual, if approved, would be designated
on the license as an AU. These other functions may include leak testing
of sealed sources or instrument calibration services for the pharmacy
and its customers; however, the term Authorized User, as used in this
document should not be confused with the definition of an "Authorized
User" contained in 10 CFR 35.2 for medical use.
In order to demonstrate adequate training and experience, the proposed
AU should have (1) as a minimum, a college degree at the bachelor level,
or equivalent training and experience in physical, chemical, biological
sciences, or engineering; and (2) training and experience commensurate
with the scope of proposed activities. Training should include the following
subjects:
- Radiation protection principles;
- Characteristics of ionizing radiation;
- Units of radiation dose and quantities;
- Radiation detection and measurement instrumentation;
- Biological hazards of exposure to radiation (appropriate to types
and forms of byproduct material to be used);
- NRC regulatory requirements and standards; and
- Hands-on use of radioactive materials commensurate with uses proposed
by the applicant.
The length of training and experience listed above will depend upon the
type, form, quantity, and proposed use of the licensed material requested.
The proposed AU's training and experience should be sufficient to identify
and control the anticipated radiation hazards. The above training may
be obtained from formal radiation safety courses consisting of lectures
and laboratories presented by academic institutions, commercial radiation
safety consulting companies, or appropriate professional organizations.
Each hour of training may be counted only once and should be allocated
to the most representative topic.
On-the-job training may not count toward the hours listed above unless
it was obtained as part of a formal training course. A "formal" training
course is one that incorporates the following elements:
- A detailed description of the content of the course is maintained
on file at the sponsoring institution and can be made available to the
NRC upon request;
- Evidence that the sponsoring institution has examined the student's
knowledge of the course content is maintained on file at the institution
and can be made available to NRC upon request. This evidence of the
student's overall competency in the course material should include a
final grade or percentile; and
- A permanent record that the student successfully completed the course
is kept at the institution.
The AU must demonstrate training and experience with the type and quantity
of material that is to be used at the pharmacy. For example, someone with
training and experience only with microcurie quantities of unsealed radioactive
material may not be qualified to use or supervise the use of higher activity
sealed radioactive sources for instrument calibration. Applicants should
pay particular attention to the type of radiation involved. For example,
someone experienced with gamma emitters may not have appropriate experience
for high energy beta emitters.
Response from Applicant: For each proposed Authorized
User (AU):
- Name of each proposed AU;
AND
- Identify types, quantities, and proposed uses of licensed material;
AND
- A copy of license (NRC or Agreement State) on which the individual
was specifically named as an AU for the types, quantities, and proposed
uses of licensed materials;
OR
- A copy of the permit maintained by a licensee of broad scope that
identifies the individual as an AU for the types, quantities, and proposed
uses of licensed materials;
OR
- Description of the training and experience demonstrating that the
proposed AU is qualified by training and experience to use the requested
licensed materials. The applicant may find it convenient to describe
this training and experience using a format similar to Figures G-1 and
G-2 in Appendix G.
8.8 Item 8: Training for Individuals Working in
or Frequenting Restricted Areas (Instructions to Occupationally Exposed
Workers and Ancillary Personnel)
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8.8.1 Occupationally Exposed Workers and Ancillary
Personnel
Regulations: 10 CFR 19.12, 10 CFR 20.1101(a), and 10
CFR 30.33(a)(3).
Criteria: Individuals working with licensed material
must receive radiation safety training commensurate with their assigned
duties and specific to the licensee's radiation safety program. In addition,
those individuals who, in the course of employment, are likely to receive
in a year a dose in excess of 100 mrem (1 mSv) must be instructed according
to 10 CFR 19.12.
Discussion: 10 CFR 20.1101(a) requires each licensee
to develop, document, and implement a radiation protection program commensurate
with the scope and extent of licensed activities and sufficient to ensure
compliance with Part 20. Each individual working with radioactive material
must be trained in the radiation safety procedures applicable to their
job before beginning work with licensed materials. Licensees should not
assume that safety instruction has been adequately covered by prior employment
or training. Practical, site-specific training should be provided for
all individuals prior to beginning work with, or in the vicinity of, licensed
material. Training should also be performed whenever there is a significant
change in duties, procedures, regulations, or terms of the license. Each
individual should also receive periodic refresher training at a frequency
sufficient to ensure that all staff remain adequately trained.
Additional training is required if an individual is likely to receive
a dose in excess of 1 mSv (100 mrem) in a year. ANPs and others involved
in the preparation of radiopharmaceuticals are most likely to receive
doses in excess of 1 mSv (100 mrem) in a year; however, potential radiation
doses received by all employees must also be evaluated. The evaluation
must include consideration of assigned activities during both normal and
abnormal situations involving exposure to radiation and/or radioactive
material that can reasonably be expected to occur during licensed activities.
If individuals making deliveries of radioactive material at the licensees
facility are likely to receive a dose in excess of 1 mSv (100 mrem) in
a year from the licensees activities, the licensee is responsible for
ensuring that the person has received the training specified in 10 CFR
Part 19, regardless of whether that person is an employee of the licensee.
If the training has been provided by someone else (such as the shipper
or another licensee), the licensee does not have to provide training except
for instruction in site-specific radiation hazards. This issue is discussed
in NRC Generic Letter 95-09, "Monitoring and Training of Shippers and
Carriers of Radioactive Materials," dated November 3, 1995.
Training may be in the form of lecture, demonstrations, videotape, or
self-study, and should emphasize practical subjects important to the safe
use of licensed material. A method should be provided for individuals
receiving instructions and training to ask questions. The licensee should
determine whether the training succeeded in conveying the desired information
and adjust the training program as necessary. The person conducting the
training should be a qualified individual (e.g., the RSO, an ANP, AU,
or radiation safety professional familiar with the licensee's program).
Licensee personnel who work in the vicinity of, but do not handle radioactive
materials (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 radioactive material, it is prudent
for them to work under the supervision and in the physical presence of
an ANP/AU or to be provided some basic radiation safety training. Such
ancillary staff should be informed of the nature and location of the radioactive
material and the meaning of the radiation symbol, and should be instructed
not to handle radioactive materials 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 radioactive
material to ensure the control and security of the material.
The guidance in Appendix N may be used by the applicant to develop a
training program.
Response from Applicant: State, "We have developed and
will implement and maintain written procedures for a training program
for each group of workers, including: topics covered; qualifications of
the instructors; method of training; method for assessing the success
of the training; and the frequency of training and refresher training."
References: For hard copies of NRC Generic Letter 95-09,
"Monitoring and Training of Shippers and Carriers of Radioactive Materials,"
dated November 3, 1995, see the Notice of Availability (on the inside
front cover of this report).
8.8.2 Personnel Involved in Hazardous Materials
Package Preparation and Transport
Regulation: 49 CFR 172.700; 49 CFR 172.702; 49 CFR 172.704.
Criteria: Applicants must train personnel involved in
the preparation and transport of hazardous material packages in the applicable
DOT regulations.
Discussion: Licensees who prepare packages of radioactive
materials or who transport their own packages must provide training to
their employees who perform those functions. The training must include:
- General awareness and familiarization training designed to provide
familiarity with DOT requirements, and the ability of the employee to
recognize and identify hazardous materials;
- Function-specific training concerning the DOT requirements that are
specifically applicable to the functions the employee performs, (e.g.,
if the employee's duties require affixing DOT radioactive labels to
packages, the employee must receive training in DOT's regulations governing
package labeling); and
- Safety training concerning emergency response information, discussed
above; measures to protect the employee and other employees from the
hazards associated with the hazardous materials to which they may be
exposed to in the workplace; and methods of avoiding accidents, such
as the proper procedures for handling packages containing hazardous
materials.
The training must be provided initially, and every 3 years thereafter.
Records of training must be maintained.Note:
The licensee is not responsible for providing DOT-required hazardous materials
training to common carriers to whom the pharmacy offers radioactive materials
packages for transport.
Response from Applicant: Submit the following statement:
"We have developed and will implement and maintain written procedures
for training personnel involved in hazardous materials package preparation
and transport that meet the requirements in 49 CFR 172.700, 49 CFR
172.702, and 49 CFR 172.704, as applicable."
8.8.3 Instruction for Supervised Individuals Preparing
Radiopharmaceuticals
Regulation: 10 CFR 32.72(b)(1); 10 CFR 35.25(b).
Criteria: Individuals who prepare byproduct material
for medical use under the supervision of an authorized nuclear pharmacist
must be instructed in the preparation of byproduct material for medical
use, the principles of radiation safety, and the licensee's procedures
for the use of byproduct material; follow the instructions given; and
must have their work and records kept to reflect their work periodically
reviewed by the supervising ANP.
Discussion: The applicant must instruct supervised individuals
in the preparation of byproduct material for medical use and require those
individuals to follow their instructions, the written radiation protection
program, license conditions, and NRC regulations. The supervising ANP
must review the work of supervised individuals in the preparation of byproduct
material for medical use and the records kept to reflect that work. If
an authorized nuclear pharmacist is always physically present when radioactive
drugs are prepared, supervision may be fulfilled by the day-to-day instruction
and review of the supervised individual by the ANP.
An ANP is considered to be supervising the use of radioactive materials
when directing personnel in the conduct of operations involving licensed
materials. The ANP need not be present at all times during the use of
such materials; however, the supervising ANP is responsible for ensuring
that personnel under supervision have been properly trained and instructed.
The supervising ANP is therefore responsible for the supervision of operations
involving the use of radioactive materials whether or not he or she is
present.
NRC regulations do not relieve the licensee from complying with applicable
Department of Health and Human Services (Food and Drug Administration),
other Federal, and State requirements governing radioactive drugs. From
an NRC perspective, if the supervision requirements are met, it is permissible
for the licensee to allow the supervised individual to prepare radiopharmaceuticals
without the presence of the ANP; however, some States require that a pharmacist
be physically present during the preparation and dispensing of pharmaceuticals,
including radioactive drugs. It is the licensee's responsibility to ensure
that its practices comply with any additional State requirements concerning
this issue.
Response from Applicant: No response from the applicant
is necessary. Supervision will be reviewed during inspection.
8.9 Item 9: Facilities and Equipment
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Regulations: 10 CFR 32.72(a)(2); 10 CFR 30.33(a)(2),
10 CFR 20.1406, 10 CFR 20.1101(b), 10 CFR 30.35 (g).
Criteria: Radiopharmacies must demonstrate that they
are a pharmacy. Facilities and equipment must be adequate to protect health
and minimize danger to life or property, minimize the likelihood of contamination,
and keep exposures to workers and the public ALARA.
Discussion: Applicants must demonstrate that they are
a pharmacy by submitting evidence of at least one of the following:
- Licensure as a pharmacy by a State Board of Pharmacy; and
- Operation as a nuclear pharmacy within a Federal medical institution.
If the registration or license has not been issued by the State Board
of Pharmacy at the time of application, the applicant may provide it at
a later date, but prior to license issuance from NRC.
Applicants must provide NRC with documentation demonstrating that their
facilities and equipment provide sufficient engineering controls and barriers
to protect the health and safety of the public and their employees. The
facilities and equipment must also keep exposures to radiation and radioactive
materials ALARA, and minimize the risks from the uses of the types and
quantities of radioactive materials. The applicant should provide clear
delineations between its restricted and unrestricted areas through the
use of barriers, postings, and worker instructions.
Applicants may delay completing facilities and acquiring equipment until
after the application review is completed, in case changes are required
as a result of the application review. This also ensures the adequacy
of the facilities and equipment before the applicant makes a significant
financial commitment. In all cases, the applicant cannot possess or use
licensed material until after the facilities are approved, equipment is
procured, and the license is issued.
Applicants are reminded that records important to decommissioning are
required to be maintained in an identifiable location. For further information,
see the section entitled, "Financial Assurance and Record Keeping for
Decommissioning."
Figure 8.3 Typical Facility Diagram.
Response from Applicant: Applicants must provide: Copies
of their registration or license from a State Board of Pharmacy as a pharmacy;
or evidence that they are operating as a nuclear pharmacy within a Federal
medical institution;
Note: There may be jurisdictions that do not
recognize the practice of commercial radiopharmacy. In those cases, the
applicant must submit evidence that it is registered or licensed with
the FDA as a drug manufacturer.
AND
- Description of the facilities and equipment to be made available at
each location where radioactive material will be used. A diagram should
be submitted showing the applicant's entire facility and identify activities
conducted in all contiguous areas surrounding the facility (see Figure
8.3, above). Diagrams should be drawn to a specified scale, or dimensions
should be indicated.
Include the following information:
- Descriptions of the area(s) assigned for the receipt, storage, preparation,
and measurement of radioactive materials and the location(s) for radioactive
waste storage;
- Sufficient detail in the diagram to indicate locations of shielding,
the proximity of radiation sources to unrestricted areas, and other
items related to radiation safety;
- A general description of the ventillation system including representative
equipment such as glove boxes or fume hoods. Pertinent airflow rates,
differential pressures, filtration equipment, and monitoring systems
should be described in terms of the minimum performance to be achieved.
Confirm that such systems will be employed for the use or storage of
radioactive materials with the probability of becoming airborne, such
as compounding radioiodine capsules and dispensing radioiodine solutions;
and
- Verification that ventilation systems ensure that effluents are within
the dose limits of 10 CFR 20.1301, the ALARA contraints for
air emissions established under 10 CFR 20.1101(d), and are
ALARA.
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 annually 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 I contains a suggested audit program
that is specific to commercial radiopharmacies and is acceptable to NRC.
All areas indicated in Appendix I 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 during inspections is to perform actual
observations of work in progress. As a part of their audit programs, applicants
should consider performing unannounced audits of the radiopharmacy to
observe whether radiation safety procedures are being followed, etc.
It is essential that once identified, problems be corrected comprehensively
and in a timely manner; Information Notice (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 can exercise discretion and will normally
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 three 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 the audit,
persons contacted by the auditor(s), areas audited, audit findings, corrective
actions, and follow-up.
Response from Applicant: No response is required. The
licensee's program for auditing its radiation safety program will be reviewed
during inspection.
References: The current version of NUREG-1600 is available
electronically at <http://www.nrc.gov>. 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 87117, "Radiopharmacy
Programs," see the Notice of Availability (on the inside front cover of
this report).
8.10.2 Radiation Monitoring Instruments
Regulations: 10 CFR 20.1501; 10 CFR 32.72(c); 10 CFR
30.33(a)(2); 10 CFR 20.2103(a).
Criteria: Licensees must possess radiation monitoring
instruments to evaluate possible radiation hazards that may be present.
Instruments used for quantitative radiation measurements must be calibrated
periodically for the radiation measured.
Discussion: Licensees must possess calibrated radiation
detection/measurement instruments to perform, as necessary, the following:
- Package surveys;
- Personnel and facility contamination measurements;
- Sealed source leak tests;
- Air sampling measurements;
- Bioassay measurements;
- Effluent release measurements; and
- Dose rate surveys
For the purposes of this document, radiation monitoring instruments are
defined as any device used to measure the radiological conditions at a
licensed facility. Some of the instruments that may be used to perform
the above functions include:
- Portable or stationary count rate meters;
- Portable or stationary dose rate or exposure rate meters;
- Single or multichannel analyzers;
- Liquid Scintillation Counters (LSC);
- Gamma counters;
- Proportional counters;
- Solid state detectors; and
- Hand and foot contamination monitors.
Figure 8.5 Examples of
Portable and Stationary Survey Instruments Used by Radiopharmacies.
The choice of instrument should be appropriate for the type of radiation
to be measured and for the type of measurement to be taken (count rate,
dose rate, etc.). Radiopharmacies typically use a broad energy range of
gamma and beta radiation emitters and need to use radiation detectors
appropriate for those energies. Figure 8.5 illustrates some common survey
instruments used for contamination surveys. Applicants should discuss
the types of instruments to be used for each type of survey to be performed
and the availability of a sufficient quantity of these instruments at
their facility.
Instrument calibrations may be performed by the pharmacy or by another
person specifically authorized by NRC, an Agreement State, or a licensing
state to perform that function. If the pharmacy utilizes the services
of another person for instrument calibration, the pharmacy should ensure
that person has been authorized by either the NRC, an Agreement State,
or a licensing State to perform that activity. Appendix J provides information
about instrument specifications and model calibration procedures.
Response from Applicant: Provide one of the following:
- A statement that: "We will use equipment that meets the radiation
monitoring instrument specifications and implement the model survey
meter calibration program published in Appendix J to NUREG-1556, Vol.
13, 'Program-Specific Guidance About Radiopharmacy Licenses' dated September
1999";
OR
- A statement that: "We will use equipment that meets the radiation
monitoring instrument specifications published in Appendix J to NUREG
- 1556, Vol. 13, 'Program-Specific Guidance About Radiopharmacy Licenses'
dated September 1999, and instruments will be calibrated by other persons
authorized by the NRC, an Agreement State, or a licensing State to perform
that service";
OR
- A description of alternative minimum equipment to be used for radiation
monitoring and/or alternative procedures for the calibration of radiation
monitoring equipment.
8.10.3 Material Receipt and Accountability
Regulations: 10 CFR 20.1501(a), 10 CFR 20.2001, 10 CFR
20.1801, 10 CFR 20.1802, 10 CFR 20.1906, 10 CFR 20.2201, 10
CFR 30.41, 10 CFR 30.51.
Criteria: Licensees must ensure the security and accountability
of licensed material and must open packages safely.
Discussion: As illustrated in Figure 8.6, licensed materials
must be tracked from receipt to disposal in order to ensure accountability,
identify when licensed material could be lost, stolen, or misplaced, and
ensure that possession limits listed on the license are not exceeded.
Licensees exercise control over licensed material accountability by including
the following items (as applicable) in their radiation protection program:
- Physical inventories of sealed sources at intervals not to exceed
6 months;
- Ordering and receiving licensed material;
- Package opening;
- Maintaining material inventory within license possession limits;
- Transfer of material, including distribution; and
- Disposal of material.
Licensees are required to develop, implement, and maintain written procedures
for safely opening packages in accordance with 10 CFR 20.1906. Some packages
may require special procedures that take into consideration the type,
quantity, or half-life of the nuclide being delivered.
A model procedure for safely opening packages containing licensed materials
is included in Appendix P.
NRC regulations in 10 CFR 20.1906(b) and (c) state the requirements for
monitoring packages containing licensed material. These requirements are
described in Table 8.1, below.
Table 8.1 Package Monitoring Requirements
Package |
Contents |
Survey Type |
Survey Time* |
Labeled (White I, Yellow II, Yellow III) |
Gas or Special Form
Greater Than Type A |
Radiation Level |
As soon as practicable, but not later than 3 hours after receipt
of package |
Labeled (White I, Yellow II, Yellow III) |
Not Gas Nor Special Form
Greater Than Type A |
Contamination
Radiation Level |
As soon as practicable, but not later than 3 hours after receipt
of package |
Labeled (White I, Yellow II, Yellow III) |
Gas or Special Form
Less Than Type A |
None |
None |
Labeled (White I, Yellow II, Yellow III) |
Not Gas Nor Special Form
Less Than Type A |
Contamination |
As soon as practicable, but not later than 3 hours after receipt
of package |
Not Labeled |
Licensed Material |
None |
None |
Damaged |
Licensed Material |
Contamination
Radiation Level |
As soon as practicable, but not later than 3 hours after receipt
of package |
* Assumes packages are received during normal working
hours. If packages are received outside of normal working hours, the
licensee has three hours after the beginning of the next work day
to perform the required surveys. |
10 CFR 20.1906(d) requires that the licensee immediately notify the final
delivery carrier and NRC Operations Center when removable radioactive
surface contamination exceeds the limit of 22 disintegrations per minute
per square centimeter (dpm/cm2) averaged over 300 cm2;
or external radiation levels exceed 2.0 mSv/hr (200 mrem/hr) at the
surface.
Figure 8.6 Accountability.
Licensees must maintain records of receipt, transfer, and disposal
of licensed material.
Licensees must secure and control licensed material and should have a
means of promptly detecting losses of licensed material. 10 CFR 20.1801
and 20.1802 require licensees to secure radioactive materials from unauthorized
removal or access while in storage and to control and maintain constant
surveillance over licensed material that is not in storage.
Licenses will normally contain specific conditions requiring the licensee
to perform inventories and leak tests of sealed sources every six months
(see sample license in Appendix E). Since the leak tests require an individual
to locate and work with the sealed source, records of leak tests may be
used as part of an inventory and accountability program. Sources in storage
that are used infrequently may not require leak testing; however, the
inventory must still be performed at the specified interval.
With regard to unsealed licensed material, licensees use various methods
(e.g., computer programs, manual ledgers, log books) to account for receipt,
use, transfer, disposal, and radioactive decay. These methods help to
ensure that possession limits are not exceeded.
Table 8.2 list the types and retention times for the records of receipt,
use, transfer, and disposal (as waste) of all licensed material the applicant
must maintain. Other records such as transfer records could be linked
to radioactive material inventory records.
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 |
Material accountability records typically contain the following information:
- Radionuclide and activity (in units of becquerels or curies), and
date of measurement of byproduct material;
- For each sealed source, manufacturer, model number, location and,
if needed for identification, serial number and as appropriate, manufacturer
and model number of device containing the sealed source;
- Date of the transfer and name and license number of the recipient,
and description of the radioactive material (e.g., radionuclide, activity,
manufacturer's name and model number, serial number); and
- For licensed materials disposed of as waste, include the radionuclide,
activity, date of disposal, and method of disposal (decay, sewer, etc.).
See the section on "Waste Disposal" for additional information.
Information about locations where licensed material is used or stored
are among the records important to decommissioning and required by
10 CFR 30.35(g). See also the section on "Financial Assurance and
Record Keeping for Decommissioning." |
Response from Applicant: Provide the following statements:
- "We have developed, and will implement and maintain, written procedures
for safely opening packages that meet the requirements in 10 CFR 20.1906";
AND
- "We will conduct physical inventories of sealed sources of licensed
material at intervals not to exceed 6 months";
AND
- "We have developed, and will implement and maintain written procedures
for licensed material accountability and control to ensure that:
- -license possession limits are not exceeded;
- --licensed material in storage is secured from unauthorized access
or removal;
- --licensed material not in storage is maintained under constant surveillance
and control; and
- --records of receipt, transfer, and disposal of licensed material
are maintained."
8.10.4 Occupational Dose
Regulations: 10 CFR 20.1501, 10 CFR 20.1502, 10 CFR
20.1201, 10 CFR 20.1202, 10 CFR 20.1203, 10 CFR 20.1204,
10 CFR 20.1207, 10 CFR 20.1208, 10 CFR 20.2106, 10 CFR 20 Appendix
B.
Criteria: Each licensee shall evaluate the potential
occupational exposures of all workers and monitor occupational exposure
to radiation when required.
Discussion: The licensee should perform an evaluation
of the dose the individual is likely to receive prior to allowing the
individual to receive the dose (prospective evaluation). When performing
the prospective evaluation, only a dose that could be received at the
facilities of the applicant or licensee performing the evaluation needs
to be considered. These estimates can be based on any combination of work
location radiation monitoring, survey results, monitoring results of individuals
in similar work situations, or other estimates to produce a "best estimate"
of the actual dose received. For individuals who have received doses at
other facilities in the current year, the previous dose need not be considered
in the prospective evaluation if monitoring was not required at the other
facilities. This evaluation need not be made for every individual; evaluations
can be made for employees with similar job functions or work areas. Further
guidance on evaluating the need to provide monitoring is provided in Regulatory
Guide 8.34, "Monitoring Criteria and Methods to Calculate Occupational
Doses, dated July 1992."
If the prospective evaluation shows that an individual's dose is not
likely to exceed 10% of any applicable regulatory limit, the individual
is not required to be monitored for radiation exposure and there are no
recordkeeping or reporting requirements for doses received by that individual.
If the prospective dose evaluation shows that the individual is likely
to exceed 10% of an applicable limit, monitoring is required.
Licensees shall monitor worker exposures for:
Adults who are likely to receive an annual dose in excess of any of the
following:
- 5 mSv (0.5 rem) deep-dose equivalent;
- 15 mSv (1.5 rems) eye dose equivalent;
- 50 mSv (5 rems) shallow-dose equivalent to the skin; and
- 50 mSv (5 rems) shallow-dose equivalent to any extremity.
Minors who are likely to receive an annual dose in excess of any of the
following:
- 1.0 mSv (0.1 rem) deep-dose equivalent;
- 1.5 mSv (0.15 rem) eye dose equivalent;
- 5 mSv (0.5 rem) shallow-dose equivalent to the skin; and
- 5 mSv (0.5 rem) shallow-dose equivalent to any extremity.
Declared pregnant women who are likely to receive an annual dose from
occupational exposures in excess of 1.0 mSv (0.1 rem) deep-dose equivalent,
although the dose limit applies to the entire gestation period.
Internal exposure monitoring is required for:
- Adults likely to receive in 1 year an intake in excess of 10% of the
applicable ALIs for ingestion and inhalation; and
- Minors and declared pregnant women likely to receive in 1 year a committed
effective dose equivalent in excess of 1.0 mSv (0.1 rem).
If an individual is likely to receive in 1 year a dose greater than 10%
of any applicable limit (see Figure 8.7 for annual dose limits for adults),
monitoring for occupational exposure is required. ANPs and radiopharmacy
technologists are generally likely to receive 10% of the limits for occupational
dose. Most radiopharmacies provide these employees with whole body and
extremity monitors.
Figure 8.7 Annual Dose Limits for Occupationally
Exposed Adults.
TOTAL EFFECTIVE DOSE EQUIVALENT (TEDE) = DEEP DOSE FROM EXTERNAL
EXPOSURE + DOSE FROM INTERNALLY DEPOSITED RADIONUCLIDES |
Most licensees use either film badges or thermoluminescent dosimeters
(TLDs) that are supplied by a NVLAP-approved processor to monitor for
external exposure. The exchange frequency for film badges is generally
monthly due to technical concerns about film fading. The exchange frequency
for TLDs is generally quarterly. Applicants should verify that the processor
is NVLAP-approved. Consult the NVLAP-approved processor for its recommendations
for exchange frequency and proper use. If monitoring is required, then
the licensee must maintain records of the monitoring regardless of the
actual dose received.
The types and quantities of radioactive material used at most commercial
radiopharmacies provide a reasonable possibility for an internal intake
by ANPs and radiopharmacy technologists. Uses such as preparing radioiodine
capsules from liquid solutions, and opening and dispensing from vials
containing millicurie quantities of radioiodine and other isotopes require
particular caution. Precautionary measures for personnel to follow during
iodine capsule preparation should involve the use of a fume hood and glove
box or shoulder length gloves (see Appendix Q for additional guidance
on precautionary measures). To monitor internal exposure from such operations,
most pharmacies institute a routine bioassay program to periodically monitor
these workers.
A program for performing thyroid uptake bioassay measurements should
include adequate equipment to perform bioassay measurements, procedures
for calibrating the equipment, including factors necessary to convert
counts per minute into becquerel or microcurie units and should address
the technical problems commonly associated with performing thyroid bioassays
(e.g., statistical accuracy, attenuation by neck tissue). Thyroid bioassay
procedures should also specify the interval between bioassays, action
levels, and the actions to be taken at those levels. Generally, thyroid
uptake bioassay measurements at radiopharmacies are performed weekly for
those workers who routinely handle radioiodine or are in the immediate
vicinity when radioiodine is being handled. For guidance on developing
bioassay programs and determination of internal occupational dose and
summation of occupational dose, refer to Regulatory Guide 8.9, Revision
1, Acceptable Concepts, Models, Equations and Assumptions for a Bioassay
Program" dated July 1993, Regulatory Guide 8.34, "Monitoring Criteria
and Methods to Calculate Occupational Doses," dated July 1992, and NUREG
- 1400, "Air Sampling in the Workplace," dated September 1993.
Response from Applicant: Submit the following statement:
"We have developed and will implement and maintain written procedures
for monitoring occupational dose that meet the requirements in 10 CFR
20.1501, 10 CFR 20.1502, 10 CFR 20.1201, 10 CFR 20.1202, 10 CFR 20.1203,
10 CFR 20.1204, 10 CFR 20.1207, 10 CFR 20.1208, 10 CFR 20.2106,
as applicable."
Note: Some licensees choose to monitor their
workers for reasons other than compliance with NRC requirements (e.g.,
in response 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. See the Notice
of Availability (on the inside front cover of this report) to obtain copies
of Regulatory Guide 8.7, Revision 1, "Instructions for Recording and Reporting
Occupational Radiation Exposure Data," dated June 1992; Regulatory Guide
8.9, Revision 1, Acceptable Concepts, Models, Equations and Assumptions
for a Bioassay Program" dated July 1993; Regulatory Guide 8.34, "Monitoring
Criteria and Methods to Calculate Occupational Radiation Doses," dated
July 1992 and NUREG-1400, "Air Sampling in the Workplace," dated
September 1993.
8.10.5 Public Dose
Regulations: 10 CFR 20.1003, 10 CFR 20.1101(d), 10 CFR
20.1301, 10 CFR 20.1302, 10 CFR 20.1801, 10 CFR 20.1802, 10
CFR 20.2107, 10 CFR 20.2203.
Criteria: Licensees must do the following:
- Ensure that licensed material will be used, transported, stored, and
disposed of in such a way that members of the public will not receive
more than 1 mSv (100 mrem) (TEDE) in one year from licensed activities;
- Ensure that air emissions of radioactive material to the environment
will not result in exposures to individual members of the public in
excess of 0.1 mSv (10 mrem) (TEDE) in one year from those emissions;
- Ensure that the dose in any unrestricted area will not exceed 0.02
mSv (2 mrem) in any one hour, from licensed operations; and
- Prevent unauthorized access, removal, or use of licensed material.
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, sanitary sewerage discharges from
licensees, 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. For guidance about accepted
methodologies for determining dose to members of public, please refer
to Appendix K.
There are many possible internal dose pathways that contribute to the
TEDE. The TEDE can, however, be broken down into three major dose pathway
groups:
1. Airborne radioactive material;
2. Waterborne radioactive material; and
3. External radiation exposure.
The licensee should review these major pathways and decide which are
applicable to its operations. The licensee must ensure that the total
effective dose equivalent from all exposure pathways arising from licensed
activities does not exceed 1.0 mSv (100 mrem) to the maximally exposed
member of the public. In addition, the licensee must control air emissions,
such that the individual member of the public likely to receive the highest
total effective dose equivalent (TEDE) does not exceed the constraint
level of 0.1 mSv (10 mrem) per year from those emissions. If exceeded,
the licensee must report this, in accordance with 10 CFR 20.2203, and
take prompt actions to ensure against recurrence.
Licensees should design a monitoring program to ensure compliance with
10 CFR 20.1101(d) and 20.1302(b). The extent and frequency of monitoring
will depend upon each licensee's needs. For additional guidance regarding
monitoring of effluents, refer to the section entitled, "Radiation Safety
Program - Surveys."
During NRC inspections, licensees must be able to provide documentation
demonstrating, 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 and the dose constraint. See
Appendix K for examples of methods to demonstrate compliance.
Response from Applicant: No response is required from
the applicant in a license application, but records demonstrating compliance
will be examined during inspection.
8.10.6 Safe Use of Radionuclides and Emergency Procedures
Regulations: 10 CFR 20.1101, 10 CFR 20.1801, 10 CFR
20.1802, 10 CFR 20.2201, 10 CFR 20.2202, 10 CFR 20.2203, 10 CFR
30.34(g), 10 CFR 30.50, 10 CFR 19.11(a)(3).
Criteria: Licensees are required to do the following:
- Keep radiation doses to workers and members of the public ALARA;
- Ensure security of licensed material; and
- Make the required notifications of events to NRC.
Discussion: Licensees are responsible for the security
and safe use of all licensed material from the time it arrives at their
facility until it is used, transferred, and/or disposed. Licensees should
develop written procedures to ensure safe use of licensed material, and
the procedures should also include operational and administrative guidelines.
The written procedures should provide reasonable assurance that only appropriately
trained personnel will handle and use licensed material without undue
hazard to workers or members of the public.
General Safety Procedures
The written procedures should include the following elements:
- Contamination controls;
- Waste disposal practices;
- Personnel and area monitoring (including limits);
- Use of protective clothing and equipment;
- Safe handling of radioactive materials;
- Recording requirements;
- Reporting requirements; and
- Responsibilities.
These procedures should include policies for:
- Frequency of personnel monitoring;
- Performing molybdenum-99 breakthrough measurements on each elution
from a generator;
- Use of appropriate shielding (see Figure 8.8);
- Frequent glove changes to minimize exposure to the individual and
to avoid spread of contamination in the laboratory; and
- Special procedures for higher risk activities, such as use of radioiodine.
Applicants should also develop radioisotope-specific procedures based
on the respective hazards associated with the radioisotopes. General safety
guidelines are described in Appendix Q. Applicants should use these guidelines
to aid in the development of their own procedures for the safe use of
radioisotopes.
Licensees should determine if they have areas that require posting in
accordance with 10 CFR 20.1902, unless they meet the exemptions
listed in 10 CFR 20.1903. Also, containers of licensed material (including
radioactive waste) must be labeled in accordance with 10 CFR 20.1904,
unless they meet the exemptions in 10 CFR 20.1905.
Figure 8.8 Use of Appropriate Shielding.
Emergency Procedures
Accidents and emergencies can happen during any operation with radioisotopes,
including their receipt, transportation, use, transfer, and disposal.
Such incidents can result in contamination or release of material to the
environment and unintended radiation exposure to workers and members of
the public. In addition, loss or theft of licensed material, and fires
involving radioactive material can adversely affect the safety of personnel
and members of the public. Applicants should therefore develop and implement
procedures to minimize, to the extent practical, the potential impact
of these incidents on personnel, members of the public, and the environment.
Applicants should establish written procedures to handle events ranging
from a minor spill to a major accident that may require intervention by
outside emergency response personnel. These procedures should include
provisions for immediate response, after-hours notification, handling
of each type of emergency, equipment, and the appropriate roles of staff
and the radiation safety officer. In addition, the licensee should develop
procedures for routine contacts with its local fire department to inform
them of its operations and identify locations of radioactive materials
and elevated radiation levels in the event of their response to a fire.
Except for minor spills or releases of radioactivity that can be controlled
and cleaned up by the user, licensee staff should have a clear understanding
of their limitations in an emergency with step-by-step instructions and
clear direction of whom to contact. The licensee should establish clear
delineations between minor contamination events, minor spills, and major
spills and events.
Emergency spill response materials should be strategically placed in
well-marked locations for use by all trained staff. All equipment should
be periodically inspected for proper operation and replenished as necessary.
Appendix Q includes model emergency procedures. Applicants may adopt these
procedures or develop their own incorporating the safety features included
in these model procedures.
Certain incidents and emergencies require notification of NRC. Appendix
T provides a listing of major NRC reporting and notification requirements
relevant to commercial radiopharmacies.
Response from Applicant: Submit the following statement:
"We have developed and will implement and maintain written procedures
for the safe use of radioactive materials that address:
- Facility and personnel radioactive contamination minimization, detection,
and control;
- Performing molybdenum-99 breakthrough measurements on all generator
elutions used to prepare radioactive drugs for human medical use; and
- Use of protective clothing and equipment by personnel
that meet the requirements in 10 CFR 20.1101, 10 CFR 20.1801, 10 CFR
20.1802, 10 CFR 30.34(g), and 10 CFR 19.11(a)(3) as applicable";
AND
"We have developed and will implement and maintain written procedures
for identifying and responding to emergencies involving radioactive material,
including:
- Lost, stolen, or missing licensed material;
- Exposures to personnel and the public in excess of NRC regulatory
limits;
- Releases of licensed materials in effluents and the sanitary sewer
in excess of NRC regulatory limits;
- Excessive radiation levels or radioactive material concentrations
in restricted or unrestricted areas;
- Radioactive spills and contamination;
- Fires, explosions, and other disasters with the potential for the
loss of containment of licensed material; and
- Routine contacts with local fire departments
that meet the requirements in 10 CFR 20.1101, 10 CFR 20.2201-2203, and
10 CFR 30.50, as applicable."
Reference: See the Notice of Availability on the inside
front cover of this report to obtain copies of: NUREG-1460, Revision
1, "Guide to NRC Reporting and Recordkeeping Requirements," dated July
1994.
8.10.7 Surveys
Regulations: 10 CFR 30.53, 10 CFR 20.1501, 10 CFR 20.2103.
Criteria: Licensees are required to make surveys of
potential radiological hazards in their workplace. Records of survey results
must be maintained.
Discussion: Surveys are evaluations of radiological
conditions and potential hazards (see Figure 8.9). These evaluations
may be measurements (e.g., radiation levels measured with survey instrument
or results of wipe tests for contamination), calculation, or a combination
of measurements and calculations. The selection and proper use of appropriate
instruments is one of the most important factors in ensuring that surveys
accurately assess the radiological conditions. In order to meet regulatory
requirements for surveying, measurements of radioactivity should be understood
in terms of its properties (i.e., alpha, beta, gamma) and compared to
the appropriate limits.
Figure 8.9 Types of Surveys. There
are many different types of surveys performed by radiopharmacy licensees.
Radiation surveys are used to detect and evaluate contamination of:
- Facilities (restricted and unrestricted areas);
- Equipment;
- Incoming and outgoing radioactive packages; and
- Personnel (during use, transfer, or disposal of licensed material)
(see Figure 8.10).
Surveys are also used to plan work in areas where licensed material or
radiation exists and to evaluate doses to workers and individual members
of the public.
Figure 8.10 Personnel Surveys.
Users of unsealed licensed material should check themselves for contamination
(frisk) before leaving the restricted areas within the radiopharmacy.
Figure 8.11 Typical Surveys at Radiopharmacy.
Surveys are required when it is reasonable under the circumstances to
evaluate a radiological hazard and when necessary for the licensee to
comply with the appropriate regulations. Many different types of surveys
may need to be performed due to the particular use of licensed materials.
The most important are as follows:
- Surveys for radioactive contamination that could be present on surfaces
of floors, walls, laboratory furniture, and equipment;
- Measurements of radioactive material concentrations in air for areas
where radiopharmaceuticals are handled or processed in unsealed form
and where operations could expose workers to the inhalation of radioactive
material (e.g. radioiodine) or where licensed material is or could be
released to unrestricted areas;
- Bioassays to determine the kinds, quantities or concentrations, and
in some cases, the location of radioactive material in the human body.
Radioiodine uptake in a worker's thyroid gland is commonly measured
by external counting using a specialized thyroid detection probe;
- Surveys of external radiation exposure levels in both restricted and
unrestricted areas; and
- Surveys of radiopharmaceutical packages entering (e.g., from suppliers
and returns from customers) and departing (e.g., prepared radiopharmaceuticals
for shipment to customers).
The frequency of routine surveys depends on the nature, quantity, and
use of radioactive materials, as well as the specific protective facilities,
equipment, and procedures that are designed to protect workers from external
and internal exposure. Also, the frequency of the survey depends on the
type of survey, such as those listed above. Appendix R, "Radiation Surveys,"
contains a model procedure for radiation survey frequencies.
Not all instruments can measure a given type of radiation (e.g. alpha,
beta and gamma). The presence of other radiation may interfere with a
detector's ability to measure the radiation of interest. The energy of
the radiation may not be high enough to penetrate some detector windows
and be counted. The correct selection, calibration and use of radiation
detection instruments is an important aspect of any radiation safety program.
10 CFR Part 20 does not specify limits for surface contamination, but
it does specify dose limits for unrestricted areas (2 millirem in any
one hour) and posting requirements (5 millirem in any one hour for "Radiation
Areas"). Each applicant should propose and justify their removable surface
contamination and radiation level action limits that will require action
to (1) reduce the contamination or radiation level; or (2) institute additional
restrictions on access to the area. See Tables R.1 and R. 2 in Appendix
R for guidance on surface contamination limits acceptable to the NRC.
Undetected Contamination and Loss of Control of Licensed Material
Due to the large quantities of licensed material in liquid form often
handled by radiopharmacy personnel, there can be a greater potential for
radioactive material contamination. Radiation surveys, if properly conducted
as outlined in this section, will normally detect contamination before
it leaves the licensee's restricted area (e.g., radiopharmceutical preparation
and packaging areas). If detected within the restricted area during or
shortly following radiopharmaceutical preparation, the licensee can normally
complete standard decontamination activities to mitigate the spread of
the contamination outside the restricted area.
There have been several instances involving NRC licensees, including
radiopharmacies, in which contamination has not been detected (usually
due to no survey being done, or else an inadequate survey being performed)
and which is inadvertently removed from the restricted area. Typically
the contamination has been deposited on an outgoing package containing
radioactive material, the skin or clothing of a licensee employee leaving
the facility, or both. Once the contamination leaves the licensee's restricted
area, control of the radioactive material is lost. At this point the contamination
has a high probability of reaching public locations outside the radiopharmacy
including one or more of its customers (e.g., a hospital). Contamination
incidents such as this can create public health, regulatory, and public
relations problems for licensees. In virtually all cases, the events could
have been avoided if licensee personnel had performed an adequate radiation
survey to detect the contamination before leaving the restricted area.
NRC Information Notice 98-18, "Recent Contamination Incidences Resulting
From Failure to Perform Adequate Surveys," dated May 13, 1998, describes
some such incidents involving NRC licensees followed by a summary of the
NRC requirements to perform adequate and timely surveys.
Response from Applicant: Submit the following statement:
"We have developed and will implement and maintain written procedures
for a survey program that specifies the performance of radiation and contamination
level surveys in restricted and unrestricted areas, personnel contamination
monitoring, action levels, and the frequencies and records maintenance
of those surveys and monitoring that meet the requirements in 10 CFR 30.53,
10 CFR 20.1501, and 10 CFR 20.2103, as applicable."
References: See the Notice of Availability on the inside
front cover of this report to obtain copies of NRC Information Notice
98-18, "Recent Contamination Incidences Resulting From Failure to Perform
Adequate Surveys," dated May
8.10.8 Dosage Measurement Systems 13, 1998.
Regulations: 10 CFR 32.72(c).
Criteria: Commercial radiopharmacy licensees must possess
and use instrumentation capable of accurately measuring the radioactivity
in radioactive drugs.
Discussion: Due to the potential for radiopharmacy errors
to adversely affect their customers (medical facilities) and their customers'
patients, each dosage of a radioactive drug must be measured prior to
transfer to provide high confidence that the correct amount of the radioactive
drug is transferred in accordance with the customer's request.
The applicant must have procedures for the use of the instrumentation,
including the measurement, by direct measurement or by combination of
measurement and calculation, of the amount of radioactivity in dosages
of alpha-, beta-, or photon-emitting radioactive drugs prior to their
transfer for commercial distribution.
These procedures must ensure that the dose calibrator, or other dose
measurement system, functions properly. This is accomplished by performing
periodic checks and tests prior to first use, followed by checks at specified
intervals, and following repairs that could affect system performance.
Equipment used to measure dosages that emit gamma, alpha, or beta radiation
must be calibrated for the applicable radionuclide being measured. Currently,
no alpha-emitting nuclides are used in unsealed form in medicine; therefore,
guidance is not provided in this document on the measurement of these
radionuclides. For photon-emitters, activity measurement is a fairly straightforward
determination; however, for beta-emitters, a correction factor is often
necessary to accurately determine the activity. There are inherent technical
difficulties to overcome in the determination and application of beta-correction
factors. These difficulties include dependence on geometry, lack of an
industry standard for materials used in the manufacture of both vials
and syringes, and lack of a National Institute of Standards and Technology
(NIST) traceable standard for all radionuclides currently in use. If radiopharmacies
intend to initially distribute, i.e., measure, prepare,
and label, beta-emitting radionuclides, the applicant must provide the
calculation to demonstrate its ability to accurately dispense such materials.
If the applicant intends to use beta-correction factors supplied by the
instrument manufacturer, or other entity, it should include a means for
ensuring the accuracy of the supplied factor. If radiopharmacy applicants
intend to only redistribute beta-emitting radionuclides that have been
previously prepared and distributed by other persons licensed pursuant
to 10 CFR 32.72, then the correction factor calculation is not
required.
Licensees must assay patient dosages in the same type of vial and geometry
as used to determine the correct dose calibrator settings. The use of
different vials or syringes may result in measurement errors, for example,
due to the variation of bremsstrahlung created by interaction between
beta particles and the differing dosage containers. Licensees are reminded
that beta emitters should be shielded using a low-atomic-numbered material
to minimize the production of bremsstrahlung, followed by a high-atomic-numbered
material thick enough to attenuate the bremsstrahlung intensity.
For each dose measurement system, specific periodic tests must be performed,
as appropriate to the system, to ensure correct operation. Typically,
all systems must be checked each day of use for constancy to ensure continued
proper operation of the system. In addition, other appropriate tests may
include accuracy (for the range of energies to be measured), linearity
(for the range of activities to be measured), and geometry dependence
(for the range of volumes and product containers).
The applicant should ensure that it possesses a sufficient number of
such instruments to allow for periods when instruments are out of service
for repair and calibration.
Appendix O contains a model procedure for dose calibrator testing.
Response from Applicant: The applicant shall describe
the types of systems (measurement or combination of measurement and calculation)
it intends to use for the measurement of alpha-, beta-, and photon-emitting
radioactive drugs;
AND
For each dose measurement system used to measure the amount of radioactivity
in alpha-, beta-, or photon-emitting radioactive drugs, state: "We have
developed, and will implement and maintain a written procedure for the
performance of dose measurement system checks and tests that meets the
requirements in 10 CFR 32.72(c)";
AND
If applicable, the applicant must include a sample calculation for determining
beta-correction factors for dose calibrators with ionization chambers;
Radiopharmacies that intend to initially distribute (i.e., measure,
prepare, and label) beta- emitting radionuclides must provide the
calculation to demonstrate its ability to accurately dispense such
materials; however, a correction factor calculation is not required
if radiopharmacy applicants intend to only redistribute beta-emitting
radionuclides that were previously prepared and distributed by others
who are licensed pursuant to 10 CFR 32.72. |
OR
If applicable, the applicant must include a means for ensuring the accuracy
of beta-correction factors supplied by the instrument manufacturer, or
other entity.
8.10.9 Transportation
Regulations: 10 CFR 71.5, 10 CFR 71.12, 10 CFR 71.13,
10 CFR 71.14, 10 CFR 71.47, 10 CFR 71.87, 49 CFR Parts
171-178, 10 CFR 20.1101, 10 CFR 30.41, 10 CFR 30.51.
Criteria: Applicants who will prepare for shipment,
ship, or transport radioactive materials, including radioactive waste,
must develop, implement, and maintain safety programs for the transport
of those materials to ensure compliance with NRC and U.S. Department of
Transportation (DOT) regulations.
Discussion: In accordance with a Memorandum of Understanding
between the DOT and NRC, the NRC inspects and enforces DOT's regulations
governing the transport of radioactive materials by the NRC's licensees.
The types and quantities of radioactive materials shipped by commercial
radiopharmacy licensees will nearly always meet the criteria for shipment
in a "Type A" package, as defined by the DOT. The requirements for these
packages include the provisions for shipping papers, packaging design
standards, package marking and labeling, and radiation and contamination
level limits. For radiopharmacies who transport their own packages, the
packages must be blocked and braced, and shipping papers must be used
and located properly in the driver's compartment.
Packaging used by commercial radiopharmacies typically includes military
ammunition boxes, "briefcases," and cardboard/fiberboard boxes. These
packages will normally meet the criteria for "Type A" quantities, which
must meet specified performance standards to demonstrate that they will
maintain the integrity of containment and shielding under normal conditions
of transport. Such packages will normally withstand minor accident situations
and rough handling conditions. The testing criteria for Type A packages
are listed in 49 CFR 173.465. Before offering a Type A package for shipment,
the shipper is responsible for ensuring that the package has been tested
to meet the criteria for the contents and the configuration to be shipped
and maintaining a certificate of testing. Shippers are not required to
personally test the packages, but must ensure that the testing was performed
before use and maintain a record of the testing.
DOT regulations also require that individuals who perform functions related
to the packaging and shipment of radioactive material packages receive
training specific to those functions. The training must include a general
awareness of DOT requirements, function-specific training for the individuals'
duties, and safety training. DOT also specifies the frequency of the training
and a record retention requirement for training (see section 8.8.2).
An outline of DOT and NRC requirements generally relevant to commercial
radiopharmacy operations is included for applicant and licensee reference
in Appendix M.
Response from Applicant: No response is required. The
licensee's program for transportation of radioactive materials will be
reviewed during inspection.
References: "A Review of Department of Transportation
Regulations for Transportation of Radioactive Materials," can be obtained
be calling DOT's Office of Hazardous Material Initiatives and Training
at (202) 366-4425. The Memorandum of Understanding with DOT on the Transportation
of Radioactive Material, signed June 6, 1979, is available from NRC upon
request.
8.10.10 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 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 commercial radiopharmacy
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.
The bulk of unsealed radioactive material utilized by radiopharmacies
have short half-lives (under 120 days). These radionuclides do not pose
a source of long-term contamination. Additionally, nearly all radioactive
waste generated by radiopharmacies is stored for decay rather than transferred
to a radioactive waste disposal facility.
The licensee may possess and redistribute sealed sources that contain
radionuclides with long half lives. These sealed sources have been approved
by NRC or an Agreement State and, if 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.
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 in the following sections: Facilities and
Equipment; Radiation Safety Program - Safe Use of Radionuclides and Emergency
Procedures; Radiation Safety Program - Surveys; Radiation Safety Program
- Leak Testing; and Waste Management, of NUREG-1556, Vol. 13, "Consolidated
Guidance About Materials Licenses, Program Specific Guidance About Commercial
Radiopharmacies," dated September 1999.
8.10.11 Radioactive Drug Labeling for Distribution
Regulations: 10 CFR 20.1901; 10 CFR 20.1904; 10 CFR
20.1905; 10 CFR 30.34(g); and 10 CFR 32.72(a)(4).
Criteria: The labels affixed to radioactive drugs for
distribution must have the required color, symbol, and wording.
Discussion: The licensee must label each "transport
radiation shield" to show the radiation symbol as described in 10 CFR
20.1901. The label must also include the words "CAUTION, RADIOACTIVE MATERIAL"
OR "DANGER, RADIOACTIVE MATERIAL," the name of the radioactive drug or
its abbreviation, and the quantity of radioactivity at a specified date
and time. The phrase "transport radiation shield" refers to the primary
shield for the radioactive drug, which may include the syringe, vial,
or syringe or vial shield. The "transport radiation shield" should be
constructed of material appropriate for the isotope to be transferred
for commercial distribution. The "transport radiation shield" does not
refer to the outer suitcase, packaging, or other carrying device, even
though that barrier may provide some radiation shielding.
The licensee must label each syringe, vial, or other container (e.g.,
generator or ampule) used to hold radioactive drugs to be transferred
for commercial distribution to show the radiation symbol, as described
in 10 CFR 20.1901. The label must include the words "CAUTION, RADIOACTIVE
MATERIAL" OR "DANGER, RADIOACTIVE MATERIAL," and an identifier that ensures
the syringe, vial, or other container can be correlated with the information
on the "transport radiation shield" label. The identifier must provide
a correlation between the syringe, vial, or other container and the information
on the label of its "transport radiation shield." Identifiers may include
the prescription number, the name of the radioactive drug or its abbreviation,
the name of the patient, or the clinical procedure.
Applicants Response: The applicant must:
- Describe all labels, indicating the colors to be used, that will accompany
the products and describe where each label is placed (e.g., on the "transport
radiation shield" or the container used to hold the radioactive drug);
and
- Agree to affix the required labels to all "transport radiation shields"
and each container used to hold the radioactive drugs.
8.10.12 Radioactive Drug Shielding for Distribution
Regulations: 10 CFR 32.72(a)(3); 10 CFR 20.1201; 10
CFR 20.1207; 10 CFR 20.1208.
Criteria: The shielding provided for each radioactive
drug to be distributed must be adequate for safe handling and storage
by the pharmacy's customers to maintain occupational exposures ALARA.
Discussion: The applicant must provide appropriate "transport
radiation shields" for the primary container of each radioactive drug
that it intends to distribute. The shielding must be adequate for the
types and quantities of radioactive materials that the applicant intends
to distribute. Typically, "transport radiation shields" used by radiopharmacies
have included two-piece, shielded syringe and vial containers (or "pigs").
Pharmacies have used lead and tungsten shields for gamma-emitting materials
and plexiglass inserts for beta-emitters.
As general guidelines, "transport radiation shields" for technetium-99m
products have ensured surface radiation levels of not more than 0.03 milliSievert
per hour (mSv/hr) (3 mrem/hr), due to the ease of shielding the low energy
gamma emitted. For iodine-131, surface dose rates on "transport radiation
shields" have been approved up to 0.5 mSv/hr (50 mrem/hr) for diagnostic
dosages and up to 1.5 mSv/hr (150 mrem/hr) for therapeutic dosages. The
applicant should select appropriate shielding materials and dimensions
to not only ensure that occupational doses are ALARA, but also that the
"transport radiation shield" can be easily handled.
Applicants Response: For each radioactive drug
to be distributed (except for products intended for redistribution without
manipulation and in the manufacturer's original shipping package):
- Indicate the radionuclide and the maximum activity for each type of
container (e.g., vial, syringe);
- Describe the type and thickness of the "transport radiation shield"
provided for each type of container; and
- Indicate the maximum radiation level to be expected at the surface
of each "transport radiation shield" when the radioactive drug container
is filled with the maximum activity.
Note: It is not acceptable to state that the
applicant will comply with DOT regulations. The dose rate limits that
DOT imposes apply to the surface of the package, not the surface of the
"transport radiation shield."
8.10.13 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 sealed sources. 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 microcuries)
of radioactivity.
Commercial radiopharmacies may have their sealed sources leak tested
by an individual licensed by the NRC or an Agreement State to perform
leak testing, or radiopharmacies may perform leak testing of their own
sealed sources. Appendix L contains a model procedure for performance
of leak testing and sample analysis. If the radiopharmacy has its leak
testing performed by a licensed leak test provider, the radiopharmacy
is expected to take the leak test samples according to the sealed source
manufacturer's and the leak test provider's kit instructions and return
it to the provider 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.
Some radiopharmacies have been authorized to perform leak testing as
a service for other licensees (customers). The subsection titled "service
activities" addresses requests to perform leak testing as a service for
other licensees.
Response from Applicant: Submit the following statement:
"We have developed and will implement and maintain written procedures
for leak testing that meet the requirements in 10 CFR 30.53,
10 CFR 20.1501, and 10 CFR 20.2103."
Note: Leak testing is authorized via a license
condition.
Applicants must specifically request authorization to perform leak testing
as a service to other licensees. Requests to provide leak testing as a
service to other licensees will be reviewed and, if approved, NRC staff
will authorize via a license condition.
8.11 Item 11: Waste Management
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Regulations: 10 CFR 20.2001(a), 10 CFR 20.2003, 10 CFR
20.2006, 10 CFR 20.1904(b), 10 CFR 20.2108, 10 CFR 30.51.
Criteria: Radioactive waste must be disposed of in accordance
with regulatory requirements and license conditions. Appropriate records
of waste disposal must be maintained.
Discussion: Radioactive waste is normally generated
when conducting licensed activities. Such waste may include used or unused
radioactive material, unusable items contaminated with radioactive material,
e.g., absorbent paper, gloves, etc. Licensees may not receive radioactive
waste from other licensees for processing, storage or disposal, unless
specifically authorized to do so by NRC. Commercial radiopharmacies may
request to receive certain radioactive waste returned from their customers.
For guidance on receiving radioactive waste from customers, refer to the
section titled, "Radiation Safety Program - Waste Management, Returned
Wastes from Customers."
All radioactive waste must be stored in appropriate containers until
its disposal and the integrity of the waste containers must be assured.
Radioactive waste containers must be appropriately labeled. All radioactive
waste must be secured against unauthorized access or removal. NRC requires
commercial radiopharmacy licensees to manage radioactive waste generated
at their facilities by one or more of the following methods:
- Decay-in-Storage (DIS);
- Transfer to an authorized recipient; and
- Release into sanitary sewerage.
Licensees may chose any one or more of these methods to dispose of their
radioactive waste. It has been NRC's experience that most commercial radiopharmacies
dispose of radioactive waste by decay-in-storage because the majority
of licensed materials used by these facilities have short half-lives.
Applicant's programs for management and disposal of radioactive waste
should include procedures for handling of waste, safe and secure storage,
characterization, minimization, and disposal of radioactive waste. Appropriate
training should be provided to waste handlers. Regulations require that
licensees maintain all appropriate records of disposal of radioactive
waste.
Disposal By Decay-in-Storage (DIS)
NRC permits licensed materials with half-lives of less than or equal
to 120 days to be disposed by DIS. The minimum holding period for decay
is ten half-lives of the longest-lived radioisotope in the waste. Applicants
should assure that adequate space and facilities are available for the
storage of such waste. Procedures for management of waste by DIS should
include methods of segregation, surveys prior to disposal, and maintenance
of records of disposal.
Licensees can minimize the need for storage space, if radioactive waste
is segregated according to physical half-life. Segregation of waste is
accomplished by depositing radioisotopes of shorter physical half-lives
in containers separate from those used to store radioactive waste with
longer physical half-lives. Radioactive waste with shorter half-lives
will take less time to decay and thus may be disposed in shorter periods
of time, freeing storage space.
Used syringes/needles and vials returned from pharmacy customers (medical
facilities) are considered both biohazardous and radioactive waste since
these items may be contaminated with customer's patients' blood or other
body fluids. Following completion of decay-in-storage, such waste may
be disposed of as biohazardous waste (medical waste) if radiation surveys
(performed in a low background area and without any interposed shielding)
of the waste at the end of the holding period indicate that radiation
levels are indistinguishable from background.
Radioactive material labels on the used syringes/needles cannot be defaced
without exposing employees to the risk of injury from the needles. Additionally,
exposing employees to the risk of injury from needles would place licensees
in violation of the Occupational Safety and Health Administration regulations
in 29 CFR 1910.1030(d)(1), which requires precautions to prevent contact
with blood or other potentially infectious materials, including recommendations
not to manipulate used syringes/needles by hand. Thus, radiopharmacy licensee's
do not have to deface or remove radiation labels from individual containers
and packages (e.g., syringes, vials) inside waste barrels/containers intended
for disposal as medical waste, provided the following conditions are met:
- The radioactive material labels on the outer waste barrels/containers
will be defaced or removed prior to transfer to waste disposal firm;
- Waste barrels are sealed prior to delivery to the waste disposal firm;
- Waste barrels/containers will be delivered directly from the licensee's
facility to a waste disposal firm for disposal;
- Medical waste is incinerated, and not sent to a medical waste landfill;
and
- The waste disposal firm is notified that the barrels must not be opened
at any point, and for any reason, prior to incineration.
Other pharmacy radioactive waste that has not been returned from customers
and has not otherwise come into contact with blood or body fluids should
not have a biohazardous component. Following completion of decay-in-storage
and provided it has been stored separate from radioactive, biohazardous
waste and contains no other hazardous components (e.g. needles, hazardous
chemicals), such waste may require disposal as ordinary trash if radiation
surveys (performed in a low background area and without any interposed
shielding) of the waste at the end of the holding period indicate that
radiation levels are indistinguishable from background. All radiation
labels must be defaced or removed from containers and packages prior to
final disposal as ordinary trash. If the decayed waste is compacted, all
labels that are visible in the compacted mass must also be defaced or
removed.
Records of DIS should include the date when the waste was put in storage
for decay, date when ten half-lives of the longest-lived radioisotope
have transpired, date of disposal, results of final survey before disposal
as ordinary trash and results of the background survey, identification
of the instrument used to perform the survey and the signature or initials
of the individual performing the survey.
Transfer to an Authorized Recipient
Licensees may transfer radioactive waste to an authorized recipient for
disposal. It has been NRC's experience that most commercial radiopharmacies
only dispose of radioactive wastes with half-lives greater than 120 days
to authorized recipients (e.g., low-level radioactive waste disposal facilities).
Since radiopharmacy licensees typically possess small quantities of these
materials, the volume of materials disposed in this manner would also
be minimal, if any. Currently, radiopharmacies use this system for waste
disposal infrequently; therefore, detailed guidance is not provided in
this document on the specific requirements related to the transfer of
wastes to authorized recipients for disposal.
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. |
Release Into Sanitary Sewerage
Licensees may dispose of radioactive waste by release into sanitary sewerage
if each of the following conditions are met:
- Material is readily soluble (or is easily dispersible biological material)
in water;
- Quantity of licensed material that the licensee releases into the
sewer each month averaged over the monthly volume of water released
into the sewer does not exceed the concentration specified in 10 CFR
Part 20, Appendix B, Table 3;
- If more than one radioisotope is released, the sum of the ratios of
the average monthly discharge of a radioisotope to the corresponding
limit in 10 CFR Part 20, Appendix B, Table 3 cannot exceed unity; and
- Total quantity of licensed material released into the sanitary sewerage
system in a year does not exceed the limits specified in 10 CFR 20.2003(a)(4).
Licensees are responsible for demonstrating that licensed materials discharged
into the sewerage system are indeed readily dispersible in water. NRC
IN 94-07, "Solubility Criteria for Liquid Effluent Releases to Sanitary
Sewerage Under the Revised 10 CFR Part 20," dated January 1994, provides
the criteria for evaluating solubility of liquid waste.
Applicants should develop and implement procedures to ensure that all
releases of radioactive waste into the sanitary sewerage, if any, meet
the criteria stated in 10 CFR 20.2003. Licensees are required to maintain
accurate records of all releases of licensed material into the sanitary
sewerage.
Response from Applicant: Submit the following statement:
"We have developed and will implement and maintain written procedures
for waste management that meet the requirements in 10 CFR 20.1904(b),
10 CFR 20.2001(a), 10 CFR 20.2003, 10 CFR 20.2006, 10 CFR 20.2108, 10
CFR 30.51, as applicable."
Note: Decay-in-storage is authorized via a
license condition.
References: See the Notice of Availability on the inside
front cover of this report to obtain copies of Policy and Guidance Directive
PG 94-05, "Updated Guidance on Decay-In-Storage," dated October 1994;
Information Notice 94-07, "Solubility Criteria for Liquid Effluent Releases
to Sanitary Sewerage Under the Revised 10 CFR 20," dated January 1994;
and Information Notice 84-94, "Reconcentration of Radionuclides Involving
Discharges into Sanitary Sewerage Systems Permitted Under 10 CFR 20.203
(now 10 CFR 20.2003)," dated December 1984.
Information Notices are available at <http://www.nrc.gov>.
8.11.1 Returned Wastes from Customers
Regulations: 10 CFR 20.2001(a), 10 CFR 30.33, 10 CFR
71.5.
Criteria: Commercial radiopharmacies may receive radioactive
waste from customers. This radioactive waste is limited to items that
originated at the radiopharmacy and that contained (or contain) radioactive
material delivered for customer use (e.g., pharmacy supplied syringes
and vials and their contents).
Discussion: Commercial radiopharmacy licenses contain
a license condition that permits radioactive waste, consisting of pharmacy
supplied items, to be received from their customers. The customer may
return, and the radiopharmacy may accept for disposal, only items originating
at the radiopharmacy that contained or contain radioactive material. This
is limited to pharmacy-supplied syringes and vials and their contents.
It is not acceptable for customers to return items originating
at their facilities that are contaminated with radioactive material supplied
by the pharmacy (e.g., gloves, absorbent material, IV tubing, patient
contaminated items). If an applicant wishes a broader authorization for
radioactive waste retrieval, the applicant must apply for a separate license
as a radioactive waste broker under the general provisions of 10 CFR 20.2001(b)
and 10 CFR 30.33.
Figure 8.12 Returned Waste.
Only items that originated at the radiopharmacy (pharmacy supplied
syringes and vials and their contents) may be returned to the radiopharmacy
for disposal.
Radiopharmacy customers, who act as the shipper for returned materials,
should be supplied with detailed written instructions on how to properly
prepare and package radioactive waste for return to the radiopharmacy.
These instructions should clearly indicate that only items that contained
or contain radioactive materials supplied by the radiopharmacy may be
returned. In addition, these instructions should be adequate to ensure
that customers comply with Department of Transportation (DOT) and NRC
regulations for the packaging and transport of licensed materials and
for the radiation safety of drivers/couriers. Since customers may return
unused syringes and vials, which may contain significant quantities of
licensed material, the radiopharmacy should also include in their instructions
methods for determining that the activities of radioisotopes returned
to the pharmacy are "limited quantities," or otherwise ensure that customers
prepare and offer packages for transport that meet NRC and DOT requirements
if the packages contain greater than limited quantities of radioactive
material. The radiopharmacy should also have written instructions for
pharmacy staff to address pick-up, receipt and disposal of the returnable
radioactive waste. Appendix S contains a model procedure for return of
pharmacy radioactive wastes from customers.
If the pharmacy chooses to take the responsibility to act as the shipper
for returned materials, the pharmacy must ensure that its customer follows
DOT and NRC regulations for the packaging and transport of licensed materials
and for the radiation safety of drivers/couriers in the return process.
Response from Applicant: Submit the following statement:
"We have developed and will implement and maintain written procedures
for customer return of pharmacy supplied syringes and vials and their
contents, to specify that:
- Only pharmacy supplied syringes and vials and their contents may be
returned to the pharmacy;
- Instructions will be provided to radiopharmacy customers for the proper
preparation and packaging of the radioactive waste for return to the
radiopharmacy; and
- Instructions will be provided to pharmacy staff for the pick-up, receipt,
and disposal of the returned radioactive waste that meet the requirements
in 10 CFR 20.2001(a), 10 CFR 30.33, 10 CFR 71.5, as applicable."
Note: Retrieval, receipt and disposal of pharmacy
supplied syringes and vials from customers is authorized via a license
condition.
8.12 Item 12: Fees
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The next two items on NRC Form 313 are to be completed on the form itself.
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, Maryland, (301) 415-7554. You may
also call NRC's toll free number, (800) 368-5642 and then 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; however, in accordance with 10 CFR 32.72(b)(5),
commercial radiopharmacy licensees may allow individuals not named on
their licenses to work as ANPs, provided that the individuals meet the
minimum training and experience requirements of 10 CFR 32.72(b)(2) or
(4), and the licensee notifies the NRC in writing, with the documentation
specified in 10 CFR 32.72(b)(5), as applicable, no later than 30 days
after the licensee allows the individual to work as an ANP. 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 or renewal 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. Alternatively, describe clearly the
exact nature of the changes, additions, and deletions;
- If a renewal is requested, provide the appropriate fee.
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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Regulations: 10 CFR 19.31; 10 CFR 20.2301, 10 CFR 30.11.
Criteria: Licensees may request exemptions to regulations.
The licensee must demonstrate that the exemption is authorized by law,
will not endanger life or property or the common defense and security,
and is otherwise in the public interest.
Discussion: 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)). These regulations state that NRC may grant an exemption,
acting on its own initiative or on an application from an interested person.
Exemptions are not intended to revise regulations, are not intended for
large classes of license, and are generally limited to unique situations.
Exemption requests must be accompanied by descriptions of the following:
- Exemption and justification 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; and
- Alternative methods for complying with the regulation and why compliance
with the existing regulation is not feasible.
Until NRC has granted an exemption in writing, NRC expects strict
compliance with all applicable regulations. |
11 Termination of Activities
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Regulations: 10 CFR 30.34(b), 10 CFR 30.35(g), 10 CFR
30.36(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 cease licensed activities permanently at the entire
site (regardless of contamination levels);
- --a decision to cease licensed activities permanently 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; and
- --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 a 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); and
- 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 Section 8.11
on "Waste Management." For guidance on decommissioning records, see Section
8.5.2 on "Radioactive Materials - Financial Assurance and Record
Keeping for Decommissioning."
Response from Applicant: The applicant's obligations
in this matter begin when the license expires or at the time the licensee
ceases operations, whichever is earlier. These obligations are to undertake
the necessary decommissioning activities, to submit NRC Form 314 or equivalent
information, and to perform any other actions as summarized in the Criteria.
The applicant is not required to submit a response to the NRC during the
initial application.
Reference: 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: United States Nuclear Regulatory
Commission Form 313
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Appendix B: List of Documents Considered
in Development of This NUREG
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This report incorporates and updates the guidance previously found in
the NUREG reports, Regulatory Guides (RGs), Policy and Guidance Directives
(P&GDs), and Information Notices (INs) listed below. Other NRC documents,
such as Manual Chapters (MCs), Inspection Procedures (IPs), and Memoranda
of Understanding (MOU) were also consulted during the preparation of this
report. The documents marked with an asterisk (*) have been superseded
and should not be used.
Table A.1 List of NUREG Reports, Regulatory Guides, and Policy
and Guidance Directives
Document Identification |
Title |
Date |
Draft RG DG-0006* |
Guide for the Preparation of Applications for Commercial Nuclear
Pharmacy Licenses |
3/97 |
FC 410-4* |
Guide for the Preparation of Applications for Nuclear Pharmacy Licenses |
8/85 |
SRP 85-14* |
Standard Review Plan for Applications for Nuclear Pharmacy Licenses |
8/85 |
P&GD
FC 86-9* |
Authorizing Possession and Use of Depleted Uranium as Shielding
for High Activity Molybdenum-99/Technetium-99m Generators |
6/86 |
IN 89-25,
Rev. 1 |
Unauthorized Transfer of Ownership or Control of Licensed Activities |
12/94 |
IN 97-03 |
Defacing of Labels to Comply with 10 CFR 20.1904(b) |
2/97 |
IN 98-18 |
Recent Contamination Incidences Resulting from Failure to Perform
Adequate Surveys |
5/98 |
GL 95-09 |
Monitoring and Training of Shippers and Carriers of Radioactive
Materials |
11/95 |
Appendix C: Suggested Format for Providing
Information Requested in Items 5 through 11 of NRC Form 313
[ Prev | Next | Top of file
]
Item No. |
Title and Criteria |
Yes |
Description Attached |
5. |
RADIOACTIVE MATERIAL |
|
Sealed And/Or Unsealed Byproduct Material |
|
For unsealed materials: |
|
• |
Identify each radionuclide (element name and mass number) that
will be used, the form, and the maximum requested possession limit. |
|
[ ] |
|
AND |
|
|
|
For potentially volatile materials (e.g., iodine-131): |
|
• |
Specify whether the material will be manipulated at the radiopharmacy |
[ ] |
N/A |
|
For sealed materials: |
|
• |
Identify each radionuclide (element name and mass number) that
will be used in each source; |
|
[ ] |
|
• |
Provide the manufacturer's (distributor's) name and model number
for each sealed source and device requested; |
|
[ ] |
|
• |
We 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; |
[ ] |
N/A |
|
• |
We confirm that the activity per source and maximum activity in
each device will not exceed the maximum activity listed on the approved
certificate of registration issued by NRC or by an Agreement State |
[ ] |
N/A |
|
For depleted uranium, specify the total amount (in
kilograms). |
|
[ ] |
5 |
RADIOACTIVE MATERIAL (Cont'd) |
|
Financial Assurance and Record Keeping for
Decommissioning |
|
If financial assurance is required, submit documentation
required by 10 CFR 30.35. |
|
[ ] |
6. |
PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL
BE USED |
|
For radiopharmaceuticals: |
|
• |
We confirm that radiopharmaceuticals will be prepared under the
supervision of an ANP or will be obtained from a supplier authorized
pursuant to 10 CFR 32.72; and |
[ ] |
|
|
• |
Describe all licensed material to be distributed or redistributed. |
|
[ ] |
|
For generators: |
|
• |
We confirm that the generators will be obtained from a manufacturer
licensed pursuant to 10 CFR 32.72, or under equivalent Agreement
State requirements; and |
[ ] |
|
|
• |
We confirm that unused generators will be redistributed without
opening or altering the manufacturer's packaging. |
[ ] |
|
6. |
PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL
BE USED (Cont'd) |
|
For redistribution of used generators: |
|
• |
Describe the procedures and instructions for safely repackaging
the generators, including the use of the manufacturer's original
packaging and minimization of migration of radioactive fluids out
of the generator during transport; |
|
[ ] |
|
• |
We confirm that the manufacturer's packaging and labeling will
not be altered; |
[ ] |
|
|
• |
We confirm that the generator will not be distributed beyond the
expiration date shown on the generator label; |
[ ] |
|
|
• |
We confirm that the redistributed generator will be accompanied
by the manufacturer-supplied leaflet or brochure that provides radiation
safety instructions for handling and using the generator; and |
[ ] |
|
|
• |
We confirm that only generators used in accordance with the manufacturer's
instructions will be redistributed. |
[ ] |
|
|
For Redistribution of Sealed Sources C for Brachytherapy
or Diagnosis: |
|
• |
We confirm that the sealed sources for brachytherapy or diagnosis
to be redistributed will be obtained from a manufacturer authorized
to distribute sealed sources for brachytherapy or diagnosis in accordance
with a specific license issued pursuant to 10 CFR 32.74
or under equivalent Agreement State requirements; and |
[ ] |
|
|
• |
We confirm that the manufacturer's packaging, labeling, and shielding
will not be altered and that redistributed sources will be accompanied
by the manufacturer-supplied package insert, leaflet, brochure,
or other document that provides radiation safety instructions for
handling and storing the sources. |
[ ] |
|
6. |
PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL
BE USED (Cont'd) |
|
For Redistribution of Calibration and Reference Sealed
Sources: |
|
• |
We confirm that calibration and reference sealed sources to be
redistributed to medical use licensees will be obtained from a person
licensed pursuant to 10 CFR 32.74 to initially distribute such sources;
and |
[ ] |
|
|
• |
We confirm that the manufacturer's labeling and packaging will
not be altered and that redistributed sources will be accompanied
by the manufacturer-supplied calibration certificate and the leaflet,
brochure, or other document that provides radiation safety instructions
for handling and storing the sources. |
[ ] |
|
|
For Redistribution of Prepackaged Units for In
Vitro Tests: |
|
• |
We confirm that the prepackaged units for in vitro tests to be
redistributed will have been obtained from a manufacturer authorized
to distribute the prepackaged units for in vitro tests in accordance
with a specific license issued pursuant to 10 CFR 32.71
or under an equivalent license of an Agreement State. |
[ ] |
|
|
For Redistribution to General Licensees: |
|
• |
We confirm that the manufacturer's packaging and labeling of the
prepackaged units for in vitro tests will not be altered in any
way; and |
[ ] |
|
|
• |
We confirm that each redistributed prepackaged unit for in
vitro tests will be accompanied by the manufacturer-supplied
package insert, leaflet, or brochure that provides radiation safety
instructions for general licensees. |
[ ] |
|
6. |
PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL
BE USED (Cont'd) |
|
For radiopharmaceutical preparation, we will perform: |
|
• |
compounding of iodine-131 capsules; |
[ ] |
|
|
• |
radioiodination; |
[ ] |
|
|
• |
technetium-99m kit preparation; and |
[ ] |
|
|
• |
other, specify. |
[ ] |
[ ] |
|
Supply specific information concerning the use of
sealed sources for reference and calibration, and depleted uranium. |
|
[ ] |
|
We will provide customer the following radiation protection
services involving licensed material: |
|
• |
leak testing; |
[ ] |
[ ] |
|
• |
instrument calibration; and |
[ ] |
[ ] |
|
• |
other, specify. |
[ ] |
[ ] |
7. |
INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY
PROGRAM AND THEIR TRAINING AND EXPERIENCE |
|
For applicant's management structure, provide: |
|
• |
An organizational chart describing the management structure, reporting
paths, and the flow of authority between executive management and
the RSO. |
|
[ ] |
7. |
INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY
PROGRAM AND THEIR TRAINING AND EXPERIENCE (Cont'd) |
|
For the Radiation Safety Officer (RSO), provide: |
|
• |
Name of the proposed RSO; |
[ ] |
|
|
AND |
|
• |
A copy of the license (NRC or Agreement State) that authorized
the uses requested and on which the individual was specifically
named as the RSO, an ANP, or an AU; |
|
[ ] |
|
OR |
|
• |
Description of the training and experience demonstrating that
the proposed RSO is qualified by training and experience as applicable
to commercial nuclear pharmacies. |
|
[ ] |
|
Note: See Appendix G for
convenient formats to use for documenting hours of training in basic
radioisotope handling techniques and hours of experience using radioisotopes.Figures
G-1 and G-2 are specific to RSO training and experience. |
7. |
INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY
PROGRAM AND THEIR TRAINING AND EXPERIENCE (Cont'd) |
|
For each proposed Authorized Nuclear Pharmacist
(ANP), provide the following: |
|
• |
Name of the pharmacist; |
|
[ ] |
|
AND |
|
• |
A copy of the State pharmacy licensure or registration of the
pharmacist; |
[ ] |
|
|
AND |
|
• |
A copy of the license (NRC or Agreement State) on which the individual
was specifically named as an ANP; |
[ ] |
|
|
OR |
|
• |
A copy of the permit maintained by a licensee of broad scope that
identifies the individual as ANP; |
[ ] |
|
|
OR |
|
• |
A copy of previous NRC license issued to a commercial radiopharmacy
prior to December 2, 1994, on which the pharmacist was specifically
named as an authorized user; |
[ ] |
|
|
OR |
|
• |
A copy of the pharmacist's certification(s) from the radiopharmacy
board(s) approved by NRC; |
[ ] |
|
7. |
INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY
PROGRAM AND THEIR TRAINING AND EXPERIENCE (Cont'd) |
|
OR |
|
• |
Description of the training and experience demonstrating that
the proposed ANP is qualified by training and experience; and written
certification, signed by a preceptor ANP, that the above training
and experience has been satisfactorily completed and that the individual
has achieved a level of competency sufficient to independently operate
a nuclear pharmacy; |
|
[ ] |
|
AND |
|
• |
Description of the recentness of training, if necessary. |
|
[ ] |
7. |
INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY
PROGRAM AND THEIR TRAINING AND EXPERIENCE (Cont'd) |
|
For each proposed Authorized User (AU), provide
the following: |
|
• |
Name of each proposed AU; |
|
[ ] |
|
AND |
|
• |
Identify types, quantities, and proposed uses of licensed material; |
|
[ ] |
|
AND |
|
• |
A copy of license (NRC or Agreement State) on which the individual
was specifically named as an AU for the types, quantities, and proposed
uses of licensed materials; |
[ ] |
|
|
OR |
|
• |
A copy of the permit maintained by a licensee of broad scope that
identifies the individual as an AU for the types, quantities, and
proposed uses of licensed materials; |
[ ] |
|
|
OR |
|
• |
Description of the training and experience demonstrating that
the proposed AU is qualified by training and experience to use the
requested licensed materials. The applicant may find it convenient
to describe this training and experience using a format similar
to Figures G-1 and G-2 in Appendix G. |
|
[ ] |
8. |
TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING
RESTRICTED AREAS (INSTRUCTIONS TO OCCUPATIONALLY EXPOSED WORKERS
AND ANCILLARY PERSONNEL) |
|
Occupationally Exposed Workers and Ancillary
Personnel |
|
We have developed and will implement and maintain
written procedures for a training program for each group of workers,
including: topics covered; qualifications of the instructors; method
of training; method for assessing the success of the training; and
the frequency of training and refresher training. |
[ ] |
|
|
Personnel Involved in Hazardous Materials
Package Preparation and Transport |
|
We have developed and will implement and maintain
written procedures for training personnel involved in hazardous
materials package preparation and transport that meet the requirements
in 49 CFR 172.700, 49 CFR 172.702, and 49 CFR 172.704, as applicable. |
[ ] |
|
|
Instruction for Supervised Individuals Preparing
Radiopharmaceuticals |
Need Not Be Submitted with
Application |
9. |
FACILITIES AND EQUIPMENT |
|
Provide a copy of the registration or license from
a State Board of Pharmacy as a pharmacy; or provide evidence that
the facility is operating as a nuclear pharmacy within a Federal
medical institution; |
[ ] |
[ ] |
|
AND |
|
Describe the facilities and equipment to be made available
at each location where radioactive material will be used. A diagram
should be submitted showing the applicant's entire facility and
identify activities conducted in all contiguous areas surrounding
the facility. Diagrams should be drawn to a specified scale, or
dimensions should be indicated. |
|
[ ] |
|
Include the following information: |
|
• |
Descriptions of the area(s) assigned for the receipt, storage,
preparation, and measurement of radioactive materials and the location(s)
for radioactive waste storage; |
|
[ ] |
|
• |
Sufficient detail in the diagram to indicate locations of shielding,
the proximity of radiation sources to unrestricted areas, and other
items related to radiation safety; |
|
[ ] |
|
• |
Descriptions of the ventilation systems, including gloveboxes
or fume hoods, with pertinent airflow rates, area differential pressures,
filtration equipment, and monitoring systems for the use or storage
of radioactive materials with the probability of becoming airborne,
such as compounding radioiodine capsules and dispensing radioiodine
solutions; and |
|
[ ] |
|
• |
Verification that ventilation systems ensure that effluents are
within 10 CFR 20.1301 and are ALARA constraints for air emissions
established under 10 CFR 20.1101(d) |
|
[ ] |
10. |
RADIATION SAFETY PROGRAM |
Need Not be Submitted with
Application |
|
Audit Program |
|
|
The applicant's program for reviewing the content
and implementation of its radiation protection program will be examined
during inspections, but it should not be submitted in the license
application. |
|
|
Instruments |
|
We will use equipment that meets the radiation monitoring
instrument specifications and implement the model survey meter calibration
program published in Appendix J to NUREG - 1556, Vol.
13, "Program-Specific Guidance About Radiopharmacy Licenses," dated
September 1999; |
[ ] |
|
|
OR |
|
We will use equipment that meets the radiation monitoring
instrument specifications published in Appendix J to NUREG-1556,
Vol. 13, "Program-Specific Guidance About Radiopharmacy Licenses,"
dated September 1999, and instruments will be calibrated by other
persons authorized by the NRC, an Agreement State, or a licensing
State to perform that service; |
[ ] |
|
|
OR |
|
A description of alternative minimum equipment to
be used for radiation monitoring and/or alternative procedures for
the calibration of radiation monitoring equipment. |
|
[ ] |
10. |
RADIATION SAFETY PROGRAM (Cont'd) |
|
Material Receipt and Accountability |
|
We have developed, and will implement and maintain
written procedures for safely opening packages that meet the requirements
in 10 CFR 20.1906; |
[ ] |
|
|
AND |
|
We will conduct physical inventories of sealed sources
of licensed material at intervals not to exceed 6 months; |
[ ] |
|
|
AND |
|
We have developed, and will implement and maintain
written procedures for licensed material accountability and control
to ensure that: |
[ ] |
|
|
• |
license possession limits are not exceeded; |
|
|
|
• |
licensed material in storage is secured from unauthorized access
or removal; |
|
|
|
• |
licensed material not in storage is maintained under constant
surveillance and control; and |
|
|
|
• |
records of receipt, transfer, and disposal of licensed material
are maintained. |
|
|
|
Occupational Dosimetry |
|
We have developed and will implement and maintain
written procedures for monitoring occupational dose that meet the
requirements in 10 CFR 20.1501, 10 CFR 20.1502, 10 CFR 20.1201,
10 CFR 20.1202, 10 CFR 20.1203, 10 CFR 20.1204, 10 CFR
20.1207, 10 CFR 20.1208, and 10 CFR 20.2106, as applicable. |
[ ] |
|
10. |
RADIATION SAFETY PROGRAM (Cont'd) |
Need Not Be Submitted with
Application |
|
Public Dose |
|
|
The applicant's program to control doses received
by individual members of the public will be examined during inspection,
but it should not be submitted in a license application. |
|
|
Safe Use of Radionuclides and Emergency Procedures
|
|
We have developed and will implement and maintain
written procedures for the safe use of radioactive materials that
address: |
[ ] |
|
|
• |
facility and personnel radioactive contamination minimization,
detection, and control; |
|
|
|
• |
performing molybdenum-99 breakthrough measurements on all generator
elutions used to prepare radioactive drugs for human medical use;
and |
|
|
|
• |
use of protective clothing and equipment by personnel |
|
|
|
that meet the requirements in 10 CFR 20.1101, 10 CFR
20.1801, 10 CFR 20.1802, 10 CFR 30.34(g), and 10 CFR 19.11(a)(3),
as applicable; |
10. |
RADIATION SAFETY PROGRAM (Cont'd) |
|
AND |
|
We have developed and will implement and maintain
written procedures for identifying and responding to emergencies
involving radioactive material, including: |
[ ] |
|
|
• |
lost, stolen, or missing licensed material; |
|
|
|
• |
exposures to personnel and the public in excess of NRC regulatory
limits; |
|
|
|
• |
releases of licensed materials in effluents and the sanitary sewer
in excess of NRC regulatory limits; |
|
|
|
• |
excessive radiation levels or radioactive material concentrations
in restricted or unrestricted areas; |
|
|
|
• |
radioactive spills and contamination; |
|
|
|
• |
fires, explosions, and other disasters with the potential for
the loss of containment of licensed material; and |
|
|
|
• |
routine contacts with local fire departments |
|
|
|
that meet the requirements in 10 CFR 20.1101, 10 CFR 20.2201-2203,
and 10 CFR 30.50, as applicable. |
|
Surveys |
|
We have developed and will implement and maintain
written procedures for a survey program that specifies the performance
of radiation and contamination level surveys in restricted and unrestricted
areas, personnel contamination monitoring, action levels, and the
frequencies and records maintenance of those surveys and monitoring
that meet the requirements in 10 CFR 30.53, 10 CFR 20.1501,
and 10 CFR 20.2103 as applicable. |
[ ] |
|
10. |
RADIATION SAFETY PROGRAM (Cont'd) |
|
Dosage Measurement Systems |
|
Describe the types of systems (measurement or combination
of measurement and calculation) to be used for the measurement of
alpha-, beta-, and photon-emitting radioactive drugs; |
|
[ ] |
|
AND |
|
For each dose measurement system used to measure the
amount of radioactivity in alpha-, beta-, or photon-emitting radioactive
drugs, state: "We have developed, and will implement and maintain
a written procedure for the performance of dosage measurement system
checks and tests that meets the requirements in 10 CFR 32.72(c)"; |
[ ] |
|
|
AND |
|
If applicable, include a sample calculation for determining
beta-correction factors for dose calibrators with ionization chambers; |
|
[ ] |
|
OR |
|
If applicable, include a means for ensuring the accuracy
of beta-correction factors supplied by the instrument manufacturer
or other entity. |
|
[ ] |
|
Transportation |
Need Not Be Submitted with
Application |
|
The applicant's program for transportation will be
examined during inspection, but should not be submitted in a license
application. |
|
10. |
RADIATION SAFETY PROGRAM (Cont'd) |
Need Not Be Submitted
with Application |
|
Minimization of Contamination |
|
|
The applicant does not need to provide a response
to this item under the following condition: NRC will consider that
the criteria have been met if the applicant's responses meet the
criteria for the following sections: "Facilities and Equipment;
Radiation Safety Program - Safe Use of Radionuclides and Emergency
Procedures; Radiation Safety Program - Surveys; Radiation Safety
Program - Leak Testing; and Waste Management" of NUREG - 1556,
Vol. 13, dated September 1999. |
|
|
Radioactive Drug Labeling for Distribution |
|
Describe all labels, indicating the colors to be used,
that will accompany the products and describe where each label is
placed (e.g., on the "transport radiation shield" or the container
used to hold the radioactive drug); and agree to affix the required
labels to all "transport radiation shields" and each container used
to hold the radioactive drugs. |
|
Radioactive Drug Shielding for Distribution |
|
For each radioactive drug to be distributed (except
for products intended for redistribution without manipulation and
in the manufacturer's original shipping package), provide: |
[ ] |
|
|
• |
The radionuclide and the maximum activity for each type of container
(e.g., vial, syringe); |
|
|
|
• |
Describe the type and thickness of the "transport radiation shield"
provided for each type of container; and |
|
|
|
• |
Indicate the maximum radiation level to be expected at the surface
of each "transport radiation shield" when the radioactive drug container
is filled with the maximum activity. |
|
|
10. |
RADIATION SAFETY PROGRAM (Cont'd) |
|
Leak Tests |
|
We have developed and will implement and maintain
written procedures for leak testing that meet the requirements in
10 CFR 30.53, 10 CFR 20.1501, and 10 CFR 20.2103 |
[ ] |
|
Appendix D: Checklist for License Application
[ Prev | Next | Top of file
]
D.1 ITEM 1: ACTION TYPE
[ Prev | Next | Top of file
]
ACTION TYPE: |
ADMINISTRATIVE REVIEW: |
[ ] New |
[ ] Current Guidance Used |
[ ] Amendment |
[ ] References in Application Based On Current Regulations |
[ ] Renewal |
[ ] All Attachments Referenced Included |
|
[ ] Signature on Application |
D.2 ITEM 2: LEGAL IDENTITY
[ Prev | Next | Top of file
]
D.3 ITEMS 2 & 3: ADDRESS
[ Prev | Next | Top of file
]
STORAGE & LOCATION OF USE ADDRESS: |
MAILING ADDRESS: |
D.4 ITEM 4: PERSON TO BE CONTACTED ABOUT
THIS APPLICATION
[ Prev | Next | Top of file
]
CONTACT PERSON: |
TELEPHONE NUMBER: |
D.5 ITEMS 5 & 6: MATERIALS TO BE POSSESSED AND
PROPOSED USES
[ Prev | Next | Top of file
]
Yes |
No |
Radioisotope |
Form or Mfg/Model No. |
Quantity |
Purpose of Use |
Specify Other Uses Not Listed on SSD Certificate |
|
|
Byproduct Materials with Atomic No. 1-83 |
Any |
___ |
millicuries per nuclide, 1 curie total possession,
except as noted: |
10 CFR 32.72 |
[ ] |
Not applicable |
and |
[ ] |
Uses are: |
10 CFR 30.41 |
|
|
Molybdenum-99 |
Any |
___ |
curies |
10 CFR 32.72 |
[ ] |
Not applicable |
and |
[ ] |
Uses are: |
10 CFR 30.41 |
|
|
Technetium-99m |
Any |
___ |
curies |
10 CFR 32.72 |
[ ] |
Not applicable |
and |
[ ] |
Uses are: |
10 CFR 30.41 |
|
|
Iodine-131 |
Any |
___ |
Millicurries |
10 CFR 32.72 |
[ ] |
Not applicable |
and |
[ ] |
Uses are: |
10 CFR 30.41 |
|
|
Xenon-133 |
Any |
___ |
curies |
10 CFR 32.72 |
[ ] |
Not applicable |
and |
[ ] |
Uses are: |
10 CFR 30.41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Any Byproduct Material in a Brachytherapy Source, as
listed in 10 CFR 35.400 |
Sealed Sources |
___ |
Millicurries |
10 CFR 32.72 |
[ ] |
Not applicable |
and |
[ ] |
Uses are: |
10 CFR 30.41 |
|
|
Any Byproduct Material in a sealed source for diagnosis,
as listed in 10 CFR 35.500 |
Sealed Sources |
___ |
Curies per source
and
curies total |
10 CFR 32.72 |
[ ] |
Not applicable |
and |
[ ] |
Uses are: |
10 CFR 30.41 |
|
|
Any byproduct material listed in 10 CFR 3111(a) |
Prepackaged units for in vitro diagnostic tests |
___ |
Millicuries |
10 CFR 32.72 |
[ ] |
Not applicable |
and |
[ ] |
Uses are: |
10 CFR 30.41 |
|
|
Any byproduct material authorized under 10 CFR
35.57(a) |
Sealed Sources |
___ |
Millicuries |
10 CFR 32.72 |
[ ] |
Not applicable |
and |
[ ] |
Uses are: |
10 CFR 30.41 |
|
|
Depleted Uranium |
|
|
|
10 CFR 32.72 |
[ ] |
Not applicable |
and |
[ ] |
Uses are: |
10 CFR 30.41 |
|
|
Cesium-137 |
|
|
|
10 CFR 32.72 |
[ ] |
Not applicable |
and |
[ ] |
Uses are: |
10 CFR 30.41 |
|
|
Other (specify) |
|
|
|
|
D.6 ITEMS 7 THROUGH 11: TRAINING AND EXPERIENCE,
FACILITIES AND EQUIPMENT, RADIATION SAFETY PROGRAM, AND WASTE DISPOSAL
[ Prev | Next | Top of file
]
Item Number and Title |
Suggested Response |
Yes |
Alternative Procedures Attached |
7. |
Individual(s) Responsible for Radiation Safety Program and Their
Training and Experience |
An organizational chart describing the management
structure, reporting paths, and the flow of authority between executive
management and the radiation safety officer. |
[ ] |
[ ] |
7.1 |
Management Structure |
7. |
Individual(s) Responsible For Radiation Safety
Program And Their Training And Experience |
A copy of the license (NRC or Agreement
State) that authorized the uses requested and on which the individual
was specifically named as the RSO, an ANP, or an AU; |
[ ]
|
[ ] |
7.2
Name:____________ |
Radiation Safety Officer (RSO) |
OR
|
|
Description of the training and experience
demonstrating that the proposed RSO is qualified by training and experience
as applicable to commercial nuclear pharmacies |
[ ] |
|
7. |
Individual(s) Responsible for Radiation
Safety Program and Their Training and Experience |
A copy of the State pharmacy licensure
or registration for the pharmacist; |
[ ]
|
[ ] |
AND
|
7.3
Name(s):_________ |
Authorized Nuclear Pharmacist(s) |
A copy of the license (NRC or Agreement
State) on which the individual was specifically named as an ANP; |
[ ]
|
OR
|
A copy of the permit maintained by
a licensee of broad scope that identifies the individual as ANP; |
[ ] |
OR
|
A copy of previous NRC license issued
to a commercial radiopharmacy prior to December 2, 1994,
on which the pharmacist was specifically named as an authorized user |
[ ]
|
OR
|
A copy of the pharmacist's certification(s)
from the radiopharmacy board(s) approved by the NRC; |
[ ]
|
OR
|
Description of the training and experience
demonstrating that the proposed ANP is qualified by training and experience;
and written certification, signed by a preceptor ANP, that the above
training and experience has been satisfactorily completed and that
the individual has achieved a level of competency sufficient to independently
operate a nuclear pharmacy; |
[ ]
|
[ ] |
AND
|
Description of the recentness of training,
if necessary. |
[ ] |
7. |
Individual(s) Responsible for Radiation
Safety Program and Their Training and Experience |
Identify types, quantities, and proposed
uses of licensed material; |
[ ] |
[ ] |
AND
|
|
|
7.4 |
Authorized User(s) |
A copy of license (NRC or Agreement
State) on which the individual was specifically named as an AU for
the types, quantities, and proposed uses of licensed materials; |
[ ] |
|
Name(s):_________ |
|
|
|
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|
OR
|
|
|
|
|
A copy of the permit maintained by
a licensee of broad scope that identifies the individual as an AU
for the types, quantities, and proposed uses of licensed materials; |
[ ] |
|
|
|
OR
|
|
|
|
|
Description of the training and experience
demonstrating that the proposed AU is qualified by training and experience
to use the requested licensed materials |
[ ] |
|
8. |
Training for Individuals Working or Frequenting
Restricted Areas (Occupationally Exposed and Ancillary Personnel) |
We have developed and will implement
and maintain written procedures for a training program for each group
of workers, including: topics covered; qualifications of the instructors;
method of training; method for assessing the success of the training;
and the frequency of training and refresher training. |
[ ] |
[ ] |
8. |
Training for Personnel Involved in Hazardous Materials
Package Preparation and Transport |
We have developed and will implement
and maintain written procedures for training personnel involved in
hazardous materials package preparation and transport that meet the
requirements in 49 CFR 172.700, 49 CFR 172.702, and
49 CFR 172.704, as applicable. |
[ ] |
[ ] |
8. |
Training for Supervised Individuals Preparing
Radiopharmaceuticals |
The applicant's program for training of supervised in
individuals preparing radiopharmaceuticals will be examined during
inspections, but should not be submitted in the license application.
|
N/A |
9. |
Facilities and Equipment |
Provide a copy of the registration
or license from a State Board of Pharmacy as a pharmacy; or provide
evidence that the facility is operating as a nuclear pharmacy within
a Federal medical institution; |
[ ] |
|
AND
|
Describe the facilities and equipment
to be made available at each location where radioactive material will
be used. A diagram should be submitted showing the applicant's entire
facility and identify activities conducted in all contiguous areas
surrounding the facility. Diagrams should be drawn to a specified
scale, or dimensions should be indicated. |
[ ] |
[ ] |
|
|
|
Include the following information: |
|
|
|
|
• |
Descriptions of the area(s) assigned for the receipt,
storage, preparation, and measurement of radioactive materials and
the location(s) for radioactive waste storage; |
[ ] |
[ ] |
• |
Sufficient detail in the diagram to indicate locations
of shielding, the proximity of radiation sources to unrestricted areas,
and other items related to radiation safety; |
[ ] |
• |
Descriptions of the ventilation systems, including
gloveboxes or fume hoods, with pertinent airflow rates, area differential
pressures, filtration equipment, and monitoring systems for the use
or storage of radioactive materials with the probability of becoming
airborne, such as compounding radioiodine capsules and dispensing
radioiodine solutions; and |
[ ] |
• |
Verification that ventilation systems ensure that
effluents are within 10 CFR 20.1301 and the ALARA constraints
for air emissions established under 10 CFR 20.1101(d). |
[ ] |
10. |
Radiation Safety Program |
The applicant's program for reviewing the content and
implementation of its radiation protection program will be examined
during inspections, but it should not be submitted in the license
application.
|
N/A |
10.1 |
Audit Program |
|
|
|
10. |
Radiation Safety Program |
We will use equipment that meets the
radiation monitoring instrument specifications and implement the model
survey meter calibration program published in Appendix J to NUREG - 1556,
Vol. 13, "Program-Specific Guidance About Radiopharmacy Licenses,"
dated September 1999; |
[ ] |
[ ] |
10.2 |
Survey Instruments |
|
|
|
OR
|
|
|
|
|
We will use equipment that meets the
radiation monitoring instrument specifications published in Appendix
J to NUREG-1556, Vol. 13, "Program-Specific Guidance About Radiopharmacy
Licenses," dated September 1999, and instruments will be calibrated
by persons authorized by the NRC, an Agreement State, or a licensing
State to perform that service; |
[ ] |
|
|
|
OR
|
|
|
|
|
A description of alternative minimum
equipment to be used for radiation monitoring and/or alternative procedures
for the calibration of radiation monitoring equipment. |
[ ] |
[ ] |
10. |
Radiation Safety Program |
We have developed, and will implement
and maintain, written procedures for safely opening packages that
meet the requirements in 10 CFR 20.1906; |
[ ] |
[ ] |
10.3 |
Material Receipt and Accountability |
|
|
|
AND
|
|
|
|
|
We will conduct physical inventories
of sealed sources of licensed material at intervals not to exceed
six months; |
[ ] |
|
|
|
AND
|
|
|
|
|
We have developed, and will implement
and maintain written procedures for licensed material accountability
and control to ensure that: |
[ ] |
|
|
|
• |
License possession limits are not exceeded; |
|
|
|
|
• |
Licensed material in storage is secured from unauthorized
access or removal; |
|
|
|
|
• |
Licensed material not in storage is maintained
under constant surveillance and control; and |
|
|
|
|
• |
Records of receipt, transfer, and disposal of
licensed material are maintained. |
|
|
10. |
Radiation Safety Program |
We have developed and will implement
and maintain written procedures for monitoring occupational dose that
meet the requirements in 10 CFR 20.1501, 10 CFR 20.1502,
10 CFR 20.1201, 10 CFR 20.1202, 10 CFR 20.1203,
10 CFR 20.1204, 10 CFR 20.1207, 10 CFR 20.1208,
and 10 CFR 20.2106, as applicable. |
[ ] |
[ ] |
10.4 |
Occupational Dosimetry |
|
10.
10.5 |
Radiation Safety Program
Public Dose |
The applicant's program to control doses received by
individual members of the public will be examined during inspection,
but it should not be submitted in a license application. |
N/A |
10.
10.6 |
Radiation Safety Program
Safe Use of Radionuclides and Emergency Procedures |
We have developed and will implement
and maintain written procedures for the safe use of radioactive materials
that address: |
[ ] |
[ ] |
• |
Facility and personnel radioactive contamination
minimization, detection, and control; |
• |
Performing molybdenum-99 breakthrough measurements
on all generator elutions used to prepare radioactive drugs for human
medical use; and |
• |
Use of protective clothing and equipment by personnel |
|
|
that meet the requirements in 10 CFR 20.1101,
10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 30.34(g),
and 10 CFR 19.11(a)(3), as applicable. |
[ ] |
[ ] |
10
10.7 |
Radiation Safety Program
Safe Use of Radionuclides and Emergency Procedures |
We have developed and will implement
and maintain written procedures for identifying and responding to
emergencies involving radioactive material, including |
[ ][ ] |
• |
Lost, stolen, or missing licensed material; |
• |
Exposures to personnel and the public in excess
of NRC regulatory limits; |
• |
Releases of licensed materials in effluents and
the sanitary sewer in excess of NRC regulatory limits; |
• |
Excessive radiation levels or radioactive material
concentrations in restricted or unrestricted areas; |
• |
Radioactive spills and contamination; |
• |
Fires, explosions, and other disasters with the
potential for the loss of containment of licensed material; and |
• |
Routine contacts with local fire departments |
that meet the requirements in 10 CFR 20.1101,
10 CFR 20.2201, 20.2202, 20.2203, and 10 CFR 30.50,
as applicable. |
10 |
Radiation Safety Program
|
We have developed, and will implement
and maintain, written procedures for a survey program that specifies
the performance of radiation and contamination level surveys in restricted
and unrestricted areas, personnel contamination monitoring, action
levels, and the frequencies and records maintenance of those surveys
and monitoring that meet the requirements in 10 CFR 30.53,
10 CFR 20.1501, and 10 CFR 20.2103, as applicable. |
[ ] |
[ ] |
10.8 |
Surveys |
|
|
|
10
10.9 |
Radiation Safety Program
Dosage Measurement Systems |
Describe the types of systems (measurement
or combination of measurement and calculation) to be used for the
measurement of alpha-, beta-, and photon-emitting radioactive drugs; |
[ ] |
[ ] |
AND
|
|
|
For each dosage measurement system
used to measure the amount of radioactivity in alpha-, beta-, or photon-emitting
radioactive drugs, state: "We have developed, and will implement and
maintain, a written procedure for the performance of dosage measurement
system checks and tests that meets the requirements in 10 CFR 32.72(c)"; |
[ ] |
[ ] |
AND
|
|
|
If applicable, include a sample calculation
for determining beta-correction factors for dose calibrators with
ionization chambers; |
[ ] |
[ ] |
OR
|
|
|
If applicable, include a means for
ensuring the accuracy of beta-correction factors supplied by the instrument
manufacturer or other entity. |
[ ] |
[ ] |
10
10.10 |
Radiation Safety Program
Transportation |
The applicant's program for transportation
will be examined during inspection, but it should not be submitted
in a license application. |
N/A |
10
10.11 |
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 criteria have been met if the applicant's responses meet
the criteria for the following sections: |
|
[ ] |
• |
Facilities and Equipment; |
[ ] |
|
• |
Radiation Safety Program - Safe Use of Radionuclides
and Emergency Procedures; |
[ ] |
|
• |
Radiation Safety Program - Surveys; |
[ ] |
|
• |
Radiation Safety Program - Leak Testing; and |
[ ] |
|
• |
Waste Management. |
[ ] |
|
10
10.12 |
Radiation Safety Program
Radioactive Drug Labeling for Distribution |
Describe all labels, indicating the
colors to be used, that will accompany the products and describe where
each label is placed (e.g., on the "transport radiation shield" or
the container used to hold the radioactive drug); and agree to affix
the required labels to all "transport radiation shields" and each
container used to hold the radioactive drugs. |
[ ] |
|
|
|
|
|
10
10.13 |
Radiation Safety Program
Radioactive Drug Shielding for Distribution |
For each radioactive drug to be distributed
(except for products intended for redistribution without manipulation
and in the manufacturer's original shipping package): |
|
|
• |
Provide the radionuclide and the maximum activity
for each type of container (e.g., vial, syringe); |
[ ] |
|
|
|
• |
Describe the type and thickness of the "transport
radiation shield" provided for each type of container; and |
[ ] |
|
|
|
• |
Indicate the maximum radiation level to be expected
at the surface of each "transport radiation shield" when the radioactive
drug container is filled with the maximum activity. |
[ ] |
|
10
10.14 |
Radiation Safety Program
Leak Tests |
We have developed, and will implement
and maintain, written procedures for leak testing that meet the requirements
in 10 CFR 30.53, 10 CFR 20.1501, and 10 CFR 20.2103 |
[ ] |
[ ] |
11. |
Waste Management Pharmacy-Generated Radioactive
Wastes |
We have developed, and will implement
and maintain, written procedures for waste management that meet the
requirements in 10 CFR 20.2001(a), 10 CFR 20.2003, and 10 CFR
20.2006, 10 CFR 20.2108, 10 CFR 30.51, as applicable. |
[ ] |
[ ] |
11 |
Waste Management Returned Wastes from Customers |
We have developed and will implement
and maintain written procedures for customer return of pharmacy supplied
syringes and vials and their contents, to specify that: |
[ ] |
[ ] |
|
|
• |
only pharmacy supplied syringes and vials and
their contents may be returned to the pharmacy; |
|
|
|
• |
instructions will be provided to radiopharmacy
customers for the proper preparation and packaging of the radioactive
waste for return to the radiopharmacy; and |
|
|
• |
instructions will be provided to pharmacy staff
for the pick-up, receipt and disposal of the returned radioactive
waste |
|
|
that meet the requirements
in 10 CFR 20.2001(a), 10 CFR 30.33, and 10 CFR 71.5,
as applicable. |
|
|
Appendix E: Sample License
[ Prev | Next | Top
of file ]
A sample license appears on the following pages.
Form 374 - Sample Materials License
[ Prev | Next | Top
of file ]
Appendix F: 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 transferring
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. |
Appendix G: Model Formats for Documenting
Training and Experience for Individuals Responsible for Radiation Protection
Program
[ Prev | Next | Top
of file ]
Figure G-1 Authorized User or Radiation Safety Officer Training
in Basic Radioisotope Handling Techniques
Name (Last, First, Initial) |
Location of Training |
Dates |
Title |
Total Hours |
Breakdown of Course in Clock Hours |
RPP |
BH |
IR |
INST |
REG |
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TOTALS |
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RPP - Radiation Protection Principles BH - Biological Hazards
IR - Ionizing Radiation Units & Characteristics INST - Radiation
detection instrumentation
REG - NRC Regulations and Standards
Figure G-2 Authorized User and Radiation Safety Officer Experience
in Handling Radioisotopes
(Actual use of radioisotopes under the supervision of an authorized
user or Radiation Safety Officer, respectively)
Name (Last, First, Initial) |
Isotope(s) used |
Maximum amount used at any one time |
Location of use |
Purpose of use* |
Total Hours of Experience |
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*Purpose of Use
1. Shipping, receiving, and performing related radiation surveys
2 Using and performing checks for proper operation of dose calibrators,
survey meters, and other instruments used to measure photon- and high
energy beta- emitting radionuclides
3 Using and performing checks for proper operation of instruments used
to measure alpha- and low energy beta- emitting radionuclides
4 Calculating, assaying, and safely preparing radioactive materials
5 Use of procedures to prevent or minimize contamination and/or use of
proper decontamination procedures
Figure G-3 Authorized Nuclear Pharmacist Training in Basic Radioisotope
Handling Techniques
Name (Last, First, Initial) |
Location of Training |
Dates |
Title |
Total Hours |
Breakdown of Course in Clock Hours |
RP&I |
RP |
MATH |
RB |
CHEM |
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TOTALS |
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Signature of Preceptor Authorized Nuclear Pharmacist:
"I certify that the above described training/experience has been
satisfactorily completed and that the individual has achieved a
level of competency sufficient to independently operate a nuclear
pharmacy."
|
Date |
RP&I - Radiation Protection Principles RP - Biological Hazards
RB - Ionizing Radiation Units & Characteristics Math - Radiation
detection instrumentation
Chem - NRC Regulations and Standards
Figure G-4 Authorized Nuclear Pharmacist Experience in Handling
Radioisotopes
(Actual use of radioisotopes under the supervision of an authorized
user or Radiation Safety Officer, respectively)
Name (Last, First, Initial) |
Isotope(s) used |
Maximum amount used at any one time |
Location of use |
Purpose of use* |
Total Hours of Experience |
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Signature of Preceptor Authorized Nuclear Pharmacist:
"I certify that the above described training/experience has been
satisfactorily completed and that the individual has achieved a
level of competency sufficient to independently operate a nuclear
pharmacy."
|
Date |
*Purpose of Use
1. Shipping, receiving, and performing related radiation surveys
2 Using and performing checks for proper operation of dose calibrators,
survey meters, and other instruments used to measure photon- and high
energy beta- emitting radionuclides
3 Using and performing checks for proper operation of instruments used
to measure alpha- and low energy beta- emitting radionuclides
4 Calculating, assaying, and safely preparing dosages for patients or
human research subjects
5 Use of administrative controls to avoid mistakes in the administration
of byproduct material
6. Use of procedures to prevent or minimize contamination and/or use
of proper decontamination procedures
Appendix H: Typical Duties and Responsibilities
[ Prev | Next | Top
of file ]
The RSO's duties and responsibilities include ensuring radiological safety
and compliance with NRC and DOT regulations, and with the conditions of
the license (see Figure H.1). Typically, these duties and responsibilities
include ensuring that:
- General surveillance is provided over all activities involving radioactive
material, including routine monitoring, special surveys, and responding
to events.
- Incidents are responded to, investigated, and cause(s) and appropriate
corrective action(s) are identified, and timely corrective action(s)
are taken;
- Proper authorities are notified of incidents such as damage, fire,
or theft;
- Corrective actions are developed, implemented, and documented when
violations of regulations or license conditions or program weaknesses
are identified;
- Immediate termination of all activities following any unsafe condition
or activity that is found to be a threat to public health and safety;
- He or she is the primary source of radiation protection information
for personnel at all levels of responsibility;
- All radiation workers are properly trained;
- Procedures for the safe use of radioactive materials are developed
and implemented;
- The licensees procedures and controls, based upon sound radiation
protection principles, are periodically reviewed to ensure that occupational
doses and doses to members of the public are as low as is reasonably
achievable (ALARA). Documentation is maintained to demonstrate, by measurement
or calculation, that the total effective dose equivalent to the individual
member of the public likely to receive the highest dose from the licensed
operation does not exceed the annual limit;
- Prospective evaluations are performed of occupational exposures, and
those individuals likely to receive, in one year, a radiation dose in
excess of 10% of the allowable limits are provided personnel monitoring
devices;
- When necessary, personnel monitoring devices are used and exchanged
at the proper intervals, and records of the results of such monitoring
are maintained;
- The performance of fume hoods and gloveboxes used for volatile radioactive
material work are monitored for proper operation;
- The receipt, opening, and delivery of all packages of radioactive
material arriving at the nuclear pharmacy are overseen and coordinated;
- An inventory of all radioactive materials is maintained and the types
and quantities of radionuclides at the facility are limited to the forms
and amounts authorized by the license;
- Sealed sources are leak-tested at required intervals;
- There is effective management of the radioactive waste program, including
effluent monitoring;
- Packaging and transport of radioactive material is in accordance with
all applicable DOT requirements;
- An up-to-date license is maintained and amendment and renewal requests
and notifications of new ANPs are submitted in a timely manner;
- Radiation safety program audits are performed at least annually and
documented;
- He or she acts as liaison to the NRC; and
All required records are properly maintained.
Figure H.1 Typical Duties and Responsibilities
of the RSO.
Appendix I: Suggested Commercial Radiopharmacy
Audit Checklist
[ Prev | Next | Top
of file ]
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 the licensee's activities and activities which have not
occurred since the last audit need not be reviewed at the next audit.
Date of This Audit |
__________________ |
Date of Last Audit |
__________________ |
Next Audit Date |
_______________________________________________________________ |
Auditor |
__________________ |
Date |
_________________________________________ |
|
(Signature) |
|
(Signature) |
Management Review |
Date |
__________________ |
Audit History
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of file ]
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
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]
A. |
If the mailing address or places of use changed, was
the license amended? [10 CFR 30.34] |
B. |
If ownership changed or bankruptcy filed, was NRC prior
consent obtained or was NRC notified? [10 CFR 30.34] |
C. |
Authorized Nuclear Pharmacists |
1. |
New ANP since last audit? If so, does new ANP meet NRC training
requirements? [10 CFR 32.72, 10 CFR 35.2, 10 CFR 35.980(b), 10
CFR 35.972] |
2. |
If an individual began work as an ANP, was NRC notified within 30
days or was license amended? [10 CFR 32.72] |
D. |
Radiation Safety Officer |
1. |
New RSO since last audit? If so, does new RSO meet NRC training
requirements |
2. |
If the RSO was changed, was license amended? |
3. |
Is RSO fulfilling his/her duties? |
4. |
To whom does RSO report? |
E. |
Authorized Users |
1. |
New AU since last audit? If so, does new AU meet NRC training requirements? |
2. |
If an AU was added, was license amended? |
F. |
If the designated contact person for NRC changed, was
NRC notified? |
G. |
Type and quantity of byproduct material |
1. |
Does the license authorize all of the NRC regulated radionuclides
possessed? |
2. |
Is actual possession of those radionuclides within the limits on
the license? |
Facilities
A. |
Are facilities as described in NRC license application? |
B. |
If facilities have changed, has NRC license been amended |
Equipment and Instrumentation
A. |
Sufficient numbers of portable and fixed radiation monitors? |
B. |
Do survey meters meet the NRC's criteria? [10 CFR 20.1501] |
C. |
Are calibration records maintained? [10 CFR 20.2103(a)] |
D. |
Are there sufficient lead shields (L-block, etc.) for
work with radionuclides? |
E. |
Are generators housed in separate room and/or properly
shielded to keep doses ALARA? |
F. |
Are procedures established for identifying, evaluating
and reporting safety component defects? [10 CFR 21.21] |
G. |
Dose Calibrators for Photon-emitters [10 CFR 32.72(c)] |
1. |
Constancy, at least once each day prior to assay of patient dosages
(±10%)? |
2. |
Linearity, at installation and at required frequency (±10%)? |
3. |
Geometry dependence, at installation (±10%)? |
4. |
Accuracy, at installation and at required frequency (±10%)? |
5 |
After repair, adjustment, or relocation of the dose calibrator,
were appropriate tests above repeated? |
H. |
Dose Measurement Systems for Beta- and Alpha-emitters
[10 CFR 32.72(c)] |
1. |
Calibrated for each isotope used, with that isotope? |
2. |
Constancy, at least once each day prior to assay of patient dosages
(±10%)? |
3. |
Geometry dependence, at installation (±10%)? |
4. |
Accuracy, at installation and at required frequency (±10%)? |
5. |
Linearity, at installation and at required frequency (±10%)? |
6. |
After repair, adjustment, or relocation of the dose calibrator,
were appropriate tests above repeated? |
Area Surveys and Contamination Control [10 CFR 20.1501]
A. |
Are area surveys being performed at applicable locations and required
frequencies? Records maintained? [10 CFR 20.2103] |
B. |
Are removable contamination surveys being performed at applicable
locations and required frequencies? Records maintained? [10 CFR 20.2103] |
C. |
Is appropriate corrective action taken and documented when excess
radiation or contamination levels are detected? |
Leak Tests
A. |
Was each sealed source leak tested every six 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? |
Sealed Source Inventory
A. |
Is a record kept showing the receipt of each sealed source? [10
CFR 30.51(a)(1)] |
B. |
Are all sealed sources physically inventoried every six months? |
C. |
Are records of inventory results with appropriate information maintained? |
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. |
Were other workers trained as needed (e.g., radiopharmacy technicians,
authorized users, couriers/drivers, ancillary personnel)? [10 CFR
30.33] Records maintained? |
C. |
Are workers knowledgeable of applicable 10 CFR Part 20 radiation
protection procedures, emergency response procedures and license conditions? |
D. |
HAZMAT training provided, if required? [49 CFR 172.700, 49 CFR 172.701,
49 CFR 172.702, 49 CFR 172.703, 49 CFR 172.704] |
Material Use Control and Transfer
A. |
Are restricted and unrestricted areas delineated? |
B. |
Are radioactive materials that are stored in a controlled or unrestricted
area secured from unauthorized access or removal? [10 CFR 20.1801] |
C. |
Are radioactive materials that are in a controlled or unrestricted
area and not in storage controlled and maintained under constant surveillance?
[10 CFR 20.1802] |
D. |
Procedures for receiving and opening packages? [10 CFR 20.1906] |
E. |
Transfer of byproduct material only to authorized recipients?
[10 CFR 30.41, 10 CFR 32.71, 10 CFR 32.72, 10 CFR 32.74] |
F. |
Records of receipt and transfer? [10 CFR 30.51] |
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 which 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 at appropriate frequency? |
3. |
Are dosimetry reports reviewed by the RSO when they
are received? |
4. |
Are the records on NRC Forms or equivalent? [10 CFR
20.2104(d), 10 CFR 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. |
Monitoring for internal dose if individuals likely to
receive >10% of ALI? |
G. |
Are workers notified annually of their exposures? |
H. |
Are records of exposures, surveys, monitoring, and evaluations
maintained [10 CFR 20.2102, 10 CFR 20.2103, 0 CFR 20.2106 |
Waste Management
A. |
Waste storage areas |
1. |
Is storage area properly posted? [10 CFR 20.1902] |
2. |
Are containers properly labeled? [10 CFR 20.1904] |
B. |
Decay-in-Storage |
1. |
Do radionuclides being stored all have half-lives less
than 120 days? |
2. |
Are radionuclides being segregated for storage according
to half-life? |
3. |
Each radionuclide in radioactive waste stored for a
minimum of 10 half-lives? |
4. |
Before waste is disposed of: |
a. |
Survey performed at the container surface with an appropriate survey
instrument set on its most sensitive scale with no interposed shielding
to determine that its radioactivity cannot be distinguished from background? |
b. |
All radiation labels removed or obliterated, as appropriate? |
5. |
Record Keeping? |
|
C. |
Disposal by release into sanitary sewerage. |
1. |
Is licensed material readily soluble (or readily dispersible
biologically material) in water? [IN 94-07] Solubility Criteria for
Liquid Effluent Releases to Sanitary Sewerage Under the Revised 10
CFR Part 20. [10 CFR 20.2003] |
2. |
Quantity of licensed material that the licensee releases
into the sewer each month averaged over the monthly volume of water
released into the sewer does not exceed the concentration specified
in 10 CFR Part 20, Appendix B, Table 3? |
3. |
If more than one radioisotope is released, the sum of
the ratios of the average monthly discharge of a radioisotope to the
corresponding limit in 10 CFR Part 20, Appendix B, Table 3 does not
exceed unity? |
4. |
Total quantity of licensed material released into the
sanitary sewerage system in a year does not exceed the limits specified
in 10 CFR 20.2003(a)(4)? |
D. |
Transfer to Authorized Recipient |
|
1. |
Waste being transferred to a person specifically authorized
to receive it? [10 CFR 20.2001] |
|
2. |
Waste properly manifested? [10 CFR 20.2006] |
Receipt of Radioactive Waste from Customers
A. |
Waste returned consists only of items that contained radioactive
materials that the radiopharmacy supplied (e.g. pharmacy supplied
syringes, vials)? |
B. |
Waste package checked for removable contamination upon receipt? |
Effluents
A. |
Effluents from materials being maintained As Low As Reasonably Achievable
(ALARA)? |
B. |
Fume hoods checked to confirm an adequate airflow? |
C. |
Effluent monitored to determine activity being released? |
D. |
Filters being maintained according to the manufacturer's instructions
and pharmacy procedures? |
Public Dose
A. |
Public access to radioactive materials and exposure to effluents
controlled in a manner to keep doses below 1 mSv (100 mrem) in a year?
[10 CFR 20.1301(a)(1)] |
B. |
Air emissions maintained below constraint limit of 0.1 mSv (10 Millirem)
in a year? [10 CFR 20.1101(d)] |
C. |
Survey or prospective evaluation 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? |
D. |
Unrestricted area radiation levels exceed 0.02 mSv (2 mrem) in any
one hour? [10 CFR 20.1301(a)(2)] |
E. |
Records maintained? [10 CFR 20.2103, 10 CFR 20.2107] |
Use and Emergency Procedures
A. |
Procedures for safe use of radioactive materials and
emergency procedures developed and implemented? |
B. |
Do the procedures contain the required elements? |
C. |
Radioactive materials being handled safely? |
D. |
Staff wearing protective clothing and personnel monitors
as appropriate? |
E. |
Assistance coordinated with outside agencies for emergency
response (e.g., fire department)? |
F. |
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, 10
CFR 20.2202, 10 CFR 20.2203] |
Transportation
A |
DOT-7A or other authorized packages used? [49 CFR 173.415, 49 CFR
173.416(b)] |
B. |
Package performance test records on file? |
C. |
Package has two labels (ex. Yellow-II) with TI, Nuclide, Activity,
and Hazard Class? [49 CFR 172.403, 49 CFR 173.441] |
D. |
Package properly marked? [49 CFR 172.301, 49 CFR 172.304, 49 CFR
172.310, 49 CFR 172.324] |
E. |
Package closed and sealed during transport? [49 CFR 173.475(f)] |
F. |
Shipping papers prepared and used? [49 CFR 172.200(a)] |
G. |
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, Emergency Response
Information, and Cargo Aircraft Only (if applicable)} [49 CFR 172.200,
49 CFR 172.201, 49 CFR 172.202, 49 CFR 172.203, 49 CFR 172.204,
49 CFR 172.604] |
H. |
Shipping papers within drivers reach and readily accessible during
transport? [49 CFR 177.817(e)]. |
I. |
Package secured against movement? [49 CFR 177.834] |
J. |
Any incidents reported to DOT? [49 CFR 171.15, 49 CFR 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),
10 CFR 20.1502(a)] |
Notification and Reports
A. |
Was any radioactive material lost or stolen? Were reports made?
[10 CFR 20.2201, 10 CFR 30.50] |
B. |
Did any reportable incidents occur? Were reports made? [10 CFR 20.2202,
10 CFR 30.50] |
C. |
Did any overexposures and high radiation levels occur? Reported?
[10 CFR 20.2203, 10 CFR 30.50] |
D. |
Were any contaminated packages or packages with surface radiation
levels exceeding 200 mrem received? Reported to NRC? |
E. |
If any events (as described in items A through D above) did occur,
what was root cause? Were appropriate notifications made and corrective
actions taken? |
F. |
Is the management/RSO aware of telephone number for NRC Emergency
Operations Center? [(301) 816-51 |
Posting and Labeling
A. |
NRC-Form 3 "Notice to Workers" posted? [10 CFR 19.11] |
B |
NRC regulations, license documents posted or a notice posted? [10
CFR 19.11, 10 CFR 21.6; Section 206 of Energy Reorganization
Act of 1974] |
C. |
Other posting and labeling? [10 CFR 20.1902, 10 CFR 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 |
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 by the facility. 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 J: Radiation Monitoring Instrument
Specifications and Model Survey Instrument Calibration Program
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]
The specifications in Table J.1 will help applicants and licensees choose
the proper radiation detection equipment for monitoring the radiological
conditions at their facility(ies).
Table J.1 Typical Survey Instruments1 Instruments
used to measure radiological conditions at licensed facilities.
Portable Instruments Used for Contamination and Ambient
Radiation Surveys |
Detectors |
Radiation |
Energy Range |
Efficiency |
Exposure Rate Meters |
Gamma, X-ray |
mR-R |
N/A |
Count Rate Meters |
|
|
|
GM |
Alpha |
All energies (dependent on window thickness) |
Moderate |
|
Beta |
All energies (dependent on window thickness) |
Moderate |
|
Gamma |
All energies |
<1% |
NaI Scintillator |
Gamma |
All energies (dependent on crystal thickness |
Moderate |
Plastic Scintillator |
Beta |
C-14 or higher (dependent on window thickness) |
Moderate |
Stationary Instruments Used to Measure Wipe, Bioassay,
and Effluent Samples |
Detectors |
Radiation |
Energy Range |
Efficiency |
LSC* |
Alpha |
All energies |
High |
|
Beta |
All energies |
High |
|
Gamma |
|
Moderate |
Gamma Counter (NaI)* |
Gamma |
All energies |
High |
Gas Proportional |
Alpha |
All energies |
High |
|
Beta |
All energies |
Moderate |
|
Gamma |
All energies |
<1% |
1 Table from The Health Physics & Radiological
Health Handbook, Revised Edition, Edited by Bernard Shleien, 1992
(except from * items) |
Model Instrument Calibration Program
Training
Before allowing an individual to perform survey instrument calibrations,
the RSO will ensure that he or she has sufficient training and experience
to perform independent survey instrument calibrations.
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 using instruments;
- Mathematics and calculations basic to using and measuring radioactivity;
and
- Biological effects of radiation.
Appropriate on-the-job-training consists of the following:
- Observing authorized personnel performing survey instrument calibration;
and
- Conducting survey meter calibrations under the supervision and in
the physical presence of an individual authorized to perform calibrations.
Facilities and Equipment for Calibration of Dose Rate or Exposure
Rate Instruments
- 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;
and
- 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) used for calibrating survey instruments
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);
- Approximate the same energy and type of radiation as the environment
in which the calibrated device will be employed; and
- For dose rate and exposure rate instruments, the source should be
strong enough to give an exposure rate of at least about 7.7 x 10-6
coulombs/kilogram/hour (30 mR/hr) at 100 cm
[e.g., 3.1 gigabecquerels (85 mCi) of cesium-137 or 7.8 x 102
megabecquerels (21 mCi) of cobalt-60.
The three kinds of scales frequently used on dose or dose rate survey
meters are calibrated as follows(2):
- Linear readout instruments with a single calibration control for all
scales shall be adjusted at the point recommended by the manufacturer
or at a point within the normal range of use. Instruments with calibration
controls for each scale shall be adjusted on each scale. After adjustment,
the response of the instrument shall be checked at approximately 20%
and 80% of full scale. The instrument's readings shall be within ± 15%
of the conventionally true values for the lower point and ± 10% for
the upper point;
- Logarithmic readout instruments, which commonly have a single readout
scale spanning several decades, normally have two or more adjustments.
The instrument shall be adjusted for each scale according to site specifications
or the manufacturer's specifications. After adjustment, calibration
shall be checked at a minimum of one point on each decade. Instrument
readings shall have a maximum deviation from the conventionally true
value of no more than 10% of the full decade value;
- Meters with a digital display device shall be calibrated the same
as meters with a linear scale;
- Readings above 2.58 X 10-4 coulomb/kilogram/hour (1 R/hr)
need not be calibrated, but such scales should be checked for operation
and response to radiation; and
- The inverse square and radioactive decay law should be used to correct
changes in exposure rate due to changes in distance or source decay.
Surface Contamination Measurement Instruments2
- Survey meters' efficiency must be determined by using radiation sources
with similar energies and types of radiation that the survey instrument
will be used to measure.
- If each scale has a calibration potentiometer, the reading shall be
adjusted to read the conventionally true value at approximately 80%
of full scale, and the reading at approximately 20% of full scale shall
be observed. If only one calibration potentiometer is available, the
reading shall be adjusted at mid-scale on one of the scales, and readings
on the other scales shall be observed. Readings shall be within 20%
of the conventionally true value.
Model Procedures for Calibrating, Liquid Scintillation Counters,
Gamma Counters, Gas Flow Proportional Counters, and Multichannel Analyzers
A radioactive sealed source used for calibrating instruments will do
the following:
- Approximate the geometry of the samples to be analyzed;
- Have its apparent source activity traceable by documented measurements
to a standard certified to be within ± 5% accuracy by National Institutes
of Standards and Technology (NIST); and
- Approximate the same energy and type of radiation as the samples that
the calibrated device will be used to measure.
Calibration
- Calibration must produce readings within ± 20% of the actual values
over the range of the instrument.
- Calibration of liquid scintillation counters will include quench correction.
Calibration Records
Calibration reports, for all survey instruments, will indicate the procedure
used and the data obtained. The description of the calibration will include:
- The owner or user of the instrument;
- A description of the instrument, including 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 or activity on a specified date;
- For each calibration point, the calculated exposure rate or count
rate, the indicated exposure rate or count rate, the deduced correction
factor (the calculated exposure rate or count rate divided by the indicated
exposure rate or count rate), and the scale selected 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 or count rate from a check source, if used; and
- The name of the person who performed the calibration and the date
it was performed.
The following information will be attached to the instrument as a calibration
sticker or tag:
- For exposure rate meters, the source isotope used to calibrate the
instrument (with correction factors) for each scale;
- The efficiency
, of the instrument, for each isotope
the instrument will be used to measure (if efficiency is not calculated
before each use);
- 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; and
- The apparent exposure rate or count rate from the check source, if
used.
Air Sampler Calibration
In order to assess accurately the air concentration of radioactive materials
in a given location, the volume of air sampled and the quantity of contaminant
in the sample must be determined. Accurate determination of the volume
of air sampled requires standard, reproducible, and periodic calibration
of the air metering devices that are used with air sampling instruments.
The publication entitled "Air Sampling Instruments" found in the 7th
Edition, American Conference of Governmental Industrial Hygienists, 1989,
provides guidance on total air sample volume calibration methods acceptable
to NRC staff, as supplemented below.
Frequency of Calibration
- A licensee committed to a routine or emergency air sampling program
should perform an acceptable calibration of all airflow or volume metering
devices at least annually (see Regulatory Guide 8.25).
- Special calibrations should be performed at any time there is reason
to believe that the operating characteristics of a metering device have
been changed, by repair or alteration, or whenever system performance
is observed to have changed significantly.
- Routine instrument maintenance should be performed as recommended
by the manufacturer.
- Primary or secondary standard instruments used to calibrate air sampling
instruments should be inspected frequently for consistency of performance.
Error Limit For Measurement of Air Sample Volume
Most methods of calibrating airflow or air volume metering devices require
direct comparison to a primary or secondary standard instrument, to determine
a calibration curve or a correction factor. An example of a primary standard
is a spirometer that measures total air volume directly with high precision
by liquid displacement. An example of a secondary standard is a wet-test
meter that has been calibrated against a primary standard. Primary standards
are usually accurate to within ± 1% and secondary standards to within
± 2%.
The following are significant errors associated with determining the
total air volume sampled:
EC: |
The error in determining the calibration factor. (An acceptable
estimate is the percentage error associated with the standard instrument
used in the calibration.)(3) |
ES: |
Intrinsic error in reading the meter scale. (An acceptable estimate
is the percentage equivalent of one-half of the smallest scale division,
compared to the scale reading.) |
Et: |
The percentage error in measurement of sampling time that should
be kept within 1%. |
EV: |
The most probable value of the cumulative percentage
error in the determination of the total air volume sampled can be
calculated from the following equation, provided there are no additional
significant sources of errors: |
EV = [ES2 + EC2
+ Et2]1/2
The most probable value of the cumulative error EV, in the
determination of total volume, should be less than 20%.
A sample calculation of the most probable value of the cumulative error
in total volume measured is as follows: If accuracies of the scale reading,
the calibration factor, and sample time are ± 4, 2, and 1%, respectively,
and there are no other significant sources of error, the cumulative error
would be:
EV = [42 + 22 + 12]1/2
= 4.58% or approx. 5%
If there are significant differences in pressure and temperature between
the calibration site and the sampling site, appropriate corrections should
be made using the ideal gas laws provided below:
Vs = V1 * (P1/760) * (273/T1)
where Vs = volume at standard conditions (760 mm & 0C)
V1 = volume measured at conditions P1 and T1
T1 = temperature of V1 in K
P1 = pressure of V1 in mm Hg
Documentation of Calibration of Air Metering Devices
The licensee should maintain records of all routine and special calibrations
of airflow or volume metering devices, including the primary or secondary
standard used, method employed, and estimates of accuracy of the calibrated
metering devices. All instruments should be clearly labeled as to the
date and results of the most recent calibration and should include the
appropriate correction factors to be used.
References: See the Notice of Availability on the inside
front cover of this report to obtain a copy of:
|
1. |
Draft Regulatory Guide 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; |
2. |
Regulatory Guide 8.25, Revision 1, "Air Sampling in the Workplace,"
dated June 1992; and |
3. |
NUREG-1400, "Air Sampling in the Workplace," dated September 1993. |
Additional References:
|
4. |
The Health Physics & Radiological Health Handbook, Revised Edition,
Edited by Bernard Shleien, dated 1992; |
5. |
ANSI N323A-1997, "Radiation Protection Instrumentation Test and
Calibration." Copies may be obtained from the American National Standards
Institute, 1430 Broadway, New York, NY 10018 or ordered electronically
at the following address: <www.ansi.org>; and |
6. |
"Air Sampling Instruments," American Conference of Governmental
Industrial Hygienists, 7th Edition, dated 1989. |
Appendix K: Public Dose
[ Prev | Next | Top
of file ]
This Appendix describes different methods for determining radiation doses
to members of the public.
Licensees must ensure that:
- The radiation doses received by individual members of the public do
not exceed 1 millisievert (mSv) [100 millirem (mrem)] in one calendar
year resulting from the licensee's possession and/or use of licensed
materials. (10 CFR 20.1301);
- Air emissions of radioactive material to the environment will not
result in exposures to individual members of the public in excess of
0.1 mSv (10 mrem) (TEDE) in one year from those emissions. (10 CFR 20.1101);
and
- The radiation dose in unrestricted areas does not exceed 0.02 mSv
(2 mrem) in any one hour. (10 CFR 20.1301)
Members of the public include persons who live, work, or may be
near locations where byproduct material is used or stored and employees
whose assigned duties do not include the use of byproduct material
but may who work in the vicinity where such materials are used or
stored. |
Doses to Members of the Public http://www.ansi.org
|
INCLUDES doses from: |
DOES NOT INCLUDE doses from: |
|
• |
Radiation and/or radioactive material released by a licensee; |
• |
Sanitary sewerage discharges from licensees; |
• |
Sources of radiation under the control of a licensee; and |
• |
Natural background radiation; |
• |
Air effluents from sources of licensed radioactive materials. |
• |
Medical administration of radioactive material; or |
|
• |
Voluntary participation in medical research. |
Typical unrestricted areas may include offices, shops, areas outside
buildings, property, and 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 |
The licensee may show compliance with the annual dose and constraint
limits for individual members of the public by:
- Demonstrating by measurement or calculation that the TEDE to the individual
like to receive the highest dose at the boundary of the unrestricted
area does not exceed 1 mSv (100 mrem) from all exposure pathways, and
does not exceed 0.1 mSv (10 mrem) from air emissions.; and
- Demonstrating that the annual average concentration of radioactive
material released in gaseous and liquid effluents at the boundary of
the unrestricted area does not exceed the values specified in Table
2 of Appendix B to Part 20 (20% of the values for gaseous effluents);
and if an individual were continuously present in an unrestricted area
the dose from external sources would not exceed 0.02 mSv (2 mrem) in
an hour and 0.5 mSv (0.05 rem) in a year.
In order to perform a dose assessment, the licensee should identify all
potential sources of external and internal radiation exposure to members
of the public and all locations of use, transport and storage of radioactive
material at their facility. The licensee must then take radiation measurements
or perform calculations to demonstrate compliance.
Measurements
The licensee may use measurements to demonstrate that the TEDE to the
individual likely to receive the highest dose at the boundary of the unrestricted
area does not exceed 1 mSv (100 mrem) and does not exceed 0.1 mSv
(10 mrem) from air emissions. These measurements may include:
- Dose rate surveys for radiation exposures from external radiation
sources; and
- Measurements of radionuclides in air and water effluent.
The method used to measure dose will depend upon the nature of the radiation
source. If the source of radiation is constant, it may be adequate to
measure the dose rate and integrate it over time. If the source of radiation
differs or changes over time, it may be necessary to perform continuous
measurements.
Radioactivity releases may be determined by effluent monitoring or by
effluent sampling and analysis. At radiopharmcies, airborne effluents
are discharged when potentially volatile materials are used, such as during
iodine capsule preparation, but the discharge itself is usually not continuous
since volatile materials are used periodically rather than continuously.
Liquid effluents may be discharged continuously or may be stored and subsequently
discharged on a batch basis. For each type of source and for each route
of potential exposure, consider the location of measurement points, whether
continuous or periodic monitoring is required, the frequency of sampling
and measurement, and any additional information. For discharges of airborne
radionuclides, for example, it may be necessary to obtain information
on the efficiency of filters and the air flow rate of the discharge system,
as well as meteorological data and the distance to the nearest individual
member of the public.
Calculation Method
Using a calculation method, the licensee must determine the highest dose
an individual is likely to receive at the boundary of the unrestricted
area. The licensee must take into account the individual's exposure from
external sources and the concentration of radionuclides in gaseous and
liquid releases. In practice, the licensee may wish to make conservative
assumptions to simplify the dose calculation.
The public dose limit applies to the individual who is likely to receive
the highest dose from licensed operations, therefore, the dose calculations
must consider the location with the potential for the highest internal
and external exposures. This calculation should assume that the individual
was continuously present 24 hours a day, 365 days a year, or an occupancy
factor of 1 (see Table K.1). If the result of the calculation using an
occupancy factor of 1 demonstrates that the public dose and constraint
limits are not exceeded, then there is no need for further evaluation.
If the calculation demonstrates that either the public dose or constraint
limit is exceeded with an occupancy factor of 1, then more realistic assumptions
of the individual's occupancy at the points of highest internal and external
exposures must be made. The licensee may use the occupancy factors in
Table K.1 or may calculate a specific occupancy factor by determining
the likely fraction of time that the individual is present.
Table K.1 Standard Occupancy Factors
Occupancy Factor |
Description |
1 |
Work areas such as offices, laboratories, shops, and occupied space
in nearby buildings or outdoor areas |
1/4 |
Corridors, lounges, elevators using operators, unattended parking
lots |
1/16 |
Waiting rooms, rest rooms, stairways, unattended elevators, janitor's
closets, outside areas used only for pedestrians or vehicular traff |
Figure K.1 Calculating
Public Dose. Steps to calculate the annual dose to an
individual member of the public.
Records
The licensee must maintain records to demonstrate compliance with the
dose limit for individual members of the public, until the Commission
terminates the license. In general, survey and monitoring records of ambient
radiation and effluent radioactivity should be adequate.
Records demonstrating the dose to an individual member of the public
should identify the instruments used in the survey, the name of the surveyor,
the date of the survey, the location of the survey(s), including a description
or drawing of the area surveyed, survey results, and, if applicable, the
occupancy factors used and justification for their use. In addition, records
demonstrating the dose to an individual member of the public that involve
effluent sampling analysis should include information on concentrations
of specific radionuclides, minimum detectable activity of the system and
the estimated uncertainty of measurements.
Appendix L: Model Leak Test Program
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Training
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Before allowing an individual to perform leak testing, the licensee must
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 using instruments;
- Mathematics and calculations basic using and measuring radioactivity;
and
- Biological effects of radiation.
Appropriate on-the-job-training consists of:
- Observing authorized personnel collecting and analyzing leak test
samples; and
- 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
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- To ensure achieving the required sensitivity of measurements, leak
tests will be analyzed in a low-background area.
- Use a calibrated and operable survey instrument to check leak test
samples for gross contamination before they are analyzed.
- Analyze the leak test sample using an instrument that is appropriate
for the type of radiation to be measured (e.g., NaI(Tl) well counter
system for gamma-emitters, liquid scintillation for beta-emitters, gas-flow
proportional counters for alpha-emitters).
- If the sensitivity of the counting system is unknown, the minimum
detectable activity (MDA) needs to be determined. The MDA may be determined
using the following formula:
where: MDA = minimum detectable activity in disintegrations per minute
(dpm)
bkg = background count rate in counts per minute (cpm)
t = background counting time in minutes
E = detector efficiency in counts per disintegration
For example:
where: bkg = 200 cpm
E = 10%, or 0.1
t = 2 minutes
MDA = |
3 + 4.65(200 cpm/2 minutes)½ |
|
(0.1) |
= 495 dpm
Frequency for Conducting Leak Tests of Sealed Sources
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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
sealed source 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
microcuries) of the radionuclide.
- Using the selected instrument, count and record background count rate.
- Check the instrument's counting efficiency using a 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 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
mCi).
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 (10 CFR 20.2103(a)). 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 M: Transportation DOT Regulations
Applicable to Radiopharmacy Shipments
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The major areas in the DOT regulations most relevant to commercial radiopharmacies
for the transportation of radioactive material are:
- Hazardous Materials Table, 49 CFR 172.101, App. A, list of hazardous
substances and reportable quantities (RQ), Table 2: Radionuclides.
For the majority of packages shipped by radiopharmacies to their customers,
the proper shipping name to use will be "Radioactive Material, N.O.S."
Other shipments, involving primarily small quantities of radioactive material,
and especially return shipments by customers, will likely be excepted
packages of limited quantity. The DOT requirements for those shipments
can be found in 49 CFR 173.421 and 173.422.
Likewise, for the majority of packages shipped by radiopharmacies, it
will not be necessary to identify the radioactive material as a Hazardous
Substance in accordance with Table 2 of 49 CFR 172.101. For the majority
of radionuclides contained in packages from radiopharmacies (i.e., technetium-99m
and thallium-201) the threshold for identification as a Hazardous Substance
is on the order of 100 to 1000 curies, which is significantly more than
is contained in the typical shipment. However, for shipments containing
more than 10 millicuries of iodine-131, the packages and shipping
papers must include the "RQ" designation of the shipment as containing
a reportable quantity. The "RQ" must appear either before or after the
basic description of the shipment on the shipping papers (i.e., "RQ Radioactive
Material, N.O.S., UN 2982") and must be included in the package markings
(Ref. 49 CFR 172.203(c) and 49 CFR 172.324).
- Shipping Papers 49 CFR 172.200-204: General entries, description,
additional description requirements, shipper's certification
For most packages likely to be shipped by commercial radiopharmacies
shipping papers are required. These must include:
- proper shipping name (as described above);
- hazard class of the material; for radioactive materials, the hazard
class is 7;
- identification number; for the proper shipping name, "Radioactive
Material, N.O.S.," the identification number is UN 2982;
- package type, which will usually be Type A;
- name and quantity of each radionuclide in the shipment; the radionuclide
may be abbreviated (i.e., Tc-99m);
- physical and chemical form of the radioactive material;
- category of label applied to each package in the shipment (i.e., "Radioactive
White-I");
- transport index (TI) of each package bearing Radioactive Yellow-II
or Radioactive Yellow-III labels;
- emergency response telephone number; and
- shipper's certification and signature.
Shipping papers may include additional information; however, the additional
information must not detract from the required entries.
For most, if not all, return shipments of wastes from radiopharmacy customers,
the packages can be shipped as excepted packages (limited quantity of
radioactive material) and will not require shipping papers; however, such
shipments must include a statement on, in, or transported with, the package.
The statement is contained in 49 CFR 173.422(a)(1), and must be verbatim.
Although the proper preparation of the package of returned waste is the
responsibility of the shipper (i.e., the customer), radiopharmacies should
be aware of the specific requirements if they intend to provide guidance
to their customers regarding these types of shipments.
- Package Markings 49 CFR 172.300, 49 CFR 172.301, 49 CFR 172.303, 49
CFR 172.304, 49 CFR 172.310, 49 CFR 172.324: General marking requirements
for non-bulk packaging, prohibited marking, marking requirements, radioactive
material, hazardous substances in non-bulk packaging
All certification packages shipped by commercial radiopharmacies (i.e.,
Type A packages) must be properly marked, as follows:
- proper shipping name and identification number (i.e., "Radioactive
Material, N.O.S., UN 2982");
- the letters RQ if the packages contain a hazardous substance, which
will only likely occur when the packages contain more than 10 millicuries
of iodine-131; and
- the designation Type A, if the package conforms to the Type A requirements.
DOT also specifies the size and appearance of the markings and markings
that are prohibited.
- Package Labeling 49 CFR 172.400, 49 CFR 172.401, 49 CFR 172.403, 49
CFR 172.406, 49 CFR 172.407, 49 CFR 172.436, 49 CFR 172.438, 49
CFR 172.440: General labeling requirements, prohibited labeling, radioactive
materials, placement of labels, specifications for radioactive labels.
All packages routinely prepared and shipped by commercial radiopharmacies
are required to be labeled in accordance with DOT regulations. The labels
will usually be either "Radioactive White-I," or "Radioactive Yellow-II."
Radiopharmacies have rarely offered a package labeled as "Radioactive
Yellow-III" for shipment. Packages exhibiting surface radiation levels
equal to or less than 0.5 millirem per hour will be labeled as "Radioactive
White-I." There is no TI, defined as a unitless number equivalent to the
radiation level, in millirems per hour, at one meter from the surface
of the package, for a White-I label. Packages with surface radiation levels
greater than 0.5 millirem per hour, but less than or equal to 50 millirems
per hour, will be labeled with a Yellow-II label. The TI for a Yellow-II
label must be less than or equal to "1." The lowest TI is "0.1,"
and all TIs are rounded to the nearest tenth.
Packages required to be labeled must have two labels affixed, on opposite
sides, but not on the top or bottom. The labels must include the identity
and quantity of the radionuclides in the package. Yellow-II and Yellow-III
labels must also include the TI. A label may not be affixed to a package
that does not meet the applicable labeling requirements.
- Placarding of Vehicles 49 CFR 172.500, 49 CFR 172.502, 49 CFR 172.504,
49 CFR 172.506, 49 CFR 172.516, 49 CFR 172.519, 49 CFR 172.556:
Applicability, prohibited and permissive placarding, general placarding
requirements, providing and affixing placards: highway, visibility and
display of placards, specifications for RADIOACTIVE placards.
DOT regulations specify when vehicles carrying hazardous materials must
be placarded. For radiopharmacy shipments, this is usually applicable
only when packages with Yellow-III labels affixed are offered or transported.
Since commercial radiopharmacies rarely, if ever, offer Yellow-III packages
for transport, placarding of the vehicles is not of concern and will not
be discussed in detail.
- Emergency Response Information, Subpart G, 49 CFR 172.600, 49 CFR
172.602, 49 CFR 172.604: Applicability and general requirements,
emergency response information, emergency response telephone number.
Persons who offer hazardous materials for transport, including radioactive
materials, must provide or make available emergency response information,
including:
- An emergency response telephone number must be included on the shipping
papers and the number must be monitored at all times that the material
is being transported. The person monitoring the telephone number must
be either knowledgeable of the hazardous material being shipped or have
comprehensive emergency response and incident mitigation information
for that material, or have immediate access to a person who has such
knowledge and information; and
- Emergency response information for the shipment that will aid emergency
responders in mitigating the consequences of an accident, including
the health hazards of the material, handling fires and spills involving
the material, and first aid measures must be included on, or with, the
shipping papers.
Applicants and licensees should review the specific DOT requirements
applicable to emergency response information in the development of their
programs and procedures.
- Training, Subpart H, 49 CFR 172.700, 49 CFR 172.702; and 49 CFR 172.704:
Purpose and Scope; applicability and responsibility for training and
testing, training requirements.
Licensees who prepare packages of radioactive materials and who transport
their own packages must provide training to their employees who perform
those functions. The training must include:
- General awareness and familiarization training designed to provide
familiarity with DOT requirements, and enable the employee to recognize
and identify hazardous materials;
- Function-specific training concerning the DOT requirements which are
specifically applicable to the functions the employee performs (i.e.,
if the employee's duties require him/her to affix DOT Radioactive labels
to packages, he or she must receive training in DOT's regulations governing
package labeling); and
- Safety training concerning emergency response information, discussed
above; measures to protect the employee and other employees from the
hazards associated with the hazardous materials to which they may be
exposed in the workplace; and methods of avoiding accidents, such as
the proper procedures for handling packages containing hazardous materials.
The training must be provided initially, and then every three years.
Records of training must be maintained.
- Shippers - General Requirements for Shipments and Packaging, Subpart
I, 49 CFR 173.403, 49 CFR 173.410, 49 CFR 173.412, 49 CFR 173.415,
49 CFR 173.431, 49 CFR 173.433, 49 CFR 173.435, 49 CFR 173.441,
49 CFR 173.443, 49 CFR 173.448, 49 CFR 173.475: 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.
Package Activity Limits
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Before offering a radioactive materials package for transport, the shipper
must determine the category of the shipment. Licensees will likely prepare
or transport two categories of packages containing radioactive material.
The categories are based, in part, on the activity of the radioactive
material contained in the package. The categories, activity ranges, packaging
requirements, and examples are provided in Table M.1. All quantities referenced
here are multiples of the A2 (normal form) values specified
for radionuclides in 49 CFR 173.435, and the physical form is assumed
to always be liquid.
Table M.1 Package Activity Limits
Category |
Activity Range |
Packaging Requirements |
Example |
Excepted packages, limited quantity of radioactive material |
Less than 10-4 A2 |
49 CFR 173.421 and 173.422 |
Less than 21.6 millicuries of technetium-99m (usually for returned
waste shipments) |
Radioactive Material, N.O.S. |
Greater than 10-4 A2 but less than A2 |
Type A packaging (49 CFR 173.410;
49 CFR 173.412;
49 CFR 173.415;
49 CFR 173.431;
49 CFR 173.433) |
More than 21.6 millicuries, but less than 216 curies of technetium-99m |
Once the quantity of material in the package has been determined, the
appropriate packaging must be selected.
Packaging Design
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Packages of radioactive material offered as excepted packages, limited
quantity of radioactive material, in accordance with 49 CFR 173.421, are
required to meet the minimum packaging requirements of 49 CFR 173.410.
Those requirements primarily address, but are not limited to, maintaining
package integrity and contents during conditions normally expected to
occur during transport. This does not include survival during accidents.
Packaging normally used by commercial radiopharmacies (i.e., military
ammunition boxes, "briefcases," and cardboard/fiberboard boxes, typically
meet and exceed those minimal requirements).
Packages containing "Type A" quantities must meet more stringent criteria,
including testing to demonstrate that the packages will maintain their
integrity of containment and shielding during normal conditions of transport.
The testing criteria for Type A packages are listed in 49 CFR 173.465.
Before offering a Type A package for shipment, the shipper is responsible
for ensuring that the package has been tested to meet the criteria for
the contents and the configuration to be shipped and maintaining a certificate
of testing. Shippers are not required to personally test the packages,
only to ensure that the testing was performed before use.
Quality Control
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Prior to each shipment, the shipper is required to determine that the
package is in condition for shipment. The determinations must include,
but are not limited to verification of the following:
- Package is proper for the contents to be shipped;
- Packaging is in unimpaired physical condition; and
- External radiation and contamination levels are within the allowable
limits.
The quality control requirements for radioactive material packages are
located in 49 CFR 173.475.
The external radiation and contamination level limits are located in
49 CFR 173.441 and 173.443. The applicant should ensure that its procedures
for preparing radioactive material packages include provisions to survey
the handle on ammunition boxes and briefcases used as packaging, in addition
to the closure clasp on ammunition boxes. Excessive contamination has
been identified in those locations in several package contamination events
reported to NRC in the past.
Carriage by Public Highway - General Information and Regulations, Subpart
A, 49 CFR 177.816, 49 CFR 177.817, 49 CFR 177.834, 49 CFR 177.842:
Driver training, shipping paper, general requirements (secured against
movement), Class 7 (radioactive) material.
Licensees who intend to transport their own packages must ensure that
their drivers receive training in the safe operation of the vehicle transporting
the hazardous material packages. The training requirements include, but
are not limited to:
- Pre-trip safety inspection of the vehicle;
- Requirements pertaining to vehicle attendance and incident reporting;
and
- Loading and unloading of the materials, including blocking and bracing
the packages and separation from occupied compartments.
The specific training requirements are located in 49 CFR 177.816.
The licensee must also ensure that its drivers maintain the shipping
papers accessible during transport and when the driver is not at the vehicle
controls. During transport, the shipping papers must be located within
the driver's reach while restrained by the lap belt -- either in a pocket
in the driver's door of the vehicle or readily visible to someone entering
the driver's compartment. In an accident, emergency responders are instructed
to look in those locations for the shipping papers to aid in handling
the hazardous material aspects, if any. Failure to properly locate shipping
papers could adversely impact the response to an accident, result in actions
that spread radioactive contamination, and result in unnecessary radiation
exposures to the responders. When the driver is not at the vehicle controls,
such as during deliveries to customers, the shipping papers for the packages
remaining in the vehicle must be either in the pocket in the driver's
side door or on the driver's seat in the vehicle.
49 CFR 177.834(a) and 177.842 require that packages of radioactive materials
be blocked and braced so that they cannot change position during conditions
normally incident to transportation. The method used must prevent lateral
movement of the packages during normal transport conditions (turns, curves,
potholes, dips, stopping and acceleration, etc.). This does not include
accident situations. The key test for evaluating the effectiveness of
blocking and bracing is to attempt to move the package by hand after it
is loaded. If the package can be moved through normal (non-Herculean)
effort, then it is not properly blocked and braced. The use of a non-skid
material on the vehicle surface where the package is loaded is not sufficient
by itself. Additional means are necessary to block the package within
the vehicle.
Appendix N: Model Personnel Training Program
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Training Program
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1. |
General instructions |
1.1 |
Training will be provided: vided: |
• |
Before an employee assumes duties with or in the immediate
vicinity of radioactive materials; |
• |
At least annually, as refresher training for all employees;
and |
• |
Whenever a significant change occurs in duties, regulations,
or the terms of the NRC licens |
1.2 |
Subjects covered for individuals working with, or in
the vacinity of, radioactive materials or radiation: |
• |
Safe radiation practices associated with the job (examples
of topics that may be covered are found in Section 3 of this Appendix); |
• |
Site-specific radiation safety practices; and |
• |
applicable NRC regulations. |
1.3 |
Subjects covered for ancillary personnel: |
• |
Significance of the radiation symbol and its use on
signs and labels; |
• |
Location of unrestricted areas; and |
• |
Whether the individual is authorized access to the restricted
areas of the pharmacy. |
1.4 |
Type of instruction: |
• |
Instruction in the licensee's site-specific radiation
safety program and NRC regulatory requirements may be in the form
of lecture, demonstrations, videotape, or self-study, and should emphasize
practical subjects important to the safe use of licensed material;
and |
• |
Individuals receiving instructions should be provided
an opportunity to ask questions |
2. |
Instruction for individuals likely to receive an occupational
dose in excess of 100 mSv (100 mrem) |
2.1 |
Instruction will be provided: |
• |
Before an employee assumes duties with or in the immediate
vicinity of radioactive materials; |
• |
At least annually, as refresher training; and |
• |
Whenever a significant change occurs in duties, regulations,
or terms of the NRC license. |
2.2 |
Licensee must provide instruction in subjects covered
in 10 CFR 19.12. |
2.3 |
Records of initial and refresher training should be
maintained and should include: |
• |
Name of the individual who provided the instruction; |
• |
Names of the individuals who received the instruction;
and |
• |
Date of instruction List of the topics covered. |
3. |
Suggested radiation safety training topics for individuals
working with, or in the vicinity of, byproduct material (this section
is intended as a guide to topics covered in a typical radiation safety
training program; topics selected should be commensurate with the
individuals' duties). |
3.1 |
Basic radiation safety information: |
• |
Basic radiation biology (e.g., interaction of ionizing
radiation with cells and tissues); |
• |
Radiation safety |
--- |
radiation vs. contamination; |
--- |
internal vs. external exposure; |
--- |
biological effects of radiation; |
--- |
ALARA concept; and |
--- |
use of time, distance, and shielding to minimize exposure; |
• |
Risk estimates, including comparison with other health
risks (10 CFR 19.12); |
• |
Regulatory requirements |
--- |
RSO; |
--- |
material control and accountability; |
--- |
dose to individual members of the public; |
--- |
personnel dosimetry; |
--- |
occupational dose limits and their significance; |
--- |
dose limits to the embryo/fetus, including instruction on declaration
of pregnancy; |
--- |
workers' right to be informed of occupational radiation exposure; |
--- |
radiation safety program audits; |
--- |
ordering and receipt of packages; |
--- |
transfer; |
--- |
waste disposal; |
--- |
recordkeeping; |
--- |
surveys; |
--- |
postings; |
--- |
labeling of containers; |
--- |
handling and reporting of incidents or events; |
--- |
licensing and inspection by NRC; |
--- |
need for complete and accurate information; |
--- |
employee protection; and |
--- |
deliberate misconduct. |
3.2 |
General topics for safe use of radioisotopes: |
• |
Wear a laboratory coat or other protective clothing
at all times when working with radioactive materials; |
• |
Use syringe shields and vial shields when preparing
and handling radioactive drugs; |
• |
Measure all radiopharmaceuticals prior to transfer; |
• |
Measure the molybdenum-99 content of each generator
elution and do not transfer those radiopharmaceuticals for human medical
use that will contain more than 0.15microcuries of molybdenum-99 per
mCi of technetium-99m at the time of administration; |
• |
Wear disposable gloves at all times when handling radioactive
materials and change gloves frequently to minimize the spread of contamination; |
• |
Before leaving the hot lab, monitor hands, shoes, and
clothing for contamination in a low-background area, allowing sufficient
time for instrument response; |
• |
Do not eat, drink, smoke, or apply cosmetics in any
area where licensed material is stored or used; |
• |
Do not store food, drink, or personal effects in areas
where licensed material is stored or used (see Figure P.1). Personal
items brought into the restricted area (i.e., radios, compact discs,
notepads, books, etc.) should be surveyed for contamination before
removal from the area; |
• |
Food and beverages used in the preparation of radiopharmaceuticals
should be clearly labeled "Not for personal consumption" if stored
with radioactive materials; |
• |
Wear personnel monitoring devices, if required, at all
times while in areas where licensed materials are used or stored; |
• |
Dispose of radioactive waste only in designated, labeled
and properly shielded receptacles; |
• |
Never pipette by mouth; |
• |
Store radioactive solutions in clearly labeled containers;
and |
• |
Secure all licensed material when it is not under the
constant surveillance and immediate control of the user(s). |
3.3 |
Instruction on radiopharmacy-specific program elements: |
• |
Applicable regulations and license conditions; |
• |
Areas where radioactive material is used or stored; |
• |
Potential hazards associated with radioactive material
in each area where the individuals will work; |
• |
Special procedures for handling volatile materials; |
• |
Proper use of radiation shielding; |
• |
Proper use of survey and analytical instruments; |
• |
Appropriate response to spills, emergencies or other
unsafe conditions; |
• |
Emergency procedures; |
• |
Previous incidents, events and/or accidents; |
• |
Survey program; |
• |
Effluent monitoring and control; |
• |
Customer-returned waste pickup, receipt, and handling; |
• |
Waste management and minimization; |
• |
Personnel monitoring; |
• |
Procedures for receiving packages containing radioactive
materials; |
• |
Procedures for opening packages; |
• |
Sealed sources and leak tests; and |
• |
Other topics, as applicable. |
Appendix O: Model Dose Calibrator Testing
Program
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Model Procedures for Testing Dose Calibrators Used
to Measure Photon-emitting Radionuclides
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]
This model procedure can be used by applicants and licensees for checking
and testing dose calibrators.
Model Procedure |
1. |
Test for the following at the indicated frequency. Consider
repair, replacement, or arithmetic correction if the dose calibrator
falls outside the suggested tolerances. |
1.1 |
Constancy, at least once each day prior to assay of
patient dosages (a safe margin is considered to be below ±10%). |
1.2 |
Linearity at installation and at least quarterly thereafter
(a safe margin is considered to be below ±10%). |
1.3 |
Geometry dependence at installation (a safe margin is
considered to be below ±10%). |
1.4 |
Accuracy, at installation and at least annually thereafter
(a safe margin is considered to be below ±10%). |
2. |
After repair, adjustment, or relocation of the dose
calibrator, such that proper function of the ionization chamber or
electronics would likely be in doubt, repeat the above tests as appropriate. |
3. |
Constancy means reproducibility in measuring a constant
source over a long period of time. Assay at least one relatively long-lived
source such as cesium-137, cobalt-60, cobalt-57, or radium-226 using
a reproducible geometry each day before using the calibrator; however,
cobalt-57 and radium-226 are not subject to NRC licensing; the appropriate
State agency should be consulted to determine its requirements for
possessing this material. Consider using two or more sources with
different photon energies and activities. |
Use the following procedure: |
3.1 |
Assay each reference source using the appropriate dose
calibrator setting (i.e., use the cesium-137 setting to assay cesium-137). |
3.2 |
Measure background at the same setting, and subtract
or confirm the proper operation of the automatic background circuit
if it is used. |
3.3 |
For each source used either plot or log (i.e., record
in the dose calibrator log book) the background level for each setting
checked and the net activity of each constancy source. |
3.4 |
Using one of the sources, repeat the above procedure
for all commonly used radioisotope settings. Plot or log the results. |
3.5 |
Establish an action level or tolerance for each recorded
measurement at which the individual performing the test will automatically
notify the authorized nuclear pharmacist or the radiation safety officer
of a suspected malfunction of the calibrator. These action levels
should be written in the log book or posted on the calibrator. The
dose calibrator should be repaired or replaced if the error exceeds
10%. |
4. |
The linearity of a dose calibrator should be ascertained
over the range of its use between the maximum activity in a vial and
30 microcuries. Linearity means that the calibrator is able
to indicate the correct activity over the range of use of that calibrator.
This example uses a vial of technetium-99m that has the anticipated
maximum activity to be assayed (e.g., the first elution from a new
generator) and assumes your predetermined safety margin is ±5%. |
4.1 |
Time Decay Method |
4.1.1 |
Inspect the instrument to ascertain that the measurement
chamber liner is in place and that instrument zero is properly set
(see manufacturer's instructions). |
4.1.2 |
Assay the technetium-99m vial in the dose calibrator
and subtract background to obtain net activity in millicuries. |
4.1.3 |
Repeat step 4.1.2 at time intervals of 6, 24, 30, and
48 hours after the initial assay. |
4.1.4 |
Using the 30-hour activity measurement as a starting
point, calculate the predicted activities at 0, 6, 24, and 48 hours
using the following table: |
Assay Time(4) (hours) |
Correction Factor |
0 |
31.6 |
6 |
15.8 |
24 |
2.00 |
30 |
1.00 |
48 |
0.126 |
4.1.5 |
Plot both the measured net activity and the calculated
activity versus time. |
4.1.6 |
On the graph, the measured net activity plotted should
be within ±5% of the calculated activity if the instrument is linear
and functioning properly. If variations greater than 5% are noted,
adjust the instrument, have it repaired, or use arithmetic correction
factors to correct the readings obtained in daily operations. |
4.1.7 |
If instrument linearity cannot be corrected, for routine
assays it will be necessary to use either an aliquot of the eluate
that can be accurately measured or the graph constructed in step 4.1.5
to relate measured activities to calculated activities. |
4.2 |
Shield Method:
If a set of "sleeves" of various thicknesses are used to test for
linearity, it will first be necessary to calibrate them. |
4.2.1 |
Begin the linearity test by assaying the technetium-99m
syringe or vial in the dose calibrator, and subtract background to
obtain the net activity in millicuries. Record the date, time to the
nearest minute, and net activity. This first assay should be done
in the morning at a regular time. After making the first assay, the
sleeves can be calibrated as follows. (Steps 4.2.2 through 4.2.4 must
be completed within 6 minutes.) |
4.2.2 |
Put the base and sleeve 1 in the dose calibrator with
the vial. Record the sleeve number and indicated activity. |
4.2.3 |
Remove sleeve 1 and put in sleeve 2. Record the sleeve
number and indicated activity. |
4.2.4 |
Continue for all sleeves. |
4.2.5 |
Complete the following decay method linearity test steps: |
4.2.5.1 |
Repeat the assay at about noon, and again at about 4:00
p.m. Continue on subsequent days until the assayed activity is less
than 30 microcuries. For dose calibrators on which the range is selected
with a switch, select the range normally used for the measurement. |
4.2.5.2 |
Convert the time and date information recorded to hours
elapsed since the first assay. |
4.2.5.3 |
On a sheet of semilog graph paper, label the logarithmic
vertical axis in millicuries and label the linear horizontal axis
in hours elapsed. At the top of the graph, note the date and the manufacturer,
model number, and serial number of the dose calibrator. Plot the data. |
4.2.5.4 |
Draw a "best fit" straight line through the data points.
For the point farthest from the line, calculate its deviation from
the value on the line.
(A-observed - A-line)/(A-line) = deviation |
4.2.5.5 |
If the worst deviation is more than ±0.05, the dose
calibrator should be repaired or adjusted. If this cannot be done,
it will be necessary to make a correction table or graph that will
allow conversion from activity indicated by the dose calibrator to
"true activity." |
4.2.6 |
From the graph made in step 4.2.5.3, find the decay
time associated with the activity indicated with sleeve 1 in place.
This is the "equivalent decay time" for sleeve 1. Record that time
with the data recorded in step 4.2.2. |
4.2.7 |
Find the decay time associated with the activity indicated
with sleeve 2 in place. This is the "equivalent decay time" for sleeve
2. Record that time with the data recorded in step 4.2.3. |
4.2.8 |
Continue for all sleeves. |
4.2.9 |
The table of sleeve numbers and equivalent decay times
constitutes the calibration of the sleeve set. |
The sleeve set may now be used to test dose calibrators
for linearity. |
4.2.10 |
4.2.10 Assay the technetium-99m syringe or vial in the
dose calibrator, and subtract background to obtain the net activity
in millicuries. Record the net activity. |
4.2.11 |
Steps 4.2.12 through 4.2.14 below must be completed
within 6 minutes. |
4.2.12 |
Put the base and sleeve 1 in the dose calibrator with
the vial. Record the sleeve number and indicated activity. |
4.2.13 |
Remove sleeve 1 and put in sleeve 2. Record the sleeve
number and indicated activity. |
4.2.14 |
Continue for all sleeves. |
4.2.15 |
On a sheet of semilog graph paper, label the logarithmic
vertical axis in millicuries, and label the linear horizontal axis
in hours elapsed. At the top of the graph, note the date and the model
number and serial number of the dose calibrator. |
4.2.16 |
Plot the data using the equivalent decay time associated
with each sleeve. |
4.2.17 |
Draw a "best fit" straight line through the data points.
For the point farthest from the line, calculate its deviation from
the value on the line. (A-observed - A-line)/A-line = deviation. |
4.2.18 |
If the worst deviation is more than ±0.05, the dose
calibrator should be repaired or adjusted. If this cannot be done,
it will be necessary to make a correction table or graph that will
allow conversion from activity indicated by the dose calibrator to
"true activity." |
5. |
Geometry independence means that the indicated
activity does not change with volume or configuration. The test for
geometry independence should be conducted using syringes and vials
that are representative of the entire range of size, shape, and constructions
normally used for injections and a vial similar in size, shape, and
construction to the radiopharmaceutical kit vials normally used. The
following example assumes that injections are done with 3-cc plastic
syringes, that radiopharmaceutical kits are made in 30-cc glass vials,
and that the predetermined safety margin is ±5%. |
5.1 |
In a small beaker or vial, mix 2 cc of a solution of
technetium-99m with an activity concentration between 1 and 10 mCi/ml.
Set out a second small beaker or vial with nonradioactive saline.
Tap water may be used. |
5.2 |
Draw 0.5 cc of the technetium-99m solution into the
syringe and assay it. Record the volume and millicuries. |
5.3 |
Remove the syringe from the calibrator, draw an additional
0.5 cc of nonradioactive saline or tap water, and assay again. Record
the volume and millicuries indicated. |
5.4 |
Repeat the process until a volume of 2.0-cc has been
assayed. The entire possess must be completed within 10 minutes. |
5.5 |
Select as a standard the volume closest to that normally
used for injections. For all other volumes, divide the standard millicuries
by the millicuries indicated for each volume. The quotient is a volume
correction factor. Alternatively, graph the data and draw horizontal
error lines above and below the chosen "standard volume." |
5.6 |
If any correction factors are greater than 1.05 or less
than 0.95, or if any data points lie outside the error lines, it will
be necessary to make a correction table or graph that will allow a
conversion from "indicated activity" to "true activity." If this is
necessary, be sure to label the table or graph "syringe geometry dependence,"
and note the date of the test and the model and serial number of the
calibrator. |
5.7 |
To test the geometry dependence for a 30-cc glass vial,
draw 1.0 cc of the technetium-99m solution into a syringe and then
inject it into the vial. Assay the vial. Record the volume and millicuries
indicated. |
5.8 |
Remove the vial from the calibrator and, using a clean
syringe, inject 2.0 cc of nonradioactive saline or tap water, and
assay again. Record the volume and millicuries indicated. |
5.9 |
Repeat the process until a volume of 19.0-cc has been
assayed. The entire process must be completed within 10 minutes. |
5.10 |
Select as a standard the volume closest to that normally
used for mixing radiopharmaceutical kits. For all other volumes, divide
the standard millicuries by the millicuries indicated for each volume.
The quotient is a volume correction factor. Alternatively, the data
may be graphed, with horizontal 5% error lines drawn above and below
the chosen "standard volume." |
5.11 |
If any correction factors are greater than 1.05, or
less than 0.95, or if any data points lie outside the 5% error lines,
it will be necessary to make a correction table or graph that will
allow conversion from "indicated activity" to "true activity." If
this is necessary, be sure to label the table or graph "vial geometry
dependence," and note the date of the test and the model number and
serial number of the calibrator. |
6. |
Accuracy means that, for a given calibrated reference
source, the indicated millicurie value is equal to the millicurie
value determined by the National Institute of Standards and Technology
(NIST) or by the supplier who has compared that source to a source
that was calibrated by NIST. Certified sources are available from
NIST and from many radioisotope suppliers. At least two sources with
different principal photon energies (such as cobalt-57, cobalt-60,
cesium-137) should be used. One source should have a principal photon
energy between 100 keV and 500 keV. If a radium-226 source is used,
it should be at least 10 microcuries; other sources should be at least
50 microcuries. Consider using at least one reference source whose
activity is within the range of activities normally assayed. |
6.1 |
Assay a calibrated reference source at the appropriate
setting (i.e., use the cobalt-57 setting to assay cobalt-57), and
then remove the source and measure background. Subtract background
from the indicated activity to obtain the net activity. Record this
measurement. Repeat for a total of three determinations. |
6.2 |
Average the three determinations. The average value
should be within the predetermined safety margin, which in this example
is 5% of the certified activity of the reference source, mathematically
corrected for decay. |
6.3 |
Repeat the procedure for other calibrated reference
sources. |
6.4 |
If the average value does not agree, within 5%, with
the certified value of the reference source, the dose calibrator may
need to be repaired or adjusted. The dose calibrator should be repaired
or replaced if the error exceeds 10%. |
6.5 |
At the same time the accuracy test is done, assay the
source that will be used for the daily constancy test (it need not
be a certified reference source) on all commonly used radioisotope
settings. Record the settings and indicated millicurie values with
the accuracy data. |
6.6 |
Put a sticker on the dose calibrator noting when the
next accuracy test is due. |
7. |
The individual performing the tests will sign or initial
the records of all geometry, linearity, and accuracy tests. |
Appendix P: Material Receipt and Accountability
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Sample Model Procedure for Ordering and Receiving
Radioactive Material
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]
- The RSO should approve or place all orders for radioactive material
and should ensure that the requested material, quantities, manufacturer,
and model are authorized by the license and that the possession limits
are not exceeded.
- Carriers should be instructed to deliver radioactive packages directly
to the designated receiving area.
Sample Instructions to Personnel Involved in Material
Receipt
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Shipping and Receiving Personnel
During normal working hours, within 3 hours of receipt of any package
of licensed material, each package must be visually inspected for any
signs of shipping damage, such as crushed or punctured containers or signs
of dampness. Any suspected damage must be reported to the RSO immediately.
Do not touch any package suspected of leaking. Request the person delivering
the package, if still on site, to remain until monitored by the RSO.
Outside of normal working hours (e.g., nights, weekends, and holidays),
deliveries may be made to a designated, secured storage area. These packages
must be checked for contamination and external radiation levels within
3 hours after personnel arrive at the facility. They should not be allowed
to remain in the designated storage area any longer than necessary, as
they may be a source of exposure for pharmacy personnel.
Sample Model Procedure for Safely Opening Packages
Containing Licensed Materials
For packages received under the specific license, authorized individuals
should implement procedures for opening each package, as follows:
- Wear gloves to prevent hand contamination;
- Visually inspect the package for any sign of damage (e.g., crushed,
punctured). If damage is noted, stop and notify the RSO;
- Check DOT White I, Yellow II, or Yellow III label or packing slip
for activity of contents, to ensure that the shipment does not exceed
license possession limits;
- Monitor the external surfaces of a labeled package according to specifications
in Table 8.1;
- Open the outer package (following supplier's directions if provided)
and remove packing slip. Open inner package to verify contents, comparing
requisition, packing slip and label on the container. Check integrity
of the final source container (e.g., inspecting for breakage of seals
or vials, loss of liquid, discoloration of packaging material, high
count rate on smear). Again check that the shipment does not exceed
license possession limits. If anything other than the expected observation
is identified, stop and notify the RSO;
- Survey the packing material and packages for contamination before
discarding. If contamination is found, treat as radioactive waste. If
no contamination is found, obliterate the radiation labels prior to
discarding in the regular trash;
- Maintain records of receipt, package survey, and wipe test results;
and
- Notify the final carrier and the NRC Operations Center when removable
radioactive surface contamination exceeds the limits of 22 disintegrations
per minute per square centimeter (dpm/cm2) averaged over
300 cm2; or external radiation levels exceed 2.0 mSv/hr (200 mrem/hr)
at the surface.
Appendix Q: General Topics for Safe Use
of Radioisotopes and Model Emergency Procedures
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General Topics for Safe Use of Radioisotopes
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]
- Each licensee using radioactive material should establish general
rules for the safe use of the material so that workers know what is
required. Typical instructions should include:
- Wear a laboratory coat or other protective clothing at all times when
working with radioactive materials;
- Use syringe shields and vial shields when preparing and handling radioactive
drugs;
- Measure all radiopharmaceuticals prior to transfer;
- Measure the molybdenum-99 content of each generator elution and do
not transfer those radiopharmaceuticals for human medical use that will
contain more than 0.15 microcuries of molybdenum-99 per millicurie of
technetium-99m at the time of administration;
- Wear disposable gloves at all times when handling radioactive materials
and change gloves frequently to minimize the spread of contamination;
- Before leaving the hot lab, monitor hands, shoes, and clothing for
contamination in a low-background area, allowing sufficient time for
instrument response;
- Do not eat, drink, smoke, or apply cosmetics in any area where licensed
material is stored or used;
- Do not store food, drink, or personal effects in areas where licensed
material is stored or used (see Figure Q.1). Personal items brought
into the restricted area (i.e., radios, compact discs, notepads, books,
etc.) should be surveyed for contamination before removal from the area;
- Food and beverages used in the preparation of radiopharmaceuticals
should be clearly labeled "Not for personal consumption" if stored with
radioactive materials;
- Wear personnel monitoring devices, if required, at all times while
in areas where licensed materials are used or stored;
- Dispose of radioactive waste only in designated, labeled, and properly
shielded receptacles;
- Never pipette by mouth;
- Store radioactive solutions in clearly labeled containers; and
- Secure all licensed material when it is not under the constant surveillance
and immediate control of the user(s).
Figure Q.1 Storage of Food and Drink.
Food or drink for personal consumption should not be stored in refrigerators
with radioisotopes.
Model Procedures for Handling Millicurie Quantities
of Radioiodine
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]
Due to the potential for significant intakes, due to volatility and accidental
ingestion, and skin exposures (SDE) from contamination, licensees should
establish specific procedures for the containment and handling of millicurie
quantities of radioiodine, most commonly iodine-131. The following guidance
is the minimum that should be considered if the applicant intends to manipulate
radioiodine:
- Manipulation of radioiodine (e.g., handling or compounding capsules,
performing radioiodination, dispensing from bulk solution) should be
conducted in an isolated area within the main hot lab of the pharmacy.
This will aid in maintaining exposures ALARA and provide a means to
isolate the area in the event of a spill;
- Radioiodine handling should only be performed inside a glovebox or
fume hood. The ventilation for gloveboxes and fume hoods should be checked
at least once every six months to ensure adequate airflow and confirm
negative pressure with respect to the area around the glovebox or fume
hood. Exhaust stacks for gloveboxes and fume hoods used for handling
radioiodine should not be located near ventilation intakes to minimize
the likelihood of recirculation to the pharmacy or to other tenants
in a shared building;
- Gloveboxes and fume hoods must include appropriate filters (activated
charcoal) to minimize effluents from radioiodine handling;
- Filters must be installed and used in accordance with the manufacturer's
specifications (e.g., adequate air flow to ensure adequate residence
time);
- Filters should be checked at installation and periodically, based
on use, but not less than once per calendar quarter, to ensure continued
efficiency;
- Air flow through fume hoods and gloveboxes should be confirmed before
each use;
- Magna-helic sensors, if used, should be checked before each use of
the glovebox or fume hood, to ensure minimum flow across the filter;
- Absorbent materials and dry chemical buffers, for use in the event
of a spill, should be located near the area where millicurie quantities
of radioiodine are handled;
- Additional protective clothing should be used when handling millicurie
quantities of radioiodine. Personnel should be double gloved and use
shoulder-length sleeve guards. The gloves and glove seals on gloveboxes
should be checked periodically and replaced when needed; and
- All personnel handling greater than 500 millicuries of iodine-131
in a year should be considered for bioassay. This is the threshold below
which intakes over 1% of the annual limit on intake (ALI) are not likely,
and assumes no containment. When used in a properly operating fume hood,
the threshold for consideration of the need for bioassay rises to 5
curies of iodine-131. If used in a properly operating glovebox, with
properly sealed glove ports and well maintained gloves, the threshold
rises to 50 curies of iodine-131 handled by one person per year. Pharmacies
using gloveboxes that do not have sealed glove ports may not use the
threshold indicated for that equipment, but may use the threshold for
properly maintained fume hoods.
Model Procedures for Handling Events
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Suggested Thresholds for Defining Minor Contamination
Events, Minor Spills, and Major Spills
Licensees should establish clearly delineated thresholds for describing
these types of events. Licensees should establish a graded response to
emergencies, incorporating increasing formality of a response based on
the potential risks posed by the events. No emergency procedure can anticipate
every likely event; therefore, flexibility and judgment must be incorporated
into such procedures. Most importantly, if licensee staff are not sure
of the proper or expected response to any event, no matter how minor,
they should be instructed to immediately cease further action, control
access to the area, contact the RSO and wait for instructions.
Although the following is only suggested guidance for establishing response
thresholds, significant deviations in actual
licensee emergency procedures should be clearly justified.
Minor Contamination Events
Those events typically identified through routine surveys that involve
removable contamination levels greater than the licensee's action limit,
but less than ten times the licensee's action limit. Minor contamination
events can be easily decontaminated without the need for strict adherence
to a step-by-step procedure. Such events require judgment on the part
of the individual responding to determine the scope and extent of the
contamination and to assess their ability to respond effectively. In order
to prevent the spread of contamination, coworkers should be notified if
decontamination of the area will be delayed. The RSO should be notified
promptly of such events, either before, or immediately after, cleanup
of the area. Isolated minor contamination events may not require a formal
root cause evaluation or extensive corrective action determinations; however,
several events in the same location, involving the same individual, or
during similar processes may warrant such in-depth evaluations and determinations.
Minor Spills |
Those events typically identified at the time they occur
(i.e., a dropped syringe or vial containing radioactive material)
involving the release (spill) of radioactive material requiring a
more formal adherence to a step-by-step procedure. Such events will
usually involve millicurie quantities of material and have a potential
for exposures to personnel or the public if not properly controlled
and decontaminated. The upper limit for defining minor spills should
not be more than five times the lowest annual limit on intake (ALI)
of the material involved in the spill. Such a limit would include
the following quantities of radioactive material: |
|
1 |
Up to 400 millicuries of technetium-99m; |
2. |
Up to 150 microcuries of iodine-131; |
3. |
Up to 100 millicuries of thallium-201; and |
4. |
Up to 10 millicuries of samarium-153. |
|
Minor spills may warrant root cause evaluations and
corrective action determinations, depending on the circumstances.
The RSO should be notified immediately of such events so that decontamination
procedures can be monitored. Minor spills involving quantities of
radioactive material near the upper threshold may require more than
one person to respond to assist in the cleanup, perform confirmation
surveys, or monitor materials and personnel exiting the area. |
|
Major Spills |
|
|
Any spill involving a quantity of radioactive material
in excess of the quantity defined for a minor spill is considered
a major spill. Such spills have a greater potential for exposures
to workers and the public, including the possibility of overexposure,
if not properly contained. Individuals should never attempt to clean
a major spill by themselves, or without the personal supervision and
direction of the RSO. Major spills should generally be reported to
NRC in accordance with the requirements of 10 CFR 30.50. Major spills
may also require evaluations of intakes and skin doses, if personnel
contamination is identified, as well as root cause evaluations and
corrective action determinations. Qualified assistance should be sought
immediately for those major spills that are beyond the licensee's
capability to address. |
|
General Safety Procedures to Handle Spills |
|
• |
Name and telephone number of RSO or an alternate person(s)
should be posted conspicuously in areas of use, so that it is readily
available to workers in case of emergencies. Licensees should have
emergency equipment readily available for handling spills. Spill response
materials should include the following: |
--- |
disposable gloves; |
--- |
housekeeping gloves; |
--- |
disposable lab coats; |
--- |
disposable shoe covers; |
--- |
roll of absorbent paper with plastic backing; |
--- |
masking tape; |
--- |
plastic trash bags with twist ties; |
--- |
"Radioactive Material" labeling tape; |
--- |
marking pen; |
--- |
pre-strung "Radioactive Material" labeling tags; |
--- |
box of wipes; |
--- |
instructions for "Emergency Procedures"; |
--- |
clipboard with a copy of the Radioactive Spill Report Form for the
facility; and |
--- |
pencil. |
|
|
|
Minor Contaminations and Spills of Liquids and Solids |
|
• |
Instructions to Workers |
--- |
These instructions apply to minor contamination events (less than
10 times the licensee's action limit) and minor spills of radioactive
material. The response to each is similar; however, the response to
minor contamination events need not be as formal as the response to
spills involving millicurie quantities of radioactive material; |
--- |
Notify persons in the area that a spill has occurred; |
--- |
Prevent the spread of contamination by covering the spill with absorbent
paper. Paper should be dampened if solids are spilled; |
--- |
Clean up the spill, wearing disposable gloves and using absorbent
paper; |
--- |
Carefully fold the absorbent paper with the clean side out and place
in a plastic bag for transfer to a radioactive waste container. Put
contaminated gloves and any other contaminated disposable material
in the bag; |
--- |
Resurvey the area. Check the area around the spill for contamination.
Also check hands, clothing, and shoes for contamination; and |
--- |
Report the incident to the Radiation Safety Officer (RSO) promptly. |
|
• |
Reminders to RSO |
--- |
Follow up on the decontamination activities and document the results; |
--- |
As appropriate, determine cause and corrective actions needed; consider
bioassays if licensed material may have been ingested or inhaled;
and |
--- |
If necessary, notify NRC. |
|
Major Spills of Liquids and Solids |
|
• |
Instructions to Workers |
--- |
Clear the area. If appropriate, survey all persons not involved
in the spill and vacate the room; |
--- |
Prevent the spread of contamination by covering the spill with absorbent
paper (paper should be dampened if solids are spilled), but do not
attempt to clean it up. To prevent the spread of contamination, limit
the movement of all personnel who may be contaminated; |
--- |
Shield the source only if it can be done without further contamination
or significant increase in radiation exposure; |
--- |
Close the room and secure the area to prevent entry. Post the room
with a sign to warn anyone trying to enter that a spill of radioactive
material has occurred; |
--- |
Notify the RSO immediately; |
--- |
Survey all personnel who could possibly have been contaminated.
Decontaminate personnel by removing contaminated clothing and flushing
contaminated skin with lukewarm water and then washing with a mild
soap; |
--- |
Allow no one to return to work in the area unless approved by the
RSO; and |
--- |
Follow the instructions of the RSO (e.g., decontamination techniques,
surveys, provision of bioassay samples, requested documentation). |
|
• |
Reminders to RSO |
--- |
Confirm decontamination of personnel. If decontamination of personnel
was not fully successful, consider inducing perspiration by covering
the area with plastic. Then wash the affected area again to remove
any contamination that was released by the perspiration; |
--- |
Skin contamination must be evaluated to determine potential exposures.
Beta-emitting radionuclides have a high potential for resulting in
shallow-dose exposures in excess of regulatory limits from small (microcurie)
quantities of contamination; |
--- |
Supervise decontamination activities and document the results. Documentation
should include location and results of surveys and decontamination
results; |
--- |
Determine root cause and needed corrective actions; consider need
for bioassays if licensed material may have been ingested, inhaled,
or absorbed; and |
--- |
If necessary, notify NRC. |
|
Minor Fires |
|
• |
Instructions to Workers |
--- |
If possible, immediately attempt to put out the fire by approved
methods (i.e., fire extinguisher) if other fire hazards or radiation
hazards are not present; |
--- |
Notify all persons present to vacate the area and have one individual
immediately call the RSO and fire department (as instructed by RSO); |
--- |
Once the fire is out, isolate the area to prevent the spread of
possible contamination; |
--- |
Ensure injured personnel receive medical attention; |
--- |
Survey all persons involved in combating the fire for possible contamination; |
--- |
Decontaminate personnel by removing contaminated clothing and flushing
contaminated skin with lukewarm water, then washing with a mild soap; |
--- |
In consultation with the RSO, determine a plan of decontamination
and the types of protective devices and survey equipment that will
be necessary to decontaminate the area; |
--- |
Allow no one to return to work in the area unless approved by the
RSO; and |
--- |
Follow the instructions of the RSO (e.g., decontamination techniques,
surveys, provision of bioassay samples, requested documentation). |
|
• |
Reminders to RSO |
--- |
Notify emergency medical personnel of any injured individuals who
may be contaminated. Provide radiation safety assistance (e.g., monitoring)
as needed or requested; |
--- |
Supervise decontamination activities at the facility; |
--- |
If decontamination of personnel was not fully successful, consider
inducing perspiration by covering the area with plastic. Then wash
the affected area again to remove any contamination that was released
by the perspiration; |
--- |
Consult with fire safety officials to ensure that there is no likelihood
of fire restarting; |
--- |
Determine cause and needed corrective actions; consider need for
bioassays if licensed material may have been ingested or inhaled.
Document incident; and |
--- |
If necessary, notify NRC. |
|
Fires, Explosions, or Major Emergencies |
|
• |
Instructions to Workers |
--- |
Notify all persons in the area to leave immediately; |
--- |
Notify the fire department; |
--- |
Notify the RSO and other facility safety personnel; |
--- |
Ensure injured personnel receive medical attention; |
--- |
Upon arrival of firefighters, inform them where radioactive materials
are stored or where radioisotopes were being used; inform them of
the present location of the licensed material and the best possible
entrance route to the radiation area, as well as any precautions to
avoid exposure or risk of creating radioactive contamination by use
of high pressure water, etc; |
--- |
Allow no one to return to work in the area unless approved by the
RSO; and |
--- |
Follow the instructions of the RSO (e.g., decontamination techniques,
surveys, provision of bioassay samples, requested documentation). |
|
• |
Reminders to RSO |
--- |
Notify emergency medical personnel of any injured individuals who
may be contaminated. Provide radiation safety assistance (e.g., monitoring)
as needed or requested; |
--- |
Coordinate activities with local fire department; |
--- |
Consult with the firefighting personnel and set up a controlled
area where the firefighters can be surveyed for contamination of their
protective clothing and equipment after the fire is extinguished; |
--- |
Once the fire is extinguished, provide assistance to firefighters
who may need to re-enter restricted areas to determine the extent
of the damage to the licensed material use and storage areas. To the
extent practical, assist firefighters in maintaining their exposures
ALARA if the fire resulted in a significant release of radioactive
material or loss of shielding capability, such that excessive radiation
levels (greater than 100 millirems per hour) are created; |
--- |
Perform thorough contamination surveys of firefighters and their
equipment before they leave the controlled area, and decontaminate
if necessary; |
--- |
Supervise decontamination activities; |
--- |
Consider bioassays if licensed material may have been ingested or
inhaled. Document incident; and |
--- |
If necessary, notify NRC. |
Copies of emergency procedures should be provided to all users.
A current copy of the emergency procedures should be posted in each
area where radioactive material is used. |
Appendix R: Model Radiation Survey
Procedures
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This Appendix provides applicants and licensees with additional information
on surveys, including training requirements, survey frequency, contamination
limits, and bioassays.
Ambient Radiation Level Surveys
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- Dose-rate surveys, at a minimum, should be performed in locations
where workers are exposed to radiation levels that might result in radiation
doses in excess of 10% of the occupational dose limits.
- Dose-rate surveys, at a minimum, should be performed in locations
where members of the public could receive a total effective dose equivalent
of 1 mSv (100 mrem) in a year, or the dose in any unrestricted area
from external sources could exceed 0.02 mSv (2 mrem) in any one hour.
- Dose-rate surveys should be performed in a manner and frequency that
is representative of the use of radioactive materials. At a minimum,
these surveys should be conducted daily in areas of radioactive material
use, where exposures to workers could reasonably occur, e.g. generator
storage/elution and dose preparation stations. Other areas, where radiological
conditions are not expected to change appreciably from day-to-day, should
be surveyed weekly, e.g. radioactive waste storage areas.
Contamination Surveys
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Licensees' contamination surveys should be sufficient to identify areas
of contamination that might result in unacceptable levels of exposure
to workers or to the public. Combined removable and fixed contamination
should be surveyed using appropriate radiation detection equipment. Removable
contamination can be detected and measured through wipe tests, which should
be analyzed using an appropriate counting instrument. Fixed contamination
may be measured directly at the surface of the contamination with the
appropriate instrument detector held at close proximity to the surface
without direct contact. See Table J.1 for examples of appropriate instruments.
Contamination surveys should be performed:
- To evaluate radioactive contamination that could be present on surfaces
of floors, walls, laboratory furniture, or equipment;
- After any spill or contamination event;
- To evaluate contamination of users and the immediate work area at
the end of each day when licensed material is used;
- In unrestricted areas at frequencies consistent with the types and
quantities of materials in use; and
- In areas adjacent to restricted areas and in all areas through which
licensed materials are transferred and temporarily stored before shipment.
Contamination Survey Frequency
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All areas where radioactive materials are eluted, prepared, assayed,
dispensed, or packaged for transport should be surveyed daily. All other
areas where radioactive materials are used or stored should be surveyed
weekly.
Contamination in Unrestricted Areas
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Contamination found in unrestricted areas should be immediately decontaminated
to background levels. When it is not possible to get to background levels,
the licensee must ensure that the amounts do not exceed the contamination
levels listed in Table R.1.
Table R.1 Recommended Action Levels in dpm/100 cm2
for Removable Surface Contamination by Radiopharmaceuticals
|
P-32, Se-75, Sr-85, Sr-89, In-111, I-123, I-125, I-131,
Sm-153, Yb-169, Re-186, Au-198 |
Cr-51, Ga-67, Tc-99m, Tl-201 |
1. Unrestricted areas, personal clothing |
200 |
2000 |
2. Restricted areas, protective clothing used only in restricted
areas, skin |
2000 |
20000 |
When equipment or facilities that are potentially contaminated are to
be released for unrestricted use, the above table provides the maximum
acceptable residual levels. To the extent practicable, it is appropriate
to decontaminate below these levels. Surface contamination surveys should
be conducted for both removable and fixed contamination before these facilities
or equipment are released from restricted to unrestricted use to ensure
that they meet these limits.
A standardized method for wipe testing of a relatively uniform area should
be used to aid in comparing contamination at different times and places.
A wipe taken from an area of approximately 100 cm2 is acceptable
to indicate levels of removable contamination.
Survey Record Requirements
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- Each survey report should include the following:
- Diagram of the area identifying specific locations surveyed (See Figure
8.3);
- Ambient radiation levels with appropriate units;
- Contamination levels with appropriate units;
- Make and model number of instruments used;
- Background levels;
- Name of the person making the evaluation and recording the results
and date; and
- Corrective actions taken for elevated levels identified and results
of resurveys.
Licensees should record contamination levels observed and procedures
followed for incidents involving contamination of individuals. The record
should include names of individuals involved, description of work activities,
calculated dose, probable causes (including root causes), steps taken
to reduce recurrence of contamination, times and dates, and surveyor's
signature.
Air Sampling
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- Air sampling can be used to do the following:
- Determine whether the confinement of radioactive materials is effective;
- Measure airborne radioactive material concentrations in the workplace;
- Estimate worker intakes of radioactive material;
- Determine posting requirements;
- Determine what protective equipment and measures are appropriate;
and
- Warn of significantly elevated levels of airborne radioactive materials.
Refer to Regulatory Guide 8.25, Revision 1, "Air Sampling in the Workplace,"
dated June 1992 and NUREG-1400, "Air Sampling in the Workplace," dated
September 1993 for further guidance on air sampling.
Air Stack Release Monitoring
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Airborne radioactive effluents should be monitored at the release points
(e.g., stack) to provide accurate measurements to estimate public exposure.
Licensees should verify the performance of effluent monitoring systems
by regular calibration of equipment and checks of filtration to ensure
their reliability.
Regulatory Guide 4.20, "Constraints on Release of Airborne Radioactive
Materials to the Environment for Licensees Other Than Power Reactors,"
dated December 1996, provides guidance on methods acceptable (calculation
or COMPLY code) to NRC for compliance with the constraint on air emissions
to the environment.
Regulatory Guide 8.37, "ALARA Levels for Effluents from Materials Facilities,"
dated July 1993, provides guidance on designing an acceptable program
for establishing and maintaining ALARA levels for gaseous and liquid effluents
at materials facilities.
Effluent monitoring systems should be designed in accordance with ANSI
N13.1 (1969), "Document to Sampling Airborne Radioactive Materials in
Nuclear Facilities," and ANSI N42.18, "Specification and Performance of
On-site Instrumentation for Continuously Monitoring Radioactive Effluents."
Radioiodine Monitoring
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The handling of radioiodine requires additional surveys and monitoring.
Such surveys and monitoring include:
- Routine surveys should be performed of air filters incorporated in
fume hoods and gloveboxes to identify when filters should be exchanged
prior to saturation;
- Routine surveys should be performed in the area where radioiodine
is handled immediately following each use to identify elevated radiation
and contamination levels; and
- Continuous monitoring of the air effluent should be performed during
radioiodine use. In-line filters should be monitored periodically to
determine actual effluents.
Sanitary Sewerage Release Monitoring
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The licensee should evaluate the concentrations of radioactive material
in water that is released to the environment and to the sanitary sewer.
The licensee must show that these releases meet the limits in 10 CFR 20.
1301 and 20.2003, respectively.
Bioassay Monitoring
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Frequency of Required Bioassay Measurements
Determining the appropriate frequency of routine bioassay measurements
depends upon the exposure potential and the physical and chemical characteristics
of the radioactive material and the route of entry to the body. Consider
the following elements:
- Potential exposure of the individual;
- Retention and excretion characteristics of the radionuclide;
- Sensitivity of the measurement technique; and
- Acceptable uncertainty in the estimate of intake and committed dose
equivalent.
Bioassay measurements used for demonstrating compliance with the occupational
dose limits should be conducted often enough to identify and quantify
potential exposures and resultant intakes that, during any year, are likely
to collectively exceed 0.1 times the ALI. The 10% ALI criterion is consistent
with 10 CFR 20.1502(b), which requires licensees to monitor intakes and
assess occupational doses for exposed individuals who are likely to exceed
10% of the applicable limit (i.e., intakes likely to exceed 0.1 ALI for
adults).
Separate categories of bioassay measurements, routine measurements, and
special measurements further determine the frequency and scope of measurements.
Routine Measurements
Routine measurements include baseline measurements, periodic measurements,
and termination measurements. These measurements should be conducted to
confirm that appropriate controls exist and to assess dose.
An individual's baseline measurement of radioactive material within the
body should be conducted before beginning work that involves exposure
to radiation or radioactive materials for which monitoring is required.
In addition to the baseline measurements, periodic bioassay measurements
should be performed. The frequency of periodic measurements should be
based on the likelihood of significant exposure of the individual. In
determining the worker's likely exposure, consider such information as
the worker's access, work practices, measured levels of airborne radioactive
material, and exposure time. Periodic measurements should be made when
the cumulative exposure to airborne radioactivity, since the most recent
bioassay measurement, is > 0.02 ALI (40 DAC hours). Noble gases and
airborne particulates with a radioactive half-life of less than two hours
should be excluded from the evaluation, since external exposure generally
controls these radionuclides.
When an individual is no longer subject to the bioassay program because
of change in employment status, termination bioassay measurement should
be made, when practicable, to ensure that any unknown intakes are quantified.
Special Monitoring
Because of uncertainty in the time of intakes and the absence of other
data related to the exposure (e.g., physical and chemical forms, exposure
duration), correlating positive results to actual intakes for routine
measurements can sometimes be difficult. Abnormal and inadvertent intakes
from situations such as inadequate engineering controls, inadvertent ingestion,
contamination of a wound, or skin absorption, should be evaluated on a
case-by-case basis. When determining whether potential intakes should
be evaluated, consider the following circumstances:
- Presence of unusually high levels of facial and/or nasal contamination;
- Operational events with a reasonable likelihood that a worker was
exposed to unknown quantities of airborne radioactive material (e.g.,
loss of system or container integrity);
- Known or suspected incidents of a worker ingesting radioactive material;
and
- Incidents that result in contamination of wounds or other skin absorption.
|
1. |
Regulatory Guide 4.20, "Constraints on Release of Airborne Radioactive
Materials to the Environment for Licensees Other Than Power Reactors,"
dated December 1996. |
2. |
Regulatory Guide 8.9, Revision 1, "Acceptable Concepts, Models,
Equations, and Assumptions for a Bioassay Program," dated July 1993 |
3.. |
Regulatory Guide 8.25, Revision 1, "Air Sampling in the Workplace,"
dated June 1992. |
4. |
Regulatory Guide 8.37, " ALARA Levels for Effluents from Materials
Facilities," dated July 1993. |
5. |
NUREG-1400, "Air Sampling in the Workplace," dated September 1993. |
6. |
NUREG/CR - 4884, "Interpretation of Bioassay Measurements," dated
July 1987. |
7. |
ANSI N13.1 (1969), "Document to Sampling Airborne Radioactive Materials
in Nuclear Facilities," dated 1991. |
8. |
ANSI N42.18, "Specification and Performance of On-site Instrumentation
for Continuously Monitoring Radioactive Effluents," 1991. |
Appendix S: Model Procedure for Return
of Radioactive Wastes from Customers
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Procedures for Customers to Return Radioactive
Waste to The Radiopharmacy
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Return only items that contained or contain radioactive materials supplied
by the radiopharmacy (e.g., pharmacy-supplied syringes and vials and their
contents). Most return shipments to radiopharmacies will qualify as excepted
packages of limited quantity, in accordance with DOT requirements (49
CFR 173.421). For those packages containing radioactive material in excess
of the limited quantity, customers should ensure that all applicable DOT
requirements are met for the packages. This includes, but is not limited
to, certification packaging (Type A), package marking and labeling, and
shipping papers. For specific guidance on preparing these types of packages,
please follow your in-house procedures for shipping radioactive material
packages or contact the pharmacy for guidance.
Preparation of radioactive materials for return as excepted package of
limited quantity:
- Ensure that the activities of material being returned are limited
quantities as defined by DOT (see table below). Special attention should
be given for the return of unused doses that may still contain significant
activities of radionuclides. The amount of radioactivity in unused doses
may necessitate that a syringe or vial be held for decay to reduce the
activity to that permitted for shipment of limited quantities.
- Place the syringe or vial in the original, labeled, lead shield in
which it was delivered; and
- Place shielded waste into the shipping package (e.g., padded briefcase
or ammo box) in which it was delivered. Note: Packages used to ship
radioactive material to customers meet the DOT package requirements
for transport of limited quantities.
Preparation of package:
- Using a calibrated survey meter, measure the radiation levels at all
points on the surface of the package to ensure that levels are less
than or equal to 0.5 mrem/hr;
- Use contamination wipes on the surface of the package to ensure that
the removable contamination does not exceed the limit specified in 49
CFR 173.443(a), 22 dpm/cm2 over a 300 cm2 area;
- Label the package as a "Excepted Package - Limited Quantity of Material";
and
- Seal the package so that it will be evident upon receipt whether the
package accidentally opened during shipment.
Note: Shipping papers are not required when
shipping limited quantities however, the statement specified in 49 CFR
173.422 ("This package conforms to the conditions and limitations specified
in 49 CFR 173.421 for radioactive material, excepted package-limited quantity
of material, UN2910.") must be included in, on, or otherwise provided
with the shipment.
Limited Quantities (49 CFR 173.421) For Typical Radionuclides
as Liquid Used by Radiopharmacies (49 CFR 173.425 - Table 7)
Table S.1 Limited Quantity Values for Liquid Radioactive Material
Packages
Radionuclide - Liquids |
A2 Value (Ci) |
Limited Quantity Shipment (mCi)
A2 X 10-4 |
Co-57 |
216 |
21.6 |
Co-58 |
27 |
2.7 |
Cr-51 |
811 |
81.1 |
Ga-67 |
162 |
16.2 |
I-123 |
162 |
16.2 |
I-125 |
54.1 |
5.41 |
I-131 |
13.5 |
1.35 |
In-111 |
54.1 |
5.41 |
Mo-99 |
20 (for domestic use) |
2 |
P-32 |
8.11 |
0.81 |
Se-75 |
81.1 |
8.1 |
Sr-89 |
13.5 |
1.35 |
Tc-99m |
216 |
21.6 |
Tl-201 |
270 |
27 |
Table S.2 Limited Quantity Values for Gaseous Radioactive Material
Packages
Radionuclide Uncompressed Gas |
A2 Value (Ci) |
Limited Quantity Shipment (mCi)
A2 X 10-3 |
Xe-133 (uncompressed) |
541 |
541 |
Table S.3 Limited Quantity Values for Special Form Radioactive
Material Packages
Radionuclide Solid - Special Form |
|
Limited Quantity Shipment (mCi)
A1 X 10-3 |
Ir-192 |
27 |
27 |
Cs-137 |
54.1 |
54.1 |
The values above are derived from 49 CFR 173.423, Table 7, and the Table
of A1 and A2 values for radionuclides in 49 CFR 173.435. If shipping more
than one radionuclide in the same package, the limits in 173.433(d) apply
as follows: The sum of the ratios of the activity of each radionuclide
divided by its respective A2 value must be less than, or equal to, one.
For special form material, the sum of the ratios of the activities of
each radionuclide divided by its respective A1 value must be less than,
or equal to, one.
Procedure for Driver or Courier for Pick-up of Radioactive Waste
from Customers
- Ensure that the shipping package is properly labeled "Excepted Package
- Limited Quantity of Material";
- Ensure that the shipping package has been sealed; and
- Do not accept any package that is not properly labeled and sealed.
Procedure for Receipt and Opening of Packages from Customers
Containing Radioactive Waste
- Place all returned packages in an identifiable location within the
radiopharmacy;
- Put on disposable gloves;
- Monitor the package for removable contamination. If wipe tests indicate
contamination levels greater than 22 dpm/cm2 over a 300 cm2
area, take the following actions:
-- Notify the customer and the NRC; and
- Survey the driver/courier who retrieved the waste and the vehicle
used to transport the waste to the radiopharmacy.
-- Decontaminate the package or remove it from service for decay.
Open the package and identify each nuclide in the shielded containers.
Dispose of radioactive waste into the appropriate container for the half-life
of the nuclide being disposed, in accordance with the radiopharmacy's
procedures for disposal of waste by decay-in-storage.
Survey the dose shields for contamination with a low-level survey meter.
Any dose shields that indicate activity exceeding background should be
decontaminated or removed from service.
Appendix T: NRC Incident Notifications
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Table T.1 Typical Notifications Required for Radiopharmacy 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) |
Intake of five times the annual limit on intake |
immediate |
30 days |
10 CFR 20.2202(a)(2) |
Removable contamination exceeding the limits of 10 CFR 71.87(I)
- [beta/gamma/low toxicity alpha - 22 dpm/cm2; all other
alpha - 2.2 dpm/cm2] |
immediate |
none |
10 CFR 20.1906(d)(1) |
External radiation levels exceeding the limits of 10
CFR 71.47 - [any point on the surface - 2 mSv/hr (200 mrem/hr)] |
immediate |
none |
10 CFR 20.1906(d)(2) |
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) |
Intake of one annual limit on intake |
24 hours |
30 days |
10 CFR 20.2202(b)(2) |
Occupational dose greater than the applicable limit
in 10 CFR 20.1201 |
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) |
An unplanned contamination event involving greater than
5 times the ALI, and half-life greater than 24 hours requiring
access to be restricted for more than 24 hours |
24 hours |
30 days |
10 CFR 30.50(b)(1) |
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 U: Addendum: Summary of Comments
Received on Draft NUREG 1556, Vol. 13, and Other Changes
[ Prev | Top of file ]
Table U.1 Comment from Jose O. Morales, MD, Dated March 19, 1999
Location |
Subject |
Comment |
Appendix S |
Return Shipments to Radiopharmacies |
Appendix S of NUREG-1556, Vol. 13 does not allow for the return
of unused doses until they have decayed enough to qualify for shipment
as a "limited quantity." This will create additional problems, requiring
the need for additional space in the "hot lab." The present practice
of returning unused doses works well since it is the same carrier
that takes back the material. The preparation of the package is done
following the present standards. Therefore, I suggest that both options
be allowed. |
NRC Staff Response: It was not the
writing team's intent to limit return shipments to radiopharmacies
to excepted packages of limited quantity. Appendix S has been modified
to clarify that return shipments are not limited to excepted packages.
Since most return shipments will likely be as excepted packages of
limited quantity, we have elected to limit the guidance in the NUREG
to these types of packages. |
Table U.2 Comment from Carol S. Marcus, Ph.D., M.D., Dated December 21, 1998
Location |
Subject |
Comment |
Appendix R, Table R.1 |
Removable Contamination Survey Action Limits |
I read with interest the NRC's "acceptable license termination screening
values of common radionuclides for building surface contamination,"
which appear in Table 1 of Fed. Reg. 63 (222) 64134, attached. These
actually appear to have been based on science.
Compare these with NRC's "acceptable surface contamination levels
in unrestricted areas," found in Table R.3, p. R-4 of Draft
"Program-Specific Guidance About Medical Use Licensees", NUREG-1556
Vol. 9, attached. (The comment was also applicable to NUREG - 1556,
Vol. 13)
For the same radionuclide, the medical licensee limits
are about 3-10,000 times more restrictive than for decommissioned
licensees. Please explain. |
NRC Staff Response: The contamination
levels listed in Table 1 of the Federal Register notice are for relatively
long-lived radionuclides that are likely to result in 25 millirem
per year to members of the public. Therefore, use of the Table and
the dose criteria do not lend themselves to meaningful use for those
licensees who use short half-life materials, such as radiopharmacies.
The values in Appendix R, Table R.1 of the Draft NUREG, are suggested
values that have historically been used in other NRC guidance documents
and been demonstrated to be reasonably achievable. Applicants and
licensees are able to set their own values for contamination limits
in unrestricted areas, as long as the values are as low as is reasonably
achievable. No changes have been made to the Draft guidance. |
Table U.3 Comments from Mallinckrodt, Inc., Dated June 7, 1999
Location |
Subject |
Comment |
Section 8.2 |
Timely Notification of Transfer of Control |
The criteria states that licenses must provide full information
and provide NRC's prior written consent before transferring
control of the license, or, as some licensees call it, "transferring
the license." This criteria may be difficult for the licensees
to implement - particularly since the details of the NRC's requirements
are not generally available to the licensee in advance. This requirement
may result in an unnecessary licensing burden. Instead, we suggest
that the criteria for advance notice be better defined and which
are likely going to be met - for example, unlicensed possessions
or lack of management oversight. |
NRC Staff Response: The NUREG provides
guidance on the type of information required by NRC in order for to
evaluate potential control transfers. Section 30.34 of 10 CFR Part
30 specifically prohibits the transfer of a license, either voluntarily
or involuntarily, unless the Commission finds that the transfer is
in accordance with the provisions of the Act and gives its consent
in writing. The guidance includes the type of information required
by the NRC for its review and this information has been included in
Appendix F of the NUREG. This is so stated in the Response from Applicant
section on the same page (8-3), therefore, no additional guidance
or changes are necessary to further address this comment. |
Section 8.5.1 |
Manipulation of Volatile Materials |
With respect to the use of potentially volatile materials (e.g.,
1- 13 1), the regulatory guide requires for the applicant to specify
whether the material will be manipulated at the radiopharmacy in a
volatile form. A clarification is warranted between the terms "manipulation"
and "compounding." In particular, it should be clarified if the handling
of sealed 1- 13 1 vials for the purpose of re-distribution is classified
as a "manipulation" - as compared to handling of unsealed 1-131 under
a glovebox or a fume hood for the purpose of manipulating the desired
therapeutic activity of liquid 1-131 or producing the desired activity
in a capsule form. |
NRC Staff Response: The guidance has
been clarified to indicate that "manipulation" does not apply to the
re-distribution of sealed I-131 vials, as long as the seal remains
intact. |
Section 8.5.1 |
Use of Sealed Sources |
The regulatory guide states that the applicants will be authorized
to possess and use only those sealed sources, such as calibration
and reference sources, that are specifically approved or registered
by the NRC or an Agreement State. The NRC is going to require the
applicants to provide the manufacturer's name and model number for
each requested sealed source and device so that the NRC can verify
that they have been evaluated in an SSD Registration Certificate or
specifically approved on a license. We suggest, instead, that the
applicants should be able to provide to the NRC reference of the approved
SSD Registrants with a specific upper activity limit for each sealed/reference
source and without the make and model number. This will allow the
flexibility for the radiopharmacies to procure the desired sources
on an as needed basis - as long as the possession limits are not exceeded.
This current practice appears to be functioning effectively, and should
not be changed. |
NRC Staff Response: 10 CFR 30.32(g)
states that an application for a specific license to use byproduct
material in the form of a sealed source or in a device that contains
the sealed source must either (1) identify the source or device by
manufacturer and model number as registered with the Commission under
10 CFR 32.210 or with an Agreement State; or (2) contain the information
identified in 10 CFR 32.210. Applicants may gain greater
flexibility by identifying any sources or devices they may possess
by manufacturer and model number and by requesting a possession limit
sufficient to cover their use. |
Section 8.5.1 |
Use of Depleted Uranium |
Please note that the DU shielding provided for the Mo-99/Tc-99m
generators qualifies for the exemption under 10 CFR 40.13(c)(6). Therefore,
the DU shielding information required for submittal by the applicants
should be deleted. |
NRC Staff Response: The NRC clarified
its position with regard to DU shielding used in generators in Policy
and Guidance Directive (P&GD) 86-9, "Authorizing Possession and
Use of Depleted Uranium as Shielding for High Activity Molybdenum-99/Technetium-99m
Generators," dated June 1986. This P&GD will be considered superseded
with the issuance of NUREG-1556, Vol. 13 in final form and, therefore,
the general guidance contained in that document was incorporated into
the Draft NUREG. The P&GD states, in summary, that:
"Depleted uranium associated with Mo-99/Tc-99m generators is exempted
from licensing requirements (see 10 CFR 40.13(c)(6)) only when it
is used as a shipping container (e.g., when the generator is in
transit from its manufacturer to the pharmacy). However, a specific
license or authorization from NRC is needed to possess and use the
depleted uranium as a shield (e.g., during the time that the pharmacy
uses or stores the Mo-99/Tc-99m generator at its facility)."
Therefore, applicants that intend to use DU as shielding must provide
the requested information in order to be authorized. |
Section 8.5.1 |
Activity Levels of Generators Using DU as a Shield |
It is not necessarily true that the DU shielding is frequently used
for generators with Mo-99 activity in excess of 148 GBq (4 Curies).
Some licensees may not use the DU shielding unless the activity is
even higher than 4 Curies. We suggest that the reference to any specific
activity level be deleted. |
NRC Staff Response: The activity level
referenced is accurate. Therefore, no change has been made. |
Section 8.5.2 |
Financial Assurance |
The Discussion section of this item indicates that this requirement
is not applicable to the commercial radiopharmacies since the vast
majority of radioactive materials they possess and re-distribute do
not have half-lives greater than 120 days. Please note, however, that
radiopharmacies may possess sealed sources with greater than 120-day
half-lives. The above statement should be clarified to indicate that
the sealed sources may be excluded from the financial requirement. |
NRC Staff Response: The guidance already
addresses this issue by referencing the activity level thresholds
referenced in 10 CFR 30.35(b) and (d), which include financial assurance
requirement thresholds for sealed sources. |
Section 8.6.1 |
Re-distribution of Sealed Sources |
The regulatory guide requires an applicant's response to include
a confirmation that the manufacturer's labeling and packaging will
not be altered for re-distribution of sources (e.g., to radiopharmacy
customers). We believe that this requirement creates an unnecessary
licensing burden on the radiopharmacies, without any added benefit
to the health and safety. As long as the re-distribution of these
sources is performed in accordance with the performance-based NRC
and DOT regulatory requirement, the prescriptive guidance provided
in this section is unwarranted and should be deleted. Please note
that the primary packaging provided by the manufacturer is frequently
altered since the radiopharmacies generally use their own packaging
for transporting orders to their customers. |
NRC Staff Response: 10 CFR 32.74(a)(3)
requires that applicants for licenses to manufacture and distribute
sources or devices containing byproduct material for medical use must
describe the label affixed to the source or device or to the permanent
storage container for the source or device. The label must contain
information on the radionuclide, quantity and date of assay, and a
statement that the U.S. Nuclear Regulatory Commission has approved
distribution of the (name of source or device) to persons licensed
to use byproduct material identified in Sections 35.57, 35.400, and
35.500 of 10 CFR Part 35, as appropriate, and to persons who hold
an equivalent license issued by an Agreement State. If other persons
wish to re-distribute sources or devices previously approved for distribution
under 10 CFR 32.74, the person re-distributing may not alter, remove,
cover, or deface the label affixed by the initial distributer to meet
the requirements of 10 CFR 32.74(a)(3). If applicants wish to affix
their own label to sources or devices for re-distribution to persons
licensed to use byproduct material identified in Sections 35.57,
35.400, and 35.500 of 10 CFR Part 35, and to persons who hold an equivalent
license issued by an Agreement State, the applicant must apply for
and receive specific authorization pursuant to 10 CFR 32.74. To the
extent that the manufacturer's original packaging is an integral part
of its authorization to distribute the source or device in accordance
with 10 CFR 32.74, persons who desire to re-distribute the source
or device must use that original packaging; however, if the packaging
is not specified in the approval for initial distribution, other persons
may repackage the source or device for re-distribution. |
Section 8.7.2 |
State Registration of Authorized Nuclear Pharmacists |
The response from an applicant requires, among other things, a copy
of the state pharmacy license or registration for the pharmacist.
Please note that the radiopharmacy licenses issued to Mallinckrodt
in various states includes the names of approximately 100 Authorized
Nuclear Pharmacists (ANPs) -these names were included in one of our
licenses prior to December 2, 1994. Subsequently, the remaining radiopharmacy
licenses issued to Mallinckrodt pharmacies were amended to name the
same ANPs. We are assuming that, upon renewal of the existing pharmacy
licenses and for new pharmacy license applications, we will be able
to continue to reference the existing ANPs, even though the pharmacy
licenses are issued to these ANPs by different states. |
NRC Staff Response: NRC's definition
of "Authorized Nuclear Pharmacist" does not require the individual
to be registered in the State in which he or she practices. The individual
must be a pharmacist and demonstration of this is usually accomplished
by evidence of State licensure or registration. Although an individual
may qualify as an ANP under NRC's regulations, nothing in that qualification
relieves the licensee or the ANP from complying with other applicable
Federal or State requirements governing radioactive drugs. |
Section 8.9 |
Description of Ventilation Systems |
The response required by the applicants includes the description
of ventilation systems, including gloveboxes or fume hoods, with
pertinent airflow rates, ventilation systems, and monitoring systems.
While we commend the NRC for proposing the performance-based approach
to the licensing of radiopharmacies, we believe that the above requirements
are rather too prescriptive, and not in the spirit of the performance-based
rulemaking. It is likely that, under the requirements of the present
regulatory guide, any changes in the ventilation system may require
an amendment to the license. We suggest that the NRC provide only
performance-based regulatory requirements to the applicants - in
terms of the facilities and equipment. |
NRC Staff Response: The applicant is
not required to provide descriptions of specific systems and operating
parameters but may include a description of minimal performance and
operating criteria. |
Section 8.10.1 |
Licensee Self-identified Deficiencies |
This regulatory guide indicates that 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
can exercise discretion and will normally elect not to cite a violation.
As indicated in the report, the NRC's goal is to encourage prompt
identification and prompt comprehensive correction of violations
and deficiencies. It Is imperative that the NRC recognize the efforts
of a licensee to identify and take appropriate actions for their
"self-identified" deficiencies and not to penalize the license for
its pro-active regulatory compliance program. Therefore, the effectiveness
of a program should be evaluated based on the end results rather
than the contents of the internal audit reports. |
NRC Staff Response: In order to evaluate
the effectiveness of a licensee's self-assessment and corrective action
program, the NRC must review the nature of the licensee's findings
during program audits and evaluate the appropriateness of the proposed
or enacted corrective actions. It is not the NRC's intention to "penalize"
licensees for proactive regulatory compliance programs. For this reason,
the NRC enforcement policy (NUREG - 1600) specifically affords
inspectors the authority to withhold the issuance of a Notice of Violation
for licensee-identified violations in those cases where it is warranted
and appropriate. |
Section 8.10.3, Table 8.1 |
Type B Packaging |
Some of the requirements in Table 8-1 are related to Type B
packages (packages containing quantities greater than Type A). Since
radiopharmacies do not generally either receive or ship Type B packages,
this information should be deleted. |
NRC Staff Response: The NRC recognizes
that radiopharmacies do not generally receive or ship these types
of packages; however, the guidance is provided for those licensees
and applicants for whom it may be warranted. |
Section 8.10.8 |
Dose Calibrator Beta-correction Factors |
The discussion and the applicant's response requires a sample calculation
for determining beta-correction for dose calibrators with ionization
chambers for beta emitting radionuclides. However, 10 CFR 35.53(b)
provides an exemption for unit doses prepared by manufacturers or
prepared under 10 CFR 32.72 (or equivalent Agreement State requirements).
This information should be added under Item 10.8.8. (sic) |
NRC Staff Response: Since 10 CFR 35.53(b)
does not apply to licensed radiopharmacies, discussion of the exemption
described in the comment is not appropriate for this guidance document.
If radiopharmacy applicants intend to only redistribute beta-emitting
radionuclides that have been previously prepared and distributed by
other persons licensed pursuant to 10 CFR 32.72, then the correction
factor calculation is not required. If radiopharmacies intend to initially
distribute, i.e., measure, prepare, and label, beta-emitting radionuclides,
the applicant must provide the calculation to demonstrate its ability
to accurately dispense such materials. |
Section 8.10.12 |
Transport Radiation Shields |
The regulatory guide provides, as general guidelines, the surface
dose rates for the "transport radiation shields" (e.g., not more
than 3 mrem/hr of Tc-99m products, 50 mrem/hr for diagnostic dosages
of 1-131, and up to 150 mrem/hr for therapeutic 1-131 dosages).
As stated earlier in our comments under Comment #6 (Item 8.9 (Item
9), Facilities and Equipment), we believe that the above dose rate
criteria for the transport radiation shields are rather prescriptive
and do not fall under the performance-based approach of the requirements
of this regulatory guide. We suggest that these dose rate criteria
be deleted, and, instead, the licensees should be evaluated based
on compliance with the DOT requirements for transporting radiopharmaceutical
products. We agree, however, that the applicant should select appropriate
shielding materials and dimensions to not only ensure that the occupational
doses are ALARA, but also that the "transport radiation shields"
can be easily handled for occupational safety. |
NRC Staff Response: The dose rates
contained in the "Discussion" Section of the guidance are provided
as a reference to dose rate emissions for previously NRC-approved
transport radiation shields. The dose rates are not prescriptive,
but informative. The decision to approve or deny new transport radiation
shields will be based on the ability of the shield to achieve compliance
with DOT requirements as well as to maintain worker (pharmacy and
customer) radiation exposures as low as is reasonably achievable,
while assuring ease of handling for occupational safety purposes. |
Appendix I |
Dose Calibrator Testing Deviations |
The audit checklist under Equipment and Instrumentation (G-Dose
Calibrators for Photon-Emitters, and H-Dose Measurement Systems for
Beta and Alpha Emitters, 10 CFR 32.72(c)), the constancy, linearity,
geometry, and accuracy deviations are indicated as + 10%. We believe
the deviations should be indicated as ± 10% (as correctly indicated
in Appendix 0). |
NRC Staff Response: Comment acknowledged
and correction made. |
Appendix N |
Conversion |
Item 2 under the training program indicates the training criteria
for individuals who are likely to receive an occupational dose in
excess of 100 mSv (100 mrem). Please note that the criteria should
be corrected to indicate 1 mSv (100 mrem). |
NRC Staff Response: Comment acknowledged
and correction made. |
Appendix O, Item 2 |
Installation of Dose Calibrators |
Model program requires repeat of the above tests (constancy, linearity,
geometry, accuracy) after repair, adjustment, or relocation to another
building. The present NRC interpretation indicated to Mallinckrodt
radiopharmacies is that these tests are required after "any" relocation.
Please clarify the interpretation of this requirement - in particular,
is the relocation intended to mean only upon relocation to another
building? |
NRC Staff Response: Operational tests
must be repeated when the dose calibrator is relocated to another
location, if the relocation involves extensive handling. If the handling
could reasonably call into question the proper functioning of the
ionization chamber or electronics, then the applicable tests must
be repeated. Relocation includes movement to another location within
the same building. |
Appendix O, Item 4 and 4.2.5.1 |
Lower Limit of Linearity Testing |
There appears to be a conflict in these two requirements; Item 4
indicates that the linearity of a dose calibrator should be ascertained
over the range of its use between the maximum activity in a vial and
30 microcuries, whereas 4.2.5.1 indicates the lower ranges as
10 microcuries. Please provide the corrected values for the lower
range. We believe the correct value should be 30 microcuries, as specified
in 10 CFR 35.50(b)(3). |
NRC Staff Response: The range in 4.2.5.1
should be changed to indicate a lower range of 30 microcuries
for linearity testing. |
Appendix O, Item 1.2 and 4.2.5.5 |
Acceptable Linearity Deviation |
There appears to be a conflict in these two requirements: Item 1.2
indicates a deviation of ±10% whereas Item 4.2.5.5 indicates a deviation
of 5% for the linearity test. Please make the necessary corrections
to indicate that the acceptable deviation is ±10%. |
NRC Staff Response: Item 1.2 states
that an acceptable level of deviation is ±10%. Item 4.2.5.5 indicates
that if the deviation is more than ±5%, then the dose calibrator should
be repaired or replaced. If not repaired or replaced, then it is necessary
to make a correction table or graph that will allow conversion from
activity indicated by the dose calibrator to "true activity." There
is no conflict between these two sections. The maximum acceptable
error is 10%. For errors between 5 and 10%, the dose calibrator reading
must be corrected to reflect the "true activity" of the measured dose. |
Table U.4 Comments from the Council on Radionuclides and Radiopharmaceuticals,
Inc. (CORAR), Dated June 2, 1999
Location |
Subject |
Comment |
Appendix C and Appendix D |
Licensee Versus NRC Model Formats |
There are two listings for Appendix D. Appendix C and the second
Appendix D both have the same title, "Suggested Format for Providing
Information Requested in Items 5 through 11I on NRC Form 313."
This is confusing.
Whereas this title is appropriate for Appendix C, the Appendix
D is to be used as a checklist by NRC to review applications and
the second listing for Appendix D should be re-titled to reflect
this use. |
NRC Staff Response: The title of Appendix
D has been changed to reflect its use as a checklist for NRC license
reviewers. |
Section 8.2 |
Timely Notification of Transfer of Control |
Page 8-3 and Appendix F both state that licensees must provide
full information and obtain NRC's prior written consent before
transferring control of the license. Our experience tells us that
this is an unreasonable expectation of NRC and one that is subject
to inconsistent interpretation at the regional level. In some cases,
NRC has cited licensees for failing to obtain prior written approval
when there have been changes such as changes in subsidiary business
relationships or name changes of subsidiaries where the effect of
day to day control of and responsibility for licensed activities
has not changed. In other cases, similar changes have been reported
informally to NRC before and after the fact without formal written
consent required.
Regardless of the inconsistent approach taken by NRC on this, the
difficulty we have as licensees is that the details required by
NRC concerning these activities are rarely available in advance.
The expectation is one that cannot be achieved and sets up licensees
for needless noncompliance. |
NRC Staff Response: This comment has
already been addressed in the response to the comment from Mallinckrodt,
Inc., which is similar. |
Section 8.2 |
Timely Notification of Transfer of Control |
In the third paragraph on page 8-7 it states that applicants should
review requirements for financial surety arrangements for decommissioning
before specifying possession limits of any radioisotope with a half-life
greater than 120 days. This statement should address the fact that
material such as this possessed in the form of sealed sources may
be excluded from financial assurance requirements. |
NRC Staff Response: This comment has
already been addressed in the response to the comment from Mallinckrodt,
Inc., which is similar. |
Section 8.5.1 |
Sealed Versus Unsealed Materials |
In the discussion of the contents of license application, the
terms sealed and unsealed are used in a fashion that is misleading.
These terms need to be more clearly defined and the fact that material
in a form other than sealed sources can be contained and not in
an open form should be considered. If "sealed" means "sealed sources,"
then use of the term "unsealed" as in the beginning of the second
paragraph on page 8-7 under 8.5.1 is inappropriate. A sealed vial
of radioiodine does not present the same concerns over volatility
as does open form material removed from a vial.
In many licenses, the form of material for which possession is
authorized is "any" unless the form is specified as "sealed source."
It would be useful to limit the forms authorized in licenses to
"any" and "sealed source" while providing some degree of credit
in this guide for containment of material to sealed forms other
than those encapsulated as "sealed sources." |
NRC Staff Response: The NRC has consistently
applied the terms "sealed" and "unsealed" sources for all of its licensees,
regardless of particular nuances used by specific professions. As
used in this, and all, NRC references, "sealed source" means any byproduct
material that is encased in a capsule designed to prevent leakage
or escape of the byproduct material. This is NRC's definition of "sealed
source," and can be found in 10 CFR 30.5. The design of sealed sources
is such that access to the encased byproduct material can only be
gained by destruction of the containing capsule. Unsealed sources
are, by default, everything else that does not meet the definition
of a sealed source. |
Section 8.5.1 |
Use of Depleted Uranium |
Possession of depleted uranium as shielding is exempt under 10 CFR
40.13(c)(6). The shielding provided in Mo-99 generators qualifies
for this exemption. The instruction provided and the reference to
the use of depleted uranium in Mo-99 generators on page 8-8, on page
C-4 of Appendix C, under 8.6.2 on page 8-15 and in the table on page
D-4 of Appendix D should be removed. |
NRC Staff Response: This comment has
already been addressed in the response to the comment from Mallinckrodt,
Inc., which is similar. |
Section 8.5.1 |
Manipulation of Volatile Materials |
Under 8.5.1 on page 8-8, the instruction states that the applicant
must specify whether potentially volatile material will be "manipulated"
at the pharmacy. The term "manipulated" needs to be defined in order
for an applicant to provide the appropriate response. In other words,
"manipulated" for an applicant may be interpreted as including the
handling of sealed vials of radioiodine for the purposes of redistribution
to customers. It could also be the handling of open form radioiodine
in a hood to produce therapeutic capsules for distribution. The use
of the term is unclear and this needs to be addressed to prevent applicants
from providing needlessly specific detail. |
NRC Staff Response: This comment has
already been addressed in the response to the comment from Mallinckrodt,
Inc., which is similar. |
Section 8.6.1 |
Compounding Non-FDA Approved radiopharmaceuticals |
There is a lengthy and comprehensive discussion under 8.6.1 on page
8-12 concerning the distribution and redistribution of medical use
material. This characterization should include the compounding of
non-FDA approved radiochemicals by an applicant or pharmacy currently
licensed by the NRC or Agreement States for the redistribution
of radiopharmaceuticals to customers licensed by the NRC or Agreement
States to possess radiopharmaceuticals. In addition to including this
scenario in the discussion, NRC should also state its position as
to whether or not this is acceptable from a licensing standpoint.
The NRC's position should then be considered in the response instructions
provided on page 8-13 and under 8.6.2 on page 8-15 for radiopharmaceuticals. |
NRC Staff Response: The NRC regulates
the possession, use, and distribution of radiochemicals and radiopharmaceuticals
from the standpoint of worker and public radiation protection. The
fitness of a particular radiochemical for use in compounding radiopharmaceuticals
for ultimate use in medicine is outside NRC's regulatory authority,
and therefore, discussion of this issue is not appropriate in this
guidance document. |
Section 8.6.1 |
Re-distribution of Sealed Sources |
On pages 8-13 and 8-14, and on pages C-1 and C-3 of Appendix
C, it is stated that the applicant's response must provide a confirmation
that the manufacturer's packaging, labeling and shielding will not
be altered when sources are redistributed. This instruction applies
to brachytherapy sources as well as calibration and reference sources.
The requirement to provide this confirmation is unreasonable and
unnecessary and should be removed.
In many cases, the primary container may be transferred from packaging
provided by the manufacturer into another package that the pharmacy
uses to transport orders to customers. For these cases, it is not
possible for the applicant to confirm that packaging will not
be altered. In situations where transfer of sources for redistribution
from manufacturer's packaging involves the use of different shielding
in pharmacy packaging, confirmation that shielding will not
be altered is unnecessary and duplicative, especially in light of
the NRC's requirement under 10 CFR 32.72 and 8.10.12 of the guide
to specify the shielding that is used. |
NRC Staff Response: This comment has
already been addressed in the response to the comment from Mallinckrodt,
Inc., which is similar. |
Section 8.8.1 |
Dose Terminology |
Section 8.8.1 starting on page 8-23 provides criteria and discussion
regarding control of dose. Throughout this section the term "dose"
is used in the context of the annual limit of 1 mSv. For the purpose
of technical accuracy and to be consistent with the regulations that
are referenced in this section, the term "dose" should be replaced
with "total effective dose equivalent." |
NRC Staff Response: 10 CFR 20.1003
defines "dose" as an acceptable generic term for "total effective
dose equivalent." The term, as used, is accurate and consistent with
the regulations pertaining to occupational exposure. |
Section 8.9 |
Description of Ventilation System |
The response required under 8.9 on page 8-29 includes descriptions
of ventilation and containment systems with airflow rates and pressure
differentials. Also required is detail in diagrams that indicates
specific locations of shielding, sources and other items "related
to radiation safety."
While this draft, overall, takes a more risk-informed, performance-based
approach to licensing nuclear pharmacies than in previous documents,
section 8.9 requires information that is not performance-based and
is unnecessarily restrictive in terms of the level of detail that
would be included in the application. It is likely, with the detail
provided, that subtle changes would later occur without any impact
on the ability to meet NRC performance expectations and would require
an amendment to the license. 8.9 should simply require the applicant
to confirm that facilities and equipment will be sufficient to meet
performance expectations such as 10 CFR 20.1301 and other relevant
regulations. |
NRC Staff Response: This comment has
already been addressed in the response to the comment from Mallinckrodt,
Inc., which is similar. |
Section 8.10.1 |
Licensee Self-identified Deficiencies |
The discussion in 8.10.1 on page 8-30 concerning licensee audits
states that NRC will review the licensee's audit results and determine
if corrective actions are satisfactory. The discussion goes on to
state that audit findings would be included in the audit records
that NRC will review.
For a variety of reasons not related directly to NRC involvement,
licensees may be unwilling to document specific observations made
in the course of audits. If observations are recorded, some licensees
may not be willing to make these available to outside agencies.
NRC's insistence that this information be made available could ultimately
be counterproductive in that audit reports may be documented in
the format of a summary rather than a detailed roadmap of licensee
performance.
At the same time, if it is the NRC's intent as reported to streamline
and make the licensing and inspection programs more risk-informed
and performance-based, then the focus of NRC's attention should
be the end product or performance of licensee programs rather than
licensees' internal audit reports and the information contained
therein. The effectiveness of audit programs will be determined
by NRC inspections not by the information regarding observations
in the audits themselves. If the NRC's goal is to have licensees
take prompt and corrective action to self-identified deficiencies,
this can be achieve by licensee corrective action programs. The
effectiveness of these programs and the documentation of their activities
can be monitored without a review of audit reports. Regardless,
it is the overall licensee performance that should ultimately be
of interest to the NRC and not the details of observations made
in the course of internal audits. |
NRC Staff Response: This comment has
already been addressed in the response to the comment from Mallinckrodt,
Inc., which is similar. |
Section 8.10.3, Table 8.1 |
Type B Packaging |
Table 8.1 on page 8-34 contains labeling and survey requirements
for packages of radioactive material. This table includes requirements
for packages containing quantities greater than Type A. Since commercial
nuclear pharmacies do not receive Type B shipments, this information
is superfluous and should be removed from this table. |
NRC Staff Response: This comment has
already been addressed in the response to the comment from Mallinckrodt,
Inc., which is similar. |
Section 8.10.5 |
Constraints on Air Emissions |
The discussion in 8.10.5 on page 8-41 includes the following
statements: "In addition, the licensee must control air emissions,
such that the individual member of the public likely to receive
the highest exposure does not exceed 0. 1 mSv (10 mrem)(TEDE)
per year from those emissions. If the exposure to a member of the
public has exceeded the constraint on emissions, the licensee must
report this exceedance, in accordance with 10 CFR 20.2203, and take
prompt actions to ensure against recurrence."
The intent of these statements is recognized yet the wording is
confusing and technically incorrect. We recommend that these statements
be reworded as follows:
"In addition, the licensee must control air emissions, such that
the individual member of the public likely to receive the highest
total effective dose equivalent (TEDE) does not exceed the constraint
level of 0.1 mSv (10 mrem) per year from those emissions. If
exceeded, the licensee must report this in accordance with 10 CFR
20.2203, and take prompt actions to ensure against recurrence. |
NRC Staff Response: We agree with the
commenter's proposed wording. The text will be changed. |
Section 8.10.8 |
Dose Calibrator Beta-correction Factors |
The discussion and required response concerning assay of beta-emitting
radionuclides in 8.10.8 makes no mention of the provision in 10 CFR
35.53(b) which exempts unit doses prepared by manufacturers and/or
in accordance with 10 CFR 32.72 from the requirement for direct measurement
of activity. This should be added to the discussion and provided as
a response option in 8.10.8 and as a condition to the sample license
provided as Appendix E. |
NRC Staff Response: This comment has
already been addressed in the response to the comment from Mallinckrodt,
Inc., which is similar. |
Section 8.10.9 |
Type A Package Testing |
On page 8-54 under 8.10.9 it states in the discussion that Type
A packages must meet stringent criteria, including testing to "withstand
accident situations and rough handling conditions." While we agree
that these packages are robust enough to withstand rough handling
and the most extreme conditions normally encountered in the course
of commercial distribution, Type B containers and not Type A packages
are designed to withstand accidents. Type B quantities of radioactive
material are not handled within the scope of commercial nuclear pharmacy
operations. |
NRC Staff Response: We agree that Type
B packages are specifically defined by DOT and NRC to withstand hypothetical
accident conditions and that there is no mention of ability to withstand
accidents in the DOT definition of Type A packages. When the draft
guidance was written, we envisioned minor accidents in our description
of the "robustness" of Type A packages, not the catastrophic accidents
hypothesized for testing of Type B packages. The wording in Section
8.10.9 will be clarified to address the intended meaning. |
Section 8.10.12 |
Drug Versus Radiochemicals |
8.10.12 starting on page 8-56 is titled "Radioactive Drug Shielding
for Distribution." The use of the word "drug" in the title, discussion
and applicant response section, as well as on page C-14 in Appendix
C, requires information that is not performance-based and is unnecessarily
restrictive in terms of the level of detail that would be included
in the application implies that radiochemicals, sealed sources, radiobiologics
and radiopharmaceuticals may be excluded. If it is NRC's intent to
ensure all these materials are shielded adequately, then the title
and wording should be revised to reflect this. |
NRC Staff Response: 10 CFR 32.72(a)(3)
requires that applicants provide information on the shielding provided
by the packaging to show it is appropriate for the safe handling and
storage of the radioactive drugs by medical use licensees. As used
in this guidance document, the term "radioactive drug" is used interchangeably
with the terms "radiopharmaceutical" and "radiobiologic"; therefore,
no changes are needed. |
Section 8.10.12 |
Transport Radiation Shields |
The required response from applicants on page 8-57 is to include
the maximum content and the type and thickness of the "transportation
radiation shield" for each type of container. This is another example
of where the information is not performance-based and is unnecessarily
restrictive in terms of the level of detail that would be included
in the application. If dose rates or shielding need to be provided
to ensure that dose rates are acceptable, then the applicant should
be able to provide ranges or maximums that would not be exceeded to
allow licensees to make modifications, including improvements, to
packaging and shielding without having to amend a license to do so. |
NRC Staff Response: This comment has
already been addressed in the response to the comment from Mallinckrodt,
Inc., which is similar. |
Section 8.10.13 |
Leak Testing of Sealed Sources |
The discussion and response requirements included under 8.10.13
on page 8-57 and the conditions stated in the example license provided
as Appendix E include leak test performance criteria but do not include
the provision in 10 CFR 35.59(f)(1-5) which specifies sources for
which leak testing is not required. This needs to be added to avoid
the implication that all sealed sources must be leak tested. |
NRC Staff Response: The provisions
in 10 CFR 35.59(f) are not applicable to radiopharmacy licensees.
The leak testing criteria for specific sealed sources is established
in the Sealed Source and Device Registration Certificate. If the conditions
of the issuance of the registration certificate do not require leak
testing, then the source is exempted from leak testing. |
Section 9 |
License Amendments |
Section 9 on page 9-1 states that the licensee must submit an
application for license amendment before a change takes place if
any of the information provided in the original application is modified
or changed. While the need to keep licenses current is understood
and appreciated, the requirement to amend a license for any changes
is an unnecessary and unrealistic performance expectation placed
upon both the NRC staff and the licensee. This demand contravenes
the NRC initiative to streamline the licensing process and does
not, at face value, provide licensees with the reasonable flexibility
to make changes without amendment that do not have health and safety
implications.
A more reasonable approach would be the ability of the licensee
to file reports that could be added to the licensee file to inform
NRC of changes without the need to go through a formal amendment
application and review process. Another option would be for the
NRC to establish a schedule of items typically specified in license
applications that would or would not be subject to the amendment
process if changes were made. |
NRC Staff Response: Due to the nature
of the new application format implemented for this NUREG, submission
of amendment requests to address changes in licensee programs will
likely become rare occurrences. Changes that will necessitate submission
of an amendment request include, but are not limited to: modifications
or additions to facilities; appointing a different individual to the
position of radiation safety officer; and adding new activities not
previously authorized by the license (such as service activities).
Changes to specific procedures will not require a license amendment
prior to implementation due to the flexibility designed in the responses
from the applicant. |
Table U.5 Comment by the American Pharmaceutical Association,
Dated June 29, 1999
Location |
Subject |
Comment |
Numerous, and Specifically Sections 8.6.1, 8.8.3, and 8.10.8 |
Interference in the Practice of Pharmacy |
To paraphrase, the commenter is concerned that the draft guidance
document included suggested responses from applicants that would interfere
in the practice of pharmacy, and lists Sections 8.6.1 (Distribution
and Redistribution of Sealed and Unsealed materials); 8.8.3 (Instruction
for Supervised Individuals Preparing radiopharmaceuticals); and 8.10.8
(Dosage Measurement Systems) as evidence of this interference. |
NRC Staff Response: The writing team
took special care to ensure that the draft guidance did not include
anything that would interfere in the practice of pharmacy. Nowhere
in the draft guidance is there discussion of specific pharmacy practices.
The guidance document is intended to be used as an "implementation
instrument," to aid applicants and licensees in meeting specific regulatory
requirements, but it does not impose any new requirements that are
not found in the regulations. Since the practice of pharmacy is outside
NRC's regulatory jurisdiction, the guidance document is limited to
the discussion of radiation safety practices to meet those regulatory
requirements.
With regard to the sections referenced, the comment did not address
specific aspects of the suggested responses from applicants that
interfered with the practice of pharmacy. Furthermore, Section 8.8.3
(Instruction for Supervised Individuals Preparing radiopharmaceuticals)
does not require a response. Without providing more specific information,
we cannot adequately address this comment. |
Entire Document
|
Coordination with Issuance of Proposed Revision to 10 CFR Part
35 |
It is our understanding that notable changes are currently taking
place in 10 CFR 35, with significant changes to requirements for medical
licensees. It is inappropriate to publish this NUREG document when
it is not in line with the requirements of the upcoming 10 CFR 35
final rule. Although the final language and requirements of the new
10 CFR 35 are not yet known by licensees and members of the general
public, enough is known about the intent of such changes to see that
the suggested procedures in NUREG - 1556 Vol. 13 are not
aligned with those changes. It would be inappropriate for the procedures
for commercial nuclear pharmacy licensees under Part 32 to be different
from that required of medical licensees under Part 35. The two documents
need to be coordinated in their requirements and/or suggested procedures
for licensing documents. |
NRC Staff Response: The only section
in the proposed revision to 10 CFR Part 35 that will apply to radiopharmacies
is the definition and training requirements for an authorized nuclear
pharmacist, as is found in the current version of the regulation.
10 CFR Part 35 is concerned with the medical use of byproduct materials,
i.e., the application of radiation and administration of radioactive
materials to humans in the practice of medicine. 10 CFR 32.72, the
"Radiopharmacy Rule," governs the manufacture and distribution of
byproduct materials for medical use. Since the requirements of the
current and proposed revision of 10 CFR Part 35, with the exception
noted above, do not and will not apply to radiopharmacy licensees,
it is not necessary to coordinate publication of the proposed guidance
document in final form and the issuance of the proposed revision of
10 CFR Part 35. |
[ Top of file
]
1. See "Amendments and Renewals to a License" later
in this document.
2. ANSI N323A-1997, "Radiation Protection Instrumentation
Test and Calibration."
3. The calibration factor should be based on two kinds
of determinations. First, correction factors should be determined at several
flow rates distributed over the full-scale range. Each flow rate correction
factor should be determined while adjusting flow rates upscale and again
while adjusting flow rates downscale, and the two sets of data should
be compared. Second, subsequent calibrations should compare the new correction
factors to those determined during the previous calibration. If observed
differences are significant compared to the overall volume error limit
of 20%, an additional error term should be included in the calculation
above.
4. Assay times should be measured in whole hours and
correction factors should be used to three significant figures as indicated.
The half-life of T1/2 = 6.02 hours has been used in calculating
these correction factors.
Example: If the net activity measured at 30 hours was 15.6 mCi,
the calculated activities for 6 and 48 hours would be 15.6 mCi x 15.9
= 248 mCi and 15.6 mCi x 0.126 = 1.97 mCi, respectively.
|