Georgetown University Radiation Safety Manual

Georgetown University
Radiation Safety
Manual
Georgetown University Radiation Safety
LM-12 Preclinical Science Building
3900 Reservoir Road, N. W.
Washington D.C. 20057-1431
(202) 687-4712
Table of Contents
Chapter 1
Georgetown University Radiation Safety Program Management. . . . . . . . . . . . . . . . . . . . . . . .
1.1 Executive Management.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2 Radiation Safety Committee (RSC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3 Radiation Safety Officer (RSO). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4 Radiation Safety Office Staff (RSOS). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.5 Deputy Radiation Safety Officer (DRSO). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.6 Authorized Users (AU). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.7 Assistant Authorized Users (AAU). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8 Radioactive Materials (RAM) Workers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1-1
1-1
1-2
1-3
1-4
1-5
1-6
1-7
1-8
Chapter 2
Authorized User Applications and Amendments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.1 Approval Criteria for Authorized Users (AU). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.2 New Applications for an Authorization to Use Radioactive Materials (RAM). . . . . . . . . .
2.3 Amendments to an Existing Authorization to Use Radioactive Materials (RAM). . . . . . .
2.4 Assistant Authorized Users (AAU). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.5 Authorization to Use Radioactive Materials (RAM) in Animals. . . . . . . . . . . . . . . . . . . . .
2.6 Radiation Monitoring Instruments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.7 Approved Irradiator Operators (AIO). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.8 Renewal of the Authorization to Use Radioactive Materials (RAM).. . . . . . . . . . . . . . . . .
2-1
2-1
2-2
2-3
2-4
2-5
2-6
2-7
2-8
Chapter 3
Facilities and Equipment .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.1 Facilities Designated for Special Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.2 Radionuclide Toxicity and Laboratory Classification. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.3 Designated “Clean Areas”. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3-1
3-1
3-2
3-3
Chapter 4
Radiation Safety Training Requirements.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 1
4.1 Authorized Users (AU). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 1
4.2 Assistant Authorized Users (AAU). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 2
4.3 Authorized User (AU) Laboratory Specific Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 3
4.4 Georgetown University (GU) Radioactive Materials (RAM) Workers. . . . . . . . . . . . . . . . 4 - 4
4.5 Authorized User (AU) and Radioactive Materials (RAM) Worker Enforcement Training . ..4 - 5
4.6 Non-Radioactive Materials Workers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 6
4.7 Ancillary Personnel.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 7
4.8 Approved Irradiator Operators (AIO). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 8
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Chapter 5
Authorized User Survey Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1 Undocumented Survey Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2 Documented Survey Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.3 Documented Clean Area Survey Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.4 Personnel Contamination Monitoring.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.5 Surveys for Facility Release for Unrestricted Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.6 Sealed Source Leak Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5-1
5-1
5-2
5-3
5-4
5-5
5-6
Chapter 6
Radiation Safety Audit Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 1
6.1 Radiation Safety Committee (RSC) Audits of the Radiation Safety (RS) Office.. . . . . . . . 6 - 1
6.2 Radiation Safety Office Staff (RSOS) Audits of Authorized User (AU) Laboratories. . . . . 6 - 2
Chapter 7
Radioactive Material Receipt and Accountability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 1
7.1 Purchasing Radioactive Material (RAM). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 1
7.2 Receipt of Radioactive Materials (RAM). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 2
7.2.1 Normal Work Hours. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 2.1
7.2.2 After Normal Work Hours. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 2.2
7.2.3 Radiation Safety (RS) Office - Radioactive Materials (RAM) Receipt Surveys. . . . 7 - 2.3
7.3 Authorized User (AU) Receipt of Radioactive Materials (RAM). . . . . . . . . . . . . . . . . . . . 7 - 3
7.4 Control and Accountability of Radioactive Material (RAM). . . . . . . . . . . . . . . . . . . . . . . . 7 - 4
7.4.1 Unsealed Radioactive Materials (RAM). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 4.1
7.4.2 Sealed Sources. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 4.2
7.4.3 Internal Transfers of Radioactive Materials (RAM). . . . . . . . . . . . . . . . . . . . . . . . . 7 - 4.3
7.4.4 Radioactive Material (RAM) Shipments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 4.4
7.5 Radioactive Materials (RAM) Security. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 5
Chapter 8
Personnel Dosimetry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.1 External Dosimetry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.2 Internal Dosimetry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.3 As Low As Reasonably Achievable (ALARA). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.4 Declared Pregnant Workers (DPW). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.5 Public Dose. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8-1
8-1
8-2
8-3
8-4
8-5
Chapter 9
Safe Use of Radioactive Materials.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 - 1
9.1 Guidelines for the safe use of Radioactive Materials (RAM).. . . . . . . . . . . . . . . . . . . . . . . 9 - 1
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Chapter 10
Emergency Procedures.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 - 1
10.1 Radiation Emergency Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 - 1
Chapter 11
Radiation Producing Devices.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 - 1
11.1 Authorization for the Use of Radiation Producing Devices (RPD). . . . . . . . . . . . . . . . . 11 - 1
11.2 Regulatory Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 - 2
Chapter 12
Radioactive Waste Management. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12.1 General Requirements.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12.2 Radioactive Waste Disposal to Radiation Safety Office Staff (RSOS). . . . . . . . . . . . . .
12.3 Radioactive Waste Reduction Methods. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12.4 Sink Disposals.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12.5 Transfer to An Authorized Recipient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12.6 Decay In Storage (DIS). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12.7 RSOS Disposals Via the Sanitary Sewer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12.8 Incineration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12.9 Effluent Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12 - 1
12 - 1
12 - 2
12 - 3
12 - 4
12 - 5
12 - 6
12 - 7
12 - 8
12 - 9
APPENDIX A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A - 1
APPENDIX B. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B - 1
APPENDIX C. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C - 1
APPENDIX D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D - 1
GLOSSARY OF TERMS AND ACRONYMS.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E - 1
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Chapter 1
Georgetown University Radiation Safety Program Management
1.1 Executive Management
The executive management’s written statement to the Radiation Safety Committee (RSC) and
Radiation Safety Officer (RSO) providing requisite authority to communicate with, enforce, and direct
personnel regarding NRC regulations and license provisions is provided in Appendix A of this manual.
The RSO reports to the Director, Office of Environmental Health & Safety (EH&S) for routine
operations, and may report directly to the Senior Associate Vice President (SAVP), Office of
Regulatory Affairs, for radiological concerns and license compliance. The SAVP for Regulatory
Affairs serves on the RSC as the Management Representative and reports directly to the Executive
Vice President (EVP) for Health Sciences.
The organizational chart which shows the RSC and RSO reporting path to executive management is
provided in Appendix B of this manual.
1.2 Radiation Safety Committee (RSC)
Membership meets the requirements in 10 CFR § 33.13. The RSC members may change without
notification to the NRC. Membership consists of at least three individuals, the RSO, the Chairman,
and, a management representative who is neither an Authorized User (AU) nor a RSO. An AU of the
type of use performed under the license will also be included. Other members may be included as
management deems appropriate.
The Chairman of the RSC must have served as a RSC member for at least one year; qualified by
experience or training to work with radioactive materials (RAM) and/or radiation producing devices
(RPD), or direct or supervise related activities as a member of management. The Chairman must by
virtue of his/her experience or position have stature as a senior institutional figure.
The RSC meets as often as necessary to conduct business (routinely on a quarterly basis). A quorum
for a RSC meeting requires one-half of the membership be present including the RSO, the Chairman,
and the management's representative, or their designees. Acceptable attendance includes
teleconferencing and video conferencing. A quorum is required for voting. The RSC quorum will
include a representative from each area of byproduct material use for which a specific issue will be
discussed, and any other member whose field of expertise is necessary for the discussion. It should be
pointed out that, although faculty hold appointments in various academic departments, the majority of
research undertaken at GU involves cellular & molecular biology, and cancer research.
The meeting minutes will be recorded and include: date of the meeting; members present; a summary
of discussions, recommendations and results of votes; review of new users, uses and program changes;
ALARA program reviews; and, the annual Radiation Safety (RS) program audit review.
RSC control functions and administrative procedures include but are not limited to:
• Conducting periodic reviews of the RS program, making recommendations and ensuring
that changes are made when necessary;
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Reviewing AU applications for radiation safety and regulatory requirements;
Approving, disapproving or requiring modifications of AU applications;
Reviewing the ALARA program and making recommendations when necessary;
Appointing subcommittees to review policies, procedures and incidents when appropriate;
Reviewing the RS program's annual report to determine that all activities are being
conducted safely, in accordance with NRC regulations, conditions of the license, and,
consistent with the ALARA program and philosophy;
Adjudicating matters relating to RS if disagreement arises between the RSO and individual
users on interpretation of policies for the safe use of radiation;
Acting directly or through management and/or the RSO to ensure that policies,
recommendations and acts of enforcement are carried out;
Developing procedures and criteria for training and testing;
Developing safety manuals as needed;
Ensuring that records of meetings are maintained; and,
Ensuring that records of proposed users and uses of RAM and RPDs are maintained.
The RSC reviews each Radioactive Materials Authorization (Authorization) every three years. The
renewal includes: a review of the AU's safety and compliance history; types & quantities of RAM
requested; facilities & equipment; and, training and supervision of radiation workers in the users'
laboratory. If there have been no changes to the Authorization since the last renewal, or minor
additions or deletions, an abbreviated application may be submitted. Otherwise, a complete application
must be submitted.
The RSC may make program changes and revise procedures which were previously approved by the
NRC and incorporated into the license, without prior NRC approval in the following areas:
C Training for Individuals Working in or Frequenting Restricted Areas;
C the Audit Program;
C Radiation Monitoring Instruments;
C Material Receipt and Accountability;
C Occupational Dose;
C Safe Use of Radionuclides and Emergency Procedures; and,
C Surveys.
The RSC may make the program changes and revise procedures, as stated above, as long as the
program change or revised procedure:
C Is reviewed, approved, and documented by the RSC prior to implementation;
C Satisfies regulatory requirements;
C Does not change existing license conditions;
C Does not decrease the effectiveness of the RS Program; and,
C Is reviewed with Licensee staff prior to implementation.
All substantive procedural changes submitted for review by the RSC will include details of:
• the previous procedure;
• the proposed changes;
• the reasons for the changes; and,
• a summary of the radiation safety matters that were considered prior to the approval of the
revised procedure.
The current RSC membership is listed in Appendix C of this manual.
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1.3 Radiation Safety Officer (RSO)
The RSO's duties, responsibilities and authority include but are not limited to:
C Surveillance of overall activities involving RAM, including routine monitoring and special
surveys of all RAM use areas;
C Determining compliance with rules and regulations, license conditions, and the conditions
of project approvals specified by the RSC;
C Approving orders and receiving, inspecting and distributing all RAM arriving at the
facility;
C Conducting training programs - initial, refresher, and special training when dictated by
changes in regulations, policies or procedures;
C Maintaining the RAM inventory within the license limits;
C Providing a personnel monitoring program, and assuring exposures are ALARA;
C Supervising and conducting a radioactive waste disposal program, including effluent
monitoring, and, maintenance of waste storage and disposal records;
C Performing or arranging for leak tests on all sealed sources, and calibration of radiation
survey instruments;
C Supervising decontamination and recovery operations;
C Furnishing consulting services on all aspects of radiation protection to personnel at all
levels of responsibility;
C Reviewing and approving radiation monitoring instruments to ensure that appropriate
radiation monitoring equipment will be used during licensed activities;
C Maintaining records of receipt, transfer and disposal of byproduct material;
C Packaging, labeling, surveying, etc., all RAM shipments leaving the institution;
C Terminating any activity that is found to be a threat to health or property;
C Meeting with management in a setting other than an RSC meeting to discuss issues of
concern or interest; and,
C Administrative Approval of Amendments to the Radioactive Materials Authorization in
accordance with Section 2.3.2 of this manual.
The RSO, approved by the RSC and the NRC, is the individual who is named on the NRC License
[08-03114-05]. The current RSO is Catalina E. Kovats, M.S.
1.4 Radiation Safety Office Staff (RSOS)
Management is committed to providing adequate resources to the RS Program (i.e., space, equipment,
personnel, adequate salaries, time, and, if needed, contracted support). The RSO is currently supported
and assisted in carrying out the duties and responsibilities by the following: an Assistant RSO
(ARSO); a Senior Health Physicist (Sr. HP); a Health Physicist (HP); a Radiation Safety Technician
(RST); and, Administrative Support.
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1.5 Deputy Radiation Safety Officer (DRSO)
The RSC may appoint Deputy Radiation Safety Officer(s) (DRSO) who will maintain continued
compliance with NRC requirements when the RSO will be away for short periods of time (i.e.
professional conferences, training, vacations, or illness). In those instances, the DRSO would be
delegated authority to sign records and reports as required by the regulations. These individuals would
be directly responsible to the RSO and to the RSC. The DRSO will have a minimum of: a bachelors
degree from an accredited college/university in physical science, engineering or biological science with
a minimum of 20 semester hours in physical science; or 200 hours of classroom and laboratory training
in radiation safety; and, one year full time experience in radiation safety. Consideration will be given
to an individual having a combination of education and radiation safety experience. Upon return, the
RSO will review all required records. Therefore, the DRSO is delegated the duties but not the
responsibility.
1.6 Authorized Users (AU)
An AU of radiation sources (RAM or RPD) is a researcher who has submitted a written application to
the RSC describing the proposed use of the radiation sources, and has received an approved
Authorization to Use Radioactive Materials. The general responsibilities of an AU are to assure that:
• All radiation sources are used in accordance with:
• GU Radiation Safety Manual;
• NRC and District of Columbia Department of Health (DCDH) Regulations; and,
• the Authorization to Use Radioactive Materials as issued by the RSC.
• All policies and procedures are implemented and documented.
• All personnel radiation exposures are ALARA.
• All individuals who work with, or near, radiation sources, read, understand, have access to,
and comply with all relevant policies and procedures related to RAM and radiation safety.
• All RAM workers have received the proper radiation safety training as outlined in Chapter
4 of this manual.
1.7 Assistant Authorized Users (AAU)
The AAU would maintain continued laboratory compliance and act on behalf of the AU when he/she
is unavailable or out of town for short periods of time (i.e., professional conferences, training,
vacations, or illness). During these absences, the AAU is expected to comply with the responsibilities,
as stated above, for an AU.
1.8 Radioactive Materials (RAM) Workers
A RAM worker is a person who voluntarily works with or near RAM or RPD under the supervision of
an AU of radiation sources. The general responsibilities of a RAM worker are:
• Read, understand and comply with the policies and procedures related to the use of RAM or
RPD.
• Read, understand and comply with the authorization issued by the RSC and the application
to use RAM submitted by the AU to the RSC.
• Maintain radiation exposures ALARA.
• Report all known or suspected radiation safety problems to both the AU and the RS Office.
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Chapter 2
Authorized User Applications and Amendments
2.1 Approval Criteria for Authorized Users (AU)
The minimum criteria used by the Radiation Safety Committee (RSC) and Subcommittee to grant an
Authorization to Use Radioactive Materials to an Authorized User (AU) is:
1) A college degree at the bachelor level, or equivalent training and experience, in the physical
or biological sciences or in engineering; and
2) At least 40 hours of training and experience in the safe handling of radioactive materials
(RAM), in the characteristics of ionizing radiation, units of radiation dose and quantities,
radiation detection instrumentation, and biological hazards of exposure to radiation
appropriate to the type and forms of byproduct material to be used.
2.2 New Applications for an Authorization to Use Radioactive Materials (RAM)
The RSC reviews and approves all AUs and uses of RAM at Georgetown University (GU). An
Authorization may be issued solely for RAM use, or in conjunction with Research Irradiator Facility
(RIF) use. All individuals requesting an Authorization to Use Radioactive Materials must submit an
application in writing. The required application forms may be obtained from the Radiation Safety
(RS) Office. The application requests details of the following information:
• the training and experience of the user;
• a description of the proposed facilities, use locations, and safety equipment available;
• appropriate measures to maintain exposures as low as reasonably achievable (ALARA);
• details regarding the proposed uses of RAM or the Research Irradiator Facility (RIF):
isotopes; experimental activities; proposed possession limits; and the type of chemical
compounds (i.e. Nucleosides,Nucleotides, Amino Acids, etc.); the intended uses and/or
experimental protocols; the physical form of the material; and, the professional or technical
personnel who will be working under their supervision; and,
• justification for the requested possession limits.
Each completed application is initially reviewed by at least one member of the Radiation Safety Office
Staff (RSOS). This review ensures that the application is complete and that there is sufficient
information provided to allow for a thorough review. If additional information is required, it is
obtained from the AU at that time. The RSOS may require additional modifications, safety equipment
or procedures.
The application is submitted to a Subcommittee (which includes the RSO, Chairman, Management
Representative, and at least one AU), which reviews and approves the application for the RSC. The
Subcommittee represents a quorum of the full RSC. Interim approval is granted to the AU upon
subcommittee approval, pending formal RSC approval at the subsequent RSC meeting.
Upon Interim approval, the following must be performed to complete the Authorization process:
• the AU must pass an exam based upon this Radiation Safety Manual.
• the AU and the RAM workers in their lab, must attend an initial training session which is
held with the RSOS. This training reviews the RS program requirements and
documentation necessary for maintaining the Authorization.
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2.3 Amendments to an Existing Authorization to Use Radioactive Materials (RAM)
Approved AUs requesting an amendment to an existing Authorization to Use Radioactive Materials in
subsequent protocols, must submit a written application to the RSOS. Each submitted application is
reviewed by the RSOS for completeness to determine whether approval is required from the RSC, or
whether the RSO may grant Administrative approval.
2.3.1 RSC Required Approvals
If the requested amendment substantially deviates from the original protocol (i.e., the addition
of isotopes, additional protocols, or a substantial increase in possession limits), the submitted
amendment application must detail the proposed uses of RAM as described in Section 2.2.
The application is submitted to the Subcommittee which reviews and provides Interim approval
of the amendment for the RSC. Formal approval is granted to the AU at the subsequent RSC
meeting.
2.3.2 RSO Administrative Approval
All other amendments to an Authorization, which do not significantly modify the existing
Authorization, may be approved administratively by the RSO and the Chairman of the RSC:
• Increase in possession limits for approved radioactive materials (RAM) to take advantage
of price breaks when purchasing the material.
• Increase in possession limits for approved RAM for increased research activities.
• Changes in authorized RAM laboratory locations (i.e. deletions or additions).
• Requests for inactive status for a period of time (i.e. will not use, store or possess RAM).
• Requests for reactivation of Authorization from an inactive status in good standing.
• Requests for decreases in possession limits for approved RAM.
• Deletions of approved RAM from the Authorization.
• Reinstatement of previously approved RAM. The AU must be in good standing, and must
have explored the possibility of using non-radioactive methods.
• Changes in laboratory classification when requested, or when the change is required by
increases or decreases of RAM use, and/or compliance performance.
• Corrections to Authorizations when errors are discovered.
• Modification to sewer disposal limits to accommodate changes in RAM use and/or
procedures.
• Approval of the use of an isotope, or chemical compound, on a one time basis, to determine
whether a new protocol or technique will be successful. An application must be submitted
for continued use of the isotope.
• Georgetown University Animal Care and Use Committee (GUACUC) protocol renewals.
The renewal protocol must not contain substantive modifications to the RAM use
procedures described in the original previously approved protocol.
• The use of Radiation Producing devices (i.e., Faxitron Cabinet X-Ray devices, X-Ray
Machines and Bone Densitometers) on animals in GUACUC protocols, and on cells, cell
cultures and animal tissue.
Any changes to Authorizations made administratively by the RSO, and approved by the
Chairman of the RSC, will be reported to the RSC at the next committee meeting.
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2.4 Assistant Authorized Users (AAU)
The AU may also request that at least one individual working under the Authorization is approved as
an AAU. The AAU would maintain continued laboratory compliance and act on behalf of the AU
when he/she is out of town for short periods of time (i.e., professional conferences, training, vacations,
or illness). The minimum criteria which will be used by the RSC and Subcommittee to grant approval
as an AAU are the same as listed above for the AU.
2.5 Authorization to Use Radioactive Materials (RAM) in Animals
All in vivo radioactive materials use in animals is approved by both the RSC and the GU Animal Care
and Use Committee (GUACUC). A strategy meeting is held between the AU, the RSO, and a
Veterinarian prior to initiation of in vivo work in the Research Resources Facility. This assures that all
safety procedures have been adequately addressed. Contact the RSOS for application forms and
additional information.
2.6 Radiation Monitoring Instruments
When required by the RSOS and the Authorization to Use Radioactive Materials, the AU must
purchase portable radiation survey instruments in accordance with RSOS recommendations. The
RSOS will then log the instrument information into a database to assure that the meter will be
calibrated on an annual basis. The RSOS is responsible for performing instrument calibrations. At the
discretion of the RSOS, repairs to portable radiation survey instruments may also be performed.
2.7 Approved Irradiator Operators (AIO)
The RIF is available for the irradiation of animals, cell cultures, and tissue samples. An Authorization
is required for use of the facility. A researcher may become an AIO after he/she has: applied to become
an AIO; attended the RIF training session; taken and passed the AIO exam with a grade of 80% or
better; and, has successfully performed three irradiations under the supervision of an AIO or RSOS.
Contact the RSOS for application forms and additional information.
2.8 Renewal of the Authorization to Use Radioactive Materials (RAM)
Each Authorization to Use Radioactive Materials must be renewed once every three years. The
renewal includes a review of the AU's safety and compliance history, types and quantities of materials
requested, facilities and equipment, and training and supervision of radiation workers in the users'
laboratory. If there have been no changes to the Authorization since the last renewal, or minor
additions or deletions, an abbreviated application may be submitted. Otherwise, a complete
application must be submitted. Contact the RSOS to obtain the appropriate Authorization renewal
forms.
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Chapter 3
Facilities and Equipment
3.1 Facilities Designated for Special Use
The following laboratories have been designed for special use applications. These facilities will be
added to the Authorization to Use Radioactive Materials (RAM) when required by the Radiation
Safety Office Staff (RSOS).
C
Iodination / Tritiation Laboratory:
Research protocols where RAM may become airborne, including iodinations and tritiations,
must be performed in EG-06 The Research Building. The room is under the control of the
RSOS and contains a fume hood with controlled air flow and a HEPA/charcoal filtered exhaust
system. Sampling ports are present at the hood exterior and in the hood duct work for
monitoring breathing zone and environmental effluent releases. Use of the lab is by reservation
only. The key is controlled and signed out through the RS Office.
C
Beta-Plate Facility:
A cell harvester and a beta-plate liquid scintillation counter, located in LM-9A Preclinical
Science Building, are available to researchers. Use of the lab is by reservation only. The key is
controlled and signed out through the RS Office.
C
Research Irradiator Facility (RIF):
A research gamma irradiator, is available for the irradiation of animals, cell cultures, and, tissue
samples. An Authorization is required for use of the RIF (refer to section 2.7 of this manual).
C
Research Resources Facility (RRF):
The RRF is available for in vivo animal research using RAM. An Authorization is required for
use of the facility (refer to section 2.5 of this manual). Disposed animal carcasses are stored in
a freezer located in the Radioactive Waste Storage Facility (RWSF), under the control of the
RSOS (see below). RPDs are available for use in the RRF, pending RSOS approval.
C
Radioactive Waste Storage Facility (RWSF):
Radioactive waste is segregated, stored, and disposed via various methods in WG-01 The
Research Building.
C
RS Office Package Receipt Room:
Room LM-12A in the Preclinical Science Building is used for receipt, distribution, and
shipment of all RAM packages.
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3.2 Radionuclide Toxicity and Laboratory Classification
The criteria for evaluating and approving laboratory facilities and equipment is an updated version of
Appendix K of NUREG-1556, Vol. 11, Final Report, April 1999. Specifically, the radionuclides listed
in Table 1 have been reclassified in accordance with the Annual Limit on Intake (ALI) for Inhalation
using the appropriate class and the non-stochastic value. The relative radiotoxicities are then grouped
by order of magnitude as indicated in the Table below. It should be noted that the type of research
performed and anticipated does not involve the use of radionuclides having a very high relative
radiotoxicity.
Limitations on Activities In Various Types of Laboratories
Relative Radiotoxicities Radionuclide Groups
Minimum
Quantity
Type C
Type of Laboratory Required
Type B
Type A
1. Very High (ALI <100) 241
Am, 244Cm, 226Ra, etc.
0.1 ìCi
< 10 ìCi
10 ìCi - 10 mCi
10 mCi or more
2. High (ALI 100 - 101) 125 131 22
I, I, Na, etc.
1.0 ìCi
< 100 ìCi
100 ìCi - 100 mCi
100 mCi or more
3. Moderate (ALI 102 - 103) 14
C, 45Ca, 32P, 33P, 86Rb, etc.
10ìCi
< 1 mCi
1 mCi - 1 Ci
1 Ci or more
100 ìCi
< 10 mCi
10 mCi - 10 Ci
10 Ci or more
4. Low (ALI 104 - 105) 51
Cr, 3H, 35S, etc.
Laboratory Class Characteristics
Facility
Description
Type C:
Low-Risk
Facility
Type B:
Moderate-Risk Facility
Type A:
Substantial or High Risk Facility
Risk to workers,
the public or the
environment
None or
minimal
risk
Improper use could pose
some risk
May pose a substantial or highrisk if operations are not
performed according to specific
safety requirements.
Radioactive
Materials Use
On open
benches
Most operations may be
performed on an open bench
- radionuclides having higher
activities which generate
aerosols or gases require use
of a fume hood or glove box
All procedures which generate
aerosols or gases are performed
in fume hoods or closed glove
boxes; a containment trap or
exhaust filtration system will be
required.
The research laboratories where RAM is used and stored are modern chemical laboratories. The labs
have: adequate ventilation; floors, walls and benches which are nonporous and easily cleaned; sinks
that are easily cleaned; fume hood interiors and benches capable of supporting shielding, if needed;
and, refrigerators and freezers for storage. The facility and equipment requirements for a given lab are
reviewed by the RSC and the RSO.
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3.3 Designated “Clean Areas”
Upon request, the RSOS will review the locations of storage and use within a posted RAM laboratory
to determine whether it is possible to establish an area where eating, drinking, and storage of food,
drinks and personal effects are allowed. Criteria necessary for establishing a "clean area" includes:
C
the area must be separated from the RAM area by a barrier (i.e. file cabinets,
benches, portable partitions, aisle, etc.) so that a clean area is visually apparent,
C
the laboratory research may not involve procedures which will result in airborne
radioactivity, and,
C
the areas must conform to recommended guidelines for safe laboratory practices
as determined by EH&S staff.
If it is determined that a “clean area” may be established, then appropriate postings are used to indicate
the clean and RAM use areas. Undocumented surveys are performed each day RAM is used.
Documented meter and wipe surveys of the "clean areas" must be performed at the same frequency as
established for the laboratory. The RSOS includes these areas in its’ surveys, and audits the AU’s
survey records to ensure compliance. "Clean areas" are generally provided only for those labs where
building facilities provide no other alternative for establishing eating and drinking areas.
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Chapter 4
Radiation Safety Training Requirements
4.1 Authorized Users (AU)
Upon Interim approval, all new AUs must perform the following to complete the Authorization
process:
• the AU must pass an exam based upon this Radiation Safety Manual.
• the AU and the radioactive material (RAM) workers in their lab, must attend an initial
training session which is held with the Radiation Safety Officer (RSO), or designee. This
initial training reviews all the Georgetown University (GU) Radiation Safety (RS) program
requirements, including documentation, which are necessary for maintaining the
Authorization to Use Radioactive Materials.
All active AUs must attend the Refresher Training annually or change their Authorization status to
Inactive.
4.2 Assistant Authorized Users (AAU)
Upon Interim approval, all new AAUs must pass an exam based upon this Radiation Safety Manual in
order to complete the Authorization process.
All AAUs must attend the Refresher Training annually or change their status to Inactive.
4.3 Authorized User (AU) Laboratory Specific Training
An AU or AAU is required to provide initial, practical, laboratory specific training, to all individuals
working or frequenting the laboratories listed on the Authorization. The training is performed prior to
working in the RAM laboratories, and includes the following instructions:
• the storage, transfer and use of RAM in the laboratory;
• the laboratory radiation safety procedures to minimize exposure;
• to observe, the applicable radiation safety policies and procedures;
• the appropriate response to unusual occurrences (i.e., spills or contamination) involving
RAM; and,
• their responsibility to report promptly to the Radiation Safety Office Staff (RSOS) any
condition, which may lead to, or cause, a violation of U. S. Nuclear Regulatory
Commission (NRC) regulations, the GU Radiation Safety Manual and/or the Authorization
to Use Radioactive Materials.
The AU or AAU provides periodic training in this regard, and maintains a record of the training on the
Authorized User Training Record. The training includes the requirements in 10 CFR §19.12 and a
review of emergency response procedures.
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4.4 Georgetown University (GU) Radioactive Materials (RAM) Workers
The AU or AAU are also responsible for ensuring that each new individual who is to work with RAM
will attend the appropriate training class conducted by the RS Office. The training program is based
upon the model training program described in NUREG-1556, Volume 7, Appendix J, 1999, and
includes:
C applicable regulations and license conditions;
C areas where RAM is used and stored;
C potential hazards associated with RAM;
C appropriate radiation safety procedures;
C special in-house rules pertaining to the employee’s work;
C obligation to report unsafe conditions to the RSOS and/or applicable authorities;
C appropriate response to emergencies or unsafe conditions;
C worker's right to be informed of occupational radiation exposure and bioassay results;
C locations of pertinent regulations, licenses, and other material required by regulations.
The RSOS provides the following radiation safety training classes based upon the topics listed above.
Basic Radiation Safety - for laboratory personnel who will use RAM, and:
C have never attended a basic radiation safety class in the United States which includes a
written exam of the presented material, or
C cannot provide a copy of their training certification.
Lab personnel must attend prior to working with RAM unless: the work is performed under the
direct supervision of an AU or an AAU; or, the individual has challenged the course and passed
the exam with a minimum grade of 70 percent.
GU RAM Worker - for laboratory personnel who will use RAM:
C and have previously taken a basic radiation safety class and provided a copy of the training
certificate to the RSO; or,
C have challenged the course and passed the exam with a minimum grade of 70 percent.
Lab personnel should attend within one month of beginning work with RAM.
Refresher Training - after attending the Basic Radiation Safety or GU RAM Worker class, all
personnel who work with RAM (and those who perform room surveys, pickup RAM packages,
or deliver RAM waste) must attend a refresher training session annually. All AUs must attend
annually or change their Authorization status to Inactive.
Records of all training sessions are maintained. These records include a list of topics covered, the date
and time spent, the instructor and student names. The effectiveness of the training will be assessed by
the RSOS during the routine audits through observation and/or direct communication with laboratory
personnel.
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4.5 Authorized User (AU) and Radioactive Materials (RAM) Worker Enforcement Training
Special enforcement training is performed by the RSO (or designee) for the AU and their RAM
Workers. These special training sessions are scheduled whenever the RSOS laboratory inspections
have revealed several concerns or violations that have occurred for consecutive calendar quarters, with
inadequate corrective actions taken by the AU.
4.6 Non-Radioactive Materials Workers
All personnel working in or frequenting a posted RAM laboratory must receive the AU Laboratory
Specific Training as detailed in Section 4.3.
4.7 Ancillary Personnel
Periodic training is provided by the RSOS for ancillary personnel (i.e., animal caretakers,
housekeeping, facilities management, security, shipping and receiving, and/or purchasing). The
training provided to such persons is practical, and commensurate with potential radiological hazards
and the specific job requirements. Records of all training sessions are maintained, and include a list of
topic(s) covered, the date and time spent, the instructor and student names.
4.8 Approved Irradiator Operators (AIO)
The RSOS provides training for the use of the Research Irradiator Facility (RIF). The training may be
in the form of lecture, videotape, hands-on, or self-study. Prior to receiving RIF training, the individual
must have successfully completed a Basic Radiation Safety training class. The RIF training
emphasizes practical subjects important to the safe use of the RIF, including:
• Practical Explanation of the Theory and Operation for the Irradiator
- Routine vs. non-routine maintenance
- Operating and emergency procedures
- Prior events involving self-shielded irradiators.
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Chapter 5
Authorized User Survey Requirements
5.1 Undocumented Survey Frequency
All users of radioactive materials (RAM) must perform undocumented surveys of their work area,
upon completion of the RAM procedure, for each day of RAM use.
5.2 Documented Survey Frequency
The survey frequencies for the documented wipe and meter laboratory surveys performed by the
Authorized Users (AU) are based upon a classification of the laboratory. The classifications, which
are assigned by the Radiation Safety Officer (RSO), are initially based upon the authorized possession
limits for each radionuclide.
Minimum Documented Survey Frequency
Classification
Possession Limit
Survey Frequency
Class 1
Possession limit is greater than either of the
Weekly
following:
H-3, C-14 or S-35:
1.0 millicurie / radionuclide
Cr-51 or P-33:
1.0 millicurie / radionuclide
I-125 or P-32:
0.5 millicurie / radionuclide
Other isotopes as determined by the Radiation
Safety Office Staff (RSOS).
Class 2
Possession limit is equal to or less than the above
listed possession limits for the listed isotopes; and,
Tissue Culture Labs and Warm/Cold Rooms.
Monthly
Class 3
Shared Equipment Rooms, Counting Rooms and
Dark Rooms.
RSO - Quarterly
Class 4
Sporadic RAM use.
After each use
Class 5
No RAM possessed, stored or used.
None
The procedures for performing the documented laboratory surveys include, the survey frequencies
discussed above, and may include a physical survey of the location of materials and equipment; survey
meter measurements of contamination levels in the area; and wipe surveys of RAM surface
contamination levels in each area. AUs who have a weekly survey frequency, but have not used or
handled RAM since during the survey cycle, may use the statement “NO RAM Used since last survey”
to fulfill the survey requirement. This statement may only be used for three weeks in a row since the
minimal documented survey frequency for Georgetown University (GU) is once every thirty days.
Therefore, the statement may not be used for those labs which have a monthly survey frequency.
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5.3 Documented Clean Area Survey Frequency
Documented meter and wipe surveys of the "clean areas" must be performed at the same frequency as
established for the laboratory. The RSOS includes these areas in its survey and audits the AU’s records
to ensure compliance.
5.4 Personnel Contamination Monitoring
Undocumented personnel contamination monitoring surveys should be performed at frequent intervals
while using RAM.
The personnel contamination surveys of the researcher’s hands, skin, shoes and clothing, must be
performed and documented on the Personnel Contamination Monitoring Form (PCMF):
• prior to food consumption, and,
• daily, upon termination of RAM use.
The record must be maintained and available for inspection.
5.5 Surveys for Facility Release for Unrestricted Use
Facilities and equipment will not be released for unrestricted use until surveys for contamination levels
are performed by the RSOS. The surveys will include portable count rate meter measurements, if
applicable, and wipe surveys. The criteria in Table S.5 of NUREG-1556, Volume 11, dated April
1999, will be followed (with the exception of I-125). Since the inhalation and ingestion ALI for I-125
is similar to that of I-131, the release criteria specified for I-131 will be followed. The survey results
will be reviewed by the Deputy RSO or the RSO.
A record of the survey will be maintained by RSOS, and will include a physical description, surveyor,
and instrumentation used. Records relevant to decommissioning will be maintained.
5.6 Sealed Source Leak Tests
Sealed sources are leak tested using absorbent material. Sources which cannot be accessed directly
(within a piece of equipment or shielding) will be leak tested by wipes taken of accessible areas
surrounding (housing) the source. The wipes are assayed in a gamma well counter or liquid
scintillation counter, as appropriate for the source being wipe tested. The equipment is capable of
detecting the presence of 0.005 microcuries of radioactive material on the wipe test sample. Records
of the leak test results will be maintained for a minimum of five years.
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Chapter 6
Radiation Safety Audit Program
6.1 Radiation Safety Committee (RSC) Audits of the Radiation Safety (RS) Office
The RSC annually reviews, the Radiation Safety Office Staff (RSOS) annual report of the RS program
to determine that all activities are being conducted safely, in accordance with NRC regulations,
conditions of the license, and, consistent with the ALARA program and philosophy. Additionally, the
RSC performs, with the assistance of the Radiation Safety Officer (RSO), an annual audit of the RS
program, including RSOS performance.
6.2 Radiation Safety Office Staff (RSOS) Audits of Authorized User (AU) Laboratories
The RSOS performs unannounced audits of each AU research laboratory quarterly. The audit consists
of:
C a review of all records (i.e., inventory, room surveys, training), to ensure compliance with
the Authorization requirements;
C a wipe and meter survey (except in a lab or area where only H-3 is used, a meter survey
may or may not be performed).
C exposure rate surveys (when appropriate).
The audit findings are reviewed with the AU or a member of lab staff. When necessary, the RSOS
provides hands-on training.
The following RSC policy ensures that AU’s provide timely and adequate responses to the RSOS
audits:
C Minor violations (i.e., procedural problems) will be cited to the AU by the RSOS and will
be resolved between the RSOS and the AU or designee.
C Recurrence of a previously cited violation, a pattern of recurrent violations over time, or
failure to promptly correct violations, may require a written response by the AU.
C Serious violations (i.e., RAM security or witnessed eating and drinking in posted labs), or
repeated violations which were not addressed, will be reported to the RSC Chair,
Department Chair or Center Director, and the AU. The RSC may require: a meeting
between the RSOS, the AU and lab staff; suspension of the privilege of using RAM (e.g.
for a specified period of time, until specified training is accomplished, etc.); or revocation
of the AU’s Authorization.
The RSOS makes every effort to deliver these citations, and acknowledge AU corrective actions in a
timely fashion. The RSC requires full compliance with policies and regulations by a specified date.
The severity of the sanctions imposed is proportional to the seriousness of the violation.
Laboratories in which procedures with open sources of RAM are not performed and in which materials
are not stored (i.e., rooms with liquid scintillation or gamma counters, cold rooms, etc.), will be
audited quarterly.
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Chapter 7
Radioactive Material Receipt and Accountability
7.1 Purchasing Radioactive Material (RAM)
All orders for RAM are submitted in writing to the Radiation Safety Office Staff (RSOS) for approval
prior to ordering. All orders are reviewed to ensure that the RAM requested is permitted by conditions
in the Authorization, and approved only if it meets those conditions. The order must identify the
Authorized User (AU), isotope, chemical form, activity, catalog number, researcher who is ordering,
and supplier. GU purchasing departments are instructed to refuse all RAM orders that do not have a
RSOS release number.
Prior to arranging to receiving a free sample of RAM, or receiving a shipment of RAM from another
Institution, you must notify the Radiation Safety Office Staff (RSOS). The RAM must be delivered to
the RS Package Receipt Room, LM-12A Preclinical Science Building. The AU is responsible for
immediately notifying the RSOS if any RAM shipments are delivered directly to the laboratory.
7.2 Receipt of Radioactive Materials (RAM)
7.2.1 Normal Work Hours
All RAM packages are delivered to RS Package Receipt Room, LM-12A Preclinical Science
Building. Upon receipt, the contents of a package are compared to the originally approved
order. After inspection and survey, the researcher is notified of its arrival.
7.2.2 After Normal Work Hours
If a RAM package is delivered after hours, weekends, holidays, or when GU is closed, the
courier is directed to use the emergency call down phone which indicates to the Department of
Public Safety (DPS) Communications Officer (CO) that the package is for “Radiation Safety.”
In these situations, the procedure for the DPS Officers is as follows:
• The CO must contact the RSOS and inform him/her of the package delivery.
C The CO dispatches a Patrol Officer to the RS Package Receipt Room.
C After recording the Patrol Officer’s name, the RSOS will provide means of access to
the RS Package Receipt room.
• DPS places the package into the RS Package Receipt room refrigerator.
C DPS will log the package into the RAM package receipt logbook.
C DPS will ensure the RS Package Receipt room door is securely locked.
• The RSOS will change the combination to the RS Package Receipt room, as soon as
possible, but no later than 3 hours from the beginning of the next working day.
7.2.3 Radiation Safety (RS) Office - Radioactive Material (RAM) Receipt Surveys
Packages received by the RSOS are surveyed within three hours, in accordance with the
U. S. Nuclear Regulatory Commission (NRC) and Department of Transportation (DOT)
regulations. The RSOS places a notice on each package indicating that it has passed this
inspection. If the RAM package bypasses the RSOS inspection, the AU must immediately
request such testing from the RSOS.
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7.3 Authorized User (AU) Receipt of Radioactive Materials (RAM)
After picking up the RAM package(s), the researcher must immediately return to the laboratory. The
procedures for the safe opening of packages must be followed:
C Visually inspect the package for any sign of damage. If damage is noted, notify the RSOS.
C Wear proper personal protective equipment (PPE).
C Open the outer package and remove the packing slip. Open the inner package (the plastic
shipping container) and verify the contents and integrity of the RAM stock vial (inspecting
for breakage of the seal or vial, loss of liquid, and discoloration of packaging material).
C Wipe the external surface of the RAM stock vial, assay and attach results to the
corresponding Radioactive Materials Control Sheet (RMCS).
C Ensure that there is one RMCS for each stock vial contained in the package. If not, notify
the RSOS immediately.
C Inspect the package contents to ensure that there are no additional RAM stock vials.
C Using the portable meter, survey the packing material and empty packages for
contamination before discarding.
C If materials are not contaminated, deface radiation warning labels before discarding in
regular trash containers.
C If materials are contaminated, treat them as radioactive waste.
C If contamination greater than the calculated Decontamination Action Level (DCAL) is
detected on the stock vial, notify the RSOS immediately.
7.4 Control and Accountability of Radioactive Material (RAM)
7.4.1 Unsealed Radioactive Materials (RAM)
Each calendar quarter all RAM AUs must submit a RAM inventory report. This report is a real
time inventory of an AU’s RAM.
The RSOS compares the RAM inventory report with the records maintained by the RSOS. If
discrepancies exist, they are resolved and appropriate records are updated. All records of RAM
orders and AU waste disposals to the RSOS are maintained.
7.4.2 Sealed Sources
A physical inventory of all non-exempt sealed sources and/or devices received and possessed
under the license will be conducted at least each six months. Records of the inventory will be
maintained for a minimum of five years.
Sealed Sources contained in Liquid Scintillation Counters and Gas Chromatographs shall only
be removed by RSOS to ensure proper disposal.
7.4.3 Internal Transfers of Radioactive Materials (RAM)
All transfers of RAM between AUs require prior approval by the RSOS. The RSOS confirms
that the requested isotope, chemical compound and activity is allowed by the recipient’s
Authorization. A RSOS release number is assigned and the researcher is provided with the
appropriate documentation. A record of the transfer is documented to ensure that all
appropriate RAM inventory records are updated.
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7.4.4 Radioactive Material (RAM) Shipments
Transportation of RAM off campus must be performed through the RSOS to ensure that all
regulations issued by NRC, DOT or International Air Transport Association (IATA) are met.
Contact the RSOS for additional information.
7.5 Radioactive Materials (RAM) Security
RAM must be secured to preclude unauthorized. The RAM can be secured by locking a restricted area
or storage in a locked refrigerator/freezer and/or lock box. RAM in an unrestricted area must be under
constant surveillance.
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Chapter 8
Personnel Dosimetry
8.1 External Dosimetry
Personnel monitoring is accomplished using a whole body or extremity optically stimulated
luminescent dosimeter (OSL). Personnel dosimetry is required for:
• Radioactive Materials (RAM) Workers using Na-22, Rb-86, or greater than 10 millicuries,
at one time, of P-32;
• RAM Workers Performing Iodinations;
• Approved Irradiator Operators (AIO);
• Radiation Producing Device (RPD) Users; and,
• Any individual at the discretion of the Radiation Safety Office Staff (RSOS).
Personnel monitoring devices are not required for persons working with tritium (H-3), C-14,
S-35, or less than 100 microcuries of I-125 in pre-labeled compounds.
Contact the RSOS for application forms and additional information.
8.2 Internal Dosimetry
Bioassay requirements are specified in each Authorization To Use Radioactive Materials, as follows:
• All researchers using 10 millicuries or more of H-3 or P-32, at one time, must submit a
baseline urine bioassay sample and routine urine bioassay samples at the frequency
specified by the RSOS.
• All researchers performing iodinations are required to have a baseline thyroid bioassay and
must have routine thyroid bioassays performed within 6 to 72 hours after each iodination.
8.3 As Low As Reasonably Achievable (ALARA)
Individual and collective personnel radiation exposures shall be kept ALARA. The Radiation Safety
Committee (RSC) has established ALARA exposure trigger levels. Individual exposures which
exceed Level I values will be reviewed by the RSOS and reported to the RSC. Individual exposures
which exceed Level II values will be investigated by the Authorized User (AU) and the RSOS. A
written report from the AU to the RSC is required for exposures exceeding Level II values. The report
shall include reasons for the exposure and actions taken to prevent such exposures in the future. A
copy of the ALARA trigger levels may be obtained from Radiation Safety (RS).
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8.4 Declared Pregnant Workers (DPW)
The U. S. Nuclear Regulatory Commission (NRC) regulations require that licensees instruct
individuals working with RAM in radiation protection as appropriate for the situation. The regulations
allow a pregnant woman to decide whether she wants to formally declare her pregnancy in writing to
take advantage of lower dose limits for the embryo/fetus. The choice to declare is completely
voluntary. If you are unsure whether to declare your pregnancy, you may request that the RSOS
provides you with information which will assist you with your decision.
Once a declaration of pregnancy is made in writing, the maximum permissible radiation exposure to
the fetus during the entire gestation period may not exceed 500 millirem, at a rate that should not
exceed 50 millirem per month. The following outlines the steps that need to be followed:
•
•
•
•
•
Women who are pregnant may voluntarily inform the AU and the Radiation Safety Officer
(RSO) in writing by completing the NOTIFICATION OF PREGNANCY form.
The RSOS will evaluate personnel monitoring records, existing working conditions, types
of RAM and/or RPD being used and, the procedures being performed by the worker.
The RSOS may recommend any special precautions or actions that could be taken to ensure
that the dose to the embryo/fetus is maintained ALARA.
The RSO or designee will meet with the individual to review the evaluation and discuss the
risks and possible changes to any procedures that may be necessary.
DPW shall not participate in iodination procedures using radioactive iodine.
8.5 Public Dose
RAM will be used, transported, stored, and disposed in such a way that the total effective dose
equivalent (TEDE) to members of the public will not exceed more than 100 mrem in one year, and the
dose in any unrestricted area will not exceed 2 mrem in any one hour.
The RSOS performs radiation surveys of posted areas quarterly to ensure that the requirements in 10
CFR 20.1302 are met. The radiation survey results are reviewed and when necessary corrective action
is taken to ensure that the exposure to a member of the general public in unrestricted areas and
controlled areas (accessible to the general public) will not exceed the limits in 10 CFR 20.1301.
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Chapter 9
Safe Use of Radioactive Materials
9.1 Guidelines for the safe use of Radioactive Materials (RAM)
The Radiation Safety Office Staff (RSOS) have developed guidelines for the safe use of RAM as
follows:
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Wear lab coats or other protective clothing at all times in areas where unsealed RAM are
used or stored.
•
Wear disposable gloves at all times while handling RAM.
•
Either after each procedure or before leaving the area, monitor yourself for contamination
in a low-background area, and document the results on the Personnel Contamination
Monitoring Form (PCMF).
•
Do Not eat, drink, smoke, apply cosmetics or contact lenses, in any area where RAM is
used or stored.
•
Do Not store food, drinks, or personal effects in areas where RAM are used or stored.
•
Appropriate personnel monitoring devices shall be worn at all times while in areas where
RAM are used or stored.
•
Dispose of radioactive waste only in designated, labeled, and properly shielded containers.
•
Never pipette by mouth.
•
Radioactive solutions must be confined in clearly labeled containers, used, and stored in
approved locations.
•
Secure all RAM when they are not under constant surveillance and immediate control.
•
Absorbent pads shall be used when working with liquid RAM.
•
Time, distance, and shielding shall be utilized to keep exposures As Low As Reasonably
Achievable (ALARA).
•
Shoes having enclosed toes must be worn whenever working with or handling RAM.
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Chapter 10
Emergency Procedures
10.1 Radiation Emergency Procedures
The Radiation Safety Office Staff (RSOS) has developed Radiation Emergency Procedures for
handling radioactive material (RAM) spills. This procedure is conspicuously posted in all areas where
RAM are used or stored. The procedure provides instructions for the proper responses to: major and
minor spills in laboratories and public areas; accidents and injuries involving RAM; fires; and, X-ray
injuries.
This procedure is provided in Appendix D of this manual.
The RSOS maintains an emergency spill kit for use in emergency situations.
Georgetown University (GU) Department of Public Safety (DPS) personnel have written procedures
for responding to emergencies. These include notifying RSOS, the Metropolitan Police Department
(MPD) of the District of Columbia (DC), the DC Fire Department (DCFD), emergency medical and
GU Facilities personnel, contingent on the type of emergency. RSOS cell and home phone numbers are
provided to DPS to ensure 24/7 communication. The GU Hospital Emergency Room and the
Georgetown Emergency Response Medical Service (GERMS) are available to respond to medical
emergencies. The various services are trained to interact with each other as needed.
Since we do not possess RAM in excess of the quantities listed in 10 CFR 30.72, an Emergency
Response Plan for Responding to a Release is not required at this time.
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Chapter 11
Radiation Producing Devices
11.1 Authorization for the Use of Radiation Producing Devices (RPD)
The use of RPD is treated by the Radiation Safety Committee (RSC) in the same manner as the use of
radioactive materials (RAM). Persons who intend to use new or existing RPD must submit an
application to the RSC requesting authorization. The required application forms may be obtained from
the Radiation Safety (RS) Office.
11.2 Regulatory Requirements
The use of RPD is governed by the District of Columbia Department of Health (DCDH). Researchers
proposing to use RPD should consult with the Radiation Safety Officer (RSO) prior to submitting an
application to the RSC.
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Chapter 12
Radioactive Waste Management
12.1 General Requirements
All laboratory personnel are instructed to sort their radioactive waste by isotope, and type (i.e. solid,
aqueous liquid, organic liquid, scintillation vials, stock vials, and animals). All containers must be
labeled with appropriate radioactive material (RAM) labels and the isotope it is to be used for. Liquid
containers must also be labeled either aqueous or organic, and list the chemical solutions. All
containers transported to the Radioactive Waste Storage Facility for disposal must have a tag or sticker
which, when properly completed, indicates the isotope, activity, waste type, pH (if applicable),
chemical content with each solution present, (if applicable) and the Authorized User (AU). In
addition:
• Acids and bases must be neutralized to pH 5.5 - 8.5.
• Bulk liquids must be stored in closed plastic containers, provided by Radiation Safety (RS).
• All bulk liquids stored on the floor, or in glass containers, must be stored in secondary
containment.
• Scintillation vials must be stored in trays which keep the vials upright. Caps must be on
each vial and tightly closed. Segregate the vials according to radionuclide. Each tray of
vials must be labeled with the name of the radionuclide, the total activity, total number of
vials, the date and the name of the generator.
• Dry solid wastes may not contain any free liquids, not even one milliliter.
• Broken glass, pipettes, needles or sharp objects must be individually protected so that
containers and fingers are not punctured. These sharp objects must be placed inside a rigid,
plastic sharps container, which may be obtained through RS.
• Biologically hazardous materials may not be placed in radioactive wastes (they must be
autoclaved prior to disposing through RS).
• Large flasks, beakers, tissue culture flasks, pipettes, etc., that can be rinsed and cleaned in
the laboratory should not be discarded as radioactive waste.
• Animal tissue, parts or carcasses must be wrapped in absorbent material, frozen solid,
sealed inside plastic bags and labeled with the isotope, activity, date, and generator's name.
12.2 Radioactive Waste Disposal to Radiation Safety Office Staff (RSOS)
Radioactive waste is to be delivered to the Radioactive Waste Storage Facility:
• WG-01 of The Research Building
Mondays and Thursdays – 11:00 a.m. to 11:30 a.m.
• 151D of the Regents Hall
First Wednesday of each month – 2:30 p.m. to 3:00 p.m.
Radioactive Waste packages may not be left unattended in these locations.
All Radioactive Waste transfers must be accompanied by a completed Radioactive Waste Transfer
Form. The form may be obtained by contacting the RSOS.
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12.3 Radioactive Waste Reduction Methods
Radioactive waste storage in the laboratories must be kept to a minimum. This helps ensure that
personnel radiation exposures are kept As Low As Reasonably Achievable (ALARA), as well as
reducing the total inventory maintained in the laboratory. Additionally:
• Glassware, such as beakers, should be cleaned in the laboratory and not placed in
radioactive waste containers.
• Whenever possible, experiments should be designed to use short-lived radionuclides or
non-radioactive methods.
12.4 Sink Disposals
AUs must specifically request, and receive approval, for disposal of radioactive materials (RAM) in
the laboratory sinks. The approved isotopes, activities, and solubility class are stated in each
Authorization To Use Radioactive Materials. The disposal will always be less than the activity listed
for the isotope in 10 CFR 20, Appendix C. All sewer disposals performed by AUs must be
documented on the Radioactive Materials Control Sheet (RMCS) and reported through the
Environmental Health & Safety Assistant (EHSA) database. All AUs who have not received
Authorization to perform sink disposals, are required to collect their aqueous liquids in bulk for
disposal through the RSOS. Additionally:
• Materials must be readily soluble or dispersible in water.
• Organic solvents must not be disposed via the sink.
• A written record of each disposal must be maintained by the AU. The RMCS may be used
for this purpose, but must include the isotope, activity, volume, pH, and, solubility of the
solution.
• Sinks used for disposal of RAM shall be labeled with the "CAUTION--RADIOACTIVE
MATERIALS" warning sign. Only one sink in a laboratory should be used for this
purpose. The inside surface of the sink should be included in the random areas tested for
contamination as a part of the routine survey requirements.
12.5 Transfer to An Authorized Recipient
Radioactive waste will only be transferred by the RSOS to recipients who are properly licensed to
receive such waste. The waste disposal service company may be changed without notice to the U. S.
Nuclear Regulatory Commission (NRC) knowing that the broker must be licensed by the NRC or
agreement state.
12.6 Decay In Storage (DIS)
Radioactive waste with half-lives of less than 120 days may be held by the RSOS for decay for a
minimum of ten half-lives. Prior to disposal as general trash, the waste will be surveyed in a low
background area at the container surface, with an appropriate survey instrument set to its most
sensitive scale, and with no interposed shielding to determine that its radioactivity cannot be
distinguished from background. If the decayed waste is to be disposed of as general trash, all “Caution
- Radioactive Materials” labels will be removed or obliterated. Records of the surveys will be
maintained.
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12.7 RSOS Disposals Via the Sanitary Sewer
The RSOS will ensure and document that the solutions are readily soluble using either of the methods
described in NRC Information Notice 94-07 depending on the knowledge available of the chemical
form of all materials contained in the liquid effluent. The solutions will be assayed to ensure that the
pH of the solutions are within the range of 5.5 and 8.5. The solutions are sampled and counted to
determine the actual radioactivity present on the release date.
12.8 Incineration
GU does not have a functional animal incinerator, therefore disposal via incineration is not performed.
12.9 Effluent Monitoring
In accordance with NRC Regulatory Guide 8.25, when an AU handles or processes unsealed or loose
RAM in one year in quantities that are less than 10,000 times the annual limit on intake (ALI), air
sampling is generally not needed. The RSOS will perform an assessment of the need for bioassays and
air sampling at the time of the annual report. The assessment can be made in accordance with the
methodology specified in NRC Regulatory Guide 8.25 and NUREG-1400.
Compliance with 10 CFR 20.1302(b)(2)(i) will be determined and reviewed by the RSOS. Any result
which could exceed the limits are reported to the Radiation Safety Officer (RSO) or Deputy Radiation
Safety Officer (DRSO) for corrective action.
Procedures which have the potential to release airborne radioactive effluents must be performed in a
fume hood having a stack which is monitored to quantify the effluent released. The RS Office has a
specific lab for this purpose, that has an effluent monitoring system which was designed in accordance
with ANSI N13.1 (1969), "Guide to Sampling Airborne Radioactive Materials in Nuclear Facilities."
The sampling and collection are performed using solid adsorbents, charcoal, silica gel, or gas washing,
depending on the radioisotope, the chemical compound and physical state (gas or vapor). The volume
sampled will be large enough to permit one tenth the permissible level to be determined with
reliability. Use of the lab is by reservation through the RSOS only. The key is controlled and signed
out through the RSOS.
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APPENDIX A
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APPENDIX B
GEORGETOWN UNIVERSITY
RADIATION SAFETY PROGRAM
Office of Environmental Health and Safety
Susan Martin, M.S., CSHM, Director
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APPENDIX C
GEORGETOWN UNIVERSITY
RADIATION SAFETY COMMITTEE
MEMBERSHIP ROSTER 2011-2012
Hakima Amri, Ph.D.
Assistant Professor, Biochemistry,
Molecular & Cellular Biology
217 Basic Science
phone 7-8594
(12/06)
[email protected]
Insoo Bae, Ph.D.
Assoc. Professor, Oncology
LD-08B Preclinical Science Building
phone 7-5267
(12/06)
[email protected]
Sean Collins, M.D., Ph.D.
Instructor, Radiation Medicine,
Clinical
W 201 The Research Building
phone 7-8811
(12/08)
[email protected]
Sandra Jablonski, Ph.D.
Assistant Professor, Oncology
W322A The Research Building
phone 7-5368
(12/11)
[email protected]
Timothy Jorgensen, Ph.D., MPH1
Assoc. Professor, Radiation Medicine
and Biochemistry, Molecular &
Cellular Biology
E 212A The Research Building
phone 7-1810
(07/93)
[email protected]
Catalina Kovats, M.S.2
Radiation Safety Officer, EH & S
LM-12 Preclinical Science Building
phone 7-4712
Perm. Member
[email protected]
Susan Martin, M.S., CSHM
Director, EH & S
LM-12 Preclinical Science Building
phone 7-4712
Perm. Member
[email protected]
Italo Mocchetti, Ph.D.
Professor, Neuroscience
WP-13 The Research Building
phone 7-1197
(07/98)
[email protected]
Sheila Zimmet, B.S.N., J.D.3
Sr. Assoc. VP, Regulatory Affairs
243A Basic Science Building
phone 7-8437
Perm. Member
[email protected]
Rodney Freeman 4
Administrative Officer, EH & S
LM-12 Preclinical Science Building
phone 7-4712
Perm. Member
[email protected]
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Chairman
2
Radiation Safety Officer
3
Management Representative
4
Executive Administrator
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APPENDIX D
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GLOSSARY OF TERMS AND ACRONYMS
AAU:
Assistant Authorized User (as approved by the Radiation Safety Committee).
AIO:
Approved Irradiator Operator.
ALARA:
As Low As Reasonably Achievable.
ALI:
Annual Limit on Intake.
ANSI:
American National Standards Institute.
ARSO:
Assistant Radiation Safety Officer.
AU:
Authorized User (as approved by the Radiation Safety Committee).
CFR:
U.S. Code of Federal Regulations.
Ci:
Curie
Curie:
A unit used to express the quantity of radioactivity. One curie (Ci) equals 3.7 x 1010 disintegrations
per second (dps). Fractional units of the curie are:
millicurie (mCi) = 0.001 Ci = 3.7 x 107 dps
(10-3 Ci)
4
microcurie (uCi) = 0.000001 Ci = 3.7 x 10 dps (10-6 Ci)
nanocurie (nCi) = 37 dps
(10-9 Ci)
-12
picocurie (pCi) = 1 x 10 Ci = 0.037 dps
(10-12 Ci)
DC:
District of Columbia.
DCDH:
District of Columbia Department of Health.
DOT:
U.S. Department of Transportation.
DPS:
Department of Public Safety (at Georgetown University).
DPW:
Declared Pregnant Workers.
DRSO:
Deputy Radiation Safety Officer (as approved by the Radiation Safety Committee).
Dose Equivalent:
A quantity used to express the biological effects of radiation to an individual. It is defined as the
product of the absorbed dose in tissue and certain modifying factors to correct for the varying
biological effectiveness of the different types of radiation. The unit of dose equivalent is the rem,
or fractions of the rem:
millirem (mrem) = 0.001 rem
(10-3 rem)
microrem (urem) = 0.000001 rem
(10-6 rem)
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Dosimeter: A method of personnel monitoring using a whole body or extremity optically stimulated luminescent
crystal in a badge which measures radiation dose. The badge may contain filters to shield parts of
the crystal from certain types of radiation to determine the type of radiation and depth of penetration.
EH&S:
Environmental Health & Safety (includes Radiation Safety).
External Radiation:
Exposure to radiation from a source located outside of the body.
GU:
Georgetown University.
GUACUC: Georgetown University Animal Care and Use Committee.
GU RAM Worker:
Georgetown University Radioactive Materials Worker.
HEPA:
High Efficiency Particulate Air filter.
IATA:
International Air Transportation Association.
Internal Radiation:
Exposure to radiation from a source located inside the body.
mCi:
millicurie (see Curie).
mrem:
millirem (see dose equivalent).
NRC:
U.S. Nuclear Regulatory Commission.
PCMF:
Personnel Contamination Monitoring Form.
RAM:
Radioactive Material(s).
RMCS:
Radioactive Materials Control Sheet.
rem:
See dose equivalent.
Restricted Area:
An area, access to which is limited by the licensee for the purpose of protecting individuals against
undue risks from exposure to radiation and radioactive materials.
RS:
Radiation Safety.
RSC:
Radiation Safety Committee.
RSO:
Radiation Safety Officer, as approved by the RSC and NRC, and listed on the NRC License and
DCDH Registration.
RSOS:
Radiation Safety Office Staff.
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Sealed Source:
Radioactive material encased in a capsule designed to prevent leakage or escape of the radioactive
material.
TEDE:
Total Effective Dose Equivalent is the radiation dose to an individual from both internal and external
radiation sources.
TLD:
Thermoluminescent Dosimeter, which is a device for monitoring radiation absorbed dose.
uCi:
microcurie (see Curie).
Unrestricted Area:
An area, access to which is neither limited nor controlled by the licensee.
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