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; 31210/121024.11

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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. 31210/121024.11

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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. 31210/121024.11

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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. 31210/121024.11

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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