GU Radiation Safety Manual



 

 

 

Table of Contents

 

Chapter 1

Georgetown University Radiation Safety Program Management 1 - 1

1.1 Executive Management 1 - 1

1.2 Radiation Safety Committee (RSC) 1 - 1

1.3 Radiation Safety Officer (RSO) 1 - 3

1.4 Radiation Safety Office Staff (RSOS) 1 - 3

1.5 Deputy Radiation Safety Officer (DRSO) 1 - 4

1.6 Authorized Users (AU) 1 - 4

1.7 Assistant Authorized Users (AAU) 1 - 4

1.8 Radioactive Materials (RAM) Workers 1 - 4



 

Chapter 2

Authorized User Applications and Amendments 2 - 1

2.1 Approval Criteria for Authorized Users (AU) 2 - 1

2.2 New Applications for an Authorization to Use Radioactive Materials (RAM) 2 - 1

2.3 Amendments to an Existing Authorization to Use Radioactive Materials (RAM) 2 - 2

2.4 Assistant Authorized Users (AAU) 2 - 3

2.5 Authorization to Use Radioactive Materials (RAM) in Animals 2 - 3

2.6 Radiation Monitoring Instruments 2 - 3

2.7 Approved Irradiator Operators (AIO) 2 - 3

2.8 Renewal of the Authorization to Use Radioactive Materials (RAM) 2 - 3



 

Chapter 3

Facilities and Equipment 3 - 1

3.1 Facilities Designated for Special Use 3 - 1

3.2 Radionuclide Toxicity and Laboratory Classification 3 - 2

3.3 Designated "Clean Areas" 3 - 3



 

Chapter 4

Radiation Safety Training Requirements 4 - 1

4.1 Authorized Users (AU) 4 - 1

4.2 Assistant Authorized Users (AAU) 4 - 1

4.3 Authorized User (AU) Laboratory Specific Training 4 - 1

4.4 Georgetown University (GU) Radioactive Materials (RAM) Workers 4 - 2

4.5 Authorized User (AU) and Radioactive Materials (RAM) Worker Enforcement Training 4 - 3

4.6 Non-Radioactive Materials Workers 4 - 3

4.7 Ancillary Personnel 4 - 3

4.8 Approved Irradiator Operators (AIO) 4 - 3







 

Chapter 5

Authorized User Survey Requirements 5 - 1

5.1 Undocumented Survey Frequency 5 - 1

5.2 Documented Survey Frequency 5 - 1

5.3 Documented Clean Area Survey Frequency 5 - 2

5.4 Personnel Contamination Monitoring 5 - 2

5.5 Surveys for Facility Release for Unrestricted Use 5 - 2

5.6 Sealed Source Leak Tests 5 - 2



 

Chapter 6

Radiation Safety Audit Program6 - 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 - 1



 

Chapter 7

Radioactive Materials Receipts and Accountability 7 - 1

7.1 Purchasing Radioactive Material (RAM) 7 - 1

7.2 Receipt of Radioactive Materials (RAM) 7 - 1

7.2.1 Normal Work Hours 7 - 1

7.2.2 After Normal Work Hours 7 - 1

7.2.3 Radiation Safety (RS) Office - Radioactive Material (RAM) Receipt Surveys 7 - 1

7.3 Authorized User (AU) Receipt of Radioactive Materials (RAM) 7 - 2

7.4 Control and Accountability of Radioactive Material (RAM) 7 - 2

7.4.1 Unsealed Radioactive Materials (RAM) 7 - 2

7.4.2 Sealed Sources 7 - 2

7.4.3 Internal Transfers of Radioactive Materials (RAM) 7 - 2

7.4.4 Radioactive Material (RAM) Shipments 7 - 3

7.5 Radioactive Materials (RAM) Security 7 - 3



 

Chapter 8

Personnel Dosimetry 8 - 1

8.1 External Dosimetry 8 - 1

8.2 Internal Dosimetry 8 - 1

8.3 As Low As Reasonably Achievable (ALARA) 8 - 1

8.4 Declared Pregnant Workers (DPW) 8 - 2

8.5 Public Dose 8 - 2



 

Chapter 9

Safe Use of Radioactive Materials 9 - 1

9.1 Guidelines for the safe use of Radioactive Materials (RAM) 9 - 1





 

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 - 1

11.3 RPD Training Requirements 11 - 1

11.3.1 Analytical X-Ray Diffraction Units 11 - 1

11.3.2 Diagnostic X-Ray Units 11 - 1 - 1

11.3.3 Cabinet X-Ray Units 11 - 1

11.3.4 Bone Density Machines 11 - 2

Chapter 12

Radioactive Waste Management 12 - 1

12.1 General Requirements 12 - 1

12.2 Radioactive Waste Disposal to Radiation Safety Office Staff (RSOS) 12 - 1

12.3 Radioactive Waste Reduction Methods 12 - 2

12.4 Sink Disposals 12 - 2

12.5 Transfer to An Authorized Recipient 12 - 2

12.6 Decay In Storage (DIS) 12 - 2

12.7 RSOS Disposals Via the Sanitary Sewer 12 - 3

12.8 Incineration 12 - 3

12.9 Effluent Monitoring 12 - 3



 

APPENDIX A A - 1

APPENDIX B B - 1

APPENDIX C C - 1

APPENDIX D D - 1

GLOSSARY OF TERMS AND ACRONYMS E - 1

 

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;

  • 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 Authorization to Use Radioactive Materials (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:

  • Training for Individuals Working in or Frequenting Restricted Areas;
  • the Audit Program;
  • Radiation Monitoring Instruments;
  • Material Receipt and Accountability;
  • Occupational Dose;
  • Safe Use of Radionuclides and Emergency Procedures; and,
  • Surveys.

The RSC may make the program changes and revise procedures, as stated above, as long as the program change or revised procedure:

  • Is reviewed, approved, and documented by the RSC prior to implementation;
  • Satisfies regulatory requirements;
  • Does not change existing license conditions;
  • Does not decrease the effectiveness of the RS Program; and,
  • 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.

 

1.3 Radiation Safety Officer (RSO)

The RSO's duties, responsibilities and authority include but are not limited to:

  • Surveillance of overall activities involving RAM, including routine monitoring and special surveys of all RAM use areas;
  • Determining compliance with rules and regulations, license conditions, and the conditions of project approvals specified by the RSC;
  • Approving orders and receiving, inspecting and distributing all RAM arriving at the facility;
  • Conducting training programs - initial, refresher, and special training when dictated by changes in regulations, policies or procedures;
  • Maintaining the RAM inventory within the license limits;
  • Providing a personnel monitoring program, and assuring exposures are ALARA;
  • Supervising and conducting a radioactive waste disposal program, including effluent monitoring, and, maintenance of waste storage and disposal records;
  • Performing or arranging for leak tests on all sealed sources, and calibration of radiation survey instruments;
  • Supervising decontamination and recovery operations;
  • Furnishing consulting services on all aspects of radiation protection to personnel at all levels of responsibility;
  • Reviewing and approving radiation monitoring instruments to ensure that appropriate radiation monitoring equipment will be used during licensed activities;
  • Maintaining records of receipt, transfer and disposal of byproduct material;
  • Packaging, labeling, surveying, etc., all RAM shipments leaving the institution;
  • Terminating any activity that is found to be a threat to health or property;
  • Meeting with management in a setting other than an RSC meeting to discuss issues of concern or interest; and,
  • Administrative Approval of Amendments to the Authorization to Use Radioactive Materials 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.

 

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.

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.

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.

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.

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).

  • 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.
     
  • 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.
     
  • 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). Use of the lab is by reservation only. The key is controlled and signed out through the RS Office.
     
  • 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.
     
  • Radioactive Waste Storage Facility (RWSF): Radioactive waste is segregated, stored, and disposed via various methods in WG-01 The Research Building.
     
  • RS Office Package Receipt Room: Room LM-12A in the Preclinical Science Building is used for receipt, distribution, and shipment of all RAM packages.

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 of Laboratory Required

 

Type C Type B Type A

1. Very High (ALI <100) -

 

241Am, 244Cm, 226Ra, etc.

0.1 Ci
< 10 Ci 10 Ci - 10 mCi 10 mCi or more
2. High (ALI 100 - 101) -

 

125I, 131I, 22Na, etc.

1.0 Ci
< 100 Ci 100 Ci - 100 mCi 100 mCi or more
3. Moderate (ALI 102 - 103) -

 

14C, 45Ca, 32P, 33P, 86Rb, etc.

10Ci
< 1 mCi 1 mCi - 1 Ci 1 Ci or more
4. Low (ALI 104 - 105) -

 

51Cr, 3H, 35S, etc.

100 Ci
< 10 mCi 10 mCi - 10 Ci 10 Ci or more
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 high-risk 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.

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:

  • 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,
  • the laboratory research may not involve procedures which will result in airborne radioactivity, and,
  • 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.

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.

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:

  • applicable regulations and license conditions;
  • areas where RAM is used and stored;
  • potential hazards associated with RAM;
  • appropriate radiation safety procedures;
  • special in-house rules pertaining to the employee's work;
  • obligation to report unsafe conditions to the RSOS and/or applicable authorities;
  • appropriate response to emergencies or unsafe conditions;
  • worker's right to be informed of occupational radiation exposure and bioassay results;
  • 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:

  • have never attended a basic radiation safety class in the United States which includes a written exam of the presented material, or
  • 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:

  • and have previously taken a basic radiation safety class and provided a copy of the training certificate to the RSO; or,
  • 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 complete 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.

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.

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 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).

Weekly
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.

 

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.

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:

  • a review of all records (i.e., inventory, room surveys, training), to ensure compliance with the Authorization requirements;
  • 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).
  • 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:

  • 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.
  • 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.
  • 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.

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.

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.
  • The CO dispatches a Patrol Officer to the RS Package Receipt Room.
  • 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.
  • DPS will log the package into the RAM package receipt logbook.
  • 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.

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:

  • Visually inspect the package for any sign of damage. If damage is noted, notify the RSOS.
  • Wear proper personal protective equipment (PPE).
  • 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).
  • Wipe the external surface of the RAM stock vial, assay and attach results to the corresponding Radioactive Materials Control Sheet (RMCS).
  • Ensure that there is one RMCS for each stock vial contained in the package. If not, notify the RSOS immediately.
  • Inspect the package contents to ensure that there are no additional RAM stock vials.
  • Using the portable meter, survey the packing material and empty packages for contamination before discarding.
    • If materials are not contaminated, deface radiation warning labels before discarding in regular trash containers.
    • If materials are contaminated, treat them as radioactive waste.

  • 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 Verification Report. This report is a real time inventory of an AU's RAM.

The RSOS compares the RAM Inventory Verification 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.

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 access. 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 survelliance.

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).

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.

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:

  • 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.

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.

Chapter 11

Radiation Producing Devices

11.1 Authorization for the Use of Radiation Producing Devices (RPD)

The Radiation Safety Committee (RSC) treats the use of RPD 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. The RS Office ensures regulatory compliance with all required audits and Medical Physicist inspections.

11.3 RPD Training Requirements

11.3.1 Analytical X-Ray Diffraction Units

X-ray diffraction unit operators must complete and sign the "X-ray Scattering Facility - Users Contact Information and Training Documentation" form. This form is located at each diffractometer location, and includes information regarding instrument safety interlocks & warning lights, radiation safety, and how to recognize an acute localized x-ray exposure.

11.3.2 Diagnostic X-Ray Units

Animal Use Units - Only Veterinarians or Veterinary Technicians are permitted to operate these units. All operators of veterinary x-ray machines must complete the GU Basic Radiation Safety course. In addition, they must document their unit specific training on the appropriate RPD training log (located at the x-ray unit).

Human Use Units - Only licensed practitioners of the healing arts, or radiologic technologists may operate these type units. Their training requirements are met by the education received while obtaining their license/certification.

11.3.3 Cabinet X-Ray Units

All cabinet X-ray system operators must complete the GU Basic Radiation Safety course. In addition, they must document their unit specific training on the appropriate RPD training form (located at each cabinet x-ray system).

11.3.4 Bone Density Machines

Animal Use Units - All operators of bone density x-ray units used on animals must complete the GU Basic Radiation Safety course. In addition, they must document their unit specific training on the appropriate RPD training form (located at each bone density unit).

Human Use Units - Licensed practitioners of the healing arts, or radiologic technologists may operate these type units. Their training requirements are met by the education received while obtaining their license/certification. In addition, other individuals may be permitted to operate the system if they:

  • complete the GU Basic Radiation course,
  • have documented training in the operation of the system (including system safety functions and patient positioning) provided by the system vendor. Subsequently, currently trained individuals may provide training to new operators (train the trainer).

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.

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.

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.

APPENDIX A

APPENDIX B

GEORGETOWN UNIVERSITY

RADIATION SAFETY PROGRAM

 


 

Office of Environmental Health and Safety

Susan Martin, M.S., CSHM, Director

APPENDIX C

GEORGETOWN UNIVERSITY

RADIATION SAFETY COMMITTEE

MEMBERSHIP ROSTER 2014-2015

Hakima Amri, Ph.D.
Assoc. Professor - SOM Medical Educator.
Biochemistry  Molecular & Cellular Biology
217 Basic Science 
phone 7-8594
 
 
Sean Collins, M.D., Ph.D.
Asst. Professor - SOM Clinician Scholar, Radiation Medicine, Clinical
S-170A Lombardi Cancer Center
phone 7-8811 (12/08)
 
 
Sandra Jablonski, Ph.D.
Assistant Professor - Research Track, Oncology
W322A The Research Building
phone 7-5368 (12/11)
Timothy Jorgensen, Ph.D., MPH1
Assoc. Professor, Radiation Medicine and Biochemistry, Molecular & Cellular Biology
EG-16A The Research Building
phone 7-1810 (07/93)
Catalina Kovats, M.S.2
Radiation Safety Officer, EH & S
LM-12 Preclinical Science Building
phone 7-4712 Perm. Member
 
 
Susan Martin, M.S., CSHM
Director, EH & S
LM-12 Preclinical Science Building
phone 7-4712 Perm. Member
Italo Mocchetti, Ph.D.
Professor, Neuroscience
WP-13 The Research Building
phone 7-1197 (07/98)
 
 
Paul Roepe, Ph.D.
Professor, Chemistry and
Biochemistry,
Molecular & Cellular Biology
353 Basic Science Building
phone  7-7300
 
Sheila Zimmet, B.S.N., J.D.3
Sr. Assoc. VP, Regulatory Affairs
243A Basic Science Building
phone 7-8437 Perm. Member
 
Rodney Freeman4
Administrative Officer, EH & S
LM-12 Preclinical Science Building
phone 7-4712 Perm. Member
 1Chairman
2Radiation Safety Officer
3Management Represenative 
4Executive Administrator

APPENDIX D

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)

microcurie (uCi) = 0.000001 Ci = 3.7 x 104 dps (10-6 Ci)

nanocurie (nCi) = 37 dps (10-9 Ci)

picocurie (pCi) = 1 x 10-12 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)

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 RadiationExposure to radiation from a source located outside of the body.

GU: Georgetown University.

GUACUC: Georgetown University Animal Care and Use Committee.

GU RAM WorkerGeorgetown University Radioactive Materials Worker.

HEPA: High Efficiency Particulate Air filter.

IATA: International Air Transportation Association.

Internal RadiationExposure 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 AreaAn 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.

Sealed SourceRadioactive 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.