Any University faculty or staff member needing to utilize radioactive material in research studies, must obtain approval of the Radiation Control Committee. Approval is obtained by submitting a proposal to the Committee through the Radiation Control Office describing such items as: (a) the facility where the radioactive materials will be used, (b) the radionuclide(s) which will be used, and (c) the procedures which will be followed in using radioactive materials. This proposal should point out radiation safety precautions which will be taken to prevent the spread of radioactivity to the environs and to protect University personnel.
NOTE: (See Appendix B for content and suggested format for proposals).
No request for approval to use radioactive material will be denied by the Radiation Control Committee before the investigator is given an opportunity to discuss his application with the Committee.
The following forms must be completed and submitted with the proposal:
Prior to Committee approval and usage of radioactive material, facilities will be inspected by Radiation Control and Radiological Services personnel. The Radiation Control Office will also screen submitted RC-1 Forms. If it is determined an individual needs additional training or insufficient information is submitted, a Documentation of Training Form, Appendix B, will be sent. This form offers three options of training for consideration by the RCO.
NOTE: Investigators wanting to conduct studies involving human subjects must submit proposals to the Human Use of Radioisotopes and Radiation Committee. A set of forms, separate from those used for the Radiation Control Committee proposals, must be used and can be obtained by contacting the Radiation Control Office at 392-7359. The Institutional Review Board's Investigators Manual also contains the application forms (846-1494).
Renewal of proposals is required on a two year frequency. A renewal form, Appendix B, will be sent from the Radiation Control Office 15 days prior to expiration of current approval.
If radioactive materials other than those which were included in the initial proposal and approval are requested, an amendment to the proposal must be submitted to the Radiation Control Office describing the additional radioactive material, how, why and where it will be used. A Proposal Summary Form, Appendix B, must also be submitted.
Principal Investigators may obtain radioactive materials after their proposal has been approved by the Committee. To comply with inventory and control requirements of the NRC and DOH, the Radiation Control Office shall approve all radioactive material requisitions and purchase orders prior to placement of orders.
Radioactive materials are not to be used in any University facility without approval of the Radiation Control Committee and/or the Radiation Control Officer from the standpoint of radiation safety. Plans for all new buildings and modifications of existing structures, where radioactive materials are to be used, must be approved by the Radiation Control Committee prior to the construction or modification of the structure.
Prior to termination of activities involving radionuclides, the Radiation Control Office must be notified in order to assure that facilities are free from contamination and that transfer of material is in accordance with regulations.
The Radiation Control Officer and Radiation Control Committee are required to assure that all individuals approved to use radioactive material are competent to do so. The following standards and definitions are established in this regard.
The Principal Investigator is the individual primary responsible for planning, initiating and ultimately interpreting the results of the particular research or project employing radioactive material. In addition, there may be experienced assistants or trainees associated with the work. Any of these individuals might be faculty, staff, students or approved visitors to the University.
The Principal Investigator (PI) must possess formal course or preceptor (on the job) training in all categories (A through F) called for in Appendix B, Statement of Training and Experience. If the above requirement is not met, a faculty associate already approved as a PI for the radionuclide(s) to be used who does have this training and experience and will take responsibility for the radiation safety aspects of planning and execution of the experiment, must be added to the professional team undertaking the work. The level and extent of training and/or experience must be commensurate with the amount and type of radioactive material to be employed, extent of hazard involved and sophistication of the techniques being employed. No individual may work independently with radioactive material unless he has been approved by the Radiation Control Committee in regard to training and experience. Trainees (whether students or otherwise) may handle radioactive material only under the direct supervision of an approved experienced worker. Experienced, approved workers may undertake to train previously inexperienced individuals in the use of radioactive material using the traditional, well accepted Preceptor Method ("on the job training"). However, the individual in question must possess appropriate general technical experience and education to undertake the work, and his credentials must be registered with the Radiation Control Officer.
Furthermore, the nature of the initial experimental work undertaken must be appropriate for the training of the inexperienced individual. Since preceptor training alone has limitations, formal or informal coursework may be required in some cases (Section D).
The Principal Investigator in charge of any facility utilizing sealed sources of radioactive material must be qualified in all aspects as listed on the Statement of Training and Experience, Appendix B. Generally, other individuals can be designated experienced workers for use of the device in question provided they are trained in the normal use of the device, potential hazards, safety precautions and emergency procedures. In recent years, it has become common to include a moderate amount of radioactive material in certain devices designed for general laboratory or even consumer use, such as gas chromatography electron capture detectors. To use such a device, the Principal Investigator is not necessarily required to meet all training requirements for general use of radioactive material, but, must be able to demonstrate competence in regard to use of the device, potential hazards, safety precautions and emergency procedures.
Individuals applying to use radioactive material may be required by the Radiation Control Committee to successfully pursue a formal course, short course or other organized training session, in the following circumstances:
The Principal Investigator is responsible for assuring that personnel monitoring is provided in all radiation facilities for which he is responsible.
Personnel monitoring devices must be worn by personnel as specified below
All monitoring devices shall be obtained from the Radiation Control Office. Each Luxel/film/TLD badge shall be assigned to and worn by only one individual. Luxel/film/TLDs may be exchanged montly, bi-monthly, or quarterly depending upon monitoring device wear location and expected radiation exposure Delivery, exchange and pickup of badges shall be the responsibility of the Radiation Control Office; however, these functions are performed in cooperation with Film Badge Coordinators in some work areas. In the event that a monitor is damaged, lost, or accidentally exposed, it is the responsibility of the Principal Investigator to notify the Radiation Control Office immediately for monitor replacement or processing. Permanent records of monitor readings are maintained by the Radiation Control Office. A copy of the monthly readings is mailed to the Film Badge Coordinator in each work area.
The Radiation Control Office will provide annual radiation exposure reports to those individuals who have been assigned a film badge or other monitoring device. Termination radiation exposure reports will also be provided to those badged individuals who terminate employment requiring personnel dosimetry. Forwarding addresses must be available to facilitate this mailing.
Biological samples may be taken from all personnel working with heavy elements, millicurie quantities of tritium or other radionuclides, at intervals specified by the Radiation Control Officer. Biological samples will be taken from all personnel who have ingested or who are suspected to have ingested, radioactive material and on other occasions deemed necessary. Requirements of the bioassay program for tritium are found in Appendix F, Application of Bioassay for Tritium.
Thyroid monitoring of individuals working with radioiodine is required as specified in Appendix G, Application of Bioassay for I-125 and I-131.
All personnel working with tritium and radioiodine will receive a questionnaire each month regarding their use of these radionuclides. If the amount of activity used does not meet the participation criteria this fact should be noted on the questionnaire. The questionnaire serves to remind individuals of the program requirements and to verify participation of all individuals in the program.
Analysis for other radionuclides can be performed upon request.
The Radiation Control Office shall include bioassay results in the annual radiation exposure reports.
In order to maintain safety and security associated with the use of radioactive material, the Principal Investigator or other individuals responsible for the use of radioactive material, will maintain these materials in a locked enclosure (cabinet, refrigerator, etc.) or otherwise secure the facility from unauthorized access or removal.
Each Principal Investigator is responsible for posting of proper warning signs in all areas in which radioactive materials and radiation producing devices are used. Appropriate warning signs are available from the Radiation Control Office.
The following signs must be posted in each radionuclide lab:
Emergency Notification Notice to Employees Emergency Procedures Safety Rules for a Radioisotope Laboratory.
Calibrated survey meters which are appropriate for the type and level of ionizing radiation being used must be available. Survey meters must be calibrated every 6 months. Contact the Radiation Control Office for instrument calibration and minor repair services.
Each Principal Investigator is responsible for routine (weekly) area surveying and monitoring of radiation facilities to assure the absence of contamination. Monthly surveys are required when radioactive materials are in storage. Permanent records shall be maintained by the investigator, for at least three years, for review by Radiation Control and DOH inspectors. The Radiation Control Office provides Radiation/Contamination Survey Forms, Appendix A, for recording survey results. Periodic and unannounced surveys and monitoring of radiation facilities will be made by representatives of the Radiation Control Office. Upon request, the Radiation Control Officer or his representative will survey and monitor a laboratory, experimental setup, and/or waste storage facilities.
A. Minor Spills: (Less than 100 microcuries of activity and/or 5 mR/hr @ 1 foot)
NOTE: Decontamination shall be the responsibility of the experimenter and/or his supervisor and shall be carried out under the direction of the Radiation Control Officer or persons designated by him, and with the cognizance of the other University officials who may be responsible for the facility or laboratory.
Each Principal Investigator is responsible for providing quarterly radioactive material inventory reports to the Radiation Control Office. Permanent records of inventories shall be maintained by the Principal Investigator for review by Radiation Control and DOH inspectors. Inventory record forms are available from Radiation Control. Appendix H contains detailed instructions for completing the Quarterly Radioactive Material Inventory form. Maintenance of the Utilization Form, also described in Appendix H, will facilitate this process.
Since approval for the procurement and use of radioactive material was initially given for the original working area and proposed research under the supervision of the approved Principal Investigator, radioactive material shall not be transferred from one area to another or to other individuals without approval of the Radiation Control Office.
After approval on the proper transfer form, transfers must be recorded on both the transferring and receiving laboratory's' radionuclide utilization forms.
Radioactive material shall not be shipped or transferred to, or from any University facility, or outside organization without prior approval of the Radiation Control Office.
Prior to the disposal of obsolete or irreparable equipment (radioactive material refrigerators, liquid scintillation counters, gas chromatographs, etc.), the Radiation Control Office must be notified in order to remove warning labels and sources, amend inventory lists, and to verify the absence of contamination, where applicable.
Radiation Control Technique #2, Instructions for Preparation of Radioactive Waste for Disposal, contains radioactive waste disposal procedures which are applicable to the majority of waste generated in laboratories and is available from the Radiation Control Office or the Hazardous Materials Management Office. The Hazardous Materials Management Office (392-8400) should be contacted for disposal information for unusual types of waste. In addition to the radioactive material warning label, waste must be identified as to other hazards present such as poisons, carcinogens, organics or corrosives. Red or biohazard bagged waste will not be picked up. If you have active biohazardous waste and are unsure of a inactivation procedure, contact the Biological Safety Officer (392-1591).
All radioactive materials labels on empty shipping containers must be removed or defaced prior to disposing of the container in regular trash.
All beta, gamma, and neutron sealed sources shall be leak tested at intervals not to exceed six months, and all alpha sealed sources shall be leak tested at intervals not to exceed three months, unless more frequent intervals are prescribed by the Radiation Control Officer and/or the Radiation Control Committee. Leak tests shall be performed according to written procedures.