9.2 - ADMINISTRATIVE PROCEDURES
- The administrative procedures prescribed herein are intended to facilitate University compliance with applicable regulations for the control of radioactive material and exposure to ionizing radiation. Authorized and Individual Users are required to comply with these procedures. Any individual who observes practices or conditions with respect to radioactive material or radiation-emitting equipment, which are believed to be unsafe, should bring them to the attention of the cognizant Authorized User and RSO. In addition, any individual who believes that there is a violation of Nuclear Regulatory Commission (NRC) regulations or the terms of the University's licenses with regard to radiological safety conditions, may request an inspection by notifying Region I, Office of Inspection and Enforcement, US Nuclear Regulatory Commission, 1200 Renaissance Park, King of Prussia, Pennsylvania 19406, by letter or telephone (toll free at 1-800-432-1156). The request must set forth the specific grounds for the notice as explained in NRC Form 3.
NRC Form 3 -- NOTICE TO EMPLOYEES (reproduced in Appendix A) is required to be posted conspicuously to permit individuals working with radioactive materials to observe the form on the way to or from any particular licensed activity location. It is available from the RSO, full size, or may be reproduced from the reduced copy in the appendix.
Publications which are required by law or regulation to be made available to radiation workers are listed in Appendix A. They are available for inspection in the Radiation Safety Office, together with other publications which may be useful for planning for the safe use of sources of ionizing radiation..
- Authority To Possess And Use Radioactive Material
No one may bring onto CUA property any radioactive material in amounts which would exceed license-exempt quantities (as defined in 10 CFR 30) without authorization from the RSC. A separate application is required for each project which contemplates the use of radioactive material. The scope of an application is the prerogative of the applicant; the scope of an authorization will be determined by the RSC based on its evaluation of the information provided, and the training, experience and facilities of the applicant.
- Application for Authority to Possess and Use Radioactive Material or Radiation-Producing Equipment
Application shall be made on Form RSO-2 (Appendix B). Copies of the form are available from the RSO. Reapplication must be made when an increase in the authorized amount of activity of a previously approved isotope is desired, when a significant change of equipment or procedure is desired, or when additional isotopes are to be used. Instructions to the applicant for completing Form RSO-2 are contained in Appendix C.
- Review of Applications
Review shall be conducted to:
- Ensure the radiological safety of the University community;
- Ensure compliance with applicable laws, regulations and licenses;
- Facilitate the work of competent researchers.
a. RSO Review
Each application shall be reviewed by the RSO who shall, within two weeks of its receipt in final form:
When the RSO has returned an application for revision, the applicant may:
The RSO shall then forward the application, including RSO comments and recommendations to the RSC. Unless amended by the RSC, the recommendations of the RSO shall be binding on the applicant.
- Complete Section 1 Parts a, b, and c, with comments and recommendations, and forward it to the RSC; or
- Advise the applicant and the RSC Chair that review can not be completed within two weeks, the reasons therein, and the estimated date of completion; or
- Return the application to the applicant with a request for specific revisions.
- Make the suggested revision(s); or
- Return the application to the RSO with reasons for disagreeing with the RSO's recommendation(s).
b. RSC Review
In order to afford RSC members time for careful consideration and to provide timely service to applicants, the RSC shall meet to review an application not earlier than one week nor later than one month after the application (including the RSO's comments) has been distributed to committee members. (Note that ordinarily the committee will not meet during the summer months because of 9-month faculty contracts.) When RSC review cannot be completed within one month, the Chair shall advise the applicant in writing of the reasons and the estimated date of completion of the review. As a result of its review the RSC may:
Upon approval by the RSC, an authorization number and expiration date shall be assigned. An acknowledgment letter containing the expiration date along with one copy of the application endorsed by the RSC Chair shall be returned to the applicant, one copy shall be provided to the RSO and one copy shall be retained in the Chair's files. If an application is rejected the record shall show the reason(s) therein, which shall be communicated by the Chair, in writing, to the applicant.
- Approve the application and the recommendations of the RSO, amended as it may find appropriate; or
- Reject the application.
- Criteria for Approval of Applications
The RSO and the RSC are concerned only with safety and regulatory compliance and not with the technical merit of the proposed use of radioactive material. Their reviews are to determine whether:
a. The applicant has the necessary training and qualifications to conduct the proposed operation safely;
b. The applicant has the necessary facilities and equipment to use the radioactive materials safely and in a manner which will comply with applicable regulations;
c. Amendment of CUA license(s) is required before commencement of the proposed operation.
- Termination of Authorizations
All authorizations by the RSC shall terminate automatically at the termination date assigned, which normally will be three years from the first day of the month following approval. It is the responsibility of the Authorized User to submit a timely request for extension of ongoing programs. The RSO will maintain a tickle file to remind the user of the impending termination.
Should the Authorized User choose not to renew, he/she shall notify the RSO at least 30 days prior to the expiration (or termination) of an authorized use of radioactive material. The RSO shall ensure that the affected area and facilities are surveyed for radioactive contamination and shall advise the Authorized User and the cognizant administrator as to whether the area may be released to unrestricted use.
- Control Of Radiation Exposure of Individuals
- Prior Occupational Exposure
A reasonable effort shall be made by the RSO to determine the prior occupational radiation exposure of each Authorized User.
- Baseline Bioassay Evaluations
Individuals desiring to undertake work with radioactive materials may be required by the RSC to undergo a pre-operational baseline bioassay. Depending on the individual's exposure and work history, such tests as urine bioassay and/or controlled background body-burden may be required.
- Personal Monitoring Services
Each person, who enters a posted "Radioactive Materials" area under such circumstances that he or she is likely to receive in one year an external whole body dose in excess of 500 mrem (5 mSv), shall be monitored for occupational radiation exposure as indicated below.
The RSO shall provide appropriate monitoring services and devices to Authorized Users and maintain a record of exposures and/or body burdens thus detected. The RSO and individual user shall ensure that such devices and services are properly utilized.
a. External Dosimeters
External dosimeter badges and/or rings shall be provided by the RSO to those individuals who work with or in the vicinity of sources which emit:
Film badges will normally be processed on a monthly basis and readings which exceed the minimum detectable limit (10 mrem or 100 µSv) will be reported to the individual concerned (and to the responsible supervisor if considered appropriate by the RSO) upon receipt of the readings from the dosimetry vendor.
The use of one or more ring badge dosimeters may be required by the RSC during operations in which the dose to the hands and forearms is likely to be significantly in excess of the whole-body dose. Ring badges shall be provided by the RSO when required.
beta particles with energies greater than 0.2 MeV, or
- x-rays, gamma rays or neutrons.
Bioassay is the determination of the kind, quantity or concentration, and location of radioactive material in the human body by direct (in vivo) measurement or by in vitro analysis of materials excreted or removed from the body. Depending on the nature of the material and the circumstances, uptake may occur by inhalation, ingestion (swallowing), skin puncture or diffusion through the skin. Bioassay may be required for pre-operational baselines and to evaluate any unusual event which causes or threatens to cause internal exposure. All suspected uptakes shall be reported immediately to the RSO, who shall provide or arrange for appropriate bioassay services.
Special Bioassay Requirements for Tritium
All persons who handle individual tritium sources (in any chemical or physical form other than in sealed containers) whose activity exceeds Table 1 values of NRC Regulatory Guide 8.32 shall submit urine samples to the RSO for bioassay. The frequency of bioassay shall be established by the RSO and stated in the radiation safety procedure covering work with tritium.
Special Bioassay Requirements for Iodine
NRC Regulatory Guide 8.20 suggests that bioassay be performed for individuals who handle unsealed quantities of I-125 or I-131 which exceed certain amounts specified under various working conditions. Bioassay services shall be performed for all individuals who handle unsealed quantities of I-125 or I-131 which exceed the Table 1 values of NRC Regulatory Guide 8.20 and at the required frequency stated in the radiation safety procedure covering work with iodine.
c. Special Precautions for Declared Pregnant WomenAuthorized Users shall ensure that women, working under their jurisdiction with sources of ionizing radiation, are aware that radiation exposure may increase health risks to the fetus. A "declared pregnant woman" means a female who has voluntarily informed her supervisor, in writing, of her pregnancy and the estimated date of conception. The NRC has published a general guide on this subject which is available in the RSO office. (See also Sections 9.3.3 & 9.3.15 j(2).)
- Procurement Of Sources Of Ionizing Radiation
- Radioactive Material
Requests for procurement of any source of ionizing radiation, whether as a radiation-producing machine or as naturally occurring or artificially produced byproduct, source, or special nuclear material, shall be submitted to the RSO for approval.
The RSO shall approve such requests and transmit them to the CUA Purchasing Department (or other appropriate addressee) provided:
- The originator has an approved authorization for the source on file with the RSO;
- The activity requested, in the case of radioactive material, will not result in exceeding the user's limits or the limits provided in the applicable CUA license; and
- The Authorized User's isotope inventory on file with the RSO is current.
b. Preparation of Requisitions
Requisitions for radioactive material shall be prepared on the standard CUA requisition form. Such requisitions should not include requests for non-radioactive materials or laboratory supplies. A copy of the requisition shall be included for retention by the RSO as part of the permanent records of the office. Requisitions for radioactive material shall include the following information:
- The words "RADIOACTIVE MATERIAL ORDER";
- The identity of the proposed user; and
- The symbol and mass number of each radionuclide, its chemical or physical form and the amount of activity ordered, expressed in millicuries.
- Radiation-Producing Machines and Equipment
A radiation-producing machine is any equipment whose primary purpose is to produce ionizing radiation, or which produces ionizing radiation coincidental to its primary purpose.
Before acquiring any radiation-producing machine (whether by purchase, loan, consignment for evaluation, or other means), the individual who is to be primarily responsible for its use shall consult with the RSO to determine whether any special restrictions will be necessary and to acquaint himself/herself with applicable regulations.
- The responsible individual shall provide to the RSO a copy of the purchase order or other acquisition document.
- The RSO shall be notified immediately upon receipt of a radiation-producing machine and supplied with the necessary information for registration with the government of the District of Columbia, if registration is required.
- The RSO shall be present to survey the machine at its initial testing and at such additional testing periods as may be required to satisfactorily characterize the radiation field under all operational modes.
- Proposals For Contracts And Grants Involving Ionizing Radiation
- Investigator Responsibilities
Each proposal for or solicitation of support (of whatever form, such as a contract, grant, gift, etc.) for research which anticipates the use of radioactive material or other sources of ionizing radiation shall be submitted to the RSO for review prior to submittal to the Director of Sponsored Programs and Research Services. The purpose of the RSO review is to ensure that the proposal budget includes the cost of such radiation monitoring and protection devices and equipment as may be appropriate (if not already at hand), and to evaluate the prospective impact of the proposal on the RSO operating budget. The investigator submitting the proposal should involve the RSO sufficiently early in its preparation that agreement may be reached with respect to the required equipment and facilities. Any disagreement which cannot be resolved between the investigator and the RSO shall be referred in writing to the Chair of the RSC for resolution by the Committee, whose decision shall be binding.
- RSO Responsibilities
The RSO shall endorse each proposal submitted for review to the effect that:
a. Adequate provision has (or has not) been made in the proposal budget for the cost of appropriate radiation safety measures.
b. Augmentation of the RSO budget will (or will not) be required in order to provide necessary radiation safety support services to the investigator if the contract sought is awarded. If budget augmentation is expected to be required, the RSO shall append to the endorsement a supporting budget impact analysis. A copy of the analysis shall be provided to the Chair of the RSC.
- Receiving Shipments Of Radiation Sources
Shipments of radioactive material intended for Authorized Users at CUA shall be delivered to:
- The Catholic University of America
Radiation Safety Officer
Environmental Health & Safety
620 Michigan Avenue, NE
Washington, DC 20064
- The Catholic University of America
Department of Public Safety
- The Catholic University of America
All shipments of radioactive material arriving at CUA during normal working hours shall be delivered to the RSO; carriers attempting to deliver such material which has been erroneously consigned to a department or laboratory shall be directed to the RSO. Shipments arriving outside of normal working hours shall be accepted by the Department of Public Safety. Small packages shall be physically accepted. They shall not be retained longer than necessary in the Dispatchers Office, but shall be deposited in the Radiation Safety Office by the first available campus police officer. If a package is too large or too heavy to be handled conveniently by a campus police officer, the delivering truck shall be escorted by a campus police officer to the Radiation Safety Office so that the package can be off-loaded directly.
The RSO shall maintain a log of all incoming radioactive material documenting the date of receipt, the symbol and mass number of the isotope and its chemical or physical form, the activity, the supplier, the Authorized User, and the user's receipt for the material.
All incoming shipments of radioactive material shall be inspected by the RSO in accordance with 10 CFR 20.1906.
- Delivery to Authorized User
Upon satisfactory completion of the arrival inspection, the RSO shall deliver the material or inform the Authorized User (or Departmental or Laboratory office as appropriate) of its availability for pickup. The User or designated representative shall indicate receipt of the material on the form provided by the RSO.
- Outgoing Shipments Of Radioactive Material
No individual or organization, except the RSO, is authorized to ship or transport radioactive material from a campus location to an off-campus location.
- Transportation Of Radioactive Material On Campus
Radioactive material may be hand-carried outside of restricted areas and between buildings on-campus, with the approval of the RSO, provided that all the following conditions are met:
a. The material is enclosed within an approved shipping container which is properly labeled;
b. The radiation exposure does not exceed either 20 mrem/hr (200 µSv/hr);at the surface of the container or 5 mrem/hr (50 µSv/hr);at a distance of one meter from the container surface;
c. There is no detectable contamination of the container's exterior surface as determined by a wipe test and survey meter measurement of the wipe test, and;
d. During transit, the radioactive material is in the continuous possession of an individual who is authorized to use or transport the material.
- Inventory Of Sources Of Ionizing Radiation
Licenses granted the University by the NRC impose total possession limits for radioactive material by element name and mass number, and by chemical or physical form. Certain naturally occurring radioactive materials and much equipment which produces ionizing radiation are not subject to federal or local government license requirements. However, in order to ensure that the University remains in compliance with the possession limits imposed by license(s) and protects the health and safety of the University community, the RSO shall maintain a running inventory of all sources of ionizing radiation on the campus, or possessed by University Departments or Laboratories.
- To provide the RSO with the information required to carry out this duty, the inventory control procedures described in the following sections shall be followed by all users of sources of ionizing radiation.
- Consumable Radioactive Material
Consumable radioactive material is defined, for inventory control purposes, as radioactive material which is withdrawn incrementally from a stock container for user-determined end use.
b. Radioactive Material Inventory Control Number
A radioactive material inventory control number (RMIC) shall be assigned by the RSO to each container of consumable radioactive material received. The RMIC number shall be permanently affixed by the Authorized User to each stock container and shall be used in identifying the material in all inventory records. (The user may have additional identification of the material.) If the contents of the original container are partitioned into two or more stock containers, each shall have permanently affixed the RMIC number and a letter suffix.
c. Radioactive Material Inventory Control Form (RSO-1)
Form RSO-1 (Appendix B) shall be prepared in duplicate by the RSO for each container of consumable radioactive material received. The original will be used to maintain the RSO master inventory; the copy will be delivered to the Authorized User with the radioactive material. The Authorized User shall maintain the form current by recording the date, quantity and disposition of each withdrawal from the container. Upon depletion or decay of the consumable radioactive material, the completed RMIC form shall be returned to the RSO.
d. Radioactive Material Disposal Report
Interim disposal of consumable radioactive material into radwaste holding containers in the user's laboratory shall be recorded on the appropriate RMIC form (RSO-1). In addition, a running record of radioactive material deposited in each container shall be maintained. Based on these records, a Radioactive Material Disposal Report shall be prepared and shall be delivered to the RSO with each lot of radwaste. The disposal report shall show the total activity in millicuries for each radioisotope included in each container of radwaste.
- Sealed Sources
Sealed radioactive sources and other radioactive material which are not intended to be consumed by incremental experimental use (such as liquid scintillation standards or other liquid reference standards) shall be recorded on a master inventory by each Department or independent Laboratory . Form RSO-3 (Appendix B) shall be used.
- Inter-User Transfer Of Radioactive Material
Radioactive material and radiation-producing machines shall be transferred between Authorized Users only with the prior knowledge and approval of the RSO.
Radioactive material to be transferred shall be taken to the Radiation Safety Office where each container will be logged in, checked for external contamination, removed from the RMIC record of the former Authorized User and a RMIC form prepared for the new Authorized User in accordance with Section 126.96.36.199.
- Disposal Of Radioactive Waste
No radwaste may be disposed of by conventional methods. This means, particularly, that solid radwaste may not be placed in the standard waste containers to be collected by housekeeping personnel, and that users shall not discharge radioactive waste into drains. Incineration and burial of radwaste on the CUA campus are prohibited. Radwaste contaminated only with short-lived isotopes (120 day half-life or less) will be collected by the RSO and held for decay in accordance with the provisions of applicable licenses. After a minimum 10 half-lives of decay, the waste will be surveyed to confirm the absence of detectable radioactivity, radioactive markings will be removed or obliterated, and the material will be disposed of to ordinary trash.
Radioactive material combined with or in the form of material which is hazardous, (such as toxic chemicals, biohazardous agents, etc.) shall not be disposed of without prior authorization from the RSO. The Authorized User shall advise the RSO of proposed experiments involving these or other unusual radwaste disposal problems prior to initiation of the experiments. The RSO, after consultation with the RSC and the Director of Environmental Health & Safety, shall furnish appropriate guidance to the Authorized User.
Authorized Users shall store and dispose of radwaste only in accordance with the detailed procedures set forth in Appendix D. The RSO shall provide for removal and lawful disposition of all CUA radioactive waste. In the event that access to a licensed low-level waste site is denied, the RSO shall store radwaste in the CUA radwaste storage and handling facility until access is restored.
- Corrective Action
It is anticipated that most questions of radiological safety will be resolved by consultation between an Authorized User and the RSO. To ensure that the safety of users and the public are protected, the RSO has been granted the authority to take possession of any radioactive material or suspend any procedure or operation involving the use of radioactive material or radiation producing machines which is believed to pose a radiological threat to health or property. Such action shall be reported promptly by the RSO to the RSC Chair.
- Radiation Safety Committee Responsibility
The Radiation Safety Committee shall:
a. Review and confirm, modify or vitiate, for the record, all peremptory corrective action taken by the RSO;
b. Review all allegations, by whatever party, of infractions or unsafe practices involving the possession or use of sources of ionizing radiation. The RSC may require that such allegations be placed in writing and shall respond in writing thereto;
c. Take corrective action, if required, which may include:
- Requiring additional training of personnel prior to permitting resumption of their work under a User Authorization;
- Alteration of the terms of a User Authorization;
- Suspension of a User Authorization; or
- Recommendation of administrative discipline be taken by the Associate Vice President for Facilities Operations.
- Right of Appeal
The action of the RSC may be appealed to the Associate Vice President for Facilities Operations, and ultimately to the President, by the originator of allegations brought under Section 9.2.1 or Section 188.8.131.52, or by a User in disagreement with the action of the RSC. Such appeals shall be in writing and shall set forth succinctly the factual basis for the appeal..
- Education And Training For Radiation Safety
The RSO, the Departmental RSC representative and the Authorized User shall work together to ensure the adequacy of the radiation safety training of CUA radiation workers, as well as students whose only use of ionizing radiation may be in a closely supervised laboratory course. To assist them in sharing the University's obligation to provide radiation safety training, this section imposes certain responsibilities which partially overlap.
- Responsibility of the RSO
The RSO shall ensure that the education and training of CUA radiation workers required by law, regulation, or safety considerations, is accomplished to an extent consistent with their work. To this end the RSO shall, as appropriate:
a. Supplement the prior training of applicants for authorization to use radioactive material or radiation- producing machines in order to assist them to qualify themselves for work they desire to undertake;
b. At the request of a Departmental RSC representative or Authorized User, conduct or assist in training for radiation workers;
c. Maintain records of such training conducted by the RSO, Departmental RSC representatives and Authorized Users;
d. Acquire and maintain current a collection of radiation safety related reference publications consistent with the nature and extent of the use of ionizing radiation at CUA.
- Responsibility of Departmental RSC Representatives
Within each department the overall responsibility for ensuring the radiation safety education and protection of CUA personnel using, or in the proximity of the use of, sources of ionizing radiation rests with Departmental RSC representative. He/she shall:
a. Ensure that each Authorized User within the department provides appropriate radiation safety instruction of all radiation workers for whose work and safety she/he is responsible;
b. When necessary or desirable, conduct or assist in conducting radiation safety training for departmental radiation workers;
c. Adhere to the additional instructions (as appropriate) detailed in Section 9.4;
d. Keep the RSO informed regarding the need for and the accomplishment of radiation safety training.
- Responsibility of Authorized Users
Each Authorized User is directly responsible for the safe use of radioactive material and radiation-producing equipment for which he/she is responsible by all persons who may be permitted to use them. He/she shall:
a. Ensure that they have obtained the training and indoctrination required to enable safe working habits and to maintain the radiation dose to themselves and others as low as is reasonably achievable;
b. Teach those for whose radiological safety they are responsible (by instruction and example) the use of safe techniques and the application of approved radiation safety practices;
c. Enlist the assistance, as appropriate, of the RSO, the Departmental RSC representative, or others, in training their radiation workers in matters of radiation safety;
d. Maintain a record of the radiation safety training of each individual working under their authorization. The record need not include incidental instruction of students whose only use of radioactive material or radiation-producing equipment is in a regularly scheduled laboratory course under the direct supervision of appropriately trained individuals;
e. For educational or safety purposes, consider the advisability of conducting (or requiring others to conduct) experimental procedures "cold," to ensure that the procedures are sound, before they are performed with dispersible radioactive material. (The RSC may so-require by the terms of a User's Authorization.)
- Incident And Emergency Reporting
- Authorized User Responsibility
Each Authorized User shall notify the RSO immediately of the following types of incidents involving sources of ionizing radiation subject to his/her control:
a. Possible personnel contamination by or ingestion of radioactive material;
b. Unplanned exposure to radiation;
c. Unanticipated contamination of equipment or facilities;
d. Misplacement, loss, or suspected theft of radioactive material.Any other individual (including co-worker, subordinate or student) possessing such information shall communicate it immediately to the Authorized User, if known and available. If the responsible Authorized User is unknown or unavailable, the individual shall notify the RSO.
- RSO Responsibility
The RSO shall investigate all reports of incidents involving ionizing radiation. The RSO shall inform the Chair of the RSC of any findings and recommendations. The RSO shall prepare, for the signature of the RSC Chair, any notification to the NRC or other regulatory agency, required by law or regulation concerning such incident. Prior to notifying the NRC, the RSO shall advise the least senior of the following University Officials (or their designees) who can be reached: The RSC Chair, the Associate Vice President for Facilities Operations or the President. If none of these individuals can be contacted, the RSO shall make the required notification, take charge of the emergency situation which required the notice and inform the indicated University officials as soon as practicable.