Objective

This procedure establishes the authority, function and membership of the University of Tennessee Health Science Center Radiation Safety Committee (RSC).

Scope

This procedure has been developed and implemented by UTHSC Office of Research and applies to all UTHSC activities involving radioactive materials obtained under license R79019-D30 on campus in accordance with the license, Rules of the Tennessee Department of Environment and Conservation, Division of Radiologic Health Chapter 0400-20-10-13(04). The Nuclear Regulatory Commission Radiation Safety Committee organization and function guidance can be found in Appendix A.

The Vice Chancellor for Research has also extended the RSC authority and oversite to include general licensed radioactive devices and equipment, analytical, veterinary, medical, and dental x-ray devices, oversite of class 3B and Class 4 open beam and embedded lasers, ultraviolet light sources other than lasers, nuclear magnetic resonance (NMR) and Magnetic Resonance imaging (MRI) on the UTHSC campus. This oversite includes registration and inventory requirements for these devices, protocol review for research activities, development of safety procedures for each of these categories of hazards, and safety training requirements for persons potentially exposed when these activities are underway.

Definitions

Quorum – consists of at least a majority of the appointed voting membership.

Roles

1. UTHSC employees and students – Responsibilities
   1. Ensure all protocols required by the RSC are completed in a timely manner
   2. Comply with all procedures adopted by the RSC.
2. Chair: The Chair will perform functions including, but not limited to the following:
   1. Direct the proceedings of the full RSC. The position of Chair is a voting position.
   2. Enforce UTHSC RSC policies and standards, as well as all applicable state and federal rules, regulations and statutes concerning radiation safety, use and disposal.
   3. Oversee the review of all protocols and amendments submitted to the committee.
   4. Oversee the review of violations of the UTHSC Radiation Safety Program, as well as applicable state and federal laws and regulations.
   5. (iv) Ensure transparency in the conduct of all Committee meetings, including providing meeting agendas, and documenting members present, numerical results of all votes taken, and dissemination of written meeting minutes.
3. Committee Members:
   1. Review at least quarterly the Radiation Safety Officer’s summary report of occupational radiation exposure records of all personnel working with radioactive materials.
   2. Provide professional advice to the Radiation Safety Officer on matters regarding radiation safety.
   3. Review and approve all requests for the use of radioactive material or other forms of radiation within the institution.
   4. Prescribe special conditions that will be required during a proposed use of radioactive material or other forms of radiation within the institution such as requirements for bioassays, physical examinations of users, and special monitoring procedures.
   5. Review the RSO’s annual evaluation of the radiation safety program at least annually to determine that all activities are being conducted safely and in accordance with UTHSC policies, as well as state and federal regulations, and the conditions of UTHSC’s Broad Scope license.
   6. Recommend remedial action to correct any deficiencies identified in the radiation safety program.
   7. Ensure that UTHSC’s radiation safety program complies with state and federal regulations, as well as institutional policy.
   8. Review instances of non-compliance by authorized users, and take corrective action, as appropriate, per policy.
   9. In collaboration with the RSO, formulate and recommend policy in the use of radioactive materials and other sources of radiation.
4. Radiation Safety Officer’s Responsibilities and Relationship to the RSC
   1. Implement and maintain the Radiation Safety Program as described in the Position Description for the Radiation Safety Officer and in the Delegated Authority under UTHSC’s Broad Scope License.
   2. Ensure that all individuals who work with and/or in the vicinity of radioactive material etc. have sufficient training and experience to enable them to perform their duties safely and in accordance with UTHSC policy and the conditions of UTHSC’s Broad Scope License.
   3. Ensure that all use of radiation sources is conducted in a safe manner and in accordance with current regulations and the conditions of UTHSC’s Broad Scope License.
   4. Review the training and experience of all individuals who use radioactive material and radiation sources and determine that their qualifications are sufficient to enable them to perform their duties safely and in accordance with applicable UTHSC policies and state and federal regulations and the conditions of UTHSC’s Broad Scope License.
   5. Review occupational radiation exposure records of all personnel working with radioactive materials at least quarterly and report these records to the RSC.
   6. Review and approve all requests for acquisition of radioactive material or other forms of radiation within the institution.
   7. Review and evaluate the performance of the entire radiation safety program at least annually to determine that all activities are being conducted safely and in accordance with UTHSC policies, as well as state and federal regulations and the conditions of UTHSC’s Broad Scope License.
   8. Audit the work areas of all Authorized Users at least annually and report findings to the RSC.
   9. Provide remedial action to correct any deficiencies identified in the radiation safety program.
   10. Report instances of non-compliance and the enforcement of corrective actions to the RSC, per policy.
   11. Ensure that UTHSC’s Broad Scope License is amended, when necessary, prior to any changes in facilities, equipment, policies, procedures, radioactive material, possession limits, and personnel, as specified in the license.

Procedure

1. Reporting Structure
   1. In accordance with the UTHSC Broad Scope License R-79019, the Radiation Safety Committee reports to the ViceChancelorfor Research through the Senior Associate Vice Chancellor. The Radiation Safety Officer, while working collaboratively with the RSC to ensure a safe and compliant program, reports directly to the Director of Research Safety Affairs. The Director also works collaboratively with the RSC to ensure a safe and compliant research program.
2. Committee Composition and Membership
   1. Composition

Member	Qualifications/Selection Criteria	Voting Member
Radiation Safety Officer	Named on license R-79019-D30	Yes
Committee Chair	UTHSC employee meeting minimum criteria for a member	Yes
Business Office Representative	Named by the Vice Chancellor of Research	Yes
Management Representative	Named by the Vice Chancellor of Research	Yes
At least one trained or experiences in the safe use of each modality of ionizing	Named by the Vice Chancellor of Research. Selected from the campus community based on evidence of education and training in the area of	Yes

and non-ionizing radiation on the UTHSC campus	expertise in one or more of the modalities of ionizing and non- ionizing radiation overseen by the RSC
Vice Chancellor for Research	Ex Officio	No
Senior Associate Vice Chancellor for Research	Ex Officio	No
Director of Research Safety Affairs	Ex Officio	No

2. Member terms of appointment
   1. Members are appointed for a three-year initial term and may be appointed for successive terms at the discretion of the Vice Chancellor for Research or designee.
   2. A member may be removed from the RCS with or without cause as follows:
      1. By the action of the Vice Chancellor for Research or designee, on recommendation from the RSC Chair, or,
      2. Automatically, if a member misses three consecutive meetings or has a pattern of non-attendance.
   3. Meeting Frequency
      1. The Radiation Safety Committee shall meet as often as necessary to conduct its business but not less than once each calendar quarter and must have a quorum present to conduct official business.
3. Documentation
   1. Committee Minutes
      1. All meetings of the RSC will be recorded and transcribed to create and maintain a written record of all Committee discussions and actions, including a record of members present, members absent, non-voting members present, and the numerical results of all votes taken.
      2. A copy of the RSC approved minutes will be kept on file by the Research Safety Affairs Office.
   2. Protocols
      1. Protocol requirements
         1. All radioactive materials activities utilizing radioactive materials or sources obtained on License R79019-D30 requires a submitted and committee approved IMEDRIS protocol.
         2. All research activities using a class 3b or 4 open beam laser requires a submitted and committee approved IMEDRIS protocol.
         3. All research activities using a x-ray machine or device requires a submitted and committee approved IMEDRIS protocol.
      2. Other associated records
         1. Other associated committee reviewed records will be maintained in the UTHSC Environmental Safety and Health Assistant database or on the Research Safety Affairs Share Point site.

Penalties/Disciplinary Action for Non-Compliance

License violations are subject to civil penalties up to $5,000 per day per violation. In the event of a threat to public health and safety, the Tennessee Division of Radiological Health has the right to confiscate radiation sources.

Additionally, instances of non-compliance with this procedure shall be reviewed by the UTHSC Radiation Safety Committee with corrective or disciplinary action enforced by the Radiation Safety Officer. Enforcement of this procedure shall be in accordance with RSP01-Enforcement of the Radiation Safety Program. Disciplinary action may include suspension of an individual’s ability to use x-ray producing equipment on campus.

References

1. Rules of the Tennessee Department of Environment and Conservation, Division of Radiologic Health Chapter 0400-20-10-13(04).
2. NUREG 1556 Volume 11 Revision 1
3. License R-79019-D30

Responsible Official & Additional Contacts

This Responsible Official and Additional Contacts section contains those who are responsible or share certain policy responsibilities, organized by subject matter, such as monitoring compliance with the policy, providing additional guidance on policy clarifications, organizing policy training, updating the policy, etc.

Subject Matter	Office Name	Telephone Number	Email/Web Address
Policy Clarification and Interpretation	Research Safety Affairs	(901) 448-6114	radsafety@uthsc.edu
Policy Training	Research Safety Affairs	(901) 448-6114	radsafety@uthsc.edu

Related Policies/Guidance Documents

1. Tennessee Administrative Code Title 0400 – Environment and Conservation Subtitle 0400-20 – Division of Radiological Health (§§ 0400-20-04-.01 — 0400-20-13-.08)
2. NUREG 1556 Volume 11 Revision 1
3. SA0300 – Ionizing Radiation Safety Policy
4. SA0500- Laser Safety Policy
5. License R-79019-D30

Appendix A

Radiation Safety Committee Role and Responsibilities

Except from Nuclear Regulatory Commission NUREG-1556 Volume 11 (Rev.1) “Consolidated Guidance About Materials Licenses Program-Specific Guidance About Licenses of Broad Scope”

Note: Other references in addition to the except below describing the RCS functions and duties can be found in Nureg-1556 Volume 11.

An applicant for a Type A broad scope license must establish an RSC pursuant to 10 CFR 33.13(c)(1). The RSC works with executive management and the RSO to implement the radiation safety program, and will be involved in establishing policies and procedures for managing the radiation safety program. The RSC, through the executive management, must have the authority and flexibility necessary to effectively fulfill its role in managing the radiation safety program. The RSC for a Type A broad scope program is composed of such persons as the RSO, executive management, and persons trained and experienced in the safe use of radioactive material. Each area of use under the license should be represented on the RSC.

The licensee should select a chairperson for the committee. There are several factors to consider when making this selection. An individual with a knowledge of radiation safety issues, good leadership abilities, the authority and credibility by virtue of his or her position within the facility, and a desire to serve as chairperson will facilitate the effectiveness of the RSC. Additionally, the individual chosen as the chairperson must have the time to devote to the position in addition to other responsibilities he or she might have within the facility. Executive management should delegate a level of authority to the position so that the chairperson is effective. In general, the RSO should not be appointed as the chairperson of the committee, since the RSO is responsible for the day-to-day operation of the radiation safety program and may be too closely involved with the licensed activities to be objective. The RSC should establish a quorum for RSC meetings. The NRC considers as acceptable the following: a quorum consisting of the chairperson of the committee (or his or her designee), the RSO, the executive management (or his or her alternate), a representative from each area of use from which specific issues will be discussed, and any other member whose field of expertise is necessary for the discussion. Regulations in 10 CFR Part 33 do not specify the meeting frequency for RSC meetings for broad scope programs. The RSC should meet as often as needed to ensure the radiation safety program is operating in compliance with the license, established procedures, and the regulations. For most programs, quarterly RSC meetings are needed to adequately oversee the program. The RSC should maintain minutes of its meetings. The minutes should include the date of the meeting, the members present and absent to demonstrate a quorum was present, a summary of the discussions, recommendations, and the results of votes. The RSC should also document its review of new users, uses, and program changes. The minutes should also include information related to the ALARA program reviews and the annual radiation safety program review.

Duties and Responsibilities The radiation safety committee is required, pursuant to 10 CFR 33.13(c)(3)(iii), to review, approve, and record safety evaluations of proposed uses of byproduct materials. Pursuant to 10 CFR 33.17(b), the material possessed under the broad scope program may only be used by, or under the direct supervision of, individuals approved by the RSC. Therefore, one of the primary responsibilities of the RSC for a broad scope program is to evaluate

new users and new uses of byproduct material. The RSC should consider all available information in making decisions. This includes evaluating the training and experience of applicants that request authorization to use radioactive material at the facility, using criteria developed by the RSC. The RSC members should be aware of the regulatory training and experience criteria that apply to each type of use at their institution. The criteria developed by the committee should include such things as the requester’s training and experience, the proposed facilities, the protocol for using radioactive material to ensure that all procedures are in accordance with good radiation safety practices, and waste disposal. Broad scope programs that also include activities that are under other NRC regulations must meet all applicable requirements of those regulations. Most common are medical licensees of broad scope, which must meet the requirements of 10 CFR Part 35, as well as those of Part 33. Broad scope licensees should review other base NUREGs that may apply to their licensed program, such as NUREG–1556, Volume 9, “Consolidated Guidance About Materials Licensees: Program Specific Guidance About Medical Use Licenses,” which provides guidance

for licensees that possess radioactive material for medical use. Similarly, guidance can be found for other uses of radioactive materials commonly found at broad scope programs, such as self-shielded irradiators (NUREG–1556, Vol. 5), use in animals including veterinary treatment (NUREG-1556, Vol. 7), and uses of small sealed sources in devices such as x-ray fluorescence devices or gas chromatographs (NUREG–1556, Vol. 7) or portable gauges (NUREG–1556, Vol. 1) and fixed gauges (NUREG–1556, Vol. 4).

In addition, the committee is responsible for reviewing personnel dosimetry results, and discussing the results of required radiation surveys and any significant incidents, including spills, contamination, and medical events. Since the licensee is required under 10 CFR 20.1101 to maintain a radiation program based upon sound radiation protection principles to achieve doses that are ALARA, the RSC should review the program for maintaining doses ALARA and provide any necessary recommendations to ensure this. The overall compliance status for authorized users should be thoroughly reviewed. The RSC, working with the executive management, shares responsibility with the RSO for conducting periodic audits of the radiation safety program.

Additionally, the RSC reviews any consultant’s audit findings and documents the acceptance or rejection of the consultant’s findings in the RSC Committee minutes. The RSC also reviews the results of the annual review of the radiation safety program. Licensees should analyze possible trends and implement timely corrective actions as needed.

Problems should be clearly defined and reviewed in the future as open items. An assessment of the effectiveness of corrective actions is also helpful in deterring or eliminating future problems and violations.

For Type A broad scope licensees or applicants for a Type A broad scope license that desire the flexibility to make certain program changes and changes to certain procedures as discussed in Section 1 of this document, the RSC, along with executive management and the RSO, will review and approve program and procedural changes in accordance with criteria developed and approved by the RSC. The criteria for reviewing and approving such changes should include provisions for training staff before implementing new procedures and ensure that the proposed changes will not degrade the effectiveness of the currently approved program. Additionally, the audit program should include an evaluation process that will ensure that changes have been properly implemented by the staff and will determine the effectiveness of changes made in achieving program goals.