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Univ. of Missouri-Columbia - Response to Request for Additional Information Regarding the License Amendment Request to Modify, the Technical Specifications to Produce Radiochemical Sodium Iodine
	ML16055A023
Person / Time
Site:	University of Missouri-Columbia
Issue date:	02/19/2016
From:	Rhonda Butler, Fruits J; Univ of Missouri - Columbia
To:	; Document Control Desk, Office of Nuclear Reactor Regulation
References
	TAC MF65 14
	Download: ML16055A023 (13)
	v • d • e

UNWVERS ITY of MISS OURI RESEARCH REACTOR CENTER February 19, 2016 U.S. Nuclear Regulatory Commission Attention: Document Control Desk Mail Station P 1-37 Washington, DC 20555-000 1

REFERENCE:

Docket 50-186 University of Missouri-Columbia Research Reactor Amended Facility License No. R-103

SUBJECT:

Written communication as specified by 10 CFR 50.4(b)(1) regarding responses to the "University of Missouri at Columbia - Request for Additional Information Regarding the License Amendment Request to Modify, the Technical Specifications to Produce Radiochemical Sodium Iodine at the University of Missouri at Columbia. Research Reactor (TAC No. MF65 14)," dated November 19, 2015 By letter dated July 20, 2015, the University of Missouri-Columbia Research Reactor (MURR) submitted a request to the U.S. Nuclear Regulatory Commission (NRC) to amend the Technical Specifications (TSs), which are appended to Amended Facility License No. R- 103, in order to produce the radiochemical sodium iodide (I-131).

There are currently no competing modalities for its use as a therapy for thyroid dysfunctions and no current supplier within the U.S. This license amendment would allow MURR to continue to perform a key role in the supply of critical medical radioisotopes, both domestically and internationally.

By letter dated November 19, 2015, the NRC requested additional information and clarification regarding the proposed license amendment request in the form of fourteen (14) questions. By letter dated December 30, 2015, MUJRR responded to those questions.

On January 7, 2016, via a conference call between MIURR and NRC staff, the NRC requested additional information/clarification on three (3) of the responses, specifically Questions 5.a, 9 and 10. By letter dated January 8, 2016, MIURR provided the additional information/clarification.

On February 19, 2016, via a conference call between MIURR and NRC staff, the NRC requested additional information/clarification on proposed TS 3.6.c, 3.6.p and 5.7.e. Below is the additional information/clarification. *"*

1513 Research Park Drive Columnbia, MO 65211 Phone: 573-882-4211 Fax: 573-882-6360 Web: www.murr.missouri.edu Fighting Cancer with Tomorrow's Technology

If there are questions regarding this response, please contact me at (573) 882-5319. I declare under penalty of perjury that the foregoing is true and correct.

ENDORSEMENT:

Sincerely, Reviewed and Approved

/a., John L. Fruits Ralph A. Butler, P.E.

Reactor Manager Director xc: Reactor Advisory Committee Reactor Safety Subcommittee Dr. Garnett S. Stokes, Provost Dr. Mark McIntosh, Vice Chancellor for Research, Graduate Studies and Economic Development Mr. Alexander Adams Jr., U.S. Nuclear Regulatory Commission Mr. Geoffrey A. Wertz, U.S. Nuclear Regulatory Commission Mr. Johnny Eads, U.S. Nuclear Regulatory Commission

References:

1. U.S. Nuclear Regulatory Commission Regulatory Guide 1.52, "Design, Inspection, and Testing Criteria for Air Filtration and Adsorption Units of Post-Accident Engineered-Safety-Feature Atmosphere Cleanup Systems in Light-Water-Cooled Nuclear Power Plants" (September 2012, Rev. 4)

2. U.S. Nuclear Regulatory Commission Regulatory Guide 1.140, "Design, Inspection, and Testing Criteria for Air Filtration and Adsorption Units of Normal Atmospheric Systems in Light-Water-Cooled Nuclear Power Plants" (June 2001, Rev. 2)

Attachments:

1. Newly Proposed and Revised Technical Specification Pages County of '< ']'- JACQUELINE LBOI-M Notary Public-Notary Seal Su~1lm wmt ~oemIi STATE OF MISSOURI C*ommissioned for Hloward County My Commission Expires: March 26, 2019

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1. Additional information/clarification regarding Technical Specification 3.6.c:

Proposed Technical Specification 3.6.c has been revised as follows: "Where the possibility exists that the failure of an experiment could release radioactive gases or aerosols to the reactor bay or atmosphere, the experiment shall be limited to that amount of material such that the airborne concentration of radioactivity averaged over a year will not exceed the limits of Appendix B, Table I of 10 CFR Part20. Exception: Fueled experiments that produce Iodine 131 through 135 and non-fueled experiments that are intended to produce Iodine 131 (See Specifications 3. 6.a and 3. 6.p)."

As discussed during the conference call, the words "are intended to" have been added to the specification. Also, the letter "I" has been capitalized in the word "iodine."

2. Additional information/clarification regarding Technical Specification 3. 6.p:

Proposed Technical Specification 3.6.p has been revised as .follows: "Each non-fueled experiment that is intended to produce Iodine 131 shall be limited such that the inventory of Iodine 131 is not greater than 150 Curies."

As discussed during the conference call, the words "that is intended to produce Iodine 131" have been added to the specification.

3. Additional information/clarification regarding Technical Specification S.7.e:

Proposed Technical Specification 5.7.e states: "The efficiency of the Iodine 131 processing hot cells charcoalfilter banks shall be verified biennially orfollowing major maintenance. It shall be verified that the charcoalfilter banks have a removal efficiency of 99% or greaterfor iodine."

Regarding the wording "or following major maintenance"~ in TS 5.7.e, MURR will follow the guidance of U.S. Nuclear Regulatory Commission (NRC) Regulatory Guide 1.52, "Design, Inspection, and Testing Criteria for Air Filtration and Adsorption Units of Post-Accident Engineered-Safety-Feature Atmosphere Cleanup Systems in Light-Water-Cooled Nuclear Power Plants" (September 2012, Rev. 4) (Ref. 1) and NRC Regulatory Guide 1.140, "Design, Inspection, and Testing Criteria for Air Filtration and Adsorption Units of Normal Atmospheric Systems in Light-Water-Cooled Nuclear Power Plants" (June 2001, Rev. 2) (Ref. 2) when performing major maintenance on the Iodine 131 processing hot cells charcoal filter banks. Section 6, "In-Place Testing Criteria," of both documents lists activities that would require testing, suach as weld repairs; filter adjustments; painting, fire, or chemical release in any ventilation zone communicating with the system; and following the detection of, or evidence of, penetration or intrusion of water or other material that may have an adverse effect on the functional capability of the system. This is just a partial list that provides examples of not only major maintenance activities but also other abnormal 3 of4

events that would warrant efficiency testing. MURR will perform efficiency testing following all of the activities listed in Section 6 of both references.

4 of 4

ATTACHMENT 1 Table of Contents

1. Definitions

2. Safety Limits and Limiting Safety System Settings 2.1 Reactor Core Safety Limit 2.2 Limiting Safety System Settings

3. Limiting Conditions of Operation 3.1 Reactivity 3.2 Control Blade Operation 3.3 Reactor Safety System 3.4 Reactor Instrumentation 3.5 Reactor Containment 3.6 Experiments 3.7 Facility Gaseous and Particulate Radioactivity Release 3.8 Reactor Fuel 3.9 Coolant System 3.10 Auxiliary Systems 3.11 Iodine 131 Processing Hot Cells

4. Design Features 4.1 Reactor Fuel 4.2 Reactor Containment 4.3 Reactor Core 4.4 Reactor Coolant System 4.5 Emergency Electrical System

5. Surveillance Requirements 5.1 Containment System 5.2 Cooling System

ATTACHMENT 1 Table of Contents (continued) 5.3 Control Blade System 5.4 Reactor Instrumentation 5.5 Fuel Elements 5.6 Auxiliary Systems 5.7 Iodine 131 Processing Hot Cells

6. Administrative Controls 6.1 Administration

ATTACHMENT 1 SEERH ECO UNIVERSITY OF MISSOURI TECHNICAL SPECIFICATION REEACHRECORFAILTNumber

_CLT 3.6 Page 2 of 5 Date _______

Amendment No._____

SUBJECT:

Experiments (continued) airborne concentration of radioactivity averaged over a year will not exceed the limits of Appendix B, Table I of 10 CFR Part 20. Exception: Fueled experiments that produce Iodine 131 through 135 and non-fueled experiments that are intended to produce Iodine 131 (See Specifications 3.6.a and 3 .6 .p).

d. Explosive materials shall not be irradiated or allowed to generate in any experiment in quantities over 25 milligrams.

e. Only movable experiments in the center test hole shall be removed or installed with the reactor operating. All other experiments in the center test hole shall be removed or installed only with the reactor shut down. Secured experiments shall be rigidly held in place during reactor operation.

f. Experiments shall be designed and operated so that identifiable accidents such as loss of reactor coolant flow, loss of experiment cooling, etc., will not result in a release of fission products or radioactive materials from the experiment.

g. Experiments shall be designed such that a failure of an experiment will not lead to a direct failure of other experiments, a failure of reactor fuel elements, or to interference with the action of the reactor control elements or other operating components.

h. Cooling shall be provided to prevent the surface temperature of a submerged irradiated experiment from exceeding the saturation temperature of the cooling medium.

ATTACHMENT 1 UNIVERSITY OF MISSOURI

~TECHNICAL SPECIFICATION RESEARCH REACTOR FACILITY Number 3.6 Page 4 of 5 Date _______

Amendment No._____

SUBJECT:

Experiments (continued)

o. Fueled experiments containing inventories of Iodine 131 through 135 greater than 1.5 Curies or Strontium 90 greater than 5 millicuries shall be in irradiation containers that satisfy' the requirements of specification 3 .6.i or be vented to the exhaust stack system through HEPA and charcoal filters which are continuously monitored for an increase in radiation levels.

p. Each non-fueled experiment that is intended to produce Iodine 131 shall be limited such that the inventory of Iodine 131 is not greater than 150 Curies.

q. Non-fueled experiments that are intended to produce Iodine 131 shall be processed in hot cells that are vented to the exhaust stack system through charcoal filters which are continuously monitored for an increase in radiation levels.

Bases

a. Specification 3.6.a restricts the generation of hazardous materials to levels that can be handled safely and easily. Analysis of fueled experiments containing a greater inventory of fission products has not been completed, and therefore their use is not permitted.

b. Specification 3.6.b is intended to reduce the likelihood of accidental voiding in the core or water annulus surrounding the center test hole by restricting materials which could generate or accumulate gases or vapors.

c. The limitation on experiment materials imposed by specification 3.6.c assures that the limits of Appendix B of 10 CFR 20 are not exceeded in the event of an experiment failure.

d. Specification 3.6.d is intended to reduce the likelihood of damage to reactor or pool components resulting from detonation of explosive materials.

e. Specification 3.6.e is intended to limit the experiments that can be moved in the center test hole while the reactor is operating, to those that will not introduce reactivity transients more severe than one that can be controlled without initiating safety system action (Ref. Add. 5 to HSR).

ATTACHMENT 1 UNIVERSITY OF MISSOURI

TECHNICAL SPECIFICATION RESEARCH REACTOR FACILITY Number 3.6 Page 5 of 5 Date _______

Amendment No._____

SUBJECT:

Experiments (continued)

f. Specifications 3.6.f and 3.6.g provide guidance for experiment safety analysis to assure that anticipated transients will not result in radioactivity release and that experiments will not jeopardize the safe operation of the reactor.

g. Specification 3.6.h is intended to reduce the likelihood of reactivity transients due to accidental voiding in the reactor or the failure of an experiment from internal or external heat generation.

h. Specification 3.6.i is intended to reduce the likelihood of damage to the reactor and/or radioactivity releases from experiment failure.

i. Specification 3.6.j provides assurance that no chemical reaction will take place to adversely affect the reactor or its components.

j. Specification 3.6.k provides assurance that the integrity of the beamports will be maintained for all loop-type experiments.

k. Specification 3.6.1 assures that corrosive materials which are chemically incompatible with reactor components, highly flammable materials and toxic materials are adequately controlled and that this information is dissem-inated to all reactor users.

I. The extremely low temperatures of the cryogenic liquids present structural problems which enhance the potential of an experiment failure. Specifica-tion 3.6.m provides for the proper review of proposed experiments con-taining or using cryogenic materials.

m. Specifications 3.6.p and 3.6.q provide assurance that the processing of Iodine 131 can be performed safely and that equipment necessary for accident mitigation has been installed.

ATTACHMENT 1 UNIVERSITY OF MISSOURI

TECHNICAL SPECIFICATION RESEARCH REACTOR FACILITY Number 3.11 Page 1 of 2 Date ________

Amendment No._____

SUBJECT:

Iodine 131 Processing Hot Cells Applicability This specification shall apply to the limiting conditions of operation on the equipment needed to safely process Iodine 131.

Objective The objective of this specification is to reasonably assure that the health and safety of the staff and public is not endangered as a result of processing Iodine 131.

Specification

a. The facility ventilation exhaust system shall be operable when processing Iodine 131 in the Iodine 131 processing hot cells.

b. The facility ventilation exhaust system shall maintain the Iodine 131 processing hot cells at a negative pressure with respect to the surrounding areas when processing Iodine 131.

c. Processing of Iodine 131 shall not be performed in the Iodine 131 processing hot cells unless the following minimum number of radiation monitoring channels are operable.

Radiation Monitoring Channel "Number 1.1 Stack Radiation Monitor 1

2. {Iodine-131 Processing Hot Cells Radiation Monitor 1 Exception: When the required radiation monitoring channel becomes inoperable, then portable instruments may be substituted for the normally installed monitor in specification 3.1 1.c.2 within one (1) hour of discovery for a period not to exceed one (1) week.

ATTACHMENT 1 UNIVERSITY OF MISSOURI

TECHNICAL SPECIFICATION RESEARCH REACTOR FACILITY Number 3.11 Page 2 of 2 Date _______

Amendment No._____

SUBJECT:

Iodine 131 Processing Hot Cells (continued)

d. At least three (3) charcoal filter banks each having an efficiency of 99% or greater shall be operable when processing Iodine 131 in the Iodine 131 processing hot cells.

Bases

a. Operation of the facility ventilation exhaust system when processing Iodine 131 in the Iodine 131 processing hot cells ensures proper dilution of effluents to prevent exceeding the limits of 10 CFR 20 Appendix B.

b. Maintaining the Iodine 131 processing hot cells at a negative pressure with respect to the surrounding areas ensures safety for the facility staff.

c. The radiation monitors provide information to operating personnel regarding routine release of radioactivity and any impending or existing danger from radiation. Their operation will provide sufficient time to take the necessary steps to prevent the spread of radioactivity to the surroundings. The Stack Radiation Monitor continuously monitors the air exiting the facility through the exhaust stack for airborne radioactivity.

The Iodine-i131 Processing Hot Cells Radiation Monitor is a six (6) detector system; two (2) detectors serving each one of the three (3) hot cells. For each hot cell, one (1) detector is located at the processor's work area where the hot cell manipulators are installed and the other is located in the bay above the hot cell next to the exhaust charcoal filters.

d. The potential radiation dose to staff and individuals at the Emergency Planning Zone boundary and beyond have been calculated following an accidental release of Iodine 131 activity. These calculations are based on the facility ventilation exhaust system directing all Iodine 131 processing hot cell effluents through charcoal filtration with an efficiency of 99% or greater prior to being released through the facility exhaust stack.

ATTACHMENT 1 UNIVERSITYSPECIFICATION OF MISSOURI

TECHNICAL RESEARCH REACTOR FACILITY Number 5.7 Page 1 of 2 Date _______

Amendment No._____

SUBJECT:

Iodine 131 Processing Hot Cells Applicability This specification shall apply to the surveillance of the equipment needed to safely process Iodine 131.

Objective The objective ofthis specification is to reasonably assure proper operation of the equipment needed to safely process Iodine 131.

Specification

a. An operability test of the facility ventilation exhaust system shall be performed monthly.

b. The operability of the facility ventilation exhaust system to maintain the Iodine 131 processing hot cells at a negative pressure with respect to the surrounding areas shall be verified daily prior to any process (channel check).

c. The radiation monitors as required by specification 3.1 1.c shall be calibrated on a semi-annual basis.

d. The radiation monitors as required by specification 3.11 .c shall be checked for operability with a radiation source at monthly intervals.

e. The efficiency of the Iodine 131 processing hot cells charcoal filter banks shall be verified biennially or following major maintenance. It shall be verified that the charcoal filter banks have a removal efficiency of 99% or greater for iodine.

Bases

a. Experience has shown that monthly tests of the facility ventilation exhaust system are sufficient to assure proper operation.

ATTACHMENT 1 TECHNICAL SPECIFICATION UNIVERSITY OF MISSOURI RESEARCH REACTOR FACILITY Number 5.7 Page 2 of 2 Date Amendment No.

SUBJECT:

Iodine 131 Processing Hot Cells (continued)

b. Verifying that the Iodine 131 processing hot cells are at negative pressure with respect to the surrounding areas prior to use ensures personnel safety.

c. Semiannual channel calibration of the radiation monitoring instrumentation will assure that long-term drift of the channels will be corrected.

d. Experience has shown that monthly verification of operability of the radiation monitoring instrumentation is adequate assurance of proper operation over a long time period.

e. Biennial verification of filter banks ensures that the filters will perform as analyzed.