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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:	Butler R A, Fruits J L; 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 MI SS OURIRESEARCH REACTOR CENTERFebruary 19, 2016U.S. Nuclear Regulatory Commission Attention:

Document Control DeskMail Station P 1-37Washington, DC 20555-000 1

REFERENCE:

Docket 50-186University of Missouri-Columbia Research ReactorAmended 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 ProduceRadiochemical Sodium Iodine at the University of Missouri at Columbia.

ResearchReactor (TAC No. MF65 14)," dated November 19, 2015By 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 nocurrent supplier within the U.S. This license amendment would allow MURR to continue to perform akey 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 December30, 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 letterdated 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 underpenalty of perjury that the foregoing is true and correct.ENDORSEMENT:

Sincerely, Reviewed and Approved/a., John L. FruitsReactor ManagerRalph A. Butler, P.E.Directorxc: Reactor Advisory Committee Reactor Safety Subcommittee Dr. Garnett S. Stokes, ProvostDr. 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 TestingCriteria 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 TestingCriteria for Air Filtration and Adsorption Units of Normal Atmospheric Systems in Light-Water-Cooled Nuclear Power Plants" (June 2001, Rev. 2)Attachments:

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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 thatthe failure of an experiment could release radioactive gases or aerosols to the reactor bay oratmosphere, the experiment shall be limited to that amount of material such that the airborneconcentration of radioactivity averaged over a year will not exceed the limits of Appendix B, Table Iof 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)."As discussed during the conference call, the words "are intended to" have been added to thespecification.

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 notgreater than 150 Curies."As discussed during the conference call, the words "that is intended to produce Iodine 131" have beenadded 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 cellscharcoal filter banks shall be verified biennially or following major maintenance.

It shall be verifiedthat the charcoal filter banks have a removal efficiency of 99% or greater for iodine."Regarding the wording "or following major maintenance"~

in TS 5.7.e, MURR will follow theguidance 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, andTesting 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 majormaintenance on the Iodine 131 processing hot cells charcoal filter banks. Section 6, "In-Place TestingCriteria,"

of both documents lists activities that would require testing, suach as weld repairs; filteradjustments;

painting, fire, or chemical release in any ventilation zone communicating with thesystem; and following the detection of, or evidence of, penetration or intrusion of water or othermaterial that may have an adverse effect on the functional capability of the system. This is just apartial list that provides examples of not only major maintenance activities but also other abnormal3 of 4 events that would warrant efficiency testing.

MURR will perform efficiency testing following all ofthe activities listed in Section 6 of both references.

4 of 4 ATTACHMENT 1Table of Contents1. Definitions

2. Safety Limits and Limiting Safety System Settings2.1 Reactor Core Safety Limit2.2 Limiting Safety System Settings3. Limiting Conditions of Operation

3.1 Reactivity

3.2 Control Blade Operation 3.3 Reactor Safety System3.4 Reactor Instrumentation 3.5 Reactor Containment

3.6 Experiments

3.7 Facility Gaseous and Particulate Radioactivity Release3.8 Reactor Fuel3.9 Coolant System3.10 Auxiliary Systems3.11 Iodine 131 Processing Hot Cells4. Design Features4.1 Reactor Fuel4.2 Reactor Containment 4.3 Reactor Core4.4 Reactor Coolant System4.5 Emergency Electrical System5. Surveillance Requirements 5.1 Containment System5.2 Cooling System ATTACHMENT 1Table of Contents (continued) 5.3 Control Blade System5.4 Reactor Instrumentation 5.5 Fuel Elements5.6 Auxiliary Systems5.7 Iodine 131 Processing Hot Cells6. Administrative Controls6.1 Administration ATTACHMENT 1TECHNICAL SPECIFICATION UNIVERSITY OF MISSOURISEERH ECO _CLTREEACHRECORFAILTNumber 3.6Page 2 of 5Date _______Amendment No._____

SUBJECT:

Experiments (continued) airborne concentration of radioactivity averaged over a year will not exceed the limits ofAppendix B, Table I of 10 CFR Part 20. Exception:

Fueled experiments that produce Iodine131 through 135 and non-fueled experiments that are intended to produce Iodine 131 (SeeSpecifications 3.6.a and 3.6.p).d. Explosive materials shall not be irradiated or allowed to generate in any experiment inquantities 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 beremoved or installed only with the reactor shut down. Secured experiments shallbe rigidly held in place during reactor operation.

f. Experiments shall be designed and operated so that identifiable accidents such as loss ofreactor coolant flow, loss of experiment

cooling, etc., will not result in a release of fissionproducts or radioactive materials from the experiment.

g. Experiments shall be designed such that a failure of an experiment will not lead to a directfailure of other experiments, a failure of reactor fuel elements, or to interference with theaction 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~TECHNICAL SPECIFICATION UNIVERSITY OF MISSOURIRESEARCH REACTOR FACILITYNumber 3.6Page 4 of 5Date _______Amendment No._____

SUBJECT:

Experiments (continued)

o. Fueled experiments containing inventories of Iodine 131 through 135 greater than 1.5 Curies orStrontium 90 greater than 5 millicuries shall be in irradiation containers that satisfy' therequirements of specification 3 .6.i or be vented to the exhaust stack system through HEPA andcharcoal 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 thatthe 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 cellsthat are vented to the exhaust stack system through charcoal filters which are continuously monitored for an increase in radiation levels.Basesa. Specification 3.6.a restricts the generation of hazardous materials to levels that can be handledsafely and easily. Analysis of fueled experiments containing a greater inventory of fissionproducts 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 orwater annulus surrounding the center test hole by restricting materials which could generate oraccumulate gases or vapors.c. The limitation on experiment materials imposed by specification 3.6.c assures that the limits ofAppendix 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 poolcomponents resulting from detonation of explosive materials.

e. Specification 3.6.e is intended to limit the experiments that can be moved in the centertest 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 systemaction (Ref. Add. 5 to HSR).

ATTACHMENT 1TECHNICAL SPECIFICATION UNIVERSITY OF MISSOURIRESEARCH REACTOR FACILITYNumber 3.6Page 5 of 5Date _______Amendment No._____

SUBJECT:

Experiments (continued)

f. Specifications 3.6.f and 3.6.g provide guidance for experiment safety analysisto assure that anticipated transients will not result in radioactivity releaseand 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 anexperiment from internal or external heat generation.

h. Specification 3.6.i is intended to reduce the likelihood of damage to thereactor and/or radioactivity releases from experiment failure.i. Specification 3.6.j provides assurance that no chemical reaction will takeplace 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 toxicmaterials 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 ofIodine 131 can be performed safely and that equipment necessary foraccident mitigation has been installed.

ATTACHMENT 1TECHNICAL SPECIFICATION UNIVERSITY OF MISSOURIRESEARCH REACTOR FACILITYNumber 3.11Page 1 of 2Date ________Amendment No._____

SUBJECT:

Iodine 131 Processing Hot CellsApplicability 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 ofthe 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 inthe Iodine 131 processing hot cells.b. The facility ventilation exhaust system shall maintain the Iodine 131 processing hotcells 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 cellsunless the following minimum number of radiation monitoring channels are operable.

Radiation Monitoring Channel "Number1.1 Stack Radiation Monitor 12. {Iodine-131 Processing Hot Cells Radiation Monitor 1Exception:

When the required radiation monitoring channel becomes inoperable, thenportable instruments may be substituted for the normally installed monitor inspecification 3.1 1.c.2 within one (1) hour of discovery for a period not to exceed one(1) week.

ATTACHMENT 1TECHNICAL SPECIFICATION UNIVERSITY OF MISSOURIRESEARCH REACTOR FACILITYNumber 3.11Page 2 of 2Date _______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 shallbe operable when processing Iodine 131 in the Iodine 131 processing hot cells.Basesa. Operation of the facility ventilation exhaust system when processing Iodine 131 in theIodine 131 processing hot cells ensures proper dilution of effluents to preventexceeding the limits of 10 CFR 20 Appendix B.b. Maintaining the Iodine 131 processing hot cells at a negative pressure with respect tothe surrounding areas ensures safety for the facility staff.c. The radiation monitors provide information to operating personnel regarding routinerelease of radioactivity and any impending or existing danger from radiation.

Theiroperation will provide sufficient time to take the necessary steps to prevent the spreadof 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 areinstalled and the other is located in the bay above the hot cell next to the exhaustcharcoal filters.d. The potential radiation dose to staff and individuals at the Emergency Planning Zoneboundary and beyond have been calculated following an accidental release of Iodine131 activity.

These calculations are based on the facility ventilation exhaust systemdirecting all Iodine 131 processing hot cell effluents through charcoal filtration with anefficiency of 99% or greater prior to being released through the facility exhaust stack.

ATTACHMENT 1TECHNICAL SPECIFICATION UNIVERSITY OF MISSOURIRESEARCH REACTOR FACILITYNumber 5.7Page 1 of 2Date _______Amendment No._____

SUBJECT:

Iodine 131 Processing Hot CellsApplicability This specification shall apply to the surveillance of the equipment needed to safelyprocess Iodine 131.Objective The objective ofthis specification is to reasonably assure proper operation of theequipment 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 131processing hot cells at a negative pressure with respect to the surrounding areas shall beverified 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 foroperability with a radiation source at monthly intervals.

e. The efficiency of the Iodine 131 processing hot cells charcoal filter banks shall beverified biennially or following major maintenance.

It shall be verified that thecharcoal filter banks have a removal efficiency of 99% or greater for iodine.Basesa. Experience has shown that monthly tests of the facility ventilation exhaust system aresufficient to assure proper operation.

ATTACHMENT 1TECHNICAL SPECIFICATION UNIVERSITY OF MISSOURIRESEARCH REACTOR FACILITYNumber 5.7Page2 of 2DateAmendment No.

SUBJECT:

Iodine 131 Processing Hot Cells (continued)

b. Verifying that the Iodine 131 processing hot cells are at negative pressure with respectto the surrounding areas prior to use ensures personnel safety.c. Semiannual channel calibration of the radiation monitoring instrumentation will assurethat 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 timeperiod.e. Biennial verification of filter banks ensures that the filters will perform as analyzed.