ML20113H720

Forwards Response to NRC Request for Addl Info Consisting of Proposed TS 6.5 Re Generation of Medical Therapy Facility Beam for Human Therapy & Quality Mgt Program for Generation of Medical Therapy Facility Beam for Human Therapy At..

ML20113H720
Person / Time
Site:	MIT Nuclear Research Reactor
Issue date:	07/30/1992
From:	Bernard J MASSACHUSETTS INSTITUTE OF TECHNOLOGY, CAMBRIDGE
To:	NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
Shared Package
ML20113H722	List: ML20113H720 ML20113H726 ML20113H727
References
TAC-M82958, NUDOCS 9208050209
Download: ML20113H720 (5)

Text

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NUCLEAR REACTOR LABORATORY 1,%m a p.kI Ef?2 W __

AN INTERDEPARTMENTAL CENTER OF T']"$/

, MASSACHU5iiTTS INSTITUTE OF TECHNOLOGY O K. H ARUNG 138 Albany Sneet. Cambodgm Mass 02139 J A BERNARD. JR Srecto, T vefan No (617 253 7300 Daector o' Reactr operabons Teien No 921473 M:T CAM TelNo 1017'253 4202 July 30,1992 U.S. Nuclear Regulatory Commission ATrN: Document Control Desk Washington, D.C. 20555

Subject:

Response to Request for Additional Information (TAC No. M82958) Concerning Generation of Medical nerapy Imcility Beam for Human nerapy, License No. R-37, Docket No. 50-20 Gentlemen:

he Massachusetts Institute of Technology hereby submits this response for additional information. Enclosed please find the following: (1) Response to request for additional information;(2) Revised version of proposed MrlR Technical Specification No. 6.5, " Generation of Medical herapy Facility ' Beam for Human Therapy; (3) Revised version of proposed Quality Management Program for Generation of Medical Therapy Facility Beam for lluman Therapy at the Massachusetts Institute of Technology; (4) a proposed new section of MITR Technical Specification No. 7.13.5 which concerns plant reporting requirements. (Note Only the new material (section (i) on p 7-32) is included. None of the existing specification is to be revised.)

For your convenience, all revisions are shown in ' bold' type. Your earliest review of this material would be nnst appreciated.

i This response has beca reviewed and approved by the MIT Reactor Safeguards Committee.

Sincerely,

% 4  !

ohn A. Bernard, Ph.D.

Director of Reactor Operations MIT Research Reactor JAB!gw Enclosun:s: Response to Request fv Additional Information on hoposed MITR TS #6.5 Appendix A: PM 1.10.10 Proposed MITR TS #6.5 Proposed Section (i)uf MITR TS #7.13.5 Proposed Quality Management Program ec: MITPSC (with enclomres)

USNRC - Project Manager, NRR/PDNP 1 USNRC- Region 1 Chief, Effluent Radiation Protection Section (ERPS)

FRSSil/DRSS USNRC- Director, NRR/PDNP 9208050209 920730

-FDR ADOCK 05000020 gg P PDR

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Response to Request for Additional Inforn ation (TAC No. M82958)

Generation of Medical Therapy Facility Ileam for lluman Therapy Massachusetts Institute of Technology, License No. R.37, Docket No. 50-20

1. A time limit of seven consecutive working days for temporary use of the intercom to contact the control room to scram the reactor if the minor scram on the medical room control panel is out of service nas been incorporated in the proposed technical specification #6.5.3. This limit was chosen to allow su1Ticient time to diagnose the problem, order and procure parts, and effect the repair.

2. Proposed technical specification #6.5.5(d) has been rewritten in the form of a

'shall' statement. (Naic: Although not requested, a similar change has be:n made to the first line of proposed technical specification #6.5.12 and to the firsiline of the last paragraph of proposed technical specification #6.5.16.)

3. In proposed technical specification #6.5.6, a time I'mit of seven consecutive woridag days has been imposed on the use of an altemate means of shutter position verification in the event of status light malfunctions.

4. A surveillance requirement for proper indication of the control panel status lights has been incorporated as proposed technical specification #6.5.12(g)

Sa. A requi ement to calibrate the medical therapy facility radiati on monitor quarterly has beca incomorated as proposed techn! cal specification #6.5.7(c), (Hete: The original provision (c) is now listed as (e).)

5b. A new provision, subparagraph (d), has been added to proposed wchnical specification #6.5.7. This new provision specifies that a local, audible alarm be available such that personnel are alerted to the presence of excessive radiation levels in the medical therapy facility room. In o.tler not to place undne stress on both patients and medical staff, the provision allows for the disabiing of this alarm once (Le medical therapy facility room has been searched and secured. The alarm will be interlocked so that the bypass is automatically removed upon open:ng of the shield door. Requirements for an operational check of the alarm and a functional check of the interlock are incorporated as proposed technical specifications #6.5.12(h) and

1. 6.5.12(i).

Sc. A time limit of seven consecutive working days has been imposed on the use of alternatives shouid the radiation monitor be inoperative. Refer to orovision (c),

which was foan y provision (c), of the proposed technical specifica' tion #6.5.7.

6. Proposed technical specification #6.5.10 has been rewritte.n in the foim of a 'may' statement on the fourth line.

7. These two criteria were originally omitted from proposed techn? cal specificatic .

1. 6.5.11 because (1) no treatments were (or are) envisioned that insolve three or fewer fractions and (2) the 30% weekly cri.'.eria was less conservative than that which we had proposed which was 30% on any fraction. However, there is no reason not to include these criteria in the specifications and we have theirfore done

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so fNote: As a result, the proposed 30% per fraction limit was deleted and provision 3(d) of the Quality Management Program was modified.)

8. Definition 1.27, ' Frequency,' of the MITR Technical Specifications establishes maximum intervals for all time-based surveillaace. These apply to proposed technical specification #6.5.

9. The interlock in proposed technical specification #6.5.5(a) has now been listed as uroposed technical specification #6.5.12(b). (Hg.te: Original provisions (b) (c)

Tave been renumbered as (c)-(f)in proposed technical :;pecification #6.5.12.)

10. Pro >osed technical specification #6.5.12 has been modified to require surveillance of tie medical therapy facility minor scram prior to reactor startup if the uctor has been shut down for more than sixteen hours.

I 1. A new provision, proposed technical specification #6.5.19 has been added that addresses calibration of the beam-monitoring instrumentation. The secondary calibration labora:ory that we presently plan to use is that of the University of '

Wisconsin.

12. The operability check of the shutter closure interlock may not verify manual door operation because the focus of the two correspoading tests will be quite different.

One will check interlock operability while the other will eneck mechanical operation. For example, the first might oaly entail moving a limit switch and verifying shutter closure. The second requires full opening of the door and inspection of moving parts. For purposes of clarification, proposed technical specification #6.5.12(c) has been modified to make clear that both automatic and manual operation are tested. Also, the parenthetical note in proposed technical specification #6.5.13 has been deleted.

13. Preposed technical specification #6.5.14 has been revised to inchtde a stipulation that "the weekly calibration check shall be made prior to any patient irradiation for that week."

14. Proposed technical specification #6.5.15 has been revised to include a stipulation that "all modifications will be reviewed pursuant to the requirements of 10 CFR 50.59." It should be realized that this was MIT's original intent and that Mll has always reported modifications to the medical therapy facility pursuant to 10 CFR 50.59.

15. Proposed technical specification #6.5.15 has been revised to stipula:e that issues related to " radiation safety (i.e., activation and/or contamination)" as they r ite to the opet _.ng couch and other medical equipment do come under the scope of this snecifierion.

16. The requested language concerning written reports has been incorporated in proposed technical specification #6.5.17. However, we question the need fw the requested change conoming verbal reports because the existing procedure (verbal report to the Region with a written re,Nrt tc the Document Control Desk) suffices for all other types of reports. In toticular, we are concerned that the requirement for two official verbal reports, v.ith each undoubtedly engendering different fobow-up questions, may only create confusion.

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17. Definition 5 of the proposed technical specification has betc revised to include a change that has "the potential to increase significantly the amount of activation products in dm medical therapy facility" as a design modification.

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18. Definition 9 of the proposed technical specification has been modified to indicate that only "ar. authonzed user physician" can provide a written directive for the administration of radiation to a pauent.

19. A requircraent to provide a summary of the use of the medical therapy facility has been added as section (i) of technical specification #7.13.5.

20. A commitment to observe the requirements of the " Quality Management Program for Generation of Medical Therapy Facility Beam for Human Therapy at the Massachusetts Institute ci Technology" for any human therapy has been incorporated as proposed technical specification #6.5.18.

21. No modifications are planned for any reactor operating procedure when human therepy is conducted. Similarly, no change of instrument setpoints will be made with the exception of those changes that are necessary for the conduct of the therany may be. Forus.n disabled example, initiation ofas explained in item #5b above, the radiation monitor ala therapy.

22. The MIT Nuclear Reactor Laboratory (NRL) currently rec es inat any experimenter fomtally qualify in (1) radiation safety and buihd evacuation procedures and (2) use of the experiraental equipment that is to be used. To this end, formal qualification cards have been prepared for each of the NRL's f expe-imental facilities. That for the Medical Therapy Facility is PM 1.10.10. A copy is enclosed, as an item of information, in Appendix A to this irsponse. The approach taken to qualification is modeled after that of the U.S. Nuclear Navy. The experimenter 7eads about the facility, studies the systems, traces them, obtains an otal checkout that includes the practical factors listed, and then (in some cases) takes a written test. A li.;t oiqualified experimenters is pasted in the reactor control rocm. PM 1.10.10 is being revised for medical personnel. For example, items 20, 22, and 23 apply only to experiments (such as foil irradiations) and would be replaced by the written directive. Also, the requirements of this technical specification reed to be incorporated in it. As for the h" ling of questions prior and during treatment, the policy given in Regulatory Guic 8.33 (Section 2.5) will be followed. 5

23. The reactor can not be shut down from inside the medical therapy room. The shutters that control beam delivery can be closed from inside the room and this capability is now specified as proposed technical specification #6.5.20. A surveillance requirement is included in that proposed technical specification.

24. Procedures for the conduct of human therapy using the MIT Reactor Medical Therapy Facility are in preparation and will be provided, as an item of information, to the U.S. Nuclear Regulatory Commission as soon as practicable and at least thirty days prior to the initiation of any human therapy. It should be nated that their completion depends on the final form of this proposed technical specitication.

25a. The requested changes in language have been made.

25b. Section 3(a) of the Quality Management Program has been revised for this purpose.

Specifically, a new subclause (v) has been added that stipulates that a copy of the

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written directive shall be hand-carried by the staff of the medical use licensee who accompanies thc patient to hilt.

25c. Section (c) of the Quality hianagement Program has been revised to focus on quality control of the beam.

25d. Section 3(c) of the Quality hianagement Program has been expanded to incorporate the gu* dance contained in Regulato'y Guide 8.33 (pp 7-8) on the review of patient case histories.

25e. The sampling criteria suggested by the U.S. Nuclear Regulatory Commission has been incorporated in Section 4(a) of the Quality hianagement Program (see last sentence).

25f Sections 4(b)(iv),3(e),5, and 7 of the Quality hianagement Program have been natiSed as requested.

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e Annerdiv A PM 1.10.10 - Operator Qualification Sheet for the MIT Research Reactor Medical nerapy Facility This procedure is submitted only as an item of infonnation. It is an example of qualification requirements imposed on an experimenter. The requirements for those conducting human therapy at the MIT Research Reactor's Medical Derapy Facility remain under development and are not addressed in their entirety by this version of PM 1.10.10.

. PM 1.10 Pg. 24 of 28 MIT Reactor 1.10.10 OPEPATOP OU ALIFICATIO'I S11EET FOR THE FEDICAL THEP.APY FACILITY

?;are of Operators (Print)

DATE AD ITDI SUPERVISOR'", SIC'? ATt'RE l

1. Shutters

a. 'faterials of construction

b. Methods of operation

1. Autonatic (3 tines)

2. Manual (1 tino)

c. Purpose of each shutter and combination of shutters

d. 1:ornal sequence and n,ethod of opening shutters

e. Reactivity effect of shutter operation

2. Use of auxiliary shielding door

3. Operation of hydraulic lif t (1 time, if installed) 4 Control panels

a. Location of panels

b. Components and use of control panel

1. Shutter buttons

2. Water shutter level meter

3. D 0 shatter icvel ecter 3

4. 3ctam button

5. Door open button

6. Key switch

7. Low air pressure supply light and interlock

5. Locat. ion of breaker for door power SR # 0-81-19 SEP 161981

la PM 1.10

'~o Pg. 25 of 28 DATE AND ITEM' SUPERVISOR'S SIGNATURE

6. Location'of door con rols

7. Location of crergency door stop

a. Manual operation of lead shielding door

8. Flov systens of water shutters

a. Principle of water shutter operation

b. Location of pump

c. Location of storage tank .

d. D,0 shutter systen principles of operation and location of equinment

9. Compressed air systen

a. princip?.e of' lead and Soral shutter operation

-b.- Location of compressor.

c. Trace. compressed air piping

d. Normal air pressure-

10. Ventilation system-

11. Approvimate . thernal' and gamma flux in beam

- 12. ' Dose rates in. medical therapy facility when shutters are open and when closed

a. By the window b.- By the door

c. -Inside the room

- 13. Radiation Protection Procedures.

14.--Communication with Control Room l

l SR # 0-81-19 SEP 161981 l:

PM 1.10 Ph. 26 of 28 DATE AND ITEM StiPERVISDR ' S SIGNATURE __

15. Radiation nonitors

a. Position of tracerlab chamber and neters

b. Alarn points

c. Use of control panel radiation nonitor indication

d. Use of survey neters

16. Use of sink in redical room

17. Alarms tied to reactor scam system

a. Medical door open

b. Radiation alarm

c. No overflow medical water shutter

18. Response to radiation alarn or high levels outside-roon

19. Principles of shielding for beam experinents

a. Protection against scattered neutrons

b. Gamma ray protection

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20.

~

Scheduling experiments

21. Rules for experimenters and Med. Shutter Guidelines

22. Part I limitatic

23. Part II

a. .Necessary approvals

b. Completion of Part II's I understand the rules and regulations for operation of the Medical Therapy Facility and agree to operate it in accordance with the above guidelines.

TSignatur e)

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