ML20137L574

Amend 30 to License R-37,allowing Mit to Conduct boron-neutron Capture Therapy on Patients from NRC & Agreement State Medical Use Licensees Whose Licenses Contain boron-neutron Specific Conditions

ML20137L574
Person / Time
Site:	MIT Nuclear Research Reactor
Issue date:	04/03/1997
From:	Weiss S NRC (Affiliation Not Assigned)
To:
Shared Package
ML20137L549	List: ML20137L545 ML20137L574 ML20137L590
References
R-037-A-030, R-37-A-30, NUDOCS 9704070267
Download: ML20137L574 (16)

Text

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L c uzu y g UNITED STATES NUCLEAR REGULATORY COMMISSION D E WASHINGTON, D.C. 3008643001

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3. MASSACHUSETTS INSTITUTE OF TECHNOLOGY DOCKET 50. 50-20 j AMENDMENT TO AMFNDED FACILITY OPERATING LICENSE i

Amendment No. 30 License No.-R-37

, . 1. The U.S. Nuclear Regulatory Commission (the Commission) has found that: '

A. The application for an amendment to Amended Facility Operating License

. No. R-37 filed by the Massachusetts-Institute of TechnoloCy (the  :

licensee) on February 18, 1997, as supplemented on. March 17, 1997, )

conforms with the standards and requirements of the Atomic Energy Act  !

.of 1954, as amended (the Act), and the regulations of the Commission i as. set forth in Chapter I of Title 10 of the Code of Federal i Reiulations (10 CFR);

B. The facility will operate in conformity with the application, the provisions of the Act, and the rules and regulations of the s Commission;

! C. There is reasonable assurance (i) that the activities authorized by this amendment can be conducted without endangering the health and .

safety of the public and (ii) that such activities will be conducted '

in compliance with the regulations of the Commission; ,

D. The issuance of this amendment will not be inimical to the common defense and security or to the health and safety of the public; E. .The issuance of this-amendment is in accordance with the regulations of the Commission as set forth in.10 CFR Part 51, and all applicable  !

requirements have been satisfied; and j F. Prior notice of this amendment was not required by 10 CFR 2.105, and publication of notice for this amendment is not required by 10 CFR  :

2.106.

m 9704070267 970403 PDR ADOCK 05000020 t P PDR f

2. Accordingly, the license is amended by changes to the Technical Specifications as indicated in the enclosure to this license amendment, and paragraph 2.C.(2) of Amended Facility Operating License No. R-37 is hereby amended to read as follows:

(2) Technical Specifications The Technical Specifications contained in Appendix A, as revised through Amendment No. 30, are hereby incorporated in the license.

The licensee shall operate the facility in accordance with the Technical Specifications.

3. This license amendment is effective as of the date of issuance.

FOR THE NUCLEAR REGULATORY COMMISSION I i Seymour H. Weiss, Director l l

Non-Power Reactors and Decommissioning Project Directorate Division of Reactor Program Management Office of Nuclear Reactor Regulation

Enclosure:

Appendix A Technical Specifications Changes Date of Issuance: April 3, 1997 l

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ENCLOSURE TO LICENSE AMENDMENT NO. 30 FACILITY OPERATING LICENSE NO. R-37 DOCKET NO. 50-20 Replace the following pages of the Appendix A Technical Specifications with the enclosed pages. The revised pages are identified by amendment number and contain vertical lines in the right-hand margin indicating the area of change.

Remove Insert 6-21 to 6-33 6-21 to 6-33 i

6.5. Generation of Medical Theraov Facility Beam for Human Thernov

'Anolicability This specification applies solely to the generation of the medical therapy facility beam for the treatment of human patients. It does not apply to any other use of the medical therapy facility and/or its beam. Surveillances listed in this specification are only required if human therapy is planned for the interval of the surveillance. However, in the event of a hiatus in

the scheduled performance of any given surveillance, that surveillance shall be performed i

prior to the initiation of human therapy during the intervalin question. ]

4 Objective ,

To provide for the protection of the public health and safety by ensuring that patients are treated in accordance with the treatment plan established by the BNCT physician authorized user and that the ALARA principle is observed for all non-therapeutic radiation exposures.  ;

Soecification

1. Patients accepted for treatment shall have been referred by written directive from a

BNCT physician authorized user from a medical center with an NRC or Agreement State medical use license that contains BNCT specific conditions and commitments i for BNCT treatment on humans conducted at the Massachusetts Institute of Technology Research Reactor's Medical Therapy Facility.

l 2. All medical treatments, including irradiations and analyses of the neutron capture agents in the patients, are the responsibility of the BNCT physician authorized user in charge of the therapy and the medical physicists from the NRC-licensed or l i

1 Agreement State-licensed medical center. The Massachusetts Institute of Technology is only responsible for providing current and accurate beam characteristic parameters to the medical use licensee and for delivery of the desired radiation fluence as requested in the written directive Before the start of a therapy, both the certified medical physicist and the Director of the Nuclear Reactor Laboratory, or his

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designate, must agree that the therapy can be initiated. The BNCT physician l  !

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authorized user is responsible for monitoring the therapy and for directing its termination. However, a radiation therapy can also be terminated c' any time if either ,

the BNCT physician authorized user or the NRL Director, or their designates, judge that the therapy should be terminated.

3. It shall be possible to initiate a minor scram of the reactor from a control panel located in the medical therapy facility area. In the event that the medican facility minor scram is inoperable, it shall be acceptable to use one of the control room scrams via communication with the reactor operator as a temporary means of satisfying this provision. Use of this temporary provision is limited to seven consecutive working days.

4. Access to the medical therapy facility shall be controlled by means of the shield door located at its entrance.

5. The following features and/or interlocks shall be operable:

(a) An interlock shall prevent opening of the shutters that control beam delivery  ;

unless the medical therapy facility's shield door is closed.

(b) The shutters that control beam delivery shall be interlocked to close automatically upon opening of the medical therapy facility's shield door.

(c) The shutters that control beam delivery shall be designed to close automatically upon failure of either electric power or on low air pressure if the shutter is operated pneumatically.

(d) Shutters that control beam delivery and that are normally pneumatically-operated shall, in addition, be designed for manual closure.

(e) It shall be possible to close the shutters that control beam delivery from l within the medical therapy facility. ,

6. Each of the shutters that controls beam delivery shall be equipped with a light that indicates the status of the shutter. These lights shall be visible at the medical therapy facility's local control panel. In the event of a status light malfunction, it shall be acceptable to use the affected shatter oravided that an alternate means of verifying 6-22 AMENDMELT No. 30

position is available. Use of this alternate means of shutter position verification is  ;

limited to seven consecutive working days.

The medical therapy facility shall be equipped with a monitor that provides a visual  :

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indication of the radiation level within the facility, that indicates both within the facility and at the local control panel, and that provides an audible alam1 both within i

the facility and at the local control panel.

This radiation monitor shall be equipped with a backup power supply such as ,

(a) the reactor emergency power sygem or a battery. .

4 (b) This radiation monitor shall be checked for proper operation by means of a check source on the calendar day of and prior to any patient irradiation.

(c) This radiation monitor shall be calibrated quarterly.

(d) The audible alarm shall be set at or Selow 50 mR/hr. This monitor and/or its -

I alarm may be disabled once the medical therapy room has been searched and secured, such as is done immediately prior to initiation of patient therapy. If this is done, the monitor and/or its alarm shall be interlocked so that they become functional upon opening of the medical therapy facility's shield door. j 1

(e) In the event that this monitor is inoperable, personnel entering the medical 1 l

therapy facility shall use either portable survey instruments or audible alarm personal dosimeters as a temporary means of satisfying this provision. These instruments / dosimeters shall be in calibration as defined by the MIT Research Reactor's radiation protection program and shall be source-checked daily prior to use on any day that they are used to satisfy this provision. Use of  !

these instruments /dosicneters as a temporary means of satisfying this )

I provision is limited to seven consecutive working days. j

'8. An intercom or other means of two-way communication shall be operable both between the medical therapy facility control panel and the reactor control room, and also between the medical therapy facility control panel and the interior of the facility.

The latter is for the monitoring of patients.

6-23 AMENDMENT No. 30

9. It shall be possible for personnel monitoring a patient to open the medical therapy facility's shield door manually.

10. It shall be possible to observe the patient through both a viewing port and by means of a closed-circuit TV camera. Both methods of patient visualization shall be operable at the outset of any patient irradiation. Should either fail during the irradiation, the treatment may be continued at the discretion of the BNCT physician authorized user. Adequate lighting to permit such viewing shall be assured by the provision of emergency lighting.

I 1. The total radiation fluence delivered by the medical therapy facility beam as measured by on-line beam moniters shall not exceed that prescribed in the patient treatment plan by more than 20%. The treatment is normally delivered in fractions in accordance with standard practice for human therapy. The 20% criterion applies to the sum of the radiation fluences associated with all fractions in a given treatment plan. A criterion of 30% applies to the difference between the administered and prescribed fluence for any given week (seven consecutive days). Finally, if the treatment consists of three or fewer fractions, then a criterion of 10% shall apply.

12. The following interlocks or channels shall be tested at least monthly and prior to treatment of human patients if the interlock or channel has been repaired or deenergized.

Interlock or Channel Surveillance a) Medical therapy facility minor scram Scram test b) Shutters will not open un!cs.; Operational test shield door is closed c) Shutters close upon both marual and Operational test automatic opening of shield door d) Shuiiers close on loss of electrical Operational test power and reduction of pressure 6-24 AMENDMENT No. 30

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in pneumatic operators,if applicable e) Manual closure of pneumatic shutters Operational test f) Shutters can be closed manually Operational test from within the facility g) Shutter status lights Operational test h) Radiation monitor alarm Operational test i) Radiation monitor and/or alarm Operational test enabled upon opening of shield door j) Intercoms Operational test In addition to the above, the medical therapy facility minor scram shall be tested prior to reactor stanup if the reactor has been shut down for more than sixteen hours.

13. Manual operation of the medical therapy facility's shield door in which the door is opened fully shall be verified semi-annually.

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14. Use of the medical therapy facility beam shall be subject to the following: ,

a) A calibration check of the beam and a functional check of the beam monitors that are described in provision 11 of this specification shall be made weekly for any week that the beam will be used for human therapy. These checks shall be made prior to any patient irradiation for a given week. In addition, a calibration check shall be performed prior to any patient irradiation in the event that any component of a given beam design has been replaced. Finally, a calibration and a functional check shall be performed prior to any patient irradiation in the l event of a design modification.

b) A characterization of the beam shall be performed every six months for any six-month interval that the beam will be used for human therapy. This six-month characterization shall be made prior to any patient irradiation for a given six-month interval. A characterization shall also be performed prior to any patient irradiation in the event of a design modification. As pan of the characterization 6 25 AMENDMENT NO. 30

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process, the proper response of the beam monitors that are described in provision 11 of this specification shall be verified.

c) A calibration of the beam monitors that are described in provision 11 of this specification shall be performed at least once every two years for any two-year interval that the beam will be used for human therapy. The two-year calibration shall be made - prior to any patient irradiation during any given two-year interval.

15. Maintenance, repair, and modification of the medical therapy facility shall be .

performed under the supervision of a senior reactor operator who is licensed by the U.S. Nuclear Regulatory Commission to operate the MIT Research Reactor. The

' medical therapy facility

• includes the beam, beam shutters, beam monitoring equipment, medical therapy facility shielding, shield door, and patient viewing equipment. All modifications will be reviewed pursuant to the requirements of 10 CFR 50.59. The operating couch, patient positioning equipment, medical instruments, and other equipment used for the direct medical support of the patient are not considered pan of the medical therapy facility for purposes of this provision, except insofar as radiation safety (i.e., activation and/or contamination) is concerned.

16. Personnel who are not licensed to operate the MIT Research Reactor but who are responsible for either the medical therapy or the beam's design including construction and/or modification may operate the controls for the medical therapy facility beam provided that:

(a) Training has been provided and proficiency satisfactorily demonstrated on the design of the facility,its controls, and the use of those controls. Proficiency shall be demonstrated annually.

(b) Instructions are posted at the medical therapy facility's local control panel that specify the procedure to be followed:

(i) to ensure that only the patient is in the treatment room before turning the primary beam of radiation on to begin a treatment; 6 26 AMENDMENT NO. 30

(ii). if the operator is unable to turn the primary beam of radiation off with controls outside the medical therapy facility, or if any other abnormal condition occurs. A directive shall be included with these instructions to notify the reactor console operator in the event of any abnormality.

(c) In the event that a shutter affects reactivity (e.g., the D2O shutter), personnel who are not licensed on the MIT Research Reactor but who have been trained under this provision may operate that shutter provided that verbal permission is requested and received from the reactor console operator immediately prior -

to such action. Emergency closures are an' exception and may be made without first requesting permission.

Records of the training provided under subparagraph (a) a'bove shall be retained in accordance with the MIT Research Reactor's training program or at least for three years. A list of personnel so qualified shall be maintained in the reactor control room.

17. Events defined as ' recordable' under definition 8 of this specification shall be recorded and the record maintained for five years. Events defined as

'misadministrations' under definition 9 of this specification shall be reported to the U.S. Nuclear Regulatory Commission (24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> verbal,15 day written report). The 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> verbal reports will be made to the Regional Administrator, Region I, or his designate. The 15 day written reports will be sent to the NRC Document Control Desk with a copy to the Regional Administrator, Region I, or his designate.

I8. The requirements of the Quality Management Program (QMP) for the Generation of l l

Medical Therapy Facility Beam for Human Therapy at the Massachusetts Institute of l Technology Research Reactor shall be observed for any human therapy. (Nate: The presence of this commitment to observe the QMP in these specifications does not preclude modifying the QMP as provided in that document. Any such modifications are not considered to be a change to the MITR Technical Specifications.) ,

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DefinitioDS

1. The medical therapy facility is equipped with shutters that are used (i) to control beam delivery and (ii) to adjust the neutron energy spectrum of the beam. The former currently include lead, boral, and light water shutters as described in Reference 6.5-1. The heavy water blister tank, which is also described in Reference 6.5-1, is .

an example of the latter. It is conceivable that thee designations may change should it be found desirable to alter the beam configuration. Accordingly, the phrase

" shutters that control beam delivery" refers either to the aforementioned three existing 4

shutters or to any future shutter or group thereof that provides an equivalent or greater reduction in beam intensity. Shutter-effect analyses shall be documented through the standard safety review process including, where appropriate, an SAR  ;

revision and submission to NRC under 10 CFR 50.59.

2. The term ' calibration check' refers to the process of checking the be~am intensity and quality via one or more of the following: foil activation; use of a fission chamber; use of an ion chamber; or an equivalent process. The purpose of a calibration check is to ensure that the beam has not changed in a significant way (e.g., energy spectrum or intensity) from the beam that was characterized. ]

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3. The term ' functional check of the beam monitors'shall consist of verifying that system output is consistent (i 10%) with previously measured values upon 1

normalization to a common reactor neutronic power level.  !

4. The term ' characterization' refers to the process of obtaining the dose-versus-depth j profile in phantoms as described in Reference 6.5-2 or an equivalent process. The l

dose versus-depth profile from the surface of the phantom to a depth at least equivalent to the total thickness of the body part to be treated on a central axis is deemed adequate for a characterization. Fast neutron, thermal neutron, and gamma ray components are determined in a characterization and monitors are normalized by 1

this characterization.

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5. The term ' calibration of the beam monitus' refers to the process whereby the beam monitors that are described in provision 11 of this specification are calibrated against instruments that measure dose including a tissue-equivalent chamber and a graphite or magnesium wall ionization chamber (or the equivalent to any of these three) that have in turn been calibrated by a secondary calibration laboratory.

6. The term ' design modification' as applied to the medical therapy facility beam refers (a) to a change that is shown to alter the dose-versus-depth profile of the fast neutrons, thermal neutrons, or gamma rays in the beam as sensed by the calibration check and (b) to a change that has the potential to increase significantly the amount of activation products in the medical therapy facility when the beam is to be used for the treatment of human patients.

7. The term ' radiation fluence' means the total Duence of neutrons and gamma radiation that is emitted in the medical therapy facility beam. The determination of the ratios of gamma, fast neutron, and thermal neutron fluences is part of the beam characterization. Knowledge of these ratios allows the total radiation fluence to be monitored by the on-line detectors, which are neutron-sensitive. Compliance with the limits specified on radiation fluence by this specification is determined by reference to the luence monitored by these detectors.

8. The term ' recordable event' means the administration of:

(a) A radiation treatment without a written directive; or (b) A radiation treatment where a written directive is required without reponing to the medical use licensee in writing each fluence given within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the treatment; or (c) A treatment delivery for which the administered radiation fluence for any given fraction is 15% greater than prescribed.

9. The term ' misadministration' means the administration of a radiation therapy:

(a) Involving the wrong patient, wrong mode of treatment, or wrong treatment site; or 6-29 'AMENDMEtE NO. 30

(b) When the treatment delivery is not in accordance with provision 11 of this speci0 cation.

10. The term ' written directive' means an order in writing for a specinc patient, dated and signed by a DNCT physician authorized user prior to the administration of radiation and which specifies the treatment site, the total radiation fluence, radiation fluence per fraction, and overall treatment period.

I 1. The term ' human therapy' means radiation treatments that are of direct therapeutic benefit to the patient and/or part ofinvestigatory studies that involve humans.

12. The term 'BNCT physician authorized user' means a medical physician authorized by the medical use licensee's radiation safety committee to act as an authorized user for BNCT on humans.

13. The term ' certified medical physicist' means a medical physicist certified in either radiological physics or therapeutic radiation physics by the American Board of Radiology, or in therapeutic radiation physics by the American Board of Medical Physics and who also has specific training in neutron dosimetry and neutron beam capture therapy.

Basis The stipulation that patients only be accepted from a medical use licensee that has an NRC or an Agreement State medical use license that contains BNCT specific conditions and commitments for BNCT treatment of humans conducted at the Massachusetts Institute of Technology Research Reactor's Medical Therapy Facility ensures that medical criteria imposed by NRC or the Agreement State on such licensees for the use of the MIT Research Reactor's medical therapy facility beam for human therapy will be fulfilled. The second provision delineates the division of responsibilities between the Massachusetts Institute of Technology and the medical licensee that refers the patient. Also, it establishes administrative authority and protocol for initiating and terminating a radiation therapy.

The requirement that it be possible to initiate a minor scram from a control panel located in the medical therapy facility area assures the attending physician and/or medical 6-30 AMENDMENT NO. 30

physicist of the capability to te minate the treatment immediately should the need arise. The provision that access to the medical therapy facility be limited to a single door ensures that there will be no inadvertent entries. The various interlocks for the shutters that control beam delivery ensure that exposure levels in the medical therapy facility will be minimal prior to entry by personnel who are attending the patient. The shutter-indication lights serve to notify personnel of the beam's status. The provision for a radiation monitor ensures that personnel  ;

t will have information available on radiation levels in the medical therapy facility prior to

. entry. The purpose of this monitor's audible alarm is to alert personnel to the presence of elevated radiation levels, such as exist when the shutters that control beam delivery are open.

This monitor and/or its alarm may be disabled once the medical therapy facility has been searched and secured so that it will (1) not disturb a patient and (2) not distract attending

, personnel. The monitor and/or its alarm are intedocked with the shield door so that they are made functional upon opening that door, and hence prior to any possible entry to the medical therapy facility. One intercom provides a means for the prompt exchange of information between medical personnel and the reactor operator (s). The second intercom is for I monitoring the patient.

The provision for manual operation of the medical therapy facility's shield door ensures access to any patient in the event of a loss of electrical power. The presence of the j viewing window and a closed-circuit TV camera provide the attending BNCT physician l authorized user and/or medical physicist with the opportunity to monitor the patient visually as well as through the use of various instruments. The viewing window will function even l

1 during an electric power failure because of the provision for emergency lighting.

The specification that the total radiation fluence for a therapy (i.e., the radiation fluences for the sum of all fractions specified in a given treatment plan) not exceed that )

prescribed in the patient treatment plan by 20% establishes a trigger limit on the delivered fluence above which NRC has to be notified of a misadministration. The 20% criterion is  !

based on the definition of misadministration (clause 4(iv)) as given in 10 CFR 35.2. The criterion that the difference between the administered and prescribed fluence for any seven 6-31 AMENDMENT NO. 30 i

consecutive days is set at 307c. This is also in accordance with the definition of misadministration (clause 4(iii)) as given in 10 CFR 35.2. Finally, if a treatment involves three or fewer fractions, then a more stringent criterion,107c, applies to the difference between the total radiation fluence for a therapy and that prescribed in the treatment plan (10 CFR 35.2(4ii)). The surveillance requirements for beam calibration checks and characterizations provide a mechanism for ensuring that the medical therapy facility and its beam will perform as originally designed. Similarly, the surveillance requirements on the beam monitors ensure that these instruments are calibrated by a means traceable to the National Institute of Standards and Technology. The chambers specified (tissue-equivalent, and graphite or magnesium-wall) were chosen because they menure dose as opposed to fluence.

The specification on maintenance and repair of the medical therapy facility ensures that all such activities are performed under the supervision of personnel cognizant of quality assurance and other requirements such as radiation safety. The provision on the training and 1

proficiency of non-licensed personnel ensures that all such personnel will receive instruction ]

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equivalent to that given to licensed reactor operators as regards use of the medical therapy facility beam. (Note: Licensed reactor operators may, of course, operate the medical therapy facility beam.) Also, this provision provides for the posting ofinstructions to be followed in the event of an abnormality.

The specification on ' recordable events' and 'misadministrations' provides for the documentation and reporting to the U.S. Nuclear Regulatory Commission of improper i

events regarding the generation and use of the medical therapy facility beam. The requirement that the Quality Management Program (QMP) be observed ensures that radiation treatments provided by the medical therapy facility beam will be administered as directed by the BNCT physician authorized user.

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I References  ;

6.5-1 MITR Staff, " Safety Analysis Report for the MIT Research Reactor (MITR-II)"

Report No. MITNE-115,22 Oct.1970, Section 10.1.3.

65^ Choi, R.J., " Development and Characterization of an Epithermal Beam for Boron Neutron Capture Therapy at the MITR-II Research Reactor," Ph.D. Thesis, Nuclear Engineering Department, Massachusetts Institute of Technology, April 1991.

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