ML20137L590

Safety Evaluation Supporting Amend 30 to License R-37

ML20137L590
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Site:	MIT Nuclear Research Reactor
Issue date:	04/03/1997
From:	NRC (Affiliation Not Assigned)
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NUDOCS 9704070270
Download: ML20137L590 (4)

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SAFETY EVALUATION BY THE OFFICE OF NUCLEAR REACTOR REGULATION SUPPORTING AMENDMENT NO. 30 TO AMENDED FACILITY OPERATING LICENSE NO. R-31.

l THE MASSACHUSETTS INSTITUTE OF TECHNOLOGY DOCKET NO. 50-20

1.0 INTRODUCTION

By letter dated February 18, 1997, as supplemented on March 17, 1997, the Massachusetts Institute of Technology (MIT) submitted a request for an amendment to Appendix A of Amended Facility Operating License No. R-37, changing Technical Specifications (TSs) for the MIT Research Reactor (MITR).

The requested changes would allow MIT to conduct boron-neutron capture therapy (BNCT) on patients from Agreement State medical use licensees whose licenses contain BNCT-specific conditions and commitments for BNCT treatments on humans conducted at the MITR Medical Therapy Facility.

2.0 EVALUATION MIT is currently conducting human irradiations under TSs for the generation of the medical therapy facility beam for human therapy. These TSs were issued as Amendment No. 27 to the amended facility operating license on February 16, 1993. These TSs allow medical use licensees authorized by NRC to utilize the  :

MITR Medical Therapy Facility beam for neutron capture therapy for humans.  !

There are currently two medical use licensees licensed by NRC to use the MITR Medical Therapy Facility. Both of these licensees are located in Massachusetts.  !

l On March 21, 1997, the Commonwealth of Massachusetts became an NRC Agreement State. Regulation of medical use licensees within Massachusetts was transferred from NRC to the Commonwealth. The current MIT TSs do not contain any reference to Agreement State licensees. When MIT proposed the current TSs, there were no public discussions in progress about Massachusetts becoming an Agreement State. Because the medical use licensee working with MIT on BNCT at that time was an NRC licensee, the current TSs were written to reflect only NRC medical use licensees. In order to continue to allow patients to be referred to MIT for BNCT following the transfer of regulatory authority over medical use licenses from NRC to the Commonwealth, the MIT TSs must now be changed. These changes will allow MIT to conduct BNCT on patients from Agreement State medical use licensees whose licenses contain BNCT-specific conditions and commitments for BNCT treatments.

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i MIT requested changes to the TSs to include Agreement State licensees in the medical therapy TSs provisions. The NRC staff, in a request for additional information dated March 14, 1997, asked MIT to consider additional changes to the proposed TSs to improve the consistency between the wording of the medical use . licenses of licensees allowed to refer patients to MIT and the MIT TSs.

The medical use licenses were issued after the MIT TSs were adopted, and contain wording that differs somewhat from the MiT TSs. Although the wording

of the current MIT TSs is acceptable, these propos>d changes improve the i consistency between the two licenses. NRC or Agreement State medical use licensees that want to refer patients to MIT for BNCT shall do so by a written directive from a BNCT physician authorized user authorized by the licensee's radiation safety committee. The NRC or Agreement State medical use licensee's license needs to contain BNCT-specific conditions and commitments for BNCT treatment on humans conducted at the MITR Medical Therapy Facility. MIT 4

agreed to the suggested wording which is reflected in the proposed TSs below.

i TS 6.5.1 currently reads:

Patients accepted for treatment shall have been referred by written 4

directive from a physician authorized user of NRC Medical Use License No. 20-03857-06 or of any other medical use licensee that has been similarly authorized by NRC to utilize the MIT Resaarch Reactor's Medical Therapy beam for neutron capture therapy for

humans.

MIT has proposed that this TS be amended to read:

l 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 for BNCT treatment on humans conducted at the Massachusetts Institute of Technology Research Reactor's Medical Therapy Facility.

TS 6.5.2 currently reads in part:

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All medical treatments, including irradiations and analyses of the I

- neutron capture agents in the patients, are the responsibility of  !

the physician authorized user in change of the therapy and the i medical physicists from the NRC-licensed medical center.

MIT has proposed that this portion of the TS be amended to read:

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 change of the therapy and the medical physicists from the NRC-licensed or Agreement State-licensed

, medical center.

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TS 6.5, definition 12 currently reads:

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The term ' physician authorized user' means a medical physician approved for neutron capture therapy by an NRC-approved medical use  ;

licensee.

I MIT has proposed that this definition be amended to read:

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

i MIT has also proposed changing the tern " physician authorized user" to "BNCT j physician authorized user" 6 erever it appears in the TS.

The basis of TS 6.5 currently reads-in part-The stipulation that patients only be accepted from NRC Medical Use  :

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Licensee No. 20-03857-06 or from any other medical use licensee that '

has been similarly authorized by NRC to utilize the MIT Research Reactor's Medical Facility beam for human therapy, ensures that ,

medical criteria imposed by NRC on such licensees for the use of the j 3 MIT Research Reactor's medical therapy facility beam for human '

therapy will be fulfilled. l l

MIT has proposed that this basis be amended to read in part:

i The stipulation that patients only be accepted from a medical use  !

4 licensee that has an NRC or an Agreement State medical use license i 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.

1 The proposed changes allow MIT to treat patients from medical use licensee medical centers in Agreement States.. The proposed changes also improve the consistency of wording between the MIT TSs and the medical use licenses. The proposed changes to the TSs help to ensure that patients will be referred to MIT 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 for BNCT treatment on humans conducted at the MITR Medical Therapy Facility.

In addition, on March 4, 1997, the Office of State Programs confirmed in discussions with officials from the Commonwealth of Hassachusetts that the conditions of the NRC medical use licenses associated with the MITR Medical Therapy Facility would be reta'nei in State licenses unchanged and that the Commonwealth would continue to enforce the license conditions.

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Because these changes correct the current MIT TSs to appropriately include l medical use licensees in Agreement States, and because the proposed TSs improve the consistency between the wording of the MIT TSs and the medical use i licenses, these changes are acceptable to the staff. l MIT provided a copy of proposed changes to the MIT Quality Management Program  !

for Generation of MITR-II Medical Therapy Facility Beam for Human Therapy ,

(QMP). The staff notes that these proposed changes are similar to the changes i proposed for the TSs. Although the QMP is required pursuant to the TSs,-the  !

QMP is not part of the TSs and may be changed by MIT without license  :

amendment. The requirements for QMP modifications are stated in the QMP.  !

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3.0 ENVIRONMENTAL CONSIDERATION

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This amendmer

• danges a requirement with respect to installation or use of a j facility component located within the restricted area as defined in 10 CFR  :

Part 20, and involves changes in recordkeeping, reporting, or administrative  !

procedures or requirements. Accordingly, the amendment meets the eligibility  !

criteria for categorical exclusion set forth in 10 CFR 51.22(c)(9) and 3 (c)(10). Pursuant to 10 CFR 51.22(b), no environmental impact statement or j environmental assessment need be prepared in connection with the issuance of this amendment.

4.0 CONCLUHQN  !

The staff has concluded, on the basis of the considerations discussed above, i that (1) because the amendment does not involve a significant increase in the probability or consequences of accidents previously evaluated, or create the possibility of a new or different kind of accident from any accident '

previously evaluated, and does not involve a significant reduction in a margin of safety, the amendment does not involve a significant hazards consideration; '

(2) there is raasonable assurance that the health and safety of the public will not be endangered by the proposed activities; and (3) such activities '

will be conducted in compliance with the Commission's regulations, and the issuance of this amendment will not be inimical to the common defense and

, security or the health and safety of the public.

Principal Contributor: A. Adams, Jr.

i Date: April 3, 1997 1

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