ML20196B754
| ML20196B754 | |
| Person / Time | |
|---|---|
| Site: | MIT Nuclear Research Reactor |
| Issue date: | 06/30/1998 |
| From: | Bernard J, Lau E, Newton T MASSACHUSETTS INSTITUTE OF TECHNOLOGY, CAMBRIDGE |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| References | |
| NUDOCS 9812010177 | |
| Download: ML20196B754 (32) | |
Text
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NUCLEAR REACTOR LABORATORY .-
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AN INTERDEPARTMENTAL CENTER OF '
MASSACHUSETTS INSTITUTE OF TECHNOLOGY l
JOHN A. BERNARD ?38 Albany Street. Cambndge MA 02139 4296 Actwaton Analysis Director 25 Coolard Ctemistry Director of Reactor Operations Telefax No. (617,)533 73004211/4202 Tel. No. (617) z Nuciear uedicine Pnnespal Research Engineer Reactor Engiraring November 4,1998 U.S. Nuclear Regulatory Commission, Washington, D.C. 20555 ATTN: Document Control Desk l
Subject:
Annual Report, Docket No. 50-20, License R-37, Technical Specification 7.13.5 Gentlemen:
Forwarded herewith is the Annual Report for the MIT Research Reactor for the period July 1,1997 to June 30, 1998, in compliance with paragraph 7.13.5 of the Technical Specifications for Facility Operating License R-37.
S' erely, J
%L Thomas H. Newton, Jr., PE Edward S. Lau, NE Asst. Superintendent for Engineering Asst. Superintendent for Operations MIT Reseamh Reactor MIT Research Reactor
( k. 6L 9812010177 990630 g ohn A. Bernard, Ph.D.
PDR ADOCK 05000020 , Director R PDR i MIT Research Reactor {
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Enclosum: As stated 4O cc: USNRC - Senior Project Manager, NRR/ONDD (M
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USNRC - Region I- Project Scientist, Effluents Radiation Protection Section (ERPS)
FRSSB/DRSS
MIT RESEARCH REACTOR NUCLEAR REACTOR LABORATORY MASSACHUSETTS INSTITUTE OF TECHNOLOGY ANNUAL REPORT to United States 1 Nuclear Regulatory Commission for the . Period July 1,1997 - June 30,1998 by l
REACTOR STAFF
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Section hgg l t l t
i In trod uc tion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 l.
l . 'A I i A. Summary of Operating Experience ................................................. 3 ;
r i' i B. React'or Operation ' . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 j i
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C. . S hutdown s and Scrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 ' )
- D. Major Maintenance ................................................................... 12
- E. . Section 50.59 Changes, Tests, and Experiments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 i
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'I F. Environmental Surveys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 a
G. Radiation Exposures and Surveys Within the Facility ................ .......... 24 4
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t H. Radioactive Effluents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
'I . Summary of Use of Medical Facility for Human Therapy ...........>........... 29
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l MIT RESEARCH REACTOR ANNUAL REPORT TO U. S. NUCLEAR REGULATORY COMMISSION l l
FOR THE PERIOD JULY L 1997 - JUNE 30.1998 INTRODUCTION This report has been prepared by the staff of the Massachusetts Institute of Technology Research Reactor for submission to the United States Nuclear Regulatory Commission, in compliance with the requirements of the Technical Specifications to Facility Operating License No. R-37 (Docket No. 50-20), Paragraph 7.13.5, which requires an annual report following the 30th of June of each year.
The MIT Research Reactor (MITR), as originally constructed, consisted of a core of MTR-type fuel, fully enriched in uranium-235 and cooled and moderated by heavy water in a four-foot diameter core tank, surrounded by a graphite reflector. After initial criticality ,
on July 21, 1958, the first year was devoted to startup experiments, calibration, and a j gradual rise to one megawatt, the initially licensed maximum power. Routine three-shift i operation (Monday-Friday) commenced in July 1959. The authorized power level was !
increased to two megawatts in 1962 and to five megawatts (the design power level) in 1965.
Studies of an improved design were first undertaken in 1967. The concept which was finally adopted consisted of a more compact core, cooled by light water, and i surrounded laterally and at the bottom by a heavy water reflector. It is under moderated for I the )urpose of maximizing the peak of thermal neutrons in the heavy water at the ends of the 3eam port re-entrant thimbles and for enhancement of the neutron flux, particularly the fast component, at in-core irradiation facilities. The core is hexagonal in shape,15 inches across, and utilizes fuel elements which are rhomboidal in cross section and which contain UALxintermetallic fuel in the form of plates clad in alu:ninum and fully enriched in uranium-235. Much of the original facility, e.g., graphite reflector, biological and thermal shields, secondary cooling systems, containment, etc., has been retained.
After Construction Permit No. CPRR-118 was issued by the former U.S. Atomic Energy Conunission in April 1973, major components for the modified reactor were i procured and the MITR-I was shut down on May 24, 1974, having logged 250,445 megawatt hours during nearly 16 years of operation.
The old core tank, associated piping, top shielding, control rods and drives, and some experimental facilities were disassembled, removed, and subsequently replaced with new equipment. After preoperational tests were conducted on all systems, the U.S.
Nuclear Regulatory Commission issued Amendment No.10 to Facility Operating License No. R-37 on July 23,1975. After initial criticality for MITR-II on August 14,1975, and several months of startup testing, power was raised to 2.5 MW in December. Routine 5-MW operation was achieved in December 1976.
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l This is the twenty-third annual report required by the Technical Specifications, and it covers the period July 1,1997 through June 30,1998. Previous reports, along with the "MITR-II Startup Report" (Report No. MITNE-198, February 14,1977) have covered the startup testing period and the transition to routine reactor operation. This report covers the twenty-first full year of routine reactor operation at the 5-MW licensed power level. It was another year in which the safety and reliability of reactor operation met the requirements of reactor users. i A summary of operating experience and other activities and related statistical data are provided in Sections A through I of this report.
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SUMMARY
OF OPERATING EXPERIENCE
- 1. General l
The MIT Research Reactor, MITR-II, has in many years been operated on a l routine, five days per week schedule, modified as necessary to facilitate experiments and ,
research and to accommodate the medical program on boron-neutron capture therapy for '
cancer-treatment studies. When operating, the rextor is normally at a nominal 5 MW.
However, as was the case for the last several years, substantial departures were made from ;
this schedule during the period covered by this repon (July 1,1997 - June 30,1998). j Specifically, for much of this reporting period, the reactor was maintained at full power almost continuously (168 hours0.00194 days <br />0.0467 hours <br />2.777778e-4 weeks <br />6.3924e-5 months <br /> / week) for four weeks. It was then shut down for half a day to a week for maintenance and other necessary outage activities. It was then started up to full power and was maintained there for another four to five weeks. The period covered by this report is the twenty-first full year of normal operation for MITR-il.
The reactor averaged 122.8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> per week at full power compared to 104.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> per week for the previous year and 116.9 hours1.041667e-4 days <br />0.0025 hours <br />1.488095e-5 weeks <br />3.4245e-6 months <br /> per week two years ago. The higher number of average full power hours per week for FY98 is due to the increased utilization of the reactor for BNCT clinical trials, other medical irradiations, neutron activation analysis, and NTD Si irradiations. ,
l The reactor was operated throughout the year with 24 elements in the core. The remaining three positions were used as follows: The first non-fueled position, B3, was used by the Irradiation-Assisted Stress Corrosion Cracking Facility (IASCC) since December 1995. The second and third core positions, Al and A3, were occupied by the D-3 and D-5 dummies. Position B3 was occupied by the solid aluminum dummy D-4 whenever the IASCC was not installed. During FY98, compensation for reactivity lost due to burnup and the installation of the IASCC in-core experiment thimble was provided by four refuelings. These followed standard MITR practice which is to introduce fresh fuel to the inner portion of the core (the A- and B-Rings) where peaking is least and to place partially spent fuelin the outer ponion of the core (the C-Ring). In addition, elements were ,
inverted and rotated so as to achieve more uniform burnup gradients in those elements. i Only six new elements versus the expected 12 elements per year were introduced into the reactor core throughout the entire period of FY98. Two of the four refuelings involved only flipping and rotation of partially spent elements. One refueling had the additional 1 purpose ofinstallation and removal of the IASCC experiment. A total of ten spent elements !
were discharged from the reactor core to the spent fuel pool in two of the four refueling operations.
The MITR-II fuel management program remains quite successful. All of the original MITR-II elements (445 grams U-235) have been permanently discharged. The average overall burnup for the discharged elements was 42%. (Rqte: One element was removed prematurely because of excess outgassing.) The maximum overall burnup achieved was 48%. A total of one hundred and one of the newer, higher loaded elements (506 grams U-235) have been introduced to the core. Of these, fifty have attained the maximum allowed fission density and were discharged from the reactor core to the spent i fuel storage pool. However, some of these may be reused if that limit is increased as l
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i would seem warranted based on metallurgical studies by DOE. Seven elements have been i l identified as showing excess outgassing and two are suspected of this. All nine have been :
l removed from service and returned to an off-site DOE storage facility. The other forty-two l are either currently in the reactor core or have been partially depleted and are in the wet storage ring awaitmg reuse. During the period of FY98, a total of sixteen spent elements j were returned to an off-site DOE facility. Details regarding shipment of spent fuel are 1 discussed in section A.7 of this report.
! Protective system surveillance tests are conducted whenever the reactor is scheduled to be shut down.
As in previous years, the reactor was operated throughout the period without the fixed hafnium absorbers, which were designed to achieve a maximum peaking of the thermal neutron flux in the heavy water reflector beneath the core. These had been removed in November 1976 in order to gain the reactivity necessary to support more in-core experiment facilities.
- 2. Experiments The MITR-II was used throughout the year fo: experiments and irradiations in support of research and training programs at MIT and elsewhere.
Experiments and irradiations of the following types were conducted:
a) Prompt gamma activation analysis for the determination of boron-10 concentration in blood and tissue. This is being performed using one of the reactor's beam tubes.
The analysis is to support our neutron capture therapy program.
b) Experimental studies of the role of metallic and organo-metallic groups in the final properties of polymers.
c) Use of neutron activation analysis to determine the concentrations of heavy metals in sludge from sewage treatment plants, d) Irradiation of. archaeological, environmental, engineering . materials, biological, geological, oceanographic, and medical specimens for neutron activation analysis purposes.
e) Production of dysprosium-165, holmium-166, copper-64 and gold-198 for nx: dical research, diagnostic, and therapeutic purposes.
f) . Irradiation of tissue specimens on particle track detectors for plutonium radiobiology. ;
g) - Irradiation of semi-conductors to determine resistance to high doses of fast I neutrons.
h)- Use of the facility for reactor operator training.
j i) - Irradiation of geological materials to determine quantities and distribution of fissile materials using solid state nuclear track detectors.
j) Use of trace analysis techniques to identify and monitor sources of acid deposition l (acid rain),
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1 k) Operation of an in-core slow strain rate testing rig to evaluate irradiation-assisted stress corrosion cracking of metals. ,
- 1) Measurements of the energy spectrum of leakage neutrons using a mechanical l chopper in a radial beam port (4DH1). Measurements of the neutron wavelength by Bragg reflection then permits demonstration of the DeBroglie relationship for physics courses at MIT and other universitiec.
m) Gammairradiation of seeds for demonstration of radiation damage effects for high I school students. '
n) Use of beam tubes for testing of prototype neutron detectors.
o) Neutron activation analysis to determine iron oxide contammation in aluminum !
specimens.
p) Neutron activation analysis of serum samples in an effort to correlate mineral deficiencies with certain diseases.
q) Determination of uranium concentrations in samples of mica.
r) Gamma irradiation of PLGA-coated alumina fibers for medical research and applications.
s) Neutron activation of uranium samples for detector calibration at the McClellan AFB, California.
t) Radiation synovectomy for treatment of arthritis using the prompt-gamma beam port facility.
u) Gamma irradiation of resins for stability analysis.
Dose reduction studies for the light water reactor industry began reactor use on a regular basis in 1989. (Planning and out-of-core evaluations had been in progress for ;
several years.) These studies entail installing loops in the reactor core to investigate the !
chemistry of corrosion and the transport of radioactive crud. Loops that replicate both pressurized and boiling water reactors have been built. The PWR loop has been operational since August 1989. The BWR loop became operational in October 1990. A third loop, one for the study of irradiation-assisted stress corrosion cracking (IASCC),
became operational in June 1994 and a fourth one, also for the study of crack growth, in April 1995. !
Throughout the period of FY98, there was continued use of the existing Medical Facility for Boron-Neutron-Capture Therapy (BNCT) research for the treatment of glioblastomas (brain cancer tumors). Six human subjects were admitted for BNCT clinical trials at an average of two fractions of irradiation for each subject. See Section I for more details on the BNCT program.
Another major research project that is now making and will continue to make extensive use of the reactor is a program called the Fission Converter project which aims to design and build a new facility for the treatment of glioblastomas (brain tumors) and melanomas (skin cancer) using neutron capture therapy. This is a collaborative effort with l
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- 3. Changes to Facility Design Except for minor changes reported in Section E, no changes in the facility design were made during the year. As indicated in past repons the uranium loading of MITR-II fuel was increased from 29.7 grams of U-235 per plate and 445 grams per element (as made by Gulf United Nuclear Fuels, Inc., New Haven, Connecticut) to a nominal 34 and l 510 grams respectively (made by the Atomics International Division of Rockwell International, Canoga Park, California). With the exception of seven elements (one Gulf, six AI) that were found to be outgassing excessively, performance has been good.
(Please see Reportable Occurrence Reports Nos. 50-20n9-4, 50-20/83-2, 50-20/85-2, 50-20/86-1, 50-20/86-2, 50-20/88-1, and 50-20/91-1.) The heavier loading results in 41.2 w/o U in the core, based on 7% voids, and corresponds to the maximum loading in Advanced Test Reactor (ATR) fuel. Atomics International completed the production of )
forty-one of the more highly loaded elements in 1982, forty of which have been used to some degree. Thirty-one with about 40% burnup have been discharged because they have attained the fission density limit. Only one other AI element remains in use. Of the other eight, six were, as previously reported to the U.S. Nuclear Regulatory Commission, removed from service because of excess outgassing and two were removed because of suspected excess outgassing. Additionalelements are now being fabricated by Babcock &
Wilcox, Naval Nuclear Fuel Division, Lynchburg, Virginia. Sixty-one of these have been received at MIT, forty-one of which are in use. One has been removed because of suspected excess outgassing and nineteen have been discharged because they have attained ,
the fission density limit.
The MITR staff has been following with interest the work of the Reduced ;
Enrichment for Research and Test Reactors (RERTR) Program at Argonne National j Laboratory, particularly the development of advanced fuels that will permit uranium loadings up to several times the recent upper limit of 1.6 grams total uranium / cubic centimeter. Consideration of the thermal-hydraulics and reactor physics of the MITR-II core design show that conversion of MITR-Il fuel to lower enrichment must await the successful demonstration of the proposed advanced fuels.
- 4. Changes in Performance Characteristics Performance characteristics of the MITR-II were reported in the "MITR-II Startup Report." Minor changes have been described in previous reports. There were no changes during the past year.
- 5. Changes in Onerating Procedures With respect to operating procedures subject only to MITR intemal review and approval, a summary is given below of those changes implemented during the past year.
Those changes related to safety and subject to additional review and approval are discussed in Section E of this report.
a) PM 3.14.3.4, " Beam Monitor System Setpoints," was updated in accordance with current components and settings. Also, the signature requirement was changed to permit review by any senior Operations Staff member, in order to avoid distracting the NRL Director's, or his/her designate's, attention from the overall proceedings.
(S R#0-97-11) 1 i
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Surveillance Schedule for the Medical Therapy Facility Procedures," PM 3.14.3.1, " General Preparation of the Medical Therapy Facility ;
for Human Use," and PM 3.14.3.3, " Conduct for Human Use of the Medical Therapy Facility Beam" were revised. All the changes were administrative rather than substantive in nature. (SR#0-97-13) c) PM 6.5.5, " Backup Steam Supply Availability," was revised to reflect the long-standing practice of recording the pressure at which the system reverts to its normal !
condition, for the purpose of highlighting trends. (SR#0-97-15) j d) PM 6.3.3, " Equipment Room Sump High 1.evel Interlock," created an improved !
arocedure for testing the interlock which secures city water flow to the containment :
>uilding sinks upon receipt of a high level sump alarm. The test procedure is '
warranted in order to ensure there is no overflow of liquids from the waste sump in l the event the sump is not drained properly. (SR#0-97-16) i e) - PM 3.1.8, "Startup with One or More Proximity Switches Inoperable," was revised based on operating experience for improved ease of use and tracking of shim blade <
proximity switch failures. (SR#0-97-17) j f) PM 6.5.10.1, " Pressure Relief Valve Calibration," was reviewed and reissued with l only typographical changes. (SR#0-97-19) g) PM 5.5.19, " Low Flow Core Purge" (alarm), and PM 6.4.20, "lew Flow Core Purge" (test and calibration) were revised to reflect reduction of the core purge flow .
setpoint from ~5 cfm to ~4 cfm (under SR#0-97-6 of the previous year). This was !
done to reduce the rate of core purge system filter deterioration by decreasing the ,
amount of entrained moisture passing through it. The result has been a marked increase in filter lifespan, and a reduction of effluent nuclides in proportion with the flow, with no rise in dose rates or contamination within the containment building.
(SR#0-97-20) h) PM 5.8.16, " Spill of Heavy Water," was revised to clarify intent regarding building ventilation in the event of heavy water spill, and to update a reference to permissible effluent concentration (EC) limits. A caution regarding ten-minute Self-Contained Breathing Apparatus units was eliminated because all units now have thirty-minute capacity. (SR#0-97-21) i) PM 6.1.2.5, " Charcoal Fiher Efficiency Test," was modified to incorporate the use of a new type of ventilated hood capable of securing and isolating the iodine generating flask to an air-tight condition, and to improve radiological safety during performance of the test. Steps were added to the procedure to ensure that the containment building ventilation' system is operating properly throughout the test.
(SR#0-98-2)
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- 6. Surveillance Tests and Insnections ;
There are many written procedures in use for surveillance tests and inspections required by the Technical Specifications. These procedures provide a detailed method for conducting each test or inspection and specify an acceptance criterion which must be met in order for the equipment or system to comply with the requirements of the Technical Specificadons. The tests and inspections are scheduled throughout the year with a frequency at least equal to that required by the Technical Specifications. Twenty-seven such tests and calibrations are conducted on an annual, semi-annual, or quarterly basis.
Other surveillance tests are done each time before startup of the reactor if shut down for more than 16 hours1.851852e-4 days <br />0.00444 hours <br />2.645503e-5 weeks <br />6.088e-6 months <br />, before startup if a channel has been repaired or de-energized, and at least monthly; a few are on different schedules. Procedures for such surveillance are incorporated into daily or weekly startup, shutdown or other checklists.
During the reporting period, the surveillance frequency has been at least equal to that required by the Technical Specifications, and the results of tests and inspections were satisfactory throughout the year for Facility Operating License No. R-37.
- 7. Status of Soent Fuel Shipment Pursuant to Amendment No. 29 to Facility Operating License No. R-37, paragraph 2.B.(2) subparagraph (b), reported herewith is the status of the establishment of a shipping capability for spent fuel and other activities relevant to the temporary increase in the possession limit.
In FY98, two shipments of eight elements each were completed using the BMI-l cask. At present, several additional shipments are needed in order to reduce the inventory of spent fuel at MIT to zero. However, it is currently unclear as to when these shipments will occur. The U.S. Department of Energy (DOE) has stopped the reprocessing of spent fuel and has only limited storage space available. However, DOE is currently allowing some shipments to proceed, and has indicated that additional shipments may be possible in calendar year 1999.
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B. REACTOR OPERATION Information on energy generated and on reactor operating hours is tabulated below:
Quarter
~1 2 3 4 Total
- 1. Energy Generated (MWD):
") - If F 308.8 351.2 296.6 282.9 1239.5 g jy 49 b) MITR-II 16,514.3 (MIT FY76-97) c) MITR-I 10,435.2 (MIT FY59-74) d) Cumulative, ,
28,189.0
- MITR-I & MITR-II
- 2. MITR-II Operation (Hrs):
(MIT FY98) .
a) At Power
(>0.5-MW) for - 1549.4 1744.9 1542.3- 1547.5 6384.1 '
Research b) low Power l
(<0.5-MW) for 52.7 53.8 65.9 62.1 234.5 Training (l) and Test !
c) TotalCritical 1602.1 1798.7 1608.2 1609.6 6618.6 l (1) These hours do not include reactor operator and other training conducted while the {
reactor is at full ?ower for research purposes (spectrometer, etc.) or for isotope ;
production. Such iours are included in the previous line. j i
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C. SHUTDOWNS ANDSCRAMS During the period of this report there were 5 inadvenent scrams and 43 unscheduled power reductions.
'Ihe term " scram" refers to shutting down of the reactor through protective system action when the reactor is at power or at least critical, while the term " reduction" or
" shutdown" refers to an unscheduled power reduction to low power or to suberitical by the reactor operator in response to an abnormal condition indication. Rod drops and electric power loss without protective system action are included in unscheduled power reductions.
The following summary of scrams and shutdowns is provided in approximately the same format as for previous years in order to facilitate a comparison.
-1. N.uclear Safety System Scrams Total a) Low voltage chamber power supply trip as result of inadvertent disconnection of Channel #5 power. 1 Subtotal 1
- 2. Process System Scrams a) Iow flow primary coolant trip as result of pump -
MM-1 breaker failure. 2 b) Iow flow primary coolant trip as result of operator error while inspecting flow recorder. I c) Imw flow primary coolant trip as result of power failure within pnmary flow recorder. 1 Subtotal 4
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- 3. ' Unscheduled Shutdowns or Power Reductions i l
a) NTD Silicon machine malfunctions. 36
, b) Shutdown due to loss of offsite electricity. 4 l 1
c) Shutdown to repair regulating rod. 1 i d)- Shutdown to repair sump pump controller. I d) .- Shutdown due to blade #4 drop. 1 l
Subtotal 43 :
Total 48
- 4. Experience during recent years has been as follows for scrams and unscheduled ;
shutd:4vns: '
Fiscal Year '- Number j Scrams Shutdowns Iqtal 93 6 14 20 .,
94 13 32 45. !
95- 17 28 45 ,
96 18' 21 39 I 97 8 10 18 98 5- 43- 48 l
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D. MAJOR MAINTENANCE Major maintenance projects performed during FY98 are described in this Section.
Much maintenance was performed to improve the safe, reliable and efficient operation of the MIT Research Reactor and to support the ongoing research programs involving clinical trials of Boron-Neutron Capture Therapy (BNCT) and the installation of a new irradiation facility called the Fission Converter Medical Therapy Facility also for the BNCT initiative.
One of the FY98 maintenance items was the preparation, installation and removal of an experiment facility in the reactor core for the IASCC project. This project, which requires operation of an INSTRON machine on top of the reactor core tank lid, was initially installed in the reactor core between July and October 1995.
The repair and maintenance of machinery and computer control and monitoring software and hardware for neutron transmutation doping of silicon (NTD Si) also required support. This machinery, installed in two of the reactor throughports, includes two twenty-foot tubes for exh port, rotating and pushing mechanisms, billet handling and storage conveyors, electronics, and associated microprocessor-based controllers and computer tracking systems. Signal validation and fault-tolerant routines were developed in-house and implemented with the existing computer control software. Also installed was the capability to remotely access the control and surveillance software of the computer system for off-site monitoring.
Other major maintenance items performed in FY98 were as follows:
(1) One of the two experimental graphite piles was completely removed from the Middle Lab experiment area and the reactor Make-Up Water tank and recirculation system were relocated to that area.
(2) All ventilation ducts in the Control Room were cleaned intemally and a new air filtration system was installed to improve air quality and dust control in the Control Room.
(3) The reactor Blanket Test Frility was defueled and completely dismantled in preparation for the installation of the Fission Converter Frility.
(4) Motor Control Centers MCC-1 and MCC-2 were completely cleaned and inspected.
(5) The SENSOR experiment thimble was disassembled under water in the spent fuel storage pool and shipped to an authorized GE site using the new GE-2000 shipping cask.
(6) Reactor nuclear safety channel No. I fission chamber was replaced and calibrated.
(7) The Cooling Tower sprinkler system piping and air compressor were replaced.
(8) Cooling Tower and Backyard area lighting was improved with the use of new high intensity lights and the installation of additional units.
(9) The Stack Base effluent monitor system blowers were replaced with improved blowers.
l (10) Nine of the reactor effluent radiation monitoring units were replaced with i new units. The remaining three units were scheduled to be installed in !
October 1998. The replacement includes new detectors, and remote readout l units in the Control Room, as well as alarms and interlock functions of the I system. All units were tested on-line in parallel with original units for at i least one month of full power operation before full installation / replacement.
(11) A radiation shield plug and beam shutter control mechanism were fabricated and assembled for installation of a future reflectometry facility.
(12) There was a complete overhaul of the reactor leak alarm system. The task l included replacement of allleak tapes. Several new leak alarm stations were j also installed.
(13) The Cooling Tower basin standpipes and drain sockets were re-designed !
and replaced for user-friendliness and improved clean-up efficiency. 1
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(14) The ventilation intake duct air filters were entirely replaced. !
(15) The cryogenic helium compressor system from the Bxk Engineering Lab was dismantled and the site prepared for reactor experiment use.
(16) The reactor heat exchanger chemical cleaning / recirculation station was .
rebuilt and recirculation motor replaced for higher flow rate and improved personnel safety. l (17) The HEPA filter bank and its AP measuring device for the Secondary Hot Cell were replaced.
(18) The. Cadmium shutter, pipe tunnel aluminum gas box, steel doors and i associated structural components, 6CH1, 2CH1, and 2PH2 facilities were removed in preparation for the installation of the Fission Converter facility. {,
A new lead slab was installed in place of the Cadmium shutter for temporary radiation shielding.
l (19) Three main secondary valves in the Equipment Room were replred for ease ,
of manual valving, thereby reducing personnel exposure in the Equipment !
Room. Operations also performed repacking of several main valves. This is part of a long-term plan for complete replacement of all major valves of the reactor secondary cooling system. Two other main valves of the system were replaced in the last fiscal year.
(20) Operations relabelled or replaced labels on the majority of valves and pumps in the Equipment Room as well as the labels on motor control centers MCC-1 in the Utility Room and MCC-2 in the Equipment Room.
(21) The Hot Cell ventilation exhaust duct was replaced to improve the Hot Cell ventilation system.
(22) The regulating rod motor was retuned and adjusted to reduce noise and sluggishness of the rod drive mechanism.
(23) The coolingjacket of the 3GV4 irradiation facility was removed and placed ,
in dry storage at the Reactor Top area. This is to prepare for installation of a new instrument port plug for fission chambers and other neutron detectors for nuclear safety and monitoring systems.
(24) The Back Experiment Platform at the Reactor Floor was partially dismantled to provide room for the eventual installation of a new medical therapy facility adjacent to the Fission Converter.
(25) A D 20 reflector recombiner temperature readout and low-temperature alarm were installed in the Control Room. The time for the recombiner middle temperature to drop fromits nominal operating value of 82 C to 50 C after heater power is turned off was measured.
(26) All six shim blade proximity switch systems were replaced including in-core aluminum wire guide tubes, gas purge lines, and water protection as well as the proximity switches, to improve longevity and reliability of the system.
(27) All hydraulic hoses on the main intake and exhaust ventilation dampers were replaced.
Many other routine maintenance and preventive maintenance items were performed throughout the fiscal year.
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i E. SECTION 50.59 CHANGES. TESTS. AND EXPERIMENTS His section contains a description of each change to the facility or procedures and of the conduct of tests and experiments carried out under the conditions of Section 50.59 of 10 CFR 50, together with a summary of the safety evaluation in exh case.
The review and approval of changes in the facility and in the procedures as described in the SAR are documented in the MITR records by means of " Safety Review Forms." These have been paraphrased for this report and are identified on the following pages for ready reference if further information should be required with regard to any item.
Pertinent pages in the SAR have been or are being revised to reflect these changes, and they either have or will be forwarded to the Document Control Desk, USNRC.
The conduct of tests and experiments on the reactor are normally documented in the experiments and irradiation files. For experiments carried out under the provisions of 10 ,
CFR 50.59, the review and approvalis documented by means of the Safety Review Form. '
All other experiments have been done in accordance with the descriptions provided in Section 10 of the S AR, " Experimental Facilities."
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1- Security Plan'
- SR#0-96-10 (12/10/96) l
~ The Security Plan was updated to reflect administrative and other routine changes. ;
No substantive change was made. Final NRC approval was received on August 6,1997. !
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- i. Emergency Plan ;
l SR#0-96-14 (0480/97), #0-96-15 '(04S 067), #0-96-16 (04S067) ;
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' The MITR Emergency Plan was rewritten in its entirety and submitted to the U.S.
Nuclear Regulatory Conumssion on June 6,1997. The changes did not decrease the plan's ;
i-effectiveness. Implementing procedures were made more " user-friendly", a more graded :
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apyroach to emergency response was adopted, and the " General Emergency" category was j de.eted because the MITR lacks the radionuclide inventory to create such an emergency. ;
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! Experiments Related to Neutron Capture Therapy SR#0-89-4 (01/23/89), #0-89-8 (03/01/89), #0-91-7 (05/06/91), #0-91-17 (03/06/92),
l #0-92-3 (03/06/92), #0-92-4 (03/02/92), #M-92-2 (05/14/92), #0-93-5 (05/28/93),
- 0-93-9 (07/13/93), #0-93-20 (l1/30/93),#0-94-19 (12/02/94),#0-96-5 (05/03/96),
- 0-97-2 (02/18/97), #0-97-11 (08/14/97), #0-97-13 (09/23/97),#0-97-14 (10/03/97).
l In conjunction with the Tufts - New England Medical Center (NEMC) and with the l support of the U.S. Department of Energy, MIT has designed an epithermal neutron beam j
for the treatment of brain cancer (glioblastoma). Thermal beams have been used successfully for this treatment in Japan. The reason for designing an epithermal beam is to allow tumor treatment without having to subject the patient to surgery involving removal of a portion of the skull. Also, an epithermal beam gives greater penetration. In October 1991, MIT hosted an international workshop for the purpose of reviewing proposed beam designs and dosimetry. Subsequent to the receipt of advice from the workshop panel members, a final design was selected for the epithermal filter for the MIT Research
, Reactor's Medical Therapy Facility beam. Approvals of the protocol for the conduct of I patient trials were received from all requisite MIT and NEMC Committees as well as from the l'.S. Food and Drug Administration. Also, a license amendment and quality i management plan for use of the MIT Research Reactor's Medical Therapy Facility was I
issued by the U.S. Nuclear Regulatory Commission as License Amendment No. 27 on February 16,1993.
Subsequent to the receipt of that license amendment and a similar one in August 1993 for our medical panner, the Tufts - New England Medical Center, procedures for performing BNCT and a preoperational test package were prepared. The latter was completed during FY94.
Patient trials were initiated in September 1994 as part of a Phase I effort that is required by the FDA. In December 1994, changes were issued to certain of the procedures that had been prepared for conduct of the irradiations. These changes were intended to reduce the signature burden on senior personnel during the trials so that their full attention could be given to the human subject.
Three subjects were irradiated in FY95. One more was done in FY96 in conjunction with NEMC. A change of medical partners then occurred, after which a second irradiation was done in FY96. The new program was a joint effort between MIT and the New England Deaconess Hospital (NEDH), which was affiliated with the Harvard Medical School. This change necessitated an amendment to the NEDH's license for radioactive materials and their use, as well as to the various internal approvals. Subsequent to receipt of these licenses / approvals, the Phase I trial for melanoma was continued. Also, a separate Phase I protocol for glioblastoma multiforme was approved. Patient trials under that protocol were initiated in July 1996. In FY97, New England Deaconess Hospital merged with the Beth Israel Hospital. The resulting organization is Beth Israel -
Deaconess Medical Center, which is now also a major teaching hospital for the Harvard Medical School. Under the new partnership, a total of fourteen human subjects have been irradiated at various dose levels. A summary of the FY98 trradiations is presented in Section 1.
Technical Specification #6.5, " Generation of Medical Therapy Facility Beam for Human Therapy," and its associated BNCT Quality Management Program were updated in FY97. The change was purely administrative in nature. No substantive changes of any l
type resulted. The language update in the two documents was to reflect transition from !
NRC regulation to State regulation of medical use licensees, and thereby to prevent any i possible subsequent disruption of the ongoing BNCT research program due to such I administrative shift. The change allows MIT to conduct BNCT on human subjects from i both NRC and Agreement State (the Commonwealth of Massachusetts) medical use licensees whose licenses contain BNCT-specific conditions and commitments for BNCT clinical trials on human subjects conducted at the MIT reactor. The change was approved 3 by the NRC on April 3,1997. l On October 3,1997, a Safety Evaluation Report and associated Technical 1 l: Specifications were submitted to NRC for the design and construction of a new Medical )
Therapy Facility utilizing a Fission Converter. The proposed facility will provide an ;
epithermal beam with a flux of ~1010 n/cm2.s. significantly reducing the time required for 1 BNCT irradiations. I l
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Irradiation-Assisted Stress Corrosion Cracking (IASCC) Exneriment SR#0-89-15 (06/19/89), #0-90-21 (10/22/90), #0-90-22 (10/22/90), #0-90-23 (l 1/05/90),
- 0-91-21 (12/27/91), #0-92-5 (04/02/92), #0-92-17 (09/28/92),#0-92-21 (01/21/94) i
- 0-93-6 (05/26/93), #M-93-1 (05/24/93), #0-93-14 (09/09/93), #0-94-4 (01/28/94),
- 0-94-7 (06/13/94).
In the past several years a variety of austenitic stainless steel components in boiling water reactor (BWR) cores have failed by an intergranular cracking mechanism called irradiation-assisted stress corrosion cracking (IASCC). Characteristics of such failures are that the component was exposed to a fast neutron fluence under tensile stress and in an oxidizing water environment.
A facility to study IASCC in typical BWR water and radiation environments has been designed, built, and put into in-core service. This facility positions a pre-irradiated test specimen in the core of the MIT Research Reactor, circulates water with controlled temperature and chemistry past the specimen, and applies a tensile load to the specimen to maintain a constant slow strain rate until specimen failure.' A DC potential drop (DCPD) . ,
technique was developed to rneasure specimen strain during in-core testing. Electrodes are incorporated to measure the specimen's electrochemical corrosion potential (ECP) under test, and for initial analysis, the sensitivity of the specimen's ECP to varying water chemistry, flowrate, in-core position, and reactor power level. A chemistry control system was designed and built to measure and control the water chemistry. Remote specimen handling tools and procedures were developed to allow the fracture surface to be analyzed by scanning electron microscopy (SEM). The facility and operating procedures were designed to minimize radiation exposure of personnel during facility operation and transfer '
to a hot cell for specimen removal and replacement.
Initial in-core tests, which measured the ECP of stainless steel in in-flux sections of the testing rig were' completed successfully. The tests showed that the desired oxidizing environment could be established and monitored during in-core slow-strain rate testing.
Results of these tests are used to investigate the effects of neutron fluence and materials variables on IASCC.
As part of the preparations for this experiment, a new reactor top lid was designed
- and installed in FY93. This lid, which provides an additional four inches of vertical ,
clearance for in-core experiments, meets or exceeds the specifications for the original lid. -
Radiation levels directly above the reactor were reduced as a result of the installation of this :
- new lid. '
The IASCC experiment was operating in-core during portions of this reporting !
period.
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SENSOR Facility SR#0-94-18 (11729/94), #0-95-8 (06/30/95)
The SENSOR facility complements the Irradiation-Assisted Stress Corrosion Cracking (IASCC) experiment. The objective of the SENSOR experiment is to place sensors in a loop that replicates the water chemistry of a Boiling Water Reactor (BWR) and then to place that loop in the core of the MIT Research Reactor (MITR-II). The sensors measure crack growth in situ and simultaneously monitor the electrochemical potential (ECP) with the objective of determining if a relation exists between crack propagation and ECP. Also, the experiment seeks to determine if hydrogen injection can arrest crack growth for several types of specimens. Some will be thermally sensitized and are expected to crack almost at once. Others will not have been presensitized. (N_ote: Sensitization is achieved by causing chromium depletion at the grain boundaries. This can be done either thermally or via neutron irradiation.) The facility is described in detail in the " Final Safety Evaluation Report (SER) for the Sensor Irradiation Facility."
In addition to the safety evaluation report, procedures for the installation and l removal of the SENSOR were prepared. These were similar to those developed earlier for l in-core experiments such as the IASCC. An ALARA plan was also prepared for the i SENSOR experiment.
The SENSOR experiment was installed in the MITR core in March 1995 and ran almost continuously until late June when all planned experiments were complete. Data analysis remains on-going. The experiment appears to have been successful in all of its !
major objectives. In particular, the capability to affect crack growth through a change in ,
water chemistry was shown.
i In August 1997, the SENSOR experiment thimble and specimen were prepared and shipped offsite to the General Electric company using the GE-2000 shipping cask. i l
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l l Revision of the Surveillance Reauirement on the Emergency Batterv ;
l SR#0-95-4 (02/22/95) >
I The emergency battery for the MIT Research Reactor was replaced in its entirety ;
during FY95. Subsequent to that replacement, a change on the surveillance requirements for measurement'of the battery's voltage and specific gravity was identified as being :
desirable. Accordingly,~ a safety analysis was prepared and, following approval by the j
( MIT. Reactor. Safeguards Committee, submitted to the- U.S. Nuclear Regulatory ,
Commission (NRC) on 02/22/95. A request for additional information was received on l 03/13/95 and a reply submitted on 04/10/95. A further request for additional information i
was then received. ,
i The original MIT request was withdrawn on July 31,1997 as newer internal i Administrative Procedures were set up.- ,
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F. -ENVIRONMENTAL SURVEYS Environmental monitoring is performed using continuous radiation monitors and
-- dosimetry devices. ' The radiation monitoring system consists of G-M detectors and associated electronics at each remote site with data transmitted continuously to the Reactor Radiation Protection Office and recorded on strip chart recorders. The remote sites are ,
located within a quarter mile radius of the facility. The detectable radiation levels per j sector, due primarily to Ar-41, are presented below, i l
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North 0.362 mrem i East 0.800 mrem j South 0.110 mrem l
West 0.440 mrem I l
Green (east) 0.043 mrem ;
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Fiscal Year Averages .
1998 0.4 mrem )
1997: 0.2 mrem l
1996 0.2 mrem l
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1995 0.4 mrem ;
1994 0.4 mrem 6 1993. 0.5 mrem i 1
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G. RADIATION EXPOSURES AND SURVEYS WITHIN THE FACILITY A summary of radiation exposures received by facility personnel and experimenters is given below:
July 1.1997 - June 30.1998 Whole Body Exnosure Rance (rems} Number of Personnel No measurable ................................................................... 106 M easurabl e - < 0.1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 39 0.1 - 0.25 .............................. ....... ............. ............. 12 0.25 - 0.5 ............................ ................. ....... ....... ... 10 0.5 - 0.75 ................................ .............................. .. 2 0.75 - 1.00 ........................................................ .. ....... 0 1.00 - 1.25 .............................. ........ . ......................... 2 Total Person Rem = 9.5 Iptal Number of Persontgj = 171 From July 1,1997. through June 30,1998, the Reactor Radiation Protection Office provided radiation protection services for the facility which included power and non-power operational surveillance (performed on daily, weekly, monthly, quarterly, and other frequencies as required), maintenance activities, and experimental project support. Specific examples of these activities include, but are not limited to, the following:
- 1. Collectiou and analysis of air samples taken within the containment buildmg !
and in the exhaust / ventilation systems. l
- 2. Collection and analysis of water samples taken from the secondary, D2 0, primary, shield coolant, liquid waste, and experimental systems, and fuel storage pool.
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- 3. Performance of radiatiori and contamination surveys, radioactive waste l collection and shipping, calibration of area radiation monitors, calibration of '
effluent and process radiation monitors,- calibration of radiation protection / survey instrumentation, and establishing / posting radiological l control areas.
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- 4. Provision of radiation protection services during fuel movements, in-core experiments, sample irradiations, beam port use, ion column removal, etc.
The results of all surveys and surveillances conducted have been within the guidelines established for the facility.
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II. RADIOACTIVE EFFLUENTS This section summarizes the nature and amount of liquid, gaseous, and solid radioactive wastes released or discharged from the facility.
- 1. Liould Waste Liquid radioactive wastes generated at the facility are discharged only to the sanitary sewer serving the facility. The possible sources of such wastes during the year include cooling tower blowdown, the liquid waste storage tanks, and various sinks. All of the liquid volumes are measured, by far the largest being the 12,136,000 liters discharged during FY98 from the cooling towers. (Larger quantities of non-radioactive waste water are discharged to the sanitary sewer system by other parts of MIT, but no credit for such dilution is taken because the volume is not routinely measured.)
Total activity less tritium in the liquid effluents (cooling tower blowdown, waste storage tank discharges, and engineering lab sink discharges) amounted to 7.53 E-5 Ci for FY98. The total tritium was 6.39 E-2 Ci. The total effluent water volume was 12,180.000 liters, giving an average tritium concentration of 5.25 E-6 pCi/ml.
The above liquid waste discharges are provided on a monthly basis in the following Table 11-3.
All releases were in accordance with Technical Specification 3.8-1, including Part 20. Title 20, Code of Federal Regulations. All activities were substantially below the limits specified in 10 CFR 20.2003. Nevertheless, the monthly tritium releases are reported in Table 11-3.
- 2. Gaseous Waste Gaseous radioactivity is discharged to the atmosphere from the containment building exhaust stack. All gaseous releases likewise were in accordance with the Technical Specifications and 10 CFR 20.1302, and all nuclides were substantially below the limits after the authorized dilution factor of 3000 with the exception of Ar-41, which is reported in the following Table 11-1. The 1469.81 Ci of Ar-41 was released at an average concentration of 3.92 E-9 pCi/ml. This represents 39.2% of EC (Effluent Concentration I (1x10-8 pCi/ml)).
- 3. Solid Waste Only one shipment of solid waste was made during the year. The information pertaining to this shipment is provided in Table 11-2.
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i TABLE H-1 ARGON-41 STACK RFIFASES FISCAL YEAR 1998 Ar-41 Average Discharged Concentration")
(Curies) (pCi/ml)
July 1997 236.78 6.38 E-9 August 159.15 5.36 E-9 September 73.21 2.47 E-9 October 170.91 4.61 E-9 November 154.17 5.19 E-9 l December 82.55 2.78 E-9 )
January 1998 75.41 3.39 E-9 February 78.07 2.63 E-9 March 251.09 8.46 E-9 April 92.88 ~2.5 E-9 May 39.67 1.34 E-9 June 55,92 1.88 E-9 i l
Totals (12 Months) 1,469.81 3.92 E-9 !
EC (Table II, Column I) 1 x 10-8 i
, % EC 39.2% <
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- l. linearly with curies discharged because of differing monthly dilution volumes.) :
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SUMMARY
OF MITR-II RADIOACTIVE SOI.In WASTE SHIPMENTS
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FISCAL YEAR 1998 i Description j i
Volume ' 90 ft3 Weight 2952 lbs.
i Activity (l) 3.9 E-3 Ci'(144.3 MBq) !
Date of shipment October 21,1997 ;
Disposition to licensee for burial- Barnwell Waste Management Facility, i Barnwell, SC - i Waste broker Scientii~ic Ecology Group, Inc., ;
Oak Ridge,TN Notes: (1) Radioactive waste includes dry active waste comprised of contaminated i and/or irradiated items and dewatered resin. The principal radionuclides are i activation and fission products such as 60Co,58Co,51Cr,65Zn,187W, ,
125 Sb, 95Zr, 95Nb, 3H, 46Sc,103Ru,137Cs, 55pe, 63Ni,129I, 99Tc,14C, 110 mag,54Mn,144Ce and 141Ce.
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TABLE H-3 i LIOUID EFFLUENT DISCHARGES .
FISCAL YEAR 1998 :
Total Total Volume Average Activity Tritium ofEffluent Tritium l Less Tritium Activity Water 0) Concentration j (x10-6 Ci) (x10-3 Ci) (x104 liters) (x10-6 pCi/ml)
July 1997 NDA(2) 3.02 118 2.56 l l
Aug. NDA 3.54 108 3.28 l Sept. NDA 1.4'6 114 1.28 Oct. 1.23 3 17 159 1.99 !
Nov. 1.75 4.f3 145 3.12 t Dec. 2.45 3.28 91.6 3.58 !
l L .Jan.1998 NDA 1.57 73.4 2.14 L Feb. 1.08 8.78- 90.3 9.72 Mar. NDA 4.23 87.2 4.85 Apr. .23.96' 7.87 71.4 11.0 l- May 44.86. I 1.2 68.7 16.3 l-June NDA 11.2 88.4 12.7 i
12 months 75.33 63.85 1215.0. 6.04 t
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- (2) No Detectable Activity (NDA); less than 1.26x10-6 pCi/ml beta for each sample.
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I.
SUMMARY
OF USE OF MEDICAL FACILITY FOR HUMAN THERAPY The use of the medical therapy facility for human therapy is summarized here pursuant to Technical Specification No. 7.13.5(i).
- 1. Investigative Studies During FY98, the major BNCT effort was on the continuation of Phase I trials for glioblastoma. Phase I studies are required by the U.S. Food and Drug Administration.
The purpose is to investigate the toxicity (or lack thereof) of a proposed therapy. No benefit is expected to those panicipating in these studies. There are three Phase I trials in progress. Each is summarized in the following.
a) Original Phase I Melanoma Study with Tufts New England Medical Center (NEMC)
This study began in September 1994. The approach used for this protocol implementation is for the subject to be given a test dose (400 mg/kg) of the boron-containing drug (BPA). Elood and punch biopsy samples are then taken in order to determine the biodistribution of the boron in both healthy tissue and tumor over time. This is necessary because the uptake of boron in tumor varies markedly from one person to another. The irradiations themselves are done in four fractions. For each, the subject is given 400 mg/kg of BPA and a limited number of blood / biopsy samples are taken to confirm the previously measured uptake curve. The starting point in the Phase I protocol was a total dose to healthy tissue of 1000 RBE-cGy. After the third subject, this was increased to 1250 RBE-cGy. Four subjects participated during 1994 and 1995, and a j summary of their responses was given in our annual reports for FY95 and FY96.
This Phase I protocol is now continued under the sponsorship of the Beth Israel-Deaconess Medical Center, b) Phase I Melanoma Study with New En glano Deaconess Hospital (NEDH) t The protocol adopted here was the same as that used for the NEMC study except that: (i) the boronated drug (BPA) was introduced intravenously (IV) and the total dose 1250 RBE-cGy was delivered in one fraction. The use ofIV BPA greatly increases boron uptake and hence dose to tumor. One subject has been irradiated thus far under this protocol, as summarized in the annual report for FY96.
i c) Phase I Glioblastoma Study with Beth Israel- Deaconess Medical Center This protocol is similar to the NEDH melanoma study in that it uses IV BPA. The total dose is delivered in multiple fractions via calculated, intersecting beam paths. Eight
- subjects participated in FY97, as summarized in our annual report for that year. During
! this reponing period, two subjects were irradiated at a total dose of 1065 RBE-cGy, three j at 1170 RBE-cGy, and one at 1280 RBE-cGy. A summary of these irradiations is as i follows:
Sybject 97-6 63 year old male, irradiation date 09/11/97.
Location ofirradiation: right frontallobe.
Subject 97-7 54 year old male, irradiation date 09/18/97.
Location ofirradiation: left parietal lobe.
Subject 97-8 45 year old male, irradiation dates 12/18/97 and 12/19/97.
Location ofirradiation: right frontotemporal region.
Subject 98-1 59 year old male, irradiation dates 02/26/98 and 02/27/98.
Location ofinadiation: right frontoparietal region.
Subject 98-2 24 year old male, irradiation dates 04/30/98 and 05/01/98.
Location ofirradiation: right frontallobe.-
! Subject 98-3 73 year old female, irradiation dates 06/11/98 and %/12/98.
Location ofirradiation: left temporoparietal mgion.
Subject irradiations are continuing under this Phase I protocol.
- 2. Human Therapv
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