ML20217J598
| ML20217J598 | |
| Person / Time | |
|---|---|
| Issue date: | 03/18/1998 |
| From: | Steven Baggett, John Lubinski NRC |
| To: | |
| Shared Package | |
| ML20217J501 | List: |
| References | |
| SSD, NUDOCS 9804060333 | |
| Download: ML20217J598 (12) | |
Text
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-103-B DATE: g ) g )ggg PAGE 1 OF 9 DEVICE TYPE: X-Ray Fluorescence Analyzer MODEL: Courier 20 DISTRIBUTOR: Metorex Incorporated (formerly Outokumpu Electronic, Inc.)
Princeton Crossroads Corporate Center 250 Phillips Boulevard Ewing, NJ 08618 MANUFACTURER: Metorex International, Oy (formerly Outokumpu Instruments, Oy)
P.O. Box 85 SF-02201 Espoo, Finland SEALED SOURCE MODEL DESIGNATION: Amersham: IEC.A1, CUC.A1N, CUC.A1, AMC.A1, or CLC.Al ISOTOPE: MAXIMUM ACTIVITY:
Americium-241 30 mci (1.11 GBq), (AMC.A1)
Cadmium-109 20 mci (0.74 GBq), (CUC.A1N or CUC.A1)
Curium-244 100 mci (3. 7 GBq) , (CLC.A1)
Iron-55 200 mci (7.4 GBq) , (IEC.A1)
T.RAK TEST FREOUENCY: 6 Months PRINCIPAL USE: (U) X-Ray Florescence CUSTOM DEVICE: YES X NO 9804060333 900318 PDR RC.
- SSD PDR
. REGISTRY OF-RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-b 103-B DATE: PAGE 2 OF 9 WAR 181998 DEVICE TYPE: X-Ray Fluorescence Analyzer-DESCRIPTION:
The Courier 20 is an on-stream X-Ray Florescence Analyzer designed to measure preselected elements and slurry densities Lfrom process. streams. The Courier 20 consists of the analyzer and an electronic control panel. The analyzer is approximately 27" x 27" x 27" (68.6 cm x 68.6.cm.x 68.6 cm). The control panel is mounted separately'from the analyzer.
The analyzer is accessed-by a " wing door" on each side. Inside the cabinet is a Si(Li) detector, its' liquid nitrogen dewar, and the radioactive sealed source (s) , all of which are bolted to a
" swivel-plate". The' test sample enters the test cell chamber (s) on the front of the cabinet via arr import pipe, and the detector apparatus is swiveled to point at that. test cell chamber and the sample is analyzed by x-ray fluorescence. In order to face a specific test cell chamber,. the swivel plate can be turned to the right or the left on of4the center " maintenance" position. A red read-out light on the control' panel informs the operator whenever the detector is not in'the maintenance position.
The sample is either in slurry or in liquid form. It is presented to the source detector assembly through the window system. Closest to the detector is a 0.002" (0.050 mm) thick mylar film. The window facing the sample is made of 0.0014" (0.038 mm) kapton film.
ItLis possible to use two different sources in the source-detector assembly. The small annular source (Iron-55), part 5 in
~
JAttachment 2,. is-located at the end of a steel tube (part 4).
The source is fixed with a source holder (part 6) which is made of copper. -
1
-REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
.(AMENDED'IN ITS ENTIRETY)-
NO.: NR-701-D-103-B DATE: PAGE 3 OF 9 WER 181998 DEVICE TYPE: X-Ray Fluorescence Analyzer DESCRIPTION (Cont'd):
/
The' bigger annular source, either Cadmium-109, Curium-244 or JAmericium-241 (part 2), is first inserted into the source holder (part.1) and the holder is then screwed to the radiation limiter
'.(part 3). This assembly is then mounted around the protection tube (part 4) and fixed with a screw to the fixing ring (part 7) .
This device was previously distributed by Princeton Gamma-Tech under the same model number designation.
DIAGRAM: See Attachments 1 and 2 LABELING:
The device is labeled in accordance with 10 CFR 20.1901 and 10
.CFR 20.1904. A nameplate near the top of the front of the device ;
bears the Metorex logo and the model number, " COURIER 20". A few
-inches below that is an adhesive label bearing the following
'information: radiation trefoil and " CAUTION RADIOACTIVE
. MATERIAL" in magenta on a yellow background serial number, the
. activity and date of assay, and the words " REMOVAL OF THIS LABEL ISjPROHIBITED."
Devices intended for distribution to persons generally. licensed also bear:a label:to meet theirequirements of 10 CFR.32.51. The i labelDis a pressure sensitive adhesive label-with black lettering 1 on a bronze background. Thel label is located on a vertical line 1 between the> nameplates and-the otheridescribed above.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
' SAFETY EVALUATION OF DEVICE (AMENDED.IN ITS ENTIRETY)
NO.: NR-701-D-103-B DATE: PAGE 4 OF 9 WER 181998 DEVICE TYPE: X-Ray Fluorescence Analyzer CONDITIONS OF NORMAL USE:
.The device is used in a laboratory environment to measure density
.and analyze elements of an on-stream slurry of liquid. The expected useful lifetime of the device is 10 to 15 years.
PROTOTYPE TESTING:
The manufacturer of the sealed sources used in the device reports the sources have achieved the following Classification as per ANSI N5.10-1968 or ANSI N542-1977.
MODEL NO. ISOTOPE ANSI RATING AMC.Al Americium-211 77C54444 CUC.A1N- Cadmium-109 68C33232 CUC.Al ' Cadmium-109 68C33232
-CLC.Al- Curium-244 77C54444 IEC.Al Iron-55 77C33232 The distributor indicates that the device has achieved an ANSI N538 rating of ANSI-22-675-985-R1.
EXTERNAL RADIATION LEVELS:
The manufacturer reported the following readings on the exterior of the device with either the 30 mci Am-241 or 20 mci Cd-109 sources installed and in the sample cell area:
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
' SAFETY EVALUATION OF DEVICE (AMENDED ' IN ITS ENTIRETY)
NO.:. NR-701-D-103-B. DATE: PAGE 5 OF 9 DEVICE TYPE: X-Ray Fluorescence Analyzer EXTERNAL RADIATION LEVELS (Cont ' d) :
Distance Dose' Rates: in Mr/hr (pSv/hr)
From Surface AMERICIUM-241 CADMIUM-109 1.97" (5 cm) 2.00 (20)' 2.50 (25) 11.8" (30 cm) 0.15 (1.5) 0.20 (2.0) 39.4" (100 cm) <0.01 (<0.1) <0.01 (<0.1)
The external dose rates for a Courier 20, loaded with both the 200 mci Iron-55 sealed source and the 100 mci Curium-244 sealed source are listed in below:
Distance Dose rates From Surface mR/hr (uSv/hr) 1.97" (5 cm) 0.17 (1.7) 3.94" (30 cm) 0.05 (0.5) 29.4" (100 cm) <0.04 (<0.4)
OUALITY ASSURANCE AND CONTROL:
Metorex. Incorporated has agreed to abide by the quality assurance and control standards previously submitted by Princeton Gamma-tech for the Model Courier 20, which were found to be adequate for licensing purposes.
<The Quality Assurance Program covers the following subjects:
- 1) Quality Assurance Organization;
'2)' General Quality Assurance Policy;
- 3) . Incoming Inspections and Vendor Qualifications; 4)- Test Procedures;
- 5) Personnel Training; i.
A REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES-SAFETY EVALUATION OF DEVICE (AMENDED IN'ITS ENTIRETY)
NO.: NR-701-D-103-B DATE: PAGE 6 OF 9 R 181998 DEVICE TYPE: X-Ray Fluorescence Analyzer OUALITY ASSURANCE AND CONTROL (Cont'd):
- 6) Non-conforming Items Policy (rejects) ;
l7)' Document Control;
- 8) Final Testing; and
- 9) Quality Audits and Reports.
I LIMITATIONS AND/OR CONSIDERATION OF USE: j
=-Courier 20 devices shall be leak tested at intervals not to exceed 6 months using techniques capable of detecting 0.005 pCi (185 Bq) . of removable contamination.
- Courier 20 devices intended for distribution to persons generally licensed pursuant to 10 CFR 31.5 or equivalent provisions of an Agreement State must be labeled in ,
accordance with the requirements of 10 CFR 32 51(a) (3) or l equivalent provisions of an Agreement State. l
- Handling, storage, use, transfer, and disposal: For specifically licensed devices, to be determined by the licensing authority. For generally licensed devices, as required by 10 CFR 31.5 or the equivalent provisions of an i Agreement State.
- This registration sheet and the information contained within ;
the-references shall not be changed without the written !
consent of the NRC.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY ~ EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-103-B DATE: ggp ) g 3ggg PAGE 7 OF 9 DEVICE TYPE: X-Ray Fluorescence Analyzer SAFETY ANALYSIS
SUMMARY
Based upon our review of the information submitted and test data
- cited below, we conclude that Metorex, Inc., has provided sufficient-information to provide reasonable assurance that:
- The Model Courier 20 can be safely operated by persons not having training in radiological protection.
- Under ordinary conditions of handling, storage, and use of the device, the byproduct material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in any period of one calendar quarter a dose in excess of 10' percent of the limits specified in the table in 10 CFR 20.1201(a).
- Under accident conditions associated with handling, storage, and use of the device, it is unlikely that any person would receive an external ~ radiation' dose or dose commitment in excess of the dose to the appropriate organias specified in the following chart:
Whole body; head'and' trunk; active blood-forming organs; gonads;;or lens of eye 15 (0.15)
Hands and forearms; feet and.
ankles; localized areas of skin averaged'over areas no larger than 1 square centimeter 200 (2.0) 9 4
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-103-B DATE: g ) g )ggg PAGE 8 OF 9 DEVICE TYPE: X-Ray Fluorescence Analyzer SAFETY ANALYSIS
SUMMARY
(Cont'd):
Other organs 50 (0.50)
Furthermore, we conclude that this device would be expected to maintain its containment integrity for normal conditions of use and accidental conditions which might occur during uses specified in this certificate.
REFERENCE:
The following supporting documents for the Model Courier 20 X-Ray Fluorescence Analyzer are hereby incorporated by reference and are made a part of this registry document.
- Princeton Gamma-Tech, Inc., letters dated June 16, 1989, May 12, 1989, November 7, 1988, May 27, 1987, May 22, 1987, and March 24, 1987, with enclosures thereto.
- Outokumpu Electronics, Inc. letter dated February 8, 1991, with enclosures thereto.
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REGISTRY OF RADIOACTIVE SEALED' SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS' ENTIRETY)
NO.: NR-701-D-103-B DATE: <
) g gggg PAGE 9 OF 9 DEVICE TYPE: X-Ray Fluorescence Analyzer EEFERENCE (Cont'd)-
- Metorex Incorporated's letter dated October 16, 1997, July 25, 1995, and July 5, 1994, with enclosures thereto.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission
/
f MAR 181998 Reviewer: . ///
Date: 1 Jo$n W. Lubinski Date: NAE I I Concurrence: / Y
/dteven L. Baggett
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-103-B DATE: MAR 181998 ATTACHMENT 1 1
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1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.; NR-701-D-103-B DATE: MAR 1 8 1999 ATTACHMENT 2
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gU w A. Q Y % ( f bl%L October 16,1997 h vo Jftt Ng(
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- !p u % L L a w f Mr. Steven Baggett #/t c d 6 + u 7f US Nuclear Regulatory Commission Sealed Source Safety Section ( ' LLh/ (WA) . f s M a Dev ce Br nch DU '
Division of Industrial and Medical Nuclear Safety, 7
Office of Nuclear Material g f{hh C
Srfety and Safeguards, 11555 Rockville Pike p k [ Mp k O tN Rockville, MD 20852 Mail Stop T8F5 d dO hk(LL -/w w Re.: Registry update h-
Dear Mr. Baggett,
(4 % T$r m; t/v l With this letter we ask that the NRC registry of the Metorex inc. manufactured / distributed devices is amended as specified point by point below. j The registries affected are: NR-70 Affected licenses are: 29-3OJ42-OP,,1-D-101 R-701 D-102-B, and N -701-D-103-B.
arid 29-30342--B. G g/ ,
' ~
- 1. Please correct t page of each registry the addres ows:
f distribut . This position should read [ as j / Metorex incorporated
! (formerly Outokumpu Electronics, Inc.()( [j '
5 Princeton Crossroads Corporate Cen ar] g~ ~
! W E n J 086 8 ,# h W ') '
~
Our company moved to' the vapentionedlocatdJai y of 1997. We have applied ,
for amendment to our licenses to reflect the changs 6f location and have received amended licenses on May 23,1997. We had an understanding that this change has been made to all 'tl documents in the system.
- 2. On page 6 of the Registry # NR-701-D-101-B add an Fe-55 (Iron-55) isotope source in the I "<
first table as follows:
- in the last column titled " Isotope Products", in the first row, for Iron-55 isotope add ' /f A38951 and A3895-2:
METOREX INC.
[ \ f N ion Crossroado Corporate Center Tesophone Te4etan 1
N Je 543-3540 /
f a
/ This isotope capsule has been approved in the State of California, and is registered under registry # CA406S166S, dated 02-03-1997, the copy of which is enclosed as Attachment
- 1. We have tested this source by installing it in Metorex devices, and measuring radioactive dose around them. In no instant the dose exceeded the value of 0.05mR/hr, when shutter of tested device was closed. The dose rates measured with this source when exposed were comparable to or below the dose rates obtained with Amersham sources, Model IEC. As a matter of fact, this source is a copy of the Amersham design. This annular sealed source is reported by its manufacturer to exceed the test requirements of the ANSI 77C44433.
Therefore, on page 7 of the registry, in paragraph " Prototype Testing", please add this IPL Model numbers A3895-1, and A3895-2, with ANSI Rating of 77C44433.
- 3. Please add to the Registry #NR-701 D-101-B new device, Model SIPS Probe. This is a new device, which utilizes new, silicon p-i-n diode, room temperature detector, and isotopes of Fe-55, Cd 109, and Am-241. The description of this new probe, its construction details and the results of test measurements of radiation dose around it are enclosed as Attachment 2.
Also enclosed is a copy of a Finnish Radiation Safety Review Report pertaining to this probe.
In the past, our registry was reviewed and updated by Mr. Douglas A. Broaddus. We would greatly appreciate if Mr. Broaddus could also work on the current application as this most certainly would speed up the review process. l The copy of this letter is being forwarded to the Licensing Section of NRC Region I, King of Prussia, along with the request for appropriate license amendment. '
Enclosed with this letter is also a cheque for $ 610.00 to cover the review fee.
Should you have any questions, please call me at 609-406-9000 ext.105, or fax at 609-530-0842. My e-mail is StanPrex@aol.com.
l Yours sincerely, l
MQ c ..
Stanislaw Piorek, Ph.D.
Radiation Safety Officer and V. President, Research and Product Development Encl.: - copy of the IPL Registry, #CA406S166S
- technical data and radiation dose measurements for Model SIPS probe.
- copy of the Finnish Authorities Test Certificate for Model SIPS probe.
- cheque #21435, for the amount of $ 610.00.
I
~- ,
PAGE1 NRC FORM 567 [jjg,s .) io e cU U. S. NUCLEAR REOULATORY COMMISSION REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION g
M- *M INSTRUCTIONS: Send tfus request AND a copy of all rotated lettere/sppilcetone and drawings to: The Scaled Source Safety Section, ATTN: CNef, l OWFN Mail Stop 6 H3. Change the Ucense Tracidng System milestone to 19 and aeoign to reviewer code I-5.
l NOTE: Retain a copy of this request with the applicahon and background flies.
NLQULSTER REGION / LOCATION:
f#W M lI 11 til IV RV R HQ R LFDCB SELEPHONE NUMBER DATE' TYPE OF ACTION REQUESTED (Check as appropriale) wS NA SOURCE REVIEW AMENDMENT OF fpg[w,) .Z.gy/,d,,,/ REGISTRATION SHEET NUMBER (S)
MAa. conTR6L NUMBER (S) DEVICE REVIEW
- LETTER /APPUCATION DATE UCENSE NUMBERM CUSTOM REVIEW 8[~ YO/3-/C'3 -h
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' TYPE OF ACTiONwec.i.ni.nor,*er.e cherp.)
l l COMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM) l SOURCE (9C) DEVICE (9A) SOURCE (90) DEVICE (9B) l NEW NEW ~
NEW ~
NEW AMENDMENT d MENDMENT AMENDMENT AMENDMENT j NO SAFETY EVALUATION REQUIRED j LICENSING ACTION REQUIRED IF KNOWN -
NO FEES REQUIRED NO j OTHER (Specify)
TOTAL NUMBER OF NOTESg v ,y' j'
^ '
DEFICIENCY LETTERS NUMBER OF DEFICIENCY CALLS FOR BILLING PURPOSES ONLY NEW REGISMON - ] PRODUCT INAME -
NAME CHANGE ADDRESS CHANGE
- ADD TO BILLING REMOVE FROM BILLING FOR FEE USE ONLY TYPE OF FEE A M D AMOUNT RECE1VED 4W/ VW
..n bF ECATEGORY n .B CHECK NUMBER
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October 16,1997-Mr. Steven Baggett US Nuclear Regulatory Commission Sealed Source Safety Section Source Containment and Devices Branch
,. Division of Industrial and Medical Nuclear Safety, Office of Nuclear Material
! Safety and Safeguards.
11555 Rockville Pike Rockville, MD 20852 Mail Stop T8F5 Re.: Registry update
Dear Mr. Baggett,
l L. With this letter we ask that the NRC registry of the Metorex inc. manufactured / distributed devices is amended as specified point by point below.
[ The registries affected are: NR 701-D-101-B, NR 701-D-102-B, and NR-701-D-103-B.
- Affected licenses are
- 29-30342-01 and 29-30342-02G.
l
- 1. Please correct on the first page of each registry the address of distributor. This position should read as follows:
Metorex Incorporated (formerly Outokumpu Electronics, Inc.)
Princeton Crossroads Corporate Center 250 Phillips Boulevard Ewing, NJ 08618 Our company moved to the above mentioned location in January of 1997. We have applied for amendment to our licenses to reflect the change of location and have received amended
~ licenses on May 23,1997. We had an understanding that this change has been made to all documents in the system.
- 2. On page 6 of the Registry # NR-701-D-101-B add an Fe-55 (Iron-55) isotope source in the first table as follows:
in the last column titled " Isotope Products", in the first row, for Iron-55 isotope add A38951 and A3895-2;
~
METOREX INC.
Pr
[ \
on crossroade Corporate Center . Telephone Telefax Qh ['.
w P. o. Box 3540
.nnceton, New Jersey 06543 3540 -
1-609 406 9000 1-604 634 9055
This isotope capsule has been approved in the State of California, and is registered under registry # CA406S166S, dated 02-03-1997, the copy of which is enclosed as Attachment
- 1. We have tested this source by installing it in Metorex devices, and measuring radioactive dose around them. In no instant the dose exceeded the value of 0.05mR/hr, when shutter of tested device was closed. The dose rates measured with this source when exposed were comparable to or below the dose rates obtained with Amersham sources, Model IEC. As a matter of f act, this source is a copy e.f the Amersham design. This annular sealed source is reported by its manufacturer to exceed the test requirements of the ANSI 77C44433.
Therefore, on page 7 of the registry, in paragraph " Prototype Testing", please add this IPL Model numbers A38951, and A3895-2, with ANSI Rating of 77C44433.
- 3. Please add to the Registry #NR-701-D-101-B new device, Model SIPS Probe. This is a new device, which utilizes new, silicon p-i-n diode, room temperature detector, and isotopes of Fe-55, Cd-109, and Am-241. The description of this new probe, its construction details and the results of test measurements of radiation dose around it are enclosed as Attachment 2.
Also enclosed is a copy of a Finnish Radiation Safety Review Report pertaining to this probe.
In the past, our registry was reviewed and updated by Mr. Douglas A. Broaddus. We would greatly appreciate if Mr. Broaddus could also work on the current application as this most certainly would speed up the review process.
The copy of this letter is being forwarded to the Licensing Section of NRC Region I, King of Prussia, along with the request for appropriate license amendment.
Enclosed with this letter is also a cheque for $ 610.00 to cover the review fee.
Should you have any questions, please call me at 609-406-9000 ext.105, or fax at 609-
% 530-0842. My e-mail is StanPrex@aol.com.
Yours sincerely, r0 Stanislaw Piorek, Ph.D.
Radiation Safety Officer and V. President, Research and Product Development Encl.: copy of the IPL Registry, #CA406S166S
- technical data and radiation dose measurements for Model SIPS probe.
- copy of the Finnish Authorities Test Certificate for Model SIPS probe.
- cheque #21435, for the amount of $ 610.00.
October 31,1997 ASSIGNMENT NUMBER: 97-64,97-65,97-66 Dr. Stanislaw Piorek Metorr:, Inc. l Princeton Crossroads Corporate Center P.O. Box 3540 Princeton, NJ 08543-3540
SUBJECT:
ACKNOWLEDGEMENT OF REQUEST FOR SAFETY EVALUATION
Dear Dr. Piorek:
This letter acknowledges the receipt of your October 16,1997, application that requested a )
safety evaluation and registration of various Model numbers. We have performed a cursory review of your application and determined that enough information has been provided to allow a technical reviewer to initiate the evaluation process. Applications are assigned to technical reviewers on a first-in basis. Therefore, your application will be assigned in turn. Please note that the technical reviewer may contact you to requert information that was omitted from your application or to obtain clarification of technicalissues concerning your application. If you have any questions concerning the status of your application, please contact me at (301) 415-8140.
Please reference the assignment number listed above in your questions or correspondence.
Please be aware that your request may be subject to the NRC's application fees in accordance with 10 CFR Part 170. Therefore, a copy of your application has been forwarded to the License Fee and Debt Collection Branch for approval of the fee category and amount. If you have any questions concerning the fees associated with your application, please contact the License Fee and Debt Collection Branch at (301) 415-7554.
Sincerely, 9/
KimBerly Randall, Registration Assistant Sealed Source Safety Section Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Distribution: ,
SSSS r/f SSD-97-64 . 97-65 ,
SBaggett NE01 '
97-66 DOCUMENT NAME:P:97 64-66.wpd T; seceive e copy of this document, indicate in the boa: "C' = Copy wsthout attachment / enclosure "E' = Copy with attachment / enclosure *N* = No copy OFFICE IMAB l l l l NAME KRandalk DATE 10/5f /97 OFFICIAL RECORD COPY Wl4W le