ML20212G361
| ML20212G361 | |
| Person / Time | |
|---|---|
| Issue date: | 01/29/1997 |
| From: | Michele Burgess NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Brown R ELSCINT, INC. |
| Shared Package | |
| ML20212G311 | List: |
| References | |
| SSD, NUDOCS 9711060150 | |
| Download: ML20212G361 (5) | |
Text
_ _. _ _
s
@t%
7t UNITED STATES e.
')
NUCLEAR REGULATORY COMMISSION Q
t WASHINGTON, D.C. 80%fM001 g
January 29, 1997 / j.
[
l Richard Brown Elscint, Inc.
505 Main Street Hackensack, NJ 07601
Dear Mr. Brown:
This letter is in response to Elscint, Inc.'s application dated March 15,1996, and letter dated October 17,1996, requesting registration of Model Transact Gadolinium 153 line source housing, and to our telephone conversation on January 15,1997, We are in the process of performing a safety evaluation for the device. However, in order to continue our evaluation, the following information is necessary:
[1, This is in reference to the affidavit, dated October 14,1990, signed by Nathan Hermony, in which Elsc'nt requested that the drawings and the operation manual for the Transact source housing be withheld from public disclosure pursuant to 10 CFR 2.790.
W3 have reviewed your application and the material in accordance with the requirements of 10 CFR 2.790 and, on the basis of Elscint, Inc.'s statements, have determined that Mions of the information sought to be withheld contains trade secrets or proprietary commercialinformation. However, the staff, in consultation with the Office of C eneral Counsel, has determined that your affidavit does not comply with 10 CFR 2.790(b)(4). An example affidavit is enclosed for your reference. Please note the similarity of the wording in the example affidavit to the wording in 10 CFR 2.790. In addition, please note that your affidavit must be notarized.
Section 2.790(b)(1) of 10 CFR Part 2 requires that each supporting application be accompanied by an affidavit that contains a full statement of the reasons on the basis of which it is claimed that the information should be withheld from public disclosure. The section further states that the Commission will consider whether the information is of a type customarily held in confidence by the upplicar,t Please note that, in general, only that I formation which can not be obtained thro Jgh observation or measurement of components or documentation obtainable by a member of the pJblic can be withheld as proprietary material, in addition,10 CFR 2.790(b)(1)(ii) requires that a non-proprietary version be submitted, in prepanng the non proprietary version place brackets around the material consid *d to be proprietary, and white out or black out the proprietary portions, leaving the non-proprietary portions intact.
With regard to engineering drawings, information typically considered to be proprietary includes information such as dimensional tolerances and specific manufacturing notes or details listed on the drawing. Any additionalinformation on the drawings would be releasable. In order to address this, please identify the specific information on each drawing th1t Elscint wishes to be held as proprietary.
9711060150 971024 PDR.RC SSD PDH i,,
j
R. Brown 2-Regarding the operations manual, we find insufficient basis for withholding the manual from public disclosure. The information appears to be obtainable by the public through purchase of the device. Consequently, based on the information and justification provided by Elscint Inc., we are unable to conclude at this time that the information referenced in the operations manualis proprietary. You may address this issue in further detail in your now affidavit.
A proprietary version (with the brackets), non proprietary version (with the marked out information), and the new affidavit must be submitted prior to the staff making its final proprietary determination in accordance with 10 CFR 2.790(c), the information sought to be withheld will be placed in the Commission's Public Document Room unless you provide the Commission with the requested information within 30 (thirty) days of the date of this letter.
/
2.
Dwg# 473 3671 1800, contained in Elscint's letter, Indicates that the label shown in Dwg# 705-3671 1305 will be attached to the scanning head. Please note that the requested labeling must be attached to the registered device. Please submit details regarding the labeling and position of the labeling on the registered device (source housing)itself. In addition, Elscint's application contained a label drawing, Dwg# 705-
./3671 0901. Please indicate the materials of construction and method of attachment for this label.
3.
Elscint's October 17,1996 leiter, stated that the onloff indicator will be tested daily du.ing the initialization of the gantry. Please provide specific details which lilustrate this procedure.
4.
Please indicate whether the manual shutter lever is visible to the user at all times and describe how the lever is labeled.
5.
The drop and puncture testing as described in Elscint's letter is not sufficient to demonstrate that, during normal use conditions, over the expected lifetime of the housing, the byproduct material will not be released to the environment, and the source will not be inadvertently unshielded. Please submit procedures and results of additional testing which adequately address this issue, i
6.
- Please provide drawings and descriptions which clearly illustrate the details of the source rod / solenoid interface, the source rod insertion tool / source rod interface, and the source shipping container / source housing interface. The drawings submitted in Elscint's October 17,1996, letter do not adequately address this issue. Please clearly explain
+
how the source rod is held in place during installation by pressure, then by closing the
' source holder.
7.
Please provide dose rates at the surface,5 cm, and 30 cm from the source shipping container, r
,,,,,--.-e.m-
-m-m 1,
e,%.-w.
t v-
<-,w
.,.w-%y-%,, -. -i i--. w p
-r-'
a---w+
m-+
e i
~
R. Brown 3-i 8.
It was noted that the original operation manual contained leak test procetfures, but the revised manual did not. Please provide a copy of the leak test procedures that will be
]
provided to the user.
)
Please provide the requested information and the new affidav;t within thirty (30) dcys of the date of this letter, if you have any questions, please contact me at (301) 415 5868 or Mr. John Lubinski at (301) 415 7868.
l Sincerely,
/a/
Michele L Burgess, Mechanical Engineer l
Sealed Source Safety Section Medical. Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety l
and Fafeguards j
Enclosure:
Example Affidavit 4
t.
4 s
I 4
Distribution:
SSSS r/f SSD-9616 NE01 Document name: C:\\SSSS\\WO RKSS D\\E LSCI NT\\N R276101. DE3
- sta previous concurrence 1
To receive a copy of this docurni.nt. Indicate in the box: 'C"
- Copy without attachmentenclosure T* a Copy with attachment / enclosure "N" = No copy l
OFFICE IMAB 6 IMAB A f-A/ OGC lC-l-
NAME MBurgessimtr)nt]4 JLubinski MPSiemien*
DATE 01/31 /97 -
^
01/ V /97 01/'.% /97 OFFICIAL RECORD COPY
i R. Brown 3-8.
It was noted that the original operation manual contained leak test procedures, but the revised manual did not. Please provide a copy of the leak test procedures that will be provided to the user.
Please provide the requested information and the new affidavit within thirty (30) days of the date of this letter, if you have any questions, please contact me at (301) 415 5868 or Mr. John Lubinski at (301) 415-7868.
Sincerely, pl Michele L. Burgess, Mechanical Engineer 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
Enclosure:
Example Affidavit 4
?
Distribution:
SSSS r/f SSD 96-16 NEC1 Document name: C:\\SSSS\\WORKSSD\\ELSCINENR276101.DE3
- see previous concurrence TT receive a copy of this document, indicate in the box: 'C's Copy without attachment / enclosure
- E" = Copy wth attachment' enclosure
- Ns No copy OFFICE IMAB E IMAB c,6 f f - N OGC C-NAMd MBurgess/mtr)giA JLubinski MPSlemien*
DATE 01/31 /97 01/ St /97 01/v4 /97 OFFICIAL RECORD COPY
R. Brown 8.
It was noted that the original operation manual contained leak test procedures, but the revised manual did not. Pleass provide a co y of the leak test procedures that will be provided to the user.
Please provide the requested informationhWGn thirty (30) days of the date of this letter.
If you have any questions, please contact me at (301) 415 5868 or Mr. John Lubinski at (301) 415 7868.
Sincerely, m
Michele L. Burgess, Mechanical Engineer S taled Source Safety Section Medical, Academic, and Commercial Use Safety Branch Divlelon of Industrial and Medical Nuclear safety Office of Nuclear Material Safety and Safeguards i
M>% :
f%pu Agiaumt-1r i
1 4
i l
Distribution:
i.SSSS r/f SSD-96 NE01 Document aame: C:\\S S SS\\WO R KS S D\\E LSCI NT\\N R276101. DE 3 Tu receive a copy t,f this document, indicate in the boa: *C' = Copy wMhout attachmert' enclosure "E* = Copy wMh uttachmerNenclosure "N" = No cop 9 OFFICE IMAB 16 IMAB M lM OGC l'
l l
NAME MBurgess/mb (fM5 JLubirisRI MPSMmien [M"/>
j DATE 01/As/97 01/ M /97 01/lfi97 OFFICIAL RECORD COPY
.. w