ML20217H721
| ML20217H721 | |
| Person / Time | |
|---|---|
| Issue date: | 10/06/1999 |
| From: | Bhachu U NRC |
| To: | NRC |
| Shared Package | |
| ML20138G633 | List: |
| References | |
| SSD, NUDOCS 9910220185 | |
| Download: ML20217H721 (6) | |
Text
i NOTE TO: File NR-0186-D-D-117-B
. From: Ujagar S. Bhachu Date: October 6,1999 RE: Basis for NO Leak Test Requirements
Background:
Use of multip'e exempt sources was discussed with Berthold during meetings held on June 22, 1998 and June 23,1998. During these meetings amongst other things NRC provided direction on the use of multiple exempt sources with reservations as follows.
Deviceu already in use having multiple exempt quantities of byproduct material may continue to -
be used. NRC does not plan to take any action with respect to these devices or users unless a radiological safety hazard is identified. NRC allowed BSI and Ronan, Companies to continue to distribute devices having multiplo exempt quantities of byproduct materials until August 25, and 28,1998, respectively.
NRC advised Berthold that NRC is planning to perform a risk assessment to determine if there are any public safety concerns with these devices and whether any further action is warranted.
if the risk assessment demonstrated a low risk to the public, NRC would initiate rulemaking to authorize the distribution of these devices to persons exempt from licensing. NRC anticipated that the risk assessment and rulemaking process will take 2 to 3 years.
NO Leak Test Requirement: ( Berthold Multiple Exempt Sources)
Berthold in their application for Cesium-137 source gauges advanced a rational as to why their
' devices were exempt from the regulatory periodic shutter testing and leak testing requirements.
NRC accepted the Berthold reasoning.
Barium-133 exempt quantity is the same as Ceslum-137 ( see 10 CFR 30.170).
Barium-133 source intensity and half life is less than Cesium-137. The severity of occumulative radiation dose damage to the bonding material of the sources is lower than in the case of Cesium-137. Therefore, no leak test requirements were extended to the sources carrying same amounts of Barium-133 activity in lieu of Cesium-137.
9910220183 991013 #
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v- APPENDIX C OfuM . f bHAWU l
SUMMARY
DATA ' ,
I
- N:me and Complete Maillag Address of the Applicant:
g ,, . Name, Title, and Telephone Number of the Individual to Be go g hft (4( hat h Contacted if AdditionalInformation or Clarification Is N go aggatartars AM M " O"9 b"% *Mi 4, i mo tea 6ool - 72A- 37E - lboo Tha Applicantis(check one):
Custom User If the Applicant is Not the Manufacturer, Provide the Name and Complete Malling Address of the Manufacturer: 1 Manufacturer Distributor l
Manufacturer and Distributor %
. If the Applicant is a Custom User, Provide the Name and Complete Mailing Address of the Distributor: Proside the Name, Complete Mailing Address, and Function of Other Companies involved:
N/A- ,
Mod;1 Number:
39007 (9wA)
Principal Use Code (see Appendix F): (O')
Nrme Used by the Industry to Identify the Product (e.g., For Use by:
R:diography Exposure Device, Teletherapy Source, Celibration Source, etc.):
Spec (.ic Ucensees Only General Licensees Only l
K Both Specific and General Licensees Persons Exempt from Licensing Le:k Test Frequency:
( .
- PrincipalSection of the 10 CFR that Applies to the User (e.g.,
Periodic Leak-Testing is Not Required
, General Licensees under 10 CFR 31.5):
6 Months ;3 gpp 3g,5 , to e F4 20 12o01 Radionuclides and Maximum Activities (including loading Attached isjustification for a leak test frequency of ' '#"##
. greater than 6 months CERTIFICATION:
Uth APPLICANT UilDERSTANDS M1AT ALL STATEMENTS AND REPRE ;
THE APPLICANT PREPARED AND ANY IN CONFORM!W WITHOf FICIAL TITLE EXECUTING 10 CODE , OF Ft3ERAL . THIS CERTIFICAT10N REGULATIONS PARTS 30ON ANDBEHALF 32 AND ULA O AND CORRECT TO TifE DEST OF TIIEIR KNGWLEDGE AND BELIEF. LL INFORMATION CONTAINED HEREIN IS TRUE WARNING: 18 U.S C. SECTION 1001 ACT OF JUNE 25.1948 62 STAT,749 MAKES IT A CRIMINAL OFFENSE T
-Certifylig REPRESENTATION TO ANY DEPARTMENT OR AGENCY Officer-~ Typed Name and Title OF THE UNITED STAT A WILIJULLY FALSE STATEMENT OR
' SigretTrs:
Date:
NUREG - 1556, Vol. 3 C-2 l l
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,4 APPENDIX C =
i l _
't CHECKLIST [
Registration Certificate Holder:
Model:
=
DESCRIPTION OK/DEF COMMENTS DESCRil' TION / CONSTRUCTION j 1 If registration certificate holder is requesting to register more than one Nw 1ol f' 5. , n W - 3o1 hvu., J
. source / device on a certificate, are designs similar enough to do so? N W. 4 o f fe o c.,
Device / source design with complete engineering drawings (dimensions, ,
tolerances, list of materials) O#- l Assembly methods (screw, welds, etc.); g, verify integrity Source mounting (size and integrity) and security o . fl.
Is source ANSI classification sumcient (from ANSI N542-1977):
Radiography - Unprotected 43515 f,, m ,,I41,, ..! M o boi I h ey dv. u l Radiography - In Device 433!3 y J
Medical Radiography , 32312 [0 3 73 "dio X o 00f- 0 00.9 rue)
Medical - y Teletherapy 53524 pf, g p q j/oj/ e, , o , f 77 n g, - /n y Gauges - Unprotected , 43333 [
y Gauges -In Device . . 43232 g,.4,4 o l ? "
p Gauges, Low Energy y Gauges, or X-ray fluorescence . 33222 Oil Well Logging , 56522 f k detr A v 4 d & n'g a dvt-4 Ponable Moist / Density , 43333 gy q, y j gg /, _ (37 Neutron Applications . . . 43323 I y irradiators (II, Ill, IV) ,, , 43424 y irradiators (1) . . 43323 ,
22222 l l Static Eliminators . , , .
! Smoke Detectors . 32222 Definition of shutter operation (lacked in OtT position, not locked in On position) Fail safe, spacing and tclerances No M4s 8WN On-Off indicators (description, qty., location) N/A.
, Safety interlocks, guards, etc. to prevent access to beam or high radiation k,,e us p ncm ,nf,, a 7ATN levels fo 4 Corrosion between unlike materials (e g., aluminum & steel, depleted uranium & steel, etc.) N/A-Shielding emeiency and integrity AcuptaA lb ory nt e}fou b m 14v W .
. For medical devices: Was a 510(k) provided? (provide written notification to be!A ~
FDA)
Welllogging sources must be nondispersible and nonsoluble. (see Appendix B for a list of approved well logging sources as of November 1991) M/A -
See " ANSI and Other Standards" list for references for particular source / device designs (e.g. radiography, Brachytherapy, etc.) Ag sr N 538 (e7.r 6 49 fra ,17AMr>
.t i
jsv/af Lbhm bf- Ik/) d N4 73,4 u.s.w /M 'L p.o J C-3 NUREG - 1556. Vol. 3
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APPENDIX C CHECKLIST i
.l Registration Certificate lloider: /wtus fgh~. , sur-- t Model: 3> (/~.A)
DESCRIPTION OK/DEF COMMENTS i LABELING I l
Copy oflabel oK/ 4 4,..fa L um Materials, dimensions, colors (note on registration certificate iflabeling is exempt from the color requirements of 10 CFR Part 20) L,6,pA<g g % c.& yspeew-C-t.,91 A % ~ p. v*/
Permanent attachment and location (s)- visible to users? og, Contents: Model#, Serial #, Isotope, Acsity, Manufagmt:r, Qate of Assan Trefoil," CAUTION - RADIOACTIVE MATERIAL"(Depleted Uranium 0' information must be included)
CONDITIONS OF USE Expected w orking life of the source / des ice (y ears, operations)
K g,t pinrAs L ua4 g Li.
Actions to be taken when product reaches end ofits working life.
papwr g dry ey e/E ifu,f,c' licma s, f
j Maximum allow able temperature, vibration. shock, corrosion, etc. (during Gde-r? + ~4 A*Al/'*>C d - * * '-' N l use, handling, storage, and transport) d"d * # M
- O [d/"141 #*' * * * #
llow the desice will be used f.,,,a foe, /,m (/?g b,r, for L, or o/L t<e. Im ') , l Meets dose limits of Pan 32 for distribution general licensees or persons exempt from licensing g, O
PROTOTYPE TESTING /111STORICAL USE 1
Tests methods and conditions (for source and device) p, fov"/w"/ (* /Ps/c4 i Tests results o.k kwla - !
Years of use (incidents, failures, etc.)
bewo 'h Cs+/RJ A /M
- Similuities to other sources /desices if they are used as basis. eM
' i RADIA TION PROFILES fo 4yomt o. e r w dr./L. .
Suncy instrument used (type, window thickness, sensitisity, etc.) [g g,p )voo G,,,/ p 64 n V Conditions including environments, scatter (product in beam), and use of gurds and shields Distance from source / surface (per ANSI 538-1979) fin /. u , /2( d. M 3f" Shuner Open and Closed / Source Shielded gf4 ,
Verify radiation suiveys for y radiation meet inv law.
3 i
{ Verify radiation survey s for non-y radiation have not been calculated using inv2 law. '
M NUREG - ! $56, Vol. 3 C-4 l
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P a
E APPENDIX C i
CHECKLIST Registration Certificate Holder: be,NLt ~, k.
M::d:l: 3Soo2 DESCRIPTION OK/DEF COMMENTS QUALITY ASSURANCE Materials, subassemblies, services f)/ p f,w &f_ w w ave.A u , / , y m A .
I Assembly methods (screws. welding. ctc.) # rep /s /lo ci'3M 7*W#^
Dimensions and tolerances 4 y>2Ju "~ 8.5f A va vcu ,<4 pd,.li #M Activity, radiation levels, leak tests /) 4 wuf + 6/I We ou 4 QA Manual and comparison of manual to Regulatory Guide 6.9 INSTALLATION Fixed, portable, movable, thed installation but portable source housing fg CD Inherent shielding, inaccessibility y Beam access: size of air gap / opening to beam and uw of interlocks, locks, gys ( /ocr M/r A*8-2 4 additional shielding or barriers %,
Mounting integrity o.y h,4 m o p.,m c6 +g SAFETY INSTRUCTIONS Operation, maintenance, calibration, damage / failure, specific w arnings, leak test, and radiation surveys 0R faanged f vuo" ACCOMPANYING DOCUMENTATION Leak tests results and radmeys M o f s ptp i <
- J - 10)!cl A**~ v u, ax Transportation documents fisfA,o [.,wy 79p. A fe.<b*h #71#II'l j
Operation, maintenance, calibration, damage / failure, specine w arnings, leak
- M l test, and radiation sursey instructions if applicable l
For Distribution to General Licensees: g, i Verify NRC Regions and Agreement Stam listing is up-to-date and copies of / l di pertinent regulations l l
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I C-5 NUREG - 1556, Vol. 3 j L J
APPENDIX C i
CHECKLIST
_ _ _.._...- _ _ _ l Registration Certificate IIolder: As,4 A#s C'jde,s, /rr Mod:1: 3 9oo t (des) o.ny A in DESCRIPTION OK/DEF COMMENTS SERVICING The f llowing activities may be performed by the persons indicated:
Activity by a General Only by a Will be OfTered Licensee Specific Licensee by the Applicant Installation 70 $11 qe e f . /
/fe) & d,eu Relocation Maintenance h Repair f, Source Exchange ,,
Calibration Leak Testing f/#44,c/
Radi: tion Survey y 1
Training FOREIGN VENDORS Drop ship Who and where is source installed f f /[
Leak test and radiation suneys
/ V[ [l QA in the U.S. ,j- _
l NUREG - 1556, Vol. 3 C-6