ML20211G977
| ML20211G977 | |
| Person / Time | |
|---|---|
| Site: | 07105796 |
| Issue date: | 08/25/1999 |
| From: | Rawl R J.L. SHEPHERD & ASSOCIATES |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| References | |
| REF-PT21-99 NUDOCS 9909010087 | |
| Download: ML20211G977 (14) | |
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1010 ARROYO M, $AN FERNANDO. CAUFORNIA 91340-1822 818-898-2361 FAX 818-361-8095 August 25.1999 Document Control Desk U.S. Nuclear Regulatory Commission Washington. D.C. 20555 NRC Operations Fax: 301-816-5151 13 Paees
Reference:
10 CFR Part 21 - Reporting Defects and Noncompliance Originally reported July 28.1999 JI.S&A's first response. per 10CFR71.95.
l On July 26.1999 J.L Shepherd and Associates (R.S&A) received a report of non-compliance from the Atomic Energy Control Board (AECB), the Canadian Competent Authority, indicating that the Certificate of Compliance (COC) Package 5796. Package Model 181361 did not meet t'
the criteria of the cenificate. According to the AECB inspection on March 29.1999 the i
Picker /AMS Model 181361 package JLS&A shipped to Canada under an Canadian re-endorse-i ment of the current certificate did not have 2 each thru rods and the 4 lifting cyes were located on g
each side, rather than 2 cyes on 2 sides.
t On receipt of the Canadian report of noncompliance, JLS&A immediately removed the packages from service. notified the U.S. Nuclear Regulatory Commission (NRC) and started an investiga-tion into why the package shipped to Canada did not seem to meet the current certificate specifi-cations.
JLS&Ns preliminary inspection confirmed that the COC 5796. Model 181361 did not have thru rods and the lifting eyes were one on each side rather than 2 on 2 sides. Since R.S&A had purchased the package as a Picker /AMS 3ackage and subsequent conversations with long-time
' 9 ll users of the package indicated that the pac cage as shipped was an original Picker package design (Picker having been the original certificate holdcr and AMS the second certifica:e holder) or an earlier version of the AMS package, an investigation was instituted to review the package history to determine if the original package and subsequent package revisions by both companies had ever been pulled from use mvalidated or if they were grandfathercrd into the current certificate.
lirief History of JLS&A's Package involvement:
JLS&A purchased this Picker /AMS package in 1991 from RTS/X-Ray Equipment Co. X-Ray, which subsequently merged with RTS was registered user of the certiticate since February 26.
1985. The NRC & DOT Certificates from 1985 that JLS&A received did not reference or in-I elude drawings of the 18136I package (see copy enclosed).
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9909010087 990825 PDR ADOCK 07105796 C
Reference:
10 CFR Pan 21 Rcponing Defects and Noncompliarice Originally reported July 28,1999 JLS&A's first response, per 10CFR71.95.
August 25.1999 Page 2.
On January 27.1993 (DOT) and on June 8.1993 (NRC; JLS&A became a registered user of the certificate. Rev.13, again neither certificate referenced or included drawings (see copies en-closed). In 1993. JI.S&A was performing a source decommissioning program ihr AMS. AMS shipped several of this identical package (the subject of the nonconformances to the current cer-titiente) as a COC 5796 to JLS&A via the hot cell facility at Southwest Research Institute.
JLS&A QA inspectors performed a detailed comparison of the AMS package to the package purchased from RTS/X-Ray in 1981 and found no discrepancies in the package design. It was then that JLS&A started refurbishment of the RTS/X-Ray package, so JLS&A could start using this package.
JLS&A then shipped the AMS package to another hot cell facility. General Electric Vallecitos (GE) which maintains a vigorous QA inspection program for incoming / outgoing packages. As a result of JLS&A shipping the package to GE, AMS instigated a NRC investigation, where to JI.S&Ns knowledge, no noncompliances were discovered. as no notices were issued to the regis-tered users (see copy of AMS letter to GF. enclosed). Please note that during this time. the NRC had also started an extensive investigation into the AMS facility in Cleveland. Again, to our j
knowledge. no noncompliances concerning the Model 181361 package were Ibund as no notices were sent to the registered users.
3 It was not until COC 5796. Rev.14 was issued by the NRC that drawings were incorporated (as they are in the current Rev.14, upon which the AECB letter of non-compliance is based) into the certiticate. Our research has discovered Rev. 2 to this Certificate, issued to Picker, references completely different drawings and/or drawing revision numbers than the current Scrtificate. as shown below.
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i Certificate 5796, Rev. 2 USA /5796/13(), exp.12/31/80 issued to Picker Corp,1020 London Rd.. Cleveland. OH Rev. 2, date unreadable.
181361 Dimensions: 39" x 39.5" x 48" Rev.13,12/16/92 18161 Dimensions : 39" x 34.5" x 44.5" l
Max. wt. same for both: 4000 lbs.
Certificate issued to Picker - on 11/30/80 AMS is a registered user only.
Both COC 5796, Rev.'s 13 and 14, clearly state that "U.*e of packaging fabricated after August 31.1986, is not authorized." There is no indication that revious (older and non-identical) ver-sions of either the Picker of AMS package design have ban restricted from use.
JLS&A has used this package in good faith. based upon direct and detailed comparison of our packaged purchased from RTS/X-Ray Equipment Co. (a registered user with a NRC Part 71 QA program) tn 1991 with the AMS packages (the current certiticate holder with a NRC Part 71 QA program) shipped under this certificate in 1993, the subject of 1993 NRC investigations without notitiention that the package was invalid. and the lack of drawings attached to the certificate under which we became a NRC registered user. We acknowledge that we did not compare our package to the ecrtificate drawings issued with Rev.14.
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Reteetch and species Programs Administrolloa FEB 26 E X-Ray Equipment Company Ai1N: Omny M. Pebhody P.O. Rcx 2411.
F ort Worth, TX 76101 Dnur Mr. Peshody:
As requested, ycur company has been registered as a user of IAEA Certificate of Competent Authority USA /$796/d().
Enclosed is a copy of the ecrtificate.
Sincerely, I
b Richard R. Rawl Chief, Radioactive Matorla!s Branch Office of Hat.ardous Materls!s t
Regulation p
Materials Transportation Bureau
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"' ** * W J AD CERTIFICAir OF CCtM.'IT2d Alf!HoruTY Spedel Progroms Admiol6'trafson g,b bdimetiw t'aterial Package Design Certificate Norber UsiV5796/B(U)T (Fevision 6)
This 6At.4bitshes tJnt the packaging desig78 descritel berein, wrtti loade,d with the aut}crized radioactive contents, have been certified by tJw Mtic:ul Q'intetent A.tCv.,rity of the United States, As r:reti.ng the regulatory require-l tents fcer. Type B packag.ng fer radicoctiw mtcrials as prescribed in IAEA 1/
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1+yalat ions and S S 49 CFF 173. 393 b, 173. 394 (c) (2) and I? 3. 395 (c) (2) of the ~
i U$iA 2/ k gulationi for the trans[ ort of radicactive Ntcridis.
1.
Packago Identification - Podels Nos: 181375 and 181361.
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II.
Pi.sckaging Description - Packaging authorized by this certificate consists of an cr/cipacF."T. hat provTJes irpact ard therm 1 protection for teletherapy head asser61ies or source cxchange asserblies. The cubical overpacks are corustructed frcr.i 2" by 4" mpic panels bolted tesether and covered with 16 gage steci panels with opening limitir.g steci straps and angles. Model 181375 is ar.oroxinutely 44" x 40" x 41" with a gzurs weight of 3750 pounds and Madel 181361 is apprcximsely 39" x 34 x 45" with a gross weight of 4000 pourds.
III. Authorized Padioactive Cor. tents - Tne authorized contents mnsist of CoholT-60 as special fom limited to a rnaxinun of 13,680 curies and a decay heat icod of 200 watts or Cesiu::r 137 in either special fonn or in sealed capsules constructsd and inspected in accordance with Picker Corporation i
ictter dated Janur_ry 4,1980, with a miwinun loading of 2,200 curies ard a decay heat load rct to exceed 17 watts.
4 All sources nust be of a design which has been tested and' deronstrated O
to be leak tight to a sensitivity of 1xly5 atm-cc/ soc or less.
IV. _Cc,neral Conditions -
a a.
Each user of this cortificate nust have in his possession a epf of this cerLificate.
12.
lach user of this certificate, otler than Advanced Wdical systats, Inc.
Cleve3ard, Ohio, s' il register his ' identity in writing to tre office.
m of M7.ardcus mtcrials P43ulation, Mate. rials Transportation Bureau, U.S. IA ptrtnent of ".Tansportation, Washington, D.C. 20590.
c.
This certifieste dces not roldeve any consignor or c+.rrier frcm em I liane.? with.any regirerrnt. c.f the Covemacnt of any country throu;h or into which the package is to be transpcrted.
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'l Page 2 - Certificate No. S796 - Revision No. 7 - Docket No. 71 5796 t
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(b) Contents (1)
Tyoe and form of material (i) Cobalt.50 scaled sources that meet the. requirements of special form as defined in 10 CFR 171.4(o); or (ii) Cosium.137 in the form of cesium chloride encapsulated in sealed sources that meet the requirements of special fonn as defined in 10 CFR $71. A(c), or in sealed sources construc ted and inspected in accordance with Picker Corporation letter dated January 4, 1980.
(2) Maximum quantity of material per package (1) 13,680 curies of Cobalt-60 with a radiosctive decay heat load not to exceed 200 watts; or (ii) 2,200 curies of Cesium-137 with a radioactive decay heat load not to exceed 17 watts.
6.
The packages authorized by this certificate are bereby aporoved for use under the general license provisions of 10 CFR 571.12(b).
i 7.
Expiration date:
July 31. 1987.
3 REFERENCES Advanced Medical Systems, Inc. application dated February 26, 1982.
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Supplemant dated: tiay 18,1982.
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~X FOR TWE U.S. NUCLEAR REr,ULATORY COMMISSION
.$1 Original S t sne d by
- 3 OLAA!.ES I. MAcconA2.0
%l, Charles E. MacDonald, Chief Transportation Certification Branch Division of Fuel Cycle and Material Safety h>
a a mz Date:
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T I*'* NA"eCla s NUCLE A2 Cf Gut AT02Y cos Aut*.'.df4
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eppt.e ation-l Advanced Medical Systems, Inc.
Advanced Medical Systems, Inc. application 1020 Londen Road dated February 26,19t!2, as supplenented.
Cleveland, OH 44110 3.tci ooe, no.
71-5796 e co 4omous T his serir* ute as mslisannel wang the twililt.r'D of the requirem.vse of Svtspett D O' If' Cr 81 11. as WD'iutle. erw$ the toetlitsons spe<lfsed la item 5 tieto-o.w,.....e r,c. 9,ne.no 4..ri,.o coni.ni. ueo.t woe e. am.a. cieu. eine co u a,on..,,- r<,ve, ac..
(a)
Packaging M'
(1) Model Nos.:
181375 and 181361
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3*hl (2) Description 1.. a Overpacks that provide impact and thennal protection for teletherapy iM head assemblics or source exchange assemblies.
The cubical overpacks j'y consist of laminated 2xa hardwood maple panels bolted tooether and 44 covered with 16 gage steel panels. Reinforcinq steel straps and W.:?
angles are welded together and spaced to limit the openings between
%'M them to less than 6 inches. Skid runners are orovided to facilitate
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fork lift usage.
Dimensions of the Model No. 181375 are 43.5"Lx39.75"Hx0 with a maximum gross weight of 3,750 pounds.
Dimensions of the Model +f!
N 8136 e 39"Lx34.25%44.5"H with a maximum gross weicht of
$d i
(3) Drawinos 9
(1) The Model No. 181375 packaging is constructed in accordance with y Advanced Medical Systees, Inc. Drawing Nos. as specified in
.h 1
Section 1.3.1 (p 1-8) of the application.
l (2)
The Model No. 181361 packagingisconstructedinaccordancewith.if' i
l Advanced Medical Systems, Inc. Drawing Nos. as specified in i.
1-Section 1.3.2 (p 1-9) of the application.
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Certificato Na der USA /5796/B(U)T, Bevision 6 Page 2 j
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This mrtifica*.rs is israe3 in ace.:tdance with the requirer ents of the IAEA arri USA }cgulations xd in tegor.se to the Ag.ist 10, 1982, petition bj Mvanced Medical syctere, Clevelard, Ohio, and in consideration of the I
associatct2 infcaration provided in U.S. Nuclear Pegulatory Ctr, mission CerLificate of Ctup)iece !b. 5796 and related corresgrdence.
Cescified by:
1 hl R. R. P&O
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(DATE)
Chief, Radioactive mterials Brarch Office of Hazardous teterials P.eg11ation Materials Trartvortation Bureau i'
t t
t 1/ " Safety Series No. 6, Peg 11ations for the Safe Transport of Radioactive Raterials,1973 Revised niition" published by the International Ateede Encrgy Agency (IAEA), Vienna, Austria.
2/ Title 49, code of Federal Pegulations, Parts 100-199, LEA.
Revision 3 assued to incorporate Ibv. 5 of USNmc certificate ib. 5796 aid to extend expirstion date.
l Revisien 4 issued to exterd e;<piration date.
Rt vision 5 issued to exterd emiraticn date.
Fevision 5 issual to incorparate Fevision 7 of USimC Certificate of l
C M liarco 16, 5795 a.-d tr. exterd expiration date.
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JtJN 1S '73 11:04 FROM GE V M ECITOS MJC CTR.
TO 5'ND PAGE.ael/agi Ad E.ed MecicalSystems, Ins.
' (2181 *as4Ef 7Ax(assi asectse June 10, 1993 General Electric Company ATTN: Mr. G. E. Cunninghas Vallecitos Nuclear Cancer P. O. Box 460, Vallecitos Read Pleasantor:. CA 945e6 RE: t!NAtTTHCRIZED USE OF ADVANCE 3 MEDICAL SYSTEMS SOURCE E.ICHANGE CONTAINER AND OViltPACK S/N 117 '
Dear Mr. Cunningham:
1'e were extremely concerned to learn, as the result of an NRC investigation. that C. E. Vallecitos had appropriated for its own use an AMS source exchange container and overpack that was not returned to us frem Southwest itesearch Institute.
The overpacks shipped to Southwest Research Institute were to be returned directly to,GS.
If you were interest =d in renting one of our source exchange containers. it would have been preferable for you to have contacted us directly rather than appropriating the container without our knowledge or consent.
Because of the long delay in the return of the other source excharige containers, we vill be contac-ing Southuest Research Institute for information regar-iing
't whether they were used for other purposes prior to their return.
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Please immediately return our source exchange container and overpack or a rental charge of 5100.00/ day, starting on May 1,1993, will be invoiced. You will be responsible for any dasage and all freight charges. We would also appreciate learning from you the reason for your appropriation of the source exchange i
container and overpack.
In the future, should you need to rent one of our overpacks for purposes in
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accordance with our Certificate of Cospliance, we would be happy to work with
-you, but would prefer that this be done beforehand.
Your prompt response is appreciated.
Very truly yours, g tax an8* #
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,%t.I A S. JL Stein I
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Di'rou ar of Regulatory Affairs f** *_
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.:f Form NRC.G1B U.S. NUCLE AA AEoVLATOMy COMMISSION 10 C 71 CERTIFICATE OF COMPLIANCE Foi hafuiuctive Materials P.ekayss
- 81) Certificaic Nument 1.tbl Revisn$n No.
1.{cl Pacapre identification No.
1,(d) Pages No.
5796 2
USA /5796/B( )
1 1, lei Tot 5 No. Pages i
- 3. Pnt AMBLE r
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2.ta t This sortwic, ate es issuari to satisf y Sections 173.393.173.39a.173.305. ano 173.3Afi of the Decartment nf Transportanon Nazarcous Meteriais Amyulations 140 CFft 170180 arul 14 CFR 1031 and seclions 1stl 19 10s and 14G-19-100 of the Datsurtment of a
Transportation Dungerous Caroo.r. negulations 146 Cr n 146 140), as emencers.
v
- 2. Ital The pockesing arut contents descriced in stent S tielow. meets tne safety saaridistds set fortn in Suitoari C of Title 10. cu,4e of Feoeral Hegulations. Part 71, "Packegang at Radionet ve Materials for Transport ene Tr n.curvation of Radioactive Materist Unce.
Certain Condetions."
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3.ict This certificate oo.s not relieve tne consianor frorn compliance nitn any reuuirement of the regulations ni the U.S cepertrnent of Transportalonn Or othes acolicable regulatory 3Denc'es. anclosing the gmgenment of any country tnrough or into which tne pact.ge will be transt:crted.
- 3. Tnis certificare is issued on tne basis of a safeiv snalysis recort of rue package desigri or sophentnin-3.las Prepared by (Nerne and addrea)-
3.Ibl Title and uJennification of report or apohsanon Picker Corporation Picker Corporation application dated 1020 London Road December 19, 1974, as supplemented Cleveland, OH 44110 3.tc)
Doemet No.
G. CONDITION 5 Vhle certificate is enarthional unun the fulfilling of the recuireneinrits ni Succart G r.' 10 Ce rt 71, as apolecants. and tne corsnia n specifiso in hem s u. sow.
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- 6. DCscription of Packen,60 and Authorited Contents. Model Numper. Fissile Class. Other Conditions, and Mete ences-a d
I (a) Packaging (1) Model Nos.: 181375 and 181361 (2) Description Overpacks that provide impact and tnermal protection for teletherapy head assemblies or source exCnange assemblies. The cubical overpacks consist of laminated 2x4 hardwood maple panels bolted togetner and covered with 16 gage steel panels. Reinforcing steel straps and angles are welded together and spaced to limit ene openings between them to less than 6 inches. Skid runners are provided to facilitate fork lift usage. Otmensions of the liedel No. 181375 are 37"x40"x41" with a maximum pross weight of 3,325 pounds. Dimensions of the tiodel No.181361 are 39"x39.5"x 48" with a maximum gross weight of 4,0n'1 pounds.
(3) Drawings The packagings are constructed in accordance with the following Picker Corpora tion Drawing Nos. :
(1) Model No. 181375: 0-18375, P,ev. ri: C-181368, Rev. B; D-181369.
Rev. B; and C-55156. Rev. B, with teletherapy neads Drawings Nos.t D-63790; C-46879, Rev. C; D-184713; B-184704; D-16424-E. Rev. D; D-16423B, Rev. F; and B-T6DA-547.
32
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l Page 2 - Certificate No. 5796 - Revision No. 2 - Docket flo. 71-5796 l
l 5.
-(a) Packaging (continued)
(3) Drawings (continued)
(ii) Model No. 181361: 0-181361, Rev. D; C-181357, Rev. D;
' C-181356, Rev. 0; B-181390, Rev. A, with source exchange assembly Drawing Nos.; D-T60-478; B-13708-A; B-37092-A, Rev. C; C-13707-A, Rev. C: 8-14241A; D-T60-558; and C-13709A or C-137098.
(b) Contents (1) Type and. form of material (i) Cobalt-60 sealed c,ources that meet the requirements of l
special form as defined in $71.4(o) of 10 CFR Part 71.
)
The sources are to be packaged in secondary inner con-tainers as described in 5(a)(3)(1) or 5(a)(3)(ii)
Drawing Nos.
(ii) Cesium-137 in tne form of cesium enloride encapsulated in sealed sources that meet the requirements of special form as defined in $71.4(o) of 10 CFR Part 71 or it.'
sealed sources constructed and inspected in accordance with Picker Corporation letter dated Januarv 4,1980.
, The sources are to be packaged in secondary inner ' con-tainers as described in 5(a)(3)(ii) Orawing Nos.(
(2) Maximum quantity of material per package i
(i) For the contents described in 5(b)(1)(1).
13,680 curies, witn a radioactive decay heat load not to exceed 200 watts.
(ii) For the contents described in 5(b)(1)(ii).
2,200 curies, with a radioactive decay heat load not to exceed 17 watts.
1 6.
The packages authorized by this certificate are hereby approved for use under the general 1 fcense provisions of 10 CFR $71.12(b).
7.
Expiration date: December 31, 1980.
33
Page 3 - Certificate No. 5796 - Revision No. 2 - Docket No. 71-5796 REFERENCES Picker Corporation application dated December 19, 1974.
Supplement dated: October 17,1975; May 29 and August 15, 1979; and January 4,19M.
J FOR THE U.S. NUCLEAR REGULATORY COMMISSION l
MJAu Y Charles E. MacDonald, Chief Transportation Certification Branen Division of Fuel Cycle and Material Safety Date:
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Reference:
'10 CFR Part 21 - Reporting' Defects and Noncomplian'ce Originally reported July 28,1999
. JLS&A's first response, per 10CFR71.95.
August 25.1999 Page 3.
Lll.S&A has requested from the NRC Public Document Room copics of all the previous NRC submittal packagesisubmitted by both Picker and AMS. to derernune if the version of the pack-age we have been using is or ever was valid, ifit had ever been rescinded and ifit is incorporated by default into the current certificate by virtue of the AMS " consolidated" upplication. As of writing this letter. the document room is still searching for this information. A further respmse date to this apparent noncompliance is unknown and will be determined when we receive mfor.
mation (or lack thereof) from the NRC Public Document Room. We will continue to maintain the current status of this package: i.e. Removed from Service, until the non-compliance issues are resolved with the NRC. NMSS. Transportation Section.
Sincerely yours.
J.l.. Sill:PliliRD AND ASSOCIATES
$.
- L [ 0 * 'R, v
Mary F. Shepherd Vice President
\\. -
1 CC: S. Faille. A!!CB j
OkOWI999 U.S. Nuclear Regulatory Commission Oper:tions Center Event Report Page1 l.
Oth;r Nucl:ar Mat:ri21 Event #
35970 a
Rep Org: JL SHEPHERD & ASSOCIATES Notification Date / Time: 07/28/1999 19:17 (EDT) l Licensee: JL SHEPHERD & ASSOCIATES Event Date / Time: 07/26/1999 00:00 (PDT)
Last Modification: 08/25/1999 l
Region: 4 Docket #:
i City: SAN FERNANDO Agreement State: Yes County:
License #:
State: CA I
NRC Notified by: J.L. SHEPHARD Notifications: BILL JONES R4 l
HQ Ops Officer: JOHN MacKINNON VERN HODGES, FAX NRR Emergency Class: NON EMERGENCY 10 CFR Section:
1 21.21(c)(3)(i)
DEFECTS / NONCOMPLIANCE 1
l PACKAGE APPEARED NOT TO BE CONSTRUCTED IN ACCORDANCE WITH DESIGN CERTIFICATE.
J.L. SHEPHERD AND ASSOCIATES HAS A USNRC APPROVED QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES, NUMBER 0122, REVISION 5, EXPlRATION DATE 01/31/2001. J. L.
SHEPHERD & ASSOCIATES RECEIVED NOTIFICATION OF NONCOMPLIANCE OF ONE OF THEIR PACKAGES FROM THE ATOMIC ENERGY CONTROL BOARD (AECB), OTTAWA, ONTARIO, CANADA BY 1
LETTER ON JULY 26,1999.
J. L. SHEPHERD & ASSOCIATES IMMEDIATELY REMOVED ALL THESE TYPES OF PACKAGES FROM SERVICE ON JULY 27,1999 AND WILL NOT USE THEM FOR TRANSPORTATION OF RADIOACTIVE MATERIAL UNTIL THE QUESTION OF NONCOMPLIANCE HAS BEEN RESOLVED.
A WRITTEN REPORT ON THE NONCOMPLIANCE WILL BE FORWARDED TO THE USNRC WITHIN 30 DAYS OF THIS NOTIFICATION.
- *
- UPDATE AT 2300 EDT ON 8/25/99 BY MARY SHEPHERD TO FANGIE JONES * *
- A f2xed update with additionalinformation was received by the Operations Center which includes copies of certificates for the packages described. These packages are still removed from service, until the non-compliance l
issues are resolved.
I Ths HOO notified the R4DO (Phil Harrell) and NMSS (Kevin Ramsey).
J