ML20141A478
| ML20141A478 | |
| Person / Time | |
|---|---|
| Issue date: | 06/12/1997 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | GENERAL, OHIO, STATE OF, OKLAHOMA, STATE OF, PENNSYLVANIA, COMMONWEALTH OF |
| References | |
| CAL, SP-97-044, SP-97-44, NUDOCS 9706230028 | |
| Download: ML20141A478 (9) | |
Text
., e ALL AGREEMENT STATES l OHIO, OKLAHOMA, PENNSYLVANIA JUN 121997 l l
TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFORMATION (SP-97-044) I 1
Your attention is invited to the enclosed correspondence which contains: l l
lNCIDENT AND EVENT INFORMATION.. ...... l l
PROGRAM MANAGEMENT INFORMATION...
TRAINING COURSE INFORMATION.. . ... .. .
TECH NIC AL IN FORM ATIO N... .... ..... .... ....... ;
1 OTH ER I N FO R M ATI O N. . . .. . . . . . .. . . . . . .. ... . . . . .. . .. X X CONFlRMATORY ACTION l LETTER TO AMERSHAM l CORPORATION l CONCERNING l TRANSPORTATION PACKAGE TESTING l Supplementary information: Enclosed for your information is a Confirmatory Action Letter l sent to Amersham Corporation on June 10,1997. The letter identifies NRC concerns with the adequacy of transportation package tests and Quality Assurance Program implementation under the provisions of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material." It also identifies actions to be taken by Amersham which includes, I as specified in item (3) on page 2, notification to all users of Amersham packages.
If you have any questions or comments regarding this letter, please contact me or the individual named below.
POINT OF CONTACT: Tom O'Brien TELEPHONE: (301) 415-2308 FAX: (301) 415-3502 INTERNET: TJO@NRC. GOV MMN RfCHARD L BANGART Paul b ohaus, Deputy Director Office of State Programs
Enclosure:
As stated Distribution:
DlR RF DCD (SP03) f l
SDroggitis PDR (YESf_ NO_)
1 Agreement State File l
FAXED TO STATES: 6/12/97
! DOCUMENT NAME: G:\TJO\ SP97044.tjo
{ To recdve a copy of this document. Indicate in the bos: "C" *( p thout attachment /enclosurp *E' = Copy with attachment / enclosure "N" = No copy OFFICE VSP , , l OSPiuf/ OSP:y/4, l NAME TJO'Brien:nb[ the PHLoha) slot RLBangartVi d DATE 06/ ll /97 06/ ' '
/97 06//p/97 OSP :lLE CODE: S P- A-4 9706230028 970612 b PR h$ hk & WW
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wou i y 9s UNITED STATES
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NUCLEAR REGULATORY COMMISSION j o WASHINGTON, D.C. 20665-4001 4
e j 4m.. June 12, 1997 a
f i ALL AGREEMENT STATES
.: TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFORMATION (SP-97-044) l Your attention is invited to the enclosed correspondence which contains: I INCIDENT AND EVENT INFORMATION.........
PROGRAM MANAGEMENT INFORMATION...
j TRAINING COURSE INFORMATION., ..........
i l TECHNICAL INFORM ATION........................ ;
l l OTH E R IN FO R M ATIO N.. ... . .... . ........ .. . ........ . X X CONFIRMATORY ACTION j LETTER TO AMERSHAM l CORPORATION f CONCERNING i TRANSPORTATION PACKAGE TESTING Supplementary information: Enclosed for your information is a Confirmatory Action Letter sent to Amersham Corporation on June 10,1997. The letter identifies NRC concerns with the adequacy of transportation package tests and Quality Assurance Program implementation under the provisions of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material." It also identifies actions to be taken by Amersham which includes, as specified in item (3) on page 2, notification to all users of Amersham packages, if you have any questions or comments regarding this letter, please contact me or the individual named below.
POINT OF CONTACT: Tom O'Brien TELEPHONE: (301) 415-2308 FAX: (301) 415-3502 INTERNET: TJO@NRC. OV
[( 47 4 ( M7M l Paul H. Lohaus, Deputy Dir ctor Office of State Programs
Enclosure:
As stated
~ . . _ . .
. _ _ _ _ _._ .._ . . _ _ _ . . - _ .__ _ . _ __ _ _._ .._.. ___ _.._,m. ___ __ __m_.
1- .. ..
pn Mou eo 4 UNITED STATES j ,j NUCLEAR REGULATORY COMMISSION
'f WASHINGTON, D.C 20555 0001
/ June'10, 1997 3
i l
CAL No. 97-7-005 l
' Amersham Corporation j ATTN: Mr. William M. McDaniel Facility Manager 40 North Avenue 1 i- Burlington. MA 01803 i
l
SUBJECT:
- CONFIRMATORY ACTION LETTER l l !
i
Dear Mr. McDaniel:
I l On June 4-6. 1997. U.S. Nuclear Regulatory Commission staff conducted an.
l inspection at Amersham Corporation, in Burlington.. Massachusetts. Amersham
- Corporation has a Quality Assurance Program approved by the NRC under the provisions of Subpart H of 10 CFR Part 71 (Docket No. 71-0040). Amersham i Corporation is also the holder of several NRC Certificates of Compliance for i
transportation packages. The inspection was related to testing under 10 CFR Part 71.
j The inspection identified problems regarding testing performed for j hypothetical accident conditions under 10 CFR Part 71.73, including:
i a) whether the steel puncture bar was properly mounted on the test pad:
l 'b) whether the condition of the drop test pad used for the tests constituted l an essentially unyielding surface: c) whether free-drop tests were performed
- in the most damaging orientation
- d) whether puncture tests were performed in
- the most damaging orientation and, e) whether the test conditions and results i were accurately and fully recorded, assessed, and reported to the NRC.
l
{ The problems we identified with the conduct of your test program call into j question the adequacy of the tests performed in support of Amersham's
, transportation package designs. Further, we are concerned that the
! implementation of your Quality Assurance Program did not disclose those j problems.
1 i
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4
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l W. McDaniel- For the reasons stated above, and pursuant _to telephone conversations between you and Dr. Susan Frant Shankman on June 9 and June 10. 1.997, it is our
)
l understanding that you will take the following actions which will be completed ,
by the dates specified: I (1) Effective immediately, suspend fabrication of all NRC-certified L transportation packagings, until you receive authorization to resume i from the NRC.
(2) For all Amersham packages that are certified by the NRC. justify why there are no immediate health and safety concerns regarding the continued use of the packages. This action will be completed and submitted to the NRC by June 16. 1997.
(3) Prepare a notice to all users of Amersham packages notifying them of l the following: a) the questions that were raised by NRC regarding the l packages: b) that retesting will be performed; and, c) any administrative controls that the users should take prior to completion of Amersham's retesting. This notice will be issued by June 16, 1997.
(4) Have an independent assessment performed of the drop test pad that was used in the testing program. The report from this independent assessment will be submitted to the NRC by June 16, 1997.
(5) Prepare detailed test plans and procedures for the packagings that will be retested. Amersham will obtain the services of an independent testing expert to assure that the proposed testing, acceptance criteria, and post-test examinations will be in accordance with the requirements of 10 CFR Part 71. The name and qualifications of the expert will be sent to the NRC by June 16, 1997 for review and approval. The test plans and procedures will be developed and submitted to the NRC within 30 calendar days after NRC approval of the expert. Following submittal of the plan and procedures. Amersham will meet with the NRC to discuss the details of the testing. Retesting will not proceed without agreement from the NRC.
(6) Conduct retesting of Type B transportation packages to demonstrate l that the designs meet the requirements of 10 CFR Part 71. Models to De tested include the 660 . series. 650 series. 650L. 702, 676. 680.
715, 920 and other appropriate packages. The retesting will be performed utilizing a puncture bar that is mounted on an essentially unyielding surface. Amersham will propose the priority for retesting these designs, considering such factors as number of existing units 1
l W. McDaniel i and estimated frequency of shipments. A schedule of proposed testing.
with dates, will be provided to the NRC upon completion of item number l 5 above. Amersham will give NRC two days notice prior to each test.
- All testing will be completed by not later then six months from NRC approval of the test plan in item number 5. above.
(7) Develop a plan to modify the Amersham Quality Assurance Program for Transportation to assure adequate packaging design and testing. This plan will be submitted to the NRC by June 23. 1997.
(8) Preserve all packaging, components. specimens, and records from testing performed on NRC-certified package designs. Amersham will not perform any tests on or modifications to test specimens.
You will also:
(1) Notify me immediately if your understanding differs from that set forth above; (2) Notify Mr. William Kane_. Director. Spent Fuel Project Office. if for any reason you cannot complete the actions within the specified schedule and advise me in writing of your modified schedule in advance of the change; and (3) Notify me in writing when you have completed the actions addressed in this Confirmatory Action Letter.
Issuance of this Confirmatory Action Letter does not preclude issuance of an order formalizing the above commitments or requiring other Certificate-holder actions: nor does it preclude NRC from taking enforcement action for violations of NRC requirements that may have prompted the issuance of this letter. In addition, failure to take the actions addressed in this Confirmatory Action Letter may result in enforcement action.
In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice." a copy of this letter and your response will be placed in the NRC Public Document Room (PDR). To the extent possible, your response should not include any personal l
privacy, proprietary, or safeguards information, so that it can be placed in j the PDR without redaction. If personal privacy or proprietary information is j necessary to provide an acceptable response, then please prcvide a bracketed l copy of your response that identifies the information that .<,hould be protected and a redacted copy of your respon w that deletes :uch infcrmation. If you
, request withholding of such material, you must specifically identify the l
l
I W. McDaniel portions of your response that you seek to have withheld and provide in detail i d
the bases for your claim of withholding (e.g., explain why the disclosure of ;
, information will create an unwarranted invasion of personal privacy or provide j the information required by 10 CFR 2.790(b) tc support a request for with- ;
.l holding confidential commercial or financial information). If safeguards I information is necessary to provide an acceptable response please provide the !
- level of protection described in 10 CFR 73.21. l
- Sincerely.
b
- [ Carl J. Paperiello. DirectoTyg.)
Office of Nuclear Material Safety and Safeguards l l
cc: R. Hallisey. State of Massachusetts ,
A. Roberts. Department of Transportation l
Dockets 71-0040, 71-9029. 71-9033
j l
U. S. NUCLEAR REGULATORY COMMISSION OFFICE OF STATE PROGRAMS t
OFFICE OF STATE PROGRAMS FAX: (301) 415-3502 l
NUMBER OF PAGES: 6 including this page .'
l 1
DATE: JUNE 12,1997 l
l TO: RADIATION CONTROL PROGRAM DIRECTORS IN l AGREEMENT STATES, OHIO, OKLAHOMA, PENNSYLVANIA NRC REGIONAL STATE AGREEMENTS OFFICERS NRC REGIONAL STATE LIAISON OFFICERS l
FROM: PAUL H. LOHAUS, DEPUTY DIRECTOR OFFICE OF STATE PROGRAMS
SUBJECT:
SP-97 044 CONFIRMATORY ACTION LETTER TO AMERSHAM CORP. CONCERNING TRANSPORTATION PACKAGE TESTING l
VERIFICATION - 415 3340 l
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< TRANSACTION REPORT > 06-13-1997(FRI) 01:25 C ESRO ADC A ST J NO. DATE TIME DESTINATION STATION PG. DURATION MODE RESUL.T 32613 6-12 23:52 610 337 5324 6 O*02'49' PORti. E OK 32614 23:55 404 562 4955 6 O*02'53" NORt1.E OK 32615 23:59 7085151096 6 O'05'29" NORt1. E OK 32616 6-13 00:05 817 860 8122 6 O*02'46' NORM.E OK 32617 00:08 5109750381 6 O*03*04" NORM.E OK 32618 00:11 334 613 5387 6 O*05'07" NORM.E OK 32619 00:16 6024370705 6 O'03'45* NORMAL OK 32620 00:21 5016612468 6 O*03'07" NORM.E OK 32621 00:24 0111916 3243610 6 O*02'48" NORt1.E OK 32622 00:27 303 343 36G7 6 O*03*00" NORM.E OK 32623 00:30 904 487 0435 6 O'02'55* PORM. E OK 32624 00:35 217 524 4724 6 O*02'53' NORM.E OK 32625 00:38 515 242 6284 6 O*02'50' NORt1.E OK 32626 00:41 913 296 0984 6 O*03'07* NORt1.E OK 32627 00:45 502 564 6533 6 O*02'47' NORM.E OK 32628 00:49 t1AINE 6 O*03'50" NORt1AL OK 32629 00:53 410 631 3198 6 O*O3'02" NORMAL OK l 32630 00:57 601+354+6167 6 O'03'52' NORt1AL OK I 32631 01:01 402 471 9449 6 O*O2'48" NORM.E OK !
32632 01:04 7026875751 6 O'03'54* PORT 1AL OK 32633 01:08 603 225 2325 6 O*02'54" tORti. E OK l 32634 01:12 5058271544 6 O*03'49' PORf1AL OK !
32635 01:16 518 458 6434 6 O*02'51" tORM.E OK l 32636 01:19 919 571 4148 6 O*02'51' NORM.E OK 32637 01:22 701 328 5200 6 O*02'46" tort 1. E OK 150 1*21'57*
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l < TRANSACTION REPORT > 06-13-1997(FRI) 02:41 l
E BROADCAST 3 l
l NO. DATE TIME DESTINATION STATION PG. DURATION MODE RESULT l 32638 6-13 01:26 503 731 4081 6 O*O2*45" NORM.E OK l l 32639 01:29 401 277 2456 6 O*O4'58' NORM.E OK i l
32640 01:34 8037377412 6 O*02'51" NORM.E OK l 32641 01:37 615 532 7938 6 O*02'51" NORM.E OK i 32642 01:40 5128346708 6 O*03'04" NORM.E OK I 32643 01:44 801 533 4097 6 O*03*18* NORM.E OK 32644 01:47 360 753 1496 6 O*O2*45* NORM.E OK I 32645 01:50 518 457 2225 6 O*02'51' NORM.E OK 32646 01:54 518 457 5545 6 O'03*06* NORM.E OK 32647 01:57 NEW YORK CITY 6 O*02'52" NORM.E OK j 32648 02:00 502 227 7862 6 O*03'11" NORMAL OK I 32649 02:04 AEC8 (613) 995-5086 6 O'03'00* NORt4AL OK 32650 02:07 WASHINOTON DC 6 O*02'46" NORM.E OK i 32651 02:10 7996726 6 O*02'48" NORM.E OK I 32652 O2:14 217 782 1328 6 O'03'17* NORM.E OK l
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1 32653 02:17 512 239 6362 6 O'02'55" NORM.E OK l 32654 02:20 4024714840 6 O'03*43- NORMAL OK i 32655 02:24 6 O*03'06" NORMAL OK I 32656 02:40 912 262620)
GEORGIA 314Q 'Ob h ['/ O UOOO '
32657 02:4i LOUISI ANA (1#) Q O UOOO 108 O'56'07* l l
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< TRANSACTION REPORT >
06-13-1997(FRI) 14:24 !
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C TRANSMIT 3 l
NO. DATE TIME DESTINAT!ON STATION PG. DURATION MODE RESULT 32665 6-13 14:21 LOU!SIANA j 6 O'03*12* NORr1.E OK 1 l
k/y 6 O*03'12-1 l
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< TRANSACTION REPORT > 06-13-1997(FRI) 07:37 E BROAOCAST 3 NO. DATE TIME DESTINATION STAJ10N ,
PG. DURATION MODE RESULT 32658 6-13 07:24 404 362 2653 6 O*02'49' NORM.E OK
( 326S9 07:37 LOU!S!ANA M 7 h'V O UOOO 6 O*O2'49" l
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< TRANSACTION REPORT > 06-12-1997(THU) 15:31 C BROADCAST 3 NO. DATE TIME DESTINATICN STATION PG. DURATION MOOE RESULT 32544 6-12 15:18 OHIO 6 O*02'54" NORM.E OK l 32545 15:22 PENNSYLW.t41 A 6 O*02'48' NORM.E OK l 32546 15 25 405 271 6425 6 O'02'44* NORM.E OK I 32547 15:28 6177272098 6 O'03*05" NORM.E OK
, l 24 O*11'31" l I
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< TRANSACTION REPORT > Oe_12_1927< Tan 1s:37 l
C TRANSMIT J NO. DATE tit 1E DESTINATION STATION PO. DURATION t100E RESULT
, 32549 6-12 15:34 NYSERDA 6 O'03'19" NORt1AL OK 1
]gg 6 O*03'19*
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