ML20128E227
| ML20128E227 | |
| Person / Time | |
|---|---|
| Site: | University of Missouri-Columbia |
| Issue date: | 12/02/1992 |
| From: | Davis A NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20128E210 | List: |
| References | |
| EA-92-170, NUDOCS 9212080026 | |
| Download: ML20128E227 (3) | |
Text
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NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY University of.Missodri Docket No.
50-186 Missouri University Research Reactor License No.
R-103 EA 92-170 During an NRC inspection conducted from S2ptember 3-4,
- 1992, violations of NRC requirements were identified, In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," 10 CFR Part 2, Appendix C, the Nuclear Regulatory Commission proposes to impnse a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act), 42 U.S.C.
2282, and 10 CFR 2.205.
The particular violations and associated civil penalty are set forth below:-
10 CFR 71.5(a) requires that'a licensee who transports-licensed material outside the confines of its plant or other place of'use, or who delivers licensed material to a carrier for transport, comply with the applicable requirements of the regulations appropriate to the mode of transport of the Department of Transportation (DOT) in 49 CFR Parts 170 through 189.
49 CFR 172.203 (d) (1) (iii) requires that the description for a shipment of radioactive material must include the activity contained in each package of the chipment in terms of curies, millicuties or microcuries.
49 CFE 172.403(a) and (g)(2) require in part that the activity of each package of radioactive-material must be entered on the radioactive label, unlesa the package in excepted from laoeling.
1.
Contrary to the above, on July 27, 1992, tlua licensee delivered a package containing 0.482 curies of holmium-166 L
to a carrier for transport to Dow Chemical ^ Company in-l Freeport, Texas with the description on the shipping papers I
dnd the radioactive Jabel stating that the shipment L
contain'ed 0.0183 curies of holmium-166, and the package was i
not excepted-from labeling.
2.
Contrary to the above, on July 27, 1992, the licensee delivered a package containing 0.0183 curies of holmium-166 to a carrier for transport to the University of Texas, M~.
D.
Anderson Cancer Center, Houston, Texas with the description L
on the shipping papers and the radioactive label stating L
that the shipment contained 0.482 curies of holmium-166, and' the package was not excepted from labeling.
This is a Severity. Level III problem (Supplement V).
Cumulative Civil Penalty - $625 (assessed equally between the two violations).
920,18G026 921202 PDR AC3CK 05000186
-O PDR 6
-2 Pursuant to the provisions of 10 CFR 2.201, University of Missouri (Licensee) is hereby required to submit a written statement of explanation to the Director, Office of Enforcement, U..S.
Nuclear Regulatory Commission, within 30 days of the date of this Notice of Violation end Proposed Imposition of Civil Penalty (Notice).
This reply should be clearly marked as a " Reply to a Notice of Violation" and should include for each alleged violation:
(1) admission or denial of the alleged violation, (2) the reasons for the violation if admitt(3, and if denied, the reasons why, (3) the corrective steps that have been taken and the results achieved, (4) the corrective steps that will be taken to avoid further violations, and (5) the date when full compliance is achieved.
If an adequate reply is not received within the time specified in this Notice, an order or a demand for information may be issued as to why the license should not be modified, suspended, or revoked or why such other actions as may be proper should not be taken.
Consideration may be given to extending the response time for good cause shown.
Under the authority of section 182 or the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.
Within the same time as provided for the response required under 10 CFR 2.201, the Licensee may pay the civil penalty by letter addressed to the Director, Office of Enforcement, U.S.
Nuclear Regulatory Commission, with a check, draft, money order, or electronic transfer payable to the Treasurer of the United States in the amount of the civil penalty proposed above, or may protest imposition of the civil penalty in whole or in part, by a written-answer addressed to the Director, Office of unforcement, U.
S.
Nuclear Regulatory Commission.
Should the Licensee fail to answer within the
.ime specified, an order imposing the civil penalty will be issued.
Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil-penalty, in whole or in part, such answer should be clearly marked as an "Ansver to a Notice of Violation"-and may:
(1) deny the violation listed in this Notice in whole or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, or (4) show other reasons why the penalty should not be imposed.
In addition to protesting the civil penalty in whole or in-part, such answer may request remission or mitigation of the penalty.
In requesting mitigation of the proposed penalty, the factors addressed in Section V.B of 10 CFR Part 2, Appendix C, shculd be addressed.
Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the-statement or explanation in reply pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g.,
citing page and paragraph numbers) to avoid repetition.
The attention of the Licensee is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penalty.
~
-3 Upon failure to-pay any civil penalty due which subsequently has-been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to.the Attorney General, and the penalty, unless compromised, remitted, or mitigated,.may be collected by civil action pursuant to Section 234c of the Act,.42 'U.S.C.-2282c.
The responses noted above (Reply to Notice of Violation, letter with payment of civil penalty,
'-d Answer to a Notice of Violation) should be addressed Director,-Office of-Enforcement,-U.S. Nuclear Regulm Commission, ATTN:
Document Control Desk, Washington, D.C.
'ns 5 24*h a copy to-the Regional Administrator, U.S.
Nucloar Regulatory Commission, Region III, 799' Roosevelt Road, Glen Ellyn, Illinois 60137.
FOR THE NUCLEAR REGULATORY COMMISSION Q
L 'A A lh A.
Bert Davin Regional Administrator Dated at Glen Ellyn, Illinois this 2nd day of Decca.ber 1992 I
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, pa uto UNITED STATES NUCLEAR REGULATORY COMMISSION f'
k' REGION 111 5
4j 799 ROOSEVELT RO AD CLEN ELLYH, ILLINOIS 60137 December 2, 1992 Docket No.
50-186 License No.
R-103 EA 92-170 University of Missouri - Columbia ATTN:
Dr. James.T.
Rhyne, Director Research Roactor Facility Operations Research Park Columbia, Missouri 65201
Dear Dr. Rhyne:
SUBJECT:
MISSOURI UNIVERSITY RESEARCH REACTOR FACILITY NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY -
$6P.5 AND DEMAND FOR INFORMATION (NRC INSPECTION REPORT NO. 50-186/92002(DRSS))
This refers to the inspection conducted on September 3 through 4, 1992, at the Missouri University Research Reactor (MURR) facility.
The inspection. included a review of the circumstances surrounding the inadvertent switching of two aliquots of a holmium-166 (Ho 166) sample which resulted in two shipments of byproduct material to the wrong recipients.
The report
-documenting this inspection was sent to you by letter dated September 23, 1992.
During this inspection violations of HRC requirements were identified.
An open enforcement conference was held on October 2, 1992, to discuss the violations, their causes, and your corrective actions.
The report summarizing the conference was sent to you-by letter dated October 7, 1992.
You voluntarily reported the event to NRC headquarters on August 26, 1992, and to Region III on August 27, 1992.
Subsequently, you voluntarily submitted a detailed written report dated August 27, 1992.
On July 27, 1992, your staff inadvertently switched two aliquots of a Ho-166 sample from the Rare Earth Radiochemical research project that produces lanthanide radionuclides for medical research.
The aliquot containing 18.3 millicuries of Ho-166 intended for the Dow Chemical Company in Freeport, Texas (Dow-Freeport) was sent to the University of-Texas M. D.
Anderson Canccr Center (M. D. Anderson) in Houston Texas.
This package was externally labeled as containing 482 millicuries of Ho-166.
1
. CERTIFIED MAIL RETUttN RECEI 41g3STED gpvotM i
I
University of Missouri December 2, 1992
- Columbia on the same day, the aliquot containing 482 millicuries of Ho-166 intended for M.
D.
Anderson was sent to Dow-Freeport.
This package as externally labeled as containing 18 millicuries of Ho-166.
Although the external labels identified incorrect activitie the labels en the internal lead sample containers identifico the correct activities.
The destinations were switched when corrections were made to the labels for the lead sample containers by the Radiopharmaceutical (RP) Research GrJ.1p.
The inadvertent switching of the Ho-166 pac); ages was discovered by M.
D.
Anderson upon opening of its package on July 28, 1992.
M.
D.
Anderson contacted the RP group regarding the discrepancy.
The RP group then contacted Dow-Freeport to alert them of the discrepancy.
Dow-Freeport had not yet received the higher activity shipment and was instructed not to open the package.
Both Dow-Freeport and M.
D.
Anderson were authorized to receive the quantities contained in these shipments.
Two violations are described in the enclosed Notice of Violation and Proposed Imposition of Civil penalty (Notice).
The violations involve two instances of failure to indicate the correct isotopic activity on the shipping papers and shipping labels for twc shipments of holmium-166.
The violations occurred after personnel in the RP group inadvertently switched the names of the recipients designated on the labels of two lead sample containers.
These sample containers were subsequently delivered to the Service Applications (SA) Group to be prepared for transport.
Although the names of the recipients on the labels were incorrect, the labels did indicate the correct isotope and activity.
Had the SA group used the 1" formation on the label to determine the isotopic activity to be entered on the shipping papers and shipping labels, the violations would not have occurred (although the packages still would have been sent to the wrong recipients).
Instead, the SA Group copied the isotopic activity from a separate form keyed to the recipient name.
Sinca the recipient names on the lead sample containers had been switched, the SA Group designated the wrong isotopic activity en the chipping papers and labels of both shipments.
Proper shipping papers and labeling allow civil authorities, in case of an accident during transport, to properly identify the type, quanticy, and form of material; allow the carrier and recipient to exercise adequate controls; and minimize the potential for overexposure, contamination, and improper transfer of material.
The events described above involve significant noncompliance with shipping paper and labeling requirements.
Therefore, in accordance with the " General Statement ol Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy) 10 CFR Part 2, Appendix C, these violations ace classified in the aggrecate as a Severity Level III problem.
The violations have b
E December 2, 1992 University of Missouri
-3
- Columbia been aggregated into one problem because they-are factually related and arose from the same cause.
In addition to the violations noted above, the fact that the shipments were sent to the wrong recipients is a matter of significant regulatory concern.
In cases where the wrong isotope, activity, or chemicul/phyuical form is shipped, serious consequences can result during package opening, initial handling, or subcequent usa.
Recipients who are not authorized to possess or are not expecting to receive certain nuclides, quantities, or forms may not have the facilities or properly trained personnel to recognize and deal with the health physics consequences of such inadvertent shipments.
Further, your shipment of isotopes to the wrong recipients is a recurring problem which was the subject of previous enforcement action (EA 91-113),_and the corrective actions that you instituted at that time were not effective in preventing this latest occurrence.
We acknowledge your immediate corrective actions which included' notifying Dcw-Freeport and requesting that they not open the mislabeled package, which contained higher activity than indicateo on the package label and shipping papers; arranging for Dow-Freeport to ship the rample to M.
D.
I.nderson; and stopping the processing of samples by the RP Group until its procedures were revised and reviewed.
Other groups that routinely coquest shipments by the Service Application Group were made awai-e of the incident and also began double verifying the-appropriate information on the Shipping Request and, verifying the Shipping Request against the sample container label.
We also acknowledge your longer-term-corrective actions which' include modifying procedures to ensure that the information on all the items associated with the shipment agrees and is accurate.
Also, any group submitting radioactive materials to the Service Applications Group for shipment must now double verify critical information on the Shipping Request.
In addition, the Service Applications Group now requires other-groups to add alphabetic designation to the end of the MURR identification number for multiple shipnents made frou a-single =
irradiat.on target and the preprinted package identification labels for their shipments'now include the activity.
Further, due to the repetition of problems involving-materials being sent to the wrong recipients, you have begun a global review of your shipping program, includir.g establishing a task force to determine the best way to ship the broad diversity of isotopes that your operation involves, hiring a consultant to assist in improving procedures and related training, and conducting a peer review of your shipping program on October 15-16, 1992.
A
4 e
University of Missouri
-4 December 2, 1992
- Columbia To emphasize the importance that the NRC places on attention to detail while preparing byproduct material for shipment in accordance with NRC and Department of Transportation (DOT) requirements, and on ensuring that corrective actions are effective, I have been authorized after consultation with the Director, Offico of Enforcement, and the Deputy Executive Director for Nuclear Reactor Regulation, Regional Operations and Reset:ch to issue the enclosed Notice of Violation and Propored Imposition of Civil Pene.ity (Notice) in the amount of $625 for the Severity Level III problem.
The base civil penalty for a Severity Level III prcblem in Cie transportation area is $500.
The civil penalty adjustment factors in the Enforcement Policy were considered.
The br
- P civil penalty was mitigated 25 percent for identification in that, while the event was self-disclosing, you demonstrated initiative in identifying the root cause of the violations.
The base civil penalty was further mitigated 50 percent for your good i
corrective actions as discussed above.
The base civil panalty was escalated 100 percent for your poor past performance, A
Notice of Violation and Proposed Imposition of Civil Ponalty (EA 91-113) was previously issued to you on October 29 1991, for s
similar events which occurred in 1991.
The other factors in the enforcement policy were considered, and no further adjustment to the base civil penalty was considered appropriate.
Therefore, based on the above, the base civil penalty has been increased by 25 percent.
Sections 3.b and 3.c of the inspection report describe two additional violations of NRC requirements.
These involved failure to ensure that a package of radioactive material was labeled with a Yellow-III label when the Transport Index was greater than 1.0, and failure to ensure that the recipient's license authorized receipt of byproduct material prior to shipment.
We recognize that you identified and corrected these i
violations, and that you reported them to NRC although you were not required to do so.
Your efforts in this regard meet the criteria specified in Section VII.B of the Enforcement Policy; therefore the violations are being treated as non-cited violetions.
You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response.
In addition, given the diverse nature and the large volume of radioactive materials produced by MURR and provided to off-campus recipients (when compared to other research reactors),
your projections of yearly growth in the volume of that activity, the number of mislabeled and misdirected shipments, and the failure of your previous carrective action to prevent recurrence, the NRC staff intends to closely monitor the initiative that you
1,
University of Missouri December 2, 1992
- Columbia are undertaking to conduct a global review of your shipping program and to improve year procedures and related personnel training for providing isotopea produced by MURR to off-campus recipients.
In order to rore closely monitor your actions to review and laprove these prcum2"-as, and in order to determine whether your ~
license should be modified or other further enforcement action taken, you are hereby required, pursuant to sections 161c, 161o, 182 and 186 of the Atomic Energy Act of 1954, as amended and the Commission's requirements in 10 CFR 2.204 and 10 CFR 50.54(f), to provide the following information:
1.
The results of the global review of your shipping program-including lessons learned and recommendations for improving control over the preparation and shipment of radioactive.
materials produced by MURR for off-campus. recipients.
2.
A milestone schedule for completing the global review and providing the information doccribed in 1. above to the NRC staff.
Your milestone schedule should be provided within 30 days of the d. ate of this letter.
3.
A statement describing your position as to whether the procedures that you have established to control the preparation and shipment of radioactive materials produced by MURR should be incorporated into your NRC license, and if not, why not.
This statement should be provided within 30 days'of the date of this letter.
The information required above should be forwarded to the Director, office of Enforcement, with a copy to the Regional Administrator, U.
S.
NRC Region III, at the addresses given in the enclosed Notice.
If you have questions concerning-this Demand for Information, please telephone Ms. Cynthia Pederson, Chief, Reactor Support Programs Branch, Division of Radiation Safety and Safeguards, U.
S. NRC Region III, at (708) 790-5173.
After reviewing your responses to this Notice and Demand for
~
Information, including your proposed' corrective actions, the NRC will determine whether further NRC enforcement action is necessary to ensure compliance with NRC regulatory requirements.
In this regard, the NRC staff intends to meet with you after receiving your responses to discuss the results of the global review and the revision of your procedures.
C.
-~
University of Missouri 6-December 2, 1992-
- Columbia In accordance'with 10 CPR 2.790 of the NRC's " Rules of Practice,"
a copy of this letter, its enclosure, and your responses.will be placed in the NRC Fublic Document Room.
The responses directed by this letter and.the enclosed Notice are not subject to the clearance procedures of the office of Management and Budget as required by thn Paperwork Reduction Act of 1980, Public Law-No.96-511.
Sincerelyr
( l f
A.
Bert Davis Regional Administrator
Enclosure:
Notice of Violation and Proposed Imposition of Civil Penalty cc/ enclosure:
PDR DCD/DCB(RIDS)
OC/LFDCB Dr. William Vernetson, Director of Nuclear Facilities
'N
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University of Missouri December 2, 1992
- Columbia DISTRIRUTION
-1 SECY CA
'JSniczek, DEDR JLiebernan, OE LChandler, OGC JGoldberg, OGC TMurley, NRR JPartlov,. NRR Enforcement Coccdinators RI, RII, RIV, RV FIngram, GPA/PA DWilliams, OIG Difayes, OI E._ Jordan, AEOD JDelMedico, OE Day File EA File
- DCS; '
State of Missouri RAO:RIII i
SLO:RIII PAO:RIII IMS:RIII 1
2 NOTICE OF' VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY University of Missouri Docket No.
50-186 Missouri University Research Reactor License No.-
R-103' EA 92-170 During an NRC inspection conducted from September 3-4,
- 1992, violations of NRC_ requirements were identified.
In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," 10 CFR Part 2, Appendix C,_the Nuclear Regulatory Commission proposes to impose a civi1~ penalty pursuant to Section 234 of the Atomic Energy Act of 1951, as anended (Act), 42 U.S.C.
2282, and 10 CFR 2.205.
The particular violations and associated civil penalty are set forth below:
10 CFR 71.5(a) requires that a licensee who transports licensed material outside the confinen of its plant or other place of use, or who delivers lict ised material to a carrier for transport, comply with the applicable requirements of the reg >11ations appropriate to the mode of transport of the Department of Transportation (DOT) in 49 CFR Parts 170 through 189.
49 CFR 172.203 (d) (1) (iii) requires that the description for a shipment of radioactive material must include the activity contained in each package of the shipment in terms of curies, millicuries or microcuries.
49 CFR 172.403(a) and (g) (2) require in part that the activity of each package of radioactive material must be entered on the radioactive label, unless the package is excepted from labeling.
1.
Contrary to the above, on July 27, 1992, the licensee delivered a package containing 0.482 curies-of holmium-166 to a carrier for transpcrt to Dow Chemical Company in.
Freeport, Texas with the description on the shipping papers and the radioactive label stating that the shipment contained 0.0183 curies of holmium-166, and the package was not excepted from labeling.
2.
Contrary to-the above, on July 27, 1992, the licensee delivered a package containing 0.0183 curies of_ holmium-166 to a carrier for transport to.the University of Texas, M.
D.
Anderson Cancer Center, Houston, Texas with the description on the shipping papers and the radioactive label _ stating that the shipment contained 0.482 curies of holmium-166, and the package was not excepted from labeling.
This is a Severity Level III problem (Supplement V).
Cumulative Civil Penalty - $62a (assessed equally between the two violations).
A W
-2 Pursuant to the provisions of 10 CFR 2.201, University of 4
Missouri (Licensee) is hereby required to submit a written statement of explanation to the Director, Office of Enforcement, i
U.S.
Nuclear Regulatory Commission, shin 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty (Notice).
This reply should be clearly marked as a " Reply to a Notice of Violation" and should include for each alleged violation:
(1) admission or denial of the alleged violation,_(2)_
the reasons for the violation if admitted, and if denied, the reasons why, (3) the corrective steps that have been taken and the results achieved, (4) the corrective steps that will be taken to avoid further violations, ar.d (5) the date when full compliance is achieved.
If an adequate reply is not received within the time specified in this Notice, an order or a demand for information may be issued as to why the license should not be modified, suspended, or revoked or why such other actions as may be proper should not be taken.
Consideration may be given to.
extending the response time for good cause shown.
Under the authority of Section 182 of the Act, 42 U.S.C.
2232, this response shall be submitted under oath or affirmation.
Within the same time as provided for the response required under 10 CFR 2.201, the Licensee may pay the civil penalty by_ letter addressed to the Director, Office of Enforcement, U.S.
Nuclear Regulatory Commission, with a check, draft, money order, or electronic transfer payable to the Treasurer of the United States in the amount of the civil penalty proposed above, or may protest imposition of-the civil penalty in whole or in part, by a written l
answer addressed to the Director, Office of Enforcement, U.
S.
Nuclear Regulatory Commission.
Should the Licensee fail to answer within the-time specified, an order imposing the civil penalty will be issued.
Should the Licensee elect to file an answer in accordance with 10 CFR_2.205 protesting the civil penalty, in whole or in part, such answer shculd be clearly marked as an " Answer to a Notice of Violation" and may:
(1) deny-the violation listed in this Notice in whole or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, or.4) show other reasons why the penalty should not be imposed.
In addition to protesting the civil penalty-in whole or in part, such answer may request remission or mitigation of the penalty.
l In requesting mitigation of the proposed penalty, the factors addressed in Section V.B of 10 CFR Part 2, Appendix C, should be addressed.
Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanation in reply pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CPR 2.201 reply by specific reference (e.g.,
citing page and puca;raph numbers) to avoid repetition.
The attention of the Licensee is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penalty.
1 i
(
l
t Notice of '~'.olation
-3 Upon failure to pay any civil penalty due whichisubsequently has
'been determined in accordance with the applicablo~ provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act, 42 U.S.C.
2282c.
The responces noted above (Reply to Notice of Violation, letter with payment of civil penalty, and Answer to a Notice of Violation) should be addressed to:
Director, Office of Enforcement, U.S.
Nuclear Pegulatory Commission, ATTN:
Document Control Desk, Washington, r,. C. 20555 with a copy to the Regional Administrator, U.S.
Nuclear Regulatory Commission, Region III, 799 Roosevelt Road, Glen Ellyn, Illinois-60137.
FOR THE NUCLEAR REGULATORY COMMISSION t, '9]tJL
'i&
A.
Bert Davis Regional Administrator Dated at Glen Ellyn, Illinois this 2nd day _of December 1992
University of_ Missouri December 2, 1992
- Columb!3 DlETRiliUTION SECY CA-JSniczek, DEDR JLieberman, OE LChandler, OGC JGoldberg, OGC TMurley, NRR sPartlow, NRR Enforcement Coordinators RI, RII, RIV, RV FIngram, GPA/PA DWilliams, OIG Bilayes, OI E. Jordan, AEOD JDelMedico, OE Day File EA Fil-DCS State of Missouri RAO:RIII SLO:RIII PAO:RIII IMS:RITI
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- concurrence]j 11/27/92.
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