IR 05000186/1992002

Discusses Insp Rept 50-186/92-02 on 920903-04 & Forwards Notice of Violation,Proposed Imposition of Civil Penalty & Demand for Info.Review of Circumstances Surrounding Inadvertent Switching of Two Aliquots Discussed

ML20128E204
Person / Time
Site:	University of Missouri-Columbia
Issue date:	12/02/1992
From:	Davis A NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To:	Rhyne J MISSOURI, UNIV. OF, COLUMBIA, MO
Shared Package
ML20128E210	List: IR 05000186/1992002 ML20128E227
References
EA-92-170, NUDOCS 9212080021
Download: ML20128E204 (7)

Text

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2 re49 UNITED STATES

.g NUCLEAR REGULATORY COMMISSION

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S ntoloN ill D i f 799 ROO5t'VELT RO AD o GLEN ELLYN, ILUNOt5 40137 g

. . . . + *j December 2, 1992 Docket No. 50-186 License No. R-103 EA 92-170 University of Missouri - Columbia ATTN: Dr. James J. Rhyne, Director Research Reactor 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 -

S625 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 Septcaber 23, 1992. During this inspection violations of NRC 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 Augimt 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 f;r the Dow Chemical Company in Freeport, Texas (Dow-Freeport) was sent to the University of Texas M. D. Anderson-Cancer Center (M. D. Anderson) in Houston Texas. This package was externally labeled as containing 482 millicuries of Ho-166.

CERTIFIED MAIL BETURN RECEIPT REOUESTED 9212080021 921202 '

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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-Freerort. This package was externally labeled as containing 18 millicuries of Ho-166. Although the external labels identified incorrect activities, the labels on the internal lead sample containers identified the correct activities. The destinations were switched when corrections were made to the labels for the lead sampic containers by the Radiopharmaceutical (RP) Research Group. .

The inadvertent switching of the Ho-166 packages was discovered-by M. D. Anderson upon opening of its package on July.28, 1992.

M. D. Anderson contacted the RP group regarding the discrepantf.

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 autnorized 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 correce isotopic activity on the shipping papers and shipping labels for two shipments of holmium-166. The violations occurred after personnel in the RP group inadvertently switched the names of the recipients dasignated 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 information 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. Since the recipient names on the lead sample containers had been switched, the SA Group designated the wrong isotopic activity on the shipping papers and labels of both shipments.

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Proper shipping papers and labeling allow civil authorities, in case of an accident during transport, to properly identify the type, quantity, and form of- caterial; allow the carrier and recipient to exercise adequate controls; (%d minimize the potential for overexposure, contamination, and improper transfer of material. The events described above involve significant-noncompliance with shipping paper and label ng requirements.

Tiiere for e , in accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy)

- 10 CFR Part 2, Appendix C, these violations are classified in the aggregate as a Severity Level III problem. The violations have

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University of Missouri -3- December 2, 1992-

- Coluubia 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 chemical / physical form is shipped, serious consequences can result during package opening, initial handling, or subsequent use. 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 rabject 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 actians which included notifying Dow-Freeport and requesting that thay not open the mislabeled package, which contained higher activity than.

indicated on the package label and shipping papers; arranging for Dow-Freeport to ship the sample to M. D. Anderson; and stopping the crocessing of samples by the RP Group until its procedures were revised and reviewed. Other groups that routinely request shipments by the Service-Application' Group were made aware of the irfident and also began double verifying the uppropriate 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 shiptent 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 shipments made from a single irradiation 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 rcuipients, you have begun a global review of your shipping program, including establishing a task force to' determine the best way to ship the broad diversity of isotopes that your operation involves, hiring a consultant to

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assist in improving procedures and related training, and conducting a peer review of your shipping program on October 15-16, 1992.

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- Columbia Decem%r 2 M92 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, Office of Enforcement, and the Deputy F*ecutive x Dh ector for Nuclear Reactor Regulation, Rcgional Operatione and Research t o issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) in the amount of $625 for the Severity Level IIi problem.

The base civil penalty for a Severity Level III problem in the transportation area is $500. The civil penalty adjustment factors in the Enforcement Policy were considered. The base 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 penalt, was further mitigated 50 percent for your good -

corrective actions as discussed above. The base civil penalty was escalated 100 percent for your poor past performance. A Notice of Violation and Proposed Imposition of Civil Penalty (EA 91-113) was previously issued to you on October 29, 1991, for 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 percant.

Sections 3.b and 3.c of the inspection report describe two additional violations of NRC requirements. These involved failure to ensure tha+ 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 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 violations.

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 o: that activity, the number of mislabeled and misdirected shipments, and the failure of your previous corrective action to prevent recurrence, the NRC staff intends to closely monitor the initiative that you l

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arr undertaking to conduct a global review of your shipping program and to irprove your procedures-and related-personnel training for providing isotopes produced by MURR'to off-campus recipients.

In order to more closely monitor your actions to review and improve these procedures, 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 requir ments in 10 CFR 2.204 and 10 CFR 50.E4(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 described in 1. above to the NRC-staff, four milestone schedule should be provided vithin 30 days of the date of tnis letter.

3. A statement describing your position as to whether the procedures that you have established to control the preparation and shipment-of redioactive materials produced by MURR should be incorporated into your NRC-license, and if not, why not, This statement should-be.prcvided 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 U3 mand 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 Cemand 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.

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- University-of-Missouri ' -6- December-2, 1992

- Columbia In accordance with 10 CFR 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 Public 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 the-Paperwork Reduction Act of 1980, Public Law No.96-511.

Sincerely,

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(Vi A. Bert ravis Regional Administrator Enclosure:

Notice of Violation and Proposed Imposition of Civil Penalty cc/ enclosure:

PDR

'DCD/ DCB (RIDS)

OC/I.FDCB Dr. William Vernetson, Director of Nuclear Facilities

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University of Missouri December 2, 1992

- Columbia DISTRIBUTIOt!

SECY CA JSniczek, DEDR JLieberman, OE LChandler, OGC JGoldberg, OGC TMurley,iiRR JPartlow, NRR

Enforcement Coordinatois RI, RII, RIV, RV FIngram, GPA/PA DWilliams, OIG BHayes, OI E. Jordan, AEOD JDelMedico, OE Day File EA File ;3 DCS State of Missouri RAO:RIIl SLO:RIII PAO:RIII IMS:RIII

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