NUREG-1405, Identifies & Assigns Responsibility for Generic & Facility Specific Actions Resulting from Investigation of Radiographic Source Incident as Documented in NUREG-1405. Summary of Plans,Schedule & Status Requested by 900615
| ML20043C097 | |
| Person / Time | |
|---|---|
| Issue date: | 05/25/1990 |
| From: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Bernero R, Harold Denton, Martin T NRC OFFICE OF GOVERNMENTAL & PUBLIC AFFAIRS (GPA), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I), NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| RTR-NUREG-1405 NUDOCS 9006040033 | |
| Download: ML20043C097 (8) | |
Text
--
m,
[*h.
o UNITED STATES
~g NUCLEAR REGULATORY COMMISSION
- .[
g WASHINGTON, D.C. 20$55 j
g e
k,**..*/*
gay 2 51930 1
MEMORANDUM FOR:
Harold R. Denton, Director, GPA Robert M. Bernero, Director, NMSS Thomas T. Martin, Regional Administrator, RI j
FROM:
James M. Taylor Executive Director for Operations
SUBJECT:
STAFF ACTIONS RESULTING FROM THE INVESTIGATION OF THE INADVERTENT SHIPMENT OF A RADIOGRAPHIC SOURCE FROM KOREA l
TO AMERSHAM CORPORATION, BURLINGTON, MASSACHUSETTS (NUREG-1405)
An advance copy of the subject report was transmitted to you by memorandum dated April 23, 1990 from the Amersham Corporation IIT team leader, Willard B.
Brown.. The report documents the Team's efforts in identitying the circumstances and causes of the March 8, 1990 incident, together with findings and conclusions which form the bases for follow on actions.
u The purpose ot this memorandum is to identify and assign responsibility for l
generic and facility-specific actions resulting from the investigation of the L
radiographic source incident as documented in NUREG-1405.
In this regard, you are requested to review the enclosure which specifies staff actions resulting trom the investigation of the radiographic source incident.
You are requested to determine the actions necessary-to resolve each of the issues in your area of responsibility and, where appropriate, identify additional staff actions or l
revisions as our review and understanding of this event are refined.
I I intend to monitor the resolution of each action item. By June 15, 1990, please' provide a written summary of the plans, schedule, status, and point of contact for each item within your responsibility listed in the enclosure.
In addition, I request.that you prepare a written status report on the dis]osition of your items (and anticipated actions for uncompleted items) wit 11n six months.
L The resolution of the case-specific actions are to be documented in a single report and each generic action item will be individually tracked via the E00's work item tracking system (WITS). Overall lead responsibility for the preparation of the staff's single report on case-specific actions rests with NMSS. Other offices involved n case-specific actions are to coordinate their efforts with NMSS. The Director, AEOD will prepare a closeout report which identifies the resolution or disposition of each IIT finding and conclusion and thus, the Director, AE0D should also be kept informed as to the resolution 1
or disposition of each action item assigned.
In addition, in accordance with
/
Q\\
the revised NRC Manual Chapter 0513, " Incident Investigation Program," the resolution of each IIT tinding and conclusion is subject to independent f g h_
_ )I~
IF assessment as to its adequacy and completeness and, turther action may be
?
/
taken at a later date.
NRC FH.E CENTER CD g
9006040033 9005-25
.h PDR ORG NE E 1
i.
a p
m.y
=. - -
r j
Addressees ;
1 The enclosure is based on the Team's findings and conclusions contained in
'NUREG-1405. Accordingly, it does not include all license actions, nor does it cover-NRC staff activities associated with normal even follow-up such as tacility inspections, or possible enforcement actions. These items are expected to be defined and implemented in a routine manner.
Original Signed Bys
+
James M. Taylor James M. Taylor Executive Director for Operations
Enclosure:
As Stated cc w/ enclosure:
H.L. Thompson, OED0 J.L. Blaha, OEDO C.C. Krammerer, GPA J.J. Fouchard, GPA R.D. Hauber, GPA R.E. Cunningham, NMSS E. TenEych, NMSS S.D. Ebneter, Rll A.B. Davis, Rlli R.D. Martin,, RIV J.B. Martin, RV W.B. Brown, NMSS J.R. White, RI A.W. Grella, NMSS E.P. Easton, HMSS P.V. Joukoff, RV D.D. ' Skov, RV Distribution:
DCS LSpessard OEDO R/F DEIIB R/F EJordan SRubin DCS AE00 R/F Dross.
RLloyd PDR TNovak RFreeman D0A R/F
- See previous concurrence UFC= :DEllB:AEOD :DE116:AEOD :C:DEIIB:AEOD:D:DOA:AEOD :D:AEOD
- E00;
- NM55
___..:.___.....__:..._____....:.......____:____..__...:___.......__:___ y...:...._____
NAME :RFreeman*:vb::RLloyd*
- SDRubin*
- GGZech*
- ELJordan
- Jda
- WBrown
- DATE :05/07/90
- 05/07/90
- 05/07/90
- 05/07/90
- 05/ /90
- 05/[90
- 05/ /90 0FFICIAL RECORD COPY
),
ENCLOSURE Staff actions resulting from the investigation of the inadvertent shipment of a Radiographic Source from Korea to a NRC Licensee in Burlington, Massachusetts on March 8, 1990 (
Reference:
NUREG-1405) l '..
The cause of the incident was that a stored source was inadvertently left in a source changer when the device was returned from the end-user to Amersham's Korean distributor for shipment. Neither the end-user, Korea Industrial Testing Company, Ltd. (KIT), nor the distributor (shipper) ND1 Corporation (NDI), used effective methods to ensure that there was no source in the changer. The inability of the two parties to detect the source was exacerbated by the fact that the connecting cable, or pigtail, had been removed, that is, cropped from the source.
(Events leading to the inclusion of the iridium-192 source in the shipment are also being investigated by the Ministry of Science and Technology, and the Korean Institute of Nuclear Safety, the responsible regulatory authorities in Korea. Their findings were not available at the time this report was published.)
Action Responsible Office Category
- 1) Provide assurance that Korean GPA/IP Case Specific authorities are aware of this event, and that they have been requested to initiate action to assure that Korean shippers will physically verify contents of source changers before shipping to the United States.
- 2) Provide assurance that other countries that return source changes to the U.S. are aware of this event.
3.
The Team was able to identify the radiographic source as a 56-curle, iridium-192 source manufactured on April 13, 1989, by Industrial-Nuclear Company, San Leandro, California. Using the manufacturer's decay curve for the iridium-192 source, the Team determined the source's activity at the times when potential exposures to individuals might have occurred.
Independent measurements made of the source's activity at the Amersham Corporation facility were consistent with the values derived from the manufacturer's decay curve for the source.
Action Responsible Office Category Assure that all NRC and Agreement NMSS/IMNS and GPA/SP Generic State licensees that export and import radioactive materials are made aware of this event for application of controls to their programs, as necessary; and to assure that their foreign clients and customers are adequately informed of. conditions and
2 constraints relative to the importation of radioactive materials into the United States.
Evaluate the practicality of requirino manufacturers to imprint the source capsule with a manu-facturer's identification mark and/or serial number.
3.
While potential radiation exposure to the general public was possible, the number of individuals that could have been exposed was limited because the shipment was maintained "in-bond" from its arrival in Los Angeles on February 11, 1990, to the time it cleared U.S. Customs Service in Boston on March 7, 1990. The transport vehicle carrying the shipment from Los Angeles to Boston was driven across country with infrequent stops of mostly short duration.
Action Responsible Office Category Inform members of the public of the GPA/PA Generic outcome of this event, and the results of the NRC investigation.
4..
Although the maximum estimated potential whole-body radiation exposures range from-27 to 35 rem for the two long-distance drivers, and 0.5 to 5.6 rem for other individuals that may have been in close proximity to the l
source for extended periods of time, these estimates are not supported by cytogenetic studies done on the five individuals that had the highest
)otential for exposure. The cytogenetic data suggest that the source may lave remained shielded so that no actual exposures occurred until the shipment was transferred from storage in Boston to Amersham's facility l
in Burlington, Massachusetts.
l Action Responsible Office Category 1
Inform all individuals that had the NMSS/IMNS Case Specific potential for measurable exposure l
to the source, of the NRC's exposure evaluation for their specific case, including discussion of the cytogenetic l
evaluation results.
5.
The safe handling and transportation of radioactive materials imported to the United States are highly dependent on the actions of foreign shippers and their agents to properly prepare packages for shipment, properly identity the contents, and accurately describe the contents in shipping documents. There are no 00T or NRC requirements on carriers or shipping agents to monitor or survey shipments during transit.
1
Action Responsible Office Category Evaltate the need to amend 00T and NMSS Generic NRC regulations relative to the performance of independent verification of the quality of radioactive material shipments imported into the United States.
6.
Carriers, freight forwarders, or shipping agents do not independently verify the accuracy of shipping documents for import shipments at the U.S.
place of entry. Misclassitied or mislabeled shipments are usually discovered by the receiving organization. There are no clear-cut require-ments for a receiver to report to 00T or NRC instances where packages are not properly prepared for shipment or where the contents are not accurately identified.
Current DOT regulations require carriers to report incidents where there is death, serious injury or substantial property damage, breakage, spillage, or suspected radioactive contamination. NRC regulations require that licensees report any instance in which there is significant reduction in the effectiveness of any NRC-authorized packaging during use (10 CFR 71.95) it there is a high radiation level or contamination on packages when received (10 CFR 20.205),(and for incidents in which there is the potential for significant exposure 10CFR20.403). The Team could not determine whether NRC regulations would have required Amersham to report previous instances where cropped sources had been inadvertently shipped from the Republic of Korea. Although the shipment was mislabeled and misidentitied in these instances, the sources arrived within the shielded source tubes of the source changers. The Team could find no evidence that the instances were reported to either the NRC or D0T. The incident being investigated, where the source was received in an unshielded position was reported pursuant to NRC requirement, 10 CFR 20.403.
Action Responsible Office Category Evaluate if NRC and DOT regulations NMSS/IMNS Generic should be amended to include requirements to report the receipt of shipments of radioactive materials that were improperly prepared, labeled, identified, or classified, or had improper contents.
l 7.
As an importer, Amersham was required to provide the shipper and the forwarding agent, at the place of entry into the United States, complete information on how to comply with 00T regulations. The instructions provided to the shipper by Amersham for classifying and preparing the source changers for shipment were incomplete. While instructions were included for preparing the shipment of the source changers as an " excepted" package, no specific directions were provided for the case where the empty source changers did not meet the requirements for an " excepted" package.
In spite of the inadvertent inclusion of an iridium-192 source, the r-+
. shipment of empty source changers was improperly prepared for transport.
Because the surface radiation level of the shipment exceeded 0.5 mrem /hr, it was required to be shipped within the United States as a Type A package.
Lack of instructions for preparing a Type A package may have contributed to the misclassification of the package as an excepted package.
- However, proper classification of the shipment as Type A would probably not have prevented the incident.
Action Responsible Office Category verify that Amersham has reviewed RI Case Specific instructions to foreign shippers relative to D0T requirements.to NMSS and GPA Generic assure that the directions are complete and accurate; and assure that other NRC and Agreement State licensees that import radioactive materials are informed of the requirements of 49 CFR 171.12.
8.
Amersham's instructions for returning an empty Model 500-SU source changer were made available to NDI and KIT and were adequate for determining whether a source changer contained an authorized (i.e., uncropped) source, since a visual examination would detect the presence of a pigtail.
However, in view of previous incidents involving the receipt by Amersham of cropped sources f rom the Republic of Korea, the instructions were deficient in that they did not anticipate that sources without pigtails might be stored in the source changer and not removed before shipment.
Specific instructions requiring both a radiation survey and a probe of source tubes, if implemented by the end-user, would have prevented this incident.
Action Responsible Office Category Initiate action to assure that each NMSS/IMNS and GPA/SP Generic NRC and Agreement State Licensee that imports (expects to have returned) empty source changers or other devices that were originally supplied to foreign entities for sources (port of radioactive the trans such as radiography exposure devices) provide their respective custoners with instructions that directs a physical determination that such devices are empty upon return to the United States.
. 9.
Amersham did not provide " shipper" instructions to the freight forwarder at the place of entry into the United States (Los Angeles), as required, but rather to its Customs broker in Boston.
In this case, Amersham provided an erroneous instruction to transport the package as an " excepted" package.
Action
. Responsible Office
- Category
- 1) Meet with DOT and determine the NMSS/IMNS Generic e-purpose and expectation of actions on the part of forwarding agents at the piece of U.S. entry, relative to shipnents of radioactive materials, 1'
it such agents are informed of the pertinent DOT requirements; and determine if such requirements are realistic and important relative to the handling of radioactive material shipments, and should be enforced.
- 2) Pending the results of Action R1 Case Specific 1 above, initiate action to assure that Amersham has taken appropriate corrective measures relative to the
. completeness and accuracy of information provided to forwarding agents.
- 10. The Team found no violation of NRC regulations with respect to the receipt of the source changer shipment at Amersham. NRC's regulations do not apply tu the shipment of these source changers across the United States, other than 10 CFR Part 110.27, which specifies requirements for importing byproduct material. Shipment of the source changers within the United States was subject to DOT transportation regulations.
Action Responsible Office Category None Required
- 11. D0T regulations permit the use of an NRC-certified Type B package, such 7
L as the Model 500-SU source changer, for shipment of a Type A quantity, l
for example, either as empty (with the DU shielding) or with source l
totaling less than 20 C1. However, D0T regulations are ambiguous as to whether an NRC-certified Type B package must be used in strict accordance with the NRC certificate for shipment of Type A quantities or whether the package need only comply with the general requirements for Type A packages in the DOT regulations. Thus, the Team could not determine whether the source involved in this incident could have been shipped in l
the Model 500-SU source changer as a Type A quantity, because the source (with or without the pigtail) is not authorized in the NRC certificate.
1
- u. ? "i:
l
- ,_4' i
. Action Responsible Office Category Meet with DOT and determine NMSS/SGTR Generic
'4
- the conditions of use that pertain to the utilization'of NRC-certified Type B packages for the shipment of Type A quantities of s
radioactive materials; and.
initiate action to amend D0T and'NRC requirements, as necessary. For example, could Model 500-5U source changers, NRC-certified as an effective shipping container for Type B quantities when used in 1
conformance with the Certiticate of Compliance, be used to ship.
Type A quantities of radio-graphic sources that were not-specifically authorized for the package in terms of design or configuration, as long as all other pertinent D0T specitications were adequately satisfied?.
. 12. The 14 source changers involved in the incident did not conform to the drawings referenced in NRC Certificate ot Compliance 9006,-Revision No. 9, in that all of these source changers were constructed without a source cable locking assembly.
In addition, 6 of the 14 source changers were-not constructed according to the dimensions specified in the drawings reference in the Certificate of Compliance. However, the Team determined that these discrepancies.did not contribute to the cause of this incident.
Action Responsible Office Category Initiate action to ensure that R1 Case Specific Amersham's source changers are brought into compliance with the NRC Certiticate of Compliance.
'l L
l l
1 L
- - l