ML20028G754
| ML20028G754 | |
| Person / Time | |
|---|---|
| Issue date: | 08/21/1990 |
| From: | Jamnes Cameron, Caniano R, Bryan Parker NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20028G752 | List: |
| References | |
| REF-QA-99990063-900821 99990063-90-05, 99990063-90-5, NUDOCS 9009040030 | |
| Download: ML20028G754 (4) | |
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U. S. NUCLEAR REGULATORY COMMISSION REGION III Report flo. 99'/90063/90005(DRSS)
Docket 110, 999-90063 License llo. - Non-Licensee Non-Licensec: 11r. Thomas Kralian 17637 Hamilton Detroit, til 48203 Inspection Conducted:
August ?-3, 1990 Inspectors:
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Radiation Specialist YYU w ww Mw Japnes L. Cameron Dete Rddiation Specialist 8 <//c Approved By:
(X; 4 ao, 4 Roy J.(f.aniano, Chief /
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Huclear Materials Safety Section ?
Inspection Summary Inspection Conducted on August 2-3,1990 (Report flo. 99990063/90005(DRSS))
Areas Inspected:
This was an unannounced, special inspection conducted in response to a telephone inquiry trom U.S. Customs at Detroit Metropolitan Airport regarding authorization for a package entering the United States bearing a "RADIDACTIVE" label. The areas exatnined included a sumary of.
events; interviews; and radiation surveys of the package and its contents.
Results:
One apparent violation was identified certaining to unauthorized acquisition, possession, and transfer of byproduct material per 10 CFR 30.3.
All byproduct material possessed has been returned to its manufacturer in Yugoslavia.
Also, as a result of discussions with NRC's International Proc /ams office, the Yugoslavian manufacturer has ceased shipments of byproduct material to the unauthorized individual.
9009040030 900821 REG 3 OA999 EMD*****
99990063 PDC
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i DETAILS
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1.
Persons Contacted q
- Thomas Kralian, Private Citizen Mila Bednarz, Consultant for Dr. Hamburger i
. Joe Argonis, British Airways Cargo Department FMr. Adams, British Airways Cargo Department -
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- Mr. Williams, U.S. Customs Inspector
-*Present at exit meeting held August 3,1990.
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- Initial telephone contacts.
2.
History On August 1,.1990, the NRC Region III office received a telephone call i
from U.S. Customs at Detroit Metropolitan Airport informing the NRC that on July 31, 1990, Customs discovered a package labeled "RADI0 ACTIVE l
during a routine inspection at British Airways Cargo Department. As t
followup to their inspection, Customs wanted assurance that the addressee l
was authorized to receive the radioactive material.
The package was i
addressed to a Mr. Thomas Kralian at 17637 Hamilton, Detroit, Michigan.
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The package was labeled with a " RADIOACTIVE" White-I label and indicated a transport index of 0.
The packing list inoicated a contents of 10-I separate packages of iodine-125 radioimmunoassay (I-125 RIA) kits and the amount of activity could not be found on the paperwork.
It was assumed
' by Region III that microcurie amounts of.1-125 were present in each -
smaller package. The package originated from Kardon Nuclear in Yugoslavia,
-which does not have an authorized distributor in the United States.
Fo110wint a search through NRC records and various telephone calls,:
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evidence that Mr. Kralian is authorized to possess any type of radioactive material was not-found.
In turn, Region III contacted British Airways Cargo in Detroit and arranged to have.Mr. Kralian contact Region. III prior to release of the package to him.
..On August 2, 1990, inspectors _enroute through Detroit Metropolitan-Airport stopped by British Airways Cargo to examine the package and shipping papers and confirm the transport index.
By coincidence, Mr. Kralian was there to pick up the package. As a result, with
'Mr. Kralian present, the inspectors began investigating the matter fully.
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Inspection Summary The inspection revealed that Mr. Kralian has been receiving a package of I-125 RIA kits from Yugoslavia at a rate of once per month for approximately four years. The packages, including the one discovered by Customs, contain 10 separate kits with an activity of 185 kiloBecquerels (kBq) (or 5 microcuries (uti)) of I-125 in each kit. The activity of each package was noted on each vial and the shipping paper as well.
Each vial was also marked with the radiation symbol and indicated the radionuclide present.
From interviews with Mr. Kralian and Ms. Mila Oednarz, it appears that the inaterial is used in a research project. The research is being conducted by Joel Hamburger, M.D., whose offices are located in Southfield, Michigan, a suburb of Detroit, and Ms. Bednarz is assisting with the research.
Essentially, Mr. Kralian is the distributor for the Yugoslavian klos. Mr. Kralian would order the material from Yugoslavia, receive it, aid transfer the material to Mr. Hamburger.
According to Mr. Kralian, te never worked with the radioactive portion of the kits and is only inter ested in the chemical properties.
The purpose of the resea"ch is to compare various similar I-125 RIA kits and determine if one prcvides superior results. Clinical diagnosis is used as part of the research for kit comparison.
The inspection also revealed that Mr. Kralian does not have a specific NRC or Agreement State license to acquire, possess or transfer L.he material and is not named as an authorized user on any license.
In addition, Mr. Kralian is not registered as a general licensee. According to Mr. Kralian, he has never had any type of radiation safety training and has never worked with radioactive material.
10 CFR 30.3 requires that no person will manufacture, produce, transfer, receive, acquire, own, possess, or use byproduct material except as authorized in a specific or general license issued pursuant to the regulations in Part 30. The unauthorized acquisition, possession, and transfer of byproduct material by Mr. Kralian constitutes an apparent violation of 10 CFR 30.3.
The root cause of the apparent violation appears to be that Mr. Kralian was unaware of the requirements to import and possess this type of material. He emphasized that had he known, he would have requested authorization. The safety significance of this activity appears to be minimal as small amounts of byproduct material were involved and Mr. Kralian never worked with the material directly.
4.
Radiation Safety Radiation surveys were performed around the package using a Xetex 305B survey instrument, NRC Serial No. 013166, last calibrated February 14, 1990.
Radiation levels at one meter and on the surface of the package were less than 0.1 mil 11 roentgen per hour (mR/hr).
Radiation levels on the surfau of each kit averaged less than 0.2 mR/hr and readings cc. the surface of the I-125 vials averaged less than 0.5 mR/hr.
Also, no gross removable contamination was detected.
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Exit Interviews.
..m Following the inspection, Mr. Kralian wasiinformed of the find'ngs and J the'NRC Enforcement-Policy was.. described to Mr. Kralian...On Alpust 8
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1990,- an: inspector contacted Mr.'Kralian by telephone and was informed' 4
b'd by Mr. Kralian that he was contacted by the. manufacturer in Yug1slavia:
g and. informed that;no more shipments could be made to him'without. proof.
.of-authorization.
This was' confirmed by the NRC International F"ograms
-(IP): office.during the week of August 13,.1990.. IP had contactec the Yugoslavian-manufacturer and informtd them of the. situation and p/.
requirements.-
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