IR 07100117/2012005
| ML20197A820 | |
| Person / Time | |
|---|---|
| Site: | 07100117, 03007609 |
| Issue date: | 12/17/1997 |
| From: | Madera J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20197A808 | List: |
| References | |
| 30-07609-97-01, 30-7609-97-1, NUDOCS 9712230202 | |
| Download: ML20197A820 (7) | |
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U.S. NUCLEAR REGULATORY COMMISSION -
REGIONlli
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Docket No.:
030-07609 License No.:
13-01264-05
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030-07609/97001(DNMS)
' Report No.:
Licensee:
Mallinckrodt Veterinary, Inc.
675 McDonnell Blvd.
P.O. Box 5840 =
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St. Louis, MO 63134.
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. l.ocation:
1331 S. First Street Terre Haute, Indiana Dates of Inspection:
November 17-18,1997, with continued NRC ia-office review through December 5,1997 Inspectors:
Mike McCann, Senior Health Physicist
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Robert Gattone, Radiation Specialist Approved By:
John R. Madera, Chief Materials inspection Branch 1 Division of Nuclear Materials Safety
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9712230202 971217 PDR. ADOCK 03007609
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EXECUTIVE SUMMARY Mallinckrodt Veterinary, Inc.
NRC Inspection Report 030-07609/97001(DNMS)
This was a reactive, announced inspection to: (1) review the circumstances surrounding a
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change of ownership; (2) assess stored radioactive waste; and (3) determirce whether activities i
authorized by the license were conducted safely and in accordance with NRC requirements.
The inspectors identified that the licensee abandoned its radiation safety program incident to cessation of principal activities and before it had decommissioned the facilities to moet NRC
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release criteria. Through lack of oversight, the licensee did not ke7p itself apprised of NRC regulatory requirements. Four apparent violations were identified.
The first apparent vio!stion concemed failure to amend the license to authorize a Radiation Safety Officer (RSO) chaqge in 1994. The cause of the apparent violation appeared to be licensee failure to continue oversight of its radiation safety program after it terminated principal activities. Through lack of oversight, the licensee did not keep itself apprised of NRC regulatory requiremertis, including the need to amend its license to remove or replace its RSO.
The second apparent violation concemed failure to certify the disposition of licensed material that was used in separate buildings that were relcased to unrestricted use and subsequently demolished. The cause of the epparent violation appeared to be licensee failure to continue oversight of its radiation safety program after it terminated principal activities. Through lack of oversight, the licensee did not keep itself apprised of new NRC regulatory requirements, including the provistors of the Decommissioning Timeliness Rule.
The third apparent violation concemed failure to provide NRC with written notification within 60 days that no principal activities were conducted in unreleasable areas for 24 months The cause of the violation appeared to be identical to that which resulted in the second apparent violation.
The fourth apparent violation concemed failure to obta5 prior NRC consent of a change nf ownership.
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RaportDatalin 1,
Organization and Scope of Program NRC Byproduct Material License No.13-01264-05 authorized Mallinckrodt Veterinary,
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inc. (licensee) to posSese and use millicurie quantit'9s of several radionuclides in any fomt for research and development, including animal studies. Additionally, the license authorized possession and use of several sealed sources containing millicurie quantities of nickel-63 for use in gas chromatographs for sample analysis.
J During this inspection, the ricensee's possession of licensed material was limited to radioactive waste locatej in four separate areas. Low millicurie quantities of hydrogen-
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3, cart >on 14, and nickel-61 as well as low kilogram quantitles of uranium and thorium were stored within labeled, sealed containers inside of a secured area. Another area was used to store severallabeled, secured barrels of iodine 125 waste that had gone through ten half lives in 1995. Uncharacterized radioactive waste remained in a buried vault on the licensee's premises. Microcurie quantities of hydrogen 3 and carbon 14 were buried at another of the licensee's faciuties located west of the Wabash River.
At the time of the inspection, no licensee staff who were knowledgeable about licensed activities were available because they had left the licensee's employ when licensed activities ceased in December 1993. The licerisee's RSO left the licensee's employ
soon afterward in 1994. The licensee sold its assets, including control of licensed material, to Schering Plough Animal Health (SPAH) during a change of ownership on
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N,a 30,1997.
Most of the information about what happened prior to the change of ownership was obtained from an employee who worked for the licensee and was subsequently employed by SPAH Incident to the change of ownership. Although the employee was not involved with licensed activities while employed by the licensee, he became informed of the licensed material and gained access to related records soon before the change of ownership occurred.
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Cessation of Principal Activities 2.1 InspectioILScope The inspectors interviewed people who were formally employed by the licensee and who had some knowledge about licensed activities that were conducted in the past. The inspectors leviewed records that reflected licensed activities including radiation surveys and radioactive waste disposal.
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The inspectors toured the facilities and performed itdependent and confinnatory measurements in selected areas where radioactive materials had been used and stored.
2.2 Observations _r.nd Findings
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The licensee was authorized to possess millicuries quantitles of licensed material to perform research and development, including animal studies. Research involved testing and developing products for animal livestock. Licensed material had half-lives less than OG days except for thiorine 36, nickel-63 (sealed sources in gas chromatographs),
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The last NRC inspection was conducted on September 29,1993. The inspector identified that most licensed activities had ceased. Only one active authorized user
remained performing infrequent experiments with low microcurie quantities of phosphorus 32 in a single lab. In addition to phosphorus 32, the licensee possessed millicurie quantities of unused cart >on 'i4 stock and carbon 14 and hydrogen 3
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radioactive waste. The licensee had a good accounting of alllicensed materials on hand, and had planned to dispose of it incident to a planned license termination in 1994.
Principal activities ceased in December 1993. Soon afterward, personnel involved with licensed activities left the licensee's employ. The RSO left his position in 1994, and his position was not refilled. License Condition 11.B. of NRC License Number 13-01264-05 required that a specifically named individual be the RSO. Failure to have the
specifically named Individual act as the RSO since 1994 is an apparent violation of License Condition 11.B.
Some of the buildings where licensed material had been used or stored were decommissioned and demclished by the licensee since the last inspection. Specifically, Buildings 3 and 84 located at 1331 S. First Street, Terre Haute, Indiana were und for licensed activities and were demolished in late 1995 and 1996, respectively. The licensee performed close-out surveys of these buildings prior to release. However, the licensee did not provide the NRC with certification that all licensed material within those buildings was disposed of. Through lack of oversight, the licensee did not keep .self apprised of new NRC regulatory requirements, including the provisions of 10 CFR 30.36 (Decommissioning Timeliness Rule) which became effective on August 15,1994.
The regulation 10 CFR 30.36(j) requires, in part, that licensees certify the disposition of alllicensed material, including accumulated wastes, by submitting a completed NRC Form 314 or equivalent information to the NRC. Failure to certify the disposition of all licensed material in Buildings 3 and 84 by submitting the required information to the NRC is an apparent violation of 10 CFR 30.36(j).
Other buildings where licensed meterial had been used remained standing during this inspection.
The inspectors reviewed available records of close-out radiation surveys that were performed in Buildings 3 and 84, and other buildings where licensed material had been used and remained standing, in general, the records did not include enough information to reflect that the facilitNs met the NRC's criteria for release to unrestricted use.
Specifically, records indicated: (1) results in units of counts per minute rather than units of activity; (2) very few areas had been sampled to represent large areas of use; and (3) ambient dose rate surveys were used to close-out areas where low energy beta emitters may have been used.
The inspectors toured all of the rooms that remained standing and were known to have been used to perform licensed activities prior to being closed out by the licensee. The inspectors performed ambient exposure rate and removable contamination surveys of selected areas within these rooms. The inspector's radiation survey results did not indicate that the licensee had released areas that did not meet the NRC release criteria.
Radioactive waste was in storage at the licensee's facilities in Terre Haute, Indiana without the oversight of a knowledgeable person from 1994 until June 1997. Access to the areas where unburied licensed material was stored was limited to a supervisor who did not go into the storage areas.
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I Buildings 209 and 201 of the licensee's facilities locateo at 2458 Chr mberlain Road, Terre Haute, Indiana contained stored radioactive waste. Building 209 contained low millicurie quantities of hydrogen 3, cart >on 14, and nickel-63 as well as low kilogram quantities of uranium and thorium stored within 21 labeled, sealed containers and one refrigerator. The inspectors verified that, based on the number of containers and associated labeling, the inventory correlated with an inventory that was performed in August 1997. The area was secured in a locked cage, and the only key was in the possession of an Individual who had received radiation safety training in August 1997.
The inspectors performed ambient dose rate and removable contamination surveys of tne area. The maximum results were 1 mR/hr (10 microsieverts per hour) at the surface of a drum containing the uranium and thorium waste. All of the removable contamination survey results were essentially indistinguishable from background.
Building 201 contained seven labeled barrels of lodine 125 waste that, based on labeling, had gone through ten half lives in 1995. The inspectors verified that, based on the number of containers and associated labeling, the inventory correlated with an inventory that was performed in August 1997. The area was secured in a locked cage, and the only key was in the possession of an Individual who had received radiation
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safety training in August 1997. The inspectors performed ambient dose rate and removable contamination tsurveys of the area. The maximum results were essentially indistinguishable from background.
The licensee's facilities at 1331 S. First Street, Terre Haute, Indiana contained uncharacterized radioactive waste in a buried vault that was vented with a pipe above ground level. Based on a letter dated March 29,1963, low millicurie quantitles of carbon 14 and an unquantified amount of chlorine 36 was placed into the vault. No other documentation of vault entries was found. The size and construction of the vault was unknown. The only access to the vault was a six inch vent pipe that extended above the ground surface. The opening of the pipe was affixed with a steel cap. A lock box enshrouded the pipe to prevent unauthorized access. The lock box was posted to warn about the presence of radioactive material and Inform interested persons about who to contact regarding questions. The inspectors performed ambient dose rate and removable contamination surveys of the area near the pipe opening as well as the approximate five foot length of the pipe leading to the vault contents. The results were essentially indistinguishable from background.
Basod on a memo from 1977, microcurie quantitles of hydrogen 3 and carbon-14 were buried in accordance with 10 CFR 20.304 at another of the licensee's facilities located west of the Wabash River. The location of the burial site within the 400 acre area was unknown. The inspectors toured the area by vehicle. The area was used as a dumping ground for disposal of non radioactive hazardous wastes in accordance with EPA oversight. The area appeared remote, and without bodies of water visible on the surhee. The inspectors performed ambient Me rate surveys of selected areas. The results were indistinguishable from background.
The Decommisdoning Timeliness Rule required that, among other things, licensees provide timely idC notification that no principal activities were conducted for a period of 24 months in areas that contained radioactivity in excess of NRC requirements for release. The licensee ceased principal activities in December 1993, and the radioactive waste in storage at the licensee's facilities exceeded the NRC requirements for release.
Therefore, the licensee should have notified the NRC no later than October 15,1996 (26 months from the effective date of the rule, August 15,1994), in accordance with the
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Decommissioning Timeliness Rule. Failure to provide timely NRC notification that no principal activities were conducted for a period of 24 months in areas that contained radioactivity in excess of NRC requirements for release is an apparent violation of 10 CFR 30.36(d).
SPAH planned to hire a contractor by December 1997 to characterize the waste within the vault by March 1998, and remediate the vault by December 1998. Additionally, SPAH planned to ship all remaining unburied waste to an authorized p3rson by January 1998.
SPAH was awaiting approval of a license amendment to change the ownership, name, RSO, and use on the license.
2.3 Conclusions The inspection identified three apparent violations regarding failure to: (1) amend the license to change the RSO; (2) certify the disposition of licensed material that was used in separate buildings that were released to unrestricted use and subsequently demolished; and (3) provide timely NRC notification that no principal activities were conducted for a period of 24 months in areas that contained radioactivity in excess of NRC requirements for release. The cause of these apparent violations appeared to be licensee failure to continue oversight of its radiation safety program after it terminated principal activities in December 1993.
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Change of ownership 3.1 Inspection _ Scope The inspectors interviewed an individual who was formally employed by the licensee and who was involved with the change of ownership.
3.2 Obsentations_and Findings in June 1997, an individual representing the licensee learned that a planned sale of licensed material and associated facilities to SPAH involved an NRC license, in mid June 1997, the individual telephoned the NRC to request guidance about Getting authorization for the change of ownership. A letter dated June 27,1997, was sent to the NRC requesting a license amendment to authorize: (1) the change of ownership;(2) a new RSO; (3) a new storage location; and (4) a change from use authorization to storage only incident to disposal. The change of ownership occurred on June 30,1997, and it was sooner than originally anticipated. The NRC had not given written consent to the change of ownershir,. The regulation 10 CFR 30.34(b) requires, in part, that no NRC license nor any right under a license shall be transferred or assigned through transfer of control of any license to any person, unless the Commission gives its consent in writing. Fallure to obtain NRC written consent of the change of ownership on June 30,1997, is an apparent violation of 10 CFR 30.34(b).
3.3 Conclusions The inspectors identified an apparent violation regarding failure to obtain NRC written consent of a change of ownership.
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4, Exit Meeting Summ.ary The inspectors discussed the preliminary conclusions described in this report with a licensee representative during an exit meeting conducted at the licensee's facilities at 1331 S. First
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Street Terre Haute, Indiana on November 18,1997. The licensee did not identify any information reviewed during this inspection and selected for inclusion in l'> s !nspection report as
proprietary in nature.
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PARTIAL LIST OF PERSONS CONTACTED
Anthony Sullivan, Attomey l
Guinn Doyle, Attomey l
Rick Chiesz, Site Manager, Schering Plough Animal Health i
Michael McKee, Manager, Environmental Health and Safety, Schering Plough Animal Health i
Robert Clarkson, Supervisor of Farm Activities, Schering Plough Animal Health Leroy Schatz, Site Services Technician, Schering Plough Animal Health i
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