ML20197A820
| ML20197A820 | |
| Person / Time | |
|---|---|
| Site: | 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) | |
See also: IR 07100117/2012005
Text
.
...
. .
..
-
-~
-
-
,+
3
U.S. NUCLEAR REGULATORY COMMISSION -
1
REGIONlli
,
-
_.
'
Docket No.:
030-07609
License No.:
13-01264-05
'
.
030-07609/97001(DNMS)
' Report No.:
Licensee:
Mallinckrodt Veterinary, Inc.
675 McDonnell Blvd.
P.O. Box 5840 =
'-
St. Louis, MO 63134.
.
. 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
-
Robert Gattone, Radiation Specialist
Approved By:
John R. Madera, Chief
Materials inspection Branch 1
Division of Nuclear Materials Safety
.
j
.
9712230202 971217
PDR. ADOCK 03007609
4
C
hL
. _ .
. _ .
..
.
-
. . - . .
_
-
-. .
.
.
.
.
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
_
.
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
{
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.
,
,
i
2
p
!
l
.
..
. . _ -
_
_
- .
...
.
.
-
--
..
. . - _ . ___
- _-
--.
.. --
._
.
'
'
RaportDatalin
1,
Organization and Scope of Program
NRC Byproduct Material License No.13-01264-05 authorized Mallinckrodt Veterinary,
'
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-
.
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
4
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
'
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.
2.
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.
'
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
,
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),
,
3
.
. -
-
.
- - -
-
- ,
- - -
-
. --
--
-
.
-
.
- - - - - . -
.
---
_.
-.
_-
.
.
.
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
'
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.
4
, _ _ - . -
_
. - _ _
_
l
.
.
.
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
,
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
5
.
_
__
. . _ . ___ __
_
_ ._
_
_
.
.
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.
3.
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.
6
-
.
.
. _ _ _
.
.-.
.
-.
. _ - _ _ . _ . _ . _ . . _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ . . _ _ .. _ __. _ _ . _ _
-
.
.
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
'
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.
!
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
7
7
..
.
,
.~
-,
.
. .
. - . .
_ . . _
. . .
. . .
- .