[Federal Register Volume 59, Number 163 (Wednesday, August 24, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20758]
[[Page Unknown]]
[Federal Register: August 24, 1994]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 030-02764; License No. 34-06903-05, EA 94-039]
University of Cincinnati, Cincinnati, Ohio; Order Imposing Civil
Monetary Penalty
The University of Cincinnati (Licensee) is the holder of Byproduct
Material License No. 34-06903-05 issued by the Nuclear Regulatory
Commission (NRC or Commission) on March 28, 1958. The license
authorizes the Licensee to use and possess, among other things,
licensed material for the purposes described in 10 CFR 35.100, 10 CFR
35.200, 10 CFR 35.300, 10 CFR 35.400, and 10 CFR 35.500, and in
accordance with the licensee conditions specified therein.
II
An inspection of the Licensee's activities was conducted from
January 16 through February 11, 1994. The results of the inspection
indicated that the Licensee had not conducted its activities in full
compliance with NRC requirements. A written Notice of Violation and
Proposed Imposition of Civil Penalty (Notice) was served upon the
Licensee by letter dated March 25, 1994. The Notice states the nature
of the violations, the provisions of the NRC's requirements that the
Licensee had violated, and the amount of the civil penalty proposed for
the violation.
The Licensee responded to the Notice by letter dated April 21,
1994. In its response, the Licensee admitted in part the violation
which was assessed a civil penalty, but contested the issuance of the
monetary penalty.
III
After consideration of the Licensee's response and the statements
of fact, explanation, and argument for mitigation contained therein,
the NRC staff has determined, as set forth in the Appendix to this
Order, that the violation occurred as stated. The NRC staff has
reevaluated the information and determined that the penalty proposed
for the violation should not have been escalated based on the
Licensee's performance. Therefore the civil penalty proposed for the
violation designated in the Notice should be mitigated by 50% based on
reconsideration of application of the Licensee Performance factor in
the Enforcement Policy and a civil penalty of $2,500 should be imposed.
IV
In view of the foregoing and pursuant to Section 234 of the Atomic
Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205,
it is hereby ordered that:
The Licensee pay a civil penalty in the amount of $2,500 within 30
days of the date of this Order, by check, draft, money order, or
electronic transfer, payable to the Treasurer of the United States and
mailed to the Director, Office of Enforcement, U.S. Nuclear Regulatory
Commission, ATTN: Document Control Desk, Washington, D.C. 20555.
V
The Licensee may request a hearing within 30 days of the date of
this Order. A request for a hearing should be clearly marked as a
``Request for an Enforcement Hearing'' and shall be addressed to the
Director, Office of Enforcement, U.S. Nuclear Regulatory Commission,
Washington, D.C. 20555, with a copy to the Commission's Document
Control Desk, Washington, D.C. 20555. Copies also shall be sent to the
Assistant General Counsel for Hearings and Enforcement at the same
address and to the Regional Administrator, NRC Region III, 801
Warrenville Road, Lisle, Illinois 60532-4351.
If a hearing is requested, the Commission will issue an Order
designating the time and place of the hearing. If the Licensee fails to
request a hearing within 30 days of the date of this Order, the
provisions of this Order shall be effective without further
proceedings. If payment has not been made by that time, the matter may
be referred to the Attorney General for collection. In the event the
Licensee requests a hearing as provided above, the issues to be
considered at such hearing shall be whether, on the basis of the
violation, this Order should be sustained.
Dated at Rockville, Maryland this 17th day of August 1994.
For the Nuclear Regulatory Commission.
James Lieberman,
Director, Office of Enforcement.
Appendix--Evaluation and Conclusion
On March 25, 1994, a Notice of Violation and Proposed Imposition of
Civil Penalty (Notice) was issued for violations identified during an
NRC inspection. The University of Cincinnati, Cincinnati, Ohio
(Licensee) responded to the Notice on April 21, 1994. The Licensee
admitted in part the violation assessed a civil penalty, but contested
the issuance of the proposed civil monetary penalty and requested
mitigation because of their recent improved performance. The NRC's
evaluation and conclusion regarding the Licensee's request follows:
Restatement of Violation I
10 CFR 20.207(a) requires that licensed materials stored in an
unrestricted area be secured against unauthorized removal from the
place of storage. 10 CFR 20.207(b) requires that licensed materials in
an unrestricted area and not in storage be tended under constant
surveillance and immediate control of the Licensee. As defined in 10
CFR 20.3(a)(17), an unrestricted area is any area access to which is
not controlled by the Licensee for purposes of protection of
individuals from exposure to radiation and radioactive materials.
Contrary to the above, between June 22, 1993, and October 5, 1993,
licensed material consisting of approximately 20 millicuries of
strontium-90 stored in Room No. 4 of the Old Operating Pavilion, an
unrestricted area, was not secured against unauthorized removal, and
was not under constant surveillance and immediate control of the
Licensee.
Summary of Licensee's Request for Mitigation
The Licensee admitted the violation in part, but contested the
civil penalty because it asserted that: (1) The licensed material was
stored in a restricted area; and (2) the NRC misapplied the civil
penalty adjustment factors of licensee performance and prior
opportunity to identify the violation.
The Licensee agreed that licensed material was lost or stolen;
however, the Licensee disagreed that the room from which licensed
material was removed was an unrestricted area. The Licensee contended
that since Room No. 4 of the Old Operating Pavilion was locked and
posted with a ``Caution--Radioactive Material'' sign, the area was a
``restricted area.'' The Licensee stated that the security of the
restricted area was compromised by unauthorized personnel.
The Licensee believes that the NRC improperly considered the
Licensee's performance. The Licensee does not believe that the
performance on July 21, 1991 (loss of three iridium-192 brachytherapy
seeds) is related to this event because the two events had dissimilar
root causes and the July 21, 1991 incident should not have been
considered in the issue at hand. The Licensee also contested the
application of this civil penalty adjustment factor because of the
Licensee's good performance in the recent past.
The Licensee further contested the civil penalty because it asserted
that the NRC incorrectly applied the civil penalty adjustment factor
for prior opportunity to identify the violation. The Licensee stated
that it did not know or suspect that NRC licensed material was missing
on either June 23 or August 3, 1993.
NRC Evaluation of Licensee's Request for Mitigation
As defined in 10 CFR 20.3(a)(14), a restricted area is any area
access to which is controlled by the Licensee for purposes of
protection of individuals from exposure to radiation and radioactive
materials. Conversely, as defined in 10 CFR 20.3(a)(17), an
unrestricted area is any area access to which is not controlled by the
Licensee for purposes of protection of individuals from exposure to
radiation and radioactive materials. While a ``Caution--Radioactive
Materials'' sign fulfills the requirement of 10 CFR 20.203(e), the mere
posting of precautionary signs on a door does not ensure that
individuals will not enter the area and, therefore, does not define an
area as either restricted or unrestricted. Positive access control can
only be achieved by mechanical means such as locking the area or by the
presence of Licensee personnel who have been instructed to control
access. If the area is locked, the key to the lock must be limited to
those individuals who are authorized to have access to the area.
The Licensee's report of the lost source, dated November 3, 1993,
states that on June 22, 1993 Radiation Safety Office staff observed
Hospital Housekeeping personnel in Room No. 4 of the Old Operating
Pavilion and determined that they had gained access through a side
door. The lock to that side door was accessible by a master key
possessed by housekeeping personnel. The Licensee's report continues
that on June 23, 1993, Radiation Safety Office staff again found
housekeeping personnel in Room No. 4 with access having been gained
through the same side door. The side door lock was rekeyed on June 23,
1993. The Licensee's report further states that housekeeping personnel
were not authorized to be in that room. Nonetheless, the key in
possession of the housekeeping staff allowed those employees unfettered
access to the area. Therefore, in the absence of positive access (key)
control, Room No. 4 of the Old Operating Pavilion became an
unrestricted area when the key was issued to the housekeeping staff.
In assessing the Licensee's performance, the NRC noted that on July
21, 1991, the Licensee lost accountability for three iridium-192
brachytheraphy sealed sources. The Licensee contends that the two
events are dissimilar and the July 21, 1991 event should not be
considered in assessing the current civil penalty. The July 21, 1991
incident related to failure to survey all items before they wee removed
from a therapy patient's room and the recent event related to
maintaining proper storage. However, both events have at their root the
inadequate control of licensed material. The corrective action for the
1991 event included providing training and revising procedures for
unusual circumstances involving the use of licensed material. Had those
procedures been followed during the recent event, the strontium-90
source might have been located. Therefore, the July 21, 1991 event is
relevant to this enforcement action.
The NRC Enforcement Policy states that when assessing licensee
performance, consideration will be given to, among other things, the
effectiveness of previous corrective action for similar problems,
overall performance and the previous enforcement history. Clearly,
prior performance is not limited to related issues, but is intended to
reflect the overall performance of a licensee over the last several
years. Consequently, weight must be given to both the area of concern
(i.e., loss of control of material) and the overall performance of the
Licensee. While the NRC expected the corrective actions for the July
21, 1991 event would have prevented this occurrence, it also recognizes
that the Licensee reported the violation and its performance has
improved over the last few years. Subsequent to the 1991 event there
have been two routine inspections and only five violations were
identified for a program of this size. Therefore, these two aspects
offset each other and neither mitigation nor escalation is appropriate
for licensee performance. Accordingly, the amount of the civil penalty
is reduced by $2,500.
Regarding the NRC's assessment of the civil penalty adjustment
factor for prior opportunity to identify the violation, the Licensee
had opportunities on at least June 23 and August 3, 1993 to perform
inventories to account for all licensed material in the restricted area
in question. On June 22, 1993, the Licensee's Radiation Safety Office
staff found unauthorized personnel in he restricted area. The
Licensee's Radiation Oncology staff performed an inventory of licensed
materials in that area and accounted for all material. However, on June
23, 1993, the Licensee's Radiation Safety Office again found
unauthorized personnel in the same restricted area, but the Licensee
did not perform an inventory to account for licensed materials.
Similarly, on August 3, 1993, the Licensee attempted to leak test the
strontium-90 source. The Licensee could not find that source and did
not make an attempt to locate it.
In the response to the Notice of Violation and Proposed Imposition
of Civil Penalty the Licensee contended that Licensee personnel were
performing leak tests, not inventories, on August 3, 1993; therefore,
the NRC incorrectly applied the civil penalty adjustment factor for
prior opportunity to identify the violation. In the Licensee's event
report of November 3, 1993, the Licensee reported, ``* * * Between
August 3, 1993, and October 5, 1993, the Radiation Safety Office Staff
member went `a couple of times' to Old Op 4 to perform the leak test.
Each time the source had not been returned.* * *'' Therefore, it
appears to NRC staff that the Licensee had many opportunities to locate
the source. The Licensee's November 3, 1993, report went on to state,
``* * *Radiation Safety personnel were reminded to question abnormal
occurrences such as sealed sources not being in their storage location
and to investigate immediately and to report missing sources
immediately to their supervisor. Assumptions are not be made by
Radiation Safety Staff members * * *.''
The purpose of the civil penalty adjustment factor for prior
opportunity to identify the violation is to encourage Licensees to take
effective action in response to opportunities to identify violations.
The Licensee's statement of November 3, 1993 clearly shows that the
Licensee did not take effective action in response to multiple
opportunities to identify the violation and supports the NRC's position
that the Licensee did not avail itself of any of the opportunities.
NRC Conclusion
The NRC has concluded that this violation occurred as stated.
However, the NRC staff has reevaluated the information and determined
that the penalty proposed for the violation should not have been
escalated based on the Licensee's performance and therefore is reducing
the proposed civil penalty from $5,000 to $2,500. Consequently, a civil
penalty in the amount of $2,500 should be imposed.
Enclosure 2--NRC Evaluation of Contested Violations not Assessed a
Civil Penalty
On March 25, 1994, a Notice of Violation and Proposed Imposition of
Civil Penalty (Notice) was issued for violations identified during an
NRC inspection. Several of the cited violations were not assessed a
civil monetary penalty. The University of Cincinnati, Cincinnati, Ohio
(Licensee) responded to the Notice on April 21, 1994, and contested
several of the violations for which a civil penalty was not proposed.
The NRC's evaluation and conclusion regarding the Licensee's points
about the violations not assessed a civil penalty follows:
License No. 34-06903-05. Restatement of Violation II.B.2
Condition 27 of License No. 34-06903-05, effective with the
issuance of Amendment No. 70 on June 29, 1992, requires that the
Licensee conduct its program in accordance with statements,
representations and procedures contained in an application received
September 20, 1990, a letter dated February 26, 1992, and other
referenced documents.
Condition 20 of License No. 34-06903-05, effective at the time of
issuance of Amendment No. 59 on March 16, 1989, required that the
Licensee conduct its program in accordance with statements,
representations and procedures contained in an application dated August
13, 1984 including attachments dated August 9, 1984, and other
referenced documents.
10 CFR 35.50(b)(4) requires, in part, that a Licensee test each
dose calibrator for geometry dependence upon installation over the
range of volumes and volume configurations for which it will be used.
Appendix 13.C., ``Dose Calibrators,'' of the referenced application
received September 20, 1990, requires, as of June 29, 1992 with the
issuance of Amendment No. 70 to License No. 34-06903-05, that the
Licensee perform dose calibrator geometry dependence testing in
accordance with the model procedure for calibrating dose calibrators
published in Appendix C to Regulatory Guide 10,8, Revision 2, August
1987. Items 6.b. through 6.f. of the model procedure require that
geometry dependence testing be performed for the type of syringe that
is normally used for injections.
Pages 24 and 25 of the referenced August 9, 1984 attachments to the
August 13, 1984 referenced application required that the Licensee
conduct geometrical dependence testing on its dose calibrators in
accordance with the procedure specified in Regulatory Guide 10.8,
Revision 1, October 1980. Section 2, Item F, of Appendix D to
Regulatory Guide 10.8, Revision 1, October 1980, requires that geometry
dependence testing be determined for a syringe.
Contrary to the above, as of February 11, 1994, the Licensee did
not conduct dose calibrator geometrical dependence testing on any of
its dose calibrators for the type of syringe that is normally used for
injections. Specifically, the Licensee did not perform syringe
geometrical dependence testing on the dose calibrator installed on
March 5, 1992 at the Radioisotope Laboratory, on the dose calibrator
installed in July 1992 at the Children's Hospital and Medical Center,
and on the dose calibrator installed on April 3, 1989 at the Medical
Arts Building.
Summary of Licensee's Response to Violation II.B.2
The Licensee admitted the violation in part and acknowledged that
personnel did not understand that the geometry test must be conducted
on various volumes using a syringe shield. The Licensee contended that
the requirement did not become effective until License Amendment No. 70
was issued on July 22, 1992.
NRC's Evaluation of the Licensee's Responses to Violations II.B.2
As described in the March 25, 1994, Notice of Violation, the
Licensee's license application of August 9, 1984, made the commitment
to conduct geometrical dependence testing on its dose calibrators in
accordance with the procedure specified in Regulatory Guide 10,8,
Revision 1, October 1980. Section 2, Item F of Appendix D to Regulatory
Guide 10.8, Revision 1, October 1980, required that geometry testing be
determined for a syringe. Therefore the Licensee was required to
conduct geometrical dependence testing as of August 9, 1984, and not
July 22, 1992, as the Licensee contended.
NRC Conclusion
The NRC has concluded that the violation occurred as stated and
neither an adequate basis for a reduction of the severity level nor for
recision of the violation was provided by the Licensee.
License No. 34-06903-13. Restatement Violations A-G
A. 10 CFR 36.23(b) requires, in part, that each entrance to a
radiation room at a panoramic irradiator have an independent backup
access control to detect personnel entry while the source is exposed.
Detection of entry while the source is exposed must cause the source to
return to its fully shielded position and must also activate a visible
and audible alarm to make the individual entering the room aware of the
hazard.
Contrary to the above, as of February 11, 1994, the entrance to the
radiation room at the Licensee's panoramic irradiator located in Room
E357 of the Medical Science Building did not have an independent backup
access control to detect personnel entry while the source was exposed.
B. 10 CFR 36.23(d) requires, in part, that before the source moves
from its shielded position in a panoramic irradiator, the source
control must automatically activate conspicuous visible and audible
alarms to alert people in the radiation room that the source will be
moved from its shielded position.
Contrary to the above, as of February 11, 1994, the source control
of the Licensee's panoramic irradiator located in Room E357 of the
Medical Science Building did not automatically activate conspicuous
visible and audible alarms to alert people in the radiation room prior
to source movement from its shielded position that the source will be
moved from its shielded position.
C. 10 CFR 36.23(f) requires, in part, that each radiation room of a
panoramic irradiator contain a control that prevents the source from
moving from the shielded position unless the control has been activated
and the door or barrier to the radiation room has been closed within a
preset time after activation of the control.
Contrary to the above, as of February 11, 1994, the radiation room
of the Licensee's panoramic irradiator located in Room E357 of the
Medical Science Building did not contain a control that prevents the
source from moving from the shielded position unless the control has
been activated and the door or barrier to the radiation room has been
closed within a preset time after activation of the control.
D. 10 CFR 36.25(c) requires, in part, that the radiation dose at 5
centimeters from the shield of a dry-source-storage panoramic
irradiator when the source is shielded not exceed 20 millirems per hour
(0.2 millisievert per hour).
Contrary to the above, on February 9, 1994, the radiation dose at 5
centimeters from the shield of the Licensee's dry-source-storage
panoramic irradiator located in Room E357 of the Medical Science
Building were approximately 40 millirems per hour (0.4 millisievert per
hour) when the source was shielded.
E. 10 CFR 36.27(a) requires, in part, that the radiation room at a
panoramic irradiator have heat and smoke detectors.
Contrary to the above, as of February 11, 1994, the radiation room
at the Licensee's panoramic irradiator located in Room E357 of the
Medical Science Building did not have heat and smoke detectors.
F. 10 CFR 36.31(a) requires, in part, that the key which actuates
the source movement mechanism of a panoramic irradiator be attached to
a portable radiation survey meter by a chain or cable.
Contrary to the above, as of February 11, 1994, the key which
actuates the source movement mechanism of the Licensee's panoramic
irradiator located in Room E357 of the Medical Science Building was not
attached to a portable radiation survey meter.
G. 10 CFR 36.31(b) requires, in part, that the console of a
panoramic irradiator have a source position indicator that indicates
when the source is in transit.
Contrary to the above, as of February 11, 1994, the console of the
Licensee's panoramic irradiator located in Room E357 of the Medical
Science Building did not have a source position indicator that
indicated when the source was in transit.
Summary of Licensee's Responses to Violations A-G
The Licensee denies each of the violations issued for NRC Byproduct
Material License No. 34-06903-13. The Licensee states that it did not
understand that the requirements contained in 10 CFR Part 36, which
became effective on July 1, 1993, applied to the teletherapy unit
authorized under the license for non-human use. In November 1993, upon
discovering that the requirements applied to its teletherapy unit, the
Licensee filed an amendment application requesting that it be exempted
from the requirements of 10 CFR Part 36. The Licensee provided
additional information on February 24, 1994 and March 14, 1994, as
requested by the NRC, regarding its exemption request. On March 28,
1994, the NRC granted the University of Cincinnati exemptions from the
requirements cited in Violations A, C, E, and F. The Licensee's
remaining exemption requests are still under review.
The Licensee claims that it identified each of the seven violations
associated with its possession and use of the teletherapy unit and was
in the process of implementing corrective actions at the time of the
inspection through its request for an exemption from 10 CFR Part 36
requirements. The Licensee states that a draft copy of its February 24,
1994 exemption request was provided during the inspection.
NRC's Evaluation of the Licensee's Responses to Violations A-G
Requests for amendments to modify or add commitments and procedures
are not effective until they are approved and an amendment has been
issued authorizing those changes. Until then, the current license
conditions and regulatory requirements remain in effect. The NRC
expects its licensees to be aware of current, revised and new NRC
requirements that pertain to the NRC license, and to submit needed
amendment applications prior to violations occurring.
In this case, 10 CFR Part 36 was published in the Federal Register
on February 9, 1993, with an effective date of July 1, 1993. Therefore,
the Licensee had approximately five months to develop and submit an
amendment request for its proposed alternatives to the requirements of
10 CFR Part 36 as authorized on 10 CFR 36.17. While the Licensee may
have identified the violations, the Licensee continued to operate the
teletherapy-type irradiator in noncompliance. The NRC did not exercise
enforcement discretion in this case because the Licensee did not
immediately correct its noncompliance or adequately develop corrective
action to prevent similar violations in the future. At the time of the
inspection, none of the exemptions requested by the Licensee had been
granted; consequently, each issue represented a violation of 10 CFR
Part 36.
The NRC Staff disagrees with the Licensee's assertion that the
Licensee identified all of the violations. The inspector identified two
additional violations of 10 CFR Part 36 requirements for which
alternative procedures were not included in the draft amendment
application reviewed by the inspector. Those requirements are contained
in 10 CFR 36.23(d), regarding visible and audible alarms to alert
people in the radiation room that the source will be moved from its
shielded position, and 10 CFR 36.31(b), regarding a source position
indicator on the console that indicates when the source is in transit.
The Licensee's failures to meet those two requirements are described in
Violations B and G, respectively.
NRC Conclusion
The NRC has concluded that these violations occurred as stated and
an adequate basis for a recision of the violations was not provided by
the Licensee.
[FR Doc. 94-20758 Filed 8-23-94; 8:45 am]
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