[Federal Register Volume 60, Number 32 (Thursday, February 16, 1995)]
[Notices]
[Pages 9060-9063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-3878]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 030-15139; License No. 37-04594-11; EA No. 94-167]
Drexel University, Philadelphia, Pennsylvania; Order Imposing a
Civil Monetary Penalty
I
Drexel University (Licensee) is the holder of Byproduct Materials
License No. 37-04594-11 (License) issued by the Nuclear Regulatory
Commission (NRC or Commission) on October 31, 1979. The License
authorizes the Licensee to possess and use certain byproduct materials
in accordance with the conditions specified therein at its facility in
Philadelphia, Pennsylvania.
II
An inspection of the Licensee's activities was conducted on July
22, July 27, and August 1, 1994, at the Licensee's facility located in
Philadelphia, Pennsylvania. The result of this 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 October 17, 1994. The Notice states the nature of the
violations, the provisions of the NRC requirements that the Licensee
had violated, and the amount of the civil penalty proposed for the
violations.
The Licensee responded to the Notice in two letters, both dated
November 14, 1994, and a letter dated January 17, 1995. In its
responses, the Licensee denies Violations A.2 and A.6; denies in part
Violation B; admits Violations A.1, A.3, A.4, A.5, C, D, and E;
disagrees with the classification of the violations collectively at
Severity Level III; and requests mitigation of the penalty.
III
After consideration of the Licensee's response and the statements
of fact, [[Page 9061]] explanation, and argument contained therein, the
NRC staff has determined, as set forth in the Appendix to this Order,
that: (1) Violation B should be modified to withdraw one of the
examples; (2) the remaining violations occurred as stated in the
Notice; (3) the violations were appropriately classified collectively
at Severity Level III; (4) partial mitigation of the penalty should be
allowed based on the Licensee's corrective actions; and (5) a penalty
of $5,000 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 $5,000 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 James Lieberman, Director, Office of Enforcement, U.S.
Nuclear Regulatory Commission, One White Flint North, 11555
Rockville Pike, Rockville, Maryland 20852-2738.
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, DC 20555, with a copy to the Commission's Document Control
Desk, Washington, DC 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 I, 475 Allendale Road, King of
Prussia, PA 19406.
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:
(a) Whether the Licensee was in violation of the Commission's
requirements as set forth in Violations A.2 and A.6 of the Notice
referenced in Section II above, and Violation B as amended in the
Appendix to this Order; and
(b) Whether on the basis of such violations, and the additional
violations set forth in the Notice of Violations that the Licensee
admitted, this Order should be sustained.
Dated at Rockville, Maryland this 8th day of February 1995.
For the Nuclear Regulatory Commission.
Hugh L. Thompson, Jr.,
Deputy Executive Director for Nuclear Materials Safety, Safeguards and
Operations Support.
Appendix--Evaluations and Conclusion
On October 17, 1994, a Notice of Violation and Proposed
Imposition of Civil Penalty (Notice) was issued for violations
identified during an NRC inspection. Drexel University (Licensee)
responded to the Notice in two letters, both dated November 14,
1994, and a letter dated January 17, 1995. In its responses, the
Licensee denies Violations A.2 and A.6; denies in part Violation B;
admits the remaining violations (A.1, A.3, A.4, A.5, C, D, and E);
disagrees with the classification of the violations collectively as
a Severity Level III Problem; and requests mitigation of the
penalty. The NRC's evaluation and conclusion regarding the
Licensee's requests are as follows:
Restatement of Violation A.2
Condition 21 of License No. 37-04594-11 requires that licensed
material be possessed and used in accordance with the statements,
representations, and procedures contained in the Licensee's
application dated April 1, 1991.
Item 10.4.1(d) of the application requires that students,
laboratory technicians and physical plant workmen including
housekeeping and security, all receive formal training workshops
concerning laboratory hazards including radioactive material.
Contrary to the above, from January 1992 to August 1994, certain
personnel working in restricted areas, including students,
laboratory technicians and physical plant workmen (housekeeping and
security), did not receive formal training workshops concerning
laboratory hazards including radioactive material. Specifically,
formal training workshops were not held for housekeeping, even
though housekeeping staff entered restricted areas. In addition,
training sessions held for graduate students were inadequate in that
several students interviewed were not aware of appropriate
procedures for using survey instruments or for cleaning up
contamination. In addition, the Assistant Radiation Safety Officer
(RSO) was not aware of the meaning of radioactive labels on
radioactive materials packages which he is required to survey.
Summary of Licensee's Response to Violation A.2
The Licensee denies violation A.2, stating that training is held
for students and staff who use radioactive materials (RAM), and that
training takes the form of both formal instruction, as well as one-
on-one between faculty and student. The licensee also states that if
the students join a laboratory at random times during the year, the
students receive instructions and training on the requisite
laboratory hazards, and training records are maintained. The
Licensee does not challenge the inspector's finding that isolated
incidents may have been uncovered revealing possible incomplete
knowledge on the part of a student. However, the Licensee contends
that this does not represent a failure to provide radiation safety
training to the staff.
The Licensee also states that the NRC was informed, at the time
of the enforcement conference on September 9, 1994, that neither
housekeeping staff nor physical plant workmen are permitted to enter
restricted areas unescorted. The licensee further indicates that the
laboratories are locked when unoccupied and are removed from the
building master key system, thereby requiring escorted entry if that
should become necessary. The Licensee notes that it confirmed with
the manager of the housekeeping staff that the staff are given
explicit instructions that they do not have unescorted access, and
when escorted, they are not to handle any trash or other containers
labeled with signs or other indications of hazardous materials. The
Licensee states that there is no evidence that housekeeping staff or
other workmen untrained in radiation safety entered restricted areas
unescorted.
The Licensee further states that at the enforcement conference
on September 9, 1994, the University representative informed the NRC
that a new Assistant Radiation Safety Officer (ARSO), with
appropriate technical background, had been appointed. Furthermore,
arrangements had already been made for the new ARSO to receive a
week of full-time training and education on the fundamentals in an
accredited short course on radiation safety at the end of September,
and that the ARSO is receiving additional on-campus training through
a graduate course given by a certified health physicist.
NRC Evaluation of Licensee's Response to Violation A.2
The Licensee's training program as described in Section
10.4.1(d) (``Instructions for personnel working in restricted
areas'') of its License application, requires that students,
laboratory technicians and physical plant workmen, including
housekeeping and security, all receive formal training workshops
concerning laboratory hazards including radioactive materials. The
Licensee's application does not identify any exceptions concerning
whether an individual is escorted or not. The inspector questioned
several students and found that the students did not know how to use
a survey meter or what to do in the event of a spill or accident. In
fact, the RSO stated to the inspector that no formal training had
been provided to housekeeping and security staffs from January 1992
to August 1994. In addition, the inspector learned that ARSO had not
been instructed on the meaning of various radioactive package
labels.
These findings indicate that adequate training was not provided
to some of the Licensee's staff. Some of the identified examples
involved users of phosphorus-32, which, if mishandled, could result
in a [[Page 9062]] significant contamination event. Although the
Licensee may have conducted some training, the Licensee: (1) did not
assure adequate training of all individuals covered by Item
10.4.1(d) of the license application as referenced in License
Condition 21; and (2) did not verify that those who were trained
understood the training that had been provided. Therefore, the NRC
maintains that the violation occurred as stated in the Notice.
Restatement of Violation A.6
Condition 21 of License No. 37-04594-11 requires that licensed
material be possessed and used in accordance with the statements,
representations, and procedures contained in the Licensee's
application dated April 1, 1991.
Item 10.3.1(j) requires that the RSO conduct periodic reviews of
the terms and conditions of the license to ensure compliance with
requirements.
Contrary to the above, between January 1992 and July 1994, the
RSO did not conduct periodic reviews of the terms and conditions of
the license, as evidenced by the fact that the RSO was unaware of
the requirements specified in the licensee's application dated April
1, 1991.
Summary of Licensee's Response to Violation A.6
The Licensee denies the violation and indicates that there were
differences of interpretation between the RSO and NRC, and that
those differences arose as a result of the process of the Licensee
proposing procedures in amendment applications and the NRC formally
incorporating those procedures into the license by amendment. The
Licensee also states that the RSO and RSC have thoroughly reviewed
the license, including the basic document and all letters of
additional commitments. The Licensee indicates that, based upon its
review and discussion with the NRC Regional Office, it is the
Licensee's intent to apply for modifications to the license which
will meet the Licensee's actual and limited need. The Licensee also
states that upon satisfactory resolution of the current issues with
the NRC, it expects to request modification to a more limited
license and to delete some of the current commitments which are not
reasonable for the circumstances of this Licensee's use of
radioactive materials.
NRC Evaluation of Licensee's Response to Violation A.6
License Condition 21 requires that licensed material be
possessed and used in accordance with the statements,
representations, and procedures contained in certain specified
applications and letters submitted by the Licensee. The requirement
is clear and leaves no room for differences of interpretation. As
required by License Condition 21, application dated April 1, 1991,
Item 10.3.1(j), the RSO is required to conduct periodic reviews of
the terms and conditions of the license to ensure compliance with
requirements.
Although the Licensee describes certain actions taken by the RSO
and RSC in reviewing the license, it appears that the Licensee is
referring to actions taken subsequent to the inspection. As
documented in the inspection report, the RSO was not aware of the
requirements for leak testing and physical inventory of sealed
sources, and was unfamiliar with area survey requirements for
authorized users, all of which are required by conditions of the
license. Therefore, the NRC concludes that the violation occurred as
stated in the Notice.
Restatement of Violation B
Condition 14 of the license requires that sealed sources and
detector cells not in storage and containing greater than 100
microcuries of gamma emitting radioactive material be tested for
leakage and/or contamination at intervals not to exceed 6 months or
at such other intervals as are specified by the certificate of
registration referred to in 10 CFR 32.210.
Contrary to the above, sealed sources and detector cells not in
storage and containing greater than 100 microcuries of gamma
emitting radioactive material were not tested for leakage and/or
contamination at intervals not to exceed 6 months and no other
intervals were specified by the certificate of registration referred
to in 10 CFR 32.210. Specifically, a cesium-137 and cobalt-60 source
with activities greater than 100 microcuries of gamma emitting
radioactive material per source and in use by the licensee, were not
tested for leakage and/or contamination during the period August
1991 to August 1994, an interval in excess of six months.
Summary of Licensee's Response to Violation B
The Licensee states that the only sealed source not in storage
and requiring leak testing at the time of the NRC inspection was a
1.06 mCi cesium-137 source used once or twice a year in the Physics
and Atmospheric Sciences Department. The Licensee also states that
the cobalt-60 source, having decayed to 64 Ci, does not
require leak testing and, for more than three years, has not
required it. In addition, the Licensee notes that subsequent to the
NRC inspection, the Cs-137 source was assayed on September 14, 1994,
and again in October 1994 and leak tested with no evidence of any
leakage found.
NRC Evaluation of Licensee's Response to Violation B
Since the Licensee acknowledges that leak-testing did not occur
with respect to the cesium-137 source, the NRC concludes that this
aspect of the violation occurred as stated in the Notice. Based on
the additional information which has now been provided by the
Licensee, but which was unavailable at the time of the inspection,
the aspect of the violation regarding the cobalt-60 source is hereby
withdrawn. The withdrawal of one example of a violation does not
change the fact that the violation occurred, nor does it change the
amount of the civil penalty assessed for the violations in this
case.
Summary of Licensee's Response Regarding Severity Level
The Licensee states that it does not concur with the NRC
classification of the violations collectively as a Severity Level
III Problem, contending that in a number of instances, the NRC
extrapolated a single, or even several replications of the
identical, adverse findings among many activities and personnel, to
suggest widespread disregard for either its radiation safety program
or its responsibility in its oversight and management. The Licensee
contends that it takes the protection of public health and safety as
a serious responsibility, and to suggest otherwise from the
violations cited by the NRC is a significant inaccuracy.
The Licensee also states that it finds it disturbing that the
October 17, 1994, letter transmitting the civil penalty suggests
that the NRC had an expectation that the corrective actions were to
be completed prior to the enforcement conference, and not having
them completed was a factor in classifying the violations at
Severity Level III.
The Licensee further states that since the 1991 inspection,
those involved at the time in the Radiation Safety Program
leadership and management are no longer with the Licensee and
significant change has taken place. The Licensee also states that
the Provost and Senior Vice President for Academic Affairs, Senior
Vice President for Administration and Finance, Vice Provost for
Research and Graduate Studies, Radiation Safety Officer, and the New
Chief Executive Officer of the University are all very seriously
committed to a Radiation Safety Program which is in complete accord
with NRC requirements.
NRC Evaluation of the Licensee's Response Regarding Severity Level
The violations identified during the 1994 inspection indicated a
lack of management attention to the radiation safety program, as
described in the October 17, 1994 letter transmitting the Notice.
This NRC determination of a lack of adequate management attention
was based on the fact that ten violations of NRC requirements were
identified and cited, and more importantly, five of those violations
were repetitive. If appropriate management attention had been
provided, appropriate corrective actions would have been taken after
the previous NRC findings in 1991, and these violations would not
have recurred, or would have been promptly identified and corrected
by current management. That did not happen. Rather, the violations
were identified by the NRC.
The NRC did not suggest, in its letter, that there was
widespread disregard for the program. If that had been the case, the
NRC would have proposed a more severe sanction. However, given the
number of violations, the repetitive nature of some of them, and the
fact that the violations would have been identified by the RSO or
RSC if adequate management attention was provided to the program,
the NRC concludes that the violations were appropriately categorized
collectively at Severity Level III.
The Licensee has confused the failure to take lasting corrective
action to prevent the recurrence of the violations identified during
the 1991 inspection with the issue of corrective actions for the
violations identified during the July 1994 inspection. The latter
issue was not a basis for considering the 1994 violations
collectively as a Severity Level III problem; however, it was
considered in determining the amount of the civil penalty for this
Severity level III problem. [[Page 9063]]
Summary of Licensee's Request for Mitigation
The Licensee, in its response disagrees with the NRC statement
in the October 17, 1994 letter that the Licensee's corrective
actions were not sufficiently prompt and comprehensive to warrant
any mitigation of the penalty. The Licensee indicates that the NRC
failed to recognize very significant additional actions that had
already been taken by the time of the Enforcement Conference. The
licensee details the corrective actions, which include the
establishment of additional management oversight and monitoring
controls. In addition, the Licensee maintains that the measures
taken were effective, timely, comprehensive, and pro-active, and
demonstrated a serious commitment to a quality and effective
radiation safety program.
NRC Evaluation of Licensee's Request for Mitigation
The NRC letter, dated October 17, 1994, transmitting the civil
penalty, notes that no credit was provided for the Licensee's
corrective actions. As a result, a penalty of $6,250 was proposed.
Upon reconsideration and evaluation of the licensee's corrective
actions, after receipt of the Licensee's November 14, 1994 and
January 17, 1995 responses, the NRC agrees that the actions taken
subsequent to the inspection were prompt and comprehensive and that
the full mitigation allowable based on corrective action should be
applied. Therefore, 50% mitigation of the base civil penalty amount
is being applied in this case based on the corrective actions, which
reduces the civil penalty amount by $1,250. The Licensee did not
provide any basis for any further mitigation of the penalty.
Accordingly, no further adjustment is warranted.
NRC Conclusion
The NRC has concluded that the violations occurred as stated in
the Notice, although an example of Violation B should be withdrawn,
as described herein. In addition, the NRC has concluded that the
Licensee provided an adequate basis for reduction of the civil
penalty based on its corrective actions. Accordingly, a civil
penalty in the amount of $5,000 should be imposed.
[FR Doc. 95-3878 Filed 2-15-95; 8:45 am]
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