[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]
BILLING CODE 7590-01-M