Drexel University, Philadelphia, Pennsylvania; Order Imposing a Civil Monetary Penalty

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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