21560 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Notices

For the Nuclear Regulatory Commission.

Guy S. Vissing,

Senior Project Manager, Project Directorate

I–4, Division of Reactor Projects—I/II, Office

of Nuclear Reactor Regulation.

[FR Doc. 95–10726 Filed 5–1–95; 8:45 am]

BILLING CODE 7590–01–M

[Docket No. 030–31765, License No. 37–

28540–01, EA 94–006]

Oncology Services Corp., Harrisburg,

PA; Order Imposing Civil Monetary

Penalties

I

Oncology Services Corporation

(Licensee) was the holder of Byproduct

Materials License No. 37–28540–01

(License) issued by the Nuclear

Regulatory Commission (NRC or

Commission) on August 3, 1990. The

License authorized the Licensee to

possess and use certain byproduct

materials in accordance with the

conditions specified therein at six

facilities in Pennsylvania. The License

was due to expire on August 31, 1995.

However, on December 13, 1993, the

Licensee requested termination of the

License, with the License to be replaced

by individual licenses issued to the

facilities named as locations of use on

the License. On August 24, 1994,

License No. 37–28540–01 was

terminated, and the NRC subsequently

issued separate licenses for the

following facilities previously named as

locations of use under License No. 37–

28540–01: Greater Pittsburgh Cancer

Center (License No. 37–30163–01);

Mahoning Valley Cancer Center

(License No. 37–30086–01); Stoneboro

Oncology Associates, P.C. (License No.

37–30092–01); Greater Harrisburg

Cancer Center (License No. 37–30084–

01); Indiana Regional Cancer Center

(License No. 37–28179–02); and Exton

Cancer Center (License No. 37–30087–

01). In addition, a license was issued to

Jefferson Radiation Oncology Center

(License No. 37–30085–01).

II

An inspection of the Licensee’s

activities at its facilities located in

Indiana, Pennsylvania and Pittsburgh,

Pennsylvania was conducted on

December 3–18, 1992, by an NRC

Incident Investigation Team, following

an event involving the Indiana,

Pennsylvania facility in which there

was a significant misadministration to a

patient who died five days later, and

significant radiological exposures to

members of the public. In addition, NRC

Region I performed an inspection on

December 8, 1992, at the Licensee’s

Exton and Lehighton, Pennsylvania

facilities. The results of these

inspections 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 Penalties

(Notice) was served upon the Licensee

by letter dated May 31, 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 penalties proposed

for the violations.

The Licensee responded to the Notice

in letters dated August 31, 1994 and

October 4, 1994. In its responses, the

Licensee admits Violations III.C.2,

III.D.5, III.E. III.F, and III.I; denies

Violations I.A, I.B, II.A, II.B, III.A, III.B,

III.C.1, III.D.1–4, III.D.6, III.G, III.H, and

III.J.1–3 protests the amount of civil

penalties proposed; and requests

mitigation of the penalties, as

appropriate.

III

After consideration of the Licensee’s

responses 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

violations occurred as stated in the

Notice, and that the penalties proposed

for the violations designated in the

Notice 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 civil penalties in the

cumulative amount of $280,000 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, 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 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

I.A, I.B, II.A, II.B, III.A, III.B, III.C.1,

III.D.1–4, III.D.6, III.G, III.H, and III.J.1–

3 of the Notice referenced in Seciton II

above, and

(b) Whether, on the basis of such

violations and the additional violations

set forth in the Notice of Violation that

the Licensee admitted, this Order

should be sustained.

Dated at Rockville, Maryland this 24th day

of April 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 May 31, 1994, a Notice of

Violation and Proposed Imposition of

Civil Penalties (Notice) was issued for

violations identified during NRC

inspections (including an Incident

Investigation Team (IIT) inspection) at

several Oncology Services Corporation

(Licensee) facilities. The Licensee

responded to the Notice on August 31,

1994 and October 4, 1994. The Licensee

admitted Violations III.C.2, III.D.5, III.E,

III.F, and III.I; denied Violations I.A, I.B,

II.A, II.B, III.A, III.B, III.C.1, III.D.1–4,

III.D.6, III.G, III.H, and III.J.1–3; and

requested remission of the civil

penalties. The NRC’s evaluation and

conclusion regarding the Licensee’s

requests are as follows:

Restatement of Violations in Section I of

the Notice

I. A. 10 CFR 20.201(b) requires that

each Licensee make such surveys as

may be necessary to comply with the

requirements of 10 CFR Part 20 and

which are reasonable under the

circumstances to evaluate the extent of

radiation hazards that may be present.

As defined in 10 CFR 20.201(a),

‘‘survey’’ means an evaluation of the

radiation hazards incident to the
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Notices 21561

production, use, release, disposal, or

presence of radioactive materials or

other sources of radiation under a

specific set of conditions.

Contrary to the above, on November

16, 1992, the Licensee did not make a

survey necessary to comply with the

requirements of 10 CFR 20.101 which

limits radiation exposure to individuals

in restricted areas, and 10 CFR 20.105(b)

which limits radiation levels in

unrestricted areas. Specifically,

although the room radiation monitor in

the treatment room (restricted area) at

the Indiana Regional Cancer Center

(IRCC), flashed the red alarm signal

even after the console of the High Dose

Rate (HDR) afterloader unit showed that

a 4.2 Curie iridium-192 source was

safety retracted (because the source had

broken off inside the patient), a

radiation survey was not performed to

confirm or discount the presence of a

radiation hazard in the room or the

patient as indicated by the alarming

room monitor.

B. Condition 17 of License No. 37–

28540–01, Amendment No. 3 dated

August 19, 1992, requires, in part, that

the Licensee conduct its program in

accordance with the statements,

representations, and procedures

contained in the application dated June

1, 1990, and the letter dated August 2,

1990.

Item 9.C.3 of the application dated

June 1, 1990, requires, in part, that a

radiation monitor (PrimAlert or

equivalent) be mounted on the wall [in

the HDR afterloader treatment room]

and will remain in place as a means of

verifying a source ‘‘safe’’ or ‘‘out’’

condition.

Item 10.15.A.3 of the application

dated June 1, 1990, requires, in part,

that all attending personnel must

remain in the control area during actual

treatment and may not re-enter the

treatment room until the room radiation

detector (PrimAlert) indicates a safe

condition prevails.

Item 6 of the letter dated August 2,

1990, states that failure of the radiation

monitor will result in termination of the

treatment until the monitor is replaced

or repaired and, in the event of failure

of the room monitor, no personnel will

enter the room without a portable

survey meter or audible dosimeter.

Contrary to the above, on November

16, 1992, during a patient treatment

utilizing an iridium-192 source in a

HDR afterloader, at the IRCC, when the

wall-mounted radiation monitor flashed

the red alarm signal to indicate a source

‘‘out’’ condition, a physician authorized

user, who had been informed that the

red alarm signal was flashing, entered

the treatment room without a portable

survey meter or audible dosimeter; and,

at some point during the event, a

Licensee technologist entered the

treatment room and unplugged and

replugged the power supply of the room

radiation monitor to reset the alarm.

These violations represent a Severity

Level I problem (Supplement IV and VI)

Civil Penalty—$100,000.

Summary of Licensee’s Response to

Violation I.A

The Licensee in its responses, denies

Violation I.A and states that the

treatment room at the Indiana Regional

Cancer Center was surveyed with what

the Licensee terms ‘‘a wall mounted

survey instrument (‘WMSI’)’’, the WMSI

did not flash red in the presence of the

authorized user, and the WMSI stopped

flashing when the electrical connection

was touched. The Licensee further

asserts that the authorized user was not

aware, prior to entering the treatment

room, that the WMSI had flashed. The

Licensee also asserts that all output on

the Omnitron unit and console

indicated that the source was parked

and safe; no alarm went off on the

Omnitron unit; and all personnel acted

in accordance with what the Licensee

terms its ‘‘NRC approved Omnitron

training.’’ The Licensee states that the

conduct of the authorized user and the

Licensee was reasonable at all times and

in conformity with NRC regulations.

The Licensee also states that the

Omnitron machine failed; that failure

was neither expected nor intended; and

that the Licensee could not have

prevented the failure. The Licensee also

notes that it believes the NRC was in a

much better position to understand the

need for adequate surveys, yet the NRC

license application reviewer did not

find it necessary to require, or even

request, the Licensee modify its license

application or procedure to include a

patient survey with a hand held survey

meter after each treatment. The Licensee

states that it believes that at all times it

followed the applicable regulations, and

that it was the victim of a machine

failure and inadequate and/or outdated

regulations. The Licensee further states

that there was no intent to violate any

regulations and that personnel were not

reckless. The Licensee states that since

the WMSI was not flashing when the

authorized user was in the treatment

room, to expect the authorized user to

act other than as he did is not rational

under the existing circumstances. The

Licensee believes that, in any event, this

violation would be classified at Severity

Level IV.

NRC Evaluation of Licensee’s Response

to Violation I.A

The specific issue addressed in

Violation I.A is whether the Licensee

performed a survey as required by 10

CFR 20.101 to confirm or discount the

presence of a radiation hazard in the

room or the patient as indicated by the

alarming room monitor. The fact that

the wall mounted radiation monitor

flashed the red alarm signal even though

the Omnitron console showed that the

source was safety retracted is the

condition that triggered the requirement

to conduct a survey pursuant to

§ 20.201. Thus, the Licensee cannot

point to the same wall mounted

radiation monitor as fulfilling the

requirement to conduct the survey

pursuant to § 20.201. Rather, the

Licensee was required under those

circumstances, pursuant to § 20.201, to

perform an independent survey, such as

by using a hand held radiation survey

instrument, to determine which

indicator was correct—the wall

mounted radiation monitor, or the

Omnitron console. The Licensee failed

to do this and chose instead to discount

the alarm from the wall mounted

radiation monitor and to rely on the

Omnitron console indicator.

As to the Licensee’s statement that the

regulations are inadequate or outdated,

the Licensee does not identify any

particular regulation. However, only 10

CFR 20.201 is cited in Violation I.A. An

extensive revision of 10 CFR Part 20

became effective January 1, 1994, and

the survey requirement of 10 CFR

20.201 is now codified at 10 CFR

20.1501. The language of the specific

requirement has been changed only

slightly. The survey requirement of 10

CFR 20.201 is not outdated or

inadequate. It would have been a simple

matter for the Licensee to comply with

the requirement using the hand held

survey instrument that the Licensee had

on hand, which is a basic radiation

protection practice.

Even before the authorized user (AU)

arrived at the treatment room, Licensee

technologists noticed that the wall

mounted radiation monitor was

flashing, knew that the Omnitron

console indicated that the source was

retracted safely, and yet they were

present in the treatment room without

having performed the survey required

pursuant to § 20.201. At this point, such

a survey was necessary to comply with

the requirements of 10 CFR 20.101,

which limits exposure to individuals in

restricted areas. Thus, Violation I.A was

occurring even before the AU entered

the room.
21562 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Notices

Although knowledge on the part of

the AU that the wall mounted radiation

monitor had been flashing is not

necessary to prove the violation, the fact

that the AU was aware that the wall

mounted radiation monitor was flashing

as he entered the treatment room is

corroborated by his testimony, as well

as the testimony of others, in

transcribed interviews. Additionally,

the transcribed interviews of the AU

consistently show that, while he was in

the treatment room, he was aware that:

(1) The wall mounted radiation monitor

had been flashing; and (2) the Omnitron

console showed that the source was

safely retracted.

NRC agrees that the Omnitron source

broke off and was not retracted, that this

was neither expected nor intended by

the Licensee, and that the Licensee

could not have prevented the break.

However, that does not change the fact

that the survey required by 10 CFR

20.201 was not performed, which is a

matter that was within the Licensee’s

control. Given the conflicting

information from the flashing wall

mounted radiation monitor and the

Omnitron control panel, such a survey

was reasonable under the circumstances

to evaluate the extent of the radiation

hazards that were present. Since such a

survey was not performed, the NRC

concludes that Violation I.A occurred as

stated in the Notice. The issue of the

severity level of the violation is

addressed in the evaluation of the

Licensee’s Response to Violation I.B,

below.

Summary of Licensee’s Response to

Violation I.B

The Licensee denies Violation I.B;

incorporates its response to Violation

I.A, summarized above; and asserts that

Violation I.B would be a Severity Level

IV violation. The Licensee states that the

wall mounted radiation monitor should

have continued to alarm, and that if the

monitor had done so, the technologist

and authorized user would have acted

accordingly.

NRC Evaluation of Licensee’s Response

to Violation I.B

Licensee employees entered the

treatment room while the wall mounted

radiation monitor was alarming,

indicating a non-safe condition, and

they did so without a portable survey

meter or audible dosimeter. If the

employees believed that the wall

mounted radiation monitor was

functioning properly, they should not

have entered the treatment room while

it was alarming, which is a violation of

License Condition 17. If the employees

discounted the alarm because they

believed that the wall mounted

radiation monitor was not functioning

properly (i.e., spuriously alarming), they

should not have entered the treatment

room without a portable survey meter or

audible dosimeter, which is also a

violation of License Condition 17.

Moreover, the requirements of License

Condition 17 as cited in Violation I.B

were being violated even before the

authorized user entered the treatment

room. The transcribed interviews clearly

show that the monitor was alarming

when the technologists entered the

treatment room. The violation occurred

upon entry. Thus, whether the monitor

should have continued to alarm after the

technologist entered the treatment room

and manipulated its plug is not relevant

to the existence of the violation.

Accordingly, the NRC concludes that

Violation I.B occurred as stated in the

Notice.

Among other things, Violations I.A

and I.B were classified in the aggregate

as a Severity Level I problem in

accordance with Supplements IV and VI

of the NRC Enforcement Policy because:

(1) Conducting the survey and

complying with the requirements of

License Condition 17 regarding the wall

mounted radiation monitor, and the use

of a portable survey meter or audible

dosimeter in the event of a failure of the

wall mounted radiation monitor,

constitute a system designed to prevent

or mitigate a serious safety event, and in

this case, the system was not operable

when actually required to perform; and

(2) the violations resulted in acute

radiation exposure and subsequent

death of a patient. See Enforcement

Policy (1993), Supplement IV, Example

A.2; and Supplement VI, Examples A.2

and A.4.

Restatement of Violations in Section II

of the Notice

II.A. 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, from November

16, 1992 to December 1, 1992, licensed

material consisting of Curie quantities of

iridium-192 was located at a nursing

home, a waste disposal facility, and

several vehicles, which are unrestricted

areas, and the licensed material was not

secured against unauthorized removal

nor was it under the constant

surveillance and immediate control of

the Licensee.

B. 10 CFR 20.105(b) requires that,

except as authorized by the Commission

in 10 CFR 20.105(a), no Licensee shall

possess, use, or transfer licensed

material in such a manner as to create

radiation levels in unrestricted areas

which, if an individual were

continuously present in the area, could

result in his receiving a dose in excess

of 2 millirems in any one hour or 100

millirems in any seven consecutive

days.

Contrary to the above, from November

16, 1992 to December 1, 1992, the

Licensee allowed the creation of

radiation levels in unrestricted areas,

such that if an individual were

continuously present in the area, he

could have received a dose in excess of

2 millirems in any one hour or 100

millirems in any seven consecutive

days. Specifically, the Licensee allowed

the creation of radiation levels of

approximately 2000 millirem per hour

at a distance of one meter in

unrestricted areas, specifically a nursing

home, a waste disposal facility, and

several vehicles.

These violations represent a Severity

Level I problem (Supplement IV) Civil

Penalty—$100,000.

Summary of Licensee Response to

Violations II.A and II.B

The Licensee denies Violations II.A

and II.B and incorporates by reference

its response to the violations in Section

I. The Licensee contends that the source

was lost, not possessed, used,

transferred or stored. According to the

Licensee, loss is an accidental act,

while, as used in NRC regulations,

possession, use, transfer and storage are

deliberate acts. The Licensee asserts that

the cited violations would have required

knowledge of attending personnel that

the source was still in the patient, but

since they did not know the source was

still inside the patient, the Licensee did

not possess, use, transfer or store

material in violation of any regulations.

NRC Evaluation of Licensee’s Response

to Violations II.A and II.B

The Notice does not assert, expressly

or otherwise, that the violations were

knowing or deliberate. Neither 10 CFR

§ 20.207 nor § 20.105 require a knowing

failure to maintain control of licensed

material, or knowing exposure of

individuals to radiation, in order to

establish a violation. Under the

regulations in 10 CFR part 20, licensees

are strictly held accountable for loss of
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Notices 21563

radioactive material and for radiation

levels in unrestricted areas caused by

such loss. As a result of the Licensee’s

use of the source on November 16, 1992,

the source escaped the Licensee’s

control and was transferred to the

nursing home and, subsequently, to

other unrestricted areas, where it

created radiation levels far in excess of

the allowable limits. Therefore, the NRC

concludes that Violations II.A and II.B

occurred as stated in the Notice.

Restatement of Violations in Section III

of the Notice

III.A. 10 CFR 19.12 requires, in part,

that all individuals working in a

restricted area be instructed in the

precautions and procedures to minimize

exposure to radioactive materials, in the

purpose and functions of protective

devices employed, and in the applicable

provisions of the Commission’s

regulations and licenses.

10 CFR 35.25(a)(1) requires, in part,

that a Licensee that permits the use of

byproduct material under the

supervision of an authorized user shall

instruct the supervised individual in the

principles of radiation safety

appropriate to that individual’s use of

byproduct material.

Condition 17 of License No. 37–

28540–01, Amendment No. 3 dated

August 19, 1992, requires, in part, that

the Licensee conduct its program in

accordance with the statements,

representations, and procedures

contained in the application dated June

1, 1990.

Item 8 of the application dated June

1, 1990, requires, in part, that training

for HDR device operators will include

emergency training where the device

operator will demonstrate emergency

routine competence during a ‘‘dry run’’

emergency of the source not retracting.

Contrary to the above, individuals

who were working in the HDR

afterloader treatment room, a restricted

area, at three of the Licensee’s six

facilities in Pennsylvania, had not been

adequately instructed in the precautions

and procedures to minimize exposure to

radioactive materials, in the purpose

and functions of protective devices

employed, and in the applicable

provisions of the Commission’s

regulations and the conditions of the

license, as evidenced by the following

examples:

1. As of December 18, 1992,

technologists working in a restricted

area at the Indiana facility were not

adequately instructed in how to use a

survey meter, the meaning of a high

radiation area, the methods of

performing HDR afterloader door

interlock checks, the significance of the

alarm setpoint (the preset value) of the

wall-mounted radiation monitor, the

meaning of HDR afterloader error

messages, the activity of the sources

contained in the HDR unit and their

potential radioactive hazard, or the

corporate policy that requires the staff to

survey each patient treated with the

HDR afterloader unit with a portable

survey meter before the patient’s

release, and in addition, individuals

who operated the HDR device had not

performed a ‘‘dry run’’ emergency; and

2. As of December 8, 1992, Licensee

personnel working in restricted areas at

the Exton and Lehighton facilities had

not been instructed in the applicable

provisions of the Commission’s

regulations and the NRC license, and

individuals who operated the HDR

device had not performed a ‘‘dry run’’

emergency of the source not retracting.

B. 10 CFR 35.25(a)(1) requires, in part,

that a Licensee that permits the use of

byproduct material by an individual

under the supervision of an authorized

user shall instruct the supervised

individual in the Licensee’s written

quality management program.

Contrary to the above, as of December

8, 1992, the Licensee did not instruct

personnel who used iridium-192 under

the supervision of an authorized user at

the Exton facility in the Licensee’s

written quality management program.

C. 10 CFR 20.202(a) (1) and (3)

requires, in part, that: Each Licensee

supply appropriate personnel

monitoring equipment to, and require

the use of such equipment by, each

individual who enters a restricted area

under such circumstances that he

receives, or is likely to receive, a dose

in any calendar quarter in excess of 25

percent of the applicable value specified

in 10 CFR 20.101(a); and each Licensee

supply appropriate personnel

monitoring equipment to, and require

the use of, such equipment by each

individual who enters a high radiation

area.

Contrary to the above,

1. On November 16, 1992, during a

treatment of a patient with iridium-192

in a HDR afterloader unit, the physician

authorized user at the Indiana facility

entered the treatment room, a restricted

area, and, although the wall-mounted

radiation monitor had flashed the red

alarm signal to indicate the presence of

a radiation field, the authorized user did

not wear his personal monitoring

equipment; and,

2. On December 1, 1992, the

authorized user at the Indiana facility,

in efforts to retrieve the iridium-192

radioactive source, entered a high

radiation area at the Browning-Ferris

Industries waste facility in Carnegie,

Pennsylvania, and did not wear his

personnel monitoring equipment.

D. Condition 17 of License No. 37–

28540–01 requires, in part, that licensed

material be possessed and used in

accordance with statements,

representations, and procedures

contained in an application dated June

1, 1990, and a letter dated August 16,

1991.

1. Item 10.2 of the application dated

June 1, 1990, states that the Licensee

will establish and implement the

ALARA program that was published in

Appendix G to Regulatory Guide 10.8,

Revision 2.

Appendix G to Regulatory Guide 10.8,

Revision 2, requires, in part, that the

RSO [Radiation Safety Officer] be in

close contact with all users and workers

in order to develop ALARA procedures

for working with radioactive materials.

Contrary to the above, as of December

3, 1992, the RSO did not maintain close

contact with all users and workers. For

example, Medical Director/Authorized

Users at the Indiana and Lehighton

facilities were not aware of who the

RSO was. Additionally, the RSO had not

visited the Lehighton facility in the past

6–9 months.

2. Item No. 10.15.A.1 of the June 1,

1990, application requires that

emergency procedures be conspicuously

posted near the control console.

Contrary to the above, on December 8,

1992, the emergency procedures were

not posted at the Exton facility.

3. Item No. 10.15.B.1 of the June 1,

1990, application requires that the

calibration of the HDR afterloader

source and device include a check of

source travel time error and accuracy of

the timing device.

Contrary to the above, as of December

8, 1992, the calibration of the HDR

afterloader source and device at the

Exton facility did not include a check of

source travel time error and accuracy of

the timing device.

4. Item No. 10.12 of the June 1, 1990,

application requires that surveys of

radiation levels in adjacent and control

areas be performed at each source

exchange and logged.

Contrary to the above, as of December

8, 1992, surveys of radiation levels in

adjacent and control areas were not

performed at each source exchange at

the Exton facility.

5. The Licensee’s letter dated August

16, 1991, requires, in part, that the key

for the linear accelerator and the key for

the HDR afterloader unit be on the same

ring to prohibit the simultaneous

activation of these units.

Contrary to the above, on December 8,

1992, the key for the linear accelerator

and the key for the HDR afterloader unit
21564 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Notices

were not on the same ring at the Exton

facility and the Lehighton facility. At

each facility, the inspector noted that

the linear accelerator key was in the

linear accelerator console and the HDR

key was in the HDR console.

6. Item 4 of the letter dated August 2,

1990, requires, in part, that ancillary

personnel will receive an orientation

program and an annual review of the

basic principles related to identifying,

and proper procedures in working in,

areas controlled under this license.

Instructions for individuals will include

the subjects listed on page A–1 of NRC

Regulatory Guide 10.8, Rev. 2.

Regulatory Guide 10.8, Rev. 2, page

A–1, requires instruction in potential

hazards associated with radioactive

material in each area where the

employee will work.

Contrary to the above, as of December

4, 1992, ancillary personnel at the IRCC

facility were not informed about

radiation hazards associated with a 3.7

Curie iridium-192 source in a source

container located in the HDR afterloader

treatment room. Specifically,

housekeeping personnel had access to

the keys to the treatment room and

offered to move the source container

which measured approximately 80

millirem per hour at the surface.

E. 10 CFR 20.203(c)(1) requires that

each high radiation area be

conspicuously posted with a sign or

signs bearing the radiation caution

symbol and the words: ‘‘Caution High

Radiation Area.’’

Contrary to the above, on December 8,

1992, the high radiation area in the HDR

afterloader treatment room at the Exton

facility was not posted as required with

the required sign bearing the radiation

caution symbol and the words: ‘‘Caution

High Radiation Area.’’

F. 10 CFR 35.51(c) requires, in part,

that a Licensee check each survey

instrument for proper operation with

the dedicated check source each day of

use.

Contrary to the above, as of December

8, 1992, the Licensee at the Exton

facility routinely did not check its

survey meter with a dedicated check

source on days when the instrument

was used.

G. 10 CFR 35.25(a)(3) requires, in part,

that a Licensee that permits the use of

byproduct material by an individual

under the supervision of an authorized

user shall periodically review the

supervised individual’s use of

byproduct material and the records kept

to reflect this use.

Condition 17 of License No. 37–

28540–01 requires, in part, that licensed

material be possessed and used in

accordance with statements,

representations, and procedures

contained in an application dated June

1, 1990, and a letter dated August 16,

1991.

Item 10.15.A.4 of the application

dated June 1, 1990, requires, in part,

that daily checks of interlocks, safety

systems, and alarms be performed and

logged.

Contrary to the above, as of December

3, 1992, supervised individuals at the

IRCC facility routinely did not perform

daily interlock checks as required in

conjunction with operating the HDR

afterloader containing iridium-192, and

the Licensee did not review their

performance of this procedure.

H. 10 CFR 35.21(b)(2) requires, in

part, that the RSO establish, collect in

one binder or file, and implement

written policy and procedures for:

(v) Using byproduct material safely,

(vi) Taking emergency action if

control of byproduct material is lost,

(viii) Performing checks of survey

instruments and other safety equipment,

and

(x) Training personnel who work in or

frequent areas where byproduct material

is used or stored.

Contrary to the above, as of November

16, 1992:

1. The RSO did not establish and

implement written policy and

procedures for using byproduct material

safely. Specifically, although iridium192 was in use in HDR afterloader units

at the Indiana, Exton, and Lehighton

facilities, written procedures entitled,

‘‘Oncology Services Corporation,

Department of Physics, HDR Treatment

Manual’’, existed only in draft form and

the RSO had not distributed them to the

staff.

2. The RSO did not establish and

implement procedures for taking

emergency action if control of

byproduct material was lost.

Specifically, the RSO had not

established or implemented such

procedures as of December 1, 1992,

when the Licensee retrieved a 3.7 Curie

iridium-192 source from a waste

disposal facility and transported it back

to the Licensee’s facility.

3. The RSO did not implement

procedures at the IRCC for performing

checks of survey instruments and other

safety equipment. Specifically, the RSO

did not implement procedures for

checking survey instruments for proper

operation with a dedicated check source

on days when the instrument was used,

as required by 10 CFR 35.51(c); and for

checking the treatment room door

interlock in conjunction with operating

the HDR afterloader, as required by

License Condition 17, application dated

June 1, 1990, Item 10.15.A.4.

4. The RSO did not establish and

implement written policy and

procedures for training personnel who

work in or frequent areas where

byproduct material is used or stored.

For example, the RSO believed that it

was the responsibility of the physicist at

the Indiana, PA, facility to provide such

training to the individuals there;

however, the medical physicist stated

that his contract did not indicate that he

should provide training.

I. 10 CFR 35.13(e) requires that a

Licensee apply for and must receive a

license amendment before it adds to or

changes the areas of use or address or

addresses of use identified in the

application or on the license.

Contrary to the above, on or about

April 23, 1991, the Licensee’s RSO

changed the area of use of iridium-192

in a HDR afterloader for a shielding

experiment from the shielded therapy

room at the Greater Harrisburg Cancer

Center, the area of use identified in the

application, to an area outside of the

building and, as of that date, the

Licensee had not applied for or received

a license amendment authorizing the

change.

J. 10 CFR 71.5(a) requires that a

Licensee who transports licensed

material outside the confines of its plant

or other place of use, or who delivers

licensed material to a carrier for

transport, shall comply with the

applicable requirements of the

regulations appropriate to the mode of

transport of the Department of

Transportation (DOT) in 49 CFR Parts

170 through 189.

1. 49 CFR 173.24(f)(ii) requires, in

part, that closures on packagings shall

be so designed and closed that under

conditions normally incident to

transportation, the closure is secure.

49 CFR 173.475(c) requires, in part,

that before each shipment of any

radioactive materials package, the

shipper shall ensure by examination or

appropriate tests that each closure

device of the packaging is properly

installed, secured, and free of defects.

Contrary to the above, on December 1,

1992, the Licensee transported a

radioactive materials package

containing 3.7 Curies of iridium-192

and there was no closure device on the

packaging.

2. 49 CFR 177.817(a) requires that a

carrier not transport a hazardous

material unless it is accompanied by a

shipping paper prepared in accordance

with 49 CFR 172.200–203. Pursuant to

49 CFR 172.101, radioactive material is

classified as hazardous material.

Contrary to the above, on December 1,

1992, the Licensee transported 3.7
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Notices 21565

Curies of iridium-192, a radioactive

material, without a shipping paper.

3. 49 CFR 172.504 prescribes

requirements for placarding vehicles

used to transport hazardous materials.

Specifically, Table 1 requires that the

transport vehicle be placarded on each

side and each end with a

‘‘RADIOACTIVE’’ placard when

transporting packages bearing a

‘‘RADIOACTIVE YELLOW–III’’ label

(footnote 4).

Contrary to the above, on December 1,

1992, the Licensee transported 3.7

Curies of iridium-192 outside the

confines of its plant in a package with

the required YELLOW–III label, and the

transport vehicle was not placarded

with a ‘‘RADIOACTIVE’’ placard.

These violations represent a Security

Level II problem (Supplement IV, V and

VI) Civil Penalty—$80,000.

Summary of Licensee’s Response to

Violations III.A and III.B

The Licensee denies Violations III.A

and III.B and states that at all times it

adequately instructed all personnel in

relevant areas consistent with 10 CFR

19.12, 10 CFR 35.25(a)(1), and the

license, and that it would be incorrect

for NRC to take the position that each

and every individual must be

knowledgeable about each and every

regulation and/or license condition. The

Licensee believes that, in any event,

these violations would be classified at

Severity Level III.

NRC Evaluation of Licensee Response to

Violations III.A and III.B

The Licensee was not cited for failure

to instruct each and every individual in

every NRC requirement. 10 CFR 19.12

requires that training for workers be

commensurate with potential

radiological health protection problems

in restricted areas. Additionally,

training must fulfill specific regulations

such as 10 CFR 35.25(a)(1), as well as

specific commitments made by the

Licensee and incorporated into the

license by condition. Violations III.A

and III.B were identified as a result of

discussions between OSC personnel and

NRC inspectors or investigators. NRC

does not dispute that some training did

occur. However, as documented in the

inspection report, the Incident

Investigation Team (IIT) report, and the

investigation by NRC’s Office of

Investigations (OI), the training that was

given was not adequate to meet the

requirements. The Licensee’s general

assertion that it complied with all

requirements does not refute the fact

that the specific subjects described in

Violations III.A and III.B were not

covered adequately in the training that

the Licensee gave to the personnel

described in Violations III.A and III.B.

Thus, the NRC concludes that the

violations occurred as stated in the

Notice.

The NRC did not categorize the

individual violations and examples of

violations in Section III of the Notice by

severity level. Rather, the NRC

considered the violations in the

aggregate as a single problem

categorized at Severity Level II. The

Enforcement Policy defines a Severity

Level II violation or problem as one of

very significant concern. Clearly, this

severity level is appropriate here

because the number and nature of the

violations represent a very significant

corporate management breakdown in

the control of licensed activities; and

the lack of attention to, and

understanding of, regulatory

requirements on the part of Licensee

management and its RSO contributed to

the November 1992 event. The purpose

of aggregating violations is to focus the

Licensee’s attention on the fundamental

underlying causes for which

enforcement action is warranted, and to

reflect the fact that several violations

with a common cause are more

significant collectively than

individually, and therefore, warrant a

more substantial enforcement action.

See Enforcement Policy, Section IV.A.

In this case it was necessary to focus the

Licensee’s attention on the importance

of meticulous oversight of the corporate

radiation safety program, the lack of

which was a common causative factor in

the violations.

Summary of Licensee’s Response to

Violation III.C

The Licensee denies Example III.C.1

and states that it supplied and required

the use of personnel monitoring

equipment; however, the authorized

user had no reason to believe that it was

necessary to wear a film badge. The

Licensee further incorporates by

reference its response to Violations A

and B in Section I of the Notice. The

Licensee believes that, in any event,

Example III.C.1 would constitute a

Severity Level V violation. The Licensee

admits Example III.C.2 but believes that

it constitutes a Severity Level V

violation.

NRC Evaluation of Licensee Response to

Violation III.C

10 CFR 20.202(a)(1) requires that the

Licensee require the use of appropriate

personnel monitoring equipment by

each individual who enters a restricted

area (the HDR treatment room) under

such circumstances that he receives, or

is likely to receive, a dose in any

calendar quarter in excess of 25 percent

of the occupations dose limits specified

in 10 CFR 20.101(a). The treatment

room constituted a restricted area

because access to this area was

controlled by the Licensee for purposes

of protection of individuals from

exposure to radiation and radioactive

materials. See 10 CFR 20.3(a)(14). With

a 4.2 Curie iridium–192 source in the

unshielded configuration, an individual

entering the treatment room would be

likely to receive a dose in excess of 25%

of the occupational dose limits specified

in 10 CFR 20.101(a).

Moreover, 10 CFR 20.202(a)(3)

requires that the Licensee require the

use of personnel monitoring equipment

by each individual who enters a high

radiation area. The treatment room

constituted a high radiation area

because, when the source is in an

unshielded configuration, radiation

levels in the treatment room are such

that a major portion of the body could

receive in any one hour a dose in excess

of 100 millirem. See 10 CFR

20.202(b)(3). The Licensee was well

aware of this fact, because it had posted

the room as a high radiation area at the

time of the November 16, 1992 event.

The requirement that the Licensee

supply and require the use of

appropriate personnel monitoring

equipment does not depend on the

individual’s perception of a radiation

hazard, but rather on the fact of a

radiation hazard that may result in an

exposure in excess of the limit in

§ 20.202(a)(1), or that requires posting as

a high radiation area as per

§ 20.202(a)(3). Any time that the

authorized user (AU) supervised the use

of the HDR unit, he could be called

upon to make an emergency entry into

the treatment room with the source in

an unshielded configuration. The

Licensee should have been well aware

of this fact, because the license

application specifies training for its

employees in emergency procedures

involving entry into the treatment room

with the source in an unshielded

configuration. See License Condition 17,

Application dated June 1, 1990, Item

10.15.C. Thus, the Licensee should have

assured that the AU wore his personnel

monitoring equipment whenever he

supervised the use of the HDR unit. The

AU did enter the treatment room with

the source in an unshielded

configuration and he was not wearing

his personnel monitoring equipment.

Therefore, the NRC concludes that

Example III.C.1 occurred as stated in the

Notice. Moreover, even if the Licensee

had provided an adequate reason to

withdraw Example III.C.1, Violation

III.C still occurred as evidenced by the
21566 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Notices

Licensee’s admission of Example III.C.2.

The issue of the Severity Level of the

violation is addressed in the evaluation

of the Licensee’s response to Violations

III.A and III.B, above.

Summary of Licensee’s Response to

Violation III.D.1

The Licensee denies Violation III.D.1,

states that the RSO did not fail to

discharge his duties, states that the RSO

did not violate any regulation relating

thereto, and notes that the NRC has not

cited any such specific regulation and

that the RSO had an ALARA program in

place. The Licensee states that there is

no requirement that the Licensee have

any physical presence at any facility. In

addition, the Licensee states that the

RSO and a physicist were in

communication with the Lehighton

facility by telephone and fax.

NRC Evaluation of the Licensee

Response to Violation III.D.1

The Licensee was required, pursuant

to License Condition 17, to follow the

commitments it made in the June 1,

1990, application to the NRC. Item 10.2

of the application required that

Appendix G of Regulatory Guide 10.8 be

followed which in turn required the

RSO to be in ‘‘close contact’’ with all

users and workers in order to develop

ALARA procedures for working with

radioactive materials. The Licensee

specifically committed in its license

application that the RSO would do this.

The development of ALARA procedures

is a continuing and evolving process

and requires firsthand observations and

audits of employee knowledge, work,

and work conditions. The fact that some

ALARA procedures may have been in

place does not relieve the Licensee of

full compliance with this requirement.

The mere fact that the RSO may have

been in communication by telephone or

facsimile does not disprove the

violation. In order for that fact to be

relevant at all, the Licensee would have

to show that such communications were

with all users and workers and were for

the purpose of developing ALARA

procedures, which the Licensee has not

done. Clearly, communications

concerning, for example, patient

treatment parameters, would have no

bearing at all.

The NRC determined, via interviews,

that the Medical Director and

authorized user at the Indiana,

Pennsylvania and Lehighton,

Pennsylvania facilities were not aware,

at the time of the IIT and the NRC

inspection in December 1992, who the

RSO was. Additionally, the RSO had not

visited the Lehighton facility in the past

6–9 months. Also, as determined during

the inspection of the Exton facility, the

technologist and the medical physicist

at the Exton facility both believed that

the medical physicist was the RSO.

Accordingly, it is appropriate to

conclude that the RSO did not maintain

close contact with all users and workers

as required by License Condition 17.

Therefore, the NRC concludes that

Violation III.D.1 occurred as stated in

the Notice.

Summary of Licensee’s Response to

Violation III.D.2

The Licensee denies Violation III.D.2

and states that emergency procedures

were available but not vertically posted

because they kept falling down, and that

it immediately posted the procedures

following the inspection. The Licensee

believes that, in any event, this

constitutes a Severity Level V violation.

NRC Evaluation of Licensee Response to

Violation III.D.2

The Licensee stated that the

emergency procedures kept falling

down. The inspection report states that

the procedures were available but not

posted at the time of the inspection, and

that this was corrected before the

inspectors left the facility. During the

inspection, the medical physicist

obtained a copy of a set of emergency

procedures which was incomplete

(contained blanks), and the Licensee

had to fill in the blanks with Licensee

specific information, and post the

procedures conspicuously near the

control console so that appropriate staff

would have access to the procedures.

The Licensee specific information had

not been entered on the emergency

procedures prior to the inspection.

Therefore, even the emergency

procedures that were available, but not

posted, were incomplete.

At the time that the Licensee

established its HDR brachytherapy

program, the blanks in the emergency

procedures should have been filled in

with Licensee specific information and

the procedures should have been

conspicuously and durably posted near

the control console so that appropriate

staff would have immediate access to it.

This was not done. There, the NRC

concludes that Violation III.D.2

occurred as stated in the Notice. The

issue of the Severity Level of the

violation is addressed in the evaluation

of the Licensee’s response to Violations

III.A and III.B, above.

Summary of Licensee’s Response to

Violation III.D.3

The Licensee denies Violation III.D.3

and states that Exton personnel always

did hand calculations and always

checked the source travel time error and

accuracy of the timing device by using

the clock on the wall and their wrist

watches. The Licensee believes that, in

any event, Violation III.D.3 would

constitute a Severity Level V violation.

NRC Evaluation of Licensee Response to

Violation III.D.3

The Licensee’s unsupported general

assertion that the calculations and

checks for timing device accuracy and

travel time error were in fact performed

does not demonstrate that the violation

did not occur. During the inspection,

the NRC found evidence that the checks

of the source travel time error and

accuracy of the timing device were not

done. Specifically, as noted in Section

7 of NRC Inspection Report 30–31765/

92–001, issued on December 23, 1992,

the record of the HDR calibration

performed at Exton indicated that the

source output was checked but that the

source travel time error and accuracy of

the timing device were not checked.

Therefore, the NRC concludes that the

violation occurred as stated in the

Notice. The issue of the Severity Level

of the violation is addressed in the

evaluation of the Licensee’s response to

Violations III.A and III.B, above.

Summary of Licensee’s Response to

Violation III.D.4

The Licensee denies Violation III.D.4

and states its belief that Omnitron

personnel performed surveys for the

benefit of the Licensee. The Licensee

believes that, in any event, Violation

III.D.4 would constitute a Severity Level

IV violation.

NRC Evaluation of Licensee Response to

Violation III.D.4

The Licensee’s response provides no

facts or records to support the

Licensee’s assertion that the surveys in

question were ever performed by

Omnitron. While Omnitron personnel

may have performed some surveys in

connection with their work during

source exchanges, the Licensee provides

no evidence that any such surveys

included all adjacent areas as well as

control areas. Therefore, the NRC

concludes that Violation III.D.4

occurred as stated in the Notice. The

issue of the Severity Level of the

violation is addressed in the evaluation

of the Licensee’s response to Violations

III.A and III.B, above.

Summary of Licensee’s Response to

Violation III.D.5

The Licensee admits the violation but

believes that it would constitute a

Severity Level IV violation.
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Notices 21567

NRC Evaluation of Licensee Response to

Violation III.D.5

The issue of the Severity Level of the

violation is addressed in the evaluation

of the Licensee’s response to Violations

III.A and III.B above.

Summary of Licensee’s Response to

Violation III.D.6

The Licensee states that since it does

not have sufficient knowledge as to the

specific truth regarding whether

ancillary personnel (specifically,

housekeeping personnel) were informed

about radiation hazards associated with

a 3.7 curie iridium-192 source in a

source container located in the High

Dose Rate (HDR) afterloader treatment

room, it must deny this violation. The

Licensee believes that, in any event,

Violation III.D.6 would constitute a

Severity Level IV violation.

NRC Evaluation of Licensee Response to

Violation III.D.6

Housekeeping personnel interviewed

by the NRC staff were not aware of the

radiation hazards associated with a 3.7

curie iridium-192 source. Specifically,

on December 4, 1992, OSC

housekeeping personnel unlocked the

area where the iridium source was being

stored following the source retrieval

operation and accompanied NRC

inspectors into the area, and the

housekeeping personnel had not been

informed about the radiation hazards

associated with the source. Therefore,

the NRC concludes that Violation III.D.6

occurred as stated in the Notice. The

issue of the Severity Level of the

violation is addressed in the evaluation

of the Licensee’s response to Violations

III.A and III.B, above.

Summary of Licensee’s Responses to

Violations III.E–F

The Licensee admits the violations

but believes that Violation III.E would

constitute a Severity Level V violation

and that Violation III.F would constitute

a Severity Level IV violation.

NRC Evaluation of Licensee Response to

Violation III.E–F

The issue of the Severity Level of the

violations is addressed in the evaluation

of the Licensee’s response to Violations

III.A and III.B, above.

Summary of Licensee’s Response to

Violation III.G

The Licensee states that daily

interlock checks were consistently done

by individuals at IRCC, and that there

was no requirement for the Licensee to

review such completed checks as of

December 1992. In addition, the

Licensee notes that such checks would

have been reviewed at an annual audit.

The Licensee believes that, in any event,

Violation III.G would constitute a

Severity Level IV violation.

NRC Evaluation of Licensee’s Response

to Violation III.G

Licensee technologists interviewed by

the Incident Investigation Team (IIT)

indicated that daily HDR interlock

checks routinely were not performed as

required. This is corroborated by the

fact that there is not a log record for

every check required. The Statements of

Consideration for 10 CFR 35.25,

‘‘Supervision’’, state: ‘‘The purpose of

supervision is to provide assurance that

technologists and physicians do not use

byproduct materials in a manner that is

contrary to the requirements of the

license, the regulations, or that is

hazardous to the public health and

safety [emphasis added].’’ See 51 Fed.

Reg. 36940. While the Licensee was not

required to review each and every check

on a daily basis, it was required,

pursuant to 10 CFR §§ 35.11, 35.25(a)(2),

and 35.25(a)(3), to perform periodic

reviews at a frequency sufficient to

provide reasonable assurance that

individuals working under the

supervision of an authorized user were

complying with, among other things,

License Condition 17 with respect to the

performance of daily interlock checks. It

is clear from the fact that the

noncompliance was occurring,

undetected to the Licensee, that a single

audit at the end of the year would not

suffice. The NRC concludes that

Violation III.G occurred as stated in the

Notice. The issue of the Severity Level

of the violation is addressed in the

evaluation of the Licensee’s response to

Violations III.A and III.B, above.

Summary of Licensee’s Response to

Violation III.H

The Licensee denies the violation and

states that at all times the RSO fully

complied with relevant regulatory

requirements, including implementing

and distributing policies and

procedures, and gathering materials.

The Licensee also states that the RSO

was immediately notified about the

November 16, 1992 incident and

instructed personnel how to respond

appropriately.

NRC Evaluation of Licensee Response to

Violation III.H

The Licensee provides no information

to support its general assertion that it

complied with all regulatory

requirements or to refute the facts

documented in the Incident

Investigation Team (IIT) report, and the

investigation by NRC’s Office of

Investigations (OI), upon which the

violations are based. Accordingly, the

NRC concludes that the violation

occurred as stated in the Notice.

Summary of Licensee’s Response to

Violation III.I

The Licensee admits that the RSO

conducted the experiment, but states

that the RSO took all measures to assure

that such experiment was done safely

and without risk, and this was not a

willful violation but was done for the

purpose, in part, of radiation safety. The

Licensee believes that, in any event,

Violation III.I would constitute a

Severity Level IV violation.

NRC Evaluation of Licensee Response to

Violation III.I

The Licensee admits that the RSO

conducted the experiment and does not

deny that the RSO changed the area of

use of iridium-192 from the shielded

therapy room to an area outside the

building without first applying for or

receiving a license amendment

authorizing the change. The Licensee

and its RSO may not pick and choose

which regulatory requirements they will

follow, even if they believe that

noncompliance would somehow further

radiation safety. 10 CFR 35.13(e)

requires that the Licensee apply for and

receive a license amendment before

changing the area of use specified in the

license. Moreover, willfulness is not a

necessary element of a violation of 10

CFR 35.13(e). Accordingly, the NRC

concludes that Violation III.I occurred

as stated in the Notice. The issue of the

Severity Level of the violation is

addressed in the evaluation of the

Licensee’s response to Violations III.A

and III.B, above.

Summary of Licensee’s Response to

Violations III/J.1–3

The Licensee states that its intent was

not to become a shipper or a carrier of

licensed material but under the

extenuating circumstances, the Licensee

contacted the NRC and was told what to

do to retrieve the source. In addition,

the Licensee states that at no time did

the NRC attempt to alert the Licensee

about the regulations cited in the

Notice. The Licensee states that at the

time of the incident, it did not transport

sources, and as such was not generally

knowledgeable about such. The

Licensee further states that the Licensee

took extreme precautions and brought

the source back in a safe, secured

container. Finally, the Licensee states

that since it quickly retrieved the source

after the NRC specifically told the

Licensee to get the source, it would be

unfair to cite the Licensee for these
21568 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Notices

violations. The Licensee believes that,

in any event, Violations III.J.1–3 would

constitute Severity Level V violations.

NRC Evaluation of Licensee Response to

Violations III.J.1–3

Prior to the incident, the Licensee

requested a license amendment to

permit it to transport licensed material

as part of its licensed activities. License

Condition No. 15 of Amendment No. 03,

dated August 19, 1992, authorized the

Licensee to transport licensed material

in accordance with the provisions of 10

CFR Part 71, ‘‘Packaging and

Transportation of Radioactive Material’’.

Therefore, the Licensee should have

been familiar with the provisions of 10

CFR Part 71. In any case, the Licensee

transported the radioactive source on

December 1, 1992, and therefore was

bound by the requirements in 10 CFR

71.5(a). The fact that the NRC advised

the Licensee to retrieve the Licensee’s

source does not excuse the Licensee

from the requirements of Part 71, nor

does it excuse the Licensee from its

ignorance of the requirements of Part 71.

At no time did NRC suggest that

applicable regulations should not be

followed. Since these requirements were

not met, the NRC concludes that

Violations III.J.1–3 occurred as stated in

the Notice. The issue of the Severity

Level of the violations is addressed in

the evaluation of the Licensee’s

response to Violations III.A and III.B,

above.

Summary of Licensee’s Request for

Mitigation

The Licensee states that subsequent to

the Indiana event, Licensee management

took corrective action by: immediately

and voluntarily suspending HDR

treatments at the Licensee’s facilities

that did not have full-time physicists for

HDR treatments in order to review its

entire HDR program; fully and timely

complying with any and all

Confirmatory Action Letters (CALs);

replacing its RSO with a brachytherapy

specialist; replacing multiple contract

physicists; and hiring additional,

qualified full-time physicists. The

Licensee states that its proposed

replacement of the RSO constitutes

corrective action regarding all issues

raised by the NRC, and notes that its

new RSO has regularly been physically

present at the Greater Pittsburgh and

Greater Harrisburg facilities to review

the entire HDR program.

The Licensee also notes that it has

completely modified its HDR program,

that the revised program has been

approved by the NRC, and that Licensee

management has been highly involved

with the HDR program and has met on

a regular basis with the new RSO. In

addition, the Licensee notes that it has

restructured its physics program, which

has resulted in at least quarterly

training/refresher courses in radiation

safety and regulatory compliance at all

facilities for all staff. Further, the

Licensee notes that is authorized users

have attended an intensive training

session with the new RSO regarding

HDR usage, safety and emergency

responses. The Licensee also notes that

it hired a Certified Health Physicist

(CHP) as Vice President of Regulatory

Affairs and gave the CHP broad

management authority, and that the

CHP is responsible for the day-to-day

radiation safety program company-wide.

The Licensee also states that it

believes that the fines imposed are

inappropriate and unsupported by the

facts and applicable law. The Licensee

states that to apply the $100,000 per

violation discretionary fine on the

Licensee is now warranted and is unfair.

In addition, the Licensee states that the

NRC has attempted to impose the

$100,000 fine twice for one alleged

failure, that being the alleged failure by

the authorized user to do a survey with

a hand held survey meter; and asserts

that the loss of the source was not a

separate action and cannot be separated

from the alleged survey failure. With

respect to the $80,000 fine for the

violations in Section III, the Licensee

submits that the alleged violations, even

if true, do not constitute a Severity

Level II problem. The Licensee claims

that it appears that NRC has not taken

the past exemplary conduct of the

Licensee into consideration and the

Licensee requests that this conduct be

reviewed again.

The Licensee cites a number of

enforcement sanctions taken by the NRC

against other licensees, which the

Licensee believes supports its claim that

the sanction imposed on the Licensee is

not only unfair and inappropriate, but

unlawful. The Licensee requests that the

fines be reduced to $14,000.

NRC Evaluation of Licensee’s Request

for Mitigation

Pursuant to Section 234 of the Atomic

Energy Act, as amended, the NRC is

authorized to impose civil penalties of

up to $100,000 per violation per day for

each day that a violation continues.

Normally, proposed civil penalties are

determined after application to the base

civil penalty of the mitigating and

escalating factors in Section VI of the

Enforcement Policy, including

corrective action and licensee

performance. Section VII.A of the

Enforcement Policy provides, however,

that notwithstanding the outcome of the

normal civil penalty adjustment

process, the NRC may exercise its full

enforcement authority to ensure that the

resulting enforcement action

appropriately reflects the level of NRC

concern regarding the violations at issue

and conveys the appropriate message to

the licensee, in order to provide an

appropriate sanction when particularly

serious violations or serious

breakdowns in management controls

have occurred. In view of the

particularly serious violations, which

resulted in the death of a patient and

exposure of numerous members of the

public to radiation in excess of

regulatory limits, and in view of the

necessity of emphasizing to the Licensee

the importance of meticulous

management oversight of the radiation

safety program, a very significant civil

penalty was warranted. The NRC

appropriately exercised its statutory

authority when it proposed a $100,000

civil penalty each for the violations in

Section I and II of the NOV, and an

$80,000 civil penalty for the violations

in Section III. The NRC also expects that

these penalties will give all other

similar licensees, including the

successor licensees to OSC, an incentive

to closely scrutinize their operations to

avoid similar violations.

The Licensee’s assertion that

Problems I and II constitute a single

violation is mistaken. Problems I and II

involve violations of separate and

distinct NRC requirements, with

separate and distinct facts and

consequences. Problem I involves a

failure to perform surveys and to use

radiation safety devices in violation of

10 CFR 20.201(b) and License Condition

17, which led to a misadministration

resulting in acute radiation exposure

and subsequent death of the patient.

Problem II involves a loss of control of

a radioactive source and the creation of

radiation levels in unrestricted areas in

violation of 10 CFR 20.206 and 10 CFR

20.105, which led to exposures of

numerous members of the public to

radiation in excess of regulatory limits.

Therefore, separate violations are clearly

justified. Atlantic Research Corporation,

ALJ–78–2, 7 NRC 701 (1978).

The issue of the severity level of the

violations in Section III of the NOV was

addressed under ‘‘NRC Evaluation of

Licensee’s Response to Violations III.A

and III.B.’’

The NRC acknowledges that the

Licensee has taken corrective actions

and is aware of the Licensee’s past

performance. However, in this case, the

NRC exercised discretion to escalate the

civil penalties, which supersedes the

normal application of the adjustment

factors, as explained above. In addition,
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Notices 21569

civil penalties are imposed, in part, to

deter future violations by not only the

involved licensee, but other licensees

conducting similar activities. See

Enforcement Policy, Section VI.B.

Contrary to the Licensee’s statements,

the civil penalties proposed in this case

are within the authority of the NRC. The

Licensee’s comparison of the civil

penalties in this case with civil

penalties in other cases does not bring

the NRC’s exercise of its lawful

authority into question. Of decisive

importance is the NRC’s clear authority

to exercise discretion in the choice of

enforcement sanctions and the ordering

of enforcement priorities. Advanced

Medical Systems, Inc., (CLI–94–6), 39

NRC 285, 320 (1994). A sanction is not

rendered invalid because it is more

severe than that issued in other cases.

Id. As explained above, the NRC acted

within its statutory authority and the

bounds of the Enforcement Policy when

NRC exercised its discretion to escalate

the civil penalties in this case. A rigid

uniformity is not required in

enforcement decisions, which

inherently involve the exercise of

informed judgment on a case-by-case

basis. Id. See also, Radiation

Technology, Inc., (ALAB–567), 10 NRC

533, 541 (1979).

NRC Conclusion

The NRC has concluded that the

violations occurred as stated in the

Notice and an adequate basis for

mitigation of the civil penalties was not

provided by the Licensee. Consequently,

the proposed civil penalties in the

amount of $280,000 should be imposed.

[FR Doc. 95–10731 Filed 5–1–95; 8:45 am]

BILLING CODE 7590–01–M

[Docket No. 50–278]

PECO Energy Company; Public

Service Electric and Gas Company;

Delmarva Power and Light Company;

Atlantic City Electric Company (Peach

Bottom Atomic Power Station, Unit 3);

Exemption

I

PECO Energy Company, et al. (PECo.,

the licensee), is the holder of Operating

License No. DPR–56, which authorizes

operation of the Peach Bottom Atomic

Power Station, Unit 3, at steady state

reactor core power levels not in excess

of 3293 megawatts thermal. The license

provides, among other things, that the

licensee is subject to the rules,

regulations and order of the

Commission now or hereafter in effect.

The plant is a boiling water reactor

located at the licensee’s site in York

County, Pennsylvania.

II

Section 50.54(o) of 10 CFR Part 50

requires that primary reactor

containments for water cooled power

reactors be subject to the requirements

of Appendix J to 10 CFR Part 50.

Appendix J contains the leakage test

requirements, schedules, and

acceptance criteria for tests of the leak

tight integrity of the primary reactor

containment and systems and

components which penetrate the

containment.

Section III.D.2(a) of Appendix J to 10

CFR Part 50 requires that Type B leak

rate tests, except for air locks, be

performed during reactor shutdown for

refueling, or other convenient intervals,

but in no case at intervals greater than

2 years. Type B tests are intended to

detect local leaks and to measure

leakage across each pressure-containing

or leakage-limiting boundary for certain

reactor containment penetrations.

Section III.D.3 of Appendix J to 10

CFR Part 50 requires that Type C leak

rate tests be performed during each

reactor shutdown for refueling but in no

case at intervals greater than 2 years.

Type C tests are intended to measure

containment isolation valve leakage

rates for certain containment isolation

valves.

III

By letter dated February 22, 1995, the

licensee requested a one-time

exemption from the requirements of

Appendix J, Sections III.D.2(a) and

III.D.3 for a period of 60 days for the

isolation valves or leakage boundaries

for 80 penetrations. In its request, the

licensee provided a list of the affected

penetrations and associated plantspecific leak test procedures, the date

when the leak tests had last been

performed and the date when the

current leak test will expire.

The licensee has implemented a 24-

month operating cycle schedule at the

Peach Bottom facility. The last refueling

outage for Unit 3, 3R09, commenced in

September 1993 and ended in

November 1993 and the next refueling

outage, 3R10 is scheduled to commence

no later than September 30, 1995. The

leak tests for which the licensee has

requested schedular exemption were

last conducted during the refueling

outage 3R09, based on the information

provided in the licensee’s application.

The licensee has stated that the affected

leak test require either that safety

systems be isolated or require access to

the drywell, either of which would

require the reactor to be shutdown.

The licensee has divided the affected

leak tests into two categories: (1) Those

that require shutdown reactor

conditions but come due prior to the

latest scheduled commencement of

3R10 on September 30, 1995, and (2)

those that require reactor shutdown

conditions and come due after the

scheduled commencement of 3R10.

There are 52 leak test surveillance

procedures affecting 47 penetrations or

penetration groups in the first category.

These tests and penetrations are listed

in Table 1 of the licensee’s February 22,

1995 request. The earliest of these tests

falls due on August 12, 1995, up to 49

days prior to the scheduled shutdown.

The licensee has requested an

exemption for 60 days which will allow

the unit to operate until the beginning

of the planned outage without shutting

down to perform leak tests and which

will allow for flexibility in planning the

leak tests during the outage.

There are 28 leak test surveillance

procedures affecting 29 penetrations in

the second category described

previously. These tests are listed in

Table 2 of the licensee’s February 22,

1995 submittal. The licensee has

requested an exemption of 60 days to

allow for flexibility in planning these

leak tests during the outage. The

licensee stated that all of the affected

penetrations will be leak tested prior to

restart from 3R10.

IV

The licensee presented information in

support of its request for a 60-day

extension of the Type B and C test

intervals. The maximum allowable

leakage rate for maintaining primary

containment (La—minimum pathway

leakage) is 125,417 cc/min. The asfound total Type B and C minimum

pathway leakage rate observed during

Unit 3 refueling outage 3R09 during the

fall of 1993 was 33,434 cc/min. The asleft leak rate for that same outage was

27,188 cc/min.

PECo stated that an extension of the

leak test interval to allow for 49 days of

operation in not likely to significantly

decrease the margin between as-found

leak rates and La.

PECo also stated that the remainder of

the total 60-day extension, requested for

outage planning flexibility, will have

minimal safety significance since the

unit will be in cold shutdown. Primary

containment integrity is not required

during cold shutdown.

The licensee provided information

regarding the requirements of 10 CFR

50.12, ‘‘Specific Exemptions.’’ With

respect to the requirements of 10 CFR