21570 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Notices

50.12(a)(1), the licensee stated that the

requested action is authorized by law in

that no prohibition of law exists which

would preclude the activities which

would be authorized by the exemption.

In addition, the licensee stated that, for

the reasons discussed above, the

requested exemption does not present

an undue risk to the public health and

safety. Finally, the licensee stated that

containment leak rate testing is not

considered in the common defense and

security of the nation.

With respect to the requirements of 10

CFR 50.12(a)(2)(iii), the licensee stated

that special circumstances are present

because compliance with the strict

requirements of Appendix J would

result in hardships significantly in

excess of those contemplated when the

regulation was adopted. The licensee

stated that at the time the regulation was

adopted, a presumption was made that

a 2-year test interval would easily

accommodate performance of the

required tests during an operating cycle.

However, development of new core

designs have resulted in cycles of 24

months, or longer. Performance of the

tests at the 24-month frequency would

result in undue financial hardship

resulting from extended reactor

shutdown beyond that intended by the

regulation with little or no

compensatory increase in the level of

safety or quality.

V

Based on the above, the staff finds

there is reasonable assurance that the

containment leakage-limiting function

will be maintained and that a forced

outage to perform Type B and C tests is

not necessary. Therefore, the staff finds

the requested exemption, to allow the

Type B and C test intervals for the

penetrations listed in the licensee’s

February 22, 1995 request to be

extended for 60 days from their current

expiration date, to be acceptable. The

exemption request has been evaluated

in a safety evaluation dated April 25,

1995.

Accordingly, the Commission has

determined that, pursuant to 10 CFR

50.12(a), the requested exemption is

authorized by law, will not present an

undue risk to the public health and

safety, and is consistent with the

common defense and security. The

Commission finds that the special

circumstances as required by 10 CFR

50.12(a)(2) are present. The

Commission’s finding is based on the

information provided by the licensee

regarding 10 CFR 50.12(a)(2)(iii). In

addition, as specified in 50.12(a)(2)(ii),

special circumstances are present

whenever the application of the

regulation in the particular

circumstance would not serve the

underlying purpose of the rule or is not

necessary to achieve the underlying

purpose of the rule. The underlying

purpose of the rule is to ensure that the

components comprising the primary

containment boundary are maintained

and leak tested at periodic and

appropriate intervals. The 24-month

maximum interval was originally

expected to bound the typical operating

cycle, including a limited amount of

mid-cycle outage time. The advent of

advanced fuel types has made it

possible to operate the facility for the 24

months with minimal, if any mid-cycle

outage time. Strict adherence to the 24-

month maximum interval is not

necessary to meet the underlying

purpose of the rule in that, taking into

consideration the 60-day extension, the

components that comprise the primary

containment boundary will still be

tested at a frequency that is appropriate

to those components and their

application. In addition, the 60-day

extension represents a minimal increase

in the existing 24-month interval

required by the rule. Therefore, the staff

finds the requested temporary

exemption, to allow the Type B and C

test intervals for penetrations described

in the licensee’s February 22, 1995

letter, to be extended for 60 days, to be

acceptable.

An exemption is hereby granted from

the requirements of Sections III.D.2(a)

and III.D.3 of Appendix J to 10 CFR Part

50, which requires that Type B and C

tests be performed during each reactor

shutdown for refueling but in no case at

intervals greater than 2 years, for a

period of 60 days from the expiration of

the current leak test for the affected

penetrations.

Pursuant to 10 CFR 51.32, the

Commission has determined that the

granting of this exemption will have no

significant impact on the quality of the

human environment (60 FR 19968).

This exemption is effective upon

issuance.

Dated at Rockville, Maryland this 25th day

of April 1995.

For the Nuclear Regulatory Commission.

Steven A. Varga,

Director, Division of Reactor Projects—I/II,

Office of Nuclear Reactor Regulation.

[FR Doc. 95–10733 Filed 5–1–95; 8:45 am]

BILLING CODE 7590–01–M

[Docket No. 030–32493; License No. 29–

28685–01; EA 93–072]

Radiation Oncology Center at Marlton,

Marlton, New Jersey; Order Imposing a

Civil Monetary Penalty

I

Radiation Oncology Center at Marlton

(Licensee) is the holder of Byproduct

Materials License No. 29–28685–01

(License) issued by the Nuclear

Regulatory Commission (NRC or

Commission) on January 17, 1992. The

License authorizes the Licensee to

possess and use certain byproduct

materials in accordance with the

conditions specified therein. The

License is due to expire on January 31,

1997. By a Confirmatory Action Letter

dated February 5, 1993, the Licensee

agreed to not obtain any sources of

radioactive material authorized under

the License until specifically authorized

by NRC Region I. By a Confirmatory

Order Modifying License (Effective

Immediately) dated March 9, 1993, the

Licensee was required to maintain any

NRC-licensed material in a locked,

stored, and shielded condition, and was

prohibited from receiving any NRClicensed material.

II

An NRC inspection of the Licensee’s

activities was conducted on February 2

and 4, 1993. The results of this

inspection indicated that the Licensee

has 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 May 31, 1994. The Notice

states the nature of the violation, the

provisions of the NRC requirements that

the Licensee had violated, and the

amount of the civil penalty proposed for

the violation.

The Licensee responded to the Notice

in letters dated August 31, 1994,

October 4, 1994, and December 1, 1994.

In its responses the Licensee denies

Examples A.3, A.4, B.1, B.2, D., and G.

of the violations, denies in part and

admits in part Examples A.1, A.2, and

C. of the violation, and admits Examples

A.5, E., and F. of the violation. The

Licensee also protests the amount of the

civil penalty proposed and requests

mitigation of the penalty as appropriate.

III

After consideration of the Licensee’s

response and the statements of fact,

explanation, and argument for

mitigation contained therein, the NRC

staff has determined, as set forth in the

Appendix to this Order, that, with the
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Notices 21571

exceptions of Examples A.3 and G of the

violation, the violation occurred as

stated in the Notice; the Examples A.3

and G of the violation will be

withdrawn; and the penalty proposed

for the violation 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 a civil penalty in the

amount of $80,000 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,

Pennsylvania 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 the violation

in the Notice referenced in Section II

above, and the following specific

examples given with the violation:

Examples A.1, A.2, A.4, B.1, B.2, C., and

D.; and

(b) whether, on the basis of the

violation set forth in the Notice of

Violation, 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 Penalty (Notice)

was issued for a violation identified during

an NRC inspection of Radiation Oncology

Center at Marlton (ROCM) (Licensee). The

licensee responded to the Notice on August

31, 1994, October 4, 1994, and December 1,

1994. The Licensee denies Examples A.3,

A.4, B.1, B.2, D., and G. of the violation,

denies in part and admits in part Examples

A.1, A.2, and C. of the violation, and admits

Examples A.5, E., and F. of the violation. In

addition, the Licensee protests the amount of

the civil penalty proposed and requests

mitigation of the civil penalty as appropriate.

The NRC’s evaluation and conclusion

regarding the Licensee’s requests are as

follows:

Restatement of Violation

10 CFR 35.21(a) requires, in part, that the

licensee, through the Radiation Safety Officer

(RSO), shall ensure that radiation safety

activities are being performed in accordance

with approved procedures and regulatory

requirements in the daily operation of the

licensee’s byproduct material program.

Contrary to the above, the Licensee,

through the RSO, did not ensure that

radiation safety activities were performed in

accordance with approved procedures and

regulatory requirements in the daily

operation of the Licensee’s byproduct

material program. Specifically, the RSO

named on the Radiation Oncology Center at

Marlton (ROCM) license stated at the

enforcement conference that, although she

had signed the license submittal, she

believed that her responsibilities and

authorities were primarily a medical function

and not a regulatory function. She said that

she was aware that she was named as the

RSO on the license and added, ‘‘I was told

that being—I was the fixed fixture there, that

was the easiest thing to do, and that is all I

was told. I had no concept of what that

entailed.’’ The following are specific

examples of the failure of the Licensee,

through the RSO, to ensure that radiation

safety activities were performed in

accordance with approved procedures and

regulatory requirements in the daily

operation of the Licensee’s byproduct

material program:

A. Condition 14 of License No. 29–28685–

01 requires that the Licensee conduct its

program in accordance with the statements,

representations, and procedures contained in

the application dated July 11, 1991, letter

received December 18, 1991, and letter dated

January 15, 1992.

1. Item 8.B of the Licensee’s application,

dated July 11, 1991, requires that all source

exchanges be carried out by Omnitron

Factory Personnel under the observation of

the RSO.

Contrary to this requirement, source

exchanges carried out by Omnitron Factory

Personnel were not always under the

observation of the RSO. Specifically, the RSO

stated that although she observed the first

source exchange at the facility on March 5,

1992, she did not observe the three

subsequent source exchanges on June 4,

September 16, and December 9, 1992.

2. Item 10.12 of the Licensee’s application,

dated July 11, 1991, requires that surveys of

radiation levels in all adjacent areas and

controlled areas be performed at initial

installation and then quarterly thereafter at

source exchanges and that results of the

surveys be maintained.

Contrary to this requirement, surveys of

radiation levels in all adjacent areas and

controlled areas were not performed during

the source exchanges which occurred on

March 5, June 4, and September 16, 1992. In

addition, the Licensee was unable to supply

the inspectors with documentation

demonstrating that surveys were performed

in any adjacent areas following the December

9, 1992 source change.

3. Item 10.15.A.4 of the Licensee’s

application, dated July 11, 1991, requires, in

part, that a daily check of all interlocks,

safety systems and alarms be performed and

documented in log books, that daily

operational system checks be recorded, and

that source position indicators (visual and

radiation detection) be checked before each

use and recorded.

Contrary to this requirement, as of

February 4, 1993, daily checks of all

interlocks, safety systems and alarms were

not performed and documented in log books.

Specifically, Licensee personnel believed

that the performance of these checks was the

responsibility of the physics consultant even

though the physics consultant was only

present for approximately one half of the

total patient treatments, and the ROCM staff

did not perform these daily checks when the

physics consultant was not present. In

addition, the Licensee was unable to provide

any documentation indicating that daily

checks of all the inter-locks, safety systems

and alarms; daily operational system checks;

and daily checks of source position

indicators (visual and radiation detection)

were performed on the occasions when the

physicist was present.

4. Item 8.E.5 of the Licensee’s application,

dated July 11, 1991, requires, in part, that

each operator/user of the HDR individually

demonstrate competence in the emergency

procedures during ‘‘dry run’’ emergencies

using several failure modes for each operator.

Contrary to this requirement, as of

February 4, 1993, each operator/user of the

HDR did not individually demonstrate

competence in the emergency procedures

during ‘‘dry run’’ emergencies using several

failure modes for each operator.

5. Item 9.1.C.4 of the Licensee’s

application, dated July 11, 1991, requires, in

part, that the radiation monitor (PrimAlert)

have a battery backup.

Contrary to this requirement, as of

February 4, 1993, the Licensee did not have

a battery back-up to operate the radiation

monitor (PrimAlert).

B. 10 CFR 19.12 requires, in part, that all

individuals working in or frequenting any
21572 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Notices

portion of a restricted area be instructed in

the purposes and functions of protective

devices employed, and in the appropriate

response to warning made in the event of any

unusual occurrence or malfunction that may

involve exposure to radiation or radioactive

material.

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.

Contrary to these requirements,

1. As of February 4, 1993, individuals

working in or frequenting portions of a

restricted area were not instructed in the

purposes and functions of protective devices

employed. Specifically, the Licensee failed to

instruct the dosimetrist in the proper use of

the radiation survey meter. The dosimetrist,

when questioned by the inspector on the

operation and use of the survey meter, stated

that the X1000 setting was the instrument’s

‘‘lowest strength’’ scale. The X1000 setting is

actually the highest scale setting on the

instrument.

2. As of February 4, 1993, individuals

working in or frequenting portions of a

restricted area were not instructed in the

appropriate response to a warning made in

the event of any unusual occurrence or

malfunction that may involve exposure to

radiation or radioactive material.

Specifically, the Licensee failed to

adequately train the dosimetrist to identify

and respond to HDR error messages.

When questioned by the inspector on

February 4, 1993, the dosimetrist did not

know the meaning of the error messages from

a random printout of a treatment execution

record, dated May 7, 1992, which contained

several error messages.

C. 10 CFR 35.31(b) requires that a licensee

that makes minor changes in radiation safety

procedures, as permitted under 10 CFR

35.31(a), retain a record of each change until

the license has been renewed or terminated.

The record shall include the effective date of

the change, a copy of the old and new

radiation safety procedures, the reason for

the change, a summary of radiation safety

matters that were considered before making

the change, the signature of the RSO, and the

signatures of the affected authorized users,

and of management or, in a medical

institution, the Radiation Safety Committee’s

chairman and the management

representative.

Contrary to this requirement, prior to

February 2, 1993:

1. The Licensee made a minor change in

its radiation safety procedures, as permitted

under 10 CFR 35.31(a), by posting emergency

procedures that differed from those

procedures submitted to the NRC in support

of the license application, and the Licensee

did not retain a record of the change that

included the effective date of the change, the

reasons for the change, a summary of the

radiation matters that were considered before

making the change, the signature of the RSO,

and the signatures of the affected authorized

users, and of management.

2. The Licensee made a minor change in

its radiation safety procedures, as permitted

under 10 CFR 35.31(a), by using HDR

calibration procedures that differed from

those procedures submitted to the NRC in

support of the license application, and the

Licensee did not retain a record of the change

that included the effective date of the change,

the reason for the change, a summary of the

radiation matters that were considered before

making the change, the signature of the RSO,

and the signatures of the affected authorized

users, and of management.

D. 10 CFR 35.32 requires, in part, that each

licensee, as applicable, establish and

maintain a written quality management

program to provide high confidence that

byproduct material or radiation from

byproduct material will be administered as

directed by the authorized user.

Contrary to this requirement, from March

through December 1992, the Licensee

engaged in licensed activities (namely, the

administration of brachytherapy radiation

doses using an iridium-192 source in an HDR

unit) which required the establishment of a

quality management program, and as of

February 5, 1993, the Licensee had not

established a written quality management

program.

E. 10 CFR 35.51(a)(3) requires that the

apparent exposure rate from a dedicated

check source as determined at the time of

calibration, be conspicuously noted on the

instrument with the date of calibration.

Contrary to this requirement, as of

February 4, 1993, the apparent exposure rate

from a dedicated check source as determined

at the time of calibration, was not

conspicuously noted on the instrument with

the date of calibration.

F. 10 CFR 19.11 (a) and (b) require, in part,

that the Licensee post current copies of Part

19 and 20, and the license, or post a notice

describing these documents and where they

may be examined. 10 CFR 19.11(c) also

requires that the licensee post a Form NRC–

3, ‘‘Notice to Employees.’’

Contary to this requirement, as of February

4, 1993, the Licensee did not post current

copies of Parts 19 and 20, and the license, or

a notice describing the documents and where

they could be examined, and did not post a

Form NRC–3.

G. 10 CFR 30.51(a) requires each licensee

to keep records showing the receipt, transfer,

and disposal of byproduct material.

Contrary to this requirement, as of

February 4, 1993, the Licensee did not keep

records showing the receipt, transfer, and

disposal of byproduct material. Specifically,

the Licensee did not maintain records of the

source receipt and transfer for disposal.

This is a Severity Level II violation

(Supplement VI).

Summary of Licensee’s Response to Example

A.1 of the Violation

The Licensee admits this example in part

and denies it in part, but does not state

specifically what it admits or denies. The

Licensee states that, although the RSO was

not present in the room during the source

exchange, the RSO or the physicist was

physically present at the facility during the

source exchanges, or readily available in case

of an emergency, and thus the RSO was

overseeing the source exchanges. The

Licensee believes that this was all that was

intended by its license application, that the

RSO may delegate duties, and that the

physical presence of the RSO during a source

exchange would violate ALARA principles.

The Licensee believes that, in any event, this

example would constitute a Severity Level IV

violation.

NRC Evaluation of Licensee’s Response to

Example A.1 of the Violation

The Licensee’s application is clear in

requiring that all source exchanges be carried

out by Omnitron Factory Personnel under the

observation of the RSO. With proper

planning and the application of common

radiation protection methods, the RSO could

observe source exchanges without violating

ALARA principles. At the transcribed

enforcement conference, the RSO confirmed

that she observed the first source exchange

but did not observe the three subsequent

source exchanges. Since source exchanges

occurred that were not under the observation

of the RSO, the NRC concludes that this

example of the violation occurred as stated

in the Notice. The issue of severity level is

addressed below under ‘‘NRC Evaluation of

Licensee’s Request for Mitigation.’’

Summary of Licensee Response to Example

A.2 of the Violation

The Licensee admits this example in part

and denies it in part, but does not state

specifically what it admits or denies. The

Licensee states its belief that surveys of

radiation levels in adjacent areas and/or

controlled areas were performed during the

source exchanges which occurred on March

5, June 4, and September 16, 1992, by

Omnitron for the Licensee’s benefit. The

Licensee, in its letter dated December 1,

1994, provided Omnitron’s record of surveys

conducted during the source exchange on

December 9, 1992, as well as other records

of surveys conducted on March 5, June 4, and

September 16, 1992. The Licensee believes

that, in any event, this would constitute a

Severity Level IV violation.

NRC Evaluation of Licensee’s Response to

Example A.2 of the Violation

Omnitron’s record of surveys conducted on

December 9, 1992 does not show that all

adjacent areas were surveyed as required by

License Condition 14. Regarding the records

of other surveys that the Licensee submitted,

the NRC inspection report indicates that the

inspectors did see documentation of partial

surveys for March 5, 1992, June 4, 1992, and

September 16, 1992. With the exception of

the survey record for December 17, 1992, the

survey records that the Licensee submitted

show that the surveys did not include all

adjacent areas as required by the license

condition. As noted in the inspection report,

examples of adjacent areas that were not

surveyed include a staff restroom, a utility

room, the patient examination room, and the

patient dressing room. Therefore, the NRC

concludes that this example of the violation

occurred as stated in the Notice. The issue of

severity level is addressed below under

‘‘NRC Evaluation of Licensee’s Request for

Mitigation.’’
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Notices 21573

Summary of Licensee Response to Example

A.3 of the Violation

The Licensee states that it denies this

example. The Licensee states that, contrary to

the NRC findings, checks were performed

and an entire log indicating that certain

checks were performed does exist. In its

letter dated December 1, 1994, the Licensee

provided numerous log entries to show that

checks were performed.

NRC Evaluation of Licensee’s Response to

Example A.3 of the Violation

The NRC staff has reviewed the log entries

provided by the Licensee on December 1,

1994. Based on those records, which were

not provided during the inspection or the

transcribed enforcement conference, the NRC

staff is withdrawing this example of the

violation. The withdrawal of this example of

the violation does not change the fact that the

violation occurred, nor does it affect the

appropriateness of the amount of the civil

penalty assessed for the violation in this case,

given the nature of the violation and the

numerous other examples of the violation

that are not being retracted.

Summary of Licensee Response to Example

A.4 of the Violation

The Licensee denies the example and

asserts that relevant personnel attended

Omnitron training where dry runs were

performed and emergency situations and

procedures were taught and discussed. The

Licensee believes that, in any event, this

could constitute a Severity Level IV

violation.

NRC Evaluation of Licensee’s Response to

Example A.4 of the Violation

While Omnitron training may have covered

emergency situations, License Condition 14

specifically requires that each operator/user

of the HDR individually demonstrate

emergency routine competence during ‘‘dry

run’’ emergencies using several failure modes

for each operator. At the transcribed

enforcement conference, the Medical

Director, recalling the portion of the

Omnitron training that pertained to

emergency situations, stated, ‘‘[t]o the best of

my recollection, I believe they went through

some of the descriptive terms on how to

recrank the machine manually, and I believe

they showed us the knob. But I cannot say

with any degree of recollection that we

actually went through it.’’ As noted in the

inspection report, the dosimetrist stated to

inspectors that she had not performed ‘‘dry

run’’ emergencies using several failure

modes. Therefore, the NRC concludes that

this example of the violation occurred as

stated in the Notice. The issue of severity

level is addressed below under ‘‘NRC

Evaluation of Licensee’s Request for

Mitigation.’’

Summary of Licensee Response to Example

A.5 of the Violation

The Licensee admits this example of the

violation, but states its belief that this would

constitute a Severity Level IV violation.

NRC Evaluation of Licensee’s Response to

Example A.5 of the Violation

The issue of severity level is addressed

below under ‘‘NRC Evaluation of Licensee’s

Request for Mitigation.’’

Summary of Licensee Response to Example

B of the Violation

The Licensee denies this example. The

Licensee states that failure to answer all

questions posed by the inspector does not

necessarily constitute evidence that

employees were not adequately trained in

accordance with the commitments in the

application or in the regulations. The

Licensee believes that at all times personnel

were trained as required under the license

and under the applicable regulations. The

Licensee states that 10 CFR 19.12 only

requires that personnel be trained

‘‘commensurate with potential radiological

health protection problems in the restricted

area.’’ The Licensee also states that ‘‘the NRC

did not allege that the dosimetrist did not

know how to operate a hand held survey

meter or that she was not trained in its

operation.’’ The Licensee asserts that the

dosimetrist was trained pursuant to license

requirements. The Licensee believes that, in

any event, this would constitute a Severity

Level IV violation.

NRC Evaluation of Licensee’s Response to

Example B of the Violation

As documented in the inspection report,

the dosimetrist was asked to demonstrate the

operation and use of the radiation survey

meter. The dosimetrist incorrectly set the

instrument response dial to the X1000 scale,

stating that this was the instrument’s lowest

strength scale. The inspectors asked the

dosimetrist to repeat this demonstration and

explanation a second time and the

dosimetrist produced the same result. The

dosimetrist is the individual who operated

the HDR unit at Marlton. When the

inspectors asked the dosimetrist to explain

the meaning of the ‘‘error code’’ and ‘‘error

class’’ messages on a printout of a treatment

record, the dosimetrist stated that she did not

know the meaning of the error messages.

The NRC staff finds that the dosimetrist’s

lack of understanding of the differences

between the highest setting on the meter and

the lowest setting on the meter, as well as the

lack of understanding concerning response to

HDR error messages are clear evidence that

adequate training was not provided.

10 CFR 19.12 also requires that all

individuals working in or frequenting any

portion of a restricted area shall be instructed

in precautions or procedures to minimize

exposure, and in the purposes and function

of protective devices employed. The extent of

these instructions shall be commensurate

with potential radiological health protection

problems in the restricted area. The

dosimetrist operated the HDR. In an

emergency situation, the dosimetrist’s duties

could involve use of a survey meter to

determine the status and location of the

source in the restricted area as a means of

protecting herself as well as other employees

and patients. The Licensee clearly recognized

that emergency situations could arise because

it discussed ‘‘dry run’’ emergency procedures

in its license application. In addition, since

the dosimetrist’s duties included operation of

the HDR, this individual should have been

knowledgeable on the meaning of error

messages and how to respond to error

messages generated by the HDR unit. Error

messages could indicate hazardous

conditions in the restricted area. Therefore,

this individual was required by 10 CFR 19.12

to be trained by the Licensee on the meaning

of the error messages, how to respond to error

messages, and the use of a hand-held survey

meter. Based on the above, the NRC

concludes that this example of the violation

occurred as stated in the Notice. The issue of

severity level is addressed below under

‘‘NRC Evaluation of Licensee’s Request for

Mitigation.’’

Summary of Licensee Response to Example

C of the Violation

The Licensee states in its response that it

admits in part and denies in part this

example. The Licensee asserts that it did

record certain changes and may not have

recorded others. The Licensee further asserts

that, in this case, there was no potential or

actual impact on health and safety. The

Licensee believes that, in any event, this

would constitute a Severity Level V

violation.

NRC Evaluation of Licensee’s Response to

Example C of the Violation

10 CFR 35.31 authorizes medical use

licensees to make minor changes in radiation

safety procedures that are not potentially

important to safety. 10 CFR 35.31(b) requires

that if these changes (ministerial changes) are

made, the licensee must maintain a record as

specified in the regulation. There is no

exception granted to the Licensee to only

record certain changes. Since the Licensee

did not maintain a record of some changes,

the NRC concludes that this example of the

violation occurred as stated in the Notice.

The issue of severity level is addressed below

under ‘‘NRC Evaluation of Licensee’s Request

for Mitigation.’’

Summary of Licensee Response to Example

D of the Violation

The Licensee states in its response that it

denies this example. The Licensee asserts

that it had a written quality management

program (QMP) which was in effect at the

relevant times. In addition, the Licensee

states that it has modified its quality

management plan pursuant to completion of

a review of its HDR program, and that the

modified plan has been submitted to the

NRC.

NRC Evaluation of Licensee’s Response to

Example D of the Violation

The requirement is that the Licensee

establish and maintain a written quality

management program to provide high

confidence that byproduct material or

radiation from byproduct material will be

administered as directed by the authorized

user. The inspection report indicates that

inspectors did find a copy of ‘‘Quality

Management of Brachytherapy Patients High

Dose Rate Techniques’’ authorized by David

Cunningham of Oncology Services

Corporation and dated January 16, 1992. This
21574 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Notices

document was in a notebook containing other

HDR records. According to the inspection

report, the facility Medical Director/RSO had

no knowledge of the document. In addition,

the Medical Director/RSO stated at the time

of the inspection that no one at the facility

had received training on the document.

Further, at the time of the inspection, the

Licensee had not submitted its quality

management program (QMP) to NRC as

required by 10 CFR 35.32(f)(2). Since the

Medical Director/RSO had no knowledge of

the QMP, had not trained the staff on the

QMP, and had not submitted the QMP to

NRC, it is clear that the QMP was neither

established nor maintained so as to provide

high confidence that radiation from

byproduct material would be administered as

directed by the authorized user. Therefore,

the NRC concludes that this example of the

violation did occur.

Summary of Licensee Response to Example

E of the Violation

The Licensee admits this example, but

states its belief that this would constitute a

Severity Level V violation.

NRC Evaluation of Licensee’s Response to

Example E of the Violation

The issue of severity level is addressed

below under ‘‘NRC Evaluation of Licensee’s

Request for Mitigation.’’

Summary of Licensee Response to Example

G of the Violation

The Licensee states in its response that it

denies this violation. The Licensee states that

it believes that certain records were

maintained and that Omnitron also kept

records for the benefit of the Licensee. The

Licensee, in its letter dated December 1,

1994, provided copies of shipping papers

showing the transfer of sources back to

Omnitron, and copies of leak test results

performed on sources by Omnitron. The

Licensee believes that, in any event, this

would constitute a Severity Level V

violation.

NRC Evaluation of Licensee’s Response to

Example G of the Violation

The NRC staff has reviewed the records

submitted by the Licensee on December 1,

1994. The particular shipping records that

the Licensee submitted, which include the

transferee, isotope, activity, and date, meet

the requirement for records of the transfer of

byproduct material. The leak test records that

the Licensee submitted meet in part the

requirement for records of receipt of licensed

material. The leak test records did identify

the transferor, isotope, and activity; but not

the date of receipt. However, because the

Licensee has other records, such as source

exchange records, that identify the date of

receipt, the NRC is withdrawing this example

of the violation. The withdrawal of this

example of the violation does not change the

fact that the violation occurred, nor does it

affect the appropriateness of the amount of

the civil penalty assessed for the violation in

this case, given the nature of the violation

and the numerous other examples of the

violation that are not being retracted.

Summary of Licensee’s Request for Mitigation

The Licensee states in its response that it

has taken numerous corrective actions to

strengthen and improve all aspects of its

radiation safety program. The licensee also

states that over the past eighteen months, it

has attempted to continually review and

update its HDR program and staff, and

emphasize the importance of radiation safety

and applicable regulations. In addition, the

Licensee indicates that management has

attended courses regarding RSO duties and

responsibilities. The Licensee also notes that

five patients were treated with the HDR unit

between March 1992 and December 1992 and

there were no misadministrations or

incidents.

The Licensee states that it: (1) Immediately

and voluntarily suspended all HDR

treatments in order to review the entire HDR

program; (2) fully and timely complied with

any and all CALs; and (3) replaced its

contract physicist with a full-time physicist

who, as RSO under the license, would

provide necessary onsite RSO continuity

needed to assure Licensee management and

the NRC that the HDR program could run

safely and in accordance with all regulations

at all times. The Licensee also states its belief

that the replacement of the RSO constitutes

required and necessary corrective action

regarding the identified issues, noting that

the new physicist has held quarterly

meetings where radiation safety, and

regulatory issues have been reviewed with

the staff. According to the Licensee, staff

members have attended additional outside

training and the authorized users have

attended a six hour Radiation Safety Officers

Review Course. In addition, the Licensee

states that it has hired a Certified Health

Physicist to assist in the coordination and

oversight of all aspects of the Licensee’s

radiation safety program.

The Licensee states its belief that by hiring

a full-time physicist to serve as RSO and

obtaining the assistance of the Certified

Health Physicist, it has clearly demonstrated

that it has committed the resources necessary

to develop and implement an appropriate,

comprehensive and long lasting commitment

to address the root cause of the violations.

The Licensee believes that its new program,

which permits only the physicist and

physician to be involved with actual HDR

patient treatments, will assure the NRC that

none of the examples of the violation will be

repeated.

The Licensee contends that a fine of

$80,000 for what the Licensee terms ‘‘a

number of Level IV and V violations’’ is

arbitrary, capricious and unsupported by any

of the NRC rules, regulations and/or

legislative history. In support of this

argument, the Licensee claims that similar

enforcement actions involving similar

violations by Part 35 licensees resulted in

substantially smaller penalties. The Licensee

further states that these citations collectively

do not constitute a Severity Level II program

and, in any case, the maximum penalty

should be $8,000 before any mitigation. The

Licensee asserts that it has an exemplary

record having had no previous violations or

misadministration. The Licensee cites a

number of NRC Enforcement sanctions which

the Licensee believes supports its claim that

the sanction imposed on the License is

inappropriate.

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 past 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. Given the

seriousness of the violation in that the RSO

failed to devote time or attention to the

radiation safety program and that corporate

management created the environment in

which this was allowed to occur, a large civil

penalty is warranted to emphasize the

unacceptable performance of the Licensee, its

RSO, and its corporate owner; and to

emphasize the need for the Licensee and its

corporate owner, as well as other licensees

engaged in similar activities, to assure that

controls are in place to avoid similar

violations. THe NRC appropriately exercised

its statutory authority when it proposed an

$80,000 civil penalty for the violation.

As the Licensee’s arguments that some of

the examples are appropriately classified at

Severity Level IV or V, the NRC did not

categorize the individual examples of the

violation in the Notice by severity level.

Rather, the NRC categorized the single

violation, including all of the listed

examples, at Severity Level II. The violation

is appropriately categorized at Severity Level

II because it is of very significant regulatory

concern and involved high potential impact

on the public. Enforcement Policy Section IV.

The guidance given by the examples in

Supplements I–VII of the Enforcement Policy

is neither exhaustive nor controlling in

classifying the severity level of violations.

The NRC reviews each enforcement action on

its own merits to ensure that the severity

level of a violation is characterized at the

level best suited to the significance of the

violation, which may warrant an adjustment

to the severity level categorization.

Enforcement Policy, Section IV. In this case,

the violation represents a near total failure of

the RSO to address her regulatory

responsibilities and an equally serious failure

of licensee management to exercise oversight

over the radiation safety program in order to

ensure that regulatory requirements were

met, all of which created a high potential

impact on the public for an incident similar

to the November 1992 misadministration and
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Notices 21575

radiological event at the owner’s facility in

Indiana, Pennsylvania.

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, 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.

The civil penalties proposed in this case

are within the authority of the NRC. The

Licensee’s comparison of the civil penalty in

this case with civil penalties in other cases

does not bring 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

neither required nor possible in enforcement

decisions, which inherently involve the

exercise of informed judgement on a case-bycase basis. Id. See also, Radiation

Technology, Inc., (ALAB–567), 10 NRC 533,

541 (1979).

NRC Conclusion

The NRC has concluded that: (1) With the

exceptions of Examples A.3 and G., the

violation occurred as stated in the Notice; (2)

Examples A.3 and G are being withdrawn; (3)

the withdrawal of these two examples of the

violation does not change the fact that the

violation occurred nor does it affect the

appropriateness of the amount of the civil

penalty assessed for the violation; and (4) an

adequate basis for mitigation of the civil

penalty was not provided by the Licensee.

Consequently, the proposed civil penalty in

the amount of $80,000 is being imposed.

[FR Doc. 95–10730 Filed 5–1–95; 8:45 am]

BILLING CODE 7590–01–M

[Docket No. 50–244]

Rochester Gas and Electric Company

(R. E. Ginna Nuclear Power Plant);

Exemption

I

Rochester Gas and Electric

Corporation (RG&E) is the holder of

Facility Operating License No. DPR–18,

which authorizes operation of R. E.

Ginna Nuclear Power Plant at steadystate power levels up to a maximum of

1520 megawatts thermal. The facility is

a pressurized water reactor located at

the licensee’s site in Wayne County,

State of New York. The license provides

among other things, that the facility is

subject to all rules, regulations, and

Orders of the Commission.

II

Appendix J of Part 50 of Title 10 of

the Code of Federal Regulations,

‘‘Primary Reactor Containment Leakage

Testing for Water-Cooled Reactors,’’

Section III.D.3, requires that Type C

leakage rate testing be performed each

reactor shutdown for refueling, but in

no case at intervals greater than 2 years.

By letter dated March 15, 1995, RG&E

requested a one-time Exemption from

two parts of 10 CFR Part 50, Appendix

J, Section III.D.3. First, RG&E requests

an Exemption from performing Type C

tests during the 1995 refueling outage

except for isolation valves which have

maintenance performed on them or

valves which have not demonstrated

acceptable leakage during the previous

two leakage rate tests. Second, RG&E

requests an Exemption from performing

Type C tests within a 2-year interval, as

required by the regulation. RG&E

requests up to a 1-month extension of

the 2-year interval for 129 containment

isolation valves.

The last Type C tests were performed

during the 1994 refueling outage after

March 10, 1994. RG&E stated in the

March 15, 1995, letter that the 1996

refueling outage will commence on

March 31, 1996, with Cold Shutdown

reached on April 1, 1996. RG&E

requested an Exemption from the 2 year

test interval until April 10, 1996, an

interval 1 month greater than the

required 2 year test interval.

The R. E. Ginna Nuclear Power Plant

has a total of 151 containment isolation

valves. RG&E has proposed to exempt

129 of these valves from Type C testing

during the 1995 refueling outage. The

other valves would be tested during the

1995 refueling outage either because

maintenance has been done on them or

they have not passed the RG&E’s

criterion for exemption of two

successful consecutive tests.

The NRC staff finds RG&E’s proposal

to be acceptable for several reasons. As

discussed in RG&E’s March 15, 1995

letter, the performance of the

containment isolation valves and the R.

E. Ginna Nuclear Power Plant overall

containment integrity have been good.

The as-left Type A test leakage rate is

35% of La. The current Type B and C

as-left maximum path leakage rate is

61% of the 0.6 La Appendix J limit.

Therefore, there is reasonable assurance

that the 1-month extension of the 2-year

interval will not result in exceeding the

Appendix J limits.

In addition, RG&E has proposed to

limit the Exemption only to those valves

on which no maintenance has been

done and which have passed the last

two consecutive Type C leakage rate

tests. The NRC staff has granted similar

requests in the past. On February 2,

1994, the NRC staff granted a similar

Exemption to the River Bend Station

licensee, and by letter dated April 29,

1987, the NRC staff granted a similar

request to the Washington Public Power

Supply System, Unit 2 licensee.

The NRC staff, therefore, grants the

requested one-time Exemption to the R.

E. Ginna Nuclear Power Plant licensee

subject to the condition that the

Exemption apply only to those valves

on which no maintenance has been

done and which have passed the last

two consecutive Type C leakage rate

tests. The Exemption is granted until

plant shutdown for the 1996 refueling

outage, not to extend beyond April 10,

1996.

III

Section 50.12 of the Commission’s

regulations permit granting an

Exemption from the regulations when

special circumstances are present.

According to 50.12(a)(2)(ii), special

circumstances are present whenever

application of the regulation in question

is not necessary to achieve the

underlying purpose of the rule.

The underlying purpose of Appendix

J, Section III.D.3, is to assure a leak tight

containment to mitigate the

consequences of an accident. The past

leakage rate data and available margin to

the allowed technical specifications, as

discussed above, are sufficient to assure

that the underlying purpose of

Appendix J, Section III.D.3, is achieved.

Accordingly, the Commission has

determined that, pursuant to 10 CFR

50.12, this Exemption is authorized by

law, will not present an undue risk to

the public health and safety, and is

consistent with the common defense

and security.

Accordingly, the Commission hereby

grants an Exemption from 10 CFR Part

50, Appendix J, Section III.D.3.

Pursuant to 10 CFR 51.32, the

Commission has determined that the

granting of the Exemption will have no

significant impact on the environment

(60 FR 20513).

Dated at Rockville, Maryland, this 26th day

of April 1995.

This Exemption is effective upon issuance.

For the Nuclear Regulatory Commission.

Steven A. Varga,

Director, Division of Reactor Projects—I/II,

Office of Nuclear Reactor Regulation.

[FR Doc. 95–10734 Filed 5–1–95; 8:45 am]

BILLING CODE 7590–01–M