Federal Register / Vol. 61, No. 105 / Thursday, May 30, 1996 / Notices 27107

time, the matter may be referred to the

Attorney General for collection.

In the event the Licensee requests a

hearing as provided above, the issue to

be considered at such hearing shall be:

whether, on the basis of the violations

admitted by the Licensee, this Order

should be sustained.

Dated at Rockville, Maryland, this 20th day

of May 1996.

For the Nuclear Regulatory Commission.

James Lieberman,

Director, Office of Enforcement.

Appendix—Evaluation and Conclusions

On February 22, 1996, a Notice of Violation

and Proposed Imposition of Civil Penalty

(Notice) in the amount of $8,000 was issued

to Madigan Army Medical Center (MAMC or

Licensee) for violations identified during an

NRC inspection and investigation. The

Licensee responded to the Notice in two

letters both dated March 21, 1996. The

Licensee admitted the violations but

requested mitigation of the proposed civil

penalty based on actions taken by MAMC to

identify and correct the violations.

Restatement of Violations Assessed a Civil

Penalty

I. Violations Assessed a Civil Penalty

A. 10 CFR 35.25(a) (1) and (2) require, in

part, that a licensee that permits the receipt,

possession, use, or transfer of byproduct

material by an individual under the

supervision of an authorized user shall: (1)

instruct the supervised individual in the

licensee’s written quality management

program (QMP); and (2) require the

supervised individual to follow the written

QMP procedures established by the licensee.

Item 4 of the licensee’s QMP specified, in

part, that when computer calculations are

performed, an individual who did not make

the original calculations will check the dose

calculation parameters.

Contrary to the above, the licensee did not

meet the above requirements as specified in

the following examples:

1. As of June 6, 1995, the licensee had not

assured that individuals working under the

supervision of an authorized user, i.e., the

medical physicist and dosimetrist, were

adequately instructed in the licensee’s

written QMP. Specifically, although the

medical physicist and dosimetrist had signed

a record indicating that they had reviewed

department procedures, including the QMP,

they had neither received specific instruction

in the procedures incorporated in the QMP

nor read each of the procedures.

2. Between February 1994 and May 1995,

the licensee took no action to require or

assure that individuals working under the

supervision of an authorized user, i.e., the

medical physicist and dosimetrist, were

aware of, or were following, the licensee

written QMP procedures established by the

licensee. Specifically, computer calculations

performed were not checked by an individual

who did not make the original calculations.

(01012)

B. 10 CFR 35.32(a) requires, in part, that

the licensee establish and maintain a written

QMP to provide high confidence that

byproduct material or radiation from

byproduct material will be administered as

directed by the authorized user.

10 CFR 35.32(a) (3) and (4) require, in part,

that the QMP include written policies and

procedures to meet the objectives that: (1)

final plans of treatment and related

calculations for brachytherapy are in

accordance with the applicable written

directives and (2) that each administration of

radiation from brachytherapy is in

accordance with the applicable written

directive.

Contrary to the above, between February

1994 and May 1995, the licensee’s QMP did

not include written procedures that met the

above stated objectives. Consequently, in five

cases involving patients undergoing

brachytherapy treatment during this time

period, incorrect data values were entered in

a computerized treatment planning system

used to develop final treatment plans. The

entry of incorrect data resulted in errors in

the calculated dose rates identified in final

treatment plans, thus causing the

administered doses to deviate substantially

from the prescribed doses specified in the

authorized users’ written directives. (01022)

These violations represent a Severity Level

II problem (Supplement VI). Civil Penalty—

$8,000

Summary of the Licensee’s Request for

Mitigation

MAMC responded to the Notice on March

21, 1996, admitting the violations but

requesting mitigation of the proposed $8,000

civil penalty based on its actions to identify

and correct the violations. MAMC noted in

its response that ‘‘NRC enforcement actions

are intended to act as a deterrent against

future violations and to encourage prompt

identification and comprehensive correction

of violations.’’ MAMC then noted that it had

identified the violations and made immediate

extensive modifications to the radiation

safety program and Quality Management

Program (QMP) to ensure that the violations

would not recur. MAMC described each of

the corrective actions and stated that

‘‘processes have been implemented to ensure

compliance with the QMP as well as a broad

range of internal controls developed to

prevent reoccurrence.’’ MAMC stated that a

standard civil penalty for a Severity Level II

violation ($4,000) should be sufficient, noting

that this would more appropriately match the

intent of NRC’s Enforcement Policy and more

accurately reflect MAMC’s efforts in

identifying and correcting the program

deficiencies.

NRC Evaluation of Licensee’s Request for

Mitigation

The Licensee is correct that among the

stated purposes of the NRC Enforcement

Policy (NUREG–1600) is to encourage prompt

identification and comprehensive correction

of violations. In this case, normal application

of the enforcement policy guidance in

Sections VI.B.2.b and c did in fact result in

credit for MAMC’s identification of the

violations and corrective actions. However,

Section VII.A. of the Enforcement Policy

provides that civil penalties may be escalated

to ensure that the proposed civil penalty

reflects the significance of the circumstances

and conveys the appropriate regulatory

message to the licensee. The violations which

led to the misadministrations are of very

significant regulatory concern to the NRC.

There were at least five cases involving

patients undergoing brachytherapy treatment

where MAMC administered radiation in

excess of what was intended before MAMC

discovered an error in its computerized

treatment planning program. At least one of

these patient misadministrations was later

determined by medical consultants of the

Licensee and the NRC to have had potential

adverse health effects for the patient

involved.

It was determined by NRC inspection and

investigation that the misadministrations

were caused, at least in part, by the

Licensee’s failure to assure that the MAMC

staff was implementing the facility’s Quality

Management Program (QMP) as required and

failure to adequately oversee the QMP.

Additional training of the Licensee’s

personnel and increased management

oversight could have prevented the

misadministrations. These

misadministrations were preventable.

The violations in this case were classified

as a Severity Level II problem in recognition

of this fundamental breakdown in the very

program that is intended to prevent such

misadministrations from occurring. The

Enforcement Policy provides at Section

VII.A.1(a) that discretion should be

considered to escalate civil penalties in cases

where problems are categorized at Severity

Level I or II. As noted in Section I of the

Enforcement Policy, enforcement action

should be used not only to encourage

identification and prompt, comprehensive

correction of violations, but also as a

deterrent to emphasize the importance of

compliance with NRC requirements. While

no violation is acceptable, the fact that these

violations were preventable cannot be

tolerated. In this case, discretion was clearly

warranted to assess a civil penalty to MAMC,

notwithstanding application of the

identification and corrective action factors, to

emphasize the importance of preventing

significant misadministrations through

supervision, training and management

oversight. Considering the significance of the

actual effects of the violations and their root

causes, it was appropriate and wholly

consistent with the Enforcement Policy

guidance to deny mitigation, exercise

discretion and assess a civil penalty of

$8,000.

NRC Conclusion

The NRC concludes that an adequate basis

for mitigation of the civil penalty is not

provided by the Licensee. The NRC also

concludes that the proposed civil penalty of

$8,000 is appropriate and should be imposed

by order.

[FR Doc. 96–13515 Filed 5–29–96; 8:45 am]

BILLING CODE 7590–01–P
27108 Federal Register / Vol. 61, No. 105 / Thursday, May 30, 1996 / Notices

[Docket No. 55–21849–EA; ASLBP No. 96–

716–04–EA]

Emerick S. McDaniel; Establishment of

Atomic Safety and Licensing Board

Pursuant to delegation by the

Commission dated December 29, 1972,

published in the Federal Register, 37 FR

28710 (1972), and Sections 2.105, 2.700,

2.702, 2.714, 2.714a, 2.717, 2.721, and

2.772(j) of the Commission’s

Regulations, all as amended, an Atomic

Safety and Licensing Board is being

established to preside over the following

proceeding.

Emerick S. McDaniel

Denial of Reactor Operator’s License

Application

This Board is being established as a

result of an April 4, 1996 letter from

NRC staff sustaining a denial of Mr.

McDaniel’s reactor operator’s license

application. The petitioner, Emerick S.

McDaniel, requests a hearing in

accordance with 10 C.F.R. § 2.103(b)(2).

The Board is comprised of the

following administrative judges:

B. Paul Cotter, Jr., Chairman, Atomic

Safety and Licensing Board Panel,

U.S. Nuclear Regulatory Commission,

Washington, D.C. 20555

Peter S. Lam, Atomic Safety and

Licensing Board Panel, U.S. Nuclear

Regulatory Commission, Washington,

D.C. 20555

Peter A. Morris, 10825 South Glen Road,

Potomac, MD 20854

All correspondence, documents and

other materials shall be filed with the

Judges in accordance with 10 CFR

§ 2.701.

Issued at Rockville, Maryland, this 23rd

day of May 1996.

B. Paul Cotter, Jr.,

Chief Administrative Judge, Atomic Safety

and Licensing Board Panel.

[FR Doc. 96–13512 Filed 5–29–96; 8:45 am]

BILLING CODE 7590–01–P

Advisory Committee on Nuclear

Waste; Notice of Meeting

The Advisory Committee on Nuclear

Waste (ACNW) will hold its 84th

meeting on June 25–27, 1996, Room T–

2B3, at 11545 Rockville Pike, Rockville,

Maryland. The date of this meeting was

previously published in the Federal

Register on Wednesday, December 6,

1995 (60 FR 62485).

The entire meeting will be open to

public attendance.

The agenda for this meeting shall be

as follows:

Tuesday, June 25, 1996—8:30 A.M. until

6:00 P.M.

Wednesday, June 26, 1996—8:30 A.M.

until 6:00 P.M.

Thursday, June 27, 1996—8:30 A.M.

until 4:00 P.M.

During this meeting, the Committee

plans to consider the following:

A. Total System Performance

Assessment 1995—The Committee will

review comments from the NRC staff on

the Department of Energy’s Total

System Performance Assessment 1995.

Participation by the staffs of both DOE

and NRC is anticipated.

B. Meeting with the Director, NRC’s

Division of Waste Management, Office

of Nuclear Materials Safety and

Safeguards—The Director will discuss

items of current interest related to the

Division of Waste Management

programs which may include: progress

at the Yucca Mountain site, the status of

EPA’s Yucca Mountain standards and

NRC’s high-level waste regulations, and

the status of NRC draft technical

guidance on expert elicitation.

C. Preparation of ACNW Reports—

The Committee will discuss proposed

reports, including: timeframes for

regulatory concern, the use of expert

elicitation, elements of an adequate lowlevel waste program, Committee

priorities and task action plans, and

biological effects from low-levels of

ionizing radiation. The Committee may

also prepare reports on topics discussed

during this meeting.

D. Meeting with the NRC

Commissioners—The Committee will

discuss items of mutual interest with

the Commissioners. Potential topics

include: Issues and NRC activities

associated with the National Research

Council’s Report, ‘‘Technical Bases for

Yucca Mountain Standards,’’ ACNW

comments on High-Level Waste

Prelicensing Program Strategy and Key

Technical Issues, ACNW Priority Issues,

health effects of low-levels of ionizing

radiation, timespan for compliance of

the proposed high-level waste

repository at Yucca Mountain, Nevada,

and the use of expert judgment in

nuclear waste licensing.

E. Discussions with Dr. Dade Moeller,

Moeller and Associates, Inc.—The

Committee will discuss several topics of

interest to the ACNW with Dr. Moeller

including: the open market trading rule

which would allow the operator of a

facility that is releasing contaminants

into the environment the option of

reducing its own discharges or those of

other sources in the same geographical

area, the use of the linear-no-threshold

model of response to doses of ionizing

radiation, and defining a critical group

to predict the anticipated effects of a

waste repository.

F. DOE’s Program Plan—The

Committee will meet with

representatives of the Department of

Energy and the NRC staff to review

DOE’s current program for developing a

high-level waste repository.

G. Specification of Critical Group and

Reference Biosphere—The Committee

will review options under consideration

for specifying the critical group and

reference biosphere to be used in a

performance assessment of a nuclear

waste disposal facility.

H. Time of Compliance in Low-Level

Waste Disposal—The Committee will

discuss options for setting a regulatory

time of compliance for a low-level waste

disposal facility. Participants may

include representatives of the NRC staff,

the DOE, and individual states.

I. Committee Activities/Future

Agenda—The Committee will consider

topics proposed for future consideration

by the full Committee and Working

Groups. The Committee will discuss

ACNW-related activities of individual

members.

J. Miscellaneous—The Committee will

discuss miscellaneous matters related to

the conduct of Committee activities and

organizational activities and complete

discussion of matters and specific issues

that were not completed during

previous meetings, as time and

availability of information permit.

Procedures for the conduct of and

participation in ACNW meetings were

published in the Federal Register on

September 27, 1995 (60 FR 49924). In

accordance with these procedures, oral

or written statements may be presented

by members of the public, electronic

recordings will be permitted only

during those portions of the meeting

that are open to the public, and

questions may be asked only by

members of the Committee, its

consultants, and staff. Persons desiring

to make oral statements should notify

the Chief, Nuclear Waste Branch, Mr.

Richard K. Major, as far in advance as

practicable so that appropriate

arrangements can be made to allow the

necessary time during the meeting for

such statements. Use of still, motion

picture, and television cameras during

this meeting may be limited to selected

portions of the meeting as determined

by the ACNW Chairman. Information

regarding the time to be set aside for this

purpose may be obtained by contacting

the Chief, Nuclear Waste Branch prior to

the meeting. In view of the possibility

that the schedule for ACNW meetings

may be adjusted by the Chairman as

necessary to facilitate the conduct of the

meeting, persons planning to attend

should check with Mr. Major if such