10118 Federal Register / Vol. 60, No. 36 / Thursday, February 23, 1995 / Notices

in any fiscal year are exempt from audit

requirements.

B. Audit Costs

Although under OMB Circular A–128

audit costs are generally allowable

charges under Federal grants, audit

costs incurred at the grantee (State) level

are determined to be an administrative

expense.

C. Financial Status Report for States

Financial Status Reports (269A) are

required from all State agencies. A

Financial Status Report shall be

submitted to the Office of the

Comptroller for each calendar quarter in

which the grant is active. This Report is

due even though no obligations or

expenditures were incurred. Financial

Status Reports shall be submitted to the

Office of the Comptroller, by the State,

within 45 days after the end of each

calendar quarter. Calendar quarters end

March 31, June 30, September 30, and

December 31. A Final Financial Status

Report is due 90 days after the end of

the VOCA grant, no later than December

31.

D. Termination of Advance Funding

If the State grantee receiving cash

advances by Letter of Credit or by direct

Treasury check demonstrates an

unwillingness or inability to establish

procedures that will minimize the time

elapsing between cash advances and

disbursement, OJP may terminate

advance funding and require the State to

finance its operations with its own

working capital. Payments to the State

will then be made by the direct Treasury

check method, which reimburses the

State for actual cash disbursements.

Monitoring

A. Office of the Comptroller/General

Accounting Office/Office of the

Inspector General

The Office of the Comptroller, the

General Accounting Office, and the

Office of the Inspector General conducts

periodic reviews of the financial

policies and procedures and records of

VOCA States. Therefore, upon request,

States must give authorized

representatives the right to access and

examine all records, books, papers, case

files, or other documents related to the

grant.

B. Office for Victims of Crime

Beginning with the FFY 1991 grant

period, OVC implemented an on-site

monitoring plan in which each State

grantee is visited a minimum of once

every three years. While on site, OVC

personnel will review various

documents and files such as (1)

financial and program manuals and

procedures governing the crime victim

compensation grant program; (2)

financial records, reports, and audit

reports for the State grantee; (3) the

State’s compensation application,

procedures, and guidelines for awarding

compensation benefits; (4) a random

sampling of victim compensation claim

files; and (5) all other applicable State

records and files.

Suspension and Termination of Funding

If, after notice and opportunity for a

hearing, OVC finds that a State has

failed to comply substantially with

VOCA, the M7100.1D (effective edition),

the Final Program Guidelines, or any

implementing regulation or

requirement, OVC may suspend or

terminate funding to the State and/or

take other appropriate action. At such

time, States may request a hearing on

the justification for the suspension and/

or termination of VOCA funds.

Approved by:

Aileen Adams

Director, Office for Victims of Crime, Office

of Justice Programs.

[FR Doc. 95–4417 Filed 2–22–95; 8:45 am]

BILLING CODE 4410–18–P

NATIONAL INDIAN GAMING

COMMISSION

Fee Rates

AGENCY: National Indian Gaming

Commission.

ACTION: Notice.

SUMMARY: Notice is hereby given,

pursuant to 25 CFR 514.1 (a)(3), that the

National Indian Gaming Commission

has adopted a preliminary annual fee

rate of 0.6% (.006) for calendar year

1995. The rate shall apply to all

assessable gross revenues (tier 1 and tier

2) from each class II gaming operation

regulated by the Commission.

FOR FURTHER INFORMATION CONTACT:

Cindy Altimus, National Indian Gaming

Commission, 1850 N Street, NW., Suite

250, Washington, DC 20036; telephone

202/632–7003; fax 202/632–7066 (these

are not toll-free numbers).

SUPPLEMENTARY INFORMATION: The

Indian Gaming Regulatory Act

established the National Indian Gaming

Commission which is charged with,

among other things, regulating Class II

gaming on Indian lands.

The regulations of the Commission

(25 CFR Part 500) provide for a system

of fee assessment and payment that is

self-administered by the Class II gaming

operations. Pursuant to those

regulations, the Commission is required

to adopt and communicate assessment

rates; the gaming operations are

required to apply those rates to their

revenues, compute the fees to be paid,

and report and remit the fees to the

Commission on a quarterly basis.

The regulations of the Commission

and this rate are effective for calendar

year 1995. Therefore, all Class II gaming

operations within the jurisdiction of the

Commission are required to selfadminister the provisions of these

regulations and report and pay any fees

that are due to the Commission before

the end of the first quarter of 1995

(March 31), and quarterly thereafter.

Harold A. Monteau,

Chairman, National Indian Gaming

Commission.

[FR Doc. 95–4463 Filed 2–22–95; 8:45 am]

BILLING CODE 7565–0–M

NUCLEAR REGULATORY

COMMISSION

Abnormal Occurrence Report; Section

208 Report Submitted to the Congress

Notice is hereby given that pursuant

to the requirements of Section 208 of the

Energy Reorganization Act of 1974, as

amended, the Nuclear Regulatory

Commission (NRC) has published and

issued another periodic report to

Congress on abnormal occurrences

(AOs), ‘‘Report to Congress on

Abnormal Occurrences: July-September

1994’’ (NUREG–0090, Vol. 17, No. 3).

Under the Energy Reorganization Act

of 1974, which created NRC, an AO is

defined as ‘‘an unscheduled incident or

event that the Commission (NRC)

determines is significant from the

standpoint of public health or safety.’’

NRC has made a determination that an

incident or event involving an actual

loss or significant reduction in the

degree of protection against radioactive

properties of source, special nuclear,

and by-product material is an AO.

This report addresses five AOs at

NRC-licensed facilities. One involved a

medical brachytherapy

misadministration, two involved

medical teletherapy misadministrations,

one involved a medical sodium iodide

misadministration, and one involved a

medical sodium iodide event. One AO

report submitted by an Agreement State

is included. It involved the loss of

management and procedural control of

a radioactive source.

The report also contains updates of

six AOs previously reported by NRC

licensees and three AOs previously

reported by Agreement State licensees.

Two ‘‘Other Events of Interest’’
Federal Register / Vol. 60, No. 36 / Thursday, February 23, 1995 / Notices 10119

concerning nuclear power reactors are

also reported. One involved the fracture

of a frozen pipe at Dresden Unit 1 with

a consequent release of water, and the

other involved the possible deliberate

exposure of a contract laborer to

radiation at Quad Cities Nuclear Power

Station.

Section 208 of the Energy

Reorganization Act of 1974, as

amended, also requires NRC to provide

a wide dissemination of information

relating to these reported occurrences.

Descriptions of the NRC licensee AOs

for the third quarter of calendar year

1994, are provided below and have been

reported to Congress in NUREG–0090,

Vol. 17, No. 3.

NRC Material and Medical Licensees

(Industrial Radiographers, Medical

Institutions, Industrial Users, etc.)

94–15 Sodium Iodide Event at

Welborn Memorial Baptist Hospital in

Evansville, Indiana

The following information pertaining

to this event is also being reported

concurrently in the Federal Register.

Appendix A (see General Criterion 1) of

this report notes that a moderate

exposure to, or release of, radioactive

material licensed by or otherwise

regulated by the Commission can be an

abnormal occurrence.

Date and Place—March 9, 1994;

Welborn Memorial Baptist Hospital,

Inc.; Evansville, Indiana.

Nature and Probable Consequences—

On May 16, 1994, the licensee reported

to NRC that a pregnant patient was

administered 185 megabecquerel (MBq)

(5 millicurie [mCi]) of sodium iodide131 (I–131) on March 9, 1994, as

prescribed in the written directive for

the treatment of Graves’ disease

(hyperthyroidism). The licensee did not

know that the patient was pregnant at

the time of the administration. On May

10, 1994, the licensee was informed by

a private practice physician that the

patient was 22-weeks pregnant at the

time of treatment. As a result, the

patient’s fetus received an unintended

radiation dose.

The patient was referred to the

licensee with possible hyperthyroidism.

To confirm the suspect condition, the

licensee administered a 440.3

kilobecquerel (11.9 microcurie) I–131

capsule of the patient on March 7, 1994,

and measured an 82-percent thyroid

uptake over the ensuing 25 hours. The

licensee stated that prior to

administering the I–131 diagnostic

capsule on March 7, 1994, the patient

was questioned and informed both the

treating physician and the nuclear

medicine technologist administering the

capsule that she was not pregnant. The

licensee diagnosed the patient’s

condition as Graves’ disease and the

treating physician perscribed a 185 MBq

(5 mCi) I–131 therapy treatment. On

March 9, 1994, a 185 MBq (5 mCi) I–131

capsule was orally administered by one

of the licensee’s nuclear medicine

technologists, as prescribed. Prior to the

treatment on March 9, 1994, the

technologist questioned the patient once

more and was again informed by the

patient that she was not pregnant.

Oak Ridge Institute for Science and

Education calculated the fetal whole

body and thyroid doses at NRC request.

The fetal dose to the thyroid was

calculated as 7,000–12,000 centigray

(cGy) (7,000–12,000 rad), and the fetal

whole body dose was calculated as 0.55

cGy (0.55 rad). Based on the calculated

fetal dose there are a range of possible

consequences, the most likely being no

significant harm to the fetus. At NRC

request, the Radiation Emergency

Assistance Center/Training Site in Oak

Ridge, Tennessee, contacted the licensee

to discuss the dose assessment and

potential fetal effects.

On May 10, 1994, a physician

specializing in maternal fetal medicine,

not affiliated with the licensee,

discussed the incident with the

licensee. The patient was informed of

the exposure and possible consequences

to the fetus by the material fetal

specialist.

NRC Region III learned the patient

was aware that she was being

administered radioactive materials, and

subsequent to the administration she

realized she was pregnant. It should be

noted that since this was not a

misadministration, there was no

requirement to notify the patient.

Cause or Causes—The principal cause

for the event was licensee reliance on

the patient’s assurance of nonpregnancy. Licensee procedures do not

require determination of pregnancy

status through serum testing, or other

appropriately documented means, for

all female patients of child bearing age.

The patient was apparently unaware of

her pregnancy status at the time of I–131

administration on March 9, 1994.

Action Taken To Prevent Recurrence

Licensee—The licensee is in the

process of developing internal policies

which will address options for

pregnancy status determination

including serum pregnancy testing or

suitable written proof, such as evidence

of a hysterectomy. The legal

implications and options for written

proof of non-pregnancy are being

evaluated by the licensee. Until policies

have been finalized, the licensee plans

to administer pregnancy tests to all

female patients of child bearing age,

unless appropriate proof of nonpregnancy is available as determined by

the authorized user. For patients

unwilling to undergo pregnancy testing,

radiopharmaceuticals will not be

administered and the authorized user

will be consulted for the appropriate

course of action.

NRC—NRC Region III conducted a

safety inspection from May 18 through

June 8, 1994, to review the

circumstances surrounding the event

and to evaluate aspects of the licensee’s

radiopharmaceutical Quality

Management Program (Reg. 1). No

regulatory violations associated with the

event were identified. The licensee’s

procedure appears to have been

followed in this specific case. NRC

regulations do not include requirements

for patient pregnancy verification prior

to administration of

radiopharmaceuticals. However, NRC is

in the process of developing regulations

which will address the administration

of radiopharmaceuticals to breast

feeding and pregnant patients.

94–16 Teletherapy Misadministration

at Medical Center Hospital in

Chillicothe, Ohio

The following information pertaining

to this event is also being reported

concurrently in the Federal Register.

Appendix A of this report notes that a

therapeutic dose that results in any part

of the body receiving unscheduled

radiation can be considered an

abnormal occurrence.

Date and Place—July 21 and 22, 1994;

Medical Center Hospital; Chillicothe,

Ohio.

Nature and Probable Consequences—

On July 27, 1994, the licensee reported

that a patient received a radiation dose

of approximately 300 centigray (cGy)

(300 rad) to an unintended treatment

site using a cobalt-60 teletherapy unit.

A patient was scheduled to receive

1400 cGy (1400 rad) in a series of seven

treatments for cancer of the esophagus.

Each of the treatments was to consist of

two radiation exposures of 100 cGy (100

rad) each delivered from different

angles. The first treatment was

performed on July 21. Following the

first of the to exposures during the

second treatment on July 22, the

technologist found inconsistencies in

the angles of treatment documented in

the written directive and in the patient

simulation sheet. Upon further review,

the licensee determined that the wrong

treatment angles had been used during

the first treatment and part of the

second treatment.
10120 Federal Register / Vol. 60, No. 36 / Thursday, February 23, 1995 / Notices

As a result of the incorrect angles of

exposure, the treatment site received

only part of the prescribed dose and

adjacent tissue received a higher does

than intended. The licensee estimates a

dose of 300 cGy (300 rad) to the

unintended site. Under normal

conditions, the unintended site would

have received approximately 20–50 cGy

(20–50 rad).

The treatment angles were corrected

on the patient’s chart, and the radiation

dose was modified to compensate for

the reduced dosage delivered in the

initial treatments. The patient was

informed and no adverse medical effects

are expected.

The patient was notified verbally on

July 26, 1994 and in writing as required

by 10 CFR 35.33. According to the

medical consultant, there will be no

medical consequences as a result of the

misadministration.

Cause or Causes—The error occurred

because the simulated gantry angles had

not been converted to the treatment unit

gantry angles, and gantry angle

conversion factors were not included in

the licensee’s treatment chart checks

conducted by the technologists.

The root causes of the problem were

discussed with the licensee on

September 1, 1994, during an

Enforcement Conference. The causes

appeared to be the following: (1) Written

procedures were not developed to

address gantry angle conversions; (2) the

technologists did not have an adequate

understanding of the informal gantry

angle conversion procedures; (3) the

informal gantry angle conversion

procedure was not part of the licensee’s

annual refresher training program; (4)

technologists did not fully understand

their responsibilities to resolve

discrepancies in a treatment plan; and

(5) gantry angle conversion factors were

not included in the licensee’s treatment

chart checks conducted by the

technologists.

Action Take To Prevent Recurrence

Licensee—The licensee’s corrective

actions included: (1) Revising the

simulation data form to include a

specific location to document the

converted gantry angles; (2) initialing all

angle conversions by the person

performing the conversion, and having

a second individual independently

verify the conversions prior to

treatment; (3) instructing the

technologists to review all treatment

information and to resolve any

discrepancy prior to continuing

treatment; (4) performing all future

gantry angle conversions by the licensee

rather than by the licensee’s simulation

contractor; and (5) conducting a review

of past treatment plans back to 1988,

with emphasis on those which did not

identify any additional errors.

NRC—NRC Region III conducted an

inspection on August 1, 1994, to review

the circumstances surrounding the

misadministration (Ref. 2). NRC also

retained a medical consultant to review

the case. An Enforcement Conference

was held on September 1, 1994, to

discuss the inspection findings and

actions taken by the licensee. On

September 20, 1994, NRC Region III

issued a Notice of Violation with a

Severity Level III (Severity Levels I

through V range from the most

significant to the least significant)

violation with no civil penalty assessed.

The licensee’s corrective and preventive

actions will be reviewed during the next

NRC inspection of the licensed program.

94–17 Sodium Iodide

Misadministration at St. Joseph Mercy

Hospital in Pontiac, Michigan

The following information pertaining

to this event is also being reported

concurrently in the Federal Register.

Appendix A of this report notes that

administering a diagnostic dose of a

radiopharmaceutical differing from the

prescribed dose by more than 50 percent

in which the event results in adverse

health effects worse than expected for

the normal range of exposures

prescribed for the diagnostic procedure

can be considered an abnormal

occurrence.

Date and Place—July 26, 1994; St.

Joseph Mercy Hospital; Pontiac,

Michigan.

Nature and Probable Consequences—

On July 27, 1994, the licensee reported

to NRC that a misadministration

occurred involving a patient receiving

the wrong radiopharmaceutical for a

diagnostic procedure.

The patient’s referring physician

requested a thyroid scan which involves

administration of a standard

prescription at St. Joseph Mercy

Hospital of a 9.25 megabecquerel (MBq)

(0.25 millicurie [mCi]) sodium iodide–

123 (I–123) capsule. However, the

licensee administered a 92.5 MBq (2.5

mCi) I–131 capsule. The amount of

activity that was administered is

normally used following removal of the

thyroid to examine a patient for the

spread of cancer from the thyroid

through the body.

NRC retained a medical consultant to

review the case. The medical consultant

concluded that the resultant

unnecessary dose to the patient’s

thyroid would result in a low, but finite,

probability of hypothyroidism

developing in the future. Also, there is

a lifetime probability of developing

radiation-induced thyroid cancer of 10

percent, including a risk of fatal thyroid

carcinoma of approximately 1 percent.

The licensee has arranged for the patient

to be seen by a endocrinologist, and for

repeat thyroid imaging with I–123 to be

performed several months after the

misadministration.

The patient was notified in person by

the Radiation Safety Officer on July 27,

1994. Subsequently, the patient was also

given a written report that was dated

August 5, 1994.

Cause or Causes—Part of the cause of

the misadministration was the lack of

the treating physician’s involvement in

the patient’s examination prior to the I–

131 administration. The administrative

staff and technologists failed to have the

examination clarified by a treating

physician with the referring physician

prior to administration of the I–131.

Causal factors for this event also

included the failure of licensee

management to ensure implementation

of the licensee’s written Quality

Management Program. Contributing

factors also appear to include

deficiencies in training, and a failure to

follow through on matters.

Action Taken To Prevent Recurrence

Licensee—The licensee took the

following corrective actions: (1) Held a

training session which included the

Radiation Safety Officer, treating

physicians and technologists; (2)

instituted a limit on the number of

individuals who will be involved in the

use of I–131; and (3) required a written

directive to be filled out and signed by

a treating physician.

NRC—NRC Region III conducted an

inspection on August 1, 1994, to review

the misadministration (Ref. 3). A

Conformatory Action Letter (CAL) was

issued to the licensee on August 2,

1994, which described the commitments

made by the licensee as to which

actions will be taken prior to the

administration of I–131. An

Enforcement Conference was held on

August 24, 1994, to discuss the

inspection findings and actions taken by

the licensee in response to the CAL.

In October 1994, NRC proposed an

$8,000 fine against the licensee for

violations of NRC requirements

involved in a diagnostic procedure

using radioactive iodine at the hospital.

The violations involve: (1) Failure to

have signed written directives by an

authorized user prior to administration

of I–131 in quantities greater than 1.11

MBq (0.03 mCi) on July 26, and in two

previous instances where the I–131 was

the intended radiopharmaceutical; (2)

failure to have a clinical procedure for

the proper administration of I–131 for
Federal Register / Vol. 60, No. 36 / Thursday, February 23, 1995 / Notices 10121

whole body scans; and (3) failure to

provide proper instruction to the

nuclear medicine staff. The licensee

paid the civil penalty.

94–18 Multiple Teletherapy

Misadministrations at Sinai Hospital in

Detroit, Michigan

The following information pertaining

to this event is also being reported

concurrently in the Federal Register.

Appendix A of this report notes that a

therapeutic dose that results in any part

of the body receiving unscheduled

radiation can be considered an

abnormal occurrence.

Date and Place—July 28 and August

3, 1994; Sinai Hospital; Detroit,

Michigan.

Nature and Probable Consequences—

On July 28, 1994, and August 3, 1994,

misadministrations occurred on two

separate patients when the licensee’s

therapists failed to verify correct

teletherapy machine parameters prior to

treatment.

Beginning on July 19, 1994, a patient

was to received 4500 centigray (cGy)

(4500 rad) in a series of 25 treatments

to the left neck area. The first seven

treatments were completed without

incident. However, on the eighth

treatment on July 28, one faction was set

up using the wrong treatment angle.

This resulted in a radiation dose of 90

cGy (90 rad) being received by the right

shoulder and neck area instead of the

left neck area.

Beginning July 5, 1994, another

patient was to receive 5000 cGy (5000

rad) in a series of 25 treatments to the

right shoulder area. The first 20

treatments were completed without

incident. However, on the 21st

treatment on August 3, the teletherapy

unit was positioned using the wrong

treatment angle. This resulted in a

radiation dose of 100 cGy (100 rad)

being received by the right lung area

instead of the right shoulder area.

An NRC medical consultant reviewed

both cases and concluded that no

significant adverse side effects or tissue

injury are expected.

Cause or Causes—The cause of both

misadministrations was human errors

by several of the licensee’s therapists.

The therapists failed to verify the

collimator angle, the wedge setting, and

the treatment site before administering

the teletherapy dose to the patients.

Action Taken To Prevent Recurrence

Licensee—The corrective actions

taken included: (1) Suspending all

teletherapy treatments pending an

internal investigation, and identification

of appropriate corrective actions prior to

re-start of the teletherapy treatments; (2)

developing procedures which require

independent verification of proper

treatment parameters during patient setup; and (3) installing a record-and-verify

system on the teletherapy unit to ensure

that all major treatment parameters are

checked prior to a treatment.

NRC—NRC Region III conducted an

inspection July 29 through August 12,

1994, to review the circumstances

surrounding the two misadministrations

(Ref. 4). NRC also retained a medical

consultant to review the case. An

Enforcement Conference was held on

September 8, 1994, to discuss the

inspection findings and actions taken by

the licensee. On September 21, 1994,

NRC Region III issued a Notice of

Violation with a Severity Level III

(Severity Levels I through V range from

the most significant to the least

significant) violation with no civil

penalty assessed. The licensee’s

corrective and preventive actions will

be reviewed during the next NRC

inspection of the licensed program.

As required by 10 CFR 35.33(a), the

licensee, for each misadministration,

notified the referring physician and

patient after the discovery of the

incident and submitted a written report

to the patient, including a statement that

the report submitted to NRC Region III

will be made available upon request.

94–19 Brachytherapy

Misadministration Involving the Use of

a Strontium-90 Eye Applicator at the

University of Massachusetts Medical

Center in Worcester, Massachusetts

The following information pertaining

to this event is also being reported

concurrently in the Federal Register.

Appendix A (see Event Type 5 in Table

A–1) of this report notes that a

therapeutic dose that results in an actual

dose less than 0.5 times the prescribed

dose can be considered an abnormal

occurrence. In addition, Criterion No. 11

under ‘‘For All Licensees’’ in Appendix

A notes that a serious deficiency in

management or procedural controls in

major areas can be considered an

abnormal occurrence.

Date and Place—July 29, 1994;

University of Massachusetts Medical

Center; Worcester, Massachusetts.

Nature and Probable Consequences—

NRC Region I was notified on August 1,

1994, by the licensee of a brachytherapy

misadministration involving the use of

a strontium-90 (Sr-90) eye applicator.

On July 29, 1994, a physician performed

an ophthalmic treatment on a patient

using a Sr-90 eye applicator without

first removing the stainless steel mask

from the source. Because of this

oversight, the licensee estimated that

the treatment site received 107 centigray

(cGy) (107 rad) of radiation, rather than

the 1250 to 2000 cGy (1250 to 2000 rad)

that was intended. In addition, whereas

the beta radiation from the eye

applicator source only affects the

surface of the eye, the bremsstrahlung

radiation resulting from the interaction

of the beta particles on the stainless

steel mask is more penetrating. The

patient returned on August 2, 1994, for

the completion of the therapy to bring

the total dose delivered within the

originally prescribed range. The licensee

expects that the clinical outcome of the

misadministration will be

inconsequential for the patient.

Cause or Causes—According to the

licensee a combination of factors led to

the misadministration: (1) Infrequent

use of the ophthalmic applicator and the

fact that its appearance with the mask

is similar to its appearance with the

mask removed; (2) the event occurred

on a Friday afternoon and the stress of

the week’s work affected the alertness of

the individuals involved; and (3) the

most experienced physicists were not

available, and a relatively inexperienced

physicist prepared the source and was

unaware that the source was equipped

with a stainless steel mask.

Actions Taken to Prevent Recurrence

Licensee—The licensee is reviewing

the feasibility of modifying the mask in

some manner to make it more easily

distinguished from the unmasked

source. In addition, the licensee has

employed two new radiation oncology

physicians and a new chief physicist.

NRC—NRC conducted a special

inspection on August 3, 1994. The

inspector determined that the physician

was assisted by a dosimetrist who had

not previously been directly involved

with the procedure. When the physician

requested that the dosimetrist provide

him with the eye applicator source in

order to perform the treatment, the

dosimetrist handed him the source with

the stainless steel mask in place. The

dosimetrist stated that she was unaware

that the source was equipped with a

mask and that the mask needed to be

removed. The physician and other

licensee staff stated that it is the

assistant’s responsibility, in this case

the dosimetrist’s responsibility, to

remove the stainless steel mask from the

source before handing the eye applicator

to the physician. The treatment was

administered by the physician with the

mask in place. While cleaning the eye

applicator later that same day, the

licensee determined that the treatment

had been performed with the mask in

place. The licensee stated that the

patient and the patient’s physician were

notified that there had been an
10122 Federal Register / Vol. 60, No. 36 / Thursday, February 23, 1995 / Notices

underdose and the patient returned on

August 2, 1994, for the completion of

the therapy. The patient was given a

written report of the misadministration

on August 9, 1994. The licensee

submitted a report for the

misadministration on August 10, 1994.

NRC Region I has enlisted the services

of a medical consultant to evaluate the

clinical consequences of this

misadministration and awaits his report.

A copy of NUREG–0090, Vol. 17, No.

3 is available for inspection or copying

for a fee at the NRC Public Document

Room, 2120 L Street NW. (Lower Level),

Washington, D.C. 20037, or at any of the

nuclear power plant Local Public

Document Rooms throughout the

country.

Copies of this report (or any of the

previous reports in this series), may be

purchased from the Superintendent of

Documents, U.S. Government Printing

Office, Post Office Box 37082,

Washington, DC 20013–7082. A year’s

subscription to the NUREG–0090 series

publication, which consists of four

issues, is also available.

Copies of the report may also be

purchased from the National Technical

Information Service, U.S. Department of

Commerce, 5285 Port Royal Road,

Springfield, VA 22161.

Dated at Rockville, MD this 16th day of

February, 1995.

For the Nuclear Regulatory Commission.

John C. Hoyle,

Acting Secretary of the Commission.

[FR Doc. 95–4382 Filed 2–22–95; 8:45 am]

BILLING CODE 7590–01–M

[Docket Nos. 50–352 and 50–353]

In the Matter of: Philadelphia Electric

Company (Limerick Generating

Station, Units 1 and 2); Exemption

I.

Philadelphia Electric Company (the

licensee), is the holder of Facility

Operating License Nos. NPF–39 and

NPF–85, which authorize operation of

the Limerick Generating Station (LGS),

Units 1 and 2. The licenses provide,

among other things, that the licensee is

subject to all rules, regulations, and

orders of the Nuclear Regulatory

Commission (the Commission) now and

hereafter in effect. The facilities consist

of two boiling water reactors located in

Montgomery 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. Sections II.H.4 and III.C.2

of Appendix J to 10 CFR Part 50 require

leak rate testing of Main Steam Isolation

Valves (MSIVs) at the calculated peak

containment pressure related to the

design basis accident, and Section

III.C.3 requires that the measured leak

rates be included in the combined local

leak rate test results. The proposed

deletion of the MSIV Leakage Control

System (LCS), and proposed use of an

alternate leakage pathway affects the

description of an existing exemption

which allows the leak rate testing of the

MSIVs at a reduced pressure and the

exclusion of the measured leakage from

the combined local leak rate test results.

The original exemption is contained in

the LGS Safety Evaluation Report (SER)

(NUREG–0991, and its Supplement 3).

By letter dated December 22, 1994,

the licensee requested an exemption

from the Commission’s regulations. The

subject exemption is from the

requirements of 10 CFR Part 50,

Appendix J, ‘‘Primary Reactor

Containment Leakage Testing for WaterCooled Power Reactors,’’ Sections II.H.4,

III.C.2, and III.C.3, to allow alternative

testing pressure and leakage limits for

the MSIVs and to exclude MSIV leakage

from the combined local leak rate test

results after deletion of the LCS.

The staff issued for LGS, Units 1 and

2, the current exemption from 10 CFR

Part 50, Appendix J, Sections II.H.4,

III.C.2, and III.C.3, based on the

conclusion that the LGS, Units 1 and 2,

MSIV leak testing methods were

acceptable alternatives to the

requirements. This conclusion was

included in the LGS SER (NUREG–0991,

and its Supplement 3). The SER also

described that in the event of a loss-ofcoolant-accident (LOCA), the MSIV LCS

will maintain a negative pressure

between the MSIV and the effluent will

be discharged into a volume where it

will be processed by the standby gas

treatment system before being released

to the environment. The licensee had

performed a radiological analysis based

on an assumed leak rate limit of 11.5

standard cubic feet per hour (scfh), and

the MSIVs were planned to be

periodically tested to ensure the validity

of the radiological analysis. The staff

concluded that the current LGS testing

procedure, where two valves on one

steam line are tested simultaneously,

between the valves, utilizing a reduced

test pressure (i.e., half a peak

containment pressure of 22 psig applied

between the MSIVs) was acceptable.

Also, the staff excluded the MSIV test

leakage rate from the combined local

leak rate because the MSIV leakage had

been accounted for separately in the

radiological analysis of the site.

By letter dated January 14, 1994, the

licensee submitted a Technical

Specifications (TS) amendment request

for LGS, Units 1 and 2, which supports

the planned modification to eliminate

the MSIV LCS and utilize an alternate

leakage pathway (main steam lines and

condenser). This proposal is based on

the Boiling Water Reactor Owners

Group (BWROG) method summarized in

General Electric Report NEDC–31858P,

Revision 2, ‘‘BWROG Report for

increasing MSIV Leakage Rate Limits

and Elimination of Leakage Control

System.’’ Therefore, the description of

the MSIV LCS and the assumed MSIV

leak rate are no longer accurate once the

proposed TS modification is performed

and implemented.

The licensee’s January 14, 1994, TS

(amendment) request states that a plantspecific radiological analysis has been

performed in accordance with NEDC–

31858P, Revision 2, to assess the effects

of the proposed increase to the

allowable MSIV leakage rate in terms of

Main Control Room (MCR) and off-site

doses following a postulated design

basis LOCA. This analysis utilizes the

hold-up volume of the main steam

piping and condenser as an alternate

method for treating MSIV leakage. The

radiological analysis uses standard

conservative assumptions for the

radiological source term consistent with

Regulatory Guide (RG) 1.3,

‘‘Assumptions Used for Evaluating the

Potential Radiological Consequences of

a Loss-of-Coolant-Accident for Boiling

Water Reactors,’’ Revision 2, dated June

1974. The analysis results demonstrate

that dose contributions from the

proposed MSIV leakage rate limit of 100

scfh per MSIV, not to exceed 200 scfh

for all four main steam lines, and

considering the proposed deletion of the

MSIV LCS, result in an acceptable

increase to the LOCA doses previously

evaluated against the regulatory limits

for the off-site doses and MCR doses

contained in 10 CFR Part 100, and 10

CFR Part 40, Appendix A, General

Design Criteria (GDC) 19, respectively.

The proposed calculated off-site and

MCR doses resulting from a LOCA are

the sum of the LOCA doses previously

evaluated (currently described in the

Updated Final Safety Analysis Report),

and the additional doses calculated

using the alternate MSIV leakage

treatment method. The method of

calculating the revised doses is

conservative, since the LOCA doses