50018 Federal Register / Vol. 62, No. 185 / Wednesday, September 24, 1997 / Notices

Arizona Public Service Company, et al.,

Docket No. STN 50-529, Palo Verde

Nuclear Generating Station, Unit No. 2,

Maricopa County, Arizona

Date of application for amendment:

August 28, 1997, as supplemented by

letter dated September 3, 1997.

Brief description of amendment: The

amendment revises Technical

Specification Table 4.3-2 to allow for a

one-time, five-day extension of the

required surveillance interval for the

main steam isolation system portion of

the engineered safety feature actuation

system logic.

Date of issuance: September 4, 1997

Effective date: September 4, 1997

Amendment No.: 105

Facility Operating License No. NPF51: The amendment revised the

Technical Specifications. Press release

issued requesting comments as to

proposed no significant hazards

consideration: Yes. September 1, 1997.

Arizona Republic Newspaper (Arizona).

Comments received: No. The

Commission’s related evaluation of the

amendment, finding of exigent

circumstances, consultation with the

State of Arizona and final determination

of no significant hazards consideration

are contained in a Safety Evaluation

dated September 4, 1997.

Local Public Document Room

location: Phoenix Public Library, 1221

N. Central Avenue, Phoenix, Arizona

85004

Attorney for licensee: Nancy C. Loftin,

Esq., Corporate Secretary and Counsel,

Arizona Public Service Company, P.O.

Box 53999, Mail Station 9068, Phoenix,

Arizona 85072-3999

NRC Project Director: William H.

Bateman

Public Service Electric & Gas Company,

Docket No. 50-311, Salem Nuclear

Generating Station, Unit No. 2, Salem

County, New Jersey Date of application

for amendment: August 19, 1997, as

supplemented August 20, 1997.

Brief description of amendment: This

amendment to the Technical

Specifications increases the allowable

band for control and shutdown rod

demanded position versus indication

position from plus or minus 12 steps to

plus or minus 18 steps when the power

level is not greater than 85% rated

thermal power.

Date of issuance: September 10, 1997

Effective date: As of date of issuance,

to be implemented within 7 days.

Amendment No. 183

Facility Operating License No. DPR75: This amendment revised the

Technical Specifications. Public

comments requested as to proposed no

significant hazards consideration: Yes.

The NRC published a public notice of

the proposed amendment, issued a

proposed finding of no significant

hazards consideration, and requested

that any comments on the proposed no

significant hazards consideration be

provided to the staff by the close of

business on September 3, 1997, and

stated that, should circumstances

change during the notice period, such

that a failure to act in a timely way

would result, for example, in derating or

shutdown of the facility, the

Commission may issue the license

amendment before the expiration of the

notice period, provided that its final

determination is that the amendment

involves no significant hazards

consideration. The notice was published

in the Wilmington News Journal on

August 22, 1997, and in Today’s

Sunbeam on August 24, 1997. No public

comments were received. The

Commission’s related evaluation of the

amendment, finding of exigent

circumstances, consultation with the

State of New Jersey and final no

significant hazards consideration

determination are contained in a Safety

Evaluation dated September 10, 1997.

Local Public Document Room

location: Salem Free Public Library, 112

West Broadway, Salem, NJ 08079

Attorney for licensee: Jeffrie J. Keenan,

Esquire, Nuclear Business Unit - N21,

P.O. Box 236, Hancocks Bridge, NJ

08038

NRC Project Director: John F. Stolz

Dated at Rockville, Maryland, this 17th day

of September 1997.

For the Nuclear Regulatory Commission

Elinor G. Adensam,

Acting Director, Division of Reactor Projects—

III/IV, Office of Nuclear Reactor Regulation

[Doc. 97-25210 Filed 9–23–97; 8:45 am]

BILLING CODE 7590–01–F

NUCLEAR REGULATORY

COMMISSION

[Docket No. 030–01786]

National Institutes of Health Issuance

of Director’s Decision Under 10 CFR

§ 2.206

Notice is hereby given that the

Director, Office of Nuclear Material

Safety and Safeguards, U. S. Nuclear

Regulatory Commission (NRC), has

acted on a Petition for action dated

October 10, 1995, submitted by

Maryann Wenli Ma, M.D., Ph.D., and

Bill Wenling Zheng, M.D., Ph.D. (Dr. Ma

and Dr. Zheng or Petitioners), as

supplemented by letters dated March

25, 1996, and July 10, 1997, with regard

to NRC Licensee, the National Institutes

of Health (NIH or the Licensee).

Petitioners requested, pursuant to 10

C.F.R. 2.206, that NRC suspend or

revoke the materials license of NIH,

NRC License No. 19–00296–10, pending

resolution of the issues raised by the

Petition, and that NRC take other

appropriate enforcement action,

including the imposition of civil

penalties against NIH for willful and

reckless violations of 10 CFR part 20.

Broadly stated, the Petitioners assert

that, as the direct and proximate result

of NIH’s: (1) Deliberate failure to control

and secure radioactive materials in

violation of 10 CFR 20.1801 and

20.1802; (2) failure to maintain an

effective bioassay program; and (3)

failure to otherwise adhere to the

requirements of 10 CFR part 20, Dr. Ma

was contaminated with phosphorus-32

(P–32), resulting in both her and her

unborn fetus receiving intakes of

radioactive material significantly in

excess of regulatory limits, additional

NIH employees were also internally

contaminated with P–32, and NIH failed

to take proper actions to assess

accurately the level of Dr. Ma’s internal

contamination or provide appropriate

medical care and follow-up treatment.

In their March 25, 1996, supplemental

Petition, Petitioners state that NIH’s

repeated denials that it has any problem

with its security over radioactive

materials suggests that the NIH

radioactive materials license should be

suspended or revoked, because the

Licensee poses a threat to public health

and safety, the Licensee has not

responded adequately to other

enforcement actions, and is unwilling or

unable to comply with NRC

requirements. On July 10, 1997,

Petitioners submitted another

supplement to their Petition, requesting

immediate revocation or suspension of

the NIH license on the grounds that NIH

continues in its failure to implement

and maintain a program to oversee

licensed radioactive materials

sufficiently secure to prevent another

contamination incident of the type Dr.

Ma experienced in 1995.

For the reasons stated in the

‘‘Director’s Decision Under 10 CFR

2.206,’’ (DD–97–22) the Director of the

Office of Nuclear Material Safety and

Safeguards has granted the following

requests of Petitioners in part: for

enforcement action against NIH for

violations of NRC security and control

requirements and for violation of NRC

requirements related to radiation safety

training, ordering radioactive materials,

inventory control of radioactive

materials, monitoring, and the issuance,

use, and collection of dosimetry.
Federal Register / Vol. 62, No. 185 / Wednesday, September 24, 1997 / Notices 50019

Petitioners’ request for NRC action to

ensure adequate procedures and

instructions to exposed persons for

sample collection was granted as

described in DD–97–22. The following

requests of Petitioners for enforcement

action against NIH were denied: for the

exposure of Dr. Ma beyond regulatory

limits, for the exposure of Dr. Ma’s

fetus, and for the contamination of the

water cooler; regarding notification to

Dr. Ma of her level of contamination;

regarding Dr. Ma’s declaration of

pregnancy; regarding the conduct of

surveys after Dr. Ma’s contamination;

and for the failure to accurately

calculate Dr. Ma’s occupational

radiation dose. Finally, Petitioners’

request to suspend or revoke the NIH

license was denied.

The complete text of DD–97–22

follows this notice and is available for

public inspection at the Commission’s

Public Document Room, the Gelman

Building, 2120 L Street, N.W.,

Washington, D.C., 20003–1527 and at

NRC’s Region I Office located at 475

Allendale Road, King of Prussia, PA,

19406–1415.

A copy of this Decision will be filed

with the Secretary of the Commission

for Commission review in accordance

with 10 CFR 2.206(c) of the

Commission’s regulations. As provided

by this regulation, the Decision will

constitute the final action of the

Commission 25 days after issuance,

unless the Commission, on its own

motion, institutes a review of the

Decision within that time.

Dated at Rockville, Maryland, this 17th day

of September, 1997.

For the Nuclear Regulatory Commission.

Carl J. Paperiello,

Director, Office of Nuclear Material Safety

and Safeguards.

Director’s Decision Under 10 CFR 2.206

I. Introduction

By a Petition addressed to the

Director, Office of Nuclear Material

Safety and Safeguards (NMSS), dated

October 10, 1995, Maryann Wenli Ma,

M.D., Ph.D., and Bill Wenling Zheng,

M.D., Ph.D. (Dr. Ma and Dr. Zheng or

Petitioners) requested that the Nuclear

Regulatory Commission (NRC) take

action with respect to the National

Institutes of Health (NIH or the

Licensee).

Petitioners request that NRC suspend

or revoke the materials license of NIH,

NRC License No. 19–00296–10, pending

resolution of the issues raised by the

Petition, and that NRC take other

appropriate enforcement action,

including the imposition of civil

penalties against NIH for willful and

reckless violations of 10 CFR part 20.

As a basis for their requests, the

Petitioners assert that NIH has willfully

and recklessly committed numerous

violations of 10 CFR part 20. Broadly

stated, the Petitioners assert that, as the

direct and proximate result of NIH’s: (1)

Deliberate failure to control and secure

radioactive materials in violation of 10

CFR § 20.1801 and 20.1802; (2) failure to

maintain an effective bioassay program;

and (3) failure to otherwise adhere to

the requirements of 10 CFR part 20; Dr.

Ma was contaminated with phosphorus32 (P–32), resulting in both her and her

unborn fetus receiving intakes of

radioactive material significantly in

excess of regulatory limits, additional

NIH employees were also internally

contaminated with P–32, and failure of

NIH to take proper actions to assess

accurately the level of Dr. Ma’s internal

contamination or provide appropriate

medical care and follow-up treatment. A

more detailed description of the

concerns raised by Petitioners appears

in Section III., below.

By letter dated October 30, 1995, Carl

J. Paperiello, Director, NMSS,

acknowledged receipt of the Petition

and denied Petitioners’ request for

immediate suspension or revocation of

the NIH license because, although

certain weaknesses had been identified

in the 1995 inspections of NIH, these

weaknesses were not sufficiently

widespread or egregious as to warrant

suspension or revocation of the license.

On November 2, 1995, NRC issued a

Demand for Information (EA 95–240) to

NIH, requesting that NIH respond to the

concerns raised in the Petition. On

December 11, 1995, NIH submitted its

‘‘Response to Demand for Information

(EA–95–240).’’ John N. Weinstein, M.D.,

Ph.D. (Dr. Weinstein), submitted a

response to the Petition dated December

15, 1995.

On March 25, 1996, Petitioners

supplemented their Petition in a written

reply to the Licensee’s December 11,

1995, ‘‘Response to Demand for

Information (EA–95–240).’’ In their

supplemental Petition, Petitioners

contend that NIH’s repeated denials that

it has any problem with its security over

radioactive materials suggest that the

NIH radioactive materials license

should be suspended or revoked,

because the Licensee poses a threat to

public health and safety, the Licensee

has not responded adequately to other

enforcement actions, and is unwilling or

unable to comply with NRC

requirements. On July 10, 1997,

Petitioners submitted another

supplement to their Petition, requesting

immediate revocation or suspension of

the NIH license on the grounds that NIH

continues in its failure to implement

and maintain a program to oversee

licensed radioactive materials

sufficiently securely to prevent another

contamination incident of the type Dr.

Ma experienced in 1995. By letter dated

August 5, 1997, the supplemental

Petition was acknowledged and the

request for immediate action was denied

because NIH has made continuing

progress in improving the security and

control of licensed radioactive material

since the 1995 contamination event. By

letter dated September 10, 1997, NIH

responded to the July 10, 1997,

supplement to the Petition.

II. Background

NRC license No. 19–00296–10 is a

broad-scope license that authorizes

possession and use of radioactive

material for medical diagnosis, therapy,

and research in humans, as well as nonhuman research and development, at

facilities in Bethesda, Rockville,

Baltimore, and Poolesville, Maryland.

The NIH main campus in Bethesda has

21 buildings housing nearly 3000

biomedical research laboratories. There

are more than 800 Authorized Users and

more than 5000 supervised users of

radioactive material under NIH’s

licensed program. NIH’s Materials

License No. 19–00296–10, originally

issued on December 7, 1956, was

renewed on June 16, 1997, and will

expire on June 30, 2002.

The internal contamination of Dr. Ma

was discovered by Dr. Zheng (Dr. Ma’s

husband) during a survey of the NIH

laboratory in which they both worked,

on the evening of June 29, 1995. At 5:58

p.m., Dr. Zheng reported the internal

contamination of his wife to the NIH

emergency number, and then to their

immediate supervisor, Dr. Weinstein,

who was on the premises at the time.

Dr. Weinstein notified the NIH

Radiation Safety Branch of Dr. Ma’s

contamination.

Shortly after 6:00 p.m., an NIH

ambulance with two emergency medical

technicians responded to the scene, and

at approximately 6:40 p.m., two

personnel from the NIH Radiation

Safety Branch (RSB) responded to the

scene. Petitioners told RSB personnel

that they believed Dr. Ma had been

internally contaminated as a result of

eating leftovers she had stored in a

conference room refrigerator. The RSB

performed surveys with portable

radiation detection instruments to

determine whether radioactive

contamination was present in the

laboratory, the adjacent hallways and

corridors, and in the conference room.

The RSB took smears of Dr. Ma’s hands,
50020 Federal Register / Vol. 62, No. 185 / Wednesday, September 24, 1997 / Notices

1REAC/TS is a Department of Energy response

asset that maintains a radiological emergency

response team consisting of physicians, nurses,

health physicists and other support personnel. It is

on 24-hour call to provide first-line responders with

consultative or direct medical and radiological

assistance at the REAC/TS facility, accident site, or

attending hospital.

2Because the system of units employed by NIH

and the Petitioner’s Consultant were non-metric,

the English unit is listed first, followed by its metric

equivalent in brackets. However, for those instances

where NRC has issued a report, metric units are

listed first as primary units, followed by the English

units in brackets, which is the usual NRC style.

3CAL 1–95–011 (July 21, 1995); CAL 1–95–011,

Rev. 1 (July 21, 1995); CAL 1–95–018 (October 27,

1995); CAL 1–95–018, Supplement 1 (November 8,

1995); CAL 1–95–018, Supplement 2 (December 1,

1995); and CAL 1–95–018, Supplement 3 (June 7,

1996).

neck and face to determine if any of the

contamination was removable and then

had Dr. Ma change out of her clothes

into clean scrubs to see if her clothing

was radioactive. None of the smears,

clothing, or surveys of Dr. Ma showed

external contamination. The RSB asked

Dr. Ma to submit a urine sample. The

sample was surveyed by the RSB and

found to contain radioactivity (later

determined to be P–32), indicating that

Dr. Ma’s contamination was internal.

Shortly after 8:00 p.m., the NIH

ambulance departed with Dr. Ma en

route to Holy Cross Hospital (Holy

Cross).

NIH RSB staff contacted the on-call

physician from the Radiation

Emergency Assistance Center/Training

Site (REAC/TS) 1 in Oak Ridge,

Tennessee, and had the REAC/TS

physician speak directly with the

emergency room (ER) physician at Holy

Cross. The REAC/TS physician stated

that he discussed with the Holy Cross

ER physician the possibility of

administering a phosphate solution for

dilution and displacement of the P–32,

but that the ER physician choose not to

follow this suggestion. The REAC/TS

physician also advised the ER physician

of the need to collect 24-hour urine

samples for determination of Dr. Ma’s

occupational radiation dose. After

consultation with REAC/TS and the NIH

Radiation Safety Officer (RSO), the Holy

Cross ER physician ordered intravenous

infusions of fluids (hydration) in order

to dilute Dr. Ma’s internal

contamination.

The Petitioners did not return to work

in the NIH Laboratory of Molecular

Pharmacology after the discovery of Dr.

Ma’s contamination, but eventually

returned to work at other laboratories at

NIH.

On June 30, 1995, NIH informed an

NRC inspector on site at the time that

Dr. Ma had been internally

contaminated with P–32. On June 30,

1995, NRC initiated an Augmented

Inspection Team (AIT) evaluation of the

event and presented its preliminary

findings to NIH on August 8, 1995.

During October 23–24, 1995, and

November 6–10, 1995, the NRC staff

conducted two special team inspections

of NIH. On December 21, 1995, NRC

Inspection Report No. 030–01786/95–

203 was issued describing the results of

those inspections. The AIT issued a

redacted version of its report on January

29, 1996, and, upon completion of

NRC’s investigation, issued the full,

unredacted report on January 13, 1997.

NRC’s Office of Investigations (OI)

began an investigation on June 30, 1995.

Additionally, the Federal Bureau of

Investigation began an investigation, as

did the Department of Health and

Human Services Office of the Inspector

General, and the NIH Police

Department. These investigative groups

worked in cooperation with each other

and shared their findings on an ongoing

basis. On January 24, 1997, NRC’s OI

issued its report, ‘‘National Institutes of

Health: Wrongful Administration of P–

32, Case No. 1–95–033.’’ That report and

its associated exhibits are being publicly

released concurrent with issuance of

this Director’s Decision.

NIH performed an assessment of Dr.

Ma’s intake of P–32, the resultant

radiation exposure received by Dr. Ma,

and the radiation exposure received by

her fetus. In its initial notification to

NRC on July 3, 1995, NIH indicated that

its estimated ingestion for Dr. Ma was

approximately 300 microcuries (μCi) or

11.1 megabequerel (MBq) of P–32.2 On

August 29, 1995, NIH reassessed Dr.

Ma’s dose and calculated her effective

dose equivalent to be 4.17 rem [41.7

millisievert (mSv)], based upon an

intake of 500 μCi (18.5 MBq), and the

dose to her fetus to be 3.2 rem (32 mSv).

Most recently, on July 30, 1996, NIH

revised its committed effective dose

equivalent (CEDE) estimates for Dr. Ma

to between 4.7 and 7.0 rem (47 and 70

mSv), corresponding to an intake range

of between 570 and 840 μCi (21.1 and

31.1 MBq). The revised dose to the fetus

was between 3.7 and 5.4 rem (37 and 54

mSv). Additional discussion of NIH’s

dose estimates appears in Section III.K.,

below.

NRC’s estimates indicate that Dr. Ma

ingested between 30.3 and 48.1 MBq

(820 and 1300 μCi) of P–32. Based on

these values, Dr. Ma’s estimated internal

CEDE was between 80 and 127 mSv (8.0

and 12.7 rem). The annual occupational

exposure limit applicable to Dr. Ma was,

however, 5 mSv (5 rem) total effective

dose equivalent per 10 CFR

§ 20.1201(a)(1)(i). The estimated dose

received by Dr. Ma’s fetus was between

51 and 81 mSv (5.1 and 8.1 rem).

NRC estimated that of the 26 other

NIH employees who received P–32

contamination from a water cooler

situated in a hallway near the

Petitioner’s laboratory, including Dr.

Zheng, one individual who was not an

occupational radiation worker received

a dose of between 1.5 and 2.5 mSv (150

and 250 millirem), in excess of the

applicable dose limit of 1.0 mSv (100

millirem) for members of the public

specified by 10 CFR § 20.1301.

NRC issued a series of Confirmatory

Action Letters (CALs) to NIH between

July 21, 1995, and June 7, 1996,

addressing various measures to be taken

by NIH, such as: (1) Reduction of the

possibility of further ingestion of

radioactive material by NIH employees;

(2) determination of the full scope of the

personnel contaminations at NIH; (3)

further enhancement and training of

NIH staff regarding security of

radioactive material; (4) documentation

of corrective actions with respect to

enforcement of a new NIH security

policy; (5) modifications to the

surveillance plan for NIH laboratories;

and (6) other specific actions for

inspections for NRC compliance.3

NRC continued its onsite inspection

through July 28, 1995. The AIT

conducted a technical debrief with NIH

RSB management and staff on August 3,

1995, and with NIH senior management

on August 8, 1995. Further NRC

inspection activities, including

assessment of radiation dose to the

exposed individuals, and evaluation of

a third-party independent dose

assessment, continued through

November 15, 1995.

On August 23, 1996, NRC issued a

Notice of Violation (NOV) and Proposed

Imposition of Civil Penalty of $2500 (EA

96–027) to NIH for failure to physically

secure licensed material or maintain

surveillance over it to prevent

unauthorized removal. Other violations

of NRC requirements were also cited,

involving: (1) Workers not wearing

extremity dosimetry, or returning

dosimetry promptly each month, as

required; (2) users obtaining radioactive

materials without providing required

information regarding the identity of the

intended user(s) or the signature of the

authorized investigator; (3) researchers

performing licensed activities without

first receiving the required training; and

(4) failure to perform thyroid bioassay

measurements of researchers who

handled gigabequerel [millicurie (mCi)]

quantities of volatile iodine-125. On

May 20, 1997, NRC issued an Order

Imposing Civil Monetary Penalty in the
Federal Register / Vol. 62, No. 185 / Wednesday, September 24, 1997 / Notices 50021

4NIH and NCI are two different licensees. Science

Applications International Corp. holds NRC

broadscope license for activities at the NCIFrederick Cancer Research and Development Center

facility located at Fort Dietrick in Frederick, MD

(NRC License No. 19–21091–0). Prior to March

1995, the license was held by Program Resources

Incorporated (PRI). Since 1985, NRC has issued to

PRI six NOVs associated with either cited severity

level (SL) IV violations or a monetary civil penalty:

(1) During a February 1995 inspection, three SL IV

violations were cited for inadequate surveys for P–

32 personnel contamination, failure to perform

thyroid bioassays, and failure to perform proper

package surveys; (2) during a January 1993

inspection, two SL IV violations were cited for

failure to wipe test packages and perform thyroid

bioassays; (3) during a February 1991 inspection,

one SL IV violation was cited for failure to perform

package surveys; (4) during a January 1989

inspection, one SL IV was cited for failure to

perform survey instrument calibration; (5) a $2500

Civil Penalty was issued on February 27, 1987, for

an SL III violation from an inspection performed

earlier that month; and (6) a December 1986

inspection resulted in five violations being cited for

extremity overexposure, inadequate training,

improper transfer and disposal of radioactive

material, and exceedance of the license possession

limits.

5 (1) The June 11–13, 1990, inspection resulted in

an NOV categorized at an SL IV, for failure to obtain

specific user estimates of solid radwaste generation,

as well as other non-cited violations for loss of

radioactive material that was licensee-identified

(Report No. 90–001). (2) The July 8–12, 1991,

inspection resulted in an NOV categorized at an SL

IV for failure to secure radioactive material (Report

No. 91–001). (3) The July 20–24, 1992, inspection

identified as inadequate dose assessment for a

lutetium-177 contamination incident, and resulted

in an NOV characterized as an SL IV (Report No.

92–001). (4) The January 13, 1993, inspection

resulted in an escalated enforcement action (EA 93–

009) categorized at two SL IVS and one SL III for

failure to survey after use of radioactive material,

a failure to supply dosimetry for a P–32 worker, and

a P–32 contamination extremity overexposure,

respectively (Report No. 93–001). (5) The April and

May 1994 inspection, resulted in enforcement

action (EA 94–123) categorized as two SL IVS for

failure to secure, as well as a failure to survey, after

using radioactive material (Report No. 94–001). The

security violations from the April-May 1994

inspection also resulted in the issuance of a CAL

on May 5, 1994. On July 12, 1994, an additional

security violation resulted in the loss of a package

containing 2.6 MBq (70 μCi) of iodine-125. The

1994 security violations were discussed at an

enforcement conference held with the Licensee on

July 27, 1994, and subsequently were cited as an SL

IV in an NOV issued to NIH on August 16, 1994.

(6) During the April and May 1994 inspections, an

apparent violation was identified for incinerator

operations (Report No. 94–001). On August 10,

1994, however, NIH informed NRC that it had

permanently discontinued incineration operations

at NIH in May 1994. Consequently, no enforcement

action regarding incineration was taken.

6See ‘‘General Statement of Policy and

Procedures for NRC Enforcement Actions,’’ 10

C.F.R. Part 2, Appendix C (1986–1995) and

NUREG–1600, ‘‘General Statement of Policy and

Procedures for NRC Enforcement Actions’’ (July

1995), Section VI.

7See NMSS Technical Assistance Request dated

June 19, 1995, from L. Camper, NRC Headquarters

to R. Bellamy, NRC Region I.

amount of $2500 (EA 96–027), which

NIH paid on June 6, 1997.

III. Discussion

A. Violations of NRC Requirements for

Security and Control of Licensed

Material

Petitioners assert that, as the direct

and proximate result of NIH’s deliberate

failure to control and secure radioactive

materials in violation of 10 CFR

§§ 20.1801 and 20.1802, and to

otherwise adhere to the requirements of

10 CFR part 20, Dr. Ma was

contaminated with P–32, resulting in

both her and her unborn fetus receiving

an intake of radioactive material in

excess of regulatory limits. In addition,

Petitioners state that 26 other NIH

employees, including Dr. Zheng, were

also internally contaminated with P–32.

Petitioners state that NIH has been

unwilling to comply with NRC safety

requirements in accordance with 10

CFR part 20. Specifically, Petitioners

state that during the summer of 1994,

NIH officials deliberately failed to lock

up radioactive material as part of an

experiment with a liberalized policy

concerning security and use of

radioactive materials, which effectively

excused laboratories from locking up

radioactive materials, in violation of 10

CFR § 20.1801. NIH requested a license

amendment on October 31, 1994, to

establish and permanently implement a

previously submitted ‘‘Interim Security

Policy,’’ and an exemption from the

requirements to secure (under lock and

key), or maintain constant surveillance

of, licensed radioactive materials not in

excess of 10 times the activity listed in

Appendix C to 10 CFR part 20, on a percontainer basis. Petitioners state that the

resultant breakdown in security led to

the issuance of CAL 1–95–018, on

October 27, 1995, which required NIH

to take immediate steps to secure

radioactive materials. Petitioners state

that NIH objected to complying with

security regulations, and did not

withdraw its application for an

exemption from the security

requirements until after the

contamination of Petitioners.

Petitioners state that NRC’s repeated

discovery of unsecured radioactive

materials and of absence of security

controls in several NIH laboratories

indicates a systemic failure of security

rather than an isolated problem, and

that NIH’s lax control and security of

radioactive materials created an

environment where acts such as the

deliberate contamination of Dr. Ma were

bound to occur, given that the means to

commit such an offense were readily

available. Petitioners state that security

over radioactive materials used in the

Petitioners’ laboratory was nonexistent.

Specifically, the refrigerator and freezer

used to store radioactive reagents were

not locked, the lab was frequently left

unattended during non-working hours,

and there were no procedures to

document individuals’ access to the

refrigerator or freezer, or to check to see

if records were kept regarding the

documented use of radioactive materials

in that laboratory.

Petitioners state that despite NIH’s

reckless disregard of NRC requirements,

since 1986 NRC has taken no

enforcement action against NIH or the

National Cancer Institute (NCI) 4 for

repeated violations of 10 CFR. Part 20

regulations related to security and

control of radioactive material,

occupational exposure, notification of

exposure, incineration, surveys,

monitoring, and dosimetry.

Contrary to the assertions in the

Petition, since 1986, and before the June

1995 contamination incident, NRC had

taken enforcement action against NIH

for violations of NRC requirements

concerning security and control of

radioactive materials, occupational

overexposures, surveys, monitoring and

dosimetry.5 Although many of these

enforcement actions involved Notices of

Violation for SL IV violations and no

civil penalty, they still constitute

enforcement action taken by NRC.6

The requirements of 10 CFR 20.1801

and 20.1802 to secure and control

licensed material are absolute in that the

rules specify no radioactivity

thresholds. NIH established a threshold

amount for the security of radioactive

materials located in laboratories based

on 10 CFR part 20, Appendix C,

quantities and NUREG/CR–6204,

‘‘Questions and Answers Based on

Revised 10 CFR part 20’’ (January 1994).

The answer to Question 129 indicates,

in part, that the security requirements

described in 10 CFR 20.1801 and

20.1802 will not be enforced for

quantities of radioactive material

described in 10 CFR part 20, Appendix

C, which are exempt from labeling by 10

CFR 20.1905(a). By an amendment

request dated October 31, 1994, NIH

asked for permission to store up to ten

times Appendix C quantities of

radioactive material per container in

posted radioactive material use areas

without the requirement for direct

oversight or lock and key. In March

1995, NIH requested an exemption from

the requirements of 10 CFR 20.1801 and

20.1802 to store less than Appendix C

quantities in unlocked (and unattended)

refrigerators or freezers in corridors.

NRC approved the NIH request in June

1995 because these quantities did not

require labeling.7 In response to the

event of June 1995, NIH revised its

security policy for
50022 Federal Register / Vol. 62, No. 185 / Wednesday, September 24, 1997 / Notices

8On July 21, 1995, CAL 1–95–011 was issued,

which described the actions that NIH would take

to reduce the possibility of further ingestion of

radioactive material and to determine that the full

scope of the personnel contaminations was known.

On July 21, 1995, CAL 1–95–011, Revision 1, was

issued to clarify certain points in the first CAL. On

October 27, 1995, NRC issued CAL 1–95–018,

which described the actions that NIH would take

following an NRC special inspection on October 23

and 24, 1995, to further enhance and train NIH staff

regarding security of radioactive material. On

November 8, 1995, NRC issued CAL 1–95–018,

Supplement 1, to further document the corrective

actions that NIH took with respect to enforcement

of the new NIH security policy, modifications to the

surveillance plan for NIH laboratories, and other

specific actions for inspections for NRC

compliance. On December 1, 1995, NRC issued CAL

1–95–018, Supplement 2, to adjust each deadline

within CAL 1–95–018 and its supplement. This

supplement described the ongoing upgrades, to the

radioactive material security program, that required

that any posted room or area which contained

radioactive materials in use, radioactive waste, or

radioactive materials in unsecured storage, would

be required to be locked when unoccupied. On June

7, 1996, NRC issued CAL 1–95–018, Supplement 3,

to further clarify issues with regard to security and

control of licensed radioactive material in building

corridors and laboratory freezers at NIH.

9These facts do not constitute a violation of NRC

regulations or the NIH license.

radioactive materials to require that all

licensed material must be in locked

storage, or in a locked room, if

otherwise unattended, effective October

26, 1995. On January 19, 1996, NIH

submitted a license amendment to,

among other things, permit licensed

material that is exempt from the labeling

requirements of 10 CFR 20.1905(a) to be

exempted from the revised October 26,

1995, NIH security policy. NRC renewed

the NIH license on June 13, 1997, but

did not authorize any exemptions to the

security and control requirements of 10

CFR 20.1801 and 20.1802.

Petitioners are correct in stating that

there have been security and control

problems at NIH that required

amelioration. In particular, the failure to

secure refrigerators and freezers used to

store radioactive reagents, and the

failure to secure or maintain

surveillance over laboratories, formed

the basis for a series of NRC

enforcement actions. Several CALs were

issued to address security and control of

radioactive material after the June 1995

contamination of Dr. Ma.8 On August

23, 1996, NRC issued a NOV and

Proposed Imposition of Civil Penalty of

$2500 (EA 96–027) to NIH for failure to

physically secure licensed material or

maintain surveillance over it to prevent

unauthorized removal. On May 20,

1997, NRC issued an Order Imposing

Civil Monetary Penalty in the amount of

$2500 (EA 96–027), which NIH paid on

June 6, 1997. Based on the inspections

and the investigation, the NRC staff does

not conclude that these violations were

willful, contrary to the assertions of

Petitioners. Moreover, although the AIT

Report stated that the Licensee’s

violations of NRC security and control

requirements could have been a

contributing factor, after review of the

various inspection and investigative

results, the NRC staff concludes that the

violations of NRC security and control

requirements did not contribute to the

internal contamination of Dr. Ma, her

fetus, or the other 26 NIH employees,

including Dr. Zheng.

Since the 1995 contamination event at

NIH, NRC performed several inspections

of NIH. Additionally, over this period,

NIH performed 90,857 laboratory audits.

The most recent NRC inspection report

in July 1997 found that NIH has made

continuing and significant progress in

improving the security and control of

licensed radioactive material since the

1995 contamination event. For example,

the average rate of noncompliance with

NRC security and control requirements

has declined to 0.25 percent of

laboratories surveyed, from an average

rate of 0.57 percent since the last NRC

inspection of September 1996. See NRC

Inspection Report No. 030-01786/97–

001 (July 29, 1997). Additional

enforcement action for security and

control violations is not warranted.

In view of the above, Petitioners

presented valid concerns regarding

security and control of licensed material

at NIH, and their request for

enforcement action with respect to

violations of NRC security and control

requirements was granted in part as

described above.

B. Dosimetry, Radiation Safety Training,

and Ordering Radioactive Materials

Petitioners state that Dr. Weinstein,

the Senior Investigator in the Laboratory

of Molecular Pharmacology and the

former supervisor of Petitioners,

insisted that the Petitioners begin

working with radioactive materials

before they were given radiation safety

training and, on two occasions, directed

the Petitioners to use Dr. Weinstein’s

and another Authorized User’s

identification number to order

radioactive material before Petitioners

were assigned their own identification

numbers. Petitioners state that the AIT

found that during the first 3 months of

their research, the Petitioners were

given radioactive materials that had

been ordered by a researcher who had

since left NIH, which was not reported

by the Authorized User, Dr. Weinstein,

as required on NIH Form 88–1; and that

in November 1994, Petitioners were

using phosphorus-33 (P–33), a lowenergy beta-emitting isotope requiring

whole body dosimetry (or whole body

badges) during its use, but that

Petitioners had not been trained to use

radioactive material. In addition,

Petitioners state that an NRC interview

of a former researcher revealed that she

had ordered radioactive materials for

herself and shared them with other

researchers, although these users were

not listed on NIH’s Form 88–1.9

NIH worker training, use of

identification numbers for procurement

of licensed materials with NIH Form

88–1, and dosimetry issuance and

collection, were reviewed during the

October 23–24 and November 6–10,

1995, NRC inspections. As a result of

those inspections, NRC cited NIH for

several violations. Specifically, the

Licensee was cited for allowing users to

order radioactive materials

electronically between October 3 and

November 20, 1995, without the

signature of the authorized investigator.

This violation was cited as a SL IV (EA

96–027). Additionally, NIH was cited

for permitting the use of sulfur-35, P–32,

and P–33 by two researchers in October

1994, before providing the researchers

with the training course entitled,

‘‘Radiation Safety in the Laboratory,’’ on

November 29, 1994. This violation was

also cited as an SL IV (EA–96–027). NIH

was not cited for Petitioners’ use of P–

33 without the use of whole body

dosimetry because neither the NIH

License nor NRC regulations require

such dosimetry for low-dose material.

See Section III.C. and n. 12, below. NIH

was cited, however, for violations of

license requirements to use extremity

dosimetry when using more than 185

MBq (0.5 mCi) of P–32 (EA 96–027).

Accordingly, Petitioners’ request for

enforcement action against NIH for

violations of dosimetry, training, and

ordering radioactive materials

requirements was granted in part as

described above.

C. NIH Routine Monitoring of, and

Dosimetry for, Petitioners

Petitioners state that Dr. Ma was

internally contaminated, in part as a

result of NIH’s failure to document Dr.

Ma’s exposure history at NIH, and failed

to properly assess Dr. Ma’s internal

radiation doses, in violation of 10 CFR

§§ 20.1202, 20.1204, 20.1501, and

20.1502. Petitioners state that NIH did

not routinely monitor Petitioners’

exposure to radiation and radioactive

material through use of an appropriate

dosimetry program. Specifically, the

dosimetry given to Petitioners when

they first arrived at NIH was never

collected or analyzed, no dosimetry was

assigned to them at the time of Dr. Ma’s

contamination, and as a result
Federal Register / Vol. 62, No. 185 / Wednesday, September 24, 1997 / Notices 50023

10 In addition, during 1995, 6374 individuals at

NIH were issued monitoring devices. Only one

individual (other than Dr. Ma) using NRC licensed

materials exceeded 10 percent of the applicable

occupational external dose standard [the total deep

dose equivalent to this individual was reported as

550 millirem (5.5 mSv)].

11 In addition, Regulatory Guide 8.34,

‘‘Monitoring Criteria and Methods to Calculate

Occupational Radiation Doses’’ addresses the

applicability of the dose recording requirements

when monitoring is not required. Regulatory Guide

8.34, paragraph 1.4 states that ‘‘While the results of

required monitoring are subject to the dose

recording requirements of § 20.2106, the results of

monitoring provided when not required by

§ 20.1502 are not subject to the dose recording

requirements.’’

12License Condition 29 requires conduct of the

NIH program in accordance with the NIH license

application dated July 28, 1986. Attachment 10–D

of the July 28, 1986, application states that persons

using or in close proximity to persons using gamma

emitters, P–32, or radiation-producing machines

‘‘* * * should wear body film badges.’’ This is a

recommendation, not a requirement, regarding

whole-body dosimetry for only P–32. P–33 usage

does not require any dosimetry. In addition,

Attachment 10–D states that the ‘‘ * * * license

requires extremity monitors for P–32>0.5 mCi.’’ See

p. 35.

13NIH ‘‘Response to Apparent Violations in

Inspection Report Nos. 030–01786/95–002

(Redacted) and 030–01786/95–203’’ (May 23, 1996),

Exhibit AIT–AV2–1.

Petitioners were not wearing dosimetry

at the time of Dr. Ma’s contamination.

Petitioners state that in November 1994,

Petitioners were using P–33, a betaemitting isotope requiring whole body

dosimetry during its use, but Petitioners

were not wearing required dosimetry,

and Petitioners had never been issued

dosimetry by Dr. Weinstein although

they used P–32 in December 1994, and

until March 1995.

NIH was not required to routinely

monitor Petitioners’ occupational

exposure to radiation, or to document

their occupational exposure history. 10

CFR § 20.2106(a), ‘‘Records of

Individual Monitoring Results,’’

provides, in part, that ‘‘Each licensee

shall maintain records of doses received

by all individuals for whom monitoring

was required pursuant to

§ 20.1502 * * *.’’ (Emphasis added) 10

CFR § 20.1502(a) provides that ‘‘Each

licensee shall monitor occupational

exposure to radiation and shall supply

and require the use of individual

monitoring devices by—(1) Adults

likely to receive, in 1 year from sources

external to the body, a dose in excess of

10 percent of the limits in § 20.1201(a).’’

(Emphasis added) Based on NRC’s

review of information maintained by

NIH for the past 10 years regarding

occupational exposures at NIH, it is

evident that it is not likely that any NIH

user of NRC-licensed radioactive

materials would exceed 10 percent of

the applicable occupational standard in

10 CFR § 20.1201.10

Accordingly, issuance of personnel

dosimetry monitoring, although done by

NIH as a prudent measure in operating

its Radiation Safety Program, was not

required by 10 CFR § 20.1502. Since

monitoring of Petitioners was not

required, the recording requirements of

10 CFR § 20.2106 were not applicable to

Petitioners.11

Condition 29 of the NIH License

required the use of extremity (wrist or

finger) monitors by occupational

workers using P–32 in quantities greater

than 0.5 mCi (185 MBq), but did not

require the use of whole-body dosimetry

by persons using P–32 or P–33.12 Based

on a review of the Petitioner’s laboratory

notebooks, it appears that Dr. Ma did

not use P–32. Additionally, Dr. Ma

states that she advised her obstetrician

that she had previously been working

with low dosage material (P–33) and,

upon learning of her pregnancy, stopped

handling radioactive isotopes altogether.

Nonetheless, NIH internal documents

demonstrate that NIH provided whole

body dosimetry to Petitioners on

October 28, 1994.13 Although

Petitioners’ laboratory notebooks

indicate that Dr. Zheng used P–32 on

October 17, 1994, 11 days before receipt

of a whole body dosimeter, this was not

a violation of NIH License Condition 29.

Moreover, because Petitioners never

worked with more than 185 MBq (0.5

mCi) of P–32, they were not required to

wear extremity dosimetry. Additionally,

since the monitoring required by

License Condition 29 is not required

pursuant to 10 CFR § 10.1502, the

results of that monitoring would not be

subject to NRC dose recording

requirements, contrary to the

Petitioners’ assertion. See n. 11, supra.

NRC conducted two special team

inspections on October 23–24, 1995,

and November 6–10, 1995, in which

NIH personnel dosimetry issuance and

collection were evaluated. Although

review of exposure records during this

inspection indicated that occupational

doses to individuals from exposure to

licensed materials were well below NRC

limits, NIH was cited for one SL IV

violation involving the failure to issue,

wear, and return, individual monitoring

devices (EA 96–027).

Accordingly, Petitioners’ request for

enforcement action against NIH for

violations of monitoring and dosimetry

requirements was granted, in part, as

described above.

D. Inventory Control of Radioactive

Materials

Petitioners assert that NIH exercised

poor inventory control of radioactive

materials. Specifically, if NIH had

accurately monitored the use and

disposal of radioactive materials,

particularly P–32, it might be possible to

ascertain who had ordered, but not

used, the requisite amounts of P–32

within the timeframe of Petitioners’

contamination, and possibly assist law

enforcement officials to ascertain who

contaminated Petitioners. Petitioners

relied on the findings of the AIT that: (1)

The accuracy of inventory records is

questionable because researchers only

estimate the amount of material

removed from each vial, radioactive

decay is rarely accounted for, and if the

vial is not emptied (because the

expiration date has passed), the users do

not check the balance before disposal;

and (2) the computerized inventory

system NIH used to replace Form 88–1

does not comply with the NIH license

because the electronic document does

not include the signature of the

Authorized User, and has no

mechanism to reasonably verify that an

Authorized User had placed an order for

radioactive materials and had received

those materials.

NIH places ultimate responsibility for

the proper use of radioactive material on

the Authorized User who orders the

material. Authorized Users are

permitted by NIH policy to order and

share radioactive material with other

users, and a Supervised User may work

under more than one Authorized User.

If an Authorized User wishes to transfer

responsibility for material ordered

under her/his authorization, an NIH 88–

1 form must be completed transferring

responsibility to another Authorized

User. The RSO stated that routine

laboratory audits include checks to see

who is using radioactive material and

that unauthorized use is dealt with

severely.

NIH License Condition 29 makes

Authorized Users responsible for

maintaining a record of the receipt, use,

and disposal of radioactive materials

under their authorization by use of

Form NIH–88–16, ‘‘Isotope Receipt,

Utilization, and Disposal Record’’ or

equivalent. In addition, the RSO, in a

memorandum dated October 3, 1995,

reminded Authorized Users that

transfers among other Authorized Users

must be documented by completion of

the same form and submittal of the form

to the RSB before the transfer. During

NRC inspections conducted October 23–

24 and November 6–10, 1995, the

inspectors were informed, during

discussions with Authorized Users and

RSB staff, that each shipment of

radioactive material delivered has

normally been accompanied by Form

NIH 88–1. Authorized Users stated that

they knew that they were required to
50024 Federal Register / Vol. 62, No. 185 / Wednesday, September 24, 1997 / Notices

14See letter from M. Gottesman, NIH, to R.

Blough, NRC Region I, dated June 23, 1997.

15License Condition 29 requires conduct of the

NIH program in accordance with the NIH license

application dated July 28, 1986. Item 10.6 of the

July 28, 1986, application required, in part, that the

Authorized User provide to the Radiation Safety

organization a completed Form NIH 88–1, ‘‘Request

for Purchase and Use of Radioactive Materials,’’ for

each incoming shipment before the materials are

released to the investigator. Form NIH 88–1, was

provided as attachment 10–F to the July 28, 1986,

application. Form NIH 88–1 requires, in part, that

the radiation safety identification number and

names of all persons who will use the radioactive

material, the name of the authorized investigator,

and the signature of the authorized investigator, be

entered on the form.

16Because Dr. Ma’s clothing was not

contaminated, there was no need for her to shower

in order to remove external contamination.

Petitioner’s assertion that RSB took 1 hour

searching for a shower to decontaminate Dr. Ma was

not substantiated by the inspections or the

investigation.

keep records of the material currently

on hand after loss by decay or disposal

of material, and all those interviewed

used the Form NIH 88–1. The inspectors

did not identify any instances in which

the inventory was not being kept

current.

Regarding the Petitioner’s concern

about the accuracy of inventory records,

NIH has recognized a need to review its

radioactive material accountability

portion of the Radiation Safety Program.

Accordingly, the NIH RSO directed a

complete and thorough physical

inventory for radioactive materials

during the latter half of 1996.14 As of

June 23, 1997, this inventory was

completed, and now serves as the

baseline for an on-line, real-time

tracking of all radioactive materials

within the RSB’s centralized database

system. Each Authorized User receives

a complete inventory of his/her

materials from the centralized database

each month and is requested by the RSB

to adjust records consistent with his/her

use and disposal of radioactive

materials.

For the NIH Authorized User to track

the use of individual items of NRClicensed materials, a new computergenerated inventory and disposal form

was developed and is currently in use

at NIH. This system permits Authorized

Users to make changes in users, if

required, and to report disposal and

other inventory changes to RSB for

update in the centralized database. This

system, not present before 1996,

substantially enhances NIH’s

accountability for radioactive material.

Increased accountability has received

NIH senior management attention and is

considered by NRC staff to be a

potential deterrent to the use of licensed

radioactive materials for unauthorized

purposes.

Initial use of the computerized

inventory system, however, involved

violation of NRC requirements. NIH

License Condition 29 requires that the

radiation safety identification number

and name of all persons who will use

the radioactive material, the name and

signature of the Authorized User, be

entered on form NIH 88–1.15 Between

October 3 and November 20, 1995,

however, the licensee allowed users to

order radioactive materials

electronically, without the signature of

the Authorized User. In addition, an

NIH 88–1, submitted for order and use

of radioactive materials received on

September 9, 1994, did not include the

radiation safety identification number

and name of all persons who would use

the radioactive material. NIH was cited

for these irregularities as an SL IV

violation (EA 96–027).

Accordingly, Petitioners’ request for

enforcement action against NIH for poor

inventory control of radioactive

materials was granted in part as

described above.

E. Timeliness of NIH Emergency

Personnel Response to Contamination

Incident

Petitioners contend that NIH

personnel responding to the scene of the

incident failed to respond in a timely

manner to the contamination event,

resulting in Dr. Ma’s transport to Holy

Cross Hospital more than 3 hours after

discovery of her contamination.

Petitioners state that after Radiation

Safety Branch (RSB) officials confirmed

Dr. Ma’s contamination, they took 1

hour searching for a shower to

decontaminate her, that RSB officials

surveyed the conference room and

refrigerator, and that RSB officials

directed Dr. Ma to provide a urine

sample, which confirmed that her

contamination was internal.

Dr. Zheng reported the internal

contamination of Dr. Ma to the NIH

emergency number at approximately

5:58 p.m., shortly after discovery of her

contamination. The first NIH personnel

(two emergency medical technicians)

responded immediately and arrived on

the scene with an ambulance at

approximately 6:00 p.m. Dr. Zheng also

notified Petitioners’ immediate

supervisor, Dr. Weinstein, who was on

the premises at the time. Dr. Weinstein,

the Authorized User, contacted the RSB

at 6:00 p.m. and notified the Chief of the

Radiation Safety Operations Section

about the contamination incident. In

addition, the NIH Fire Department

independently notified the Deputy RSO,

at approximately the same time, of a

possible radioactive material

contamination event involving an

‘‘injection of radioactive material.’’ (The

Deputy RSO is at the top of the

emergency call list for response to

incidents involving radioactive

materials). The Deputy RSO advised the

RSO of the report at approximately 6:00

p.m. and contacted the NIH

Occupational Medical Service (OMS) for

information on the incident.

At approximately 6:15 p.m., the first

of two responding RSB health physicists

was notified by the RSB receptionist

that a second health physicist was on

the phone with the RSB Section Chief

talking about a possible contamination

event in Building 37. The two

responding RSB health physicists

picked up spill and skin

decontamination kits (which is a routine

and necessary event response function)

and responded to Building 37. Both

health physicists met the Deputy RSO in

the RSB parking lot at Building 21, and

were informed that Dr. Ma was being

transported to OMS at Building 10. The

health physicists responded directly to

OMS and were advised by the physician

on duty that Dr. Ma was still in Building

37. The health physicists then

responded to the fifth floor of Building

37, arriving at approximately 6:40 p.m.

To determine if Dr. Ma’s

contamination was external or internal

and to identify the source of the

contamination, the RSB took several

measures. The emergency medical

technicians and the RSB both evaluated

Dr. Ma’s condition and questioned

Petitioners about the source of her

contamination. The RSB took smears of

Dr. Ma’s hands, neck, and face to

determine if any of the contamination

was removable and then had Dr. Ma

change out of her clothes into clean

scrubs to see if her clothing was

radioactive. None of the smears,

surveys, or clothes of Dr. Ma showed

external contamination.16 The RSB

asked Dr. Ma to submit a urine sample

at approximately 7:00 p.m. The sample

was surveyed by the RSB and found to

contain radioactivity, indicating that the

contamination was internal. The RSB

health physicists performed surveys

with portable radiation instruments to

determine whether radioactive

contamination was present in the

laboratory, adjacent hallways and

corridors, and in the conference room.

Shortly after 8:00 p.m., NIH transported

Dr. Ma to Holy Cross Hospital, where

Dr. Ma arrived at approximately 8:20

p.m. Holy Cross was selected over

Suburban Hospital, which was much
Federal Register / Vol. 62, No. 185 / Wednesday, September 24, 1997 / Notices 50025

17Petitioners assert that this provided Dr.

Weinstein with an opportunity to ‘‘find’’ a coffee

cup with a centrifuge tube, both contaminated, that

RSB officials attest were not present when they

surveyed the same area earlier, and that, on his own

initiative, Dr. Weinstein put the items in a plastic

bag and moved the items into his lab and locked

the door. In fact, two NIH employees had seen the

coffee cup and centrifuge tube in the hallway near

Petitioners’ lab over a period of 1 to 7 days before

the event. Additionally, the NIH RSB directed Dr.

Weinstein to put these items aside for the NIH

RSB’s later examination and to secure the

laboratory.

closer, because Suburban Hospital did

not have an obstetrics department.

Based on the inspections and the

investigation, NRC staff concludes that

NIH personnel responded properly and

in a timely fashion to the incident. The

actions taken by NIH to determine

whether Dr. Ma was externally or

internally contaminated and to identify

the source of her contamination are

time-consuming steps that must be

taken during event response to ensure

that the spread of radioactive

contamination is prevented, especially

when the event involves the transfer of

personnel off the licensee’s site and into

a hospital setting. Moreover, because

there were no signs of a life-threatening

condition or immediate danger to Dr.

Ma, which would have made immediate

transport necessary, the Licensee’s

attention to these measures was

eminently reasonable before transport of

Dr. Ma to the hospital.

F. Defects in NIH Emergency Response

to Dr. Ma’s Contamination

Petitioners state that NIH’s emergency

response to Dr. Ma’s contamination was

defective in that NIH gave inappropriate

and inadequate information and advice

to Dr. Ma regarding her level of

contamination, and failed to advise Dr.

Ma concerning precautions to prevent

spreading that contamination.

Specifically, Petitioners state that one of

the two RSB health physicists who

responded to the event erroneously told

Petitioners, before Dr. Ma’s transport to

Holy Cross Hospital and before any

analysis concerning the extent of Dr.

Ma’s contamination, that the exposure

Dr. Ma received was well within the

allowable limits, that there was no risk

to her, and, although it was not certain,

that there appeared to be no problem

posed to Dr. Ma’s fetus. Additionally,

Petitioners state that no one warned Dr.

Ma about the possibility of vomiting as

a consequence of her contamination, or

instructed Dr. Ma as to appropriate steps

to prevent contamination of her home as

a result of vomiting. As a result, Dr. Ma

contaminated her car and apartment.

The Petitioners are correct in stating

that at the time that the two RSB staff

responded to the event, there was no

way (within the first few minutes) to

determine if the radiation exposure that

Dr. Ma received was within NRC

regulatory limits, or if the dose received

was harmful. Indeed, the only thing that

could be determined at that time was

whether or not the radioactive

contamination was internal or external,

which the RSB staff did effectively.

There are no NRC requirements

concerning advice by licensees to their

employees during emergencies

concerning the possibility of further

contamination of the employee’s home

and belongings. As occupational

radiation safety workers at NIH, the

Petitioners were required to, and did,

complete formal radiation safety

training on November 29, 1994. As part

of that training, personnel protective

procedures were described to limit the

exposures from both external and

internal sources of radiation. In

addition, as part of their required daily

radiation surveys, the Petitioners were

aware of the potential hazards

associated with contamination and

radioactive material in their control and

the need to isolate and remove any

detected contamination.

On the evening that Dr. Ma became

internally contaminated with P–32, the

RSB staff at NIH and the hospital staff

at Holy Cross informed Dr. Zheng that

Dr. Ma’s blood and urine were

contaminated. The next day, the RSB

staff surveyed the Petitioners’

automobile because Dr. Ma had

indicated that she had vomited in it

earlier that morning. RSB staff found

contamination inside the passenger’s

side of the car and decontaminated the

affected area immediately. RSB staff also

surveyed the Petitioners’ apartment

where contaminated areas were cleaned

up or physically removed material for

radioactive decay. Effective

communications during emergencies are

difficult, at best, and might have been

improved by reminding Dr. Ma of the

potential for not only her excreta being

contaminated, but also any other bodily

fluids released as well. However, the

failure to fully advise Dr. Ma of the

potential spread of contamination via

body fluids was not a violation of any

NRC requirement.

Petitioners also state that the NIH

response to Dr. Ma’s contamination was

defective because RSB officials failed to

secure the area, thus providing an

opportunity for NIH personnel to

tamper with or contaminate evidence.17

In fact, before departing the scene of the

event on June 29, 1995, NIH RSB

personnel locked the conference room

and marked it with security tape. The

NIH RSB also asked Dr. Weinstein to

secure the laboratory, which he did by

locking it. On June 30, 1995, the NIH

RSB changed the locks to the conference

room, and again locked the laboratory

and then secured it with police tape.

Based on a review of the evidence, NRC

concludes that NIH took all reasonable

measures to secure the scene after

responding to the event.

G. NIH Conduct of Surveys After

Contamination Incident

Petitioners state that in violation of 10

CFR § 20.201(b) and an October 14,

1992, commitment by NIH to emphasize

to all users the importance of notifying

Radiation Safety promptly of spills of

radioactive materials when there is

personnel contamination, NIH failed to

conduct surveys reasonably necessary

under the circumstances surrounding

discovery of Dr. Ma’s contamination on

June 29, 1995, and thus failed to detect

P–32 contamination of a water cooler

until July 14, 1995, which caused an

additional 26 people, including Dr.

Zheng, to become internally

contaminated.

NRC stated in its AIT report of

January 13, 1997, that because NIH did

not survey the water cooler in the

corridor near Petitioners’ laboratory

until July 14, 1997, 26 other individuals

(besides Dr. Ma) were internally

contaminated with P–32 by drinking

water from the cooler. After review of

all the evidence, however, the staff

concludes that, although it would have

led to a more desirable outcome to have

identified the contaminated water

cooler earlier, under the circumstances,

NIH conducted all reasonably necessary

surveys. When NIH safety response

personnel were called to the scene, Dr.

Ma and Dr. Zheng insisted that Dr. Ma

had been contaminated by food that she

had stored in the conference room

refrigerator. Dr. Ma and Dr. Zheng also

told RSB personnel that they brought all

their own food and beverages to work

with them. Immediately after the event,

Dr. Ma and Dr. Zheng denied that they

drank any liquid from Building 37, and

stated that they brought all liquids from

home. In the days after the incident, Dr.

Zheng denied drinking water from the

water cooler. Nonetheless, NIH sought

to determine if other individuals also

had been internally contaminated. After

specimens provided by other NIH

employees on July 13, 1995,

demonstrated their internal

contamination with P–32, and in an

attempt to identify a common source of

contamination, NIH surveyed the water

coolers and coffee stations on the fifth

floor of Building 37 on July 14, 1995,

and identified contamination in a water

cooler located in the hallway. Only later
50026 Federal Register / Vol. 62, No. 185 / Wednesday, September 24, 1997 / Notices

18At the time of the incident, 10 CFR § 20.1501(a)

required licensees to perform surveys that are

reasonable under the circumstances. On January 1,

1993, 10 CFR § 20.201, with a similar requirement,

became extant.

19 Dr. Glenn’s comment was made before full

information was available regarding sample

collection after the NIH event. With the benefit of

all the evidence, it is now apparent that clear

instructions were provided to Dr. Ma and that no

information was lost. See Section III.K.(2).

did Drs. Ma and Zheng tell the NIH RSB

that they had drunk from the

contaminated water cooler. Finally,

although NRC’s AIT inspection arrived

at NIH on June 30, 1995, one day after

the discovery of Dr. Ma’s contamination,

NRC staff did not consider the

possibility that Dr. Ma might have been

contaminated by using a water cooler or

suggest surveying water coolers.

Accordingly, the NRC staff concludes

that under the circumstances, NIH did

not fail to conduct reasonably necessary

surveys after discovery of Dr. Ma’s

contamination in violation of 10 CFR

§ 20.1501(b).18

H. Procedures for Collection of Samples

in Contamination Events

Petitioners state that before Dr. Ma’s

internal contamination, NIH failed to

have a procedure in place to provide

clear instructions to Dr. Ma about

sample collection. Petitioners note that

John Glenn, Ph.D. (Dr. Glenn), Chief,

Radiation Protection and Health Effects

Branch, Office of Nuclear Regulatory

Research, NRC, stated at the December

19, 1995, Commissioner briefing that

NIH ‘‘* * * lost information about early

excretion of P–32 because clear

instructions were not provided to the

exposed individual about sample

instruction [collection of samples].’’ 19

The events and transcript from the

December 19, 1995, Commissioner

briefing on The Generic Implications of

Recent Events Involving Ingestion of

Radioactive Material at Research

Facilities reveal a similarity between the

NIH AIT and the Massachusetts Institute

of Technology (MIT) Incident

Investigation Team (IIT) events in that

both licensees lost information about

early excretion of P–32 because clear

instructions had not been provided to

the exposed individual about how to

collect samples. Although there is a

considerable amount of guidance in the

scientific literature available on the

management of contaminated persons,

NRC staff determined that it would be

beneficial to provide guidance to

licensees on the levels of intake that

should be considered for medical

evaluation, the available methods to

reduce the committed dose resulting

from an intake, as well as guidance for

the collection of samples for analysis.

Consequently, NRC staff has completed

its evaluation of current regulatory

guidance on the collection of samples

for analysis, as well as the analysis of

intakes, and will revise the existing

regulatory guidance to licensees.

Accordingly, the Petitioners’ request

for NRC action to ensure adequate

procedures and instructions to exposed

persons for sample collection is granted

as described above.

I. Dr. Weinstein’s Interactions With NIH

Radiation Safety Response Personnel

Petitioners state that Dr. Weinstein

interfered with the NIH radiation safety

response to Dr. Ma’s contamination, and

delayed transport of Dr. Ma to the

hospital for emergency treatment.

Specifically, Petitioners state that Dr.

Weinstein performed smear tests;

directed Dr. Ma to drink a lot of water;

argued with NIH RSB officials about

how to save urine samples in order to

get a correct determination of the

amount of radiation Dr. Ma had

ingested; attempted to interfere with

RSB personnel efforts to question and

counsel Dr. Ma about the biological

effects of radioactive materials and her

contamination; tried to answer

questions asked of Dr. Ma by RSB

personnel; and attempted to usurp RSB

functions by conducting a survey of the

NIH conference room where Dr. Ma had

stored her food.

Based on the inspections and the

investigation, NRC concludes that Dr.

Weinstein did not interfere with the

reasonable and necessary NIH radiation

safety personnel measures in response

to the contamination event, delay Dr.

Ma’s transport to the hospital, or usurp

or attempt to usurp RSB functions. Both

Dr. Weinstein and Dr. Zheng provided

assistance to NIH RSB personnel in

counting smears taken from Dr. Ma by

RSB personnel. Dr. Weinstein

reasonably asked Dr. Ma to drink

liquids. (Dr. Weinstein recalled that the

NIH RSB recommended over the phone

that Dr. Ma drink liquids to stay

hydrated.) The Holy Cross Hospital ER

physician and the NIH RSO agreed that

intravenous hydration of Dr. Ma was

advisable. Petitioners state that Holy

Cross Hospital issued instructions to Dr.

Ma on her discharge to maintain good

hydration. Additionally, the RSB

directed Dr. Ma to provide a urine

sample for immediate survey, a measure

necessary for the NIH RSB to determine

with certainty whether Dr. Ma was

internally contaminated and thus

whether to transport Dr. Ma to the

hospital. The evidence does not

corroborate the Petitioners’ assertion

that Dr. Weinstein argued with RSB

personnel about the proper procedure

for saving specimens from Dr. Ma. NIH

RSB personnel at the scene described

Dr. Weinstein as urging Dr. Ma’s

immediate transport to the hospital,

along with Dr. Zheng, and as being

impatient. Dr. Weinstein was not the

only non-RSB person to survey the

conference room. Dr. Zheng told an NIH

colleague that he had found radioactive

contamination in the conference room

by surveying it. That colleague and a

second colleague then surveyed the

conference room for contamination

shortly before arrival of the RSB. Dr.

Weinstein went to survey the

conference room after a third and a

fourth colleague had already begun

surveying the room.

J. Medical Care of Dr. Ma and Treatment

To Reduce Her Contamination

Petitioners state that NIH personnel

gave conflicting and harmful directions

to Holy Cross ER personnel which

delayed Dr. Ma’s treatment, that NIH

provided inadequate medical treatment

of Dr. Ma, which was completely

ineffective to reduce her contamination,

and that the only effort NIH made to

hasten the removal of the ingested

radioactivity was to give Dr. Ma

intravenous infusions of fluid at Holy

Cross Hospital. Petitioners state that the

Holy Cross ER Physician’s attempt to

consult with REAC/TS in Oak Ridge,

Tennessee, was frustrated because the

Holy Cross Hospital telefax machine

was unable to receive information from

REAC/TS. Petitioners believe that Dr.

Ma should have been given phosphate

orally as the buffered sodium salt,

calcium intravenously, and parathyroid

intramuscularly, but was only given

intravenous infusions of fluid

(hydration therapy), based on directions

by NIH personnel, which resulted in no

discernible enhancement of P–32

elimination.

Petitioners state that Dr. Weinstein’s

presence in Dr. Ma’s treatment points

up fundamental flaws in NIH medical

intervention and investigative security

protocols, and the fact that Dr. Ma was

directed by the Holy Cross ER physician

to follow-up with Mr. Zoon, Dr.

Weinstein, and Dr. Ma’s personal

obstetrician-gynecologist (OB–GYN)

‘‘demonstrate[s] that the ER physician

looked to NIH officials, including Dr.

Weinstein, to direct treatment of Dr. Ma

for internal contamination.’’

Petitioners state that NIH provided

inadequate medical care to and followup on Dr. Ma. Specifically, NIH had no

plan in place to ensure that one single

person was in charge of directing and

coordinating a contaminated employee’s

medical care and follow-up. No one

from NIH met with Dr. Ma to discuss
Federal Register / Vol. 62, No. 185 / Wednesday, September 24, 1997 / Notices 50027

20Medical data provided by Petitioners did not

substantiate this assertion.

21Blood, Vol. 61, No. 4 (1983), pp. 746–750;

Schweizerische Medizinische Wochenschrift

(Journal Suisse de medecine) Vol. 124, No. 42, pp

1848–51 (October 22, 1994); and American Journal

of Medical Sciences, Vol. 254, No. 4, pp. 451–63

(October 1967). See also ‘‘Ingestion of P–32 at

Massachusetts Institute of Technology, Cambridge,

Massachusetts, Identified on August 19, 1995,’’

NUREG–1535 (December 1995).

22 Dr. Ma’s reported nausea and vomiting started

long before her ingestion of P–32. An NIH

technician observed Dr. Ma ‘‘always’’ vomiting at

NIH for approximately two months prior to the

contamination event.

her contamination levels, and what, if

any, medical treatment might decrease

her contamination levels, except for a

copy of the early NIH contractor, Oak

Ridge Institute for Science and

Education (ORISE) intake calculation of

9.8 MBq (265 μCi), given to Dr. Ma in

July 1995 by the NIH RSO. The NIH

OMS failed to provide any medical care

or follow-up treatment to remove the

ingested radioactivity. Petitioners state

that Dr. Stansbury of OMS examined Dr.

Ma on June 30, 1995, and that no

services were provided by OMS after

that date, except to request blood work

results. Petitioners state that although

Dr. Ma told Dr. Stansbury of her severe

lower thoracic pain, Dr. Stansbury

attributed the pain to Dr. Ma’s

pregnancy and recommended no followup other than for Dr. Ma to see her OB–

GYN.

Petitioners state that on August 4,

1995, they visited OMS and reported

that Dr. Ma was experiencing vomiting

and severe pain in her lower right side,

but that Dr. Ma was again referred to her

OB–GYN. Petitioners state that on

August 8, 1995, Dr. Ma again reported

to OMS that she continued to

experience frequent vomiting and

nausea, and again no treatment or

intervention was suggested. After the

end of July 1995, no one from NIH

requested additional urine samples from

Dr. Ma, only blood samples. Dr. Ma

states that subsequent tests revealed that

the cause of Dr. Ma’s lower thoracic

pain was a significant liver function

abnormality resulting from her

contamination.20

NIH took reasonable and appropriate

measures to determine whether Dr. Ma’s

contamination presented a lifethreatening condition or immediate

danger to Dr. Ma and her fetus, and

whether her contamination was external

or internal, before transporting Dr. Ma to

a hospital for treatment. See Section

III.E., supra. NIH also contacted the oncall physician from REAC/TS and put

the REAC/TS physician in direct contact

with the ER physician at Holy Cross

Hospital, thus making expert advice

available to Holy Cross Hospital and

expediting Dr. Ma’s treatment by Holy

Cross Hospital. The ER physician

decided not to follow the

recommendation of the REAC/TS

physician to administer a phosphate

solution for dilution and displacement

of the P–32 because of Dr. Ma’s

pregnancy. After consultation with both

the REAC/TS physician and the NIH

RSO, the ER physician ordered

intravenous infusions of fluids

(hydration) in order to dilute Dr. Ma’s

internal contamination, as was his

prerogative. Additionally, based on the

inspections and the investigation, NRC

cannot conclude that Dr. Weinstein

influenced or interfered with the Holy

Cross ER physician’s treatment decision

regarding Dr. Ma’s contamination.

Before he arrived at Holy Cross at

approximately 11:15 pm, Dr. Weinstein

was aware that the NIH RSB

recommended that Dr. Ma ‘‘push’’ fluids

in order to maintain hydration. See

Section III.I., supra. The IV hydration

ordered for Dr. Ma was started around

9:00 p.m., long before Dr. Weinstein

arrived at Holy Cross or spoke to the ER

physician.

Moreover, based on the medical

information made available by

Petitioners to NRC’s Medical

Consultant, the NRC concludes that the

symptoms reported by Dr. Ma were not

related to her ingestion of P–32. The

professional literature reveals three

cases in which persons were

inadvertently administered high levels

of P–32.21 The intakes in these cases

were approximately 15 to 30 times

greater than Dr. Ma’s intake of 820 to

1300 mCi of P–32. The person with the

highest intake reported symptoms that

were consistent with low blood counts,

an expected response to exposure to

relatively high radiation doses. Blood

count depressions, with no symptoms,

were observed in the other two cases.

NRC’s Medical Consultant concluded

that Dr. Ma’s white blood cell count,

white blood cell differential count, and

her platelet count were all within

normal limits, and that minor

abnormalities in Dr. Ma’s hematological

profile, which did not include blood

count depression, were consistent with

typical plasma volume expansion

during pregnancy. Additionally,

radiation intakes sufficiently large to

cause nausea and vomiting are

accompanied by a depression or

ablation of the bone marrow, which was

not indicated by Dr. Ma’s laboratory

data. Finally, experience with intakes of

P–32 much larger than Dr. Ma’s intake,

both accidental and as part of medical

treatment, in which P–32 is frequently

injected intravenously in doses 7 to 15

times great than Dr. Ma’s intake, has not

been observed to produce clinical

symptoms. Accordingly, the NRC

concludes that any symptoms Dr. Ma

may have experienced, such as nausea

and vomiting,22 resulted from causes

other than her ingestion of P–32.

NRC licensees are clearly required to

determine the nature and extent of

radiological overexposures to

occupational workers and members of

the public, to maintain records of such

exposures, and to provide notifications

to exposed individuals and reports to

NRC. See, for example, 10 CFR §§ 19.13,

20.1204, 20.1501, 20.1502, 20.2106,

20.2107, 20.2202, 20.2203, 20.2205, and

20.2206. NRC requirements, however,

impose no additional obligations upon

licensees to provide medical care and

follow-up to individuals exposed to

radioactive materials for the purpose of

removing radioactive contamination or

ameliorating the medical effects of

contamination.

In view of the above, to the extent that

Petitioners are dissatisfied with the

medical treatment provided to Dr. Ma

by Holy Cross Hospital, or with any

medical care provided by NIH to Dr. Ma

apart from dose assessment, dose

recordkeeping, or notification and

reporting of Dr. Ma’s dose, Petitioners’

remedies, if any, do not lie with NRC.

K. Estimates of Internal Contamination

of Dr. Ma and Her Fetus

Petitioners state that NIH failed to

take proper actions to accurately assess,

and as a result, greatly underestimated

Dr. Ma’s internal contamination, that

NIH failed to consider all the relevant

data in assessing Dr. Ma’s internal

contamination, demonstrating that NIH

is not able or willing to impartially

evaluate its worker’s radiation exposure

levels when exposures are in excess of

Federal limits, and that NIH lied to Dr.

Ma, to Federal regulators and to the

public, about the magnitude of the

exposure and the likely harm to Dr. Ma

and her fetus. Specifically, the

Petitioners state the following:

• NIH failed to take suitable and

timely measurements from Dr. Ma to

accurately calculate her occupational

dose, in violation of 10 C.F.R.

§ 20.1204(a). NIH should have taken a

full 24-hour urine sample following

detection of Dr. Ma’s contamination.

Over the first two days urine was

collected as spot samples at each void,

rather than collecting the entire urinary

excretion over a 24-hour period as

recommended by NUREG/CR–4884,

‘‘Interpretation of Bioassay

Measurements,’’ (1987). Additionally,
50028 Federal Register / Vol. 62, No. 185 / Wednesday, September 24, 1997 / Notices

NIH should have continued 24-hour

urine collections and analysis until the

activity level of the samples no longer

yielded useful results. Instead, the NIH

dose evaluation was based solely on

samples collected during the first month

following the intake.

• NIH incorrectly suggests that Dr. Ma

is responsible for NIH’s inadequate

urine analysis because she returned a

weekend’s collection of urine in one

carboy (a container), rather than three,

and failed to follow through with

continuing urine collection despite

urging by NIH personnel. Dr. Ma did

everything requested of her by NIH until

it became evident that NIH had little

interest in her health or in providing her

medical care. NIH OMS and RSB

officials asked Dr. Ma to collect all of

her urine over the weekend following

her contamination. Dr. Ma returned a

weekends’ urine collection in one

carboy rather than three because two of

the three wide-mouthed containers

provided by RSB officials were defective

and leaked. Dr. Ma was asked to bring

in urine samples for the couple of weeks

following her contamination. Dr. Ma

collected her urine voluntarily until the

end of July 1995, and submitted urine

samples through July 27, 1995. Dr. Ma

stopped providing samples because she

did not receive any assistance or

information from NIH. NRC estimated a

significantly greater dose than did NIH,

using the same information available to

NIH.

• Between June 29, 1995, and July 27,

1995, Holy Cross provided NIH with

twenty-five urine samples collected by

Dr. Ma.

• Based on a whole body scan

performed by NIH on June 30, 1995, Dr.

Jorge Carrasquillo, Acting Chief, Nuclear

Medicine Department, NIH, estimated

that Dr. Ma had still retained a total of

862 μCi (31.9 MBq) of P–32 on that date.

• NIH’s preliminary estimate of Dr.

Ma’s ingestion of P–32 on July 3, 1995,

was approximately 300 μCi (11.1 MBq),

which was not based on a 24-hour

sampling of standard systemic excreta

data as recommended by NUREG/CR–

4884 and the National Council on

Radiation Protection and Measurements

(NCRP) Report No. 87, ‘‘Use of Bioassay

Procedures for Assessment of Internal

Radionuclide Deposition’’ (1987).

Additionally, the initial dose estimate

relied entirely on analysis of urine

samples and was not confirmed through

analysis of fecal samples, which led to

significant understatement of Dr. Ma’s

internal contamination.

• The July 5, 1995, NIH estimate of Dr.

Ma’s intake was 265 μCi (9.8 MBq) of P–

32 and was not based on the total

volume Dr. Ma excreted, but was based

on a sample. When the NIH RSO

provided Dr. Ma with a copy of the

ORISE estimate, he told Dr. Ma that the

NIH estimate was ‘‘more or less the

same.’’

• By letter dated July 28, 1995, Mr.

Zoon advised NRC’s Region I Office that

evaluation of the total intake of Dr. Ma

was continuing and could result in an

estimated intake potentially exceeding

the 10 CFR part 20, Appendix B, Annual

Limit on Intake (ALI) for P–32 of 600

μCi (22.2 MBq).

• At NRC’s request, NIH asked its first

consultant, ORISE, to confirm isotopic

analyses performed by the NIH RSB

with four of the first 15 urine specimens

taken on June 29 and 30, 1995, and with

three urine samples and one blood

sample. None of the samples was taken

from a full 24-hour period and NIH

failed to take any fecal samples. The

August 15, 1995, revised estimate of Dr.

Ma’s intake performed by ORISE for

NIH was between 740 and 820 μCi (27.4

and 30.3 MBq), resulting in an effective

dose. equivalent to Dr. Ma of between

5.8 and 6.4 rem (58 and 64 mSv), and

to her fetus a dose of between 4.6 and

5.1 rem (46 and 51 mSv).

• On August 29, 1995, NIH

transmitted to NRC the ‘‘final’’ NIH

assessment of Dr. Ma’s effective dose

equivalent as 4.17 rem (41.7 mSv),

based upon an estimated intake of 500

μCi (18.5 MBq), and of the dose to her

fetus as 3.2 rem (32 mSv). This analysis

was not conducted in accordance with

draft ANSI N13.30, ‘‘Performance

Criteria for Bioassay’’ (1989). NIH also

failed to continue the collection and

analysis of excreta to ensure that Dr.

Ma’s excretion of P–32 followed the

mathematical model NIH had used to

predict her initial dose, and NIH failed

to account for the effect of hydration

therapy when initially evaluating the

urine data. NIH’s use of the ‘‘weighted

least squares fit’’ method to assign its

final dose is unacceptable because

actual excretion does not follow the

anticipated model.

• NRC’s estimate of Dr. Ma’s intake

was between 30.3 and 48.1 MBq (820

and 1300 μCi) and of her internal

committed effective dose equivalent

(CEDE) was between 80 and 127 mSv

(8.0 and 12.7 rem). Although both NRC

and Petitioners’ consultant excluded

data from the first 2 days of urine

collection as unreliable, NIH relied on

that data primarily.

• The Petitioners’ consultant

estimated that Dr. Ma ingested 1000 μCi

(37 MBq) of P–32 corresponding to a

CEDE of 9.2 rem (92 mSv), and that her

fetus received a dose of between 3 and

6.4 rem (30 and 64 mSv), based on an

analysis of eleven urine specimens

collected from Dr. Ma between June 29

and August 23, 1995.

Despite the inherent limitations in

analysis based on excreta data and some

differences in the assumptions used to

evaluate the ingested activity and

radiation dosimetry, the final estimates

obtained by NIH, the Petitioners’, and

NRC are reasonably close. See Table,

infra. Accordingly, the Petitioners

concerns that NIH did not accurately

assess Dr. Ma’s dose and the dose to her

fetus are unsubstantiated.

FINAL ESTIMATES OF RADIATION DOSE TO DR. MA AND HER FETUS

Organization Date

Dr. Ma’s dose estimate Dr. Ma’s Fetal dose estimate

(rem) (mSv) (rem) (mSv)

NIH .......................................................................................................... 7/96 4.7–7.0 47–70 3.7–5.4 37–54

NRC ........................................................................................................ 12/95 8.0–12.7 80–127 5.1–8.1 51–81

Petitioners’ Consultant ............................................................................ 10/95 9.2 92 3.0–6.4 30–64

(1) Petitioners’ Estimates: Petitioners

retained the services of David A.

Dooley, Ph.D., a Certified Health

Physicist with expertise in internal dose

assessment, to perform an assessment of

the radiation dose and its effects upon

Dr. Ma and her fetus. Based upon

radioanalysis conducted by TMA/

Norcal Laboratory, of 11 urine

specimens collected by Dr. Ma between

June 29 and August 23, 1995, Dr. Dooley

estimated that Dr. Ma received an

exposure of 9.2 rem (92 mSv) and that

her fetus received an exposure of 3.0

and 6.4 rem (30 and 64 mSv). Although

Dr. Ma continued to submit urine

samples to Dr. Dooley until October 4,

1995, analysis of those samples did not
Federal Register / Vol. 62, No. 185 / Wednesday, September 24, 1997 / Notices 50029

23See Letter dated April 16, 1996, from Judith A.

Wolfer, Esq., to Cynthia Jones, NRC.

24See Letter from Dr. David Dooley, dated April

15, 1996, to Debra C. Katz, Esq.

25Letter from Ronald E. Goans, Ph.D., M.D.,

REACT/TS, dated November 8, 1995, to Shawn W.

Goggins, NIH, and memorandum from Ronald E.

Goans, Ph.D., M.D., dated July 17, 1995, to Dr.

Robert Ricks, REAC/TS.

26PNs constitute early notice of events of possible

safety or public interest significance. Information

contained in PNs is received without any

verification or evaluation, and is basically all that

is known by the licensee and NRC staff as of the

date of issuance to the public. They are also known

as preliminary notifications of occurence (PNOs)

27See NIH memorandum from the NIH RSO,

dated July 30, 1996, to Dr. Ma.

result in revision of Dr. Dooley’s

estimates.23 Dr. Dooley estimated that,

because of the P–32 intake, Dr. Ma

would suffer an increased lifetime

excess cancer risk of approximately 30

percent to 83 percent, and her fetus

would experience a risk of childhood

cancer ‘‘. . . 30 to 150 times that of an

unexposed child.’’24

(2) NIH Estimates: NIH performed an

assessment of Dr. Ma’s intake of P–32,

the resultant radiation exposure

received by Dr. Ma, and the radiation

exposure received by her fetus based on

urine specimens collected by Dr. Ma.

On June 29, 1995, the NIH RSB gave

instructions to collect all of Dr. Ma’s

urine to Dr. Ma, to the paramedics who

transferred her to the hospital, and to

the Holy Cross ER physician. The

Licensee also contacted radiation

emergency medical professionals via

telephone at REAC/TS and arranged for

the REAC/TS physician to speak

directly with the Holy Cross Hospital ER

physician, to assist with the evaluation

of Dr. Ma’s P–32 intake and the

radiation dose to Dr. Ma and to her

fetus. Given the apparent level of P–32

internal contamination, Dr. Ma’s

pregnancy, and the ER physician’s lack

of experience in dealing with

radioactive material internal

contamination events, this was an

eminently reasonable measure. The

REAC/TS physician, who also happened

to be an OB/GYN, believed that medical

intervention at the hospital would not

have been very effective in inhibiting

phosphorus absorption from the gastrointestinal tract because, by the time Dr.

Ma had arrived at Holy Cross, and based

on discussion with the RSB, the REAC/

TS physician understood that over 9

hours had elapsed since the suspected

ingestion and the P–32 would have

essentially been totally absorbed over

this time period. The REAC/TS

physician also asked the ER physician

to instruct Dr. Ma to collect 24-hour

urine samples for evaluation of P–32

kinetics.’’ 25 The Holy Cross ER

physician recalled that the NIH RSO

requested that all of Dr. Ma’s urine was

to be measured, the volume for each

void recorded, and then all of the urine

to be placed in one container every 24-

hours. In addition, Dr. Weinstein

suggested to the ER physician that each

urine void, at least during

hospitalization, be saved separately, so

that more time points would be

available for modeling in determining

the radiation exposure. He also

suggested that the same could be

accomplished by saving a small sample

from each void (and recording the

volume collected), separate from the

continuing 24-hour collection. Dr.

Weinstein believed that either

procedure, if followed, would result in

the availability of more information and

no loss of urine.

The Holy Cross ER physician decided

to develop his own method for

collection of urine, and instructed his

nurses that each time Dr. Ma voided, the

amount would be measured, a small

sample of each void would be

maintained separately, and the rest

would be put into one large container.

The instructions given by the Holy

Cross ER physician to Dr. Ma for

collection of urine did not differ

significantly from the recommendation

of the REAC/TS physician, or of Dr.

Weinstein, and were appropriate for

proper assessment of Dr. Ma’s intake

and exposure, as well as that of her

fetus. Holy Cross Hospital instructed Dr.

Ma to collect urine on a 24-hour basis.

When Dr. Ma reported to RSB on June

30, 1995, she brought the urine

collected since departing Holy Cross,

and was instructed to continue

collecting urine on a 24-hour basis.

NIH states that when Drs. Ma and

Zheng reported to the RSB for follow-up

at 11:00 a.m. on June 30, 1995, they

brought with them Dr. Ma’s urine, in

tubes and a container, and stated to RSB

staff that was all the urine collected at

the hospital and since discharge. Later

that day, when Dr. Ma complained of

back pain, she was escorted, at RSB’s

recommendation, to the NIH OMS

where she was examined by a

physician, and additional urine and

blood samples were taken for

radioanalysis. The results of the blood

samples were within the expected range

for a woman in her 17th week of

pregnancy. Dr. Ma returned for a gamma

camera scan at 5:00 p.m. at the NIH

Clinical Center, and at that time was

provided three carboys by RSB for the

upcoming weekend and was advised to

collect all her urine over the weekend

using one carboy for each day. NIH

states that on Monday, July 3, 1995, Dr.

Ma returned only one carboy full of

urine, stating to RSB staff that it was the

urine from the evening of June 30 to July

1, 1995.

Based on NIH’s preliminary

notification, NRC issued PNO-I–95–025,

‘‘Internal Contamination of Researcher,’’

on July 3, 1995, which stated that NIH

had indicated that a 32-year old female,

who was in her fourth month of

pregnancy, had received an estimated

ingestion of approximately 11.1 MBq

(300 μCi) of P–32.26

Subsequent urine samples, when

received from Dr. Ma, were analyzed

promptly. NRC’s AIT determined that

the licensee analyzed all samples

accurately, as confirmed by the analyses

performed for NRC by ORISE, and by

NRC’s Region I Laboratory. The periodic

reanalysis of samples by the Licensee to

ensure that the samples contained no

additional radioactive contaminates was

appropriate.

On August 29, 1995, based upon

additional urine analysis, NIH

performed another assessment of Dr.

Ma’s exposure. NIH calculated Dr. Ma’s

effective dose equivalent to be 4.17 rem

(41.7 mSv), based upon an estimated

intake of 500 μCi (18.5 MBq), and the

dose to Dr. Ma’s fetus to be 3.2 rem (32

mSv). This reassessment was based on

a total of 26 urine samples obtained

from Holy Cross Hospital and Dr. Ma.

In 1996, NIH contracted with Skrable

Enterprises, Inc., to perform a

reassessment of all available urine data,

as well as an evaluation of creatinine

levels in the urine samples in order to

confirm sample validity. This

consultant suggested modification of the

standard model parameters for the

short-term retention compartments and

use of creatinine normalized data to

improve the fit of the estimate to the

sample data. These suggestions

accounted for the varying time periods

of sample collection. Based upon this

reassessment, NIH revised its estimate

of Dr. Ma’s CEDE to between 4.7 and 7.0

rem (47 and 70 mSv), corresponding to

an intake range of between 570 and 840

μCi (21.1 and 31.1 MBq). The revised

dose to the fetus was calculated to be

between 3.7 and 5.4 rem (37 and 54

mSv). Also on July 30, 1996, NIH RSB

staff delivered its revised estimates

entitled, ‘‘Report of 1995 Radiation

Dose, NRC License 19–00296–10, ‘‘ to

Dr. Ma at NIH, which summarized the

doses described above and stated that

the ‘‘levels (received by Dr. Ma) are

considered to be safe and are not

expected to result in a health impact.’’ 27

Regarding the concerns of the

Petitioners’ that NIH failed to account

for the effect of hydration therapy, NIH’s

report of its last estimate of Dr. Ma’s
50030 Federal Register / Vol. 62, No. 185 / Wednesday, September 24, 1997 / Notices

28ANS N13.30, ‘‘Performance Criteria for

Radiobioassay,’’ was issued as a draft standard for

comment in September 1989, and was finalized in

May 1996. NRC has not yet endorsed it for licensee

use in any NRC Regulatory Guides.

1995 occupational radiation dose states

that NIH’s Consultant was not only

aware of the large variation exhibited by

the bioassay data as a result of hydration

therapy, but accounted for these

differences by using a modified

biokinetic model and creatininenormalized urine data to account for the

large variances in the bioassay data.

Moreover, the last NIH estimates are

reasonably close to those of NRC and

the Petitioners. Accordingly, the effects

of hydration therapy upon the NIH dose

estimates appear to raise no cause for

concern.

As to the Petitioners’ concerns that

NIH’s use of the weighted least squares

fit method was unacceptable because

actual excretion does not follow the

anticipated models, NRC’s second

consultant, Lawrence Livermore

National Laboratory (LLNL), performed

an independent assessment of the NIH

data to determine if differences in the

dose estimates may have been due to the

use of the different internal dose

assessment codes. When the first two

data values were removed from the NIH

data set, the unweighted least squares

intake assessment using the CINDY code

was 30 MBq (810 μCi). Intake

assessments from CINDY using the

LLNL treated data set ranged from 20.7

to 40.7 MBq (560 to 1100 μCi). This

range of results is also consistent with

the ORISE intake estimates of between

22.9 and 30.3 MBq (620 and 820 μCi).

These results indicate that differences in

correcting for 24-hour excretion also do

not significantly influence the intake

estimates. Therefore, the differences in

the dose assessments between NIH’s

August 29, 1995, estimate and NRC’s

estimate were mainly due to differences

in data handling. The major difference

in these two dose estimates was the

treatment of the sample data from the

first few days post intake. However,

since the last NIH estimates now yield

relatively close results with those of the

Petitioners and NRC, NIH’s use of the

least squares method in its earlier

estimate is not cause for concern.

After the surveys and bioassays of

persons who had access to the

contaminated conference room, NIH

determined that 26 individuals,

including Dr. Zheng and in addition to

Dr. Ma, were positive for P–32

contamination. All of the 21 individuals

who were occupational workers as

defined by 10 CFR § 20.1003 received

radiation exposures of less than 10

percent of NRC’s annual occupational

exposure limit of 50 mSv (5 rem)

specified by 10 CFR § 20.1201(a)(1)(i).

Of the five individuals who were

members of the public, as defined by 10

CFR § 20.1003, one individual received

a dose in excess of NRC’s annual limit

of 1 mSv (0.1 rem) for members of the

public specified by 10 CFR

§ 20.1301(a)(1). This individual’s dose

was estimated to be between 1.5 and 2.5

mSv (150 and 250 millirem].

Petitioners are correct in stating that

the July 3, 1995, preliminary NIH

estimates for Dr. Ma and her fetus’

intake were not based upon full and

complete data. NRC requires licensees

to notify NRC within 24 hours of any

event which may have caused, or

threatens to cause, an individual to

receive a dose exceeding 50 mSv (5

rem). 10 CFR § 20.2202(b)(1)(i). Once

information is reported to NRC, NRC

issues a preliminary notification in

accordance with NRC Inspection

Manual Chapter 1120, Sections 1120–07

and 1120–08. These notifications

promptly provide information to the

Commissioners, as well as other NRC

and Agreement State management on

matters that are of significant safety

concern or have, or potentially could

have, high public interest. These

notifications, however, are not assumed

to constitute final estimates.

As far as the Petitioners’ concern that

the NIH bioassay program was faulty in

not collecting and analyzing fecal

samples, NRC-approved models and

methods provides guidance for the use

of either urine or fecal samples. See

‘‘Interpretation of Bioassay

Measurements, ‘‘ NUREG/CR–4884,

(1987). Based on descriptions in the

International Commission on

Radiological Protection Publication 30,

the biokinetic model for phosphorus

predicts that about 80 percent of the

ingested phosphorus is absorbed from

the gastrointestinal tract and enters the

blood stream. From there, 15 percent is

assumed to go directly to excretion

through urine and feces, with a half-life

of 0.5 day, 15 percent goes to

intracellular fluids, 40 percent is

incorporated into soft tissue and 30

percent is incorporated into the

skeleton. The 15 percent that goes to

early excretion is considered to enter

directly into the kidney/bladder

compartment, from which it is

eliminated within a 4-hour retention

time. Because the route of Dr. Ma’s

intake was via ingestion, and because

there is little excretion of P–32 from the

systemic compartment into the feces,

NIH’s use of urinary excretion data and

decision not to use fecal excretion data

was entirely appropriate.

Although NIH did not follow ANSI

N13.30, they were not required to do so.

Not only was this guidance issued as a

draft for public comment at the time of

the event, but NRC had not endorsed its

use in any NRC Regulatory Guide. 28

Moreover, ANSI N13.30 is industryissued guidance only, and does not

constitute a regulatory requirement.

Petitioners are correct in stating that

early reports from NIH of July and

August 1995 were not based upon full

and complete data. In hindsight, the

August 29, 1995, report of NIH should

not have been referenced as ‘‘final’’

assessments of dose. As NRC’s LLNL

evaluation points out, documented

intakes of P–32 demonstrate an increase

in urinary output of radiation over the

first few days after intake. Since the

concentration of phosphorus in the

systemic compartments of the body is

reflected in the urine, it is reasonable to

conclude that urine activity may

establish an equilibrium within a few

days after the intake. Therefore, the

early NIH dose assessments during the

first month after the incident tended to

underestimate the dose because of the

nature of phosphorus biokinetics and

the limited usefulness of

internationally-accepted models derived

primarily for standard-setting. It is

understandable, however, that an

internal dosimetrist may have a strong

desire to maintain and use the first few

days of bioassay samples. Continued use

of these early excretion values also

provides more consistency with early

dose estimates, since these early values

have more statistical weight. However,

at long times after an intake (i.e., 20 to

30 days for P–32), an evaluation of the

entire set of data must be performed

relative to the projected values. It is

during this time that a reevaluation

should be made regarding the validity,

usability, and statistical weight of the

early times after intake. NIH’s last set of

consultants, as well as the NRC’s and

Petitioners’ consultants, had the

advantage of retrospective insight into

the data, and based on that insight, did

not use the urinary excretion data from

the first few days after intake.

(3) NRC Estimates: ORISE, serving as

a scientific consultant to NRC, and

using bioassay data provided by NIH,

performed an assessment for NRC of the

intake by, and resultant P–32 radiation

Dr. Ma was exposed to, and of the

radiation exposure received by her

fetus. One of the major differences

between the early estimates of the

Licensee and NRC was NIH’s use of the

annual limit on intake (ALI) that was

based on Reference Man [70 kilograms

(kg)], versus NRC’s use of an ALI based

on Reference Woman (57 kg). NRC
Federal Register / Vol. 62, No. 185 / Wednesday, September 24, 1997 / Notices 50031

requires licensees to calculate doses to

individuals in accordance with ALIs

that are based on Reference Man. See 10

CFR part 20, Appendix B, notes to Table

1, ‘‘Occupational.’’ Because NRC’s

understanding was that Dr. Ma weighed

approximately 53 kg, the model to

calculate the ALI that more

appropriately represented the

circumstances of Dr. Ma’s

contamination was Reference Woman,

and consequently all NRC dose

estimates were based upon that model.

Because of the differences in the

results of the assessments performed by

the Licensee (dated August 26, 1995)

and by NRC’s scientific consultant to

the AIT, ORISE (dated August 9, 1995),

NRC contracted with a third party,

LLNL, to independently review the

assessments performed by the Licensee,

and by ORISE, for NRC.

Based on the work of its consultants,

NRC estimates that Dr. Ma ingested

between 30.3 and 48.1 MBq (820 and

1300 μCi) of P–32, an amount of P–32

in excess of the 22.2 MBq (600 μCi)

annual limit specified by 10 CFR part

20, Appendix B, Table 1, Column 1.

Based on these values, NRC estimates

that Dr. Ma’s internal CEDE was

between 80 and 127 mSv (8.0 and 12.7

rem). The estimated radiation exposure

received by Dr. Ma’s fetus was between

51 and 81 mSv (5.1 and 8.1 rem). A

more detailed discussion of NRC’s dose

assessment can be found in the AIT

final report of January 13, 1997.

NRC also contracted with one of its

medical consultants to review and

characterize the safety significance of

the exposures to Dr. Ma and her fetus,

summarized in his final report dated

September 4, 1996. Based on NRC’s

estimated exposures to Dr. Ma and her

fetus, NRC’s medical consultant

concluded that no deterministic or

stochastic effects to Dr. Ma, and no

deterministic effects to her fetus are

expected. In regard to potential

stochastic consequences to the fetus,

although there is moderate uncertainty

in the data used for cancer risk

estimation as a result of in utero

radiation exposure, in this case, an

excess risk of 0.33% is estimated (for

comparative purposes, the natural risk

of childhood cancers is about 0.1%).

Thus the probability that the exposed

fetus will NOT develop a radiationinduced childhood cancer is 99.67%

(range 99.60 to 99.74%). It is unknown

whether this risk estimate should be

reduced because of the low dose and

low dose-rate associated with this

internal exposure from P–32.

NRC performed a review of both the

NIH AIT and the MIT IIT contamination

events in order to determine if NRC

guidance to licensees regarding

instructions for collection of excreta and

analysis of fetal dose based upon

maternal uptake is adequate. As a result

of this review, the staff issued

additional guidance to licenses on

analysis of fetal doses, NUREG/CR–

5631, Rev. 2, ‘‘Contribution of Maternal

Burdens to Prenatal Radiation Doses,’’

(May 30, 1996).

One of NRC’s scientific consultants

reviewed and confirmed the NIH

estimates of dose received by the 26

individuals who drank from the

contaminated water cooler. NRC

concluded that no deterministic or

stochastic consequences are expected

for any of the 26 individuals, including

Dr. Zheng, who were internally

contaminated with P–32.

L. Directions to Hospital Emergency

Room Personnel Concerning

Assessment of Dr. Ma’s Level of

Contamination

Petitioners state that NIH personnel

gave conflicting and harmful directions

to Holy Cross ER personnel, which

interfered with efforts to properly assess

Dr. Ma’s contamination. Specifically,

the NIH RSO directed the ER physician

at Holy Cross to collect the total volume

of urine for a 24-hour period, whereas

Dr. Weinstein instructed the ER

physician to aliquot a small part of the

samples already taken and to

discontinue efforts to collect urine over

a 24-hour period, in conflict with

NUREG/CR–4884, ‘‘Interpretation of the

Bioassay Measurements’’ (1987).

Petitioners also state that the Holy Cross

ER physician did not know whose

instructions to follow and so developed

a compromise plan, and when Dr. Ma

was released from Holy Cross, no

instructions were given to her to collect

her urine at any interval.

NRC concludes that the NIH RSB gave

appropriate instructions, in view of the

limited NRC guidance available to

licensees at the time of this event

regarding urine collection, see Section

III.H., supra, to Dr. Ma, to the

paramedics who transferred her to the

hospital on June 29, 1995, and to the

Holy Cross ER physician for urine

collection. Additionally, the three

methods for collection of Dr. Ma’s urine

recommended to the ER physician by

the REAC/TS physician, the NIH RSO,

and Dr. Weinstein were not significantly

different from each other or conflicting,

and the instructions given by the Holy

Cross ER physician to Dr. Ma for

collection of urine were appropriate for

proper assessment of Dr. Ma’s intake

and exposure, as well as that of her

fetus. See Section III.K.(2), supra.

Accordingly, NRC staff cannot conclude

that Dr. Ma was given inadequate or

conflicting instructions.

M. NIH Notification to Dr. Ma of Her

Radiation Exposure Level

Petitioners state that in violation of 10

CFR § 19.13(d), NIH deliberately failed

to notify Dr. Ma of her estimated

radiation exposure level at the same

time such notification was provided to

NRC. Specifically, the only NIH

notification provided to Dr. Ma was a

copy of the August 1995 ORISE report

estimating her contamination at 265 μCi

(9.8 MBq), despite NRC direction to NIH

to make notifications required by 10

CFR § 19.13(d). As a result, before NRC’s

actions to estimate her intake, Dr. Ma

had to learn of her exposure levels from

indirect sources and consulted with an

independent health physicist at great

personal cost.

NRC notified NIH by letter dated

December 1, 1995, from Thomas T.

Martin, Regional Director for Region I,

and by letter dated January 29, 1996,

from Charles W. Hehl, Director, NRC

Region I, Division of Nuclear Material

Safety, that NIH was required to make

notifications pursuant to 10 CFR

§ 19.13(d) regarding the estimated

radiation exposure of Dr. Ma and her

fetus. The December 1, 1995, letter

notified NIH that Dr. Ma received a dose

in excess of the applicable occupational

regulatory limits, 10 CFR

§ 20.1201(a)(1)(i), specifically that NRC

estimates her internal CEDE was

between 80 and 127 mSv (8.0 and 12.7

rem) and that NRC estimates the

radiation exposure received by Dr. Ma’s

fetus was between 51 and 81 mSv (5.1

and 8.1 rem).

By letter and facsimile dated May 15,

1997, counsel for Petitioners notified

NRC that NIH had revised its dose

estimates for Dr. Ma and her fetus, and

Petitioners’ counsel provided a copy to

NRC of an NIH memorandum dated July

30, 1996, containing the revised

estimates. Although this document is

addressed to Dr. Ma, Petitioners’

counsel state that Dr. Ma never received

this memorandum and that NIH never

notified her directly of her radiation

dose after the accident.

NIH revised its original dose estimates

after engaging an independent expert on

internal dose assessment and bioassay

interpretation to perform an analysis of

the dose to Dr. Ma and her fetus. NIH’s

independent consultant completed its

analysis and prepared a report to NIH

dated March 4, 1996. NIH provided its

memorandum dated July 30, 1996,

summarizing Dr. Ma’s 1995 revised

radiation dose estimates for her and her

fetus, to NRC at its request, on April 4,

1997, by facsimile. Based on the NIH
50032 Federal Register / Vol. 62, No. 185 / Wednesday, September 24, 1997 / Notices

29See letter dated August 15, 1997, from Robert

A. Zoon, Radiation Safety Officer, NIH, to Carl J.

Paperiello, NRC, and attached ‘‘Memorandum’’

dated August 14, 1997, from Beth Reed, NIH Area

Health Physicist, to Robert A. Zoon.

30Although there is a dispute as to whether in

fact NIH notified Dr. Ma of its revised dose

estimates, Dr. Ma was in fact provided with the

revised NIH dose estimates from another source.

31 In addition to the lack of evidence

corroborating this assertion, there are significant

inconsistencies in Dr. Ma’s account of how she

learned of the alleged request. In the Petition, Dr.

Ma stated that in the evening, after returning from

a meeting with Dr. Weinstein at NIH, Dr. Zheng

informed Dr. Ma that Dr. Weinstein had made the

alleged request earlier that day. Dr. Ma, however,

told investigators that she learned of the alleged

request during a meeting at NIH with Dr. Zheng and

Dr. Weinstein, a week after Dr. Weisnstein made the

alleged request to Dr. Zheng, and that Dr. Zheng

had not told Dr. Ma of the request.

32 In addition to the lack of evidence to

corroborate this assertion, Petitioners made

contradicatory statements regarding Dr. Weinstein’s

plans for publication of the results of Petitioners’

research. Several days after discovery of Dr. Ma’s

contamination, Dr. Ma told a colleague that the

Petitioners wanted to publish their research paper

before obtaining a patent application (contrary to

usual procedures), but that Dr. Weinstein was trying

to delay publication of the reserach paper. Dr. Ma

told investigators shortly afterwards that Dr.

Weinstein believed that her pregnancy would

prevent her from handling radioactive materials,

when Dr. Weinstein had applied for a patent and

was trying to get the Petitioners’ research paper

published. A few days later, Dr. Zheng submitted

a statement to investigators asserting that over the

past 3 or 4 months Dr. Weinstein had been trying

to delay publication of the research paper.

33The Investigation indicates that the Petitioners’

research, which was conducted to investigate a

proposal of Dr. Weinstein, did not constitute a

major scientific discovery and had little commercial

value.

34Moreover, the investigation produced evidence

that Dr. Ma was not eager to declare her pregnancy.

Dr. Ma told an NIH colleague approximately 2

months before the contamination incident that she

was reluctant to inform Dr. Weinstein of her

pregnancy, because then she might have to stop

conducting experiments involving radiation.

35Petitioners assert that Dr. Ma was contaminated

at NIH on the evening of June 28, when she ate food

that she had stored in an NIH conference room

refrigerator the previous evening. Dr. Ma’s

contamination was discovered at approximately

6:00 p.m. on June 29. The evidence indicates that

Dr. Ma was not contaminated by food she had

stored in the NIH conference room refrigerator. In

the evening of June 29, the NIH RSB found no

radioactive contamination of the conference room

refrigerator, the contents of the refrigerator, Dr. Ma’s

desk, the table at which Dr. Ma ate, the trash cans

or containers or tables in the halls near Petitioners’

lab, the lab, or Dr. Weinstein’s office. On June 30,

the microwave used by Dr. Ma to heat her food at

NIH, and the plastic containers and the utensils

consultant’s report, NIH revised its dose

estimates to a CEDE of between 4.7 and

7.0 rem (47 and 70 mSv) to Dr. Ma,

corresponding to an intake range of

between 570 and 840 μCi (21.1 and 31.1

MBq), and a dose of between 3.7 and 5.4

rem (37 and 54 mSv) to Dr. Ma’s fetus.

NRC regulations at 10 CFR § 19.13(d)

require that NIH provide Dr. Ma with a

report of her exposure data at a time not

later than NIH’s transmittal to NRC of

NIH’s report on Dr. Ma’s exposure. NIH

denies that it never provided Dr. Ma

with the revised dose estimates. NIH

states that its Area Health Physicist

hand-delivered the July 30, 1996,

memorandum to Dr. Ma on July 30,

1996. The Area Health Physicist states

that at that time, she explained the

contents of the memorandum to both Dr.

Ma and Dr. Zheng, asked if they had any

questions, and identified NIH personnel

to contact if Petitioners had any

questions. The Area Health Physicist

states that Petitioners opened the

envelope and read the memorandum in

her presence. 29

Accordingly, NIH did violate 10 CFR

§ 20.2203(a)(2)(i), because NIH did not

submit a written report to NRC within

30 days after learning of the

occupational dose to Dr. Ma in excess of

the limits for adults in 10 CFR

§ 20.1201. A Notice of Violation is being

issued concurrently with the issuance of

this Director’s Decision. However, NIH

did inform Dr. Ma of its revised dose

estimates on July 30, 1996, in

accordance with 10 CFR § 19.13(d).

Accordingly, Petitioners’ request for

enforcement action for violation of 10

CFR § 19.13(d) is denied. 30

N. Declaration of Pregnancy and

Minimization of Radiation Exposure to

Dr. Ma

Petitioners state that, in violation of

10 CFR § 20.1208, their supervisor, Dr.

Weinstein, coerced Dr. Ma to not submit

a written declaration of pregnancy to the

NIH RSB, even though it was her clear

desire to receive maximum protection

for her fetus from exposure to radiation

and radioactive materials, and thus Dr.

Weinstein constructively denied Dr. Ma

her right to receive protection for her

fetus from ionizing radiation in excess

of 0.5 rem (5 mSv). Petitioners state that

between June 19 and June 23, 1995, Dr.

Weinstein withheld the NIH form used

to file a declaration of pregnancy, and

insisted that if Dr. Ma filled out the

declaration form, it would ‘‘cause

trouble for the lab.’’ Petitioners also

state that Dr. Weinstein disagreed with

the steps proposed by Petitioners to

minimize radiation exposure of Dr. Ma

during her pregnancy.

As a related matter, Petitioners also

state that because Dr. Weinstein was in

a hurry to patent the results of their

research (a novel method to display

more efficiently the existence of

expressed genes), which would have

had significant scientific and

commercial value, Dr. Weinstein urged

Petitioners to work tirelessly, and over

a period of several weeks before the

contamination incident, repeatedly

requested Petitioners to terminate Dr.

Ma’s pregnancy. Based on the several

inspections and the investigation, NRC

concludes that the evidence does not

substantiate Petitioners’ assertions that

Dr. Weinstein urged Petitioners to work

tirelessly, requested Petitioners to

terminate Dr. Ma’s pregnancy,31 and

was in a hurry to patent the results of

Petitioners’ research,32 or that the

research would have had significant

scientific and commercial value.33

Based on the inspections and

investigation, NRC concludes that the

evidence does not substantiate

Petitioners’ assertions that Dr.

Weinstein, with coercion or otherwise,

prevented or tried to prevent Dr. Ma

from declaring, or interfered with Dr.

Ma’s declaration of, her pregnancy in

writing,34 or that Dr. Weinstein objected

to or interfered with any measures

proposed or taken by Petitioners to

minimize exposure of Dr. Ma’s fetus to

radiation. Additionally, Petitioners both

took the ‘‘NIH Radiation Safety in the

Laboratory’’ training course on

November 29, 1994. That training

covered NIH procedures on written

declarations of pregnancy for

occupational workers and instructions

for pregnant employees as to how to

obtain the NIH form used to submit a

written declaration of pregnancy.

Although not required to do so, Dr.

Weinstein obtained the NIH form for

Petitioners and provided it to

Petitioners on June 23, 1995. Dr. Ma,

however, did not request the form, nor

did she submit the formal declaration of

her pregnancy to the NIH RSB, as

provided in the materials covered in her

training. In view of the above, Dr. Ma’s

failure to submit a written declaration of

pregnancy was voluntary. Accordingly,

the 5-mSv (0.5-rem) occupational

exposure limit specified by 10 CFR

§ 20.1208(a) for the fetus of a declared

pregnant worker was not applicable to

Dr. Ma.

Based on the above, Petitioners’

request for enforcement action against

NIH for violation of 10 CFR § 20.1208 is

denied.

O. Responsibility for Contamination of

Dr. Ma and 26 NIH Employees

Based on the inspections and the

investigation, NRC concludes that Dr.

Ma and 26 NIH employees were

deliberately contaminated with P–32.

Dr. Ma’s exposure and the exposure of

one of the 26 employees contaminated

by the water cooler were beyond

regulatory limits, in violation of 10 CFR

§§ 20.1201 and 20.1301, respectively.

Neither the means of administering P–

32 to Dr. Ma,35 nor the person(s)
Federal Register / Vol. 62, No. 185 / Wednesday, September 24, 1997 / Notices 50033

used by Dr. Ma to eat the food she brought to NIH,

were surveyed, and no contamination was found.

Additionally, the evidence indicates that the P–32

contamination of the carpet in front of the

conference room refrigerator occurred sometime

after 5:00 p.m. on June 29. The AIT report states in

the chronology that the NIH RSB initial estimated

time of ingestion was noon on June 29, 1995.

However, after review of the physical evidence and

radiation surveys, NIH used 11:00 am, June 28,

1995, as the most probable initial ingestion time.

NIH also used this initial ingestion time for the

other 26 contaminated NIH individuals involved.

NRC also used this initial time of ingestion in its

dose estimates.

36The investigation produced no evidence to

corroborate Petitioners’ assertions that Dr.

Weinstein had suggested to several people either

that Petitioners already had a child in China, or that

Petitioners deliberately contaminated themselves in

order to terminate Dr. Ma’s pregnancy.

37See letter from Ashok C. Thadani, Acting

Deputy Executive Director for Regulatory

Effectiveness, to Michael M. Gottesman, M.D.,

Deputy Director for Intramural Research, NIH, dated

September 17, 1997.

responsible for the contamination of Dr.

Ma36 and of the water cooler, which was

the source of contamination to the 26

NIH employees, however, was

definitively identified. In the absence of

any evidence to the contrary, NRC

presumes that the violations were

caused by an employee(s) of NIH and

that the material belonged to NIH. As

explained above, NRC also concludes

that the contamination of Dr. Ma and of

the water cooler was not a result of the

Licensee’s violations of NRC

requirements for security and control of

radioactive material. See Section III. A,

‘‘Violations of NRC requirements for

security and control of licensed

material’’, supra. Normally, the

exposures beyond regulatory limits in

this case would be subject to significant

enforcement action. However, under the

circumstances of this case, the

Commission has decided to exercise its

enforcement discretion and not initiate

formal enforcement action against NIH

for these violations. Discretion is being

exercised because NIH fully cooperated

with the investigation, there is no

evidence that NIH contributed directly

or indirectly to the deliberate misuse of

licensed material involved, and NIH

could not reasonably foresee that an

employee or employees would

maliciously misuse radioactive material

as was done in this case.

Accordingly, enforcement action

against NIH, in addition to that already

taken in the NOV and Proposed

Imposition of Civil Penalty $2500 (EA

96–027) and the Order Imposing Civil

Penalty $2500 (EA 96–027), is not

warranted in this case for the

occupational exposure of Dr. Ma beyond

regulatory limits, the exposure of the

member of the public beyond regulatory

limits, or the contamination of the water

cooler. 37

IV. Conclusions

The following requests of Petitioners

are granted in part as described above:

for enforcement action against NIH for

violations of NRC security and control

requirements and for violation of NRC

requirements related to radiation safety

training, ordering radioactive materials,

inventory control of radioactive

materials, monitoring, and the issuance,

use, and collection of dosimetry.

Petitioners’ request for NRC action to

ensure adequate procedures and

instructions to exposed persons for

sample collection is granted as

described above. The following requests

of Petitioners for enforcement action

against NIH are denied: for the exposure

of Dr. Ma beyond regulatory limits, for

the exposure of Dr. Ma’s fetus, and for

the contamination of the water cooler;

regarding notification to Dr. Ma of her

level of contamination; regarding Dr.

Ma’s declaration of pregnancy;

regarding the conduct of surveys after

Dr. Ma’s contamination; and for the

failure to accurately calculate Dr. Ma’s

occupational radiation dose. Finally,

Petitioners’ request to suspend or revoke

the NIH license is denied.

A copy of this Decision will be filed

with the Secretary of the Commission

for Commission review in accordance

with 10 CFR § 2.206(c) of the

Commission’s regulations. As provided

by this regulation, the Decision will

constitute the final action of the

Commission 25 days after issuance,

unless the Commission, on its own

motion, institutes a review of the

Decision within that time.

This 17th day of September 1997,

Rockville, Maryland.

Carl J. Paperiello,

Director, Office of Nuclear Material Safety

and Safeguards.

[FR Doc. 97–25318 Filed 9–23–97; 8:45 am]

BILLING CODE 7590–01–P

SECURITIES AND EXCHANGE

COMMISSION

Request for Public Comment

Upon Written Request, Copies Available

From: Securities and Exchange Commission,

Office of Filings and Information Services,

Washington, DC 20549.

Extension: Rule 13e–1, SEC File No. 270–

255, OMB Control No. 3235–0305. Rule

12g3–2, SEC File No. 270–104, OMB Control

No. 3235–0119, Trust Indenture Act Rules,

SEC File No. 270–115, OMB Control No.

3235–0132.

Notice is hereby given that pursuant

to the Paperwork Reduction Act of 1995

(44 U.S.C. 3501 et seq.), the Securities

and Exchange Commission.

(‘‘Commission’’) is soliciting comments

on the collections of information

summarized below. The Commission

plans to submit these existing

collections of information to the Office

of Management and Budget for

extension and approval:

‘‘Purchase of Securities by issuer

thereof under the Securities Exchange

Act of 1934’’. Rule 13e–1 under the

Exchange Act is designed to provide

shareholders and the marketplace with

relevant information concerning issuer

repurchases during a tender offer for its

securities by a third party. Public

companies are the respondents. An

estimated 20 respondents wiil file

submissions annually at and estimated

13 hours per response for a total annual

burden of 260 hours.

‘‘Securities Exchange Act of 1934—

Rule 12g3–2.’’ Rule 12g3–2 provides an

exemption for certain foreign securities.

It affects approximately 1800 foreign

issuer respondents at an estimated one

burden hour per response for a total

annual burden of 1800 hours.

‘‘Requirements as to Form and

Content of Applications, Statements and

Reports under the Trust Indenture Act

of 1939.’’ Rules 7a–15 through 7a–37

under the Trust Indenture Act of 1939

(‘‘TIA’’) provides guidance for

complying with requirements under the

TIA. Persons and entities subject to TIA

requirements are the respondents. No

information collection burdens are

imposed directly by these rules so they

are assigned only one burden hour for

administrative convenience.

Written comments are invited on: (a)

Whether the proposed collection of

information is necessary for the proper

performance of the functions of the

agency, including whether the

information will have practical utility;

(b) the accuracy of the agency’s estimate

of the burden of the collection of

information; (c) ways to enhance the

quality, utility, and clarity of the

information collected; and (d) ways to

minimize the burden of the collection of

information on respondents, including

through the use of automated collection

techniques or other forms of information

technology. Consideration will be given

to comments and suggestions submitted

in writing on or before November 24,

1997.

Please direct your written comments

to Michael E. Bartell, Associate

Executive Director, Office of

Information Technology, Securities and

Exchange Commission, 450 5th Street,

N.W., Washington, DC 20549.