National Institutes of Health Issuance of Director's Decision Under 10 CFR Sec. 2.206
Federal RegisterSep 24, 1997
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NUCLEAR REGULATORY COMMISSION
[Docket No. 030-01786]
National Institutes of Health Issuance of Director's Decision
Under 10 CFR Sec. 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.
[[Page 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 Sec. 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 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 non-human
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,
[[Page 50020]]
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.
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\1\ REAC/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.
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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 (Ci) 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 Ci (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 Ci
(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.
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\2\ Because 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.
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NRC's estimates indicate that Dr. Ma ingested between 30.3 and 48.1
MBq (820 and 1300 Ci) 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
Sec. 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
Sec. 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
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\3\ CAL 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).
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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
[[Page 50021]]
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 Secs. 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 Sec. 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 per-container 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.
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\4\ NIH and NCI are two different licensees. Science
Applications International Corp. holds NRC broadscope license for
activities at the NCI-Frederick 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.
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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
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\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 Ci) 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.
\6\ See ``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.
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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
[[Page 50022]]
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.
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\7\ See NMSS Technical Assistance Request dated June 19, 1995,
from L. Camper, NRC Headquarters to R. Bellamy, NRC Region I.
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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.
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\8\ On 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.
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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 low-energy 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
---------------------------------------------------------------------------
\9\ These facts do not constitute a violation of NRC regulations
or the NIH license.
---------------------------------------------------------------------------
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 Secs. 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
[[Page 50023]]
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 beta-emitting 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 Sec. 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 Sec. 20.1502 * * *.'' (Emphasis added) 10 CFR
Sec. 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 Sec. 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
Sec. 20.1201.\10\
---------------------------------------------------------------------------
\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)].
---------------------------------------------------------------------------
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 Sec. 20.1502. Since monitoring of
Petitioners was not required, the recording requirements of 10 CFR
Sec. 20.2106 were not applicable to Petitioners.11
---------------------------------------------------------------------------
\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 Sec. 20.2106, the results of monitoring
provided when not required by Sec. 20.1502 are not subject to the
dose recording requirements.''
---------------------------------------------------------------------------
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 Sec. 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.
---------------------------------------------------------------------------
\12\ License 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.
\13\ NIH ``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.
---------------------------------------------------------------------------
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
[[Page 50024]]
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.
---------------------------------------------------------------------------
\14\ See letter from M. Gottesman, NIH, to R. Blough, NRC Region
I, dated June 23, 1997.
---------------------------------------------------------------------------
For the NIH Authorized User to track the use of individual items of
NRC-licensed materials, a new computer-generated 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).
---------------------------------------------------------------------------
\15\ License 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.
---------------------------------------------------------------------------
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
[[Page 50025]]
closer, because Suburban Hospital did not have an obstetrics
department.
---------------------------------------------------------------------------
\16\ Because 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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\17\ Petitioners 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.
---------------------------------------------------------------------------
G. NIH Conduct of Surveys After Contamination Incident
Petitioners state that in violation of 10 CFR Sec. 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
[[Page 50026]]
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
Sec. 20.1501(b).18
---------------------------------------------------------------------------
\18\ At the time of the incident, 10 CFR Sec. 20.1501(a)
required licensees to perform surveys that are reasonable under the
circumstances. On January 1, 1993, 10 CFR Sec. 20.201, with a
similar requirement, became extant.
---------------------------------------------------------------------------
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
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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
follow-up 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
[[Page 50027]]
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 Ci), 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 follow-up
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
---------------------------------------------------------------------------
\20\ Medical data provided by Petitioners did not substantiate
this assertion.
---------------------------------------------------------------------------
NIH took reasonable and appropriate measures to determine whether
Dr. Ma's contamination presented a life-threatening 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 on-call
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.
---------------------------------------------------------------------------
\21\ Blood, 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.
---------------------------------------------------------------------------
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 Secs. 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. Sec. 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,
[[Page 50028]]
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 Ci (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 Ci (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
Ci (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 Ci (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 Ci (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 Ci (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 Ci) 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 Ci (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
----------------------------------------------------------------------------------------------------------------
Dr. Ma's dose estimate Dr. Ma's Fetal dose
---------------------------- estimate
Organization Date --------------------------
(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
[[Page 50029]]
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
---------------------------------------------------------------------------
\23\ See Letter dated April 16, 1996, from Judith A. Wolfer,
Esq., to Cynthia Jones, NRC.
\24\ See Letter from Dr. David Dooley, dated April 15, 1996, to
Debra C. Katz, Esq.
---------------------------------------------------------------------------
(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 gastro-intestinal 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.
---------------------------------------------------------------------------
\25\ Letter 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.
---------------------------------------------------------------------------
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 Ci) of P-32.26
---------------------------------------------------------------------------
\26\ PNs 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)
---------------------------------------------------------------------------
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 Ci (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 Ci
(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
---------------------------------------------------------------------------
\27\ See NIH memorandum from the NIH RSO, dated July 30, 1996,
to Dr. Ma.
---------------------------------------------------------------------------
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
[[Page 50030]]
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 creatinine-normalized 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 Ci). Intake assessments from CINDY
using the LLNL treated data set ranged from 20.7 to 40.7 MBq (560 to
1100 Ci). This range of results is also consistent with the
ORISE intake estimates of between 22.9 and 30.3 MBq (620 and 820
Ci). 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 Sec. 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 Sec. 20.1201(a)(1)(i). Of the five
individuals who were members of the public, as defined by 10 CFR
Sec. 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
Sec. 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
Sec. 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 industry-
issued guidance only, and does not constitute a regulatory requirement.
---------------------------------------------------------------------------
\28\ ANS 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.
---------------------------------------------------------------------------
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
[[Page 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 Ci) of P-32,
an amount of P-32 in excess of the 22.2 MBq (600 Ci) 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 radiation-induced 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 Sec. 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
Ci (9.8 MBq), despite NRC direction to NIH to make
notifications required by 10 CFR Sec. 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 Sec. 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 Sec. 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
[[Page 50032]]
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 Ci (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 Sec. 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
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\29\ See 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.
---------------------------------------------------------------------------
Accordingly, NIH did violate 10 CFR Sec. 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 Sec. 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 Sec. 19.13(d). Accordingly, Petitioners'
request for enforcement action for violation of 10 CFR Sec. 19.13(d) is
denied. 30
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\30\ Although 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.
---------------------------------------------------------------------------
N. Declaration of Pregnancy and Minimization of Radiation Exposure to
Dr. Ma
Petitioners state that, in violation of 10 CFR Sec. 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\
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\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.
\33\ The 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.
---------------------------------------------------------------------------
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 Sec. 20.1208(a) for the fetus of a declared pregnant worker
was not applicable to Dr. Ma.
---------------------------------------------------------------------------
\34\ Moreover, 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.
---------------------------------------------------------------------------
Based on the above, Petitioners' request for enforcement action
against NIH for violation of 10 CFR Sec. 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 Secs. 20.1201 and 20.1301, respectively. Neither
the means of administering P-32 to Dr. Ma,\35\ nor the person(s)
[[Page 50033]]
responsible for the contamination of Dr. Ma\36\ 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.
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\35\ Petitioners 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
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.
\36\ The 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.
---------------------------------------------------------------------------
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
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\37\ See 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.
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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
Sec. 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
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