Report to Congress on Abnormal Occurrences Fiscal Year 2006; Dissemination of Information, 25339-25342 [E7-8551]
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Federal Register / Vol. 72, No. 86 / Friday, May 4, 2007 / Notices
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fingerprinted again, provided in each
case that the appropriate documentation
is made available to the Licensee’s
reviewing official. However, all other
applicable requirements must be
satisfied to allow any individual
unescorted access to the facility.
D. The Licensee may allow any
individual who currently has
unescorted access, in accordance with
applicable requirements, to continue to
have unescorted access, pending a
decision by the reviewing official (based
on fingerprinting and a FBI criminal
history records check) that the
individual may continue to have
unescorted access. The licensee shall
complete implementation of the
requirements of Attachment 2 to this
Order by July 30, 2007.
Licensee responses to Condition A.2.
shall be submitted to the Director, Office
of Nuclear Reactor Regulation, U.S.
Nuclear Regulatory Commission,
Washington, DC 20555.
The Director, Office of Nuclear
Reactor Regulation, may, in writing,
relax or rescind any of the above
conditions upon demonstration of good
cause by the Licensee.
IV
In accordance with 10 CFR 2.202, the
Licensee must, and any other person
adversely affected by this Order may,
submit an answer to this Order, and
may request a hearing on this Order,
within twenty (20) days of the date of
this Order. Where good cause is shown,
consideration will be given to extending
the time to request a hearing. A request
for extension of time in which to submit
an answer or request a hearing must be
made in writing to the Director, Office
of Nuclear Reactor Regulation, U.S.
Nuclear Regulatory Commission,
Washington, DC 20555, and include a
statement of good cause for the
extension. The answer may consent to
this Order. Unless the answer consents
to this Order, the answer shall, in
writing and under oath or affirmation,
specifically set forth the matters of fact
and law on which the Licensee or other
person adversely affected relies and the
reasons as to why the Order should not
have been issued. Any answer or
request for a hearing shall be submitted
to the Secretary, Office of the Secretary,
U.S. Nuclear Regulatory Commission,
ATTN: Rulemakings and Adjudications
Staff, Washington, DC 20555. Copies
also shall be sent to the Director, Office
of Nuclear Reactor Regulation, U.S.
Nuclear Regulatory Commission,
Washington, DC 20555, to the Assistant
General Counsel for Material Litigation
and Enforcement at the same address,
and to the Licensee if the answer or
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hearing request is by a person other than
the Licensee. Because of possible delays
in delivery of mail to United States
Government offices, it is requested that
answers and requests for hearing be
transmitted to the Secretary of the
Commission either by means of
facsimile transmission to 301–415–1101
or by e-mail to hearingdocket@nrc.gov
and also to the Office of the General
Counsel either by means of facsimile
transmission to 301–415–3725 or by email to OGCMailCenter@nrc.gov. If a
person other than the Licensee requests
a hearing, that person shall set forth
with particularity the manner in which
his/her interest is adversely affected by
this Order and shall address the criteria
set forth in 10 CFR 2.309.
If a hearing is requested by the
Licensee or a person whose interest is
adversely affected, the Commission will
issue an Order designating the time and
place of any hearing. If a hearing is held,
the issue to be considered at such
hearing shall be whether this Order
should be sustained.
Pursuant to 10 CFR 2.202(c)(2)(i), the
Licensee may, in addition to demanding
a hearing, at the time the answer is filed
or sooner, move the presiding officer to
set aside the immediate effectiveness of
the Order on the ground that the Order,
including the need for immediate
effectiveness, is not based on adequate
evidence but on mere suspicion,
unfounded allegations, or error. In the
absence of any request for hearing, or
written approval of an extension of time
in which to request a hearing, the
provisions as specified above in Section
III shall be final twenty (20) days from
the date of this Order without further
Order or proceedings.
If an extension of time for requesting
a hearing has been approved, the
provisions as specified above in Section
III shall be final when the extension
expires, if a hearing request has not
been received. AN ANSWER OR A
REQUEST FOR HEARING SHALL NOT
STAY THE IMMEDIATE
EFFECTIVENESS OF THIS ORDER.
NUCLEAR REGULATORY
COMMISSION
Dated this 30th day of April 2007.
For the Nuclear Regulatory Commission.
James T. Wiggins,
Acting Director, Office of Nuclear Reactor
Regulation.
Nuclear Power Plants
During this period, no events at U.S.
nuclear power plants were significant
enough to be reported as AOs.
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[FR Doc. 07–2207 Filed 5–3–07; 8:45 am]
Fuel Cycle Facilities
Report to Congress on Abnormal
Occurrences Fiscal Year 2006;
Dissemination of Information
Section 208 of the Energy
Reorganization Act of 1974 (Public Law
93–438) defines an abnormal occurrence
(AO) as an unscheduled incident or
event which the U.S. Nuclear
Regulatory Commission (NRC)
determines to be significant from the
standpoint of public health or safety.
The Federal Reports Elimination and
Sunset Act of 1995 (Public Law 104–66)
requires that AOs be reported to
Congress annually. During fiscal year
2006, nine events that occurred at
facilities licensed or otherwise regulated
by the NRC and/or Agreements States
were determined to be AOs. The report
describes three events at facilities
licensed by the NRC. The three AOs at
NRC-licensed facilities included a spill
of high-enriched uranium solution at a
fuel fabrication facility, a medical event,
and an unintended dose to an mbryo/
fetus. The report also addresses six AOs
at facilities licensed by Agreement
States. [Agreement States are those
States that have entered into formal
agreements with the NRC pursuant to
Section 274 of the Atomic Energy Act
(AEA) to regulate certain quantities of
AEA licensed material at facilities
located within their borders.] Currently,
there are 34 Agreement States. During
Fiscal Year 2006, Agreement States
reported six events that occurred at
Agreement State-licensed facilities,
including four medical events, one
unintended dose to an embryo/fetus,
and one industrial event. As required by
Section 208, the discussion for each
event includes the date and place, the
nature and probable consequences, the
cause or causes, and the action taken to
prevent recurrence. Each event is also
being described in NUREG–0090, Vol.
29, ‘‘Report to Congress on Abnormal
Occurrences, Fiscal Year 2006.’’ This
report is available electronically at the
NRC Web site https://www.nrc.gov/
reading-rm/doc-collections/nuregs/staff/
.
BILLING CODE 7590–01–P
PO 00000
(Other Than Nuclear Power Plants)
During this reporting period, one
event at an NRC-licensed fuel
fabrication facility was significant
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enough to be reported as an AO based
on the criteria in Appendix A to this
report.
06–01 Spill of High-Enriched
Uranium Solution at Nuclear Fuel
Services in Erwin, Tennessee.
Date and Place—March 6, 2006,
Erwin, Tennessee.
Nature and Probable Consequences—
In a facility authorized to process highenriched uranium (HEU), a transfer of
HEU solution through a transfer line
resulted in a portion of the HEU
solution, approximately 35 liters,
leaking into a glovebox where criticality
was possible and subsequently to the
floor where criticality was also possible
because of the presence of an elevator
pit.
Immediately before the event, the
facility operator decided to move the
unused filter glovebox to another
location. Workers opened and drained
the filters so that the filter glovebox
could be moved. After draining the
filters, workers failed to reseal the
system tightly. During the next transfer
of HEU solution through the line, HEU
solution leaked into the filter glovebox.
On several occasions before the event,
workers had reported signs of a
yellowish liquid in the filter glovebox.
Supervisors had failed to fully
investigate the reports because they
assumed the yellowish liquid was
natural uranium solution which had
been used to initially test the process.
Criticality was possible in the filter
glovebox because of the size and shape
of the glovebox and because there were
no controls in the filter glovebox to
prevent accumulation of solution. The
solution leaked out of the filter glovebox
through uncontrolled drains to the floor.
Investigation of the event revealed that
the floor contained an uncontrolled
accumulation point, an elevator pit,
where criticality was also possible. In
different circumstances, the total
volume of the transfer would have been
more than enough for criticality to be
possible in the filter glovebox or the
elevator pit. If a criticality accident had
occurred in the filter glovebox or the
elevator pit, it is likely that at least one
worker would have received an
exposure high enough to cause acute
health effects or death. The NRC
conducted a team inspection to
determine the root causes of the event
and performed a series of three
readiness reviews before allowing this
portion of the facility to restart. The
NRC issued an order to the licensee
delineating specific actions designed to
address this and other performance
issues at the facility.
Cause(s)—Failure to maintain
configuration control of facility
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equipment and failure to comply with
procedures.
Actions Taken to Prevent
Recurrence—The operator stopped all
processing of HEU in the affected
processing area, removed the enclosure
and associated piping, filled in an
uncontrolled accumulation point (the
elevator pit) with concrete, and
conducted an extensive review to
identify any similar configuration
issues.
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Other NRC Licensees
(Industrial Radiographers, Medical
Institutions, etc.)
During this reporting period, two
events at NRC-licensed or regulated
facilities were significant enough to be
reported as AOs based on the criteria in
Appendix A to this report.
06–02 Medical Event at Bozeman
Deaconess Hospital in Bozeman,
Montana.
Date and Place—May 9, 2006,
Bozeman, Montana.
Nature and Probable Consequences—
The licensee reported that a patient was
prescribed a brachytherapy treatment of
145 Gy (14,500 rad) to the prostate gland
for prostate cancer using 82 iodine-125
seeds, but instead received a 130 Gy
(13,000 rad) dose to an unintended
treatment site. The brachytherapy seeds
were implanted under ultrasound
guidance; however, a post-treatment
computerized tomography scan
confirmed that only 10 seeds were
implanted in the prescribed location of
the prostate, resulting in a dose of 8.6
Gy (860 rad) delivered to the intended
treatment site. Concerning the 72 seeds
not in the intended treatment site, the
urologist was able to recover 3 seeds
and determined that 69 seeds were
implanted inferior to the prostate in the
wrong treatment site. The referring
physician and the patient were
informed of this event and were advised
that the patient may experience
discomfort during urination. The NRC
staff conducted a reactive onsite
inspection on May 16, 2006. An NRC
contracted medical consultant
experienced in radiation oncology
reviewed the case and agreed with the
licensee’s analysis and conclusions. An
NRC inspection report has been issued.
Cause(s)—This medical event was
caused by human error because the
licensee did not verify that the sources
were positioned in the proper location
in the prostate. The urologist
misidentified the anatomy viewed
under the ultrasound guidance
procedure.
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Actions Taken to Prevent
Recurrence—The licensee revised its
procedures, requiring a fluoroscopic
examination early in the implant
procedure to ensure that the seeds are
placed in the correct location, thus
resolving any questions concerning
ultrasound images prior to commencing
with the implant. The licensee also
implemented additional staff training.
*
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06–03 Dose to an Embryo/Fetus at
Munson Medical Center in Traverse
City, Michigan.
Date and Place—May 3, 2006,
Traverse City, Michigan.
Nature and Probable Consequences—
The licensee reported an unintended
dose to an embryo/fetus. On May 3,
2006, the licensee administered a
therapy dosage of 5.55 GBq (150 mCi) of
I–131 to a 26-year-old female patient
who had affirmed in writing that she
was not pregnant. On May 22, 2006, the
patient informed the licensee that she
had been approximately 10 to 14 days
pregnant at the time of the
administration. Based on this new
information, the licensee estimated that
the dose to the embryo/fetus was
approximately 400 mSv (40 rem). The
referring physician and patient were
informed of this event. The NRCcontracted medical consultant agreed
with the licensee’s dose estimate and
concluded that this event should result
in no harm to the embryo because the
administration occurred during a stage
of development when the thyroid does
not take up iodine. The medical
consultant recommended that a
complete thyroid evaluation be
performed after delivery.
Cause(s)—This medical event was
caused by the patient’s incorrect written
statement that she was not pregnant
prior to receiving the therapy dosage.
The licensee did not require an
independent pregnancy test for women
of child-bearing age prior to
administering the dosage.
Actions Taken to Prevent
Recurrence—The licensee implemented
a procedure that requires pregnancy
tests for all women of childbearing age
prior to any therapy dosage of
radioactive material, a checklist to
ensure that the pregnancy test is
ordered, and staff training.
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Agreement State Licensees
During this reporting period, six
events at Agreement State-licensed
facilities were significant enough to be
reported as AOs based on the criteria in
Appendix A to this report.
AS 06–01 Industrial Radiography
Occupational Overexposure at Anvil
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International in North Kingston, Rhode
Island.
Date and Place—March 3, 2006,
North Kingston, Rhode Island.
Nature and Probable Consequences—
The licensee reported that a
radiographer and a trainee received
unintended radiation exposures in
excess of those specified in the AO
criteria. The incident occurred at a
permanent radiography facility and
involved an iridium-192 source with an
activity of 3.44 TBq (93 Ci). After
performing surveys outside a dedicated
radiography cell, where radiation levels
confirmed that radiography was in
process in the cell, the radiographer and
the trainee went to an alternate location
and performed equipment maintenance
and training. They were joined by a
third radiographer, who was performing
radiography inside the cell. All three
radiography personnel entered the cell
to view the radiography setup and
examine the guide tube for training
purposes. However, they entered
without a survey meter and were
unaware that the source was still
exposed. As a result, the first
radiographer and the trainee handled
the collimator and guide tube (which
contained the source) for approximately
15–60 seconds. The first radiographer
received a dose to the left hand ranging
from 1.4 to 2.8 Sv (140 rem to 280 rem).
The trainee received a dose to the left
hand ranging from 11 Sv to 85 Sv (1,100
rem to 8,500 rem). The third
radiographer did not receive a dose in
excess of regulatory exposure limits,
since he did not handle the equipment.
Cause(s)—This event was caused by
the failure of radiography personnel to
follow safety procedures and use survey
meters inside the cell.
Actions Taken to Prevent Recurrence.
Licensee—The licensee provided
additional training to the personnel. The
licensee also solicited the assistance of
a medical physicist and the source
manufacturer in determining the dose to
the radiographers. The licensee also
committed to keep the State updated on
the medical conditions of the
radiographer and trainee until they are
released from medical oversight.
State Agency—On March 7, 2006, the
State issued a suspension letter to the
licensee. On March 8 and March 16,
2006, the State, accompanied by NRC
Region I staff, conducted an
investigation of the event. On April 13,
2006, the State issued a Notice of
Violation and on November 3, 2006,
terminated the license after an onsite
inspection to confirm decommissioning
actions.
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AS 06–02 Medical Event at 21st
Oncology, Inc., in Coral Springs,
Florida.
Date and Place—March 31 through
April 7, 2006, Coral Springs, Florida.
Nature and Probable Consequences—
The licensee reported that an 80-yearold female patient received 100 Gy
(10,000 rad) to an unintended area of
approximately 2 cm (0.8 in) that was
three times the prescribed dose for the
mammosite brachytherapy procedure,
using a high dose rate (HDR) afterloader
containing an iridium-192 source with
an activity of 240.5 GBq (6.5 Ci). The
patient received less than 30 percent of
the prescribed dose to the prescribed
treatment site. The source stopped 6 cm
(2.4 in) short of the intended position.
The patient visited the attending
physician for followup on May 2, 2006.
The physician discovered that the
patient’s skin was abnormally red. The
referring physician, patient, and
patient’s family were notified of the
incident. The patient was treated for
erythema (skin reddening) and moist
desquamation (skin thinning and
weeping).
Cause(s)—This medical event was
caused by human error. The authorized
user entered an incorrect distance into
the computer entry data.
Actions Taken to Prevent Recurrence.
Licensee—The licensee developed
new procedures requiring the
authorized user to verify the source wire
distances during HDR treatments and
provided additional training in these
procedures.
State Agency—The State reviewed
and accepted the licensee’s corrective
actions.
*
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*
*
*
AS 06–03 Medical Event at the
McKay Dee Hospital, Inc., in Ogden,
Utah.
Date and Place—June 19, 2006,
Ogden, Utah.
Nature and Probable Consequences—
The licensee reported that a patient
undergoing treatment for
hyperthyroidism received 1.08 GBq
(29.3 mCi) of I–131 instead of the
prescribed dosage of 0.56 GBq (15 mCi).
On June 19, 2006, two patients were
scheduled to receive I–131 treatments at
the same time. However, the first patient
was administered the second patient’s
prescribed dosage resulting in the
patient receiving a higher than intended
dose. The error was identified by the
licensee prior to the administration of I–
131 to the second patient. The
administration resulted in a thyroid
dose of 1,066 Gy (106,600 rad). The
patient and referring physician were
notified of the error. No negative health
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25341
effects from this administration are
expected. On July 17, 2006, the licensee
sent a letter to the State confirming that
a medical event had occurred.
Cause(s)—This medical event was
caused by human error. The licensee
failed to verify the prescribed dosage for
a specific patient.
Actions Taken to Prevent Recurrence.
Licensee—Corrective actions taken by
the licensee included revising
procedures to improve patient
identification techniques and not
scheduling patients with similar
treatments at concurrent times.
State Agency—The State reviewed
and accepted the licensee’s corrective
actions.
*
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*
*
*
AS 06–04 Medical Event at Central
Arkansas Radiation Therapy Institute in
Little Rock, Arkansas.
Date and Place—March 28, 2006,
Little Rock, Arkansas.
Nature and Probable Consequences—
The licensee reported that a patient
undergoing implant brachytherapy for
prostate cancer received a radiation
dose to an unintended area during an I–
125 prostate-seed implant procedure.
The patient was prescribed 108 Gy
(10,800 rad) to the base of the prostate
gland with 84 I–125 seeds but it was
delivered 4 cm (1.6 in) inferior to the
intended treatment site. The postimplant dose calculation confirmed that
the dose was delivered to the wrong
treatment site. The patient will require
further brachytherapy treatment. The
patient did not incur adverse health
effects as a result of the medical event.
The patient and referring physician
were notified of the medical event.
Cause(s)—This medical event was
caused by human error. The urologist
was not able to clearly identify the base
of the prostate gland during the
ultrasound used to view the target organ
during the treatment.
Actions Taken to Prevent Recurrence.
Licensee—The licensee implemented
a new policy to ensure that the urologist
clearly defines the base of the prostate
and urethra.
State Agency—The State reviewed
and accepted the licensee’s corrective
actions.
*
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*
AS 06–05 Medical Event at
Children’s Memorial Medical Center in
Chicago, Illinois.
Date and Place—July 24, 2006,
Chicago, Illinois.
Nature and Probable Consequences—
The licensee reported that a patient
received a higher than intended dosage
of 74 MBq (2 mCi) of I–131 instead of
the prescribed dosage of 0.19 MBq
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(0.005 mCi). The physician did not
prepare a written directive. The
authorized user noted the error on July
25, 2006. The licensee estimated a
whole body dose of 0.0189 Sv (1.89 rem)
and a dose to the thyroid of 41.4 Sv
(4,140 rem), based on a 59.2-percent
uptake. Using the same assumptions,
the intended dosage of 0.19 MBq (0.005
mCi) would have given the patient a
thyroid dose of 0.104 Sv (10.4 rem). The
patient and referring physician were
notified of the medical event. The
patient incurred no adverse health
effects from the medical event.
Cause(s)—This medical event was
caused by inadequate verbal
communications between the nuclear
medicine technologist (NMT) and the
physician and the lack of a written
directive.
Actions Taken to Prevent Recurrence.
Licensee—The licensee reviewed
previous administrations of radioiodine
to confirm that this event was an
isolated occurrence. The licensee added
additional procedures to ensure proper
oversight by a physician during all
future radioidodine administrations.
State Agency—The State investigated
the event and concurred with the
licensee’s dose estimates. The State
issued a Notice of Violation to the
licensee.
*
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*
*
*
06–06 Dose to an Embryo/Fetus at
McLeod Regional Medical Center in
Florence, South Carolina.
Date and Place—May 26, 2006,
Florence, South Carolina.
Nature and Probable Consequences—
The licensee reported an unintended
dose to an embryo/fetus. The licensee
administered 555 MBq (15 mCi) of
technetium-99m on May 24, 2006, and
518 KBq (0.014 mCi) of I–131 on May
25 as a prelude to a thyroid ablation to
a patient. Prior to the administrations
and following a detailed explanation
provided by the physician, the patient
signed an informed consent indicating
that she was not pregnant. The
licensee’s radioactive materials license
requires that a pregnancy test be done
on any female of child-bearing age
undergoing radiation therapy. However,
the patient convinced the attending
NMT that she could not possibly be
pregnant. The NMT did not perform the
pregnancy test and on May 26, 2006,
administered 0.548 GBq (14.8 mCi) of I–
131 to the patient for a thyroid ablation.
At approximately 32—34 weeks of
pregnancy, the patient visited an
obstetrician and mentioned that she had
undergone a thyroid ablation procedure
when she was approximately 17 weeks
pregnant. The obstetrician notified the
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licensee on October 3, 2006. The
licensee estimated that the fetus
received a whole body dose of 0.0517
Gy (5.17 rad) and a thyroid dose of
139.2 Gy (13,920 rad). The child was
born in November 2006. The newborn
appears to have no apparent problems
resulting from the radiation exposure
with the exception of an underactive
thyroid gland (hypothyrodism). The
child is currently receiving a small
amount of thyroid supplement. The
referring physician and patient were
notified of the event.
Cause(s)—This event was caused by
human error. At the time of the
administration, the patient indicated
that she was not pregnant, and the
licensee failed to perform the required
pregnancy test.
Actions Taken To Prevent Recurrence.
Licensee—The licensee provided
instructions to staff emphasizing its
policy to administer a pregnancy test to
female patients of child-bearing age
prior to undergoing radiation therapy.
State Agency—The State reviewed
and approved the corrective actions
taken by the licensee and will followup
at the next inspection. The State is in
the process of issuing a Notice of
Violation.
Dated at Rockville, Maryland this 20th day
of April 2007.
For the Nuclear Regulatory Commission.
Andrew L. Bates,
Acting Secretary of the Commission.
[FR Doc. E7–8551 Filed 5–3–07; 8:45 am]
BILLING CODE 7590–01–P
OFFICE OF THE UNITED STATES
TRADE REPRESENTATIVE
Special 301 Report: Identification of
Countries That Deny Adequate
Protection, or Market Access, for
Intellectual Property Rights Under
Section 182 of the Trade Act of 1974
AGENCY: Office of the United States
Trade Representative.
ACTION: Notice.
SUMMARY: Notice is hereby given that
the United States Trade Representative
(USTR) has submitted its 2007 ‘‘Special
301 Report,’’ an annual report on the
identification of those foreign countries
that deny adequate and effective
protection of intellectual property rights
or deny fair and equitable market access
to United States persons that rely upon
intellectual property protection, to the
Committee on Finance of the United
States Senate and the Committee on
Ways and Means of the United States
House of Representatives, pursuant to
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section 182 of the Trade Act of 1974, as
amended (the Trade Act) (19 U.S.C.
2242).
DATES: The 2007 Special 301 Report was
released on April 30, 2007. The 2007
Special 301 Report is available on
USTR’s Web site at https://www.ustr.gov.
ADDRESSES: Office of the United States
Trade Representative, 600 17th Street,
NW., Washington, DC 20508.
FOR FURTHER INFORMATION CONTACT:
Jennifer Choe Groves, Director for
Intellectual Property and Chair of the
Special 301 Committee at (202) 395–
4510.
Pursuant
to Section 182 of the Trade Act of 1974,
as amended by the Omnibus Trade and
Competitiveness Act of 1988 and the
Uruguay Round Agreements Act
(enacted in 1994), under Special 301
provisions, USTR must identify those
countries that deny adequate and
effective protection for intellectual
property rights (IPR) or deny fair and
equitable market access for persons that
rely on intellectual property protection.
Countries that have the most onerous or
egregious acts, policies, or practices and
whose acts, policies, or practices have
the greatest adverse impact (actual or
potential) on the relevant U.S. products
must be designated as ‘‘Priority Foreign
Countries.’’
Priority Foreign Countries are
potentially subject to an investigation
under the Section 301 provisions of the
Trade Act of 1974. USTR may not
designate a country as a Priority Foreign
Country if it is entering into good faith
negotiations or making significant
progress in bilateral or multilateral
negotiations to provide adequate and
effective protection of IPR.
USTR must decide whether to
identify countries within 30 days after
issuance of the annual National Trade
Estimate Report. In addition, USTR may
identify a trading partner as a Priority
Foreign Country or remove such
identification whenever warranted.
USTR has created a ‘‘Priority Watch
List’’ and ‘‘Watch List’’ under Special
301 provisions. Placement of a trading
partner on the Priority Watch List or
Watch List indicates that particular
problems exist in that country with
respect to IPR protection, enforcement,
or market access for persons relying on
intellectual property. Countries placed
on the Priority Watch List are the focus
of increased bilateral attention
concerning the problem areas.
Additionally, under Section 306,
USTR monitors a country’s compliance
with bilateral intellectual property
agreements that are the basis for
SUPPLEMENTARY INFORMATION:
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Agencies
[Federal Register Volume 72, Number 86 (Friday, May 4, 2007)]
[Notices]
[Pages 25339-25342]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-8551]
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NUCLEAR REGULATORY COMMISSION
Report to Congress on Abnormal Occurrences Fiscal Year 2006;
Dissemination of Information
Section 208 of the Energy Reorganization Act of 1974 (Public Law
93-438) defines an abnormal occurrence (AO) as an unscheduled incident
or event which the U.S. Nuclear Regulatory Commission (NRC) determines
to be significant from the standpoint of public health or safety. The
Federal Reports Elimination and Sunset Act of 1995 (Public Law 104-66)
requires that AOs be reported to Congress annually. During fiscal year
2006, nine events that occurred at facilities licensed or otherwise
regulated by the NRC and/or Agreements States were determined to be
AOs. The report describes three events at facilities licensed by the
NRC. The three AOs at NRC-licensed facilities included a spill of high-
enriched uranium solution at a fuel fabrication facility, a medical
event, and an unintended dose to an mbryo/fetus. The report also
addresses six AOs at facilities licensed by Agreement States.
[Agreement States are those States that have entered into formal
agreements with the NRC pursuant to Section 274 of the Atomic Energy
Act (AEA) to regulate certain quantities of AEA licensed material at
facilities located within their borders.] Currently, there are 34
Agreement States. During Fiscal Year 2006, Agreement States reported
six events that occurred at Agreement State-licensed facilities,
including four medical events, one unintended dose to an embryo/fetus,
and one industrial event. As required by Section 208, the discussion
for each event includes the date and place, the nature and probable
consequences, the cause or causes, and the action taken to prevent
recurrence. Each event is also being described in NUREG-0090, Vol. 29,
``Report to Congress on Abnormal Occurrences, Fiscal Year 2006.'' This
report is available electronically at the NRC Web site https://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/.
Nuclear Power Plants
During this period, no events at U.S. nuclear power plants were
significant enough to be reported as AOs.
* * * * *
Fuel Cycle Facilities
(Other Than Nuclear Power Plants)
During this reporting period, one event at an NRC-licensed fuel
fabrication facility was significant
[[Page 25340]]
enough to be reported as an AO based on the criteria in Appendix A to
this report.
06-01 Spill of High-Enriched Uranium Solution at Nuclear Fuel
Services in Erwin, Tennessee.
Date and Place--March 6, 2006, Erwin, Tennessee.
Nature and Probable Consequences--In a facility authorized to
process high-enriched uranium (HEU), a transfer of HEU solution through
a transfer line resulted in a portion of the HEU solution,
approximately 35 liters, leaking into a glovebox where criticality was
possible and subsequently to the floor where criticality was also
possible because of the presence of an elevator pit.
Immediately before the event, the facility operator decided to move
the unused filter glovebox to another location. Workers opened and
drained the filters so that the filter glovebox could be moved. After
draining the filters, workers failed to reseal the system tightly.
During the next transfer of HEU solution through the line, HEU solution
leaked into the filter glovebox. On several occasions before the event,
workers had reported signs of a yellowish liquid in the filter
glovebox. Supervisors had failed to fully investigate the reports
because they assumed the yellowish liquid was natural uranium solution
which had been used to initially test the process.
Criticality was possible in the filter glovebox because of the size
and shape of the glovebox and because there were no controls in the
filter glovebox to prevent accumulation of solution. The solution
leaked out of the filter glovebox through uncontrolled drains to the
floor. Investigation of the event revealed that the floor contained an
uncontrolled accumulation point, an elevator pit, where criticality was
also possible. In different circumstances, the total volume of the
transfer would have been more than enough for criticality to be
possible in the filter glovebox or the elevator pit. If a criticality
accident had occurred in the filter glovebox or the elevator pit, it is
likely that at least one worker would have received an exposure high
enough to cause acute health effects or death. The NRC conducted a team
inspection to determine the root causes of the event and performed a
series of three readiness reviews before allowing this portion of the
facility to restart. The NRC issued an order to the licensee
delineating specific actions designed to address this and other
performance issues at the facility.
Cause(s)--Failure to maintain configuration control of facility
equipment and failure to comply with procedures.
Actions Taken to Prevent Recurrence--The operator stopped all
processing of HEU in the affected processing area, removed the
enclosure and associated piping, filled in an uncontrolled accumulation
point (the elevator pit) with concrete, and conducted an extensive
review to identify any similar configuration issues.
* * * * *
Other NRC Licensees
(Industrial Radiographers, Medical Institutions, etc.)
During this reporting period, two events at NRC-licensed or
regulated facilities were significant enough to be reported as AOs
based on the criteria in Appendix A to this report.
06-02 Medical Event at Bozeman Deaconess Hospital in Bozeman,
Montana.
Date and Place--May 9, 2006, Bozeman, Montana.
Nature and Probable Consequences--The licensee reported that a
patient was prescribed a brachytherapy treatment of 145 Gy (14,500 rad)
to the prostate gland for prostate cancer using 82 iodine-125 seeds,
but instead received a 130 Gy (13,000 rad) dose to an unintended
treatment site. The brachytherapy seeds were implanted under ultrasound
guidance; however, a post-treatment computerized tomography scan
confirmed that only 10 seeds were implanted in the prescribed location
of the prostate, resulting in a dose of 8.6 Gy (860 rad) delivered to
the intended treatment site. Concerning the 72 seeds not in the
intended treatment site, the urologist was able to recover 3 seeds and
determined that 69 seeds were implanted inferior to the prostate in the
wrong treatment site. The referring physician and the patient were
informed of this event and were advised that the patient may experience
discomfort during urination. The NRC staff conducted a reactive onsite
inspection on May 16, 2006. An NRC contracted medical consultant
experienced in radiation oncology reviewed the case and agreed with the
licensee's analysis and conclusions. An NRC inspection report has been
issued.
Cause(s)--This medical event was caused by human error because the
licensee did not verify that the sources were positioned in the proper
location in the prostate. The urologist misidentified the anatomy
viewed under the ultrasound guidance procedure.
Actions Taken to Prevent Recurrence--The licensee revised its
procedures, requiring a fluoroscopic examination early in the implant
procedure to ensure that the seeds are placed in the correct location,
thus resolving any questions concerning ultrasound images prior to
commencing with the implant. The licensee also implemented additional
staff training.
* * * * *
06-03 Dose to an Embryo/Fetus at Munson Medical Center in Traverse
City, Michigan.
Date and Place--May 3, 2006, Traverse City, Michigan.
Nature and Probable Consequences--The licensee reported an
unintended dose to an embryo/fetus. On May 3, 2006, the licensee
administered a therapy dosage of 5.55 GBq (150 mCi) of I-131 to a 26-
year-old female patient who had affirmed in writing that she was not
pregnant. On May 22, 2006, the patient informed the licensee that she
had been approximately 10 to 14 days pregnant at the time of the
administration. Based on this new information, the licensee estimated
that the dose to the embryo/fetus was approximately 400 mSv (40 rem).
The referring physician and patient were informed of this event. The
NRC-contracted medical consultant agreed with the licensee's dose
estimate and concluded that this event should result in no harm to the
embryo because the administration occurred during a stage of
development when the thyroid does not take up iodine. The medical
consultant recommended that a complete thyroid evaluation be performed
after delivery.
Cause(s)--This medical event was caused by the patient's incorrect
written statement that she was not pregnant prior to receiving the
therapy dosage. The licensee did not require an independent pregnancy
test for women of child-bearing age prior to administering the dosage.
Actions Taken to Prevent Recurrence--The licensee implemented a
procedure that requires pregnancy tests for all women of childbearing
age prior to any therapy dosage of radioactive material, a checklist to
ensure that the pregnancy test is ordered, and staff training.
* * * * *
Agreement State Licensees
During this reporting period, six events at Agreement State-
licensed facilities were significant enough to be reported as AOs based
on the criteria in Appendix A to this report.
AS 06-01 Industrial Radiography Occupational Overexposure at Anvil
[[Page 25341]]
International in North Kingston, Rhode Island.
Date and Place--March 3, 2006, North Kingston, Rhode Island.
Nature and Probable Consequences--The licensee reported that a
radiographer and a trainee received unintended radiation exposures in
excess of those specified in the AO criteria. The incident occurred at
a permanent radiography facility and involved an iridium-192 source
with an activity of 3.44 TBq (93 Ci). After performing surveys outside
a dedicated radiography cell, where radiation levels confirmed that
radiography was in process in the cell, the radiographer and the
trainee went to an alternate location and performed equipment
maintenance and training. They were joined by a third radiographer, who
was performing radiography inside the cell. All three radiography
personnel entered the cell to view the radiography setup and examine
the guide tube for training purposes. However, they entered without a
survey meter and were unaware that the source was still exposed. As a
result, the first radiographer and the trainee handled the collimator
and guide tube (which contained the source) for approximately 15-60
seconds. The first radiographer received a dose to the left hand
ranging from 1.4 to 2.8 Sv (140 rem to 280 rem). The trainee received a
dose to the left hand ranging from 11 Sv to 85 Sv (1,100 rem to 8,500
rem). The third radiographer did not receive a dose in excess of
regulatory exposure limits, since he did not handle the equipment.
Cause(s)--This event was caused by the failure of radiography
personnel to follow safety procedures and use survey meters inside the
cell.
Actions Taken to Prevent Recurrence.
Licensee--The licensee provided additional training to the
personnel. The licensee also solicited the assistance of a medical
physicist and the source manufacturer in determining the dose to the
radiographers. The licensee also committed to keep the State updated on
the medical conditions of the radiographer and trainee until they are
released from medical oversight.
State Agency--On March 7, 2006, the State issued a suspension
letter to the licensee. On March 8 and March 16, 2006, the State,
accompanied by NRC Region I staff, conducted an investigation of the
event. On April 13, 2006, the State issued a Notice of Violation and on
November 3, 2006, terminated the license after an onsite inspection to
confirm decommissioning actions.
AS 06-02 Medical Event at 21st Oncology, Inc., in Coral Springs,
Florida.
Date and Place--March 31 through April 7, 2006, Coral Springs,
Florida.
Nature and Probable Consequences--The licensee reported that an 80-
year-old female patient received 100 Gy (10,000 rad) to an unintended
area of approximately 2 cm (0.8 in) that was three times the prescribed
dose for the mammosite brachytherapy procedure, using a high dose rate
(HDR) afterloader containing an iridium-192 source with an activity of
240.5 GBq (6.5 Ci). The patient received less than 30 percent of the
prescribed dose to the prescribed treatment site. The source stopped 6
cm (2.4 in) short of the intended position. The patient visited the
attending physician for followup on May 2, 2006. The physician
discovered that the patient's skin was abnormally red. The referring
physician, patient, and patient's family were notified of the incident.
The patient was treated for erythema (skin reddening) and moist
desquamation (skin thinning and weeping).
Cause(s)--This medical event was caused by human error. The
authorized user entered an incorrect distance into the computer entry
data.
Actions Taken to Prevent Recurrence.
Licensee--The licensee developed new procedures requiring the
authorized user to verify the source wire distances during HDR
treatments and provided additional training in these procedures.
State Agency--The State reviewed and accepted the licensee's
corrective actions.
* * * * *
AS 06-03 Medical Event at the McKay Dee Hospital, Inc., in Ogden,
Utah.
Date and Place--June 19, 2006, Ogden, Utah.
Nature and Probable Consequences--The licensee reported that a
patient undergoing treatment for hyperthyroidism received 1.08 GBq
(29.3 mCi) of I-131 instead of the prescribed dosage of 0.56 GBq (15
mCi). On June 19, 2006, two patients were scheduled to receive I-131
treatments at the same time. However, the first patient was
administered the second patient's prescribed dosage resulting in the
patient receiving a higher than intended dose. The error was identified
by the licensee prior to the administration of I-131 to the second
patient. The administration resulted in a thyroid dose of 1,066 Gy
(106,600 rad). The patient and referring physician were notified of the
error. No negative health effects from this administration are
expected. On July 17, 2006, the licensee sent a letter to the State
confirming that a medical event had occurred.
Cause(s)--This medical event was caused by human error. The
licensee failed to verify the prescribed dosage for a specific patient.
Actions Taken to Prevent Recurrence.
Licensee--Corrective actions taken by the licensee included
revising procedures to improve patient identification techniques and
not scheduling patients with similar treatments at concurrent times.
State Agency--The State reviewed and accepted the licensee's
corrective actions.
* * * * *
AS 06-04 Medical Event at Central Arkansas Radiation Therapy
Institute in Little Rock, Arkansas.
Date and Place--March 28, 2006, Little Rock, Arkansas.
Nature and Probable Consequences--The licensee reported that a
patient undergoing implant brachytherapy for prostate cancer received a
radiation dose to an unintended area during an I-125 prostate-seed
implant procedure. The patient was prescribed 108 Gy (10,800 rad) to
the base of the prostate gland with 84 I-125 seeds but it was delivered
4 cm (1.6 in) inferior to the intended treatment site. The post-implant
dose calculation confirmed that the dose was delivered to the wrong
treatment site. The patient will require further brachytherapy
treatment. The patient did not incur adverse health effects as a result
of the medical event. The patient and referring physician were notified
of the medical event.
Cause(s)--This medical event was caused by human error. The
urologist was not able to clearly identify the base of the prostate
gland during the ultrasound used to view the target organ during the
treatment.
Actions Taken to Prevent Recurrence.
Licensee--The licensee implemented a new policy to ensure that the
urologist clearly defines the base of the prostate and urethra.
State Agency--The State reviewed and accepted the licensee's
corrective actions.
* * * * *
AS 06-05 Medical Event at Children's Memorial Medical Center in
Chicago, Illinois.
Date and Place--July 24, 2006, Chicago, Illinois.
Nature and Probable Consequences--The licensee reported that a
patient received a higher than intended dosage of 74 MBq (2 mCi) of I-
131 instead of the prescribed dosage of 0.19 MBq
[[Page 25342]]
(0.005 mCi). The physician did not prepare a written directive. The
authorized user noted the error on July 25, 2006. The licensee
estimated a whole body dose of 0.0189 Sv (1.89 rem) and a dose to the
thyroid of 41.4 Sv (4,140 rem), based on a 59.2-percent uptake. Using
the same assumptions, the intended dosage of 0.19 MBq (0.005 mCi) would
have given the patient a thyroid dose of 0.104 Sv (10.4 rem). The
patient and referring physician were notified of the medical event. The
patient incurred no adverse health effects from the medical event.
Cause(s)--This medical event was caused by inadequate verbal
communications between the nuclear medicine technologist (NMT) and the
physician and the lack of a written directive.
Actions Taken to Prevent Recurrence.
Licensee--The licensee reviewed previous administrations of
radioiodine to confirm that this event was an isolated occurrence. The
licensee added additional procedures to ensure proper oversight by a
physician during all future radioidodine administrations.
State Agency--The State investigated the event and concurred with
the licensee's dose estimates. The State issued a Notice of Violation
to the licensee.
* * * * *
06-06 Dose to an Embryo/Fetus at McLeod Regional Medical Center in
Florence, South Carolina.
Date and Place--May 26, 2006, Florence, South Carolina.
Nature and Probable Consequences--The licensee reported an
unintended dose to an embryo/fetus. The licensee administered 555 MBq
(15 mCi) of technetium-99m on May 24, 2006, and 518 KBq (0.014 mCi) of
I-131 on May 25 as a prelude to a thyroid ablation to a patient. Prior
to the administrations and following a detailed explanation provided by
the physician, the patient signed an informed consent indicating that
she was not pregnant. The licensee's radioactive materials license
requires that a pregnancy test be done on any female of child-bearing
age undergoing radiation therapy. However, the patient convinced the
attending NMT that she could not possibly be pregnant. The NMT did not
perform the pregnancy test and on May 26, 2006, administered 0.548 GBq
(14.8 mCi) of I-131 to the patient for a thyroid ablation. At
approximately 32--34 weeks of pregnancy, the patient visited an
obstetrician and mentioned that she had undergone a thyroid ablation
procedure when she was approximately 17 weeks pregnant. The
obstetrician notified the licensee on October 3, 2006. The licensee
estimated that the fetus received a whole body dose of 0.0517 Gy (5.17
rad) and a thyroid dose of 139.2 Gy (13,920 rad). The child was born in
November 2006. The newborn appears to have no apparent problems
resulting from the radiation exposure with the exception of an
underactive thyroid gland (hypothyrodism). The child is currently
receiving a small amount of thyroid supplement. The referring physician
and patient were notified of the event.
Cause(s)--This event was caused by human error. At the time of the
administration, the patient indicated that she was not pregnant, and
the licensee failed to perform the required pregnancy test.
Actions Taken To Prevent Recurrence.
Licensee--The licensee provided instructions to staff emphasizing
its policy to administer a pregnancy test to female patients of child-
bearing age prior to undergoing radiation therapy.
State Agency--The State reviewed and approved the corrective
actions taken by the licensee and will followup at the next inspection.
The State is in the process of issuing a Notice of Violation.
Dated at Rockville, Maryland this 20th day of April 2007.
For the Nuclear Regulatory Commission.
Andrew L. Bates,
Acting Secretary of the Commission.
[FR Doc. E7-8551 Filed 5-3-07; 8:45 am]
BILLING CODE 7590-01-P