Environmental Assessment and Final Finding of No Significant Impact With Regard to Exemption From Certain Regulatory Requirements, 34596-34597 [E9-16916]
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Federal Register / Vol. 74, No. 135 / Thursday, July 16, 2009 / Notices
the Atomic Safety and Licensing Board
that the request and/or petition should
be granted and/or the contentions
should be admitted, based on a
balancing of the factors specified in 10
CFR 2.309(c)(1)(i)–(viii).
Documents submitted in adjudicatory
proceedings will appear in NRC’s
electronic hearing docket which is
available to the public at https://
ehd.nrc.gov/ehd_proceeding/home.asp,
unless excluded pursuant to an order of
the Commission, an Atomic Safety and
Licensing Board, or a Presiding Officer.
Participants are requested not to include
personal privacy information, such as
social security numbers, home
addresses, or home phone numbers in
their filings, unless an NRC regulation
or other law requires submission of such
information. With respect to
copyrighted works, except for limited
excerpts that serve the purpose of the
adjudicatory filings and would
constitute a Fair Use application,
participants are requested not to include
copyrighted materials in their
submissions.
For further details with respect to this
license amendment application, see the
application for amendment dated June
15, 2009, as supplemented by letters
dated June 20 and June 23, 2009, which
are available for public inspection at the
Commission’s PDR, located at One
White Flint North, Public File Area O1
F21, 11555 Rockville Pike (first floor),
Rockville, Maryland. Publicly available
records will be accessible electronically
from the ADAMS Public Electronic
Reading Room on the Internet at the
NRC Web site, https://www.nrc.gov/
reading-rm/adams.html. Persons who
do not have access to ADAMS or who
encounter problems in accessing the
documents located in ADAMS should
contact the NRC PDR Reference staff by
telephone at 1–800–397–4209, or 301–
415–4737, or by e-mail to
pdr.resource@nrc.gov.
Attorney for licensee: Mr. Bradley J.
Fewell, Associate General Counsel,
Exelon Generation Company, LLC, 4300
Winfield Road, Warrenville, IL 60555.
erowe on DSK5CLS3C1PROD with NOTICES
Dated at Rockville, Maryland, this 10th day
of July 2009.
For the Nuclear Regulatory Commission.
Stephen P. Sands,
Project Manager, Plant Licensing Branch
3–2, Division of Operating Reactor Licensing,
Office of Nuclear Reactor Regulation.
[FR Doc. E9–16918 Filed 7–15–09; 8:45 am]
BILLING CODE 7590–01–P
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NUCLEAR REGULATORY
COMMISSION
[NRC–2009–0312; Docket No. 030–35985]
Environmental Assessment and Final
Finding of No Significant Impact With
Regard to Exemption From Certain
Regulatory Requirements
Introduction
The U.S. Nuclear Regulatory
Commission (NRC) is proposing to
exempt all NRC medical use licensees
from certain requirements in 10 CFR
35.60(b), 10 CFR 35.100(a)(1) and
35.200(a)(1), and 10 CFR 32.72. These
requirements govern calibration tests
that use technetium-99m, and
distribution of molybdenum-99/
technetium-99m generators and
technetium-99m radioactive drugs to
and from medical use licensees. NRC is
issuing these exemptions to ensure that
available technetium-99 is being used
for patient administrations during any
period of United States and worldwide
shortages of molybdenum-99, which is
used to produce molybdenum-99/
technetium-99m generators for medical
use.
These exemptions will be effective
only when there are United States
shortages of technetium-99m caused by
production shortages of molybdenum99, as documented in writing by the
supplier of molybedenum-99/
technetium-99m generators or
technetium-99m.
Environmental Assessment
Identification of the Proposed Action
The NRC proposes to issue
exemptions to all NRC medical use
licensees from the requirements in 10
CFR 35.60(b) to calibrate the
instrumentation required in paragraph
(a) of this section in accordance with
nationally recognized standards. The
licensee will not be required to perform
the calibration test at the maximum
activity or at the time interval specified
in the national standard if the licensee
would use technetium-99m needed for a
patient administration to perform the
calibration test. The exemption will
only be in effect when the licensee is
receiving reduced quantities of
technetium-99m as a result of
production shortages of molybdenum-99
affecting their generator or technetium99m supplier, as documented in writing
by the supplier. The licensee must
perform the test when adequate
supplies, as documented in writing by
the technetium-99 supplier, become
available, and document results of the
test in accordance with 10 CFR 35.2060.
Depending on the maximum activity
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
needed to perform the calibration test
and the activity of technetium-99m in
the radioactive drug, this may make
dosages available to 7–15 additional
patients at the licensee’s facility.
The NRC proposes to issue
exemptions to all NRC medical use
licensees from the requirements in 10
CFR 35.100(a)(1) and 35.200(a)(1) to
obtain unsealed byproduct material
prepared for medical use for uptake,
dilution, excretion, imaging or
localization studies from a manufacturer
or preparer licensed under § 32.72 of
this chapter or equivalent Agreement
State requirements, if the licensee
obtains the technetium-99m (or a
technetium-99m radioactive drug) from
another medical use licensee to
administer to patients. This permits
medical use licensees that cannot get
technetium-99m from their normal
supplier because of the shortage to
obtain some technetium-99m from a
local medical use licensee that has a
surplus. This exemption will only be in
effect when the licensee is unable to
obtain technetium-99m (or a
technetium-99m radioactive drug) from
its normal supplier as a result of
production shortages of molybdenum-99
affecting its generator or technetium99m supplier, as documented in writing
by the supplier. This exemption will
give some relief on a case-by-case basis
to a medical use licensee if its supplier
is severely affected by the shortage but
the other medical use licensee’s
supplier is not.
The NRC proposes to issue
exemptions to all NRC medical use
licensees from requirements in 10 CFR
32.72, to permit the licensee to transfer
surplus molybdenum-99/technetium99m generators or technetium-99m, or
technetium-99m radioactive drugs to
other medical use licensees for
administration to patients without
requiring the licensee to meet the
requirements for a commercial
distributor of radioactive drugs to
medical use licensees. This exemption
will only be in effect when the receiving
medical use licensee is unable to obtain
a generator, or technetium-99m or
technetium-99m radioactive drugs from
its normal supplier, as a result of
production shortages of molybdenum-99
affecting its generator or technetium99m supplier, as documented in writing
by the supplier. This exemption will
facilitate and give relief on a case-bycase basis to a medical use licensee with
a surplus of technetium-99m (or a
technetium-99m radioactive drug)
because its supplier is not affected by
the shortage in the transfer of the
technetium-99m to the other medical
use licensee whose supplier is affected.
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Federal Register / Vol. 74, No. 135 / Thursday, July 16, 2009 / Notices
erowe on DSK5CLS3C1PROD with NOTICES
Need for the Proposed Action
These exemptions are needed in times
of molybdenum-99 shortages in the
United States to ensure that available
technetium-99m is used for patient
treatment. On May 14, 2009, the Chalk
River National Research Universal
reactor in Canada experienced an
unexpected shutdown that has resulted
in an extended shutdown for safety
repairs. The Chalk River reactor
produces approximately 50 percent of
the United States supply of
molybdenum-99 used to produce
molybdenum-99/technetium-99m
generators. This resulted in a United
States and worldwide shortage of
molybdenum-99 for generator
production and technetium-99m for
medical uses. The High Flux Reactor in
Petten, the Netherlands, also produces a
substantial amount of molybdenum-99
used to produce generators in the
United States and the world. The reactor
in Petten is currently operating on a
temporary operating permit and
expected to be shut down in early 2010
for a number of months for repairs. This
will also cause molybdenum-99 and
technetium-99m shortages in the United
States and the world. The supply chain
for fission-produced isotopes is fragile
and may shrink dramatically at any time
when these two, or the other three aging
international reactors currently
producing these isotopes, are shut down
for safety or routine maintenance.
Environmental Impacts of the Proposed
Action
During times of supply shortages,
there is less molybdenum-99 and
technetium-99m available for
molybdenum-99/technetium-99
generator production. There are also
fewer generators to elute, and fewer
technetium-99m radioactive drugs
produced. The exemption will: (1)
Allow lower quantities of technetium99m to be used for calibrations and
delay the calibration test, making
quantities available for patient
administrations; (2) allow a licensee to
obtain unsealed byproduct material
from another licensee other than
directly from the manufacturer or
commercial nuclear pharmacy; and (3)
allow a licensee with sufficient product
to transfer excess to another authorized
licensee for patient administration. The
exemptions do not relieve the licensee
from NRC environmental release
requirements or worker dose or public
dose requirements associated with the
elution of molybdenum-99/technetium99m generators, preparation of
technetium-99m radioactive drugs,
administration of the technetium-99m
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radioactive drugs to patients, handling
of these radioactive materials, or
handling of radioactive waste. All of
those protections remain in place.
Neither molybdenium-99 nor
technetium-99m is a volatile
radionuclide. Molybdenum-99 remains
attached to the generator resins and
technetium-99m stays suspended in the
eluent. Both radionuclides have short
half-lives. None of the proposed
exemptions affects how the licensee
handles these radionuclides. Their
medical use when there are no shortages
results in minimal impact on the
environment and public dose exposures.
During times of shortage, medical use
licensees will have less technetium-99m
to use and there will be fewer patients
receiving technetium-99m radioactive
drugs even when maximizing the
medical use of available technetium99m. Therefore, the proposed action
will not result in an increase in the
release of radioactive material into the
environment or increase public
radiation exposure. There will be no
impact on the environment as a result
of the proposed action.
Alternatives to the Proposed Action
As required by Section 102(2)(E) of
NEPA (42 U.S.C. 4322(2)(E)), possible
alternatives to the final action have been
considered. The NRC identified only
one reasonable alternative for
consideration: the no action alternative.
This no action alternative would not
result in any adverse impact on the
environment but would negatively
impact the medical use licensees’
provision of medical care to their
patients. During shortages in the United
States and the world of molybdenum99, the supply of technetium-99m
available to administer to patients is less
than the amount needed to perform
important cardiac, cancer, and other
imaging procedures. Using technetium99m to perform calibration tests at
maximum activities and at preset
intervals instead of for patient
administrations would prevent a
number of patients from receiving these
needed procedures. Temporary relief
from the national standards should not
result in significantly different patient
radiation dosages because most
instruments used to measure patient
dosages today are stable if not moved
and provided with reasonable climate
controls. Also, performing the test at
lower activity levels will provide
confidence that the instrument is still
calibrated over the levels of routine
technetium-99m dosages. For higher
dosages requiring written directives, the
licensee can use the activity provided
with the radioactive drug to assure
PO 00000
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Fmt 4703
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34597
patient safety. Not granting an
exemption to permit distribution to and
receipt of excess generators and
technetium-99m by other authorized
medical use licensees that do not have
any also would reduce the number of
patients receiving needed procedures.
For these reasons, the NRC did not
adopt the no action alternative.
Alternative Use of Resources
No alternative use of resources was
considered due to the reasons stated
above.
Agencies and Persons Consulted
No other agencies or persons were
contacted regarding this proposed
action.
Identification of Source Used
None.
Finding of No Significant Impact
Based on the above environmental
assessment, the NRC finds that the
proposed action will not have a
significant effect on the quality of the
human environment. Accordingly, the
NRC has determined that a Finding of
No Significant Impact is appropriate
and preparation of an environmental
impact statement is not warranted.
Dated at Rockville, Maryland, this 10th day
of July 2009.
For the Nuclear Regulatory Commission.
Duane E. White,
Acting Chief, Radioactive Materials Safety
Branch, Division of Materials Safety and State
Agreements, Office of Federal and State
Materials and Environmental Management
Programs Safety and Safeguards.
[FR Doc. E9–16916 Filed 7–15–09; 8:45 am]
BILLING CODE 7590–01–P
NUCLEAR REGULATORY
COMMISSION
[NRC–2009–0313]
License Renewal Interim Staff
Guidance LR–ISG–2006–02: Staff
Guidance Regarding the Acceptance
Reviews for Environmental
Requirements for License Renewal
Applications; Notice of Withdrawal
AGENCY: U.S. Nuclear Regulatory
Commission (NRC).
ACTION: Notice of withdrawal.
SUMMARY: The NRC is withdrawing its
proposed License Renewal Interim Staff
Guidance (LR–ISG), LR–ISG–2006–02,
‘‘Staff Guidance on Acceptance Review
for Environmental Reports for License
Renewal Applications,’’ which was
noticed in the Federal Register (72 FR
7694 on February 16, 2007). This
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]]>Agencies
[Federal Register Volume 74, Number 135 (Thursday, July 16, 2009)]
[Notices]
[Pages 34596-34597]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-16916]
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[NRC-2009-0312; Docket No. 030-35985]
Environmental Assessment and Final Finding of No Significant
Impact With Regard to Exemption From Certain Regulatory Requirements
Introduction
The U.S. Nuclear Regulatory Commission (NRC) is proposing to exempt
all NRC medical use licensees from certain requirements in 10 CFR
35.60(b), 10 CFR 35.100(a)(1) and 35.200(a)(1), and 10 CFR 32.72. These
requirements govern calibration tests that use technetium-99m, and
distribution of molybdenum-99/technetium-99m generators and technetium-
99m radioactive drugs to and from medical use licensees. NRC is issuing
these exemptions to ensure that available technetium-99 is being used
for patient administrations during any period of United States and
worldwide shortages of molybdenum-99, which is used to produce
molybdenum-99/technetium-99m generators for medical use.
These exemptions will be effective only when there are United
States shortages of technetium-99m caused by production shortages of
molybdenum-99, as documented in writing by the supplier of molybedenum-
99/technetium-99m generators or technetium-99m.
Environmental Assessment
Identification of the Proposed Action
The NRC proposes to issue exemptions to all NRC medical use
licensees from the requirements in 10 CFR 35.60(b) to calibrate the
instrumentation required in paragraph (a) of this section in accordance
with nationally recognized standards. The licensee will not be required
to perform the calibration test at the maximum activity or at the time
interval specified in the national standard if the licensee would use
technetium-99m needed for a patient administration to perform the
calibration test. The exemption will only be in effect when the
licensee is receiving reduced quantities of technetium-99m as a result
of production shortages of molybdenum-99 affecting their generator or
technetium-99m supplier, as documented in writing by the supplier. The
licensee must perform the test when adequate supplies, as documented in
writing by the technetium-99 supplier, become available, and document
results of the test in accordance with 10 CFR 35.2060. Depending on the
maximum activity needed to perform the calibration test and the
activity of technetium-99m in the radioactive drug, this may make
dosages available to 7-15 additional patients at the licensee's
facility.
The NRC proposes to issue exemptions to all NRC medical use
licensees from the requirements in 10 CFR 35.100(a)(1) and 35.200(a)(1)
to obtain unsealed byproduct material prepared for medical use for
uptake, dilution, excretion, imaging or localization studies from a
manufacturer or preparer licensed under Sec. 32.72 of this chapter or
equivalent Agreement State requirements, if the licensee obtains the
technetium-99m (or a technetium-99m radioactive drug) from another
medical use licensee to administer to patients. This permits medical
use licensees that cannot get technetium-99m from their normal supplier
because of the shortage to obtain some technetium-99m from a local
medical use licensee that has a surplus. This exemption will only be in
effect when the licensee is unable to obtain technetium-99m (or a
technetium-99m radioactive drug) from its normal supplier as a result
of production shortages of molybdenum-99 affecting its generator or
technetium-99m supplier, as documented in writing by the supplier. This
exemption will give some relief on a case-by-case basis to a medical
use licensee if its supplier is severely affected by the shortage but
the other medical use licensee's supplier is not.
The NRC proposes to issue exemptions to all NRC medical use
licensees from requirements in 10 CFR 32.72, to permit the licensee to
transfer surplus molybdenum-99/technetium-99m generators or technetium-
99m, or technetium-99m radioactive drugs to other medical use licensees
for administration to patients without requiring the licensee to meet
the requirements for a commercial distributor of radioactive drugs to
medical use licensees. This exemption will only be in effect when the
receiving medical use licensee is unable to obtain a generator, or
technetium-99m or technetium-99m radioactive drugs from its normal
supplier, as a result of production shortages of molybdenum-99
affecting its generator or technetium-99m supplier, as documented in
writing by the supplier. This exemption will facilitate and give relief
on a case-by-case basis to a medical use licensee with a surplus of
technetium-99m (or a technetium-99m radioactive drug) because its
supplier is not affected by the shortage in the transfer of the
technetium-99m to the other medical use licensee whose supplier is
affected.
[[Page 34597]]
Need for the Proposed Action
These exemptions are needed in times of molybdenum-99 shortages in
the United States to ensure that available technetium-99m is used for
patient treatment. On May 14, 2009, the Chalk River National Research
Universal reactor in Canada experienced an unexpected shutdown that has
resulted in an extended shutdown for safety repairs. The Chalk River
reactor produces approximately 50 percent of the United States supply
of molybdenum-99 used to produce molybdenum-99/technetium-99m
generators. This resulted in a United States and worldwide shortage of
molybdenum-99 for generator production and technetium-99m for medical
uses. The High Flux Reactor in Petten, the Netherlands, also produces a
substantial amount of molybdenum-99 used to produce generators in the
United States and the world. The reactor in Petten is currently
operating on a temporary operating permit and expected to be shut down
in early 2010 for a number of months for repairs. This will also cause
molybdenum-99 and technetium-99m shortages in the United States and the
world. The supply chain for fission-produced isotopes is fragile and
may shrink dramatically at any time when these two, or the other three
aging international reactors currently producing these isotopes, are
shut down for safety or routine maintenance.
Environmental Impacts of the Proposed Action
During times of supply shortages, there is less molybdenum-99 and
technetium-99m available for molybdenum-99/technetium-99 generator
production. There are also fewer generators to elute, and fewer
technetium-99m radioactive drugs produced. The exemption will: (1)
Allow lower quantities of technetium-99m to be used for calibrations
and delay the calibration test, making quantities available for patient
administrations; (2) allow a licensee to obtain unsealed byproduct
material from another licensee other than directly from the
manufacturer or commercial nuclear pharmacy; and (3) allow a licensee
with sufficient product to transfer excess to another authorized
licensee for patient administration. The exemptions do not relieve the
licensee from NRC environmental release requirements or worker dose or
public dose requirements associated with the elution of molybdenum-99/
technetium-99m generators, preparation of technetium-99m radioactive
drugs, administration of the technetium-99m radioactive drugs to
patients, handling of these radioactive materials, or handling of
radioactive waste. All of those protections remain in place. Neither
molybdenium-99 nor technetium-99m is a volatile radionuclide.
Molybdenum-99 remains attached to the generator resins and technetium-
99m stays suspended in the eluent. Both radionuclides have short half-
lives. None of the proposed exemptions affects how the licensee handles
these radionuclides. Their medical use when there are no shortages
results in minimal impact on the environment and public dose exposures.
During times of shortage, medical use licensees will have less
technetium-99m to use and there will be fewer patients receiving
technetium-99m radioactive drugs even when maximizing the medical use
of available technetium-99m. Therefore, the proposed action will not
result in an increase in the release of radioactive material into the
environment or increase public radiation exposure. There will be no
impact on the environment as a result of the proposed action.
Alternatives to the Proposed Action
As required by Section 102(2)(E) of NEPA (42 U.S.C. 4322(2)(E)),
possible alternatives to the final action have been considered. The NRC
identified only one reasonable alternative for consideration: the no
action alternative. This no action alternative would not result in any
adverse impact on the environment but would negatively impact the
medical use licensees' provision of medical care to their patients.
During shortages in the United States and the world of molybdenum-99,
the supply of technetium-99m available to administer to patients is
less than the amount needed to perform important cardiac, cancer, and
other imaging procedures. Using technetium-99m to perform calibration
tests at maximum activities and at preset intervals instead of for
patient administrations would prevent a number of patients from
receiving these needed procedures. Temporary relief from the national
standards should not result in significantly different patient
radiation dosages because most instruments used to measure patient
dosages today are stable if not moved and provided with reasonable
climate controls. Also, performing the test at lower activity levels
will provide confidence that the instrument is still calibrated over
the levels of routine technetium-99m dosages. For higher dosages
requiring written directives, the licensee can use the activity
provided with the radioactive drug to assure patient safety. Not
granting an exemption to permit distribution to and receipt of excess
generators and technetium-99m by other authorized medical use licensees
that do not have any also would reduce the number of patients receiving
needed procedures. For these reasons, the NRC did not adopt the no
action alternative.
Alternative Use of Resources
No alternative use of resources was considered due to the reasons
stated above.
Agencies and Persons Consulted
No other agencies or persons were contacted regarding this proposed
action.
Identification of Source Used
None.
Finding of No Significant Impact
Based on the above environmental assessment, the NRC finds that the
proposed action will not have a significant effect on the quality of
the human environment. Accordingly, the NRC has determined that a
Finding of No Significant Impact is appropriate and preparation of an
environmental impact statement is not warranted.
Dated at Rockville, Maryland, this 10th day of July 2009.
For the Nuclear Regulatory Commission.
Duane E. White,
Acting Chief, Radioactive Materials Safety Branch, Division of
Materials Safety and State Agreements, Office of Federal and State
Materials and Environmental Management Programs Safety and Safeguards.
[FR Doc. E9-16916 Filed 7-15-09; 8:45 am]
BILLING CODE 7590-01-P
