Issuance of Environmental Assessment and Finding of No Significant Impact to Byproduct Materials License 53-27775-01 for Covance Clinical Research Unit, Inc., Honolulu, HI, 11060-11061 [E7-4415]
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11060
Federal Register / Vol. 72, No. 47 / Monday, March 12, 2007 / Notices
(CFR), Part 51 (10 CFR part 51). Based
on the EA, the NRC has concluded that
a Finding of No Significant Impact
(FONSI) is appropriate with respect to
the proposed action. The amendment
will be issued to the Licensee following
the publication of this FONSI and EA in
the Federal Register.
FOR FURTHER INFORMATION CONTACT:
Mary Rupp, Secretary of the Board,
Telephone: 703–518–6304.
Mary Rupp,
Secretary of the Board.
[FR Doc. 07–1175 Filed 3–8–07; 3:15 pm]
BILLING CODE 7535–01–M
NUCLEAR REGULATORY
COMMISSION
[Docket No. 030–36585]
Issuance of Environmental
Assessment and Finding of No
Significant Impact to Byproduct
Materials License 53–27775–01 for
Covance Clinical Research Unit, Inc.,
Honolulu, HI
Nuclear Regulatory
Commission.
ACTION: Issuance of environmental
assessment and finding of no significant
impact for license amendment.
AGENCY:
FOR FURTHER INFORMATION CONTACT:
Rachel S. Browder, M.S., Health
Physicist, Nuclear Materials Licensing
Branch, Division of Nuclear Materials
Safety, Region IV, U.S. Nuclear
Regulatory Commission, Arlington,
Texas 76011. Telephone: (817) 276–
6552; fax number: (817) 860–8188; or by
e-mail: rsb3@nrc.gov.
SUPPLEMENTARY INFORMATION:
pwalker on PROD1PC71 with NOTICES
I. Introduction
The U.S. Nuclear Regulatory
Commission (NRC) is considering the
issuance of an amendment to NRC
Byproduct Materials License No. 53–
27775–01, which was originally issued
on July 13, 2004, pursuant to 10 CFR
part 30. This license is held by Covance
Clinical Research Unit, Inc., (Licensee),
and authorizes the possession and use
of carbon-14 in pre-packaged capsules at
the Licensee’s laboratory located at 401
Kamakee Street, in Honolulu, Hawaii
(the facility), a commercial area of
Honolulu. The facility in which all
licensed radioactive materials were kept
and used is a room approximately 7′ x
12.5′ with a ceiling height of 8.5′, and
contains a sink and ventilation hood.
By letter dated October 10, 2006, the
Licensee stated that use of carbon-14
had been discontinued at their facility,
and accordingly requested that the
facility be released for unrestricted use,
and that the NRC license be terminated.
The NRC has prepared an
Environmental Assessment (EA) in
support of the proposed action in
accordance with the requirements of
Title 10, Code of Federal Regulations
VerDate Aug<31>2005
18:04 Mar 09, 2007
Jkt 211001
II. Environmental Assessment
Identification of Proposed Action: The
proposed action is to approve the
Licensee’s October 10, 2006, license
amendment request to release the
facility for unrestricted use and
terminate the license. Licensed
activities at the facility were limited to
conducting research trials, in which a
pre-packaged, pharmaceutical capsule
with approximately 100 microcuries
(µCi) of tagged carbon-14 was given to
each trial subject. The licensee
conducted three separate research trials
under the license, with the final trial
being conducted in February 2006. Each
trial consisted of approximately eight to
nine subjects. Upon completion of each
trial, the facility (where the subjects
remained during each trial) was
surveyed and documented to contain
less than background levels of radiation.
The subjects remained at the facility
until approximately 80–90% of the
excretion was collected. The uptake,
excretion and distribution of the
pharmaceutical in the respective
subjects were observed and measured.
The samples were collected by the
licensee and analyzed by a liquid
scintillation counter, and subsequently
disposed of in the sanitary sewerage.
The total activity of carbon-14 ordered
by the licensee was 5,089 µCi, of which
2,494 µCi was used during the Phase
one trials. The remainder of the
radioactive material was either returned
to the sponsor or transferred to a
licensed recipient.
Based on the use of the radioactive
materials in accordance with 10 CFR
30.36(g), the Licensee was not required
to submit a decommissioning plan to
the NRC since any decommissioning
activities and procedures implemented
were consistent with those approved for
routine operations.
The Need for the Proposed Action:
The Licensee has ceased licensed
activities at the facility and seeks to
release the facility for unrestricted use
and subsequent license termination.
Environmental Impacts of the Proposed
Action: The historical review of licensed
activities conducted at the facility
documents that the activities involved
the use of only carbon-14 as a tagged
pharmaceutical in a pre-packaged
capsule. The quantity amount in each
capsule was approximately 100 µCi and
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
the last use of licensed material was
conducted in February 2006. During the
research trials, the Licensee disposed of
the excretion samples into the sanitary
sewerage in accordance with the
regulatory requirements in 10 CFR
20.2003.
The licensee has requested
termination of the license because all
work with radioactive materials at the
facility have been discontinued. The
proposed release of the licensee’s
facility for unrestricted use does not
effect any environmental resource, since
there are no remediation requirements
for the facility or potential release of
radioactive materials to the
environment.
The Licensee conducted a final status
survey of the facility during August
2006. The final status survey report was
submitted on October 10, 2006, as part
of the license amendment request. The
submitted results were not statistically
significant from background and
therefore, the net results did not contain
any activity above background. The
NRC allows licensees to demonstrate
compliance with the radiological
criteria for unrestricted use as specified
in 10 CFR 20.1402 by using the
screening approach described in
NUREG–1757, ‘‘Consolidated NMSS
Decommissioning Guidance,’’ Volume
2. The Licensee’s results did not contain
any activity above background and
therefore were below any NRC criteria
and were in compliance with the As
Low As Reasonably Achievable
(ALARA) requirement of 10 CFR
20.1402. The NRC thus finds that the
Licensee’s final status survey results
acceptable.
Based on its review, the staff has
determined that the affected
environment and any environmental
impacts associated with the proposed
action are bounded by the impacts
evaluated by the ‘‘Generic
Environmental Impact Statement in
Support of Rulemaking on Radiological
Criteria for License Termination of NRCLicensed Nuclear Facilities’’ (NUREG–
1496) Volumes 1–3 (ML042310492,
ML042320379, and ML042330385). The
staff finds there were no significant
environmental impacts from the use of
radioactive material at the licensee’s
facility. The NRC staff reviewed the
docket file records and the final status
survey report to identify any nonradiological hazards that may have
impacted the environment surrounding
the facility. No such hazards or impacts
to the environment were identified. The
NRC has identified no other radiological
or non-radiological activities in the area
that could result in cumulative
environmental impacts.
E:\FR\FM\12MRN1.SGM
12MRN1
pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 72, No. 47 / Monday, March 12, 2007 / Notices
The NRC staff finds that the proposed
release of the facility for unrestricted
use and the termination of the NRC
license are in compliance with 10 CFR
20.1402. Based on its review, the staff
considered the impact of any residual
radioactivity in the laboratory and
concluded that the proposed action will
not have a significant effect on the
quality of the human environment.
Environmental Impacts of the
Alternatives to the Proposed Action:
Due to the largely administrative nature
of the proposed action, its
environmental impacts are small.
Therefore, the only alternative the staff
considered is the no-action alternative,
under which the staff would deny the
amendment request. This no-action
alternative is not feasible because it
conflicts with 10 CFR 30.36(d),
requiring that decommissioning of
byproduct material facilities be
completed and approved by the NRC
after licensed activities cease. The
NRC’s analysis of the Licensee’s final
status survey data confirmed that
release of the facility meets the
requirements of 10 CFR 20.1402 for
unrestricted use. Additionally, denying
the amendment request would result in
no change in current environmental
impacts. The environmental impacts of
the proposed action and the no-action
alternative are therefore similar, and the
no-action alternative is accordingly not
further considered.
Conclusion: The NRC staff has
concluded that the proposed action is
consistent with the NRC’s unrestricted
use criteria specified in 10 CFR 20.1402.
Because the proposed action will not
significantly impact the quality of the
human environment, the NRC staff
concludes that the proposed action is
the preferred alternative.
Agencies and Persons Contacted: NRC
provided a draft of this EA to the State
of Hawaii for review on January 22,
2006. The State of Hawaii did not
provide any comments to the draft EA.
The NRC staff has determined that the
proposed action is of a procedural
nature, and will not affect listed species
or critical habitat. Therefore, no further
consultation is required under Section 7
of the Endangered Species Act. The
NRC staff has also determined that the
proposed action is not the type of
activity that has the potential to cause
effects on historic properties. Therefore,
no further consultation is required
under Section 106 of the National
Historic Preservation Act.
III. Finding of No Significant Impact
The NRC staff has prepared this EA in
support of the proposed action. On the
basis of this EA, the NRC finds that
VerDate Aug<31>2005
18:04 Mar 09, 2007
Jkt 211001
there are no significant environmental
impacts from the proposed action, and
that preparation of an environmental
impact statement is not warranted.
Accordingly, the NRC has determined
that a Finding of No Significant Impact
is appropriate.
11061
For the Nuclear Regulatory Commission.
D. Blair Spitzberg,
Chief, Fuel Cycle Decommissioning Branch,
Division of Nuclear Materials Safety, Region
IV.
[FR Doc. E7–4415 Filed 3–9–07; 8:45 am]
BILLING CODE 7590–01–P
IV. Further Information
Documents related to this action,
including the application for
amendment and supporting
documentation, are available
electronically at the NRC’s Electronic
Reading Room at https://www.nrc.gov/
reading-rm.html. From this site, you can
access the NRC’s Agencywide
Document Access and Management
System (ADAMS), which provides text
and image files of NRC’s public
documents. The documents related to
this action are listed below, along with
their ADAMS accession numbers.
1. NRC, ‘‘Generic Environmental
Impact Statement in Support of
Rulemaking on Radiological Criteria for
License Termination of NRC-Licensed
Nuclear Facilities,’’ NUREG–1496, July
1997 (ML042310492, ML042320379,
and ML042330385).
2. NRC, ‘‘Consolidated NMSS
Decommissioning Guidance,’’ NUREG–
1757, Volume 1, Revision 1, September
2003 (ML053260027).
3. Title 10 Code of Federal
Regulations, Part 20, Subpart E,
‘‘Radiological Criteria for License
Termination.’’
4. Title 10, Code of Federal
Regulations, Part 51, ‘‘Environmental
Protection Regulations for Domestic
Licensing and Related Regulatory
Functions.’’
5. Jacobs, Mark, Covance Clinical
Research Unit, Inc., Decommissioning
Report, October 10, 2006
(ML062900229).
6. Browder, Rachel S.,
Acknowledgment of Receipt of Final
Status Survey, October 31, 2006
(ML063040400).
If you do not have access to ADAMS
or if there are problems in accessing the
documents located in ADAMS, contact
the NRC Public Document Room (PDR)
Reference staff at 1–800–397–4209, 301–
415–4737, or by e-mail to pdr@nrc.gov.
These documents may also be viewed
electronically on public computers
located at the NRC’s PDR, O 1 F21, One
White Flint North, 11555 Rockville
Pike, Rockville, MD 20852. The PDR
reproduction contractor will copy
documents for a fee.
Dated at Arlington, Texas, this 2nd day of
March 2007.
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
OFFICE OF MANAGEMENT AND
BUDGET
Draft 2007 Report to Congress on the
Costs and Benefits of Federal
Regulations
Office of Management and
Budget, Executive Office of the
President.
ACTION: Notice of availability and
request for comments.
AGENCY:
SUMMARY: The Office of Management
and Budget (OMB) requests comments
on its 2007 Draft Report to Congress on
the Costs and Benefits of Federal
Regulations. The full Draft Report is
available at https://www.whitehouse.gov/
omb/inforeg/regpolreports_congress.html, and is divided
into four chapters. Chapter I examines
the costs and benefits of major Federal
regulations issued in fiscal year 2006
and summarizes the costs and benefits
of major regulations issued between
September 1996 and 2006. It also
discusses regulatory impacts on State,
local, and tribal governments, small
business, wages, and economic growth.
Chapter II examines trends in regulation
since OMB began to compile benefit and
cost estimates records in 1981. Chapter
III provides an update on
implementation of the Information
Quality Act, and Chapter IV summarizes
agency compliance with the Unfunded
Mandates Reform Act.
DATES: To ensure consideration of
comments as OMB prepares this Draft
Report for submission to Congress,
comments must be in writing and
received by June 11, 2007.
ADDRESSES: We are still experiencing
delays in the regular mail, including
first class and express mail. To ensure
that your comments are received, we
recommend that comments on this draft
report be electronically mailed to
OIRA_BC_RPT@omb.eop.gov, or faxed
to (202) 395–7245. You may also submit
comments to Mabel Echols, Office of
Information and Regulatory Affairs,
Office of Management and Budget,
NEOB, Room 10201, 725 17th Street,
NW., Washington, DC 20503. All
comments submitted in response to this
notice will be made available to the
public, including by posting them on
OMB’s Web site. For this reason, please
E:\FR\FM\12MRN1.SGM
12MRN1
]]>Agencies
[Federal Register Volume 72, Number 47 (Monday, March 12, 2007)]
[Notices]
[Pages 11060-11061]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-4415]
=======================================================================
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[Docket No. 030-36585]
Issuance of Environmental Assessment and Finding of No
Significant Impact to Byproduct Materials License 53-27775-01 for
Covance Clinical Research Unit, Inc., Honolulu, HI
AGENCY: Nuclear Regulatory Commission.
ACTION: Issuance of environmental assessment and finding of no
significant impact for license amendment.
-----------------------------------------------------------------------
FOR FURTHER INFORMATION CONTACT: Rachel S. Browder, M.S., Health
Physicist, Nuclear Materials Licensing Branch, Division of Nuclear
Materials Safety, Region IV, U.S. Nuclear Regulatory Commission,
Arlington, Texas 76011. Telephone: (817) 276-6552; fax number: (817)
860-8188; or by e-mail: rsb3@nrc.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction
The U.S. Nuclear Regulatory Commission (NRC) is considering the
issuance of an amendment to NRC Byproduct Materials License No. 53-
27775-01, which was originally issued on July 13, 2004, pursuant to 10
CFR part 30. This license is held by Covance Clinical Research Unit,
Inc., (Licensee), and authorizes the possession and use of carbon-14 in
pre-packaged capsules at the Licensee's laboratory located at 401
Kamakee Street, in Honolulu, Hawaii (the facility), a commercial area
of Honolulu. The facility in which all licensed radioactive materials
were kept and used is a room approximately 7' x 12.5' with a ceiling
height of 8.5', and contains a sink and ventilation hood.
By letter dated October 10, 2006, the Licensee stated that use of
carbon-14 had been discontinued at their facility, and accordingly
requested that the facility be released for unrestricted use, and that
the NRC license be terminated.
The NRC has prepared an Environmental Assessment (EA) in support of
the proposed action in accordance with the requirements of Title 10,
Code of Federal Regulations (CFR), Part 51 (10 CFR part 51). Based on
the EA, the NRC has concluded that a Finding of No Significant Impact
(FONSI) is appropriate with respect to the proposed action. The
amendment will be issued to the Licensee following the publication of
this FONSI and EA in the Federal Register.
II. Environmental Assessment
Identification of Proposed Action: The proposed action is to
approve the Licensee's October 10, 2006, license amendment request to
release the facility for unrestricted use and terminate the license.
Licensed activities at the facility were limited to conducting research
trials, in which a pre-packaged, pharmaceutical capsule with
approximately 100 microcuries ([mu]Ci) of tagged carbon-14 was given to
each trial subject. The licensee conducted three separate research
trials under the license, with the final trial being conducted in
February 2006. Each trial consisted of approximately eight to nine
subjects. Upon completion of each trial, the facility (where the
subjects remained during each trial) was surveyed and documented to
contain less than background levels of radiation.
The subjects remained at the facility until approximately 80-90% of
the excretion was collected. The uptake, excretion and distribution of
the pharmaceutical in the respective subjects were observed and
measured. The samples were collected by the licensee and analyzed by a
liquid scintillation counter, and subsequently disposed of in the
sanitary sewerage. The total activity of carbon-14 ordered by the
licensee was 5,089 [mu]Ci, of which 2,494 [mu]Ci was used during the
Phase one trials. The remainder of the radioactive material was either
returned to the sponsor or transferred to a licensed recipient.
Based on the use of the radioactive materials in accordance with 10
CFR 30.36(g), the Licensee was not required to submit a decommissioning
plan to the NRC since any decommissioning activities and procedures
implemented were consistent with those approved for routine operations.
The Need for the Proposed Action: The Licensee has ceased licensed
activities at the facility and seeks to release the facility for
unrestricted use and subsequent license termination. Environmental
Impacts of the Proposed Action: The historical review of licensed
activities conducted at the facility documents that the activities
involved the use of only carbon-14 as a tagged pharmaceutical in a pre-
packaged capsule. The quantity amount in each capsule was approximately
100 [mu]Ci and the last use of licensed material was conducted in
February 2006. During the research trials, the Licensee disposed of the
excretion samples into the sanitary sewerage in accordance with the
regulatory requirements in 10 CFR 20.2003.
The licensee has requested termination of the license because all
work with radioactive materials at the facility have been discontinued.
The proposed release of the licensee's facility for unrestricted use
does not effect any environmental resource, since there are no
remediation requirements for the facility or potential release of
radioactive materials to the environment.
The Licensee conducted a final status survey of the facility during
August 2006. The final status survey report was submitted on October
10, 2006, as part of the license amendment request. The submitted
results were not statistically significant from background and
therefore, the net results did not contain any activity above
background. The NRC allows licensees to demonstrate compliance with the
radiological criteria for unrestricted use as specified in 10 CFR
20.1402 by using the screening approach described in NUREG-1757,
``Consolidated NMSS Decommissioning Guidance,'' Volume 2. The
Licensee's results did not contain any activity above background and
therefore were below any NRC criteria and were in compliance with the
As Low As Reasonably Achievable (ALARA) requirement of 10 CFR 20.1402.
The NRC thus finds that the Licensee's final status survey results
acceptable.
Based on its review, the staff has determined that the affected
environment and any environmental impacts associated with the proposed
action are bounded by the impacts evaluated by the ``Generic
Environmental Impact Statement in Support of Rulemaking on Radiological
Criteria for License Termination of NRC-Licensed Nuclear Facilities''
(NUREG-1496) Volumes 1-3 (ML042310492, ML042320379, and ML042330385).
The staff finds there were no significant environmental impacts from
the use of radioactive material at the licensee's facility. The NRC
staff reviewed the docket file records and the final status survey
report to identify any non-radiological hazards that may have impacted
the environment surrounding the facility. No such hazards or impacts to
the environment were identified. The NRC has identified no other
radiological or non-radiological activities in the area that could
result in cumulative environmental impacts.
[[Page 11061]]
The NRC staff finds that the proposed release of the facility for
unrestricted use and the termination of the NRC license are in
compliance with 10 CFR 20.1402. Based on its review, the staff
considered the impact of any residual radioactivity in the laboratory
and concluded that the proposed action will not have a significant
effect on the quality of the human environment.
Environmental Impacts of the Alternatives to the Proposed Action:
Due to the largely administrative nature of the proposed action, its
environmental impacts are small. Therefore, the only alternative the
staff considered is the no-action alternative, under which the staff
would deny the amendment request. This no-action alternative is not
feasible because it conflicts with 10 CFR 30.36(d), requiring that
decommissioning of byproduct material facilities be completed and
approved by the NRC after licensed activities cease. The NRC's analysis
of the Licensee's final status survey data confirmed that release of
the facility meets the requirements of 10 CFR 20.1402 for unrestricted
use. Additionally, denying the amendment request would result in no
change in current environmental impacts. The environmental impacts of
the proposed action and the no-action alternative are therefore
similar, and the no-action alternative is accordingly not further
considered.
Conclusion: The NRC staff has concluded that the proposed action is
consistent with the NRC's unrestricted use criteria specified in 10 CFR
20.1402. Because the proposed action will not significantly impact the
quality of the human environment, the NRC staff concludes that the
proposed action is the preferred alternative.
Agencies and Persons Contacted: NRC provided a draft of this EA to
the State of Hawaii for review on January 22, 2006. The State of Hawaii
did not provide any comments to the draft EA.
The NRC staff has determined that the proposed action is of a
procedural nature, and will not affect listed species or critical
habitat. Therefore, no further consultation is required under Section 7
of the Endangered Species Act. The NRC staff has also determined that
the proposed action is not the type of activity that has the potential
to cause effects on historic properties. Therefore, no further
consultation is required under Section 106 of the National Historic
Preservation Act.
III. Finding of No Significant Impact
The NRC staff has prepared this EA in support of the proposed
action. On the basis of this EA, the NRC finds that there are no
significant environmental impacts from the proposed action, and that
preparation of an environmental impact statement is not warranted.
Accordingly, the NRC has determined that a Finding of No Significant
Impact is appropriate.
IV. Further Information
Documents related to this action, including the application for
amendment and supporting documentation, are available electronically at
the NRC's Electronic Reading Room at https://www.nrc.gov/reading-
rm.html. From this site, you can access the NRC's Agencywide Document
Access and Management System (ADAMS), which provides text and image
files of NRC's public documents. The documents related to this action
are listed below, along with their ADAMS accession numbers.
1. NRC, ``Generic Environmental Impact Statement in Support of
Rulemaking on Radiological Criteria for License Termination of NRC-
Licensed Nuclear Facilities,'' NUREG-1496, July 1997 (ML042310492,
ML042320379, and ML042330385).
2. NRC, ``Consolidated NMSS Decommissioning Guidance,'' NUREG-1757,
Volume 1, Revision 1, September 2003 (ML053260027).
3. Title 10 Code of Federal Regulations, Part 20, Subpart E,
``Radiological Criteria for License Termination.''
4. Title 10, Code of Federal Regulations, Part 51, ``Environmental
Protection Regulations for Domestic Licensing and Related Regulatory
Functions.''
5. Jacobs, Mark, Covance Clinical Research Unit, Inc.,
Decommissioning Report, October 10, 2006 (ML062900229).
6. Browder, Rachel S., Acknowledgment of Receipt of Final Status
Survey, October 31, 2006 (ML063040400).
If you do not have access to ADAMS or if there are problems in
accessing the documents located in ADAMS, contact the NRC Public
Document Room (PDR) Reference staff at 1-800-397-4209, 301-415-4737, or
by e-mail to pdr@nrc.gov. These documents may also be viewed
electronically on public computers located at the NRC's PDR, O 1 F21,
One White Flint North, 11555 Rockville Pike, Rockville, MD 20852. The
PDR reproduction contractor will copy documents for a fee.
Dated at Arlington, Texas, this 2nd day of March 2007.
For the Nuclear Regulatory Commission.
D. Blair Spitzberg,
Chief, Fuel Cycle Decommissioning Branch, Division of Nuclear Materials
Safety, Region IV.
[FR Doc. E7-4415 Filed 3-9-07; 8:45 am]
BILLING CODE 7590-01-P
