Notice of Environmental Assessment Related to the Issuance of a License Amendment to Byproduct Material License No. 21-26519-01, for Unrestricted Release of Former Facilities for Aastrom Biosciences, Ann Arbor, MI, 58908-58909 [E7-20453]
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Federal Register / Vol. 72, No. 200 / Wednesday, October 17, 2007 / Notices
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NUCLEAR REGULATORY
COMMISSION
SAFEGUARDS:
[Docket No. 030–33266]
All records containing personal
information are maintained in secured
file cabinets or are accessed by unique
passwords and log-on procedures. Only
those employees with a need-to-know in
order to perform their duties will be
able to access the information.
Notice of Environmental Assessment
Related to the Issuance of a License
Amendment to Byproduct Material
License No. 21–26519–01, for
Unrestricted Release of Former
Facilities for Aastrom Biosciences,
Ann Arbor, MI
RETENTION AND DISPOSAL:
AGENCY:
The Data File is cumulative and is
maintained indefinitely, and documents
are disposed according to agency file
plan and disposition schedule. Nonfunded proposals are maintained onsite
for 1 year and then disposed after 3
years. Funded proposals are maintained
onsite for 1 year after completion of the
award, and then transferred to the
National Archive and Records
Administration.
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address for express mail or overnight
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EXEMPTIONS CLAIMED FOR THE SYSTEM:
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[FR Doc. E7–20485 Filed 10–16–07; 8:45 am]
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19:05 Oct 16, 2007
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Nuclear Regulatory
Commission.
ACTION: Issuance of Environmental
Assessment and Finding of No
Significant Impact for License
Amendment.
FOR FURTHER INFORMATION CONTACT:
George M. McCann, Senior Health
Physicist, Decommissioning Branch,
Division of Nuclear Materials Safety,
Region III, U.S. Nuclear Regulatory
Commission, 2443 Warrenville Road,
Lisle, Illinois 60532; telephone: (630)
829–9856; fax number: (630) 515–1259;
or by e-mail at gmm@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. 21–
26519–01. This license is held by
Aastrom Biosciences (licensee) for its
Gene Therapy Laboratory (the facility)
located at 24 Frank Lloyd Wright Drive,
Lobby L, Domino’s Farm, Ann Arbor,
Michigan. Issuance of the amendment
would authorize the unrestricted release
of the licensee’s Gene Therapy
Laboratory and associated offices for
unrestricted use. The licensee requested
this action in a letter dated July 16,
2007. The NRC has prepared an
Environmental Assessment (EA) in
support of this 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 would approve
the licensee’s July 16, 2007, license
amendment request, resulting in the
release of the facility located at 24 Frank
Lloyd Wright Drive, Lobby L, Domino’s
Farm, Ann Arbor, Michigan for
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Fmt 4703
Sfmt 4703
unrestricted use. License No. 21–26519–
01 was issued on September 10, 1993,
pursuant to 10 CFR Part 30, and has
been amended periodically since that
time. This license authorized the
licensee to use unsealed byproduct
materials for conducting research and
development activities on laboratory
bench tops and in hoods.
The licensee’s facility is situated in a
four-story commercial office building,
which is located at 24 Frank Lloyd
Wright Drive, Lobby L, Domino’s Farm,
Ann Arbor, Michigan, and consists of
office space and a ‘‘Gene Therapy
Laboratory.’’ The site is located in a
mixed residential, agricultural and
commercial area. Within the facility, use
of licensed materials was confined to
the Gene Therapy Laboratory, which
was approximately 414 square feet.
On May 16, 2007, the licensee ceased
licensed activities in the Gene Therapy
Laboratory and initiated a survey and
decontamination of the licensee’s
facility. Based on the licensee’s
historical knowledge of the site and the
conditions of the facility, the licensee
determined that only routine
decontamination activities, in
accordance with their NRC-approved,
operating radiation safety procedures,
were required. The licensee was not
required to submit a decommissioning
plan to the NRC because worker cleanup
activities and procedures are consistent
with those approved for routine
operations. The licensee conducted
surveys of the facility and provided
information to the NRC to demonstrate
that it meets the criteria in Subpart E of
10 CFR Part 20 for unrestricted release.
The licensee will continue licensed
operations at another approved location.
Need for the Proposed Action
The licensee has ceased conducting
licensed activities at the facility, and
seeks the unrestricted use of the facility.
Environmental Impacts of the Proposed
Action
The historical review of licensed
research activities conducted at the
facility shows that the activities
involved only the use of hydrogen-3,
which has a half-life greater than 120
days. Prior to performing the final status
survey, the licensee conducted
decontamination activities, as
necessary, in the areas of the facility
affected by the hydrogen-3.
The licensee conducted a final status
survey on May 29, 2007. This survey
covered the facility located at 24 Frank
Lloyd Wright Drive, Lobby L, Domino’s
Farm, Ann Arbor, Michigan (ADAMS
Accession No. ML072010257). The final
status survey report was attached to the
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Federal Register / Vol. 72, No. 200 / Wednesday, October 17, 2007 / Notices
sroberts on PROD1PC70 with NOTICES
Licensee’s amendment request dated
July 16, 2007. The licensee elected to
demonstrate compliance with the
radiological criteria for unrestricted
release as specified in 10 CFR 20.1402
by using the screening approach
described in NUREG–1757,
‘‘Consolidated NMSS Decommissioning
Guidance,’’ Volume 2. The licensee
used the radionuclide-specific derived
concentration guideline levels (DCGLs),
developed there by the NRC, which
comply with the dose criterion in 10
CFR 20.1402. These DCGLs define the
maximum amount of residual
radioactivity on building surfaces,
equipment, and materials, and in soils,
that will satisfy the NRC requirements
in Subpart E of 10 CFR Part 20 for
unrestricted release. The licensee’s final
status survey results were below these
DCGLs and are 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 are
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 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.
The NRC staff finds that the proposed
release of the facility for unrestricted
use is in compliance with 10 CFR
20.1402. Based on its review, the staff
considered the impact of the residual
radioactivity at the facility 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
VerDate Aug<31>2005
19:05 Oct 16, 2007
Jkt 214001
considered is the no-action alternative,
under which the staff would leave
things as they are by simply denying 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 the facility meets the
requirements of 10 CFR 20.1402 for
unrestricted release. 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 release 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 Consulted
NRC provided a draft of this
Environmental Assessment to the
Radioactive Material and Medical Waste
Materials Unit, Waste and Hazardous
Materials Division, Michigan
Department of Environmental Quality
for review on September 10, 2007. On
September 14, 2007, Mr. Robert
Skowronek, Chief, Radioactive Material
and Medical Waste Materials Unit,
Waste and Hazardous Materials
Division, Michigan Department of
Environmental Quality, responded by email. The State agreed with the
conclusions of the EA and otherwise
had no comments.
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
PO 00000
Frm 00106
Fmt 4703
Sfmt 4703
58909
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 license
amendment and supporting
documentation, are available
electronically at the NRC’s Electronic
Reading Room at https://www.nrc.gov/
reading-rm/adams.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. 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. The
documents related to this action are
listed below, along with their ADAMS
accession numbers.
1. Report on the Final Radiological
Status of Areas Being Vacated by
Aastrom Biosciences, Inc., dated May
29, 2007 (ADAMS Accession No.
ML072010257).
2. Title 10 Code of Federal
Regulations, Part 20, Subpart E,
‘‘Radiological Criteria for License
Termination;’’
3. Title 10 Code of Federal
Regulations, Part 51, ‘‘Environmental
Protection Regulations for Domestic
Licensing and Related Regulatory
Functions;’’
4. NUREG–1496, ‘‘Generic
Environmental Impact Statement in
Support of Rulemaking on Radiological
Criteria for License Termination of NRCLicensed Nuclear Facilities;’’ NUREG–
1757, Consolidated NMSS
Decommissioning Guidance.
These documents may also be viewed
electronically on the 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 Lisle, Illinois, this 5th day of
October 2007.
For the Nuclear Regulatory Commission,
Patrick Louden,
Chief, Decommissioning Branch, Division of
Nuclear Materials Safety Region III.
[FR Doc. E7–20453 Filed 10–16–07; 8:45 am]
BILLING CODE 7590–01–P
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Agencies
[Federal Register Volume 72, Number 200 (Wednesday, October 17, 2007)]
[Notices]
[Pages 58908-58909]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-20453]
=======================================================================
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NUCLEAR REGULATORY COMMISSION
[Docket No. 030-33266]
Notice of Environmental Assessment Related to the Issuance of a
License Amendment to Byproduct Material License No. 21-26519-01, for
Unrestricted Release of Former Facilities for Aastrom Biosciences, Ann
Arbor, MI
AGENCY: Nuclear Regulatory Commission.
ACTION: Issuance of Environmental Assessment and Finding of No
Significant Impact for License Amendment.
-----------------------------------------------------------------------
FOR FURTHER INFORMATION CONTACT: George M. McCann, Senior Health
Physicist, Decommissioning Branch, Division of Nuclear Materials
Safety, Region III, U.S. Nuclear Regulatory Commission, 2443
Warrenville Road, Lisle, Illinois 60532; telephone: (630) 829-9856; fax
number: (630) 515-1259; or by e-mail at gmm@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. 21-
26519-01. This license is held by Aastrom Biosciences (licensee) for
its Gene Therapy Laboratory (the facility) located at 24 Frank Lloyd
Wright Drive, Lobby L, Domino's Farm, Ann Arbor, Michigan. Issuance of
the amendment would authorize the unrestricted release of the
licensee's Gene Therapy Laboratory and associated offices for
unrestricted use. The licensee requested this action in a letter dated
July 16, 2007. The NRC has prepared an Environmental Assessment (EA) in
support of this 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 would approve the licensee's July 16, 2007,
license amendment request, resulting in the release of the facility
located at 24 Frank Lloyd Wright Drive, Lobby L, Domino's Farm, Ann
Arbor, Michigan for unrestricted use. License No. 21-26519-01 was
issued on September 10, 1993, pursuant to 10 CFR Part 30, and has been
amended periodically since that time. This license authorized the
licensee to use unsealed byproduct materials for conducting research
and development activities on laboratory bench tops and in hoods.
The licensee's facility is situated in a four-story commercial
office building, which is located at 24 Frank Lloyd Wright Drive, Lobby
L, Domino's Farm, Ann Arbor, Michigan, and consists of office space and
a ``Gene Therapy Laboratory.'' The site is located in a mixed
residential, agricultural and commercial area. Within the facility, use
of licensed materials was confined to the Gene Therapy Laboratory,
which was approximately 414 square feet.
On May 16, 2007, the licensee ceased licensed activities in the
Gene Therapy Laboratory and initiated a survey and decontamination of
the licensee's facility. Based on the licensee's historical knowledge
of the site and the conditions of the facility, the licensee determined
that only routine decontamination activities, in accordance with their
NRC-approved, operating radiation safety procedures, were required. The
licensee was not required to submit a decommissioning plan to the NRC
because worker cleanup activities and procedures are consistent with
those approved for routine operations. The licensee conducted surveys
of the facility and provided information to the NRC to demonstrate that
it meets the criteria in Subpart E of 10 CFR Part 20 for unrestricted
release. The licensee will continue licensed operations at another
approved location.
Need for the Proposed Action
The licensee has ceased conducting licensed activities at the
facility, and seeks the unrestricted use of the facility.
Environmental Impacts of the Proposed Action
The historical review of licensed research activities conducted at
the facility shows that the activities involved only the use of
hydrogen-3, which has a half-life greater than 120 days. Prior to
performing the final status survey, the licensee conducted
decontamination activities, as necessary, in the areas of the facility
affected by the hydrogen-3.
The licensee conducted a final status survey on May 29, 2007. This
survey covered the facility located at 24 Frank Lloyd Wright Drive,
Lobby L, Domino's Farm, Ann Arbor, Michigan (ADAMS Accession No.
ML072010257). The final status survey report was attached to the
[[Page 58909]]
Licensee's amendment request dated July 16, 2007. The licensee elected
to demonstrate compliance with the radiological criteria for
unrestricted release as specified in 10 CFR 20.1402 by using the
screening approach described in NUREG-1757, ``Consolidated NMSS
Decommissioning Guidance,'' Volume 2. The licensee used the
radionuclide-specific derived concentration guideline levels (DCGLs),
developed there by the NRC, which comply with the dose criterion in 10
CFR 20.1402. These DCGLs define the maximum amount of residual
radioactivity on building surfaces, equipment, and materials, and in
soils, that will satisfy the NRC requirements in Subpart E of 10 CFR
Part 20 for unrestricted release. The licensee's final status survey
results were below these DCGLs and are 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 are
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 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.
The NRC staff finds that the proposed release of the facility for
unrestricted use is in compliance with 10 CFR 20.1402. Based on its
review, the staff considered the impact of the residual radioactivity
at the facility 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 leave things as they are by simply denying 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 the facility meets the
requirements of 10 CFR 20.1402 for unrestricted release. 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 release 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 Consulted
NRC provided a draft of this Environmental Assessment to the
Radioactive Material and Medical Waste Materials Unit, Waste and
Hazardous Materials Division, Michigan Department of Environmental
Quality for review on September 10, 2007. On September 14, 2007, Mr.
Robert Skowronek, Chief, Radioactive Material and Medical Waste
Materials Unit, Waste and Hazardous Materials Division, Michigan
Department of Environmental Quality, responded by e-mail. The State
agreed with the conclusions of the EA and otherwise had no comments.
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
license amendment and supporting documentation, are available
electronically at the NRC's Electronic Reading Room at https://
www.nrc.gov/reading-rm/adams.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. 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. The documents related to this action are listed below,
along with their ADAMS accession numbers.
1. Report on the Final Radiological Status of Areas Being Vacated
by Aastrom Biosciences, Inc., dated May 29, 2007 (ADAMS Accession No.
ML072010257).
2. Title 10 Code of Federal Regulations, Part 20, Subpart E,
``Radiological Criteria for License Termination;''
3. Title 10 Code of Federal Regulations, Part 51, ``Environmental
Protection Regulations for Domestic Licensing and Related Regulatory
Functions;''
4. NUREG-1496, ``Generic Environmental Impact Statement in Support
of Rulemaking on Radiological Criteria for License Termination of NRC-
Licensed Nuclear Facilities;'' NUREG-1757, Consolidated NMSS
Decommissioning Guidance.
These documents may also be viewed electronically on the 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 Lisle, Illinois, this 5th day of October 2007.
For the Nuclear Regulatory Commission,
Patrick Louden,
Chief, Decommissioning Branch, Division of Nuclear Materials Safety
Region III.
[FR Doc. E7-20453 Filed 10-16-07; 8:45 am]
BILLING CODE 7590-01-P