Notice of Availability of Environmental Assessment and Finding of No Significant Impact for License Amendment to Byproduct, Materials License No. 06-13053-04, for Termination of the License and Unrestricted Release of Bayer Pharmaceuticals Corporation's Facility in West Haven, CT, 57076-57077 [E7-19688]
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57076
Federal Register / Vol. 72, No. 193 / Friday, October 5, 2007 / Notices
For the Nuclear Regulatory Commission.
Timothy J. McGinty,
Acting Director, Division of Operating Reactor
Licensing Office of Nuclear Reactor
Regulation.
[FR Doc. 07–4939 Filed 10–4–07; 8:45 am]
BILLING CODE 7590–01–M
NUCLEAR REGULATORY
COMMISSION
[Docket No. 030–30292]
Notice of Availability of Environmental
Assessment and Finding of No
Significant Impact for License
Amendment to Byproduct, Materials
License No. 06–13053–04, for
Termination of the License and
Unrestricted Release of Bayer
Pharmaceuticals Corporation’s Facility
in West Haven, CT
Nuclear Regulatory
Commission.
ACTION: Issuance of Environmental
Assessment and Finding of No
Significant Impact for License
Amendment.
AGENCY:
FOR FURTHER INFORMATION CONTACT:
yshivers on PROD1PC62 with NOTICES
Dennis Lawyer, Health Physicist,
Commercial and R&D Branch, Division
of Nuclear Materials Safety, Region I,
475 Allendale Road, King of Prussia,
Pennsylvania; telephone 610–337–5366;
fax number 610–337–5393; or by e-mail:
drl1@nrc.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction
The U.S. Nuclear Regulatory
Commission (NRC) is considering the
issuance of a license amendment to
Byproduct Materials License No. 06–
13053–04. This license is held by Bayer
Pharmaceuticals Corporation (the
Licensee), for its Bayer Pharmaceuticals
Corporation Facility located at 400
Morgan Lane in West Haven,
Connecticut (the Facility). Issuance of
the amendment would authorize release
of the Facility for unrestricted use and
termination of the NRC license. The
Licensee requested this action in a letter
dated April 17, 2007, and responded to
an information request by letters dated
July 9, 2007, and August 6, 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
VerDate Aug<31>2005
15:33 Oct 04, 2007
Jkt 214001
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 April 17, 2007, license
amendment request, resulting in release
of the Facility for unrestricted use and
the termination of its NRC materials
license. License No. 06–13053–04 was
issued on December 2, 1987, pursuant to
10 CFR part 30, and has been amended
periodically since that time. Licensed
activities at the Facility were also
conducted under the following licenses
during the dates indicated: License No.
06–13053–01 (December 17, 1968
through July 15, 1993); License No. 06–
20589–01 (April 20, 1983 through
February 25, 1988); and License No. 06–
20972–01 (March 13, 1986 through
February 5, 1988). These licenses were
transferred to License No. 06–13053–04
and terminated. These licenses
authorized the Licensee to use unsealed
byproduct material for purposes of
conducting research and development
activities typically on laboratory bench
tops and in hoods.
The Facility is situated on 137 acres
and consists of office space and
laboratories. The Facility is located in a
mixed commercial industrial and
residential area. Use of licensed
materials was confined to five buildings
within 30 acres and totaling 350,000
square feet of building space.
In January 2007, the Licensee ceased
licensed activities and initiated a survey
and decontamination of the 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 NRCapproved, 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 and for license
termination.
Need for the Proposed Action
The Licensee has ceased conducting
licensed activities at the Facility, and
seeks the unrestricted use of its Facility
and the termination of its NRC materials
license. Termination of its license
would end the Licensee’s obligation to
pay annual license fees to the NRC.
PO 00000
Frm 00096
Fmt 4703
Sfmt 4703
Environmental Impacts of the Proposed
Action
The historical review of licensed
activities conducted at the Facility
shows that such activities involved use
of the following radionuclides with halflives greater than 120 days: Hydrogen 3,
carbon 14, chlorine 36, calcium 45,
iodine 129, and gadolinium 153. Prior to
performing the final status survey, the
Licensee conducted decontamination
activities, as necessary, in the areas of
the Facility affected by these
radionuclides.
The Licensee conducted a final status
survey January 3 through February 2,
2007. The final status survey report was
attached to the Licensee’s amendment
request dated April 17, 2007, and letter
dated July 9, 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 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
E:\FR\FM\05OCN1.SGM
05OCN1
Federal Register / Vol. 72, No. 193 / Friday, October 5, 2007 / Notices
that could result in cumulative
environmental impacts.
The NRC staff finds that the proposed
release of the Facility for unrestricted
use and the termination of the NRC
materials license 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 and
for license termination. 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.
yshivers on PROD1PC62 with NOTICES
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
Connecticut Department of
Environmental Protection for review on
August 24, 2007. On September 18,
2007, State of Connecticut, Department
of Environmental Protection responded
by electronic 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
VerDate Aug<31>2005
17:30 Oct 04, 2007
Jkt 214001
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. The documents related to
this action are listed below, along with
their ADAMS accession numbers.
1. NUREG–1757, ‘‘Consolidated
NMSS Decommissioning Guidance’’;
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’’;
5. Bayer Pharmaceuticals Corporation
Termination Request Letter dated April
17, 2007 [ML071150450];
6. Bayer Pharmaceuticals Corporation
Deficiency Response Letter dated July 9,
2007 [ML072180445]; and
7. Bayer Pharmaceuticals Corporation
Deficiency Response Letter dated
August 6, 2007 [ML072210116].
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
PO 00000
Frm 00097
Fmt 4703
Sfmt 4703
57077
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 Region I, 475 Allendale Road,
King of Prussia this 28th day of September
2007.
For the Nuclear Regulatory Commission.
James P. Dwyer,
Chief, Commercial and R&D Branch, Division
of Nuclear Materials Safety, Region I.
[FR Doc. E7–19688 Filed 10–4–07; 8:45 am]
BILLING CODE 7590–01–P
NUCLEAR REGULATORY
COMMISSION
Advisory Committee on the Medical
Uses of Isotopes: Meeting Notice
U.S. Nuclear Regulatory
Commission.
ACTION: Notice of meeting.
AGENCY:
SUMMARY: NRC will convene a meeting
of the Advisory Committee on the
Medical Uses of Isotopes (ACMUI)
October 22–23, 2007. A sample of
agenda items to be discussed during the
public session includes: (1) NARM
legislation, transition plan, and
guidance; (2) status of specialty board
applications for NRC recognition; (3) Y–
90 microspheres guidance; (4) training
and experience implementation issues;
(4) recent security activities; (5)
potential changes to 10 CFR Part 35; (6)
licensing guidance for the Leksell
Gamma-Knife PerfexionTM; and (7)
review of recent medical events. A copy
of the agenda will be available at https://
www.nrc.gov/reading-rm/doccollections/acmui/agenda or by emailing Ms. Ashley M. Tull at the
contact information below.
Purpose: Discuss issues related to 10
CFR Part 35 Medical Use of Byproduct
Material.
Date and Time for Closed Sessions:
October 22, 2007, from 8 a.m. to 10 a.m.
This session will be closed so that NRC
staff and ACMUI can discuss Committee
business, which may include: Ethics
training, personnel information, and
other internal NRC issues.
Date and Time for Open Sessions:
October 22, 2007, from 10 a.m. to 5 p.m.
and October 23, 2007, from 8 a.m. to 5
p.m.
Address for Public Meeting: U.S.
Nuclear Regulatory Commission, Two
White Flint North Building, Room
T2B3, 11545 Rockville Pike, Rockville,
Maryland 20852.
Public Participation: Any member of
the public who wishes to participate in
E:\FR\FM\05OCN1.SGM
05OCN1
]]>Agencies
[Federal Register Volume 72, Number 193 (Friday, October 5, 2007)]
[Notices]
[Pages 57076-57077]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-19688]
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[Docket No. 030-30292]
Notice of Availability of Environmental Assessment and Finding of
No Significant Impact for License Amendment to Byproduct, Materials
License No. 06-13053-04, for Termination of the License and
Unrestricted Release of Bayer Pharmaceuticals Corporation's Facility in
West Haven, CT
AGENCY: Nuclear Regulatory Commission.
ACTION: Issuance of Environmental Assessment and Finding of No
Significant Impact for License Amendment.
-----------------------------------------------------------------------
FOR FURTHER INFORMATION CONTACT: Dennis Lawyer, Health Physicist,
Commercial and R&D Branch, Division of Nuclear Materials Safety, Region
I, 475 Allendale Road, King of Prussia, Pennsylvania; telephone 610-
337-5366; fax number 610-337-5393; or by e-mail: drl1@nrc.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction
The U.S. Nuclear Regulatory Commission (NRC) is considering the
issuance of a license amendment to Byproduct Materials License No. 06-
13053-04. This license is held by Bayer Pharmaceuticals Corporation
(the Licensee), for its Bayer Pharmaceuticals Corporation Facility
located at 400 Morgan Lane in West Haven, Connecticut (the Facility).
Issuance of the amendment would authorize release of the Facility for
unrestricted use and termination of the NRC license. The Licensee
requested this action in a letter dated April 17, 2007, and responded
to an information request by letters dated July 9, 2007, and August 6,
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 April 17, 2007,
license amendment request, resulting in release of the Facility for
unrestricted use and the termination of its NRC materials license.
License No. 06-13053-04 was issued on December 2, 1987, pursuant to 10
CFR part 30, and has been amended periodically since that time.
Licensed activities at the Facility were also conducted under the
following licenses during the dates indicated: License No. 06-13053-01
(December 17, 1968 through July 15, 1993); License No. 06-20589-01
(April 20, 1983 through February 25, 1988); and License No. 06-20972-01
(March 13, 1986 through February 5, 1988). These licenses were
transferred to License No. 06-13053-04 and terminated. These licenses
authorized the Licensee to use unsealed byproduct material for purposes
of conducting research and development activities typically on
laboratory bench tops and in hoods.
The Facility is situated on 137 acres and consists of office space
and laboratories. The Facility is located in a mixed commercial
industrial and residential area. Use of licensed materials was confined
to five buildings within 30 acres and totaling 350,000 square feet of
building space.
In January 2007, the Licensee ceased licensed activities and
initiated a survey and decontamination of the 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 and
for license termination.
Need for the Proposed Action
The Licensee has ceased conducting licensed activities at the
Facility, and seeks the unrestricted use of its Facility and the
termination of its NRC materials license. Termination of its license
would end the Licensee's obligation to pay annual license fees to the
NRC.
Environmental Impacts of the Proposed Action
The historical review of licensed activities conducted at the
Facility shows that such activities involved use of the following
radionuclides with half-lives greater than 120 days: Hydrogen 3, carbon
14, chlorine 36, calcium 45, iodine 129, and gadolinium 153. Prior to
performing the final status survey, the Licensee conducted
decontamination activities, as necessary, in the areas of the Facility
affected by these radionuclides.
The Licensee conducted a final status survey January 3 through
February 2, 2007. The final status survey report was attached to the
Licensee's amendment request dated April 17, 2007, and letter dated
July 9, 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
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
[[Page 57077]]
that could result in cumulative environmental impacts.
The NRC staff finds that the proposed release of the Facility for
unrestricted use and the termination of the NRC materials license 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 and for license
termination. 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
Connecticut Department of Environmental Protection for review on August
24, 2007. On September 18, 2007, State of Connecticut, Department of
Environmental Protection responded by electronic 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. The documents
related to this action are listed below, along with their ADAMS
accession numbers.
1. NUREG-1757, ``Consolidated NMSS Decommissioning Guidance'';
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'';
5. Bayer Pharmaceuticals Corporation Termination Request Letter
dated April 17, 2007 [ML071150450];
6. Bayer Pharmaceuticals Corporation Deficiency Response Letter
dated July 9, 2007 [ML072180445]; and
7. Bayer Pharmaceuticals Corporation Deficiency Response Letter
dated August 6, 2007 [ML072210116].
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 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 Region I, 475 Allendale Road, King of Prussia this 28th
day of September 2007.
For the Nuclear Regulatory Commission.
James P. Dwyer,
Chief, Commercial and R&D Branch, Division of Nuclear Materials Safety,
Region I.
[FR Doc. E7-19688 Filed 10-4-07; 8:45 am]
BILLING CODE 7590-01-P
