Notice of Availability of Environmental Assessment and Finding of No Significant Impact for License Amendment to Byproduct Materials License No. 37-30924-01, for the Unrestricted Release of the Tetralogic Pharmaceutical Facility in Malvern, PA, 9600-9601 [E8-3203]
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Federal Register / Vol. 73, No. 35 / Thursday, February 21, 2008 / Notices
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.
pwalker on PROD1PC71 with NOTICES
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. MPI Research Inc. Termination
Request dated November 15, 2007
[ML073370821].
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
VerDate Aug<31>2005
16:34 Feb 20, 2008
Jkt 214001
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.
will be issued to the Licensee following
the publication of this FONSI and EA in
the Federal Register.
Dated at Region I, 475 Allendale Road this
13th day of February 2008.
For the Nuclear Regulatory Commission.
James P. Dwyer,
Chief, Commercial and R&D Branch, Division
of Nuclear Materials Safety, Region I.
[FR Doc. E8–3200 Filed 2–20–08; 8:45 am]
The proposed action would approve
the Licensee’s March 27, 2007, license
amendment request, resulting in release
of the Facility for unrestricted use.
License No. 37–30924–01 was issued on
September 8, 2004, pursuant to 10 CFR
part 30, and has been amended
periodically since that time. This
license authorized the Licensee to use
byproduct material in any form for
purposes of conducting research and
development activities as defined in 10
CFR 30.4.
The Facility contains 4,000 square
feet of office space and laboratories.
Within the Facility, use of licensed
materials was confined to the Biology
lab and adjacent lab corridor.
In July 2004, the Licensee ceased
licensed activities, initiated a survey
and began 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.
BILLING CODE 7590–01–P
NUCLEAR REGULATORY
COMMISSION
[Docket No. 030–36603]
Notice of Availability of Environmental
Assessment and Finding of No
Significant Impact for License
Amendment to Byproduct Materials
License No. 37–30924–01, for the
Unrestricted Release of the Tetralogic
Pharmaceutical Facility in Malvern, PA
Nuclear Regulatory
Commission.
ACTION: Issuance of Environmental
Assessment and Finding of No
Significant Impact for License
Amendment.
AGENCY:
FOR FURTHER INFORMATION CONTACT:
Farrah Gaskins, Health Physicist,
Commercial and R&D Branch, Division
of Nuclear Materials Safety, Region I,
475 Allendale Road, King of Prussia,
Pennsylvania 19406; telephone (610)
337–5143; fax number (610) 337–5269;
or by e-mail: fcg@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. 37–
30924–01. This license is held by
TetraLogic Pharmaceuticals (the
Licensee), for its facility located at 365
Phoenixville Pike in Malvern,
Pennsylvania (the Facility). Issuance of
the amendment would authorize release
of the Facility for unrestricted use. The
Licensee requested this action in a letter
dated March 27, 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
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
II. Environmental Assessment
Identification of Proposed Action
Need for the Proposed Action
The Licensee has ceased conducting
licensed activities at the Facility, and
seeks the unrestricted use of its Facility.
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: Hydrogen3. 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 on January 31, 2007. This survey
covered the Biology lab, the adjacent lab
corridor, and adjacent areas. The final
status survey report was attached to the
Licensee’s amendment request dated
E:\FR\FM\21FEN1.SGM
21FEN1
Federal Register / Vol. 73, No. 35 / Thursday, February 21, 2008 / Notices
pwalker on PROD1PC71 with NOTICES
March 27, 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
considered is the no-action alternative,
VerDate Aug<31>2005
16:34 Feb 20, 2008
Jkt 214001
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
Commonwealth of Pennsylvania’s
Department of Environmental
Protection, Bureau of Radiation
Protection for review on September 10,
2007. On December 27, 2007, the
Commonwealth of Pennsylvania
responded by e-mail. The
Commonwealth 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
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
9601
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. Letter dated March 27, 2007; Final
Site Survey and NRC Form 314
(ML071550135).
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 King of Prussia, Pennsylvania this
12th day of February, 2008.
For the Nuclear Regulatory Commission.
James P. Dwyer,
Chief, Commercial and R&D Branch, Division
of Nuclear Materials Safety, Region I.
[FR Doc. E8–3203 Filed 2–20–08; 8:45 am]
BILLING CODE 7590–01–P
E:\FR\FM\21FEN1.SGM
21FEN1
Agencies
[Federal Register Volume 73, Number 35 (Thursday, February 21, 2008)]
[Notices]
[Pages 9600-9601]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-3203]
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[Docket No. 030-36603]
Notice of Availability of Environmental Assessment and Finding of
No Significant Impact for License Amendment to Byproduct Materials
License No. 37-30924-01, for the Unrestricted Release of the Tetralogic
Pharmaceutical Facility in Malvern, PA
AGENCY: Nuclear Regulatory Commission.
ACTION: Issuance of Environmental Assessment and Finding of No
Significant Impact for License Amendment.
-----------------------------------------------------------------------
FOR FURTHER INFORMATION CONTACT: Farrah Gaskins, Health Physicist,
Commercial and R&D Branch, Division of Nuclear Materials Safety, Region
I, 475 Allendale Road, King of Prussia, Pennsylvania 19406; telephone
(610) 337-5143; fax number (610) 337-5269; or by e-mail: fcg@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. 37-
30924-01. This license is held by TetraLogic Pharmaceuticals (the
Licensee), for its facility located at 365 Phoenixville Pike in
Malvern, Pennsylvania (the Facility). Issuance of the amendment would
authorize release of the Facility for unrestricted use. The Licensee
requested this action in a letter dated March 27, 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 March 27, 2007,
license amendment request, resulting in release of the Facility for
unrestricted use. License No. 37-30924-01 was issued on September 8,
2004, pursuant to 10 CFR part 30, and has been amended periodically
since that time. This license authorized the Licensee to use byproduct
material in any form for purposes of conducting research and
development activities as defined in 10 CFR 30.4.
The Facility contains 4,000 square feet of office space and
laboratories. Within the Facility, use of licensed materials was
confined to the Biology lab and adjacent lab corridor.
In July 2004, the Licensee ceased licensed activities, initiated a
survey and began 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.
Need for the Proposed Action
The Licensee has ceased conducting licensed activities at the
Facility, and seeks the unrestricted use of its Facility.
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. 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 on January 31, 2007.
This survey covered the Biology lab, the adjacent lab corridor, and
adjacent areas. The final status survey report was attached to the
Licensee's amendment request dated
[[Page 9601]]
March 27, 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
Commonwealth of Pennsylvania's Department of Environmental Protection,
Bureau of Radiation Protection for review on September 10, 2007. On
December 27, 2007, the Commonwealth of Pennsylvania responded by e-
mail. The Commonwealth 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. Letter dated March 27, 2007; Final Site Survey and NRC Form 314
(ML071550135).
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 King of Prussia, Pennsylvania this 12th day of
February, 2008.
For the Nuclear Regulatory Commission.
James P. Dwyer,
Chief, Commercial and R&D Branch, Division of Nuclear Materials Safety,
Region I.
[FR Doc. E8-3203 Filed 2-20-08; 8:45 am]
BILLING CODE 7590-01-P