[Federal Register: October 5, 2007 (Volume 72, Number 193)]
[Notices]
[Page 57076-57077]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05oc07-84]
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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.
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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 http://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]
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