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]

Download as PDF 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 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 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 http:// 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 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]
BILLING CODE 7590-01-P