Notice of Availability of Environmental Assessment and Finding of No Significant Impact for License Amendment to Byproduct Materials License No. 25-19852-01 For Unrestricted Release Of Building 7 of the Glaxosmithkline Biologicals-Hamilton Facility in Hamilton, MT, 27858-27859 [E7-9522]

Agencies

• NUCLEAR REGULATORY COMMISSION

[Federal Register Volume 72, Number 95 (Thursday, May 17, 2007)]
[Notices]
[Pages 27858-27859]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9522]


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NUCLEAR REGULATORY COMMISSION

[Docket No. 030-19324]


Notice of Availability of Environmental Assessment and Finding of 
No Significant Impact for License Amendment to Byproduct Materials 
License No. 25-19852-01 For Unrestricted Release Of Building 7 of the 
Glaxosmithkline Biologicals-Hamilton Facility in Hamilton, MT

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: Janine F. Katanic, Ph.D., Health 
Physicist, Nuclear Materials Inspection Branch, Division of Nuclear 
Materials Safety, Region IV, U.S. Nuclear Regulatory Commission, 611 
Ryan Plaza Drive, Suite 400, Arlington, Texas 76011; telephone: (817) 
860-8151; fax number: (817) 860-8188; or by e-mail: jfk@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. 25-
19852-01. The license is held by GlaxoSmithKline Biologicals-Hamilton 
(the Licensee), for its Hamilton facility (the Facility), located at 
553 Old Corvallis Road in Hamilton, Montana. Issuance of the amendment 
would authorize release of Building 7 of the Facility for unrestricted 
use. The Licensee requested this action in a letter dated June 8, 2006. 
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 June 8, 2006, 
license amendment request, resulting in the release of Building 7 of 
the Facility for unrestricted use. License No. 25-19852-01 was issued 
on June 24, 1988, pursuant to 10 CFR Part 30, and has been amended 
periodically since that time. This license authorizes the Licensee to 
possess and use small quantities of byproduct material, in both sealed 
and unsealed form, for laboratory research in immunological and 
biochemical studies. Additionally, the license authorizes the Licensee 
to possess and use a self-shielded irradiator device and to possess and 
use sealed sources for the purposes of performing instrument 
calibration.
    The Facility is situated on 35 acres (14 hectares) and consists of 
a main building comprised of office space and laboratories as well as 
several smaller buildings used for various purposes. The Facility is 
located in a mixed residential/commercial area. The Licensee's June 8, 
2006, license amendment request specifically addressed the release of 
Building 7 of the Facility for unrestricted use. Building 7 was 
constructed of filled concrete block walls set on a concrete floor, and 
its dimensions were 30 feet (9.1 meters) long by 15 feet (4.6 meters) 
wide and 8 feet (2.4 meters) in height. The building had a filled 
concrete block wall down the center which separated the building into 
an East Room and a West Room. Each room had a separate entry door on 
the south side of the building. Within Building 7, licensed materials 
were confined to the East Room. The East Room was an area of 
approximately 15 feet (4.6 meters) by 13 feet (4 meters) and had been 
used by the Licensee for the storage of licensed materials.
    On May 30, 2006, the Licensee ceased licensed activities in 
Building 7 and initiated a survey and decontamination of the East Room 
of Building 7. Based on the Licensee's historical knowledge of the site 
and the conditions of the East Room of Building 7, the Licensee 
determined that only routine decontamination activities, in accordance 
with their radiation safety procedures, were required. The Licensee was 
not required to submit a decommissioning plan to the NRC. The Licensee 
conducted surveys of the East Room of Building 7 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 in Building 
7 of the Facility and seeks the unrestricted use of Building 7.

Environmental Impacts of the Proposed Action

    The historical review of licensed activities conducted at Building 
7 of the Facility shows that such activities involved use of the 
following radionuclides with half-lives greater than 120 days: 
hydrogen-3, carbon-14, and calcium-45. Prior to performing the final 
status survey, the Licensee conducted decontamination activities, as 
necessary, in the areas of Building 7 affected by these radionuclides.
    The Licensee conducted a final status survey during May-June 2006. 
This survey covered the East Room of Building 7. The final status 
survey report was attached to the Licensee's amendment request dated 
June 8, 2006. NRC regulation 10 CFR 20.1402, Radiological Criteria for 
Unrestricted Use, states in part that a site will be considered 
acceptable for unrestricted use if the residual radioactivity that is 
distinguishable from background radiation results in a total effective 
dose equivalent not to exceed 25 millirems per year (0.25 milliSeiverts 
per year) to an average member of the critical group (the group of 
individuals reasonably expected to receive the greatest exposure to 
residual radioactivity for any applicable set of circumstances). The 
Licensee elected to demonstrate compliance with the radiological 
criteria for unrestricted release as specified in 10 CFR 20.1402 by 
referencing Regulatory Guide 1.86, Table 1, Acceptable Surface 
Contamination Levels, and NUREG-1556, Volume 11, Table S.5, Acceptable 
Surface Contamination Levels. Both tables provide a maximum 
contamination limit for uncontrolled release of facilities. Because 
these values were not dose-based calculations as required by the 
license termination rule in 10 CFR Part 20, they were compared to the 
screening values documented in NUREG-1757, Volume 1, Revision 1, 
Consolidated NMSS

[[Page 27859]]

Decommissioning Guidance, Table B.1. NUREG-1757 provides screening 
values for building surface contamination which are equivalent to 25 
millirem per year. The surface contamination levels as submitted by the 
Licensee are significantly lower than the acceptable screening values 
as documented in NUREG-1757. Accordingly, the Licensee's final status 
survey results were thus acceptable.
    The NRC staff conducted a confirmatory survey on August 3, 2006. As 
documented in the inspection report, none of the confirmatory survey 
results revealed any radiation distinguishable from accepted background 
radiation levels.
    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). 
Further, no incidents were recorded involving spills or releases of 
radioactive material in Building 7 of the Facility. Accordingly, there 
were no significant environmental impacts from the use of radioactive 
material at the Facility.
    The NRC staff finds that the proposed release of the portion of the 
Facility described above for unrestricted use is in compliance with 10 
CFR 20.1402. The NRC has found no other activities in the area that 
could result in cumulative environmental impacts. Based on its review, 
the staff considered the impact of the residual radioactivity at 
Building 7 of 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 simply deny 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. 
Additionally, this denial of the application 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 EA to the State of Montana Department 
of Public Health and Human Services for review on October 23, 2006. On 
January 8, 2007, the State of Montana Department of Public Health and 
Human Services responded by telephone and had no comments on the draft 
EA.
    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 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 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, if applicable.
    1. Federal Register Notice, Volume 65, No. 114, page 37186, dated 
Tuesday, June 13, 2000, ``Use of Screening Values to Demonstrate 
Compliance With The Federal Rule on Radiological Criteria for License 
Termination;''
    2. NRC, ``Generic Environmental Impact Statement in Support of 
Rulemaking on Radiological Criteria for License Termination of NRC-
Licensed Nuclear Facilities,'' NUREG-1496, July 1997 (ML042310492, 
ML042320379, and ML042330385);
    3. NRC, ``Consolidated NMSS Decommissioning Guidance,'' NUREG-1757, 
Volume 1, Revision 1, September 2003 (ML053260027);
    4. Title 10 Code of Federal Regulations, Part 20, Subpart E, 
``Radiological Criteria for License Termination;''
    5. Title 10, Code of Federal Regulations, Part 51, ``Environmental 
Protection Regulations for Domestic Licensing and Related Regulatory 
Functions;''
    6. Poletti, Brian, GlaxoSmithKline Biologicals--Hamilton, License 
Amendment Request, June 8, 2005 (ML062920087);
    7. Whitten, Jack E., Acknowledgment of Receipt of Final Status 
Survey, July 14, 2006 (ML061950672);
    8. NRC Inspection Report 030-19324/06-001, August 25, 2006 
(ML062370479);
    9. NRC, Telephone Conversation Record with State of Montana 
Department of Public Health and Human Services, January 8, 2007 
(ML071130330); and,
    10. E-mail correspondence between Katanic, Janine F. and Poletti, 
Brian, Questions Regarding June 8, 2006 Amendment Request, April 24-25, 
2007 (ML071160054).
    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 Arlington, Texas this 8th day of May 2007.

    For The Nuclear Regulatory Commission.
C. L. Cain,
Senior Management Analyst, Division of Nuclear Materials Safety, Region 
IV.
[FR Doc. E7-9522 Filed 5-16-07; 8:45 am]
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