[Federal Register Volume 74, Number 163 (Tuesday, August 25, 2009)]
[Notices]
[Pages 42942-42943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-20408]


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NUCLEAR REGULATORY COMMISSION

[NRC-2009-0370; Docket No. 030-04544]


Notice of Availability of Environmental Assessment and Finding of 
No Significant Impact for License Amendment to Byproduct Materials 
License No. 19-07538-01 for the Unrestricted Release of the Department 
of Health & Human Services Facility Located In Rockville, MD

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: [email protected].

SUPPLEMENTARY INFORMATION:

I. Introduction

    The U.S. Nuclear Regulatory Commission (NRC) is considering the 
issuance of a license amendment to Byproduct Materials License No. 19-
07538-01. This license is held by Department of Health & Human 
Services, Food and Drug Administration, Center for Devices and 
Radiological Health (the Licensee), for its Building T2 (the Facility), 
located at 12720 Twinbrook Parkway in Rockville, Maryland. Issuance of 
the amendment would authorize release of the Facility for unrestricted 
use. The Licensee requested this action in a letter dated April 13, 
2009. 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 13, 2009, 
license amendment request, resulting in release of the Facility for 
unrestricted use. License No. 19-07538-01 was issued on July 21, 1961, 
pursuant to 10 CFR part 30, and has been amended periodically since 
that time. This license authorized the Licensee to use unsealed 
byproduct material for purposes of conducting research and development 
activities on laboratory bench tops and in hoods; however, during the 
period of time the license has been in effect, unsealed materials have 
only been stored at the Facility.
    The Facility is a 5,121 square foot building situated on a 4-acre 
complex and consists of office and work space. The Facility is located 
in a mixed residential/commercial area.
    In March 2007, the Licensee ceased licensed activities at the 
Facility 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.

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 only sealed sources were used and that unsealed 
materials were stored in a safe. The surveys conducted at the Facility 
shows that the following unsealed radionuclides with half-lives greater 
than 120 days were stored at the Facility: Barium 133, cesium 137, 
americium 241, and uranium 238. The uranium 238 was not part of a 
specific license but was possessed under the general license described 
in 10 CFR 40.22(a). 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 between October 30 and 
November 24, 2008. The final status survey report was attached to the 
Licensee's amendment request dated April 13, 2009. Some amendments to 
the Final Radiological Status Survey Report were included in the 
Licensee's letter dated May 13, 2009. Additional survey information was 
included in the Licensee's letter dated May 27, 2009. 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. Because NRC has not established a screening value for 
barium 133, the licensee developed a DCGL for barium 133 for its 
Facility. The Licensee conducted site-specific dose modeling using 
input parameters specific to the Facility. The licensee used the 
default values in RESERAD-BUILD, Version 6.4. The NRC reviewed the 
Licensee's methodology and proposed barium 133 DCGL and concluded that 
the proposed barium 133 DCGL is acceptable for use as release criteria 
at the Facility. 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

[[Page 42943]]

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 and storage 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 and the amendment 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. 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 
Maryland Department of the Environment for review on July 8, 2008. On 
August 11, 2009, the Maryland Department of the Environment's Air and 
Radiation Management Administration and Hazardous Waste Administration 
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 Documents 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. Department of Health & Human Services amendment request dated 
April 13, 2009 (ML091040713);
    6. Department of Health & Human Services additional information 
letter dated May 13, 2009 (ML091350560); and
    7. Department of Health & Human Services additional information 
letter dated May 27, 2009 (ML091480626).
    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 [email protected]. 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, PA this 
17th day of August 2009.
    For the Nuclear Regulatory Commission.
James P. Dwyer,
Chief, Commercial and R&D Branch, Division of Nuclear Materials Safety, 
Region I.
[FR Doc. E9-20408 Filed 8-24-09; 8:45 am]
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