[Federal Register Volume 75, Number 117 (Friday, June 18, 2010)]
[Notices]
[Pages 34774-34776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-14749]


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NUCLEAR REGULATORY COMMISSION

[Docket No. 030-04544; NRC-2010-0213]


Notice of Availability of Environmental Assessment and Finding of 
No Significant Impact for License Amendment to Byproduct Materials 
License No. 19-07538-01, for Unrestricted Release of the Department of 
Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health's Facility 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: Betsy Ullrich, Senior Health 
Physicist, Commercial and R&D Branch, Division of Nuclear Materials 
Safety, Region I, 475 Allendale Road, King of Prussia, Pennsylvania 
19406; telephone (610) 337-5040; fax number (610) 337-5269; 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 the Department of Health and Human 
Services (HHS), Food and Drug Administration, Center for Devices and 
Radiological Health (FDA/CDRH) (the Licensee), for its FDA/CDRH 
Building 1 laboratory (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 December 30, 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 December 30, 2009,

[[Page 34775]]

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. The licensee also 
used uranyl acetate pursuant to the general license in 10 CFR 40.22.
    The Facility is a 19,229 square foot building situated on a 4-acre 
complex and consists of office space and laboratories. The Facility is 
located in a mixed residential/commercial area. Within the Facility, 
use of licensed materials was confined to 27 laboratories.
    In March 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.

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: Barium 133, cesium 
137, americium 241, and uranium 238. 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 during November 2009. 
The final status survey report was attached to the Licensee's amendment 
request dated December 30, 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. 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. Because NRC has 
not established a screening value for barium 133, the licensee 
developed a DCGL for barium 133 for its Facility. The Licensee 
developed the barium 133 DCGL by conducting site-specific dose modeling 
using input parameters specific to the Facility, and by using the 
default values in RESRAD-BUILD, Version 3.4. 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. The Licensee's final status survey results were below 
the relevant DCGLs and are in compliance with the As Low As Reasonably 
Achievable (ALARA) requirement of 10 CFR 20.1402. Therefore, 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 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 by the licensee 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. Because the environmental impacts of 
the proposed action and the no-action alternative are therefore 
similar, the no-action alternative is accordingly not considered 
further.

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, Air and Radiation Management 
Administration and Land Management Administration, for review on March 
9, 2010. On April 26, 2010, Maryland Department of the Environment, Air 
and Radiation Management Administration and Land Management 
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,

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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. Letter dated December 30, 2009, with the ``Final Radiological 
Status Survey Report'' dated December 2009 [ML100040232];
    2. Letter dated May 13, 2009 [ML091350560];
    3. NUREG-1757, ``Consolidated NMSS Decommissioning Guidance'';
    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;'' and
    6. NUREG-1496, ``Generic Environmental Impact Statement in Support 
of Rulemaking on Radiological Criteria for License Termination of NRC-
Licensed Nuclear Facilities.''
    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 this 10th day of June 2010.

    For the Nuclear Regulatory Commission.
James P. Dwyer,
Chief, Commercial and R&D Branch, Division of Nuclear Materials Safety, 
Region I.
[FR Doc. 2010-14749 Filed 6-17-10; 8:45 am]
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