[Federal Register Volume 72, Number 47 (Monday, March 12, 2007)]
[Notices]
[Pages 11060-11061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-4415]


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NUCLEAR REGULATORY COMMISSION

[Docket No. 030-36585]


Issuance of Environmental Assessment and Finding of No 
Significant Impact to Byproduct Materials License 53-27775-01 for 
Covance Clinical Research Unit, Inc., Honolulu, HI

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: Rachel S. Browder, M.S., Health 
Physicist, Nuclear Materials Licensing Branch, Division of Nuclear 
Materials Safety, Region IV, U.S. Nuclear Regulatory Commission, 
Arlington, Texas 76011. Telephone: (817) 276-6552; fax number: (817) 
860-8188; or by e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Introduction

    The U.S. Nuclear Regulatory Commission (NRC) is considering the 
issuance of an amendment to NRC Byproduct Materials License No. 53-
27775-01, which was originally issued on July 13, 2004, pursuant to 10 
CFR part 30. This license is held by Covance Clinical Research Unit, 
Inc., (Licensee), and authorizes the possession and use of carbon-14 in 
pre-packaged capsules at the Licensee's laboratory located at 401 
Kamakee Street, in Honolulu, Hawaii (the facility), a commercial area 
of Honolulu. The facility in which all licensed radioactive materials 
were kept and used is a room approximately 7' x 12.5' with a ceiling 
height of 8.5', and contains a sink and ventilation hood.
    By letter dated October 10, 2006, the Licensee stated that use of 
carbon-14 had been discontinued at their facility, and accordingly 
requested that the facility be released for unrestricted use, and that 
the NRC license be terminated.
    The NRC has prepared an Environmental Assessment (EA) in support of 
the 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 is to 
approve the Licensee's October 10, 2006, license amendment request to 
release the facility for unrestricted use and terminate the license. 
Licensed activities at the facility were limited to conducting research 
trials, in which a pre-packaged, pharmaceutical capsule with 
approximately 100 microcuries ([mu]Ci) of tagged carbon-14 was given to 
each trial subject. The licensee conducted three separate research 
trials under the license, with the final trial being conducted in 
February 2006. Each trial consisted of approximately eight to nine 
subjects. Upon completion of each trial, the facility (where the 
subjects remained during each trial) was surveyed and documented to 
contain less than background levels of radiation.
    The subjects remained at the facility until approximately 80-90% of 
the excretion was collected. The uptake, excretion and distribution of 
the pharmaceutical in the respective subjects were observed and 
measured. The samples were collected by the licensee and analyzed by a 
liquid scintillation counter, and subsequently disposed of in the 
sanitary sewerage. The total activity of carbon-14 ordered by the 
licensee was 5,089 [mu]Ci, of which 2,494 [mu]Ci was used during the 
Phase one trials. The remainder of the radioactive material was either 
returned to the sponsor or transferred to a licensed recipient.
    Based on the use of the radioactive materials in accordance with 10 
CFR 30.36(g), the Licensee was not required to submit a decommissioning 
plan to the NRC since any decommissioning activities and procedures 
implemented were consistent with those approved for routine operations.
    The Need for the Proposed Action: The Licensee has ceased licensed 
activities at the facility and seeks to release the facility for 
unrestricted use and subsequent license termination. Environmental 
Impacts of the Proposed Action: The historical review of licensed 
activities conducted at the facility documents that the activities 
involved the use of only carbon-14 as a tagged pharmaceutical in a pre-
packaged capsule. The quantity amount in each capsule was approximately 
100 [mu]Ci and the last use of licensed material was conducted in 
February 2006. During the research trials, the Licensee disposed of the 
excretion samples into the sanitary sewerage in accordance with the 
regulatory requirements in 10 CFR 20.2003.
    The licensee has requested termination of the license because all 
work with radioactive materials at the facility have been discontinued. 
The proposed release of the licensee's facility for unrestricted use 
does not effect any environmental resource, since there are no 
remediation requirements for the facility or potential release of 
radioactive materials to the environment.
    The Licensee conducted a final status survey of the facility during 
August 2006. The final status survey report was submitted on October 
10, 2006, as part of the license amendment request. The submitted 
results were not statistically significant from background and 
therefore, the net results did not contain any activity above 
background. The NRC allows licensees to demonstrate compliance with the 
radiological criteria for unrestricted use as specified in 10 CFR 
20.1402 by using the screening approach described in NUREG-1757, 
``Consolidated NMSS Decommissioning Guidance,'' Volume 2. The 
Licensee's results did not contain any activity above background and 
therefore were below any NRC criteria and were 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 
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 licensee's 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.

[[Page 11061]]

    The NRC staff finds that the proposed release of the facility for 
unrestricted use and the termination of the NRC license are in 
compliance with 10 CFR 20.1402. Based on its review, the staff 
considered the impact of any residual radioactivity in the laboratory 
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 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. The NRC's analysis 
of the Licensee's final status survey data confirmed that release of 
the facility meets the requirements of 10 CFR 20.1402 for unrestricted 
use. 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 use 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 Contacted: NRC provided a draft of this EA to 
the State of Hawaii for review on January 22, 2006. The State of Hawaii 
did not provide any comments to 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 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 
amendment and supporting documentation, are available electronically at 
the NRC's Electronic Reading Room at http://www.nrc.gov/reading-rm.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. 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).
    2. NRC, ``Consolidated NMSS Decommissioning Guidance,'' NUREG-1757, 
Volume 1, Revision 1, September 2003 (ML053260027).
    3. Title 10 Code of Federal Regulations, Part 20, Subpart E, 
``Radiological Criteria for License Termination.''
    4. Title 10, Code of Federal Regulations, Part 51, ``Environmental 
Protection Regulations for Domestic Licensing and Related Regulatory 
Functions.''
    5. Jacobs, Mark, Covance Clinical Research Unit, Inc., 
Decommissioning Report, October 10, 2006 (ML062900229).
    6. Browder, Rachel S., Acknowledgment of Receipt of Final Status 
Survey, October 31, 2006 (ML063040400).
    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 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 2nd day of March 2007.

    For the Nuclear Regulatory Commission.
D. Blair Spitzberg,
Chief, Fuel Cycle Decommissioning Branch, Division of Nuclear Materials 
Safety, Region IV.
 [FR Doc. E7-4415 Filed 3-9-07; 8:45 am]
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