[Federal Register Volume 71, Number 174 (Friday, September 8, 2006)]
[Notices]
[Pages 53136-53137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14874]


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NUCLEAR REGULATORY COMMISSION

[Docket No. 030-30074]


Notice of Availability of Environmental Assessment and Finding of 
No Significant Impact for License Amendment to Byproduct Materials 
License No. 29-28056-01, for Unrestricted Release of the Celgene 
Corporation's Facility in Warren, NJ

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, PA 19406; 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. 29-
28056-01. This license is held by Celgene Corporation (the Licensee), 
for the facility located at 7 Powder Horn Drive in Warren, New Jersey 
(the Facility). Issuance of the amendment would authorize release of 
the Facility for unrestricted use. The Licensee requested this action 
in a letter dated January 17, 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 January 17, 2006, 
license amendment request, resulting in release of Celgene 
Corporation's Warren, NJ facility for unrestricted use. License No. 29-
28056-01 was issued on September 10, 1987, 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 Facility occupies 38,500 square feet and consists of 
administrative office and laboratories. The Facility is located in a 
light industrial area. Use of licensed material was confined to Rooms 
13, 14, 15, 18A, 20, 105, 106, 113, Waste and Chemical Storage areas, 
associated hallways, and undeveloped areas of approximately 10,000 
square feet within the Facility.
    On August 15, 2005, the Licensee ceased licensed activities and 
initiated a survey, and decontamination of the areas in which licensed 
materials were used within 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 its 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 areas where licensed materials 
were used 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: hydrogen-3 and 
carbon-14. 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 on December 5-7, 2005. 
This survey covered Rooms 13, 14, 15, 18A, 20, 105, 106, 113, Waste and 
Chemical Storage areas, underdeveloped areas and associated hallways. 
The final status survey report was enclosed with the Licensee's 
amendment request dated January 17, 2006, as supplemented in a letter 
dated April 28, 2006. 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. 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 concludes that the Licensee's final status survey results are thus 
acceptable.

[[Page 53137]]

    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). 
Accordingly, 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 found 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 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, 
a 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 Environmental Assessment to the State 
of New Jersey Department of Environmental Protection for review on June 
13, 2006. On June 29, 2006, the Department of Environmental Protection 
responded by letter. 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. Amendment Request Letter dated January 17, 2006 [ML060240189];
    2. Letter with additional information dated April 28, 2006 
[ML061300452];
    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;''
    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 475 Allendale Road, King of Prussia, PA, this 29th day 
of August 2006.

    For the Nuclear Regulatory Commission.
James P. Dwyer,
Chief, Commercial and R&D Branch, Division of Nuclear Materials Safety, 
Region 1.
 [FR Doc. E6-14874 Filed 9-7-06; 8:45 am]
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