[Federal Register Volume 72, Number 229 (Thursday, November 29, 2007)]
[Notices]
[Pages 67609-67611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-23159]


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NUCLEAR REGULATORY COMMISSION

[Docket No. 030-04781]


Notice of Availability of Environmental Assessment and Finding of 
No Significant Impact for License Amendment to Byproduct Materials 
License No. 21-00182-03, for Unrestricted Release of the Pharmacia & 
Upjohn Company's Facilities in Kalamazoo, MI

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: William Snell, Senior Health 
Physicist, Decommissioning Branch, Division of Nuclear Materials 
Safety, Region III, U.S. Nuclear Regulatory Commission, 2443 
Warrenville Road, Lisle, Illinois 60532; telephone: (630) 829-9871; fax 
number: (630) 515-1259; or by e-mail at [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. 21-
00182-03. This license is held by Pharmacia & Upjohn Company, LLC (the 
Licensee), a subsidiary of Pfizer, Inc., and governs licensed 
activities at its 7000 Portage Road, Kalamazoo, Michigan site. Issuance 
of the amendment would authorize release of Building 172 and the 
adjoining North Tank Farm (the Facilities) for unrestricted use. 
Licensed activities will continue at other site locations.
    The Licensee requested this action in a letter dated August 22, 
2007. 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 August 22, 2007, 
license amendment request, resulting in release of the Facilities for 
unrestricted use. License No. 21-00182-03 was issued on April 24,1958, 
pursuant to 10 CFR part 30, and has been amended periodically since 
that time. This license authorizes the Licensee to use byproduct 
materials for activities involving research and development. Amendment 
21 issued on July 31, 1984, authorized the incineration of licensed 
materials in Building 172. The principal types of waste burned in the 
incinerator in Building 172 included pathologic wastes, trash, returned 
pharmaceuticals, organic process residues, waste solvents and 
laboratory chemicals. Some of this incinerated waste was contaminated 
with low levels of radioactive materials.
    The Facilities are situated on a 1728 acre pharmaceutical complex 
consisting of multiple chemical and compound manufacturing structures 
including offices and pharmaceutical manufacturing facilities. Building 
172 is a one story building of about 8500 square feet that is 24 feet 
in height which contains the incinerator, operating controls, emissions 
controls, office areas, and waste receipt, transfer and shipping areas. 
The incinerator is a rotary kiln that is 12 feet long and 5\1/2\ feet 
in diameter with a secondary combustion chamber that is 19 feet long 
and about 8 feet in diameter. The adjoining North Farm Area consists of 
three 10,000 gallon steel and carbon tanks used to store liquids prior 
to incineration. The pharmaceutical complex is located in a mixed 
residential, agricultural and commercial area.
    The licensee ceased using the 10,000 gallon tanks to receive or 
store radioactive liquids in 1996 and ceased using the incinerator in 
Building 172 in December 2006. A facility historical site assessment 
and scoping surveys were performed in January 2007, while demolition 
and final status surveys of the Facilities were initiated in June 2007. 
Based on the Licensee's historical knowledge of the site and the 
conditions of the Facilities, 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 
Facilities in June and July 2007 and provided information to the NRC to 
demonstrate that they meet the criteria in Subpart E of 10 CFR part 20 
for unrestricted release.

[[Page 67610]]

Need for the Proposed Action

    The Licensee has ceased conducting licensed activities in the 
Facilities and seeks their unrestricted use.

Environmental Impacts of the Proposed Action

    The historical review of the relevant licensed activities 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 affected by 
these radionuclides.
    The Licensee completed final status surveys in July 2007 covering 
all areas of the Facilities. The final status survey report was 
attached to the Licensee's amendment request dated August 22, 2007. The 
Licensee elected to demonstrate compliance with the radiological 
criteria for unrestricted release as specified in 10 CFR 20.1402 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 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 
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 in Building 172 and the adjoining North 
Farm Area. 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 Facilities. 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 Facilities for 
unrestricted use is in compliance with 10 CFR 20.1402, including the 
impact of residual radioactivity at previously-released site locations 
of use. Based on its review, the staff considered the impact of the 
residual radioactivity from the Facilities 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 Building 172 and the adjoining 
North Farm Area meet 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 
Michigan Department of Environmental Quality (DEQ) for review on 
October 31, 2007. On November 6, 2007, Mr. Bob Skowronek, Chief, 
Radioactive Materials Unit, with the Michigan DEQ, responded by e-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 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. Dee L. Clement, Pfizer, Inc., letter to William Snell, U.S. 
Nuclear Regulatory Commission, Region III, dated August 22, 2007 (ADAMS 
Accession No. ML072360479);
    2. NRC Inspection Report No. 030-04781/07-01(DNMS) (NRC Form 591M) 
dated June 29, 2007 (ADAMS Accession No. ML071840206);
    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. NUREG-1496, ``Generic Environmental Impact Statement in Support 
of Rulemaking on Radiological Criteria for License Termination of NRC-
Licensed Nuclear Facilities;''
    6. NUREG-1757, ``Consolidated NMSS Decommissioning Guidance.''

[[Page 67611]]

    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 Lisle, Illinois, this 16th day of November 2007.

    For the Nuclear Regulatory Commission.
Patrick L. Louden,
Chief, Decommissioning Branch, Division of Nuclear Materials Safety, 
Region III.
[FR Doc. E7-23159 Filed 11-28-07; 8:45 am]
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