E7-23159. 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 ...

AGENCY:

Nuclear Regulatory Commission.

ACTION:

Issuance of Environmental Assessment and Finding of No Significant Impact for License Amendment.

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: [phone]; fax number: [phone]; or by e-mail at [e-mail].

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 51/2 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.

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.”

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 [e-mail]. 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.