E9-6399. Notice of Environmental Assessment Related to the Issuance of a License Amendment To Terminate Byproduct Materials License No. 21-26519-01, for Aastrom Biosciences, Ann Arbor, MI

AGENCY:

Nuclear Regulatory Commission.

ACTION:

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

FOR FURTHER INFORMATION CONTACT:

Samuel J. Mulay, Health Physicist, Materials Control, ISFSI, and Decommissioning Branch, Division of Nuclear Materials Safety, Region III, U.S. Nuclear Regulatory Commission, 2443 Warrenville Road, Lisle, Illinois 60532; telephone: [phone].

SUPPLEMENTARY INFORMATION:

I. Introduction

The U.S. Nuclear Regulatory Commission (NRC) is considering the issuance of an amendment to terminate NRC Byproduct Materials License No. 21-26519-01, which is held by Aastrom Biosciences (licensee). The issuance of the amendment would authorize the unrestricted release of the licensee's facility located at 24 Frank Lloyd Wright Drive, Lobby K, Domino's Farm, Ann Arbor, Michigan (the Facility).

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 termination amendment request dated September 30, 2008, (ML090210643), and approve release of the Facility for unrestricted use in accordance with 10 CFR part 20, subpart E. The licensee operated a research laboratory in a 20,000 square foot leased space. License No. 21-26519-01 was issued on September 10, 1993, pursuant to 10 CFR part 30, and has been amended periodically since that time. This license authorized the use of unsealed byproduct materials for conducting a variety of research and development applications on laboratory bench tops and in hoods. The Facility is located in a mixed residential, agricultural and commercial area, and a former authorized location of use there was previously released by the NRC for unrestricted use. The licensee ceased licensed activities in April 2007 and Lobby K was used to store standard sources and a cell harvester. The licensee did not perform research activities involving licensed material in Lobby K. 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 submitted a license termination request in a letter dated September 30, 2008, (ML090210643). The licensee submitted a final status survey report to the NRC on October 31, 2008, (ML083080216), and additional correspondence dated February 11, 2009, (ML090500353), which demonstrates that the Lobby K facility meets the criteria in subpart E of 10 CFR part 20 for unrestricted use.

Need for the Proposed Action

The Licensee has ceased conducting licensed activities at the Facility and seeks the unrestricted use of the Facility.

Environmental Impacts of the Proposed Action

The historical review of licensed research activities performed by the licensee at the Facility determined that the activities involved primarily the use of hydrogen-3, which has a half-life greater than 120 days.

The licensee's final status survey report was attached to the Licensee's letter dated October 31, 2008, (ML083080216). The licensee's report indicated that the final status survey of its Facility was completed on October 1, 2008. Additional correspondence was submitted in a letter dated February 11, 2009, (ML090500353) to clarify and support information provided in the final status survey report.

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 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 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 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 and additional, supporting documentation 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. 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

On February 4, 2009, the NRC provided a draft of this EA to the State of Michigan, Radioactive Material and Medical Waste Materials Unit, Waste and Hazardous Materials Division, Michigan Department of Environmental Quality. The State responded by e-mail on February 4, 2009, and 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 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 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. Bradley J. Martin, PhD., Aastrom Biosciences, letter to U.S. Nuclear Regulatory Commission, Region III, dated September 30, 2008, (ADAMS Accession No. ML090210643).

2. Bradley J. Martin, PhD., Aastrom Biosciences, letter dated October 31, 2008, with the attached final status survey to U.S. Nuclear Regulatory Commission, Region III, (ADAMS Accession No. ML083080216).

3. Bradley J. Martin, PhD., Aastrom Biosciences, letter to the U.S. Nuclear Regulatory Commission, Region III, dated February 11, 2009, (ADAMS Accession No. ML090500353).

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”;

7. NUREG-1757, Consolidated 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 13th day of March 2009.

For the Nuclear Regulatory Commission.

Christine A. Lipa,

Chief, Materials Control, ISFSI, and Decommissioning Branch, Division of Nuclear Materials Safety, Region III.