[Federal Register Volume 74, Number 56 (Wednesday, March 25, 2009)]
[Notices]
[Pages 12911-12913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-6399]


-----------------------------------------------------------------------

NUCLEAR REGULATORY COMMISSION

[Docket No. 030-33266; NRC-2009-0130]


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: 
(630) 829-9837.

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

[[Page 12912]]

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'';

[[Page 12913]]

    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 [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 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.
[FR Doc. E9-6399 Filed 3-24-09; 8:45 am]
BILLING CODE 7590-01-P