[Federal Register Volume 72, Number 200 (Wednesday, October 17, 2007)]
[Notices]
[Pages 58908-58909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20453]


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NUCLEAR REGULATORY COMMISSION

[Docket No. 030-33266]


Notice of Environmental Assessment Related to the Issuance of a 
License Amendment to Byproduct Material License No. 21-26519-01, for 
Unrestricted Release of Former Facilities for Aastrom Biosciences, Ann 
Arbor, 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: George M. McCann, 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) 829-9856; 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 an amendment to NRC Byproduct Materials License No. 21-
26519-01. This license is held by Aastrom Biosciences (licensee) for 
its Gene Therapy Laboratory (the facility) located at 24 Frank Lloyd 
Wright Drive, Lobby L, Domino's Farm, Ann Arbor, Michigan. Issuance of 
the amendment would authorize the unrestricted release of the 
licensee's Gene Therapy Laboratory and associated offices for 
unrestricted use. The licensee requested this action in a letter dated 
July 16, 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 July 16, 2007, 
license amendment request, resulting in the release of the facility 
located at 24 Frank Lloyd Wright Drive, Lobby L, Domino's Farm, Ann 
Arbor, Michigan for unrestricted use. 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 
licensee to use unsealed byproduct materials for conducting research 
and development activities on laboratory bench tops and in hoods.
    The licensee's facility is situated in a four-story commercial 
office building, which is located at 24 Frank Lloyd Wright Drive, Lobby 
L, Domino's Farm, Ann Arbor, Michigan, and consists of office space and 
a ``Gene Therapy Laboratory.'' The site is located in a mixed 
residential, agricultural and commercial area. Within the facility, use 
of licensed materials was confined to the Gene Therapy Laboratory, 
which was approximately 414 square feet.
    On May 16, 2007, the licensee ceased licensed activities in the 
Gene Therapy Laboratory and initiated a survey and decontamination of 
the licensee's 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 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 facility and provided information to the NRC to demonstrate that 
it meets the criteria in Subpart E of 10 CFR Part 20 for unrestricted 
release. The licensee will continue licensed operations at another 
approved location.

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 conducted at 
the facility shows that the activities involved only the use of 
hydrogen-3, which has a half-life greater than 120 days. Prior to 
performing the final status survey, the licensee conducted 
decontamination activities, as necessary, in the areas of the facility 
affected by the hydrogen-3.
    The licensee conducted a final status survey on May 29, 2007. This 
survey covered the facility located at 24 Frank Lloyd Wright Drive, 
Lobby L, Domino's Farm, Ann Arbor, Michigan (ADAMS Accession No. 
ML072010257). The final status survey report was attached to the

[[Page 58909]]

Licensee's amendment request dated July 16, 2007. 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 
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 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

    NRC provided a draft of this Environmental Assessment to the 
Radioactive Material and Medical Waste Materials Unit, Waste and 
Hazardous Materials Division, Michigan Department of Environmental 
Quality for review on September 10, 2007. On September 14, 2007, Mr. 
Robert Skowronek, Chief, Radioactive Material and Medical Waste 
Materials Unit, Waste and Hazardous Materials Division, Michigan 
Department of Environmental Quality, 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. 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]. The documents related to this action are listed below, 
along with their ADAMS accession numbers.
    1. Report on the Final Radiological Status of Areas Being Vacated 
by Aastrom Biosciences, Inc., dated May 29, 2007 (ADAMS Accession No. 
ML072010257).
    2. Title 10 Code of Federal Regulations, Part 20, Subpart E, 
``Radiological Criteria for License Termination;''
    3. Title 10 Code of Federal Regulations, Part 51, ``Environmental 
Protection Regulations for Domestic Licensing and Related Regulatory 
Functions;''
    4. NUREG-1496, ``Generic Environmental Impact Statement in Support 
of Rulemaking on Radiological Criteria for License Termination of NRC-
Licensed Nuclear Facilities;'' NUREG-1757, Consolidated NMSS 
Decommissioning Guidance.
    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 5th day of October 2007.

    For the Nuclear Regulatory Commission,
Patrick Louden,
Chief, Decommissioning Branch, Division of Nuclear Materials Safety 
Region III.
 [FR Doc. E7-20453 Filed 10-16-07; 8:45 am]
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