[Federal Register Volume 73, Number 115 (Friday, June 13, 2008)]
[Notices]
[Pages 33856-33858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-13327]


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NUCLEAR REGULATORY COMMISSION

[Docket No. 030-04336]


Notice of Environmental Assessment Related to the Issuance of a 
License Amendment To Terminate Byproduct Material License No. 13-02249-
01, for Bayer Healthcare, LLC, Elkhart, IN

AGENCY: Nuclear Regulatory Commission.

ACTION: Issuance of Environmental Assessment and Finding of No 
Significant Impact for License termination.

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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 terminate NRC Byproduct Materials License 
No. 13-02249-01, which is held by Bayer Healthcare, LLC (licensee). The 
issuance of the amendment would authorize the unrestricted release of 
the licensee's facilities located at 1884 Miles Avenue, Elkhart, 
Indiana, and 1000 Randolph Street, Elkhart, Indiana (the facilities). 
The addresses specified in the licensee's license, 1884 Miles Avenue, 
Elkhart, Indiana, and 1000 Randolph Street, Elkhart, Indiana all refer 
to the same licensed site.
    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. 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 Bayer Healthcare's request to 
terminate its license and release the licensee's former facilities for 
unrestricted use in accordance with 10 CFR Part 20, Subpart E. The 
licensee requested termination of the Bayer Healthcare, LLC license in 
a letter dated October 23, 2006 (ADAMS Accession Number ML062970437), 
and the NRC's ``Certificate of Disposition of Materials,'' dated 
October 31, 2007 (ML073050274), with a ``Historical Site Assessment for 
the Elkhart, Indiana Facility'' (ML081400331), and a ``Final Status 
Survey Report for Selected Laboratories in Building 18,'' Report No. 
2007006/G-4349, October 29, 2007 (ML081400331) attached. The Bayer 
Healthcare License No. 13-02249-01 was originally issued March 21, 
1957, to Miles Laboratory, Inc. (later known as Miles-Ames Research 
Laboratory) 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 involving animals, production of reagent test 
kits, and on laboratory bench tops and in hoods.
    Since that time, research facilities were built on the Miles-Ames 
campus, consisting of approximately seven acres and as many as 41 
buildings. The campus was operated by Miles, Inc. until 1978 when the 
property was purchased by Bayer Corporation. The company name, Bayer 
HealthCare, LLC, was changed in 1995. The licensee's research campus is 
bounded by Bristol Street (State Route 19) to the north, North Michigan 
Street to the east, Mishawaka Street to the south, and Oak Street to 
the west. Building 9, the C.S. Beardsley Building, was the principal 
building in which radioactive materials were used. This C.S. Beardsley 
Building was demolished in 1999, and research involving radioactive 
materials was moved to Building 18. The licensee's license was amended 
by the NRC on November 18, 1999 (Amendment No. 47), authorizing the 
release of the C.S. Beardsley Building.
    Radioactive materials were used in Building 18 until 2006. The 
licensee had also used materials in other buildings and at remote 
locations approved by the NRC, which were subsequently removed from the 
license by previous amendments. A complete list of these locations of 
use, both at the Elkhart, Indiana research campus and at remote sites 
are discussed in the licensee's ``Historical Site Assessment for the 
Elkhart, Indiana Facility.''
    Building 18 is located on the Elkhart, Indiana research campus, and 
is a multi-story brick building that was constructed to house various 
chemical research and development activities. Radioactive materials 
were used in Building 18 from 1975 to 2006. The Building 18 
laboratories were equipped with cabinets, ventilation hoods, and sinks. 
The concrete floors in each of the laboratories were covered with an 
industrial-grade tile to restrict the absorption of liquids. The 
building is currently maintained by Bayer.
    A wide range of research was conducted in Building 18, wherein both 
short- and long-lived radioisotopes were used. Several areas in 
Building 18 used hydrogen-3 and carbon-14 during the late 1970s and 
into the early 1990s. These isotopes were used in quantities ranging 
from microcuries to millcuries in different chemical forms. From 1995 
until the present day, the use of radioactivity was limited primarily 
to microcurie quantities of iodine-125.
    Miles Laboratories and Bayer did not dispose of radioactive waste 
via on-site burial. All waste containing long-lived radioisotopes was 
shipped offsite to a licensed landfill approved to receive and dispose 
of radioactive materials. There were no related environmental concerns 
identified during the record search or interviews of the radiation 
safety staff. There were no recorded spills or loss of control that 
required additional investigation.
    The licensee ceased licensed activities and completed 
decontamination of the licensee's facilities in 2006. The licensee also 
completed ``in-house surveys,'' which were submitted to the NRC on 
October 23, 2006

[[Page 33857]]

(ML0629704371). The licensee completed a ``Historical Site Assessment 
for the Elkhart, Indiana Facility, Bayer Healthcare, LLC,'' and a 
``Final Status Survey Report for Selected Laboratories in Building 
18,'' which was completed between August 13 and 15, 2007. Based on the 
licensee's survey results, it was determined that only routine 
decontamination activities, in accordance with the licensee's 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 and provided information to the NRC to demonstrate 
that it meets 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 at its 
facilities and it seeks the unrestricted use of its facilities.

Environmental Impacts of the Proposed Action

    The historical review of licensed activities conducted at the 
facility 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 radiation surveys and decontamination activities, as 
necessary, in the areas of the facility affected by these 
radionuclides.
    The licensee conducted a final status survey between August 13 and 
15, 2007, in Building 18. Based on previous surveys by the licensee and 
the historical site assessment, surveys were only required in two rooms 
of Building 18, the previous Room C.05 (the former ``Rad Lab'') and the 
former Waste Storage Room. The licensee's surveys included the liquid 
drain and ventilation exhaust systems.
    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, 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 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

    The NRC provided a draft of this Environmental Assessment to the 
Emergency Response Program, Entomology and Epidemiology Labs, Radiation 
Control, Indiana State Department of Health, for review on May 18, 
2008. On May 19, 2008, the Program Director of the Emergency Response 
Program, responded by e-mail indicating, ``We concur with the NRC 
decision that a Finding of No Significant Impact (FONSI) is appropriate 
with respect to the proposed action, meaning that the licensee's 
facilities can be utilized for unrestricted use and NRC Byproduct 
Materials License No. 13-02249-01 will subsequently be terminated.''
    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/

[[Page 33858]]

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. Shannon L. Gleason, Ph.D., Bayer HealthCare, letter to U.S. 
Nuclear Regulatory Commission, Region III, dated October 23, 2006 
(ML062970437);
    2. Certificate of Disposition of Materials, dated November 31, 
2007, signed by Shannon L. Gleason, Ph.D. (ML073050274);
    3. Bayer HealthCare, LLC, Report No. 2007006/G4349, ``Final Status 
Report for Selected Laboratories in Building 18'' (ML081400331);
    4. Bayer HealthCare, LLC, Report No. 2007006/G-4351, ``Historical 
Site Assessment for the Elkhart, Indiana Facility'' (ML081400331);
    5. Title 10 Code of Federal Regulations, Part 20, Subpart E, 
``Radiological Criteria for License Termination'';
    6. Title 10 Code of Federal Regulations, Part 51, ``Environmental 
Protection Regulations for Domestic Licensing and Related Regulatory 
Functions'';
    7. NUREG-1496, ``Generic Environmental Impact Statement in Support 
of Rulemaking on Radiological Criteria for License Termination of NRC-
Licensed Nuclear Facilities'';
    8. 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 [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 5th day of June 2008.

    For the Nuclear Regulatory Commission.
Christine A. Lipa,
Chief, Decommissioning Branch, Division of Nuclear Materials Safety, 
Region III.
[FR Doc. E8-13327 Filed 6-12-08; 8:45 am]
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