[Federal Register Volume 73, Number 35 (Thursday, February 21, 2008)]
[Notices]
[Pages 9600-9601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-3203]


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NUCLEAR REGULATORY COMMISSION

[Docket No. 030-36603]


Notice of Availability of Environmental Assessment and Finding of 
No Significant Impact for License Amendment to Byproduct Materials 
License No. 37-30924-01, for the Unrestricted Release of the Tetralogic 
Pharmaceutical Facility in Malvern, PA

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: Farrah Gaskins, Health Physicist, 
Commercial and R&D Branch, Division of Nuclear Materials Safety, Region 
I, 475 Allendale Road, King of Prussia, Pennsylvania 19406; telephone 
(610) 337-5143; fax number (610) 337-5269; or by e-mail: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Introduction

    The U.S. Nuclear Regulatory Commission (NRC) is considering the 
issuance of a license amendment to Byproduct Materials License No. 37-
30924-01. This license is held by TetraLogic Pharmaceuticals (the 
Licensee), for its facility located at 365 Phoenixville Pike in 
Malvern, Pennsylvania (the Facility). Issuance of the amendment would 
authorize release of the Facility for unrestricted use. The Licensee 
requested this action in a letter dated March 27, 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 March 27, 2007, 
license amendment request, resulting in release of the Facility for 
unrestricted use. License No. 37-30924-01 was issued on September 8, 
2004, pursuant to 10 CFR part 30, and has been amended periodically 
since that time. This license authorized the Licensee to use byproduct 
material in any form for purposes of conducting research and 
development activities as defined in 10 CFR 30.4.
    The Facility contains 4,000 square feet of office space and 
laboratories. Within the Facility, use of licensed materials was 
confined to the Biology lab and adjacent lab corridor.
    In July 2004, the Licensee ceased licensed activities, initiated a 
survey and began decontamination of the 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.

Need for the Proposed Action

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

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. Prior 
to performing the final status survey, the Licensee conducted 
decontamination activities, as necessary, in the areas of the Facility 
affected by these radionuclides.
    The Licensee conducted a final status survey on January 31, 2007. 
This survey covered the Biology lab, the adjacent lab corridor, and 
adjacent areas. The final status survey report was attached to the 
Licensee's amendment request dated

[[Page 9601]]

March 27, 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 
Commonwealth of Pennsylvania's Department of Environmental Protection, 
Bureau of Radiation Protection for review on September 10, 2007. On 
December 27, 2007, the Commonwealth of Pennsylvania responded by e-
mail. The Commonwealth 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. NUREG-1757, ``Consolidated NMSS Decommissioning Guidance;''
    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;''
    5. Letter dated March 27, 2007; Final Site Survey and NRC Form 314 
(ML071550135).
    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 King of Prussia, Pennsylvania this 12th day of 
February, 2008.

    For the Nuclear Regulatory Commission.

James P. Dwyer,
Chief, Commercial and R&D Branch, Division of Nuclear Materials Safety, 
Region I.
 [FR Doc. E8-3203 Filed 2-20-08; 8:45 am]
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