[Federal Register Volume 81, Number 23 (Thursday, February 4, 2016)]
[Notices]
[Pages 6057-6059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02131]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 40-6563; NRC-2015-0139]
Mallinckrodt, LLC.
AGENCY: Nuclear Regulatory Commission.
ACTION: Environmental assessment and finding of no significant impact;
issuance.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is considering
amending the NRC's Source Materials License No. STB-401 to allow the
option to perform direct dose assessment of residual radioactivity in
addition to using derived concentration guideline levels (DCGLs) to
demonstrate compliance with the license termination criteria at the
Mallinckrodt site in St. Louis, Missouri. The NRC staff is issuing an
environmental assessment (EA) and finding of no significant impact
(FONSI) associated with the proposed action.
DATES: The EA and FONSI referenced in this document are available on
February 4, 2016.
ADDRESSES: Please refer to Docket ID NRC-2015-0139 when contacting the
NRC about the availability of information regarding this document. You
may obtain publicly-available information related to this document
using any of the following methods:
Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0139. Address
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; email: [email protected]. For technical questions, contact
the individual listed in the FOR FURTHER INFORMATION CONTACT section of
this document.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly-available documents online in the
ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``ADAMS Public Documents'' and
then select ``Begin Web-based ADAMS Search.'' For problems with ADAMS,
please contact the NRC's Public Document Room (PDR) reference staff at
1-800-397-4209, 301-415-4737, or by email to [email protected]. The
ADAMS accession number for each document referenced (if that document
is available in ADAMS) is provided the first time that a document is
referenced.
NRC's PDR: You may examine and purchase copies of public
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland 20852.
FOR FURTHER INFORMATION CONTACT: Karen Pinkston, Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington DC 20555-0001; telephone: 301-415-3650; email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Introduction
The NRC is considering issuance of an amendment to the NRC's Source
Materials License No. STB-401, issued to Mallinckrodt, for operation of
their facility located in St. Louis, Missouri. This amendment allows
Mallinckrodt the option to perform direct dose assessment of residual
radioactivity in addition to using derived concentration guideline
levels (DCGLs) to demonstrate compliance with the license termination
criteria at the Mallinckrodt site in St. Louis, Missouri. Consistent
with part 51 of title 10 of the Code of Federal Regulations (10 CFR),
the NRC performed an EA. Based on the results of the EA described
below, the NRC will not prepare an environmental impact statement for
the license amendment, and is issuing a FONSI.
The NRC received, by letter dated February 12, 2015 (ADAMS
Accession No. ML15063A404), an application from Mallinckrodt LLC to
amend the NRC's Source Materials License No. STB-401. The licensee
requests the option to perform direct dose assessment of residual
radioactivity in addition to using DCGLs to demonstrate compliance with
the license termination criteria in 10 CFR 20.1402 at the Mallinckrodt
site in St. Louis, Missouri. The license currently states that the
Decommissioning of the Columbium-Tantalum (C-T) process area building
slabs and foundations, paved surfaces, and all subsurface materials,
shall be done in accordance with the Mallinckrodt C-T Decommissioning
Project, C-T Phase II Decommissioning Plan (DP), Revision 2, submitted
to NRC on October 14, 2008 (ADAMS Accession No. ML083150652), and
revisions submitted on June 3, 2010 (ADAMS Accession No. ML101620140).
A Notice of Availability of an EA and FONSI was published for the NRC's
approval of the DP in the Federal Register on July 1, 2010 (75 FR
38148). The NRC approved
[[Page 6058]]
this DP on July 1, 2010 (ADAMS Accession No. ML091960063). The DP only
included the use of the DCGL approach to demonstrate compliance with
the license termination criteria. The NRC's guidance in NUREG-1757,
Vol. 2, allows for the use of either the DCGL or dose assessment
approach in demonstrating compliance with 10 CFR 20.1402.
On June 4, 2015, the NRC published in the Federal Register (80 FR
31927), a Notice of Opportunity for Hearing on the February 12, 2015,
Mallinckrodt license amendment request. No request for a hearing was
received.
II. Environmental Assessment
Description of the Proposed Action
The proposed action is approval of a requested license amendment.
Mallinckrodt LLC requests the option to perform direct dose assessment
of residual radioactivity in addition to using DCGLs to demonstrate
compliance with the license termination criteria in 10 CFR 20.1402 at
the Mallinckrodt site in St. Louis, Missouri. The NRC's guidance in
NUREG-1757, Vol. 2, allows for the use of either the DCGL or dose
assessment approach in demonstrating compliance with the license
termination criteria. In its amendment request, Mallinckrodt proposed
to evaluate two different scenarios in its dose assessment: an
industrial worker who works on the site and an intruder into the
subsurface material. In the first scenario, the residual radioactivity
that is located at depth is assumed to be covered with non-contaminated
material. In the second scenario, the potential dose due to an
intrusion into the material because of pipeline installation or
foundation construction is evaluated.
The proposed action is in accordance with the licensee's
application dated February 12, 2015 (ADAMS Accession No. ML15063A404).
Need for the Proposed Action
Mallinckrodt is not permitted to use the dose assessment approach
without a license amendment authorizing that approach. During site
remediation, Mallinckrodt identified areas of elevated contamination
that are located at depth in inaccessible areas. The DCGL values
developed in Mallinckrodt's DP were based on the conservative
assumption that the residual radioactivity was located at the surface.
The use of the dose assessment approach instead of the DCGL approach
allows Mallinckrodt to evaluate the actual configuration of residual
radioactivity in a more realistic manner; and thus, to avoid
conservative remediation activities not needed to protect health and
safety. The removal of the inaccessible residual radioactivity to
levels that are below the previously approved DCGL values would require
extraordinary measures such as undermining building foundations and
structures or installing sheet pilings for soil stability.
Environmental Impacts of the Proposed Action
The proposed action is administrative and would have no direct
environmental impacts, but it would authorize Mallinckrodt to adopt a
dose assessment approach to demonstrate compliance with the license
termination criteria in 10 CFR 20.1402. The EA for Mallinckrodt's Phase
II DP described the potential environmental effects from the
remediation of radiologically contaminated soil and pavement of the
site.
The maximum total radiological dose from both the proposed action
and the previously approved DCGL values will be less than the 25 mrem/
yr criteria in 10 CFR 20.1402. However, the configuration of the
residual radioactivity allowed to remain at the site would likely be
different based on the dose assessment approach than would be allowed
based on the previously approved DCGL values. The DCGL values resulted
in a lower total allowed level of residual radioactivity, while the
dose assessment approach will result in a higher allowed level located
at depth, reflecting the fact that not all contamination is at the
surface, which is assumed in the DCGL values. The projected dose from
residual radioactivity at the Mallinckrodt site is through the direct
radiation, soil ingestion, and inhalation of dust pathways. The
projected dose from the in situ residual radioactivity located at depth
under clean cover at the Mallinckrodt site is therefore much smaller
than the dose from comparable residual radioactivity located at the
surface. Mallinckrodt's evaluation of the potential dose due to an
intrusion demonstrates that the dose will remain less than 25 mrem/yr
even if the material is uncovered. The difficulty of additional
remediation of residual radioactivity located in inaccessible areas
makes such remediation unreasonable, therefore the ALARA requirement in
10 CFR 20.1402 is met for the dose assessment approach despite the
reduction in required remediation activities.
There are no cumulative effects from the proposed action and
previously approved actions at the site because the total dose from
residual radioactivity at the site will continue to be less than the 25
mrem/yr criteria and there will be no additional environmental impacts
beyond those described in the EA associated with the Phase II DP.
Environmental Impacts of the Alternatives to the Proposed Action
The alternative to the proposed action is denial of the requested
license amendment. If Mallinckrodt is not authorized to use the dose
assessment approach to demonstrate compliance with 10 CFR 20.1402, then
Mallinckrodt would have to remove the inaccessible residual
radioactivity to levels that are below the approved DCGL values in
order to terminate their license. The removal of this material would
require extraordinary measures to remove without damaging the buildings
that are over this material. The additional removal also creates a
potential for radiological environmental impacts. Radiological
environmental impacts that could result from remediation activities
include exposure, inhalation, and ingestion hazards to workers and the
public. These hazards could occur during excavation and loading of
radioactively contaminated material. Air quality and noise impacts
could also result from these remediation activities. The potential
impacts from any additional remediation activities are described in the
EA for the DP, specifically, Phase II remediation activities.
Alternative Use of Resources
The proposed action does not affect any resource implications
discussed in previous environmental reviews.
Agencies and Persons Consulted
In accordance with its stated policy, on September 15, 2015, the
staff consulted with the Missouri Department of Natural Resources
regarding the environmental impact of the proposed action. No comments
were received. The NRC did not consult with either the U.S. Fish and
Wildlife Service or the State Historic Preservation Office because the
proposed action, approval of the requested license amendment, can only
result in a reduction of previously considered impacts to these
resource areas. In fact, the need for the proposed action is to allow
Mallinckrodt to avoid previously authorized activities that would be
required in the absence of the proposed action.
III. Finding of No Significant Impact
Consistent with 10 CFR 51.21, the NRC conducted the EA for the
proposed action described in Section II of this
[[Page 6059]]
document, the EA is publicly available in ADAMS under Accession No.
ML15268A311). On the basis of the environmental assessment, the NRC
concludes that the proposed action will not have a significant effect
on the quality of the human environment. Accordingly, the NRC will not
prepare an environmental impact statement for the proposed action.
Dated at Rockville, Maryland, this 4th day of January 2016.
For the Nuclear Regulatory Commission.
Michael A. Norato,
Branch Chief, Materials Decommissioning Branch, Division of
Decommissioning, Uranium Recovery, and Waste Programs Office of Nuclear
Material Safety and Safeguards.
[FR Doc. 2016-02131 Filed 2-3-16; 8:45 am]
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