[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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