[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)]
[Pages 8256-8258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03419]



[Docket No. No. 40-6563; NRC-2016-0032]

Mallinckrodt, LLC

AGENCY: Nuclear Regulatory Commission.

ACTION: License termination; issuance.


SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is providing 
public notice of the termination of Source Materials License No. STB-
401. The NRC has terminated the license of the decommissioned 
Mallinckrodt facility in St. Louis, Missouri and has approved the site 
for unrestricted release.

DATES: Notice of termination of Source Materials License No. STB-401 
issued on February 18, 2016.

ADDRESSES: Please refer to Docket ID NRC-2016-0032 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-2016-0032. 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 
     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.

[[Page 8257]]

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: The NRC has terminated License No. STB-401, 
held by Mallinckrodt LLC (Mallinckrodt), for a site in St. Louis, 
Missouri and has approved the site for unrestricted release.
    In 1961, Mallinckrodt received License No. STB-401 to extract 
columbium and tantalum from natural ores and tin slags. In July 1993, 
the NRC amended Mallinckrodt's license to a possession only license for 
the purpose of decommissioning and license termination. The 
contamination at the site was due to licensed activities consisted of 
natural uranium, natural thorium, and their associated progeny. The 
Mallinckrodt site is a 43 acre site subdivided into ten areas called 
Plants. The former Columbium-Tantalum (C-T) process areas included 21 
support buildings on approximately 4.2 acres, primarily located within 
Plant 5, but also in portions of Plants 1, 3, 6, 7, and 8.
    In addition to the C-T activities conducted under License No. STB-
401, the Mallinckrodt site was previously used for Manhattan Engineer 
District/Atomic Energy Commission (MED/AEC) activities. The U.S. Army 
Corps of Engineers (USACE) is responsible for remediating these 
portions of the site under the Formerly Utilized Sites Remedial Action 
Program (FUSRAP).
    Mallinckrodt decommissioned the C-T project areas of the site in 
two phases. In Phase I, Mallinckrodt decommissioned the buildings and 
equipment to the extent necessary to meet the NRC's guidelines for 
unrestricted release in Sec.  20.1402 of title 10 of the Code of 
Federal Regulations (10 CFR). Phase I of the decommissioning project 
was completed in February 2007 (ADAMS Accession No. ML070530675).
    Following Phase I decommissioning, the C-T areas remaining for 
remediation were limited to the soil, pavement, and sewers in Plant 5, 
as well as portions of Plant 6 and 7. Mallinckrodt's Phase II 
Decommissioning Plan (DP) (ADAMS Accession Nos. ML083150652 and 
ML101620140) described Mallinckrodt's plan for decommissioning the 
remainder of the C-T project areas to meet the criteria for 
unrestricted release, though the remediation of portions of Plants 6 
and 7 was not included in the DP and was addressed separately, as is 
described below. The NRC approved Mallinckrodt's Phase II DP on July 1, 
2010 (ADAMS Accession No. ML091960063).
    Plants 6 and 7 contained residual contamination from both licensed 
activities and MED/AEC activities. The MED/AEC activities in Plants 6 
and 7 resulted in contamination in buildings and soil in these plants. 
Additionally, in Plant 6, approximately 300 cubic yards of unreacted 
ore (URO) generated as part of the C-T process was buried in 10 
trenches in 1972 and 1973. Plant 7 contained sewers, a grit chamber, 
and two wastewater neutralization basins that were used to support C-T 
    Mallinckrodt and the USACE entered into two agreements to delineate 
remediation responsibilities in Plants 6 and 7. Mallinckrodt's 
responsibilities included the removal of the buried URO in Plant 6 and 
the removal of the grit chamber in Plant 7. On February 9, 2015, USACE 
provided Mallinckrodt with a letter acknowledging that Mallinckrodt had 
completed the removal of the URO and grit chambers and stating that the 
USACE was proceeding with remediation of these areas under FUSRAP 
(ADAMS Accession No. ML15090A705).
    Mallinckrodt's Phase II DP requested that the NRC terminate its 
license in accordance with 10 CFR 20.1402 without accounting for MED/
AEC contamination in demonstrating compliance with the dose limits in 
Sec.  20.1402. In its approval of the Phase II DP, the NRC exempted the 
MED/AEC material from consideration in demonstrating compliance with 
license termination requirements (ADAMS Accession No. ML091960087). The 
basis for granting the exemption was: (1) Mallinckrodt will meet 25 
mrem/year unrestricted release criteria for C-T process areas; and (2) 
unlicensed MED/AEC material is being remediated to the NRC's 
unrestricted release standards of 25 mrem/year by USACE. The dose from 
the residual radioactivity at the site is primarily from the direct 
radiation pathway, therefore the NRC concluded that an individual would 
not simultaneously receive a dose from both areas. The staff, 
therefore, concluded that it is reasonable to terminate License STB-401 
after Mallinckrodt completes decommissioning activities in the C-T 
process areas and demonstrates that the C-T process areas at the site 
meet the NRC's unrestricted release criteria.
    This finding is based in part on USACE's commitment to remediate 
the site under FUSRAP. At the time, Mallinckrodt and USACE had reached 
an agreement regarding delineation of responsibility for remediating 
Plant 6, but had not yet agreed on the delineation of responsibility 
for Plant 7. Therefore, the exemption was conditioned on Mallinckrodt 
and USACE reaching a delineation agreement for Plant 7 before 
decommissioning was complete. Mallinckrodt and USACE entered into a 
delineation agreement for Plant 7 on October 31, 2014 (cover letter 
available at ADAMS Accession No. ML15041A076).
    Mallinckrodt performed remediation of the C-T project areas based 
on their Phase II DP, conducted a Final Status Survey (FSS) and 
provided the NRC with a Final Status Survey Report (FSSR) documenting 
the residual radioactivity remaining on site for which Mallinckrodt was 
responsible (ADAMS Accession No. ML14177A180). Mallinckrodt 
subsequently provided additional information in response to the NRC's 
requests for additional information (ADAMS Accession Nos. ML14339A278, 
ML15177A051, and ML15334A417). On February 12, 2015, Mallinckrodt 
submitted a license amendment application requesting the use of the 
dose assessment approach, as well as the derived concentration 
guideline level (DCGL) approach (ADAMS Accession No. ML15063A404). The 
NRC approved this license amendment request on February 4, 2016 (ADAMS 
Accession No. ML15286A174).
    The NRC has now completed its review of the FSSR and associated 
documents according to NUREG-1757, ``Consolidated Decommissioning 
Guidance,'' and guidance in the Multi-Agency Radiation Survey and Site 
Investigation Manual (MARSSIM) (NUREG 1575). The NRC staff has 
concluded that the FSS design and data collected were adequate to 
characterize the residual radioactivity in the portions of the 
Mallinckrodt site where NRC regulated activities took place. The NRC 
staff also concluded that the data analysis and dose assessments 
performed are appropriate and that the projected dose from residual 
radioactivity in these areas is less than the 25 mrem/year dose 
criterion in 10 CFR 20.1402. For these reasons, the NRC staff has 
determined that Mallinckrodt has demonstrated that the site will meets 
the radiological criteria for license termination described in 10 CFR 
part 20 subpart E and the exemption granted by the NRC in its approval 
of the Phase II DP. Therefore, Source Materials License No. STB-401 has 
been terminated.

    Dated at Rockville, Maryland, this 9th day of February 2016.

[[Page 8258]]

    For the Nuclear Regulatory Commission.
Michael A. Norato,
Chief, Materials Decommissioning Branch Division of Decommissioning, 
Uranium Recovery, and Waste Programs, Office of Nuclear Material Safety 
and Safeguards.
[FR Doc. 2016-03419 Filed 2-17-16; 8:45 am]