81 FR 6057 - Mallinckrodt, LLC.
NUCLEAR REGULATORY COMMISSION Federal Register Volume 81, Issue 23 (February 4, 2016)
Federal Register Volume 81, Issue 23 (February 4, 2016)
| Page Range | 6057-6059 | |
| FR Document | 2016-02131 |
[Federal Register Volume 81, Number 23 (Thursday, February 4, 2016)] [Notices] [Pages 6057-6059] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-02131] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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: Carol.Gallagher@nrc.gov. 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 pdr.resource@nrc.gov. 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: Karen.Pinkston@nrc.gov. 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] BILLING CODE 7590-01-P
![Federal Register / Vol. 81, No. 23 / Thursday, February 4, 2016 / Notices 6057
updates will be available at http:// For the Nuclear Regulatory Commission. ADAMS accession number for each
www.nrc.gov/reading-rm/doc- Andrew L. Bates, document referenced (if that document
collections/acmui/meetings/2016.html Advisory Committee Management Officer. is available in ADAMS) is provided the
or by emailing Ms. Sophie Holiday at [FR Doc. 2016–02121 Filed 2–3–16; 8:45 am] first time that a document is referenced.
the contact information below. BILLING CODE 7590–01–P
• NRC’s PDR: You may examine and
Purpose: Discuss issues related to 10 purchase copies of public documents at
CFR part 35 Medical Use of Byproduct the NRC’s PDR, Room O1–F21, One
Material. NUCLEAR REGULATORY White Flint North, 11555 Rockville
Date and Time for Open Sessions: COMMISSION Pike, Rockville, Maryland 20852.
March 17, 2016, from 9:30 a.m. to 5:00 FOR FURTHER INFORMATION CONTACT:
p.m. and March 18, 2016, from 8:00 a.m. [Docket No. 40–6563; NRC–2015–0139]
Karen Pinkston, Office of Nuclear
to 11:30 a.m. Material Safety and Safeguards, U.S.
Data and Time for Closed Sessions: Mallinckrodt, LLC.
Nuclear Regulatory Commission,
March 17, 2016, from 7:30 a.m. to 9:30 AGENCY: Nuclear Regulatory Washington DC 20555–0001; telephone:
a.m., March 18, 2016, from 7:30 a.m. to Commission. 301–415–3650; email: Karen.Pinkston@
8:00 a.m., and March 18, 2016, from ACTION: Environmental assessment and nrc.gov.
12:00 p.m. to 1:00 p.m. finding of no significant impact;
Address for Public Meeting: U.S. SUPPLEMENTARY INFORMATION:
issuance.
Nuclear Regulatory Commission, Two I. Introduction
White Flint North Building, Room T2– SUMMARY: The U.S. Nuclear Regulatory
B3, 11545 Rockville Pike, Rockville, The NRC is considering issuance of an
Commission (NRC) is considering amendment to the NRC’s Source
Maryland 20852. amending the NRC’s Source Materials
Public Participation: Any member of Materials License No. STB–401, issued
License No. STB–401 to allow the to Mallinckrodt, for operation of their
the public who wishes to participate in option to perform direct dose
the meeting in person or via phone facility located in St. Louis, Missouri.
assessment of residual radioactivity in This amendment allows Mallinckrodt
should contact Ms. Holiday using the addition to using derived concentration
information below. The meeting will the option to perform direct dose
guideline levels (DCGLs) to demonstrate assessment of residual radioactivity in
also be webcast live: video.nrc.gov. compliance with the license termination
Contact Information: Ms. Sophie J. addition to using derived concentration
criteria at the Mallinckrodt site in St. guideline levels (DCGLs) to demonstrate
Holiday, email: sophie.holiday@nrc.gov, Louis, Missouri. The NRC staff is
telephone: (301) 415–7865. compliance with the license termination
issuing an environmental assessment criteria at the Mallinckrodt site in St.
Conduct of the Meeting (EA) and finding of no significant Louis, Missouri. Consistent with part 51
impact (FONSI) associated with the of title 10 of the Code of Federal
Philip O. Alderson, M.D., will chair
proposed action. Regulations (10 CFR), the NRC
the meeting. Dr. Alderson will conduct
the meeting in a manner that will DATES: The EA and FONSI referenced in performed an EA. Based on the results
facilitate the orderly conduct of this document are available on February of the EA described below, the NRC will
business. The following procedures 4, 2016. not prepare an environmental impact
apply to public participation in the ADDRESSES: Please refer to Docket ID statement for the license amendment,
meeting: NRC–2015–0139 when contacting the and is issuing a FONSI.
1. Persons who wish to provide a NRC about the availability of The NRC received, by letter dated
written statement should submit an information regarding this document. February 12, 2015 (ADAMS Accession
electronic copy to Ms. Holiday at the You may obtain publicly-available No. ML15063A404), an application from
contact information listed above. All information related to this document Mallinckrodt LLC to amend the NRC’s
submittals must be received by March using any of the following methods: Source Materials License No. STB–401.
15, 2016, and must pertain to the topic • Federal Rulemaking Web site: Go to The licensee requests the option to
on the agenda for the meeting. http://www.regulations.gov and search perform direct dose assessment of
2. Questions and comments from for Docket ID NRC–2015–0139. Address residual radioactivity in addition to
members of the public will be permitted questions about NRC dockets to Carol using DCGLs to demonstrate compliance
during the meeting, at the discretion of Gallagher; telephone: 301–415–3463; with the license termination criteria in
the Chairman. email: Carol.Gallagher@nrc.gov. For 10 CFR 20.1402 at the Mallinckrodt site
3. The draft transcript and meeting technical questions, contact the in St. Louis, Missouri. The license
summary will be available on ACMUI’s individual listed in the FOR FURTHER currently states that the
Web site http://www.nrc.gov/reading- INFORMATION CONTACT section of this Decommissioning of the Columbium-
rm/doc-collections/acmui/meetings/ document. Tantalum (C–T) process area building
2016.html on or about April 29, 2016. • NRC’s Agencywide Documents slabs and foundations, paved surfaces,
4. Persons who require special Access and Management System and all subsurface materials, shall be
services, such as those for the hearing (ADAMS): You may obtain publicly- done in accordance with the
impaired, should notify Ms. Holiday of available documents online in the Mallinckrodt C–T Decommissioning
their planned attendance. ADAMS Public Documents collection at Project, C–T Phase II Decommissioning
This meeting will be held in http://www.nrc.gov/reading-rm/ Plan (DP), Revision 2, submitted to NRC
asabaliauskas on DSK5VPTVN1PROD with NOTICES
accordance with the Atomic Energy Act adams.html. To begin the search, select on October 14, 2008 (ADAMS Accession
of 1954, as amended (primarily Section ‘‘ADAMS Public Documents’’ and then No. ML083150652), and revisions
161a); the Federal Advisory Committee select ‘‘Begin Web-based ADAMS submitted on June 3, 2010 (ADAMS
Act (5 U.S.C. App); and the Search.’’ For problems with ADAMS, Accession No. ML101620140). A Notice
Commission’s regulations in Title 10 please contact the NRC’s Public of Availability of an EA and FONSI was
Code of Federal Regulations Part 7. Document Room (PDR) reference staff at published for the NRC’s approval of the
Dated at Rockville, Maryland, this 28th day 1–800–397–4209, 301–415–4737, or by DP in the Federal Register on July 1,
of January 2016. email to pdr.resource@nrc.gov. The 2010 (75 FR 38148). The NRC approved
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![Federal Register / Vol. 81, No. 23 / Thursday, February 4, 2016 / Notices 6059
document, the EA is publicly available OFFICE OF PERSONNEL B, and C appointing authorities
in ADAMS under Accession No. MANAGEMENT applicable to a single agency are not
ML15268A311). On the basis of the codified in the CFR, but the Office of
environmental assessment, the NRC Excepted Service Personnel Management (OPM)
concludes that the proposed action will publishes a notice of agency-specific
AGENCY: U.S. Office of Personnel
not have a significant effect on the authorities established or revoked each
Management (OPM).
quality of the human environment. month in the Federal Register at
ACTION: Notice. www.gpo.gov/fdsys/. OPM also
Accordingly, the NRC will not prepare
an environmental impact statement for SUMMARY: This notice identifies publishes an annual notice of the
the proposed action. Schedule A, B, and C appointing consolidated listing of all Schedule A,
authorities applicable to a single agency B, and C appointing authorities, current
Dated at Rockville, Maryland, this 4th day as of June 30, in the Federal Register.
of January 2016. that were established or revoked from
October 1, 2015, to October 31, 2015. Schedule A
For the Nuclear Regulatory Commission.
FOR FURTHER INFORMATION CONTACT: No Schedule A Authorities to report
Michael A. Norato,
Senior Executive Resources Services, during October 2015.
Branch Chief, Materials Decommissioning Senior Executive Services and
Branch, Division of Decommissioning, Performance Management, Employee Schedule B
Uranium Recovery, and Waste Programs
Services, 202–606–2246. No Schedule B Authorities to report
Office of Nuclear Material Safety and
Safeguards. SUPPLEMENTARY INFORMATION: In during October 2015.
[FR Doc. 2016–02131 Filed 2–3–16; 8:45 am] accordance with 5 CFR 213.103,
Schedule A, B, and C appointing Schedule C
BILLING CODE 7590–01–P
authorities available for use by all The following Schedule C appointing
agencies are codified in the Code of authorities were approved during
Federal Regulations (CFR). Schedule A, October 2015.
Authorization
Agency name Organization name Position title Effective date
No.
DEPARTMENT OF AGRI- Office of the Assistant Secretary Legislative Analyst ......................... DA160002 10/6/2015
CULTURE. for Congressional Relations.
Office of the Under Secretary for Special Assistant ............................ DA160004 10/19/2015
Research, Education, and Eco-
nomics.
Office of the Secretary ................... White House Liaison ...................... DA160007 10/19/2015
DEPARTMENT OF COMMERCE .. Office of the Assistant Secretary Special Assistant (2) ...................... DC16000 10/6/201
for Industry and Analysis. DC160014 10/30/2015
Office of the Under Secretary ........ Senior Advisor (2) .......................... DC16000 10/6/2015
DC160004 10/6/2015
Office of the Assistant Secretary Special Assistant ............................ DC160005 10/6/2015
for Economic Development.
Office of Public Affairs ................... Deputy Director of Public Affairs DC160006 10/6/2015
and Press Secretary.
Deputy Director of Public Affairs DC160007 10/8/2015
and Director of Digital Strategy
and Engagement.
Senior Public Affairs Coordinator .. DC160008 10/20/2015
Deputy Director of Public Affairs DC160015 10/28/2015
and Director of Speechwriting.
Office of the Chief Information Offi- Chief of Staff .................................. DC160010 10/21/2015
cer.
International Trade Administration Senior Advisor ................................ DC160011 10/21/2015
CONSUMER PRODUCT SAFETY Office of Legislative Affairs ............ Director, Office of Congressional PS160001 10/7/2015
COMMISSION. Relations.
DEPARTMENT OF DEFENSE ...... Office of the Under Secretary of Special Advisor for Russia/Ukraine DD150199 10/9/2015
Defense (Policy). External Affairs.
Washington Headquarters Serv- Defense Fellow (5) ......................... DD15020 10/13/2015
ices. DD15020 10/21/2015
DD15020 10/21/2015
DD15020 10/21/2015
DD160007 10/23/2015
Office of the Secretary ................... Special Assistant ............................ DD160004 10/15/2015
Protocol Officer (2) ......................... DD16000 10/26/2015
DD160011 10/28/2015
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Office of the Assistant Secretary of Special Assistant for Nuclear Mis- DD150200 10/21/2015
Defense (International Security sile Defense Policy.
Affairs).
Office of the Assistant Secretary of Special Assistant (Afghanistan, DD160001 10/30/2015
Defense (Asian and Pacific Se- Pakistan and Central Asia).
curity Affairs).
Office of the Under Secretary of Special Assistant (Personnel and DD160010 10/30/2015
Defense (Personnel and Readi- Readiness).
ness).
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Document Created: 2016-02-04 00:31:37
Document Modified: 2016-02-04 00:31:37
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Environmental assessment and finding of no significant impact; issuance. | |
| Dates | The EA and FONSI referenced in this document are available on February 4, 2016. | |
| 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] | |
| FR Citation | 81 FR 6057 |
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