83 FR 56379 - Exemption; Issuance: Northwest Medical Isotopes, LLC; Medical Radioisotope Production Facility
NUCLEAR REGULATORY COMMISSION Federal Register Volume 83, Issue 219 (November 13, 2018)
Federal Register Volume 83, Issue 219 (November 13, 2018)
| Page Range | 56379-56380 | |
| FR Document | 2018-24312 |
[Federal Register Volume 83, Number 219 (Tuesday, November 13, 2018)] [Notices] [Pages 56379-56380] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-24312] ======================================================================= ----------------------------------------------------------------------- NUCLEAR REGULATORY COMMISSION [Docket No. 50-0609; NRC-2018-0225] Exemption; Issuance: Northwest Medical Isotopes, LLC; Medical Radioisotope Production Facility AGENCY: Nuclear Regulatory Commission. ACTION: Exemption; issuance. ----------------------------------------------------------------------- SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing an exemption to Northwest Medical Isotopes, LLC (NWMI) from the requirement that an application for an NRC license to possess and use special nuclear material for processing and fuel fabrication, scrap recovery or conversion of uranium hexafluoride, or for the conduct of any other activity which the NRC has determined will significantly affect the quality of the environment (and the associated environmental report), be submitted at least 9 months prior to commencement of construction of the plant or facility in which the activity will be conducted. DATES: This exemption is being issued on November 13, 2018. ADDRESSES: Please refer to Docket ID NRC-2018-0225 when contacting the NRC about the availability of information regarding this document. You may access publicly-available information related to this document using any of the following methods:Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0225. Address questions about Docket IDs in Regulations.gov to Jennifer Borges; telephone: 301-287-9127; 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 ``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 it is available in ADAMS) is provided the first time that it is mentioned in this document. 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: David Tiktinsky, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-8740, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background NWMI is the holder of Construction Permit No. CPMIF-002 (issued on May 9, 2018 (ADAMS Accession No. ML18037A308) under Part 50 of title 10 of the Code of Federal Regulations (10 CFR)), which authorizes NWMI to construct a medical radioisotope production facility (RPF) in Columbia, Missouri. The facility would fabricate low-enriched uranium (LEU) targets and ship them to a network of U.S. research reactors for irradiation, receive irradiated LEU targets, disassemble and dissolve irradiated LEU targets, and recover and purify Molybdenum-99 (Mo-99). These processes would take place in a single RPF building divided into two separate areas where processes subject to different regulatory regimes would take place. The processes involved in the production area, which include receipt of irradiated LEU targets, LEU target disassembly and dissolution, and Mo-99 recovery and purification, are subject to the NRC licensing requirements of 10 CFR part 50. The processes involved in target fabrication that NWMI plans to perform in a separate area of the RPF would be subject to the separate NRC licensing requirements of 10 CFR part 70. NWMI submitted an environmental report with its construction permit application, providing environmental information about all of the processes that would occur in both portions of the RPF. In accordance with Section 102(2)(C) of the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq.) and the NRC's regulations in 10 CFR part 51, the NRC staff prepared an environmental impact statement (EIS), NUREG-2209, ``Environmental Impact Statement for the Construction Permit for the Northwest Medical Isotopes Radioisotope Production Facility,'' dated May 2017 (ADAMS Accession No. ML17130A862) assessing the potential impacts of the construction, operation, and decommissioning of the proposed RPF on the quality of the human environment and reasonable alternatives. The construction and operation impacts from the portion of the RPF in which 10 CFR part 70 target fabrication activities would occur were evaluated as a connected action to the 10 CFR part 50 construction permit. A 10 CFR part 50 construction permit was issued to NWMI on May 9, 2018. II. Request/Action The exemption request from NWMI was submitted by letter dated December 18, 2017 (ADAMS Accession No. ML17362A040), as supplemented by a letter dated March 12, 2018 (ADAMS Accession No. ML18088A175). NWMI is requesting an exemption from the requirement that the application (and associated environmental report required by 10 CFR part 51) for 10 CFR part 70 activities be submitted at least 9 months prior to commencement of construction of the 10 CFR part 70 components of the RPF. The activities that will be subject to the 10 CFR part 70 license application are described in the construction permit application that NWMI previously submitted to the NRC under 10 CFR part 50 for an RPF to be constructed in Columbia, Missouri. NWMI Preliminary Safety Analyses Report, Chapter 19, ``Environmental Report'' Corvallis, OR, Revision 0A [[Page 56380]] dated June 2015 (ADAMS Accession Nos. ML15210A123, ML15210A128, ML15210A129, and ML15210A131). The NRC evaluated the environmental impacts from the 10 CFR part 70 target fabrication activities in the RPF as part of its EIS supporting NWMI's 10 CFR part 50 construction permit application. The exemption would allow NWMI to initiate construction of the 10 CFR part 70 components of the RPF upon the issuance of the 10 CFR part 50 construction permit for the RPF even if the 10 CFR 70.21(f) timing requirement is not met. III. Discussion Pursuant to 10 CFR 70.17(a), the Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of 10 CFR part 70 as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest. Authorized by Law The applicant has stated that the requested exemption from the requirement to submit an application and associated environmental report at least 9 months prior to the commencement of construction of the RPF, including 10 CFR part 70 components (i.e., the target fabrication facility), will enable it to initiate construction of the entire RPF based upon the environmental review for the 10 CFR part 50 construction permit. The applicant has also stated there have been no significant changes to the environmental information that was previously submitted to the NRC as part of the 10 CFR part 50 construction permit application. NWMI also stated that it will submit the application and environmental report required by 10 CFR 70.21(f) as part of a consolidated operating license application for both the 10 CFR part 50 Production Facility and to possess and use special nuclear material for the 10 CFR part 70 target fabrication facility activities. The staff evaluated the environmental impacts of the RPF, including the 10 CFR part 70 target fabrication activities as a connected action, in the EIS dated May 31, 2017 (NUREG-2209, ``Environmental Impact Statement for the Construction Permit for the Northwest Medical Isotopes Radioisotope Production Facility'', ADAMS Accession No. ML17130A862). The staff concludes, as documented in the EIS, that after weighing the environmental, economic, technical, and other benefits against environmental and other costs, and considering reasonable alternatives, the NRC staff's recommendation, unless safety issues mandate otherwise, is the issuance of a construction permit to NWMI. The NRC regulation, 10 CFR 70.17, allows the NRC to grant exemptions from the requirements of 10 CFR part 70 provided certain findings are made. Granting the applicant's proposed exemption is not otherwise inconsistent with NRC regulations or other applicable laws. As explained below, the proposed exemption will not endanger life or property, or the common defense and security, and is otherwise in the public interest. NWMI indicates that it will submit an environmental report with its application for an operating license for the entire RPF which the NRC will be able to review for any significant new information. The NRC will not make a decision on an application to operate the production portion of the facility under 10 CFR part 50 or a license to possess and use special nuclear material for target fabrication under 10 CFR part 70 until after the NRC has completed a NEPA review based on NWMI's proposed application and environmental report, and made the appropriate regulatory findings. Therefore, the exemption is authorized by law. Will Not Endanger Life or Property or the Common Defense and Security Construction of the facility has not yet begun. Since the exemption request relates to the timing of when construction may begin, the proposed exemption would not: (a) Impact the probabilities of evaluated accidents; (b) affect margins of safety; (c) affect effectiveness of programs contained in licensing documents; (d) increase effluents; (e) increase occupational radiological exposures; or (f) impact operations or decommissioning activities. The proposed exemption also will not have an impact on common defense and security since the exemption only relates to the timing of construction. NWMI's construction permit does not authorize possession of any nuclear material at the RPF. Based on its evaluation, the NRC staff has determined that this exemption will not endanger life or property or the common defense and security. Otherwise in the Public Interest The NRC staff has determined that granting the proposed exemption would allow for efficient construction of the NWMI RPF at an earlier date. The purpose of the NWMI RPF is to produce medical isotopes and help meet the U.S. goal of establishing a domestic supply of Mo-99 as stated in the American Medical Isotopes Production Act, 42 U.S.C. 2065 et seq. Accordingly, the NRC staff has determined that granting the requested exemption is otherwise in the public interest. IV. Environmental Consideration As required by 10 CFR 51.21, the NRC performed an environmental assessment (EA) that analyzes the environmental impacts of the proposed exemption in accordance with NEPA. Based on that EA, the NRC staff has determined not to prepare an EIS for the proposed exemption, and has issued a finding of no significant impact (FONSI). The EA and FONSI were published in the Federal Register on August 29, 2018 (83 FR 44068- 44070). V. Conclusion Accordingly, the NRC has determined that, pursuant to 10 CFR 70.17, the exemption is authorized by law, will not endanger life or property or the common defense and security, and is otherwise in the public interest. Therefore, the NRC hereby grants NWMI an exemption from the 10 CFR 70.21(f) requirement to submit a 10 CFR part 70 application, and the associated environmental report, 9 months prior to the commencement of construction, to allow NWMI to begin construction of the 10 CFR part 70 portions of the facility along with the rest of the RPF. Dated at Rockville, Maryland, this 1st day of November 2018. For the Nuclear Regulatory Commission. LaDonna Suggs, Acting Deputy Director, Division of Fuel Cycle Safety, Safeguards, and Environmental Review, Office of Nuclear Material Safety and Safeguards. [FR Doc. 2018-24312 Filed 11-9-18; 8:45 am] BILLING CODE 7590-01-P
![Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices 56379
such research, and why those DATES: This exemption is being issued into two separate areas where processes
capabilities and objectives should be on November 13, 2018. subject to different regulatory regimes
strategic priorities. ADDRESSES: Please refer to Docket ID would take place. The processes
5. What changes to cybersecurity NRC–2018–0225 when contacting the involved in the production area, which
education and workforce development, NRC about the availability of include receipt of irradiated LEU
at all levels of education, should be information regarding this document. targets, LEU target disassembly and
considered to prepare students, faculty, You may access publicly-available dissolution, and Mo-99 recovery and
and the workforce in the next decade for information related to this document purification, are subject to the NRC
emerging cybersecurity challenges, such using any of the following methods: licensing requirements of 10 CFR part
as the implications of artificial • Federal Rulemaking Website: Go to 50. The processes involved in target
intelligence, quantum computing, and http://www.regulations.gov and search fabrication that NWMI plans to perform
the Internet of Things on cybersecurity? for Docket ID NRC–2018–0225. Address in a separate area of the RPF would be
6. What other research and questions about Docket IDs in subject to the separate NRC licensing
development strategies, plans, or Regulations.gov to Jennifer Borges; requirements of 10 CFR part 70.
activities, domestic or in other telephone: 301–287–9127; email: NWMI submitted an environmental
countries, should inform the U.S. Jennifer.Borges@nrc.gov. For technical report with its construction permit
Federal cybersecurity R&D strategic questions, contact the individual listed application, providing environmental
plan? in the FOR FURTHER INFORMATION information about all of the processes
Following the receipt of comments, CONTACT section of this document. that would occur in both portions of the
the NITRD Cyber Security and • NRC’s Agencywide Documents RPF. In accordance with Section
Information Assurance Interagency Access and Management System 102(2)(C) of the National Environmental
Working Group under the National (ADAMS): You may obtain publicly- Policy Act of 1969 (NEPA) (42 U.S.C.
Science and Technology Council will available documents online in the 4321 et seq.) and the NRC’s regulations
consider the input provided when ADAMS Public Documents collection at in 10 CFR part 51, the NRC staff
updating the Federal cybersecurity R&D http://www.nrc.gov/reading-rm/ prepared an environmental impact
strategic plan. adams.html. To begin the search, select statement (EIS), NUREG–2209,
Submitted by the National Science ‘‘Begin Web-based ADAMS Search.’’ For ‘‘Environmental Impact Statement for
Foundation on behalf of the Networking problems with ADAMS, please contact the Construction Permit for the
and Information Technology Research the NRC’s Public Document Room (PDR) Northwest Medical Isotopes
and Development (NITRD) National reference staff at 1–800–397–4209, 301– Radioisotope Production Facility,’’
Coordination Office (NCO) on 415–4737, or by email to pdr.resource@ dated May 2017 (ADAMS Accession No.
November 7, 2018. nrc.gov. The ADAMS accession number ML17130A862) assessing the potential
impacts of the construction, operation,
Suzanne H. Plimpton, for each document referenced (if it is
and decommissioning of the proposed
Reports Clearance Officer, National Science available in ADAMS) is provided the
RPF on the quality of the human
Foundation. first time that it is mentioned in this
environment and reasonable
[FR Doc. 2018–24668 Filed 11–9–18; 8:45 am] document.
alternatives. The construction and
• NRC’s PDR: You may examine and
BILLING CODE 7555–01–P operation impacts from the portion of
purchase copies of public documents at
the RPF in which 10 CFR part 70 target
the NRC’s PDR, Room O1–F21, One
fabrication activities would occur were
White Flint North, 11555 Rockville
NUCLEAR REGULATORY evaluated as a connected action to the
Pike, Rockville, Maryland 20852.
COMMISSION 10 CFR part 50 construction permit. A
FOR FURTHER INFORMATION CONTACT: 10 CFR part 50 construction permit was
[Docket No. 50–0609; NRC–2018–0225] David Tiktinsky, Office of Nuclear issued to NWMI on May 9, 2018.
Material Safety and Safeguards, U.S.
Exemption; Issuance: Northwest Nuclear Regulatory Commission, II. Request/Action
Medical Isotopes, LLC; Medical Washington, DC 20555–0001; telephone: The exemption request from NWMI
Radioisotope Production Facility 301–415–8740, email: David.Tiktinsky@ was submitted by letter dated December
AGENCY: Nuclear Regulatory nrc.gov. 18, 2017 (ADAMS Accession No.
Commission. SUPPLEMENTARY INFORMATION: ML17362A040), as supplemented by a
ACTION: Exemption; issuance. letter dated March 12, 2018 (ADAMS
I. Background Accession No. ML18088A175). NWMI is
SUMMARY: The U.S. Nuclear Regulatory NWMI is the holder of Construction requesting an exemption from the
Commission (NRC) is issuing an Permit No. CPMIF–002 (issued on May requirement that the application (and
exemption to Northwest Medical 9, 2018 (ADAMS Accession No. associated environmental report
Isotopes, LLC (NWMI) from the ML18037A308) under Part 50 of title 10 required by 10 CFR part 51) for 10 CFR
requirement that an application for an of the Code of Federal Regulations (10 part 70 activities be submitted at least
NRC license to possess and use special CFR)), which authorizes NWMI to 9 months prior to commencement of
nuclear material for processing and fuel construct a medical radioisotope construction of the 10 CFR part 70
fabrication, scrap recovery or production facility (RPF) in Columbia, components of the RPF. The activities
conversion of uranium hexafluoride, or Missouri. The facility would fabricate that will be subject to the 10 CFR part
for the conduct of any other activity low-enriched uranium (LEU) targets and 70 license application are described in
amozie on DSK3GDR082PROD with NOTICES1
which the NRC has determined will ship them to a network of U.S. research the construction permit application that
significantly affect the quality of the reactors for irradiation, receive NWMI previously submitted to the NRC
environment (and the associated irradiated LEU targets, disassemble and under 10 CFR part 50 for an RPF to be
environmental report), be submitted at dissolve irradiated LEU targets, and constructed in Columbia, Missouri.
least 9 months prior to commencement recover and purify Molybdenum-99 NWMI Preliminary Safety Analyses
of construction of the plant or facility in (Mo-99). These processes would take Report, Chapter 19, ‘‘Environmental
which the activity will be conducted. place in a single RPF building divided Report’’ Corvallis, OR, Revision 0A
VerDate Sep<11>2014 17:34 Nov 09, 2018 Jkt 247001 PO 00000 Frm 00106 Fmt 4703 Sfmt 4703 E:\FR\FM\13NON1.SGM 13NON1](https://thefederalregister.org/doc/83_FR_56598/page/1.svg)
![56380 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices
dated June 2015 (ADAMS Accession considering reasonable alternatives, the goal of establishing a domestic supply of
Nos. ML15210A123, ML15210A128, NRC staff’s recommendation, unless Mo-99 as stated in the American
ML15210A129, and ML15210A131). safety issues mandate otherwise, is the Medical Isotopes Production Act, 42
The NRC evaluated the environmental issuance of a construction permit to U.S.C. 2065 et seq. Accordingly, the
impacts from the 10 CFR part 70 target NWMI. NRC staff has determined that granting
fabrication activities in the RPF as part The NRC regulation, 10 CFR 70.17, the requested exemption is otherwise in
of its EIS supporting NWMI’s 10 CFR allows the NRC to grant exemptions the public interest.
part 50 construction permit application. from the requirements of 10 CFR part 70
The exemption would allow NWMI to provided certain findings are made. IV. Environmental Consideration
initiate construction of the 10 CFR part Granting the applicant’s proposed As required by 10 CFR 51.21, the NRC
70 components of the RPF upon the exemption is not otherwise inconsistent performed an environmental assessment
issuance of the 10 CFR part 50 with NRC regulations or other (EA) that analyzes the environmental
construction permit for the RPF even if applicable laws. As explained below, impacts of the proposed exemption in
the 10 CFR 70.21(f) timing requirement the proposed exemption will not accordance with NEPA. Based on that
is not met. endanger life or property, or the EA, the NRC staff has determined not to
common defense and security, and is prepare an EIS for the proposed
III. Discussion
otherwise in the public interest. exemption, and has issued a finding of
Pursuant to 10 CFR 70.17(a), the NWMI indicates that it will submit an no significant impact (FONSI). The EA
Commission may, upon application of environmental report with its and FONSI were published in the
any interested person or upon its own application for an operating license for Federal Register on August 29, 2018 (83
initiative, grant such exemptions from the entire RPF which the NRC will be FR 44068–44070).
the requirements of 10 CFR part 70 as able to review for any significant new
it determines are authorized by law and information. The NRC will not make a V. Conclusion
will not endanger life or property or the decision on an application to operate Accordingly, the NRC has determined
common defense and security and are the production portion of the facility that, pursuant to 10 CFR 70.17, the
otherwise in the public interest. under 10 CFR part 50 or a license to exemption is authorized by law, will not
Authorized by Law possess and use special nuclear material endanger life or property or the common
for target fabrication under 10 CFR part defense and security, and is otherwise
The applicant has stated that the 70 until after the NRC has completed a in the public interest. Therefore, the
requested exemption from the NEPA review based on NWMI’s NRC hereby grants NWMI an exemption
requirement to submit an application proposed application and from the 10 CFR 70.21(f) requirement to
and associated environmental report at environmental report, and made the submit a 10 CFR part 70 application,
least 9 months prior to the appropriate regulatory findings. and the associated environmental
commencement of construction of the Therefore, the exemption is authorized report, 9 months prior to the
RPF, including 10 CFR part 70 by law. commencement of construction, to
components (i.e., the target fabrication allow NWMI to begin construction of
facility), will enable it to initiate Will Not Endanger Life or Property or the 10 CFR part 70 portions of the
construction of the entire RPF based the Common Defense and Security facility along with the rest of the RPF.
upon the environmental review for the Construction of the facility has not yet
10 CFR part 50 construction permit. The Dated at Rockville, Maryland, this 1st day
begun. Since the exemption request of November 2018.
applicant has also stated there have relates to the timing of when For the Nuclear Regulatory Commission.
been no significant changes to the construction may begin, the proposed
environmental information that was LaDonna Suggs,
exemption would not: (a) Impact the
previously submitted to the NRC as part Acting Deputy Director, Division of Fuel Cycle
probabilities of evaluated accidents; (b)
of the 10 CFR part 50 construction Safety, Safeguards, and Environmental
affect margins of safety; (c) affect Review, Office of Nuclear Material Safety and
permit application. NWMI also stated effectiveness of programs contained in Safeguards.
that it will submit the application and licensing documents; (d) increase [FR Doc. 2018–24312 Filed 11–9–18; 8:45 am]
environmental report required by 10 effluents; (e) increase occupational
BILLING CODE 7590–01–P
CFR 70.21(f) as part of a consolidated radiological exposures; or (f) impact
operating license application for both operations or decommissioning
the 10 CFR part 50 Production Facility activities. The proposed exemption also
and to possess and use special nuclear OCCUPATIONAL SAFETY AND
will not have an impact on common
material for the 10 CFR part 70 target HEALTH REVIEW COMMISSION
defense and security since the
fabrication facility activities. exemption only relates to the timing of
The staff evaluated the environmental Privacy Act of 1974; System of
construction. NWMI’s construction Records
impacts of the RPF, including the 10 permit does not authorize possession of
CFR part 70 target fabrication activities any nuclear material at the RPF. AGENCY: Occupational Safety and Health
as a connected action, in the EIS dated Based on its evaluation, the NRC staff Review Commission.
May 31, 2017 (NUREG–2209, has determined that this exemption will ACTION: Notice of a modified system of
‘‘Environmental Impact Statement for not endanger life or property or the records.
the Construction Permit for the common defense and security.
Northwest Medical Isotopes SUMMARY: In accordance with the
amozie on DSK3GDR082PROD with NOTICES1
Radioisotope Production Facility’’, Otherwise in the Public Interest Privacy Act of 1974, the Occupational
ADAMS Accession No. ML17130A862). The NRC staff has determined that Safety and Health Review Commission
The staff concludes, as documented in granting the proposed exemption would (OSHRC) is revising the notice for
the EIS, that after weighing the allow for efficient construction of the Privacy Act system-of-records OSHRC–
environmental, economic, technical, NWMI RPF at an earlier date. The 4.
and other benefits against purpose of the NWMI RPF is to produce DATES: Comments must be received by
environmental and other costs, and medical isotopes and help meet the U.S. OSHRC on or before December 13, 2018.
VerDate Sep<11>2014 17:34 Nov 09, 2018 Jkt 247001 PO 00000 Frm 00107 Fmt 4703 Sfmt 4703 E:\FR\FM\13NON1.SGM 13NON1](https://thefederalregister.org/doc/83_FR_56598/page/2.svg)
Document Created: 2018-11-10 03:19:09
Document Modified: 2018-11-10 03:19:09
| 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 | Exemption; issuance. | |
| Dates | This exemption is being issued on November 13, 2018. | |
| Contact | David Tiktinsky, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-8740, email: [email protected] | |
| FR Citation | 83 FR 56379 |
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