Request To Submit a Two-Part Application-Northwest Medical Isotopes, LLC, 63501-63504 [2013-24882]

Download as PDF Federal Register / Vol. 78, No. 206 / Thursday, October 24, 2013 / Notices in confidence by indemnity applicants, and material that is likely to disclose trade secrets or other privileged or confidential information, and because it is important to keep the values of objects to be indemnified, and the methods of transportation and security measures confidential, I have determined that that the meeting will be closed to the public pursuant to section 552b(c)(4) of Title 5 U.S.C., as amended. I have made this determination under the authority granted me by the Chairman’s Delegation of Authority to Close Advisory Committee Meetings, dated July l9, l993. Dated: October 21, 2013. Lisette Voyatzis, Committee Management Officer. [FR Doc. 2013–25074 Filed 10–23–13; 8:45 am] BILLING CODE 7536–01–P NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES Meetings of Humanities Panel National Endowment for the Humanities. ACTION: Notice of meetings. AGENCY: Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App.), notice is hereby given that eleven meetings of the Humanities Panel will be held during November, 2013 as follows. The purpose of the meetings is for panel review, discussion, evaluation, and recommendation of applications for financial assistance under the National Foundation on the Arts and Humanities Act of 1965 (20 U.S.C. 951–960, as amended). DATES: See SUPPLEMENTARY INFORMATION section for meeting dates. ADDRESSES: The meetings will be held at the Old Post Office Building, 1100 Pennsylvania Ave. NW., Washington, DC 20506. See SUPPLEMENTARY INFORMATION section for meeting room numbers. FOR FURTHER INFORMATION CONTACT: Lisette Voyatzis, Committee Management Officer, 1100 Pennsylvania Ave. NW., Room 529, Washington, DC 20506, or call (202) 606–8322. Hearingimpaired individuals are advised that information on this matter may be obtained by contacting the National Endowment for the Humanities’ TDD terminal at (202) 606–8282. SUPPLEMENTARY INFORMATION: mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: Meetings 1. Date: November 1, 2013. Time: 8:30 a.m. to 5:00 p.m. Room: 415. VerDate Mar<15>2010 17:25 Oct 23, 2013 Jkt 232001 This meeting will discuss applications on the subjects of the History of Science, Technology, and Medicine for the Humanities Collections and Reference Resources grant program, submitted to the Division of Preservation and Access. 2. Date: November 1, 2013. Time: 8:30 a.m. to 5:00 p.m. Room: 421. This meeting will discuss applications on the subject of Art History for the America’s Historical and Cultural Organizations: Implementation Grants, submitted to the Division of Public Programs. 3. Date: November 4, 2013. Time: 8:30 a.m. to 5:00 p.m. Room: 421. This meeting will discuss applications on the subjects of World History and Culture for the America’s Historical and Cultural Organizations: Implementation Grants, submitted to the Division of Public Programs. 4. Date: November 5, 2013. Time: 8:30 a.m. to 5:00 p.m. Room: 421. This meeting will discuss applications on the subject of U.S. History for the America’s Media Makers: Production Grants, submitted to the Division of Public Programs. 5. Date: November 5, 2013. Time: 8:30 a.m. to 5:00 p.m. Room: 415. This meeting will discuss applications on the subjects of U.S. History and Culture for the Humanities Collections and Reference Resources grant program, submitted to the Division of Preservation and Access. 6. Date: November 7, 2013. Time: 8:30 a.m. to 5:00 p.m. Room: 415. This meeting will discuss applications on the subjects of U.S. History and Culture for the Humanities Collections and Reference Resources grant program, submitted to the Division of Preservation and Access. 7. Date: November 7, 2013. Time: 8:30 a.m. to 5:00 p.m. Room: 421. This meeting will discuss applications on the subject of American Studies for America’s Historical and Cultural Organizations: Implementation Grants, submitted to the Division of Public Programs. 8. Date: November 19, 2013. Time: 8:30 a.m. to 5:00 p.m. Room: 421. This meeting will discuss applications on the subject of U.S. History for America’s Historical and Cultural Organizations: Implementation Grants, submitted to the Division of Public Programs. PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 63501 9. Date: November 19, 2013. Time: 8:30 a.m. to 5:00 p.m. Room: 415. This meeting will discuss applications on the subject of American Studies for the Humanities Collections and Reference Resources grant program, submitted to the Division of Preservation and Access. 10. Date: November 22, 2013. Time: 8:30 a.m. to 5:00 p.m. Room: 415. This meeting will discuss applications on the subject of World Studies for the Humanities Collections and Reference Resources grant program, submitted to the Division of Preservation and Access. 11. Date: November 30, 2013. Time: 8:30 a.m. to 5:00 p.m. Room: 415. This meeting will discuss applications on the subjects of New World Archaeology and Culture for the Humanities Collections and Reference Resources grant program, submitted to the Division of Preservation and Access. Because these meetings will include review of personal and/or proprietary financial and commercial information given in confidence to the agency by grant applicants, the meetings will be closed to the public pursuant to sections 552b(c)(4) and 552b(c)(6) of Title 5 U.S.C., as amended. I have made this determination pursuant to the authority granted me by the Chairman’s Delegation of Authority to Close Advisory Committee Meetings dated July 19, 1993. Dated: October 21, 2013. Lisette Voyatzis, Committee Management Officer. [FR Doc. 2013–25080 Filed 10–23–13; 8:45 am] BILLING CODE 7536–01–P NUCLEAR REGULATORY COMMISSION [Project No. 0803; NRC–2013–0235] Request To Submit a Two-Part Application—Northwest Medical Isotopes, LLC Nuclear Regulatory Commission. ACTION: Exemption. AGENCY: The U.S. Nuclear Regulatory Commission (NRC) is issuing an exemption in response to an August 9, 2013, letter from Northwest Medical Isotopes, LLC (NWMI). In this letter, NWMI requested an exemption from certain regulatory requirements, which, if granted, would allow the submittal of a construction permit application for a SUMMARY: E:\FR\FM\24OCN1.SGM 24OCN1 63502 Federal Register / Vol. 78, No. 206 / Thursday, October 24, 2013 / Notices medical radioisotope production facility in two parts. The NRC staff has reviewed this request and determined that it is appropriate to grant the exemption, as requested. ADDRESSES: Please refer to Docket ID NRC–2013–0235 when contacting the NRC about the availability of information regarding this document. You may access publicly-available information related to this action by the following methods: • Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC–2013–0235. Address questions about NRC dockets to Carol Gallagher; telephone: 301–287–3422; email: Carol.Gallagher@nrc.gov. For technical questions, contact the individual(s) listed in the FOR FURTHER INFORMATION CONTACT section of this document. • NRC’s Agencywide Documents Access and Management System (ADAMS): You may access publicly available documents online in the NRC Library at http://www.nrc.gov/readingrm/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 in this document (if that document is available in ADAMS) is provided the first time that the 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: Steven Lynch, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555– 0001; telephone: 301–415–1524; email: Steven.Lynch@nrc.gov. SUPPLEMENTARY INFORMATION: The following sections include the text of the exemption in its entirety as it will be issued to NWMI. mstockstill on DSK4VPTVN1PROD with NOTICES 1.0 Background Currently, the United States receives all of its supply of molybdenum-99 (Mo99) from international sources. In recent years, outages at these international facilities have disrupted global supply and created a need to establish domestic Mo-99 production within the United States. In response to this need, NWMI stated in a letter dated August 9, 2013 (ADAMS Accession No. ML13227A295), that it intends to ‘‘design and construct VerDate Mar<15>2010 17:25 Oct 23, 2013 Jkt 232001 a [radioisotope production facility] and intends to produce Mo-99’’ in order to meet the emerging domestic demands for Mo-99 and its decay product, technetium-99m, in nuclear medicine procedures. Northwest Medical Isotopes, LLC, has proposed to submit an application to construct a radioisotope production facility pursuant to the requirements of part 50 of Title 10 of the Code of Federal Regulations (10 CFR), ‘‘Domestic Licensing of Production and Utilization Facilities,’’ and in accordance with 10 CFR 2.101(a)(5) for the purpose of producing Mo-99. As an applicant for a permit to construct such a facility, NWMI will be subject to all applicable rules, regulations, and orders of the NRC now or hereafter in effect. Generally speaking, production and utilization facility applicants subject to 10 CFR 51.20(b) 1 may submit the information required for a construction permit, under 10 CFR part 50, in two parts, in accordance with the provisions of 10 CFR 2.101(a)(5). These provisions state that one part of the submittal must include the environmental report required by 10 CFR 50.30(f), while the other part must include the preliminary safety analysis report required by 10 CFR 50.34(a). Either part of the construction permit application may be submitted first as long as the submission of each part of the application does not precede or follow the other by longer than six months. However, the first part submitted must also contain the following: • The description and safety assessment of the site required by 10 CFR 50.34(a)(1), • the filing fee required by 10 CFR 50.30(e) and 10 CFR 170.21, • the general information required by 10 CFR 50.33, and • the agreement limiting access to Classified Information required by 10 CFR 50.37. Thus, 10 CFR 2.101(a)(5) provides that applicable preliminary safety analysis report information required by 10 CFR 50.34(a)(2)–(a)(13) need not accompany the first part of the submittal. In order to facilitate the review of its application, NWMI would like to submit its application in two parts, as described above; however, based on the current language of 10 CFR 51.20, it cannot do so unless granted an exemption from certain provisions of 10 CFR 2.101(a)(5) by the Commission. The NRC staff previously addressed an exemption request from SHINE 1 10 CFR 51.20(b) enumerates the types of licensing and regulatory actions requiring an environmental impact statement or a supplement to an environmental impact statement. PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 Medical Technologies, Inc. (SHINE) to submit is construction permit application in two parts. The NRC staff responded to a letter from SHINE, dated July 10, 2012 (ADAMS Accession No. ML12214A434), that asked whether production or utilization facility applicants could submit a construction permit application in two parts even if an environmental impact statement is not explicitly required for the application by 10 CFR 51.20(b). In a letter dated December 7, 2012 (ADAMS Accession No. ML12319A192), the NRC staff responded: SHINE’s proposed action for licensing a medical isotope production facility is not an action identified in 51.20(b); therefore, 10 CFR 2.101(a)(5) is not applicable to SHINE’s licensing proposal. However, SHINE could apply for an exemption under 10 CFR 50.12 in order to submit its application for a construction permit in two parts as described in 10 CFR 2.101(a)(5). The NRC staff also explained that should an exemption to 10 CFR 2.101(a)(5) be sought, the request must set forth existing special circumstances warranting the exemption, as well as provide the proposed contents of each part of the construction permit application. Similarly, NWMI has proposed to submit an application requesting the issuance of a construction permit for a medical radioisotope production facility—a licensing action not identified in 10 CFR 51.20(b). Therefore, its application for a construction permit cannot be submitted in two parts under 10 CFR 2.101(a)(5) unless an exemption is granted by the Commission. 2.0 Request/Action Section 2.101(a)(5) of 10 CFR states, in part: An applicant for a construction permit under part 50 of this chapter . . . for a production or utilization facility which is subject to § 51.20(b) of this chapter, and is of the type specified in § 50.21(b)(2) or (b)(3) or § 50.22 of this chapter . . . may submit the information required of applicants by part 50 . . . of this chapter in two parts. By its letter dated August 9, 2013, NWMI requests an exemption from the provision of 10 CFR 2.101(a)(5) that applications for a construction permit under 10 CFR part 50 must be of the type requiring an environmental impact statement or a supplement to an environmental impact statement as described in 10 CFR 51.20(b). The exemption would allow NWMI to submit a portion of its construction permit up to six months prior to the submittal of the remainder of the application regardless of whether an environmental impact statement or a E:\FR\FM\24OCN1.SGM 24OCN1 Federal Register / Vol. 78, No. 206 / Thursday, October 24, 2013 / Notices supplement to an environmental impact statement is prepared for its construction permit application. Specifically, in accordance with the provisions of 10 CFR 2.101(a)(5), NWMI proposes to submit the following in part one of its construction permit application: • The description and safety assessment of the site required by 10 CFR 50.34(a)(1), • the environmental report required by 10 CFR 50.30(f), • the filing fee required by 10 CFR 50.30(e) and 10 CFR 170.21, • the general information required by 10 CFR 50.33, and • the agreement limiting access to Classified Information required by 10 CFR 50.37. Part two of NWMI’s construction permit application will contain the remainder of the preliminary safety analysis report required by 10 CFR 50.34(a) and 2.101(a)(5). Northwest Medical Isotopes, LLC, has proposed to ‘‘design and construct a [radioisotope production facility] and intends to produce Mo–99.’’ In its request for an exemption from certain requirements of 10 CFR 2.101(a)(5), NWMI states that the ‘‘demand for medical isotopes is a significant national public health and safety concern,’’ and the ability to submit its construction permit application in two parts would ‘‘allow for an earlier determination as to whether an [environmental impact statement] is required, allowing a potential earlier completion of the environmental review and ultimate issuance of the Construction Permit . . .’’ mstockstill on DSK4VPTVN1PROD with NOTICES 3.0 Discussion To docket NWMI’s construction permit application in two parts under 10 CFR 2.101(a)(5), as proposed, an exemption to the regulations is required. Pursuant to 10 CFR 50.12, the Commission may, upon application by any interested person or upon its own initiative, grant exemptions from the requirements of 10 CFR part 50 when (1) the exemptions are authorized by law, will not present an undue risk to public health or safety, and are consistent with the common defense and security; and (2) when special circumstances are present. While the action requested is not for an exemption to a 10 CFR part 50 regulation, it is appropriate to evaluate this exemption request using the criteria of 10 CFR 50.12 because an application for a construction permit for a radioisotope production facility cannot be accepted for docketing in accordance with 10 CFR 2.101(a) unless VerDate Mar<15>2010 17:25 Oct 23, 2013 Jkt 232001 it meets the requirements of 10 CFR part 50. Special Circumstances The application of 10 CFR 2.101(a)(5) is limited to applications for licensing actions that meet the criteria for environmental impact statements as described in the provisions of 10 CFR 51.20(b) and to facilities of the types specified in 10 CFR 50.21(b)(2) or (b)(3) or 10 CFR 50.22. Northwest Medical Isotopes, LLC, has proposed to submit an application requesting the issuance of a construction permit for a medical radioisotope production facility—a licensing action not identified in 10 CFR 51.20(b). Consequently, its application for a construction permit cannot be submitted in two parts under 10 CFR 2.101(a)(5) unless an exemption is granted by the Commission. The Commission will not consider granting an exemption under 10 CFR 50.12 unless special circumstances are present. One of the special circumstances listed in 10 CFR 50.12(a)(2) is ‘‘(ii) [a]pplication of the regulation in the particular circumstances would not serve the underlying purpose of the rule or is not necessary to achieve the underlying purpose of the rule.’’ Therefore, should the Commission determine that the underlying purpose of 10 CFR 2.101(a)(5) is achieved, application of the regulation would not be necessary, and the special circumstances would exist for granting of an exemption from certain requirements of 10 CFR 2.101(a)(5). The underlying purpose of the 10 CFR 2.101(a)(5) provision that allows certain applicants to submit an application for a construction permit in two parts is to enable the NRC review of significant portions of the application, as they become available, without unnecessary delay. The provision for two-part construction permit application submittals was added as an amendment to the regulations of 10 CFR part 2, ‘‘Agency Rules of Practice and Procedure,’’ on April 24, 1974 (39 FR 14506). The intent of this final rule was to ‘‘reduce the time required to bring on line nuclear power plants which satisfy all environmental and safety requirements . . . [and remove] unnecessary obstacles to the construction of power plants needed to meet the nation’s energy needs.’’ Recognizing the procedural nature of the amendment, the Commission made the language of the final rule effective without the customary 30-day notice. It is consistent with the procedural nature of and rationale for the rule to allow NWMI to submit its construction permit PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 63503 application in two parts to facilitate the licensing process of this facility and NWMI’s effort to respond to the nation’s demand for a domestic supply of Mo-99. Furthermore, when the rule was originally written, there was a ‘‘deep national concern over energy sources and supply.’’ Similarly, there currently exists a national concern over the sources and supply of Mo-99 in the United States. Recognizing this concern, the U.S. Department of Energy (DOE) and the National Nuclear Security Administration (NNSA) are supporting four separate entities in the development of low enriched uranium technologies to accelerate commercial production of Mo-99 in the United States through the Global Threat Reduction Initiative.2 By producing Mo99 to meet emerging domestic needs, NWMI’s proposed medical radioisotope production facility supports the efforts of DOE and NNSA and is in alignment with the underlying purpose of 10 CFR 2.101(a)(5). Therefore, since the underlying purpose of the rule is achieved, application of the regulation is not necessary, and the special circumstances, required by 10 CFR 50.12(a)(2)(ii), exist for granting an exemption from certain requirements of 10 CFR 2.101(a)(5). Additionally, in 2007, the rule language was modified to include applicants seeking combined licenses under 10 CFR part 52, ‘‘Licenses, Certifications, and Approvals for Nuclear Power Plants’’ (72 FR 49412). The Commission determined that ‘‘[t]here are no considerations unique to combined licenses which would weigh against allowing a combined license applicant to submit a two part application under paragraph (a)(5) of § 2.101.’’ Similarly, the NRC staff concludes that given the procedural nature of this rule, there are no unique considerations for medical radioisotope production facilities that would weigh against allowing an applicant such as NWMI to submit a two-part application under 10 CFR 2.101(a)(5). Authorized by Law This exemption would allow NWMI to submit its application for a 10 CFR part 50 construction permit in two parts, as provided for in 10 CFR 2.101(a)(5). The exemption would not change the quality or content of the environmental report or the preliminary safety analysis report. The NRC staff has determined that special circumstances exist to 2 To learn more about the Global Threat Reduction Initiative and U.S. Department of Energy’s support of domestic Mo-99 production, please visit http://nnsa.energy.gov/. E:\FR\FM\24OCN1.SGM 24OCN1 63504 Federal Register / Vol. 78, No. 206 / Thursday, October 24, 2013 / Notices support the issuance of an exemption. Thus, the granting of the proposed exemption is consistent with the Atomic Energy Act of 1954, as amended, and the Commission’s regulations. Therefore, the exemption is authorized by law. No Undue Risk to Public Health and Safety As described above, the requested exemption is procedural in nature and does not alter any substantive safety requirements regarding the content of a construction permit application. Due to the procedural nature of this request, no new accident precursors are created by allowing an applicant to submit a construction permit application in two parts; thus, the probability of postulated accidents is not increased. Similarly, the consequences of postulated accidents are not increased by an exemption that authorizes an application to be submitted in two parts. Therefore, there is no undue risk 3 to public health and safety. mstockstill on DSK4VPTVN1PROD with NOTICES Consistent With Common Defense and Security As discussed above, the proposed exemption would allow NWMI to submit its application for a 10 CFR part 50 construction permit application in two parts as provided for in 10 CFR 2.101(a)(5). The timing of submitting a construction permit application has no relation to security issues. Therefore, the common defense and security is not impacted by this exemption. 4.0 Conclusion Accordingly, the Commission has determined that, pursuant to 10 CFR 50.12, the exemption is authorized by law, will not present an undue risk to the public health and safety, and is consistent with the common defense and security. Also, special circumstances are present. Therefore, pursuant to 10 CFR 50.12, the Commission hereby grants NWMI an exemption from the 10 CFR 2.101(a)(5) requirement that limits the regulation’s applicability to licensing and regulatory actions requiring environmental impact statements, as described in the provisions of 10 CFR 51.20(b). The exemption granted allows NWMI to submit the construction permit application for its medical radioisotope production facility in two parts, in accordance with the remainder of the provisions of 10 CFR 2.101(a)(5). Pursuant to 10 CFR 51.32, the Commission has determined that the granting of this exemption will not have a significant effect on the quality of the human environment as it is procedural in nature. Furthermore, the Commission has determined that this exemption request meets the criteria in 10 CFR 51.22(c)(25) for a licensing action that is categorically excluded from the requirement to prepare an environmental assessment because the granting of this exemption: (1) Does not involve a significant increase in the probability or consequences of an accident previously evaluated, does not create the possibility of a new or different kind of accident from that previously evaluated, and does not involve a significant reduction in the margin of safety and, thus there is no significant hazards consideration; (2) does not authorize the release of effluents, thus there is no significant change in the types or significant increase in the amounts of any effluents that may be released offsite; (3) neither authorizes new radiological hazards nor increases existing radiological hazards, thus there is no significant increase in individual or cumulative public or occupational radiation exposure; (4) does not authorize construction, thus there is no significant construction impact; (5) does not authorize any placement of radiological components at a facility or create any new accident precursors, thus there is no significant increase in the potential for or consequences from radiological accidents; and (6) allows the submission of a construction permit application in two parts, and thus involves a scheduling requirement in accordance with 10 CFR 51.22(c)(25)(vi)(G). This exemption is effective upon issuance to NWMI. Dated at Rockville, Maryland, this 7th day of October, 2013. For the Nuclear Regulatory Commission. Lawrence E. Kokajko, Director, Division of Policy and Rulemaking, Office of Nuclear Reactor Regulation. [FR Doc. 2013–24882 Filed 10–23–13; 8:45 am] BILLING CODE 7590–01–P 3 Risk is defined as the probability of an accident multiplied by the consequences of an accident. More information on risk as it is applies to NRC regulatory activities can be found in the Commission White Paper on Risk-Informed and Performance Based Regulation, SECY–98–144 (ADAMS Accession No. ML003753601). VerDate Mar<15>2010 17:25 Oct 23, 2013 Jkt 232001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 NUCLEAR REGULATORY COMMISSION [Docket Nos. 52–027 and 52–028; NRC– 2008–0441] Virgil C. Summer Nuclear Station, Units 2 and 3; South Carolina Electric and Gas; Changes to the Primary Sampling System Nuclear Regulatory Commission. ACTION: Exemption and combined license amendment; issuance. AGENCY: The U.S. Nuclear Regulatory Commission (NRC) is granting an exemption to allow a departure from the certification information of Tier 1 of the generic design control document (DCD) and issuing License Amendment No. 8 to Combined Licenses (COL), NPF–93 and NPF–94. The COLs were issued to South Carolina Electric and Gas (SCE&G) and South Carolina Public Service Authority (Santee Cooper) (the licensee), for construction and operation of the Virgil C. Summer Nuclear Station (VCSNS), Units 2 and 3 located in Fairfield County, South Carolina. The amendment requests to modify the Primary Sampling System (PSS) design, including changes to Tier 1 information located in Tables 2.2.1–2, 2.3.13–1, and 2.3.13–3, Figures 2.2.1–1 ‘‘Containment System’’ and 2.3.13–1 ‘‘Primary Sampling System,’’ and Subsection 2.3.13, ‘‘Primary Sampling System’’ of the Updated Final Safety Analysis Report (UFSAR). The granting of the exemption allows the changes to Tier 1 information asked for in the amendment. Because the acceptability of the exemption was determined in part by the acceptability of the amendment, the exemption and amendment are being issued concurrently. SUMMARY: Please refer to Docket ID NRC–2008–0441 when contacting the NRC about the availability of information regarding this document. You may access publicly-available information related to this action by the following methods: • Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC–2008–0441. Address questions about NRC dockets to Carol Gallagher; telephone: 301–287–3422; 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 access publicly ADDRESSES: E:\FR\FM\24OCN1.SGM 24OCN1

Agencies

[Federal Register Volume 78, Number 206 (Thursday, October 24, 2013)]
[Notices]
[Pages 63501-63504]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24882]


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NUCLEAR REGULATORY COMMISSION

[Project No. 0803; NRC-2013-0235]


Request To Submit a Two-Part Application--Northwest Medical 
Isotopes, LLC

AGENCY: Nuclear Regulatory Commission.

ACTION: Exemption.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing an 
exemption in response to an August 9, 2013, letter from Northwest 
Medical Isotopes, LLC (NWMI). In this letter, NWMI requested an 
exemption from certain regulatory requirements, which, if granted, 
would allow the submittal of a construction permit application for a

[[Page 63502]]

medical radioisotope production facility in two parts. The NRC staff 
has reviewed this request and determined that it is appropriate to 
grant the exemption, as requested.

ADDRESSES: Please refer to Docket ID NRC-2013-0235 when contacting the 
NRC about the availability of information regarding this document. You 
may access publicly-available information related to this action by the 
following methods:
     Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2013-0235. Address 
questions about NRC dockets to Carol Gallagher; telephone: 301-287-
3422; email: Carol.Gallagher@nrc.gov. For technical questions, contact 
the individual(s) listed in the FOR FURTHER INFORMATION CONTACT section 
of this document.
     NRC's Agencywide Documents Access and Management System 
(ADAMS): You may access publicly available documents online in the NRC 
Library 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 in this document (if that document is 
available in ADAMS) is provided the first time that the 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: Steven Lynch, Office of Nuclear 
Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 
20555-0001; telephone: 301-415-1524; email: Steven.Lynch@nrc.gov.

SUPPLEMENTARY INFORMATION: The following sections include the text of 
the exemption in its entirety as it will be issued to NWMI.

1.0 Background

    Currently, the United States receives all of its supply of 
molybdenum-99 (Mo-99) from international sources. In recent years, 
outages at these international facilities have disrupted global supply 
and created a need to establish domestic Mo-99 production within the 
United States. In response to this need, NWMI stated in a letter dated 
August 9, 2013 (ADAMS Accession No. ML13227A295), that it intends to 
``design and construct a [radioisotope production facility] and intends 
to produce Mo-99'' in order to meet the emerging domestic demands for 
Mo-99 and its decay product, technetium-99m, in nuclear medicine 
procedures. Northwest Medical Isotopes, LLC, has proposed to submit an 
application to construct a radioisotope production facility pursuant to 
the requirements of part 50 of Title 10 of the Code of Federal 
Regulations (10 CFR), ``Domestic Licensing of Production and 
Utilization Facilities,'' and in accordance with 10 CFR 2.101(a)(5) for 
the purpose of producing Mo-99. As an applicant for a permit to 
construct such a facility, NWMI will be subject to all applicable 
rules, regulations, and orders of the NRC now or hereafter in effect.
    Generally speaking, production and utilization facility applicants 
subject to 10 CFR 51.20(b) \1\ may submit the information required for 
a construction permit, under 10 CFR part 50, in two parts, in 
accordance with the provisions of 10 CFR 2.101(a)(5). These provisions 
state that one part of the submittal must include the environmental 
report required by 10 CFR 50.30(f), while the other part must include 
the preliminary safety analysis report required by 10 CFR 50.34(a). 
Either part of the construction permit application may be submitted 
first as long as the submission of each part of the application does 
not precede or follow the other by longer than six months. However, the 
first part submitted must also contain the following:
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    \1\ 10 CFR 51.20(b) enumerates the types of licensing and 
regulatory actions requiring an environmental impact statement or a 
supplement to an environmental impact statement.
---------------------------------------------------------------------------

     The description and safety assessment of the site required 
by 10 CFR 50.34(a)(1),
     the filing fee required by 10 CFR 50.30(e) and 10 CFR 
170.21,
     the general information required by 10 CFR 50.33, and
     the agreement limiting access to Classified Information 
required by 10 CFR 50.37.
    Thus, 10 CFR 2.101(a)(5) provides that applicable preliminary 
safety analysis report information required by 10 CFR 50.34(a)(2)-
(a)(13) need not accompany the first part of the submittal. In order to 
facilitate the review of its application, NWMI would like to submit its 
application in two parts, as described above; however, based on the 
current language of 10 CFR 51.20, it cannot do so unless granted an 
exemption from certain provisions of 10 CFR 2.101(a)(5) by the 
Commission.
    The NRC staff previously addressed an exemption request from SHINE 
Medical Technologies, Inc. (SHINE) to submit is construction permit 
application in two parts. The NRC staff responded to a letter from 
SHINE, dated July 10, 2012 (ADAMS Accession No. ML12214A434), that 
asked whether production or utilization facility applicants could 
submit a construction permit application in two parts even if an 
environmental impact statement is not explicitly required for the 
application by 10 CFR 51.20(b).
    In a letter dated December 7, 2012 (ADAMS Accession No. 
ML12319A192), the NRC staff responded:

    SHINE's proposed action for licensing a medical isotope 
production facility is not an action identified in 51.20(b); 
therefore, 10 CFR 2.101(a)(5) is not applicable to SHINE's licensing 
proposal. However, SHINE could apply for an exemption under 10 CFR 
50.12 in order to submit its application for a construction permit 
in two parts as described in 10 CFR 2.101(a)(5).

    The NRC staff also explained that should an exemption to 10 CFR 
2.101(a)(5) be sought, the request must set forth existing special 
circumstances warranting the exemption, as well as provide the proposed 
contents of each part of the construction permit application.
    Similarly, NWMI has proposed to submit an application requesting 
the issuance of a construction permit for a medical radioisotope 
production facility--a licensing action not identified in 10 CFR 
51.20(b). Therefore, its application for a construction permit cannot 
be submitted in two parts under 10 CFR 2.101(a)(5) unless an exemption 
is granted by the Commission.

2.0 Request/Action

    Section 2.101(a)(5) of 10 CFR states, in part:

    An applicant for a construction permit under part 50 of this 
chapter . . . for a production or utilization facility which is 
subject to Sec.  51.20(b) of this chapter, and is of the type 
specified in Sec.  50.21(b)(2) or (b)(3) or Sec.  50.22 of this 
chapter . . . may submit the information required of applicants by 
part 50 . . . of this chapter in two parts.

    By its letter dated August 9, 2013, NWMI requests an exemption from 
the provision of 10 CFR 2.101(a)(5) that applications for a 
construction permit under 10 CFR part 50 must be of the type requiring 
an environmental impact statement or a supplement to an environmental 
impact statement as described in 10 CFR 51.20(b). The exemption would 
allow NWMI to submit a portion of its construction permit up to six 
months prior to the submittal of the remainder of the application 
regardless of whether an environmental impact statement or a

[[Page 63503]]

supplement to an environmental impact statement is prepared for its 
construction permit application. Specifically, in accordance with the 
provisions of 10 CFR 2.101(a)(5), NWMI proposes to submit the following 
in part one of its construction permit application:
     The description and safety assessment of the site required 
by 10 CFR 50.34(a)(1),
     the environmental report required by 10 CFR 50.30(f),
     the filing fee required by 10 CFR 50.30(e) and 10 CFR 
170.21,
     the general information required by 10 CFR 50.33, and
     the agreement limiting access to Classified Information 
required by 10 CFR 50.37.
    Part two of NWMI's construction permit application will contain the 
remainder of the preliminary safety analysis report required by 10 CFR 
50.34(a) and 2.101(a)(5). Northwest Medical Isotopes, LLC, has proposed 
to ``design and construct a [radioisotope production facility] and 
intends to produce Mo-99.'' In its request for an exemption from 
certain requirements of 10 CFR 2.101(a)(5), NWMI states that the 
``demand for medical isotopes is a significant national public health 
and safety concern,'' and the ability to submit its construction permit 
application in two parts would ``allow for an earlier determination as 
to whether an [environmental impact statement] is required, allowing a 
potential earlier completion of the environmental review and ultimate 
issuance of the Construction Permit . . .''

3.0 Discussion

    To docket NWMI's construction permit application in two parts under 
10 CFR 2.101(a)(5), as proposed, an exemption to the regulations is 
required. Pursuant to 10 CFR 50.12, the Commission may, upon 
application by any interested person or upon its own initiative, grant 
exemptions from the requirements of 10 CFR part 50 when (1) the 
exemptions are authorized by law, will not present an undue risk to 
public health or safety, and are consistent with the common defense and 
security; and (2) when special circumstances are present. While the 
action requested is not for an exemption to a 10 CFR part 50 
regulation, it is appropriate to evaluate this exemption request using 
the criteria of 10 CFR 50.12 because an application for a construction 
permit for a radioisotope production facility cannot be accepted for 
docketing in accordance with 10 CFR 2.101(a) unless it meets the 
requirements of 10 CFR part 50.

Special Circumstances

    The application of 10 CFR 2.101(a)(5) is limited to applications 
for licensing actions that meet the criteria for environmental impact 
statements as described in the provisions of 10 CFR 51.20(b) and to 
facilities of the types specified in 10 CFR 50.21(b)(2) or (b)(3) or 10 
CFR 50.22. Northwest Medical Isotopes, LLC, has proposed to submit an 
application requesting the issuance of a construction permit for a 
medical radioisotope production facility--a licensing action not 
identified in 10 CFR 51.20(b). Consequently, its application for a 
construction permit cannot be submitted in two parts under 10 CFR 
2.101(a)(5) unless an exemption is granted by the Commission. The 
Commission will not consider granting an exemption under 10 CFR 50.12 
unless special circumstances are present. One of the special 
circumstances listed in 10 CFR 50.12(a)(2) is ``(ii) [a]pplication of 
the regulation in the particular circumstances would not serve the 
underlying purpose of the rule or is not necessary to achieve the 
underlying purpose of the rule.'' Therefore, should the Commission 
determine that the underlying purpose of 10 CFR 2.101(a)(5) is 
achieved, application of the regulation would not be necessary, and the 
special circumstances would exist for granting of an exemption from 
certain requirements of 10 CFR 2.101(a)(5).
    The underlying purpose of the 10 CFR 2.101(a)(5) provision that 
allows certain applicants to submit an application for a construction 
permit in two parts is to enable the NRC review of significant portions 
of the application, as they become available, without unnecessary 
delay. The provision for two-part construction permit application 
submittals was added as an amendment to the regulations of 10 CFR part 
2, ``Agency Rules of Practice and Procedure,'' on April 24, 1974 (39 FR 
14506). The intent of this final rule was to ``reduce the time required 
to bring on line nuclear power plants which satisfy all environmental 
and safety requirements . . . [and remove] unnecessary obstacles to the 
construction of power plants needed to meet the nation's energy 
needs.'' Recognizing the procedural nature of the amendment, the 
Commission made the language of the final rule effective without the 
customary 30-day notice. It is consistent with the procedural nature of 
and rationale for the rule to allow NWMI to submit its construction 
permit application in two parts to facilitate the licensing process of 
this facility and NWMI's effort to respond to the nation's demand for a 
domestic supply of Mo-99.
    Furthermore, when the rule was originally written, there was a 
``deep national concern over energy sources and supply.'' Similarly, 
there currently exists a national concern over the sources and supply 
of Mo-99 in the United States. Recognizing this concern, the U.S. 
Department of Energy (DOE) and the National Nuclear Security 
Administration (NNSA) are supporting four separate entities in the 
development of low enriched uranium technologies to accelerate 
commercial production of Mo-99 in the United States through the Global 
Threat Reduction Initiative.\2\ By producing Mo-99 to meet emerging 
domestic needs, NWMI's proposed medical radioisotope production 
facility supports the efforts of DOE and NNSA and is in alignment with 
the underlying purpose of 10 CFR 2.101(a)(5). Therefore, since the 
underlying purpose of the rule is achieved, application of the 
regulation is not necessary, and the special circumstances, required by 
10 CFR 50.12(a)(2)(ii), exist for granting an exemption from certain 
requirements of 10 CFR 2.101(a)(5).
---------------------------------------------------------------------------

    \2\ To learn more about the Global Threat Reduction Initiative 
and U.S. Department of Energy's support of domestic Mo-99 
production, please visit http://nnsa.energy.gov/.
---------------------------------------------------------------------------

    Additionally, in 2007, the rule language was modified to include 
applicants seeking combined licenses under 10 CFR part 52, ``Licenses, 
Certifications, and Approvals for Nuclear Power Plants'' (72 FR 49412). 
The Commission determined that ``[t]here are no considerations unique 
to combined licenses which would weigh against allowing a combined 
license applicant to submit a two part application under paragraph 
(a)(5) of Sec.  2.101.'' Similarly, the NRC staff concludes that given 
the procedural nature of this rule, there are no unique considerations 
for medical radioisotope production facilities that would weigh against 
allowing an applicant such as NWMI to submit a two-part application 
under 10 CFR 2.101(a)(5).

Authorized by Law

    This exemption would allow NWMI to submit its application for a 10 
CFR part 50 construction permit in two parts, as provided for in 10 CFR 
2.101(a)(5). The exemption would not change the quality or content of 
the environmental report or the preliminary safety analysis report. The 
NRC staff has determined that special circumstances exist to

[[Page 63504]]

support the issuance of an exemption. Thus, the granting of the 
proposed exemption is consistent with the Atomic Energy Act of 1954, as 
amended, and the Commission's regulations. Therefore, the exemption is 
authorized by law.

No Undue Risk to Public Health and Safety

    As described above, the requested exemption is procedural in nature 
and does not alter any substantive safety requirements regarding the 
content of a construction permit application. Due to the procedural 
nature of this request, no new accident precursors are created by 
allowing an applicant to submit a construction permit application in 
two parts; thus, the probability of postulated accidents is not 
increased. Similarly, the consequences of postulated accidents are not 
increased by an exemption that authorizes an application to be 
submitted in two parts. Therefore, there is no undue risk \3\ to public 
health and safety.
---------------------------------------------------------------------------

    \3\ Risk is defined as the probability of an accident multiplied 
by the consequences of an accident. More information on risk as it 
is applies to NRC regulatory activities can be found in the 
Commission White Paper on Risk-Informed and Performance Based 
Regulation, SECY-98-144 (ADAMS Accession No. ML003753601).
---------------------------------------------------------------------------

Consistent With Common Defense and Security

    As discussed above, the proposed exemption would allow NWMI to 
submit its application for a 10 CFR part 50 construction permit 
application in two parts as provided for in 10 CFR 2.101(a)(5). The 
timing of submitting a construction permit application has no relation 
to security issues. Therefore, the common defense and security is not 
impacted by this exemption.

4.0 Conclusion

    Accordingly, the Commission has determined that, pursuant to 10 CFR 
50.12, the exemption is authorized by law, will not present an undue 
risk to the public health and safety, and is consistent with the common 
defense and security. Also, special circumstances are present. 
Therefore, pursuant to 10 CFR 50.12, the Commission hereby grants NWMI 
an exemption from the 10 CFR 2.101(a)(5) requirement that limits the 
regulation's applicability to licensing and regulatory actions 
requiring environmental impact statements, as described in the 
provisions of 10 CFR 51.20(b). The exemption granted allows NWMI to 
submit the construction permit application for its medical radioisotope 
production facility in two parts, in accordance with the remainder of 
the provisions of 10 CFR 2.101(a)(5).
    Pursuant to 10 CFR 51.32, the Commission has determined that the 
granting of this exemption will not have a significant effect on the 
quality of the human environment as it is procedural in nature. 
Furthermore, the Commission has determined that this exemption request 
meets the criteria in 10 CFR 51.22(c)(25) for a licensing action that 
is categorically excluded from the requirement to prepare an 
environmental assessment because the granting of this exemption: (1) 
Does not involve a significant increase in the probability or 
consequences of an accident previously evaluated, does not create the 
possibility of a new or different kind of accident from that previously 
evaluated, and does not involve a significant reduction in the margin 
of safety and, thus there is no significant hazards consideration; (2) 
does not authorize the release of effluents, thus there is no 
significant change in the types or significant increase in the amounts 
of any effluents that may be released offsite; (3) neither authorizes 
new radiological hazards nor increases existing radiological hazards, 
thus there is no significant increase in individual or cumulative 
public or occupational radiation exposure; (4) does not authorize 
construction, thus there is no significant construction impact; (5) 
does not authorize any placement of radiological components at a 
facility or create any new accident precursors, thus there is no 
significant increase in the potential for or consequences from 
radiological accidents; and (6) allows the submission of a construction 
permit application in two parts, and thus involves a scheduling 
requirement in accordance with 10 CFR 51.22(c)(25)(vi)(G). This 
exemption is effective upon issuance to NWMI.

    Dated at Rockville, Maryland, this 7th day of October, 2013.

    For the Nuclear Regulatory Commission.
Lawrence E. Kokajko,
Director, Division of Policy and Rulemaking, Office of Nuclear Reactor 
Regulation.
[FR Doc. 2013-24882 Filed 10-23-13; 8:45 am]
BILLING CODE 7590-01-P