2019-25788. SHINE Medical Technologies, LLC

AGENCY:

Nuclear Regulatory Commission.

ACTION:

Intent to prepare a supplement to the final environmental impact statement and conduct scoping.

SUMMARY:

The U.S. Nuclear Regulatory Commission (NRC) intends to gather information through the public scoping process to prepare a supplement the to the final environmental impact statement (FEIS) on the construction permit related to the operating license application for the SHINE Medical Isotope Production Facility. The NRC is seeking public input on the proposed action and has scheduled a public scoping meeting.

DATES:

Submit comments by January 13, 2020. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received before this date.

ADDRESSES:

You may submit comments by any of the following methods:

• Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2019-0173. Address questions about NRC docket IDs in Regulations.gov to Jennifer Borges; telephone: [phone]; email: [e-mail]. For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.
• Mail comments to: Office of Administration, Mail Stop: TWFN-7-A60M, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Program Management, Announcements and Editing Staff.
• For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT:

Jennifer A. Davis, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: [phone]; email: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Obtaining Information and Submitting Comments

A. Obtaining Information

Please refer to Docket ID NRC-2019-0173 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document by any of the following methods:

• Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2019-0173.
• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the NRC Library at https://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 [e-mail]. The ADAMS accession number for each document referenced in this document (if that document is available in ADAMS) is provided the first time that a document is referenced. SHINE Medical Technologies, LLC's (SHINE) operating license application for the SHINE Medical Isotope Production Facility can be found in ADAMS under Package Accession No. ML19211C143.
• 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.
• Library: A copy of the SHINE supplemental environmental report (ER) is available at the Hedberg Public Library, 316 South Main Street, Janesville, Wisconsin 53545.

B. Submitting Comments

Please include Docket ID NRC-2019-0173 in the subject line of your comment submission in order to ensure that the NRC is able to make your comment submission available to the public in this docket.

The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at https://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.

II. Discussion

By letter dated July 17, 2019 (ADAMS Accession No. ML19211C044), SHINE filed with the NRC, pursuant to Section 103 of the Atomic Energy Act and part 50, “Domestic Licensing of Production and Utilization Facilities,” of title 10 of the Code of Federal Regulations (10 CFR), an application for a 30-year operating license for the SHINE Medical Isotope Production Facility to be located in Janesville, Wisconsin (ADAMS Package Accession No. ML19211C143). In addition to general and financial information, the application included a final safety analysis report and a supplemental ER. A notice of receipt and availability of this application was previously published in the Federal Register (FR) on September 10, 2019 (84 FR 47557). A notice of acceptance of the application for docketing was published in the FR on October 15, 2019 (84 FR 55187). In accordance with the provisions of 10 CFR 2.105, “Notice of proposed action,” a separate notice of opportunity to file a petition for leave to intervene in a hearing will be published at a later date.

SHINE has proposed to construct and operate a facility in Janesville, Wisconsin to produce molybdenum-99 through the irradiation and processing of a uranyl sulfate solution. As described in the operating license application, the proposed SHINE facility would comprise an irradiation facility and radioisotope production facility. The irradiation facility would consist of eight subcritical operating assemblies (or irradiation units) and the radioisotope production facility would consist of hot cell structures for the processing of irradiated material.

By letters dated March 26 and May 31, 2013 (ADAMS Accession Nos. ML13088A192 and ML13172A361, respectively), SHINE (at the time known as SHINE Medical Technologies, Inc.) submitted a construction permit application, as updated in 2015, for its eight utilization facilities and one production facility (ADAMS Package Accession No. ML15258A431). The NRC issued Construction Permit No. CPMIF-001 to SHINE on February 29, 2016 (ADAMS Package Accession No. ML16041A473), as supported by NUREG-2189, “Safety Evaluation Report Related to SHINE Medical Technologies, Inc. Construction Permit Application for a Medical Radioisotope Production Facility,” dated August 2016 (ADAMS Accession No. ML16229A140), and NUREG-2183, “Environmental Impact Statement for the Construction Permit for the SHINE Medical Radioisotope Production Facility,” dated October 2015 (ADAMS Accession No. ML15288A046). In accordance with 10 CFR 51.95(b), in connection with SHINE's operating license application, the NRC will prepare a supplement to NUREG-2183, which will update the prior environmental review. The supplement will only cover matters that differ from or reflect significant new information concerning matters discussed in NUREG-2183.

III. Request for Comments

This notice informs the public of the NRC's intention to conduct scoping and prepare a supplement to NUREG-2183 as part of the review of the SHINE operating license application, and to provide the public an opportunity to participate in the environmental scoping process, as defined in 10 CFR 51.29, “Scoping-environmental impact statement and supplement to environmental impact statement.”

The regulations in 36 CFR 800.8, “Coordination with the National Environmental Policy Act,” allow agencies to use their National Environmental Policy Act of 1969 (NEPA) process to fulfill the requirements of Section 106 of the National Historic Preservation Act (NHPA). Therefore, pursuant to 36 CFR 800.8(c), the NRC intends to use its NEPA process and documentation to comply with Section 106 of the NHPA in lieu of the procedures set forth at 36 CFR 800.3 through 800.6.

In accordance with 10 CFR 51.53(b), SHINE submitted a supplement to its construction permit ER as part of the operating license application. The supplement updates the information presented in the previous ER submitted as part of the construction permit application. The supplemental ER was prepared pursuant to 10 CFR part 51 and is publicly available in ADAMS under Accession No. ML19211C139. The supplemental ER may also be viewed on the internet at https://www.nrc.gov/​docs/​ML1921/​ML19211C139.pdf. In addition, a paper copy of ER is available for public review at the Hedberg Public Library, 316 South Main Street, Janesville, Wisconsin 53545.

When a FEIS has been prepared in connection with the issuance of a construction permit for a production or utilization facility, the NRC is required to prepare a supplement to the FEIS on the construction permit in connection with the issuance of an operating license in accordance with 10 CFR 51.95(b). The supplement will only cover matters that differ from the final environmental impact statement or that reflect significant new information concerning matters discussed in the final environmental impact statement.

The NRC will first conduct scoping and will then prepare a draft supplement for public comment. Participation in the scoping process by members of the public and local, State, Tribal, and Federal government agencies is encouraged. The scoping process will be used to accomplish the following:

a. Define the proposed action;

b. Determine the scope and identify the significant issues to be analyzed in depth;

c. Identify and eliminate from detailed study those issues that are peripheral or are not significant; or were covered by a prior environmental review;

d. Identify any environmental assessments and other ElSs that are being or will be prepared that are related to, but are not part of, the scope of the supplement being considered;

e. Identify other environmental review and consultation requirements related to the proposed action;

f. Indicate the relationship between the timing of the preparation of the environmental analyses and the Commission's tentative planning and decision-making schedule;

g. Identify any cooperating agencies and, as appropriate, allocate assignments for preparation and schedules for completing the supplement; and

h. Describe how the supplement will be prepared, including any contractor assistance to be used.

The NRC invites the following entities to participate in scoping:

a. The applicant, SHINE;

b. Any Federal agency that has jurisdiction by law or special expertise with respect to any environmental impact involved or that is authorized to develop and enforce relevant environmental standards;

c. Affected State and local government agencies, including those authorized to develop and enforce relevant environmental standards;

d. Any affected Indian Tribe;

e. Any person who requests or has requested an opportunity to participate in the scoping process; and

f. Any person who has petitioned or intends to petition for leave to intervene under 10 CFR 2.309.

IV. Public Scoping Meeting

In accordance with 10 CFR 51.26, the scoping process may include a public scoping meeting to help identify significant issues related to a proposed activity and to determine the scope of issues to be addressed. The NRC will hold a public scoping meeting for the SHINE environmental review on December 12, 2019, from 6:00 p.m. to 8:00 p.m. at The Celtic House at Glen Erin Golf Club, 1417 W Airport Rd., Janesville, WI 53546. There will be an open house one hour before the meeting for members of the public to meet with the NRC staff and sign in to speak at the meeting.

The meeting will be transcribed and will include: (1) An overview by the NRC staff of the safety and NEPA environmental review processes, the proposed scope of the supplement to the FEIS; and (2) the opportunity for interested government agencies, organizations, and individuals to submit comments or suggestions on the environmental issues or the proposed scope. The main objectives of this meeting are to describe the environmental review process and receive public comments on the appropriate scope and content to be considered in the staff's review. To be considered, comments must be provided either at the transcribed public meeting or in writing, as discussed in the ADDRESSES section of this document.

Persons may register to attend or present oral comments at the meeting on the scope of the NEPA review by contacting the NRC Environmental Project Manager, Ms. Jennifer Davis, by telephone at 301-415-3835, or by email at [e-mail] no later than December 5, 2019. Members of the public may also register to speak during the registration period prior to the start of the meeting. Individual oral comments may be limited by the time available, depending on the number of persons who register. Members of the public who have not registered may also have an opportunity to speak if time permits. Public comments will be considered in the scoping process for the SHINE environmental review. Please contact Ms. Davis no later than December 5, 2019, if accommodations or special equipment is needed to attend or present information at the public meeting, so that the NRC staff can determine whether the request can be accommodated.

Participation in the scoping process does not entitle participants to become parties to the proceeding to which the supplement relates. Matters related to participation in any hearing are outside the scope of matters to be discussed at this public meeting.

Dated at Rockville, Maryland, this 22nd day of November 2019.

For the Nuclear Regulatory Commission.

Robert B. Elliott,

Chief, Environmental Review License Renewal Branch, Division of Rulemaking, Environmental, and Financial Support, Office of Nuclear Material Safety and Safeguards.