ML20352A225

Shine Environmental RAIs - Cumulative Impacts

ML20352A225
Person / Time
Site:	SHINE Medical Technologies
Issue date:	12/18/2020
From:	Jennifer Davis NRC/NMSS/DREFS/ENRB
To:	Piefer G SHINE Medical Technologies
Martinez N
References
EPID L-2019-NEW-0004
Download: ML20352A225 (6)

Text

G. Piefer UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 December 18, 2020 Gregory Piefer, Ph.D.

Chief Executive Officer SHINE Medical Technologies, LLC 101 E. Milwaukee Street, Suite 600 Janesville, WI 53545

SUBJECT:

SHINE MEDICAL TECHNOLOGIES, LLC - REQUEST FOR ADDITIONAL INFORMATION FOR ENVIRONMENTAL REVIEW OF THE PROPOSED MEDICAL ISOTOPE PRODUCTION FACILITY OPERATING LICENSE APPLICATION (EPID NUMBER: L-2019-NEW-0004)

Dear Dr. Piefer:

The U.S. Nuclear Regulatory Commission (NRC) staff is reviewing the SHINE Medical Technologies LLCs (SHINEs) application for an operating license for the proposed SHINE Medical Isotope Production Facility (SHINE facility) in Janesville, Wisconsin. As part of the environmental review, the NRC staff is developing a supplement to NUREG-2183, Environmental Impact Statement for the Construction Permit for the SHINE Medical Radioisotope Production Facility, (Agencywide Documents Access and Management System Accession No. ML15288A046).

The NRC staff has identified areas where additional information is needed to complete the environmental review related to SHINEs recent announcement of its first commercial sales of therapeutic isotope lutetium-177 (Lu-177), which would initially be produced in Building One.

The long-term production of Lu-177 would be conducted in a future therapeutics facility to be constructed adjacent to the 91-acre site for the NRC-permitted SHINE facility. Additionally, the staff is aware that SHINE plans to construct its headquarters building adjacent to the new therapeutics facility. Enclosed is a list of environmental requests for additional information (RAIs) regarding these new activities. Additionally, the SHINE final safety analysis report (FSAR) should be updated to reflect any changes resulting from production of Lu-177 in Building One and the proposed therapeutics facility. Updates to the FSAR may be submitted separately.

G. Piefer 2 These RAIs were discussed with Mr. Jeffrey Bartelme and a mutually agreeable date for the response is within 45 days from the date of this letter. If you have any questions, please contact me by telephone at 301-415-3835 or via e-mail at Jennifer.Davis@nrc.gov.

Sincerely, Signed by Davis, Jennifer on 12/18/20 Jennifer Davis, Senior Project Manager Environmental Review New Reactors Branch Division of Rulemaking, Environmental and Financial Support Office of Nuclear Material Safety and Safeguards Docket No. 50-608 Construction Permit No. CPMIF-001

Enclosure:

As stated cc: w/encl

REQUEST FOR ADDITIONAL INFORMATION REGARDING THE ENVIRONMENTAL REVIEW OF THE SHINE MEDICAL TECHNOLOGIES, LLC MEDICAL ISOTOPE PRODUCTION FACILITY OPERATING LICENSE APPLICATION DOCKET NUMBER 50-608 In accordance with Title 10 of the Code of Federal Regulations 51.95(b), the U.S. Nuclear Regulatory Commission (NRC) staff is preparing a supplement to NUREG-2183, Environmental Impact Statement for the Construction Permit for the SHINE Medical Radioisotope Production Facility, (Agencywide Documents Access and Management System (ADAMS) Accession Number ML15288A046) to reflect matters that differ from the final environmental impact statement or that reflect significant new information concerning matters discussed in the final environment impact statement. The following requests for additional information (RAIs) are issued to SHINE Medical Technologies, LLC (SHINE) to support the NRC staff in identifying and documenting any new or differing information with respect to changes in the environment. This includes any new or revised projects occurring adjacent to the SHINE Medical Isotope Production Facility (SHINE facility). These projects need to be accounted for in the NRC staffs cumulative impacts analysis.

These questions are in addition to and supplement previous requests RAIs issued on February 28, 2020 (ADAMS Accession No. ML20052C761) and April 14, 2020 (ADAMS Accession No. ML20092L592).

1. Provide an updated response to RAI CI-1 and RAI CI-2 (ADAMS Number ML20073E880) to address new information related to the proposed SHINE therapeutics facility and SHINE Headquarters (HQ) building to be located adjacent to the 91-acre SHINE facility site and anticipated production of lutetium-177 (Lu-177) at Building One.

Include in the response the following information:

a. Identify changes in prior characterization and quantities of gaseous and liquid effluents, concentrations and activity levels, radioactive waste materials and disposal paths for any such waste resulting from Lu-177 production at Building One. Provide similar information for the proposed therapeutics facility.

b. Provide an updated map depicting the new SHINE HQ building and therapeutics facility. Indicate the acreage of the land parcel on which these are being constructed and depict the location of these buildings in relation to the SHINE facility. Include the dimensions (including the number of floors, depth of excavation) of each new building.

c. Characterize the purpose of and the activities to be performed (near and long-term) in Building One, the proposed SHINE HQ building, and the proposed SHINE therapeutics facility. Describe the relationship, if any, of these activities to the operation of the SHINE facility. Briefly summarize the construction and proposed operation schedules for the SHINE HQ building and therapeutics facility, as well as for modifications to Building One.

Enclosure

2

d. With the construction of the proposed SHINE HQ building, will the administration building be constructed on the 91-acre SHINE Facility site as described in the current revision to the SHINE Supplemental Environmental Report? Are there any site layout changes on the 91-acre SHINE Facility site as a result of the proposed new HQ building and proposed therapeutics facility?

e. Specify the number of additional employees that will be associated with the operation of Building One, the proposed SHINE HQ building, and the proposed SHINE therapeutics facility to support the activities to be performed as identified in SHINEs response to part (c) of this RAI.

2. Transportation (Infrastructure) - Describe the transportation impacts associated with the production of Lu-177 at Building One, and construction and operation of the proposed new HQ building and therapeutics facility. In particular, address the following:

a. Describe the transportation impacts from inbound deliveries, workers, and outbound shipments expected to support the production of Lu-177 at Building One, HQ building, and therapeutics facility.

b. Describe the construction of any new access roads to join the proposed HQ building and therapeutics facility to U.S. Highway 51 or clarify whether these facilities would share the proposed entrance road associated with the SHINE facility.

c. Clarify whether SHINEs traffic studies submitted with the supplemental ER account for the transportation activities associated with the production of Lu-177 at Building One, and the construction and operation of the proposed SHINE HQ and therapeutics facility. If not, clarify whether impacts associated with these new facilities would be bounded by prior traffic studies.

3. Transportation (Radiological) - Provide the following information related to potential radiological impacts associated with the transportation of licensed material:

a. Provide an estimate of the number of annual shipments of licensed nuclear material, including commercial products and waste from Building One and the proposed SHINE therapeutics facility.

b. Identify who will be performing the shipments identified in response to part (a) of this RAI.

c. Identify what certified shipping package(s) will be used to perform the shipments identified in part (a) of this RAI?

4. Clarify what other products SHINE is considering producing at Building One and the proposed SHINE therapeutics facility in addition to Lu-177. As applicable, provide a brief description of the products, where they would be produced, quantities, and the projected timeframe for production.

Describe SHINEs plans, including schedule, for submittal and anticipated approval from the State of Wisconsin on applications for both Building One and the new therapeutics facility.

cc w/encl.:

Test, Research and Training Jeff Bartelme Reactor Newsletter Licensing Manager Attention: Amber Johnson SHINE Medical Technologies, Inc. Dept of Materials Science 101 E. Milwaukee Street, Suite 600 and Engineering Janesville, WI 53545 University of Maryland 4418 Stadium Drive Christopher Landers College Park, MD 20742-2115 Director, Office of Conversion National Nuclear Security Mark Freitag Administration, NA 23 City Manager U.S. Department of Energy P.O. Box 5005 1000 Independence Ave SW Janesville, WI 53547-5005 Washington, DC 20585 Field Office Supervisor Mark Paulson U.S. Fish and Wildlife Service Supervisor Ecological Services Field Office Radiation Protection Section 2661 Scott Tower Drive Wisconsin Department of Health New Franken, WI 54229 Services P.O. Box 2659 Madison, WI 53701-2659 Bill McCoy 1326 Putnam Avenue Shelley Warwick Janesville, WI 53546 Environmental Analysis Specialist-South Team Wisconsin Department of Natural Alfred Lembrich Resources 541 Miller Avenue 3911 Fish Hatchery Road Janesville, WI 53548 Fitchburg, WI 53711 Enclosure

Ltr ML20352A225 NMSS/REFS OFFICE NMSS/REFS/ERLRB NMSS/REFS/ERMB NRO/DSRA

/ERLRB NAME NMartinez NM AWalker-Smith AW RElliott RE KCoyne KC DATE Dec 17, 2020 Dec 18, 2020 Dec 18, 2020 Dec 18, 2020 OFFICE NMSS/REFS/ERNRB NAME JDavis JD DATE Dec 18, 2020