ML16015A427

Notification of Correspondence Between the NRC Staff and EPA Re Feis

ML16015A427
Person / Time
Site:	SHINE Medical Technologies
Issue date:	01/15/2016
From:	Matt Young NRC/OGC
To:	NRC/OCM
SECY RAS
References
M-50-608-CP, Mandatory Hearing 2, RAS 50859
Download: ML16015A427 (12)

Text

January 15, 2016 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION BEFORE THE COMMISSION In the Matter of )

) SHINE MEDICAL TECHNOLOGIES, INC. ) Docket No. M-50-608-CP )

(Medical Radioisotope Production Facility) )

)

NOTIFICATION OF CORRESPONDENCE BETWEEN THE NRC STAFF AND THE ENVIRONMENTAL PROTECTION AGENCY REGARDING THE FINAL ENVIRONMENTAL IMPACT STATEMENT

Consistent with its obligation to inform the adjudicator about information that is potentially relevant to the proceeding, 1 the U.S. Nuclear Regulatory Commission (NRC) staff (Staff) attaches correspondence between the Environmental Protection Agency (EPA) and the Staff concerning NUREG-2183, Final Environment al Impact Statement for the Construction Permit for the SHINE Medical Radioisotope Production Facility (Oct. 2015) (FEIS or Exhibit NRC-009-MA-CM01).

2 The EPA letter, dated November 30, 2015, 3 provides comments on the FEIS regarding the generation and disposal of greater than Class C (GTCC) waste that could be generated by SHINE Medical Technologies, Inc. (SHINE). The Staff letter, dated January 14, 2016, 4 1 E.g., Metropolitan Edison Co. (Three Mile Island Nuclear Station, Unit 1), ALAB-771, 19 NRC 1350, 1357-58 (1984); Duke Power Co. (William B. McGuire Nuclear Station, Units 1 & 2), ALAB-143, 6 AEC 623, 625 n.15 (1973).

2 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML15351A231).

3 Letter from Kenneth A Westlake, EPA, Region 5, to Michele Moser, NRC, Re: [FEIS] for the SHINE Medical Radioisotope Production Facility, Janesville, Wisconsin - NUREG-2183 - CEQ #20150299 (Nov. 30, 2015) (ML15355A205).

4 Letter from James G. Danna, NRC, to Kenneth A. Westlake, EPA, Region 5, Re: Response to [EPA] Comments Regarding the [FEIS] for the Construction Permit for the Proposed SHINE Medical Isotope Production Facility (Jan. 14, 2016) (ML15355A421). (1) concludes that the comments and recommendation in EPA Letter are addressed in the published FEIS and (2) informs EPA of statements SHINE made regarding the generation and disposal of GTCC waste during the December 15, 2015, construction permit hearing.

Respectfully submitted, /Signed (electronically) by/

Mitzi A. Young Counsel for NRC Staff U.S. Nuclear Regulatory Commission Office of the General Counsel

Mail Stop O-14-G10 Washington, DC 20555 Telephone: (301) 415-3830 E-mail: Mitzi.Young@nrc.gov Dated at Rockville, Maryland this 15th day of January, 2016

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY REGION 5 77 WEST JACKSON BOU L EVARD C HI CAGO , I L 60604-3590 N OV 3 O l 0 15 R E P L Y T O THE A TIE N T ION O F: Michelle Moser Div i sion of License Renewal Nuclear Regulatory Commission

• Office of Nuclear Reactor Regulation Mail Stop 0-1 lFl 11555 Rockville Pike Rockville , Maryland 20852 E-19J Re: Final Environmental Impact Statement for the Construction Pe rmi t for the SHINE Medical Radioisotope Production Facility, Janesville, Wisconsin

-NUREG-2183

-CEQ #20150299

Dear Ms. Moser:

The_ U.S. Environmental Prntection Agency has reviewed t h e Final Environmental Impact Statement (EIS) for the SHINE Medical Radioisotope Production Fac i lity in Janesville , Wisconsin, as prepared by the Nuclear Regulatory Commission (l\TRC). Our comments are provided pursuant to the National Environmental Policy Act (NEPA), the Counci l on Environmenta l Quality's NEPA Implementing Regulations found at 40 CFR 1500-1508 , arid Section 309 of the Clean Air Act. SHINE Med ical Technologies, Inc. (the Applicant) applied t o t he NRC for a co nstruction permit to build and operate a med i ca l radioisotope production facility in Janesville , W isconsin.

The U.S. Department of Energy (DOE) i s a cooperating agency and must decide whether to provide costsharing financial support to the Applicant under a cooperative agreement, which will accelerate the commerc i al production of medical rad i oisotopes without th e use of highly enriched uranium. The proposed prefe rr ed alternative is for NRC to issue the license. EPA prov i ded comments on t he Draft EIS in a letter dated July 2, 20 15 ,

a rating of E n vironmental Concerns -Adequate Information (EC-1 ). Our comments primarily focused on waste stream management , re commenda tions of additional mitigation measures, and parts of the Draft EIS that required clarity. Based o n our review of the Final EIS, we recommend no furthe r information o r clarifications on the follmving comments from the D raft EIS: Recycled/Recyclable

• Printed with Vegetable Oi l Based I nks on 100% Recycled Paper (100% Post-Consumer)

• Radiation (Draft EIS -Comment 6-2): EPA previously recommended that the Final EIS clarify the UREX process, including raffinate generation, storage, and waste streams. EPA has re-reviewed sections of the Environmental Report (ER), particularly Table 19.2.5-1 and Section 19.2.5.3.2.

The term "low specific activity" is a U.S. Department of Transportation (DOT) designation for shipment of radioactive materials, not a waste disposal designation as stated in NRC's response.

Section 19.2.5.3.2 of the ER (Liquid Radioactive Waste System) provides a more accurate description of the management of the liquid radioactive wastes. Further, EPA appreciates the additional information provided in the October 1, 2015 letter from SHINE to NRC (SHINE Medical Technologies, Inc. Application for Construction Permit Description of the SHINE Process for Preparing Consolidated Liquid Waste Streams for Disposal as Class A Waste), which provides sufficient clarification on the processing and management of the UREX raffinate waste stream. EPA does not require further information or clarification on this comment.

• Radiation (Draft EIS -Comments 6-3, 6-4, 6-5, 6-6, and 6-7 1): These comments recommended clarification or additional information on the radioactive materials generation, storage, and waste stream processes.

NRC provided sufficient information in the Final EIS; no further clarification is regnired.

• Green Infrastructure (Draft EIS -Comment 6-8): EPA recommended green infrastructure mitigation measures.

NRC forwarded these recommendations to the applicant and included the measures (as recommendations) in Section 6.3.l of the Final EIS. No further clarification or information is needed.

• Climate Change and Greenhouse Gases (Draft EIS -Comment 6-9): EPA recommended the Final EIS include measures to reduce greenhouse gas emissions and improve climate resiliency.

NRC clarified that SHINE committed to the follo'Wing in the ER: participating in several climate and green power initiatives; developing a greenhouse gas inventory program; implementing energy efficiency and conservation programs; and, encouraging carpooling and other programs to reduce vehicle traffic during construction and operation.

These measures were included in Table 6-2 of the Final EIS. EPA commends the applicant for committing to these measures.

No further clarification or information is needed.

• Transportation (Draft EIS -Comment 6-10): This comment recommended on-going coordination during construction and operation between the applicant and the Wisconsin Department of Transportation and the Janesville Transit System in order to maintain appropriate levels of service. NRC forwarded these recommendations to the applicant and recommended mitigation has been added to Section 6.3.1. No fui-ther information or clarification is needed. 1 NRC assigned numbers to comments in the Final EIS. 2

• Editorial (Draft EIS -Comments 6-11, 6-12, and 6-13): These comments were editorial in nature; no further information or clarification is needed. EPA retains the following comment and recommendation, based on information provided in the Final EIS and ER, in addition to follow-up conversations held between NRC and EPA:

• Radiation (Draft EIS -Comment 6-1): NRC states in Table 19.2.5-1 of the ER "that waste streams would be stored on site, during which time decay would occur such that the material would be sent to Waste Control Specialists (WCS) for disposal as Class B waste. Therefore, no GTCC [Greater Than Class C (wastes)]

would be transported off the SHINE site." The table does not provide information on waste storage location, although it is mentioned elsewhere in this chapter. Column 3 of Table 19.2.5-1 provides information on the waste classification as generated.

Column 8 of Table 19.2.5-1 provides info on the U.S. DOT shipment type for the waste streams. For example, given the information provided in the Table, the zeolite beds are generated as GTCC, and shipped in a Type B container to WCS. However, it cannot be inferred from Table 19.2.5-1 that "no GTCCwould be transported off the SHINE site." As detailed in Chapter 19.2.5.3.1 of the ER (Solid Radioactive Waste Handling System) states the following with regard to the zeolite bed solids: Only iodine is adsorbed in the zeolite beds. The waste classification for this material is a function of both the efficiency of the zeolite beds and the change out frequency of the beds. It is likely the beds, in terms of operational lifetime, could build up enough iodine-129 to be greater than Class C (GTCC) waste. The zeolite is shipped to an off-site processor.

The shipment is a Type B shipment and occurs infi*equently.

lodine-129 has a half-life of 15.7 million years; iflodine-129 activity is driving the GTCC designation then decay-in-storage does not seem practical.

Chapter 19.2.5.3.1 also states that the zeolite material may exceed toxicity characteristic leaching procedure (TCLP) regulatory levels, and if so then the zeolite waste stream would be a mixed low level waste (MLL W). Mixed waste is jointly regulated under both the Resource Conservation and Recovery Act (RCRA) and the Atomic Energy Act (AEA). RCRA applies to the hazardous waste portion of the waste as any other hazardous waste, while AEA applies to the RCRA-exempt radioactive portion (52 FR 15939; May 1, 1987). While solidification and processing ofzeolite at Waste Control Specialists (WCS) is mentioned in Chapter 19.2.5.3.1, the resulting waste classification following solidification/processing is not clear. It should also be noted that Chapter 19.2.5.3.

l discusses the ion exchange resin and associated cesium-13 7 (30 year half-life), and Table 19.2.5-1 states that the Cs/Ce Media Resin is generated as GTCC as well. Chapter 19.2.5.3.1 also states "the spent resins are solidified in a shielded waste processing hot cell and the used resin is classified as GTCC 3 waste and is shippedas Type B to an off-site location.for long-term storage at WCS." We note that Section 2.7.1.2 of the EIS (Liquid and Solid Waste) states "if a disposal pathway for GTCC waste does not exist, DOE will be responsible for its safe storage and disposal." Recommendation:

NRC and SHINE should ell.sure the miriiniization of GTCC generation and should avoid generating waste without a clear treatment and disposal path. Thank you in advance for your consideration of our recommendations to reduce environmental impacts of the project and to improve the quality of the document.

Please be aware that we reserve the right to provide additional comments or recommendations under other permitting processes.

If you have any questions, please feel free to contact Elizabeth Poole of my staff at 312-353-2087 or poole.elizabeth@epa.gov.

Sincerely, ,/ £/::

/ . ./' / Kenneth A. Westlake( Chief, NEPA Implementation Section Office of Enforcement and Compliance Assurance Cc (via email): Randy Howell, Department of Energy Jim Costedio, SHINE Medical Technologies, Inc. Mark Freitag, City of Janesville Bethaney Bacher-Gresock, Federal Highway Administration

-Wisconsin Ian Chidester, Federal Highway Administration

-Wisconsin Jay Waldschmidt, Wisconsin Department of Transportation Roseanne Meer, Wisconsin Department of Transportation

-Southwest Rebecca Smith, Janesville Transit System Alice Halpin, Department of Agriculture, Trade, and Consumer Protection 4

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 January 14, 2016

Mr. Kenneth A. Westlake, Chief NEPA Implementation Section US EPA - Region 5 77 W Jackson Blvd Mail Code: E-19J Chicago, IL 60604

SUBJECT:

RESPONSE TO ENVIRONMENTAL PROTECTION AGENCY COMMENTS REGARDING THE FINAL ENVIRONMENTAL IMPACT STATEMENT FOR THE CONSTRUCTION PERMIT OF THE PROPOSED SHINE MEDICAL RADIOISOTOPE PRODUCTION FACILITY

Dear Mr. Westlake:

On November 30, 2015, the Environmental Protection Agency (EPA) Region 5, provided comments on the final Environment Impact Statement (FEIS) for the SHINE Medical Technologies, Inc. (SHINE) application for a construction permit for a medical radioisotope production facility (NUREG-2183) (October 2015) (Agencywide Documents Access and Management System (ADAMS) Accession No. ML15288A046). Appendix A of the FEIS, includes U.S. Nuclear Regulatory Commission (NRC) staff responses to EPA Region 5 comments on the draft EIS that was published for comment in May 2015 (ML151527A241). Your November 30, 2015, letter (ML15335A205) states that EPA has no further information or clarifications on its comments labeled 6-2 through 6-13 in the FEIS, but retains a comment and recommendation as to its Comment 6-1, restating concerns about the generation and disposal of greater than class C (GTCC) waste. This letter responds to your November 30, 2015, letter.

It is the NRC staff's view that the information provided in Comment 6-1 in your November 30, 2015, letter, is already addressed in the published FEIS. The NRC staff notes that Comment 6-1 quotes, in part, a non-public draft of the FEIS that was shared with EPA.

That text was revised in the published FEIS.

Specifically, Comment 6-1 (on FEIS pages A-36 to A-37) recommended that, because of the lack of a disposal pathway and offsite storage capacity for GTCC waste, (1) the FEIS should clarify who would be responsible for storage of GTCC waste generated by SHINE, (2) the FEIS should state that the Department of Energy (DOE) should promptly facilitate disposal of such GTCC waste once a disposal pathway is established and (3) SHINE should clarify whether it can engineer its process to eliminate generation of GTCC waste and otherwise reduce waste streams. FEIS, Appendix A, page A-36 to A-37.

The NRC staff's response (on FEIS page A-37) states that the American Medical Isotopes Production Act of 2012 (AMIPA) requires DOE to establish a Uranium Lease and Take Back (ULTB) Program and to be responsible for the final disposition of radioactive waste generated by a medical isotope producer that does not have access to a disposal path. The response indicates that, because the ULTB Program has not yet been established, DOE "cannot yet

describe the process through which wastes would be accepted or disposed." However, further NRC staff evaluation of the programs and controls related to SHINE's waste management would occur during the review of SHINE's Final Safety Analysis Report in support of an

operating license application" and the NRC staff must "prepare a supplement to the EIS" to address "any new or updated information provided in the operating license application or identified during the NRC staff's independent review." In addition, the FEIS states (on page 2-15) that operation of the SHINE facility would generate wastes up to GTCC waste and notes (on pages 2-16 and 4-42) DOE's responsibility to provide a disposal pathway for GTCC waste created from irradiation, processing or purification of uranium DOE leases to medical isotope producers. The FEIS (on page 2-15) also notes that SHINE would accumulate and temporarily store Class A to GTCC wastes, and that wastes would be transported offsite for storage or final disposal.

The NRC staff also concludes that your recommendation (on page 4 of the November 30 letter) that "NRC and SHINE should ensure the minimization of GTCC generation and should avoid generating waste without a clear treatment and disposal path" is addressed in the FEIS and by the obligations that AMIPA imposes on DOE. In particular, pages 2-16, 4-42, and A-37 of the FEIS state that DOE is required by AMIPA to provide a disposal pathway. As indicated on page A-37 of the FEIS, if SHINE submits an operating license, the NRC staff will further evaluate the SHINE programs and controls related to waste management and update its analysis of potential environmental impacts of the operation of the SHINE facility based on information identified at

that time.

After publication of the FEIS, SHINE provided additional information regarding the generation and minimization of GTCC waste. During the December 15, 2015, mandatory hearing held on the SHINE construction permit application, Commissioners asked about the availability of a national disposal pathway for GTCC waste that might be generated during SHINE operations and whether DOE would physically take possession of such waste. Transcript of Hearing on Construction Permit for SHINE Medical Isotope Production Facility (December 15, 2015) (ML15355A440) Tr. 158-59, 206-07. SHINE stated that its designation of small waste streams of GTCC waste is based on its preliminary design and conservative assumptions, and indicated that refinement of its design may limit or eliminate GTCC waste streams. Tr. 158. SHINE also indicated that under the DOE ULTB program, DOE would dispose of any radioactive waste that does not have a commercial disposal path, as required by AMIPA, and that the program could be in place in early 2016. Tr. 158-59, 206-208.

The NRC staff contacted SHINE to confirm that SHINE received your November 30 letter. The NRC staff also reminded SHINE of its responsibility to comply with applicable Federal, State, and local permit requirements. If you need further information, please contact Ms. Michelle Moser, Environmental Project Manager, by telephone at 301-415-6509 or by e-mail at Michelle.Moser@nrc.gov. Sincerely, /RA/ James G. Danna, Chief Environmental Review and Guidance Update Branch Division of License Renewal Office of Nuclear Reactor Regulation

Docket No. 50-608

cc: Distribution List

ML15355A421 *concurrence via e-mail OFFICE LA:DLR* PM:RERB:DLR OGC NLO* BC:RPB2:DLR NAME IBetts MMoser MYoung JDanna DATE 12/22/15 1/4/16 1/14/16 1/14/16 Letter to K. Westlake from J. Danna dated January 14, 2016

SUBJECT:

RESPONSE TO ENVIRONMENTAL PROTECTION AGENCY COMMENTS REGARDING THE FINAL ENVIRONMENTAL IMPACT STATEMENT FOR THE CONSTRUCTION PERMIT OF THE PROPOSED SHINE MEDICAL RADIOISOTOPE PRODUCTION FACILITY DISTRIBUTION

E-MAIL: PUBLIC Public DHowe SLynch JLynch SHarwell RTR r/f MAdams CWeber CFrazier MConley RidsNrrDpr MMoser DBarss LLondon JWeil RidsNrrDprPrta AAdams ASapountzis MYoung VHuckabay RidsNrrDprPrtb LTran DSeymour TZaki DWrona RidsOgcRp Resource RidsAcrsAcnw_MailCTR Resource HARD COPY: Jeff Bartelme Licensing Manager SHINE Medical Technologies, Inc.

2555 Industrial Drive Monona, WI 53713

Matt Heavner, Ph.D. National Security and International Affairs Office of Science and Technology Policy Executive Office Building 1650 Pennsylvania Avenue Washington, DC 20503 Randy Howell National Nuclear Security Administration, NA-212 U.S. Department of Energy 1000 Independence Ave SW Washington, DC 20585

Paul Schmidt Manager Radiation Protection Section Wisconsin Department of Health Services P.O. Box 2659 Madison, WI 53701-2659

Laura Bub Environmental Analysis and Review Specialist State of Wisconsin Department of Natural Resources 3911 Fish Hatchery Road Fitchburg, WI 53711 TRTR Newsletter University of Florida Department of Nuclear Engineering Sciences 202 Nuclear Sciences Center Gainesville, FL 32611

Mark Freitag City Manager

P.O. Box 5005 Janesville, WI 53547-5005

Bill McCoy 1326 Putnam Avenue Janesville, WI 53546

Alfred Lembrich 541 Miller Avenue Janesville, WI 53548 Gerald and Muriel Bumgarner 1735 S Osborne Ave Janesville, WI 53546

UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION BEFORE THE COMMISSION In the Matter of )

)

SHINE MEDICAL TECHNOLOGIES, INC. ) Docket No. M-50-608-CP

) (Medical Radioisotope Production Facility) ) )

CERTIFICATE OF SERVICE Pursuant to 10 C.F.R. § 2.305, I hereby certify that copies of the foregoing "NOTIFICATION OF CORRESPONDENCE BETWEEN THE NRC STAFF AND THE ENVIRONMENTAL PROTECTION AGENCY REGARDING THE FINAL ENVIRONMENTAL IMPACT STATEMENT," dated January 15, 2016, have been served upon the Electronic Information Exchange, the NRC's E-Filing System, in the above-captioned proceeding, this 15th day of January, 2016.

/Signed (electronically) by/ Mitzi A. Young Counsel for NRC Staff U.S. Nuclear Regulatory Commission Office of the General Counsel

Mail Stop O-14-G10 Washington, DC 20555 Telephone: (301) 415-3830

E-mail: Mitzi.Young@nrc.gov Dated at Rockville, Maryland this 15th day of January, 2016 January 15, 2016 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION BEFORE THE COMMISSION In the Matter of )

) SHINE MEDICAL TECHNOLOGIES, INC. ) Docket No. M-50-608-CP )

(Medical Radioisotope Production Facility) )

)

NOTIFICATION OF CORRESPONDENCE BETWEEN THE NRC STAFF AND THE ENVIRONMENTAL PROTECTION AGENCY REGARDING THE FINAL ENVIRONMENTAL IMPACT STATEMENT

Consistent with its obligation to inform the adjudicator about information that is potentially relevant to the proceeding, 1 the U.S. Nuclear Regulatory Commission (NRC) staff (Staff) attaches correspondence between the Environmental Protection Agency (EPA) and the Staff concerning NUREG-2183, Final Environment al Impact Statement for the Construction Permit for the SHINE Medical Radioisotope Production Facility (Oct. 2015) (FEIS or Exhibit NRC-009-MA-CM01).

2 The EPA letter, dated November 30, 2015, 3 provides comments on the FEIS regarding the generation and disposal of greater than Class C (GTCC) waste that could be generated by SHINE Medical Technologies, Inc. (SHINE). The Staff letter, dated January 14, 2016, 4 1 E.g., Metropolitan Edison Co. (Three Mile Island Nuclear Station, Unit 1), ALAB-771, 19 NRC 1350, 1357-58 (1984); Duke Power Co. (William B. McGuire Nuclear Station, Units 1 & 2), ALAB-143, 6 AEC 623, 625 n.15 (1973).

2 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML15351A231).

3 Letter from Kenneth A Westlake, EPA, Region 5, to Michele Moser, NRC, Re: [FEIS] for the SHINE Medical Radioisotope Production Facility, Janesville, Wisconsin - NUREG-2183 - CEQ #20150299 (Nov. 30, 2015) (ML15355A205).

4 Letter from James G. Danna, NRC, to Kenneth A. Westlake, EPA, Region 5, Re: Response to [EPA] Comments Regarding the [FEIS] for the Construction Permit for the Proposed SHINE Medical Isotope Production Facility (Jan. 14, 2016) (ML15355A421). (1) concludes that the comments and recommendation in EPA Letter are addressed in the published FEIS and (2) informs EPA of statements SHINE made regarding the generation and disposal of GTCC waste during the December 15, 2015, construction permit hearing.

Respectfully submitted, /Signed (electronically) by/

Mitzi A. Young Counsel for NRC Staff U.S. Nuclear Regulatory Commission Office of the General Counsel

Mail Stop O-14-G10 Washington, DC 20555 Telephone: (301) 415-3830 E-mail: Mitzi.Young@nrc.gov Dated at Rockville, Maryland this 15th day of January, 2016

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY REGION 5 77 WEST JACKSON BOU L EVARD C HI CAGO , I L 60604-3590 N OV 3 O l 0 15 R E P L Y T O THE A TIE N T ION O F: Michelle Moser Div i sion of License Renewal Nuclear Regulatory Commission

• Office of Nuclear Reactor Regulation Mail Stop 0-1 lFl 11555 Rockville Pike Rockville , Maryland 20852 E-19J Re: Final Environmental Impact Statement for the Construction Pe rmi t for the SHINE Medical Radioisotope Production Facility, Janesville, Wisconsin

-NUREG-2183

-CEQ #20150299

Dear Ms. Moser:

The_ U.S. Environmental Prntection Agency has reviewed t h e Final Environmental Impact Statement (EIS) for the SHINE Medical Radioisotope Production Fac i lity in Janesville , Wisconsin, as prepared by the Nuclear Regulatory Commission (l\TRC). Our comments are provided pursuant to the National Environmental Policy Act (NEPA), the Counci l on Environmenta l Quality's NEPA Implementing Regulations found at 40 CFR 1500-1508 , arid Section 309 of the Clean Air Act. SHINE Med ical Technologies, Inc. (the Applicant) applied t o t he NRC for a co nstruction permit to build and operate a med i ca l radioisotope production facility in Janesville , W isconsin.

The U.S. Department of Energy (DOE) i s a cooperating agency and must decide whether to provide costsharing financial support to the Applicant under a cooperative agreement, which will accelerate the commerc i al production of medical rad i oisotopes without th e use of highly enriched uranium. The proposed prefe rr ed alternative is for NRC to issue the license. EPA prov i ded comments on t he Draft EIS in a letter dated July 2, 20 15 ,

a rating of E n vironmental Concerns -Adequate Information (EC-1 ). Our comments primarily focused on waste stream management , re commenda tions of additional mitigation measures, and parts of the Draft EIS that required clarity. Based o n our review of the Final EIS, we recommend no furthe r information o r clarifications on the follmving comments from the D raft EIS: Recycled/Recyclable

• Printed with Vegetable Oi l Based I nks on 100% Recycled Paper (100% Post-Consumer)

• Radiation (Draft EIS -Comment 6-2): EPA previously recommended that the Final EIS clarify the UREX process, including raffinate generation, storage, and waste streams. EPA has re-reviewed sections of the Environmental Report (ER), particularly Table 19.2.5-1 and Section 19.2.5.3.2.

The term "low specific activity" is a U.S. Department of Transportation (DOT) designation for shipment of radioactive materials, not a waste disposal designation as stated in NRC's response.

Section 19.2.5.3.2 of the ER (Liquid Radioactive Waste System) provides a more accurate description of the management of the liquid radioactive wastes. Further, EPA appreciates the additional information provided in the October 1, 2015 letter from SHINE to NRC (SHINE Medical Technologies, Inc. Application for Construction Permit Description of the SHINE Process for Preparing Consolidated Liquid Waste Streams for Disposal as Class A Waste), which provides sufficient clarification on the processing and management of the UREX raffinate waste stream. EPA does not require further information or clarification on this comment.

• Radiation (Draft EIS -Comments 6-3, 6-4, 6-5, 6-6, and 6-7 1): These comments recommended clarification or additional information on the radioactive materials generation, storage, and waste stream processes.

NRC provided sufficient information in the Final EIS; no further clarification is regnired.

• Green Infrastructure (Draft EIS -Comment 6-8): EPA recommended green infrastructure mitigation measures.

NRC forwarded these recommendations to the applicant and included the measures (as recommendations) in Section 6.3.l of the Final EIS. No further clarification or information is needed.

• Climate Change and Greenhouse Gases (Draft EIS -Comment 6-9): EPA recommended the Final EIS include measures to reduce greenhouse gas emissions and improve climate resiliency.

NRC clarified that SHINE committed to the follo'Wing in the ER: participating in several climate and green power initiatives; developing a greenhouse gas inventory program; implementing energy efficiency and conservation programs; and, encouraging carpooling and other programs to reduce vehicle traffic during construction and operation.

These measures were included in Table 6-2 of the Final EIS. EPA commends the applicant for committing to these measures.

No further clarification or information is needed.

• Transportation (Draft EIS -Comment 6-10): This comment recommended on-going coordination during construction and operation between the applicant and the Wisconsin Department of Transportation and the Janesville Transit System in order to maintain appropriate levels of service. NRC forwarded these recommendations to the applicant and recommended mitigation has been added to Section 6.3.1. No fui-ther information or clarification is needed. 1 NRC assigned numbers to comments in the Final EIS. 2

• Editorial (Draft EIS -Comments 6-11, 6-12, and 6-13): These comments were editorial in nature; no further information or clarification is needed. EPA retains the following comment and recommendation, based on information provided in the Final EIS and ER, in addition to follow-up conversations held between NRC and EPA:

• Radiation (Draft EIS -Comment 6-1): NRC states in Table 19.2.5-1 of the ER "that waste streams would be stored on site, during which time decay would occur such that the material would be sent to Waste Control Specialists (WCS) for disposal as Class B waste. Therefore, no GTCC [Greater Than Class C (wastes)]

would be transported off the SHINE site." The table does not provide information on waste storage location, although it is mentioned elsewhere in this chapter. Column 3 of Table 19.2.5-1 provides information on the waste classification as generated.

Column 8 of Table 19.2.5-1 provides info on the U.S. DOT shipment type for the waste streams. For example, given the information provided in the Table, the zeolite beds are generated as GTCC, and shipped in a Type B container to WCS. However, it cannot be inferred from Table 19.2.5-1 that "no GTCCwould be transported off the SHINE site." As detailed in Chapter 19.2.5.3.1 of the ER (Solid Radioactive Waste Handling System) states the following with regard to the zeolite bed solids: Only iodine is adsorbed in the zeolite beds. The waste classification for this material is a function of both the efficiency of the zeolite beds and the change out frequency of the beds. It is likely the beds, in terms of operational lifetime, could build up enough iodine-129 to be greater than Class C (GTCC) waste. The zeolite is shipped to an off-site processor.

The shipment is a Type B shipment and occurs infi*equently.

lodine-129 has a half-life of 15.7 million years; iflodine-129 activity is driving the GTCC designation then decay-in-storage does not seem practical.

Chapter 19.2.5.3.1 also states that the zeolite material may exceed toxicity characteristic leaching procedure (TCLP) regulatory levels, and if so then the zeolite waste stream would be a mixed low level waste (MLL W). Mixed waste is jointly regulated under both the Resource Conservation and Recovery Act (RCRA) and the Atomic Energy Act (AEA). RCRA applies to the hazardous waste portion of the waste as any other hazardous waste, while AEA applies to the RCRA-exempt radioactive portion (52 FR 15939; May 1, 1987). While solidification and processing ofzeolite at Waste Control Specialists (WCS) is mentioned in Chapter 19.2.5.3.1, the resulting waste classification following solidification/processing is not clear. It should also be noted that Chapter 19.2.5.3.

l discusses the ion exchange resin and associated cesium-13 7 (30 year half-life), and Table 19.2.5-1 states that the Cs/Ce Media Resin is generated as GTCC as well. Chapter 19.2.5.3.1 also states "the spent resins are solidified in a shielded waste processing hot cell and the used resin is classified as GTCC 3 waste and is shippedas Type B to an off-site location.for long-term storage at WCS." We note that Section 2.7.1.2 of the EIS (Liquid and Solid Waste) states "if a disposal pathway for GTCC waste does not exist, DOE will be responsible for its safe storage and disposal." Recommendation:

NRC and SHINE should ell.sure the miriiniization of GTCC generation and should avoid generating waste without a clear treatment and disposal path. Thank you in advance for your consideration of our recommendations to reduce environmental impacts of the project and to improve the quality of the document.

Please be aware that we reserve the right to provide additional comments or recommendations under other permitting processes.

If you have any questions, please feel free to contact Elizabeth Poole of my staff at 312-353-2087 or poole.elizabeth@epa.gov.

Sincerely, ,/ £/::

/ . ./' / Kenneth A. Westlake( Chief, NEPA Implementation Section Office of Enforcement and Compliance Assurance Cc (via email): Randy Howell, Department of Energy Jim Costedio, SHINE Medical Technologies, Inc. Mark Freitag, City of Janesville Bethaney Bacher-Gresock, Federal Highway Administration

-Wisconsin Ian Chidester, Federal Highway Administration

-Wisconsin Jay Waldschmidt, Wisconsin Department of Transportation Roseanne Meer, Wisconsin Department of Transportation

-Southwest Rebecca Smith, Janesville Transit System Alice Halpin, Department of Agriculture, Trade, and Consumer Protection 4

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 January 14, 2016

Mr. Kenneth A. Westlake, Chief NEPA Implementation Section US EPA - Region 5 77 W Jackson Blvd Mail Code: E-19J Chicago, IL 60604

SUBJECT:

RESPONSE TO ENVIRONMENTAL PROTECTION AGENCY COMMENTS REGARDING THE FINAL ENVIRONMENTAL IMPACT STATEMENT FOR THE CONSTRUCTION PERMIT OF THE PROPOSED SHINE MEDICAL RADIOISOTOPE PRODUCTION FACILITY

Dear Mr. Westlake:

On November 30, 2015, the Environmental Protection Agency (EPA) Region 5, provided comments on the final Environment Impact Statement (FEIS) for the SHINE Medical Technologies, Inc. (SHINE) application for a construction permit for a medical radioisotope production facility (NUREG-2183) (October 2015) (Agencywide Documents Access and Management System (ADAMS) Accession No. ML15288A046). Appendix A of the FEIS, includes U.S. Nuclear Regulatory Commission (NRC) staff responses to EPA Region 5 comments on the draft EIS that was published for comment in May 2015 (ML151527A241). Your November 30, 2015, letter (ML15335A205) states that EPA has no further information or clarifications on its comments labeled 6-2 through 6-13 in the FEIS, but retains a comment and recommendation as to its Comment 6-1, restating concerns about the generation and disposal of greater than class C (GTCC) waste. This letter responds to your November 30, 2015, letter.

It is the NRC staff's view that the information provided in Comment 6-1 in your November 30, 2015, letter, is already addressed in the published FEIS. The NRC staff notes that Comment 6-1 quotes, in part, a non-public draft of the FEIS that was shared with EPA.

That text was revised in the published FEIS.

Specifically, Comment 6-1 (on FEIS pages A-36 to A-37) recommended that, because of the lack of a disposal pathway and offsite storage capacity for GTCC waste, (1) the FEIS should clarify who would be responsible for storage of GTCC waste generated by SHINE, (2) the FEIS should state that the Department of Energy (DOE) should promptly facilitate disposal of such GTCC waste once a disposal pathway is established and (3) SHINE should clarify whether it can engineer its process to eliminate generation of GTCC waste and otherwise reduce waste streams. FEIS, Appendix A, page A-36 to A-37.

The NRC staff's response (on FEIS page A-37) states that the American Medical Isotopes Production Act of 2012 (AMIPA) requires DOE to establish a Uranium Lease and Take Back (ULTB) Program and to be responsible for the final disposition of radioactive waste generated by a medical isotope producer that does not have access to a disposal path. The response indicates that, because the ULTB Program has not yet been established, DOE "cannot yet

describe the process through which wastes would be accepted or disposed." However, further NRC staff evaluation of the programs and controls related to SHINE's waste management would occur during the review of SHINE's Final Safety Analysis Report in support of an

operating license application" and the NRC staff must "prepare a supplement to the EIS" to address "any new or updated information provided in the operating license application or identified during the NRC staff's independent review." In addition, the FEIS states (on page 2-15) that operation of the SHINE facility would generate wastes up to GTCC waste and notes (on pages 2-16 and 4-42) DOE's responsibility to provide a disposal pathway for GTCC waste created from irradiation, processing or purification of uranium DOE leases to medical isotope producers. The FEIS (on page 2-15) also notes that SHINE would accumulate and temporarily store Class A to GTCC wastes, and that wastes would be transported offsite for storage or final disposal.

The NRC staff also concludes that your recommendation (on page 4 of the November 30 letter) that "NRC and SHINE should ensure the minimization of GTCC generation and should avoid generating waste without a clear treatment and disposal path" is addressed in the FEIS and by the obligations that AMIPA imposes on DOE. In particular, pages 2-16, 4-42, and A-37 of the FEIS state that DOE is required by AMIPA to provide a disposal pathway. As indicated on page A-37 of the FEIS, if SHINE submits an operating license, the NRC staff will further evaluate the SHINE programs and controls related to waste management and update its analysis of potential environmental impacts of the operation of the SHINE facility based on information identified at

that time.

After publication of the FEIS, SHINE provided additional information regarding the generation and minimization of GTCC waste. During the December 15, 2015, mandatory hearing held on the SHINE construction permit application, Commissioners asked about the availability of a national disposal pathway for GTCC waste that might be generated during SHINE operations and whether DOE would physically take possession of such waste. Transcript of Hearing on Construction Permit for SHINE Medical Isotope Production Facility (December 15, 2015) (ML15355A440) Tr. 158-59, 206-07. SHINE stated that its designation of small waste streams of GTCC waste is based on its preliminary design and conservative assumptions, and indicated that refinement of its design may limit or eliminate GTCC waste streams. Tr. 158. SHINE also indicated that under the DOE ULTB program, DOE would dispose of any radioactive waste that does not have a commercial disposal path, as required by AMIPA, and that the program could be in place in early 2016. Tr. 158-59, 206-208.

The NRC staff contacted SHINE to confirm that SHINE received your November 30 letter. The NRC staff also reminded SHINE of its responsibility to comply with applicable Federal, State, and local permit requirements. If you need further information, please contact Ms. Michelle Moser, Environmental Project Manager, by telephone at 301-415-6509 or by e-mail at Michelle.Moser@nrc.gov. Sincerely, /RA/ James G. Danna, Chief Environmental Review and Guidance Update Branch Division of License Renewal Office of Nuclear Reactor Regulation

Docket No. 50-608

cc: Distribution List

ML15355A421 *concurrence via e-mail OFFICE LA:DLR* PM:RERB:DLR OGC NLO* BC:RPB2:DLR NAME IBetts MMoser MYoung JDanna DATE 12/22/15 1/4/16 1/14/16 1/14/16 Letter to K. Westlake from J. Danna dated January 14, 2016

SUBJECT:

RESPONSE TO ENVIRONMENTAL PROTECTION AGENCY COMMENTS REGARDING THE FINAL ENVIRONMENTAL IMPACT STATEMENT FOR THE CONSTRUCTION PERMIT OF THE PROPOSED SHINE MEDICAL RADIOISOTOPE PRODUCTION FACILITY DISTRIBUTION

E-MAIL: PUBLIC Public DHowe SLynch JLynch SHarwell RTR r/f MAdams CWeber CFrazier MConley RidsNrrDpr MMoser DBarss LLondon JWeil RidsNrrDprPrta AAdams ASapountzis MYoung VHuckabay RidsNrrDprPrtb LTran DSeymour TZaki DWrona RidsOgcRp Resource RidsAcrsAcnw_MailCTR Resource HARD COPY: Jeff Bartelme Licensing Manager SHINE Medical Technologies, Inc.

2555 Industrial Drive Monona, WI 53713

Matt Heavner, Ph.D. National Security and International Affairs Office of Science and Technology Policy Executive Office Building 1650 Pennsylvania Avenue Washington, DC 20503 Randy Howell National Nuclear Security Administration, NA-212 U.S. Department of Energy 1000 Independence Ave SW Washington, DC 20585

Paul Schmidt Manager Radiation Protection Section Wisconsin Department of Health Services P.O. Box 2659 Madison, WI 53701-2659

Laura Bub Environmental Analysis and Review Specialist State of Wisconsin Department of Natural Resources 3911 Fish Hatchery Road Fitchburg, WI 53711 TRTR Newsletter University of Florida Department of Nuclear Engineering Sciences 202 Nuclear Sciences Center Gainesville, FL 32611

Mark Freitag City Manager

P.O. Box 5005 Janesville, WI 53547-5005

Bill McCoy 1326 Putnam Avenue Janesville, WI 53546

Alfred Lembrich 541 Miller Avenue Janesville, WI 53548 Gerald and Muriel Bumgarner 1735 S Osborne Ave Janesville, WI 53546

UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION BEFORE THE COMMISSION In the Matter of )

)

SHINE MEDICAL TECHNOLOGIES, INC. ) Docket No. M-50-608-CP

) (Medical Radioisotope Production Facility) ) )

CERTIFICATE OF SERVICE Pursuant to 10 C.F.R. § 2.305, I hereby certify that copies of the foregoing "NOTIFICATION OF CORRESPONDENCE BETWEEN THE NRC STAFF AND THE ENVIRONMENTAL PROTECTION AGENCY REGARDING THE FINAL ENVIRONMENTAL IMPACT STATEMENT," dated January 15, 2016, have been served upon the Electronic Information Exchange, the NRC's E-Filing System, in the above-captioned proceeding, this 15th day of January, 2016.

/Signed (electronically) by/ Mitzi A. Young Counsel for NRC Staff U.S. Nuclear Regulatory Commission Office of the General Counsel

Mail Stop O-14-G10 Washington, DC 20555 Telephone: (301) 415-3830

E-mail: Mitzi.Young@nrc.gov Dated at Rockville, Maryland this 15th day of January, 2016