ML15062A111

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Issuance of Environmental Scoping Summary Report Associated with the Staff'S Review of the Application by Shine Medical Technologies, Inc., for a Construction Permit for a Medical Radioisotope Production Facility
ML15062A111
Person / Time
Site: SHINE Medical Technologies
Issue date: 04/02/2015
From: Wrona D J
NRC/NRR/DLR/RERGUB
To: Bynum R V
SHINE Medical Technologies
Moser M, 415-6509
References
TAC MF2308
Download: ML15062A111 (59)


Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555

-0001 April 2, 2015 R. Vann Bynum, PhD Chief Operating Officer SHINE Medical Technologies, Inc.

2555 Industrial Drive Monona, WI 53713

SUBJECT:

ISSUANCE OF ENVIRONMENTAL SCOPING SUMMARY REPORT ASSOCIATED WITH THE STAFF'S REVIEW OF THE APPLICATION BY SHINE MEDICAL TECHNOLOGIES, INC. FOR A CONSTRUCTION PERMIT FOR A MEDICAL RADIOISOTOPE PRODUCTION FACILITY (TAC NO. MF2308)

Dear Dr. Bynum:

The U.S. Nuclear Regulatory Commission (NRC or the staff) conducted an environmental scoping process and solicited public comments from July 1 to August 30, 2013. This process determined the scope of the staff's environmental review of the application for a construction permit for the proposed SHINE Medical Technologies, Inc.

(SHINE), Medical Radioisotope Production Facility (SHINE facility). The scoping process is the first step required by Title 10 of the Code of Federal Regulations (10 CFR) Section 51.26(a) after publication of a notice of intent to prepare an environmental impact statement (EI S). As part of the scoping process, the staff held two public meetings in Janesville, WI, on July 17, 2013, to solicit public input regarding the scope of the review.

The staff also received written comments by letter, e

-mail, and through www.Regulations.gov. At the conclusion of the scoping process, the staff prepared the enclosed environmental scoping summary report identifying comments received during the scoping period. In accordance with 10 CFR 51.29(b), the staff will send a copy of the scoping summary report to all participants in the scoping process.

The transcripts of the public scoping meetings are available for public inspection in the NRC Public Document Room (PDR), located at One White Flint North, 11555 Rockville Pike, Rockville, MD 20852, or from the NRC's Agencywide Documents Access and Management System (ADAMS). The ADAMS Public Electronic Reading Room is accessible at http://www.nrc.gov/reading

-rm/adams.html. The transcripts for the afternoon and evening meetings are listed under ADAMS Accession Nos. ML13260A280 and ML13260A281, respectively. Persons who encounter problems in accessing documents in ADAMS should contact the NRC's PDR reference staff by telephone at 1

-800-397-4209 or 301

-415-4737 or by e-mail at pdr.resource@nrc.gov

.

R. Vann Bynum, PhD A notice of the availability of the draft EIS and the procedures for providing comments will be published in the Federal Register following issuance of the draft document. If you have any questions concerning the staff's environmental review of this construction permit application, please contact Ms. Michelle Moser, Project Manager, at 301

-415-6509 or by e

-mail to Michelle.Moser@nrc.gov.

Sincerely,

/RA/ David J. Wrona, Chief Environmental Review and Guidance Update Branch Division of License Renewal Office of Nuclear Reactor Regulation Docket No. 50

-608

Enclosure:

As stated

cc w/encl: See Distribution List

ML15062A111

  • concurred via email OFFICE LA:DLR QTE PM:RERB:DLR OGC BC:RERB:DLR NAME IBetts JDougherty MMoser MYoung DWrona DATE 3/3/15 *3/6/15 3/9/15 3/31/15 4/2/15

SUBJECT:

ISSUANCE OF ENVIRONMENTAL SCOPING SUMMARY REPORT ASSOCIATED WITH THE STAFF'S REVIEW OF THE APPLICATION BY SHINE MEDICAL TECHNOLOGIES, INC. FOR A CONSTRUCTION PERMIT FOR A MEDICAL RADIOISOTOPE PRODUCTION FACILITY (TAC NO. MF2308)

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PUBLIC RTR r/f CFrazier MConley RidsNrrDpr LLondon JWeil RidsNrrDprPrta MYoung VHuckabay RidsNrrDprPrtb RidsOgcRp Resource RidsAcrsAcnw_MailCTR Resource AAdams SLynch CWeber MMoser DWrona DHowe JLynch MYoung SHarwell DBarss LTran TZaki DSeymour ASapountzis Randy.Howell@nnsa.doe.gov HARD COPY:

Jim Costedio Licensing Manager SHINE Medical Technologies, Inc.

2555 Industrial Drive Monona, WI 53713

Janet Piraino District Director at U.S. Representative Mark Pocan Madison District Office 10 East Doty Street Suite 405 Madison, WI 53703

Kirsten Cutler, Ph.D.

National Security and International Affairs Office of Science and Technology Policy Executive Office Building 1650 Pennsylvania Avenue

Washington, DC 20503

Kenneth Westlake U.S. Environmental Protection Agency 77 West Jackson Boulevard, E

-19J Chicago, IL 60604 Elizabeth Poole, Environmental Scientist NEPA Implementation Section

U.S. Environmental Protection Agency 77 West Jackson Boulevard, E

-19J Chicago, IL 60604 Melissa Cook, Tribal Historic Preservation Officer Forest County Potawatomi Community 8130 Mish Ko Swen Drive P.O. Box 340 Crandon, Wl 54520 Paul Schmidt Manager Radiation Protection Section Wisconsin Department of Health Services P.O. Box 2659 Madison, WI 53701

-2659 Eric P. Heggelund Environmental Analysis and Review Specialist State of Wisconsin Department of Natural Resources 3911 Fish Hatchery Road Fitchburg, WI 5371 1

Mark Freitag

City Manager P.O. Box 5005 Janesville, WI 53547

-5005 Douglas Marklein City Council City Hall P.O. Box 5005 Janesville, WI 53547 5005

Dave Dobson Friends of Welty Environmental Center P.O. Box 131 Beloit, WI 53512 TRTR Newsletter University of Florida Department of Nuclear Engineering Sciences 202 Nuclear Sciences Center Gainesville, FL 32611 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

Richard Henning 2003 Meadow Lane Janesville, WI 53546

Richard Miller 2908 W Avalon Road Janesville, WI 53546 Environmental Impact Statement Scoping Process Summary Report Proposed SHINE Medical Radioisotope Production Facility Janesville, WI April 2015 U.S. Nuclear Regulatory Commission Rockville, Maryland

1 1 Introduction By letter dated March 26, 2013, SHINE Medical Technologies, Inc. (SHINE), submitted Part 1 of a two-part application to the U.S. Nuclear Regulatory Commission (NRC) for a construction permit for a medical radioisotope production facility (SHINE facility) in Janesville, WI. The purpose of this report is to provide a concise summary of the determinations and conclusions reached, including the significant issues identified, as a result of the scoping process in the NRC's environmental review of this construction permit application.

Part 1 of the SHINE application included an environmental report (ER) (SHINE 2013) prepared consistent with Title 10 of the Code of Federal Regulations (CFR) Part 51, "Environmental protection regulations for domestic licensing and related regulatory functions," which contains the NRC requirements for implementing the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq., herein referred to as NEPA).

Guidance for the preparation and submittal of an ER for licensing radioisotope production facilities to the NRC is outlined in "Final Interim Staff Guidance Augmenting NUREG

-1537, Part 1

" (NRC 2012).

On July 1, 2013, the NRC initiated the scoping process for the SHINE facility by issuing a Federal Register notice (78 FR 39343). This Federal Register notice notified the public of the NRC staff's intent to prepare an environmental impact statement (EIS) related to the review of the construction permit application for the SHINE facility. The NRC staff will prepare the EIS in accordance with 10 CFR Part 51. The scoping process provides an opportunity for public participation to identify issues to be addressed in the EIS and to highlight public concerns. The notice of intent (78 FR 39343) identified the following objectives of the scoping process:

Define the proposed action, which is to be the subject of the EIS; Determine the scope of the EIS and identify the significant issues to be analyzed in depth; Identify and eliminate from detailed study those issues that are peripheral or that are not significant; 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 EIS being considered; Identify other environmental review and consultation requirements related to the proposed action; Indicate the relationship between the timing of the preparation of the environmental analyses and the Commission's tentative planning and decision

-making schedule; Identify any cooperating agencies and, as appropriate, allocate assignments for preparation, and schedules for completing the EIS to the NRC and any cooperating agencies; and Describe how the EIS will be prepared and include any contractor assistance to be used.

2 The proposed Federal action is for the NRC to decide whether to issue a construction permit, under 10 CFR Part 50, that would allow construction of a medical radioisotope production facility, which would include utilization facilities

. The scope of the EIS includes an evaluation of the environmental impacts of constructing, operating, and decommissioning the proposed SHINE facility and of the reasonable alternatives to the proposed action. The "Scoping Comments and Responses" section of this report includes specific issues identified by the comments. The subsequent NRC responses explain whether the issues will be addressed in the EIS and, if so, where in the report they will likely be addressed.

Throughout the scoping process, the NRC staff identified and eliminated peripheral issues. This report provides responses to comments that were determined to be out of the scope of this environmental review. Comments that are within the scope of the environmental review will be evaluated in detail and documented in the appropriate sections of the EIS for the proposed SHINE facility.

In parallel with its NEPA review, the NRC staff is conducting section 7 consultation under the Endangered Species Act of 1973 (ESA) to ensure the protection of listed species and designated critical habitat that may be affected by the activities described in the construction permit application. The regulations that implement section 7 (50 CFR 402, "Interagency cooperation

-Endangered Species Act of 1973, as amended") describe the consultation procedures that Federal agencies must follow in order to fully comply with the act. Depending on the project, the NRC may need to consult with the U.S.

Fish and Wildlife Service (FWS), the National Marine Fisheries Service (NMFS), or both. In the case of the proposed SHINE facility, no species under NMFS's jurisdiction occur within the action area; therefore, the NRC staff is only consulting with the FWS.

In accordance with 36 CFR 800.8, "Coordination with the National Environmental Policy Act," the NRC will coordinate compliance with Section 106 of the National Historic Preservation Act (NHPA) through the requirements of NEPA. NRC staff has initiated consultation with the Advisory Council on Historic Preservation, the Wisconsin Historical Society, and Federally

-recognized tribes with historic ties to the area surrounding the proposed SHINE site. The NRC staff expects to publish the draft EIS in May 2015. The EIS will be prepared by NRC staff with contract support from Los Alamos Technical Associates and Idoneous Consulting.

The NRC invited the applicant; Federal, State, and local government agencies; Indian Tribal governments; local organizations; and individuals to participate in the scoping process by providing oral comments at the scheduled public meetings or by submitting written comments before the end of the scoping comment period on August 30, 2013. The scoping process included two public meetings held on July 17, 2013, at the Rotary Botanical Gardens, 1455 Palmer Drive, Janesville, WI. The NRC issued press releases, purchased newspaper advertisements, and distributed flyers locally to advertise these meetings. Approximately 60 people attended the meetings. Each session began with NRC staff members providing a brief overview of the construction permit process and the NEPA environmental review process. Following the NRC staff's prepared statements, an opportunity was provided for public comments.

Five attendees provided separate oral comments that were recorded and transcribed by a certified court reporter. The NRC staff issued a summary of the scoping meetings on September 23, 2013 (NRC 2013). In addition to the comments received at the meetings, the NRC also received seven letters with comments about the review. All documents associated with this scoping process are available 3 for public inspection in the NRC Public Document Room (PDR), located at One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, or from the NRC's Agencywide Documents Access and Management System (ADAMS). The ADAMS Public Electronic Reading Room is accessible at http://www.nrc.gov/reading

-rm/adams.html

. Persons who encounter problems in accessing documents in ADAMS should contact the NRC's PDR Reference staff by telephone at 1

-800-397-4209 or 301

-415-4737 or by e

-mail at pdr.resource@nrc.gov

. The ADAMS accession number for each document is listed below in Table 1. At the conclusion of the scoping period, the staff reviewed the transcripts (NRC 2013) and all written material received in order to identify individual comments. Each comment was marked with a unique identifier consisting of the commenter identification (

ID) (specified in Table

1) and a comment number. This unique identifier allows each comment to be traced back to the transcript, letter, or e

-mail in which the comment was identified. Comments were consolidated and categorized according to the topic within the proposed EIS or according to the general topic if outside the scope of the EIS. Once comments were grouped according to subject area, the NRC staff determined the appropriate action for the comment. The action or resolution for each comment is described in the NRC staff's responses within this report.

1.1 Scoping Participants Table 1 identifies the individuals who provided comments and the assigned commenter ID. Individuals are listed alphabetically, along with the source document by which the comment was submitted.

4 Table 1. Individuals Providing Comments During the Scoping Comment Period Commenter Affiliation (if stated)

ID Comment Source ADAMS No.

Dave Dobson None given 01 Afternoon Transcript ML13260A280 Melissa Cook Forest County Potawatomi Community 02 Letter ML13224A164 Eric Heggelund Wisconsin Department of Natural Resources 03 Letter ML14045A298 Richard Henning None given 04 Letter ML13233A023 Al Lembrich None given 05 Letter ML13233A022 Douglas Marklein Janesville City Council 06 Afternoon Transcript ML13260A280 Bill McCoy None given 07 Afternoon Transcript ML13260A280 Richard Miller None given 08 Afternoon Transcript ML13260A280 Janet Piraino Congressman Mark Pocan 09 Afternoon Transcript ML13260A280 Jamie Stout None given 10 Letter ML13263A012 Kenneth Westlake U.S. Environmental Protection Agency 11 Letter ML13238A121 1.2 Scoping Comments The process for addressing the comments and suggestions received as part of the scoping process is discussed in this section. The disposition of each comment is discussed in Section 2. The comments received during the scoping period are grouped into the following general categories:

1. Accidents 2. Air quality and meteorology;
3. Alternatives;
4. Ecological resources
5. Geologic environment
6. Historical and cultural resources;
7. Human health;
8. Land use; 9. Transportation
10. Water resources
11. Waste management
12. Support for the proposed SHINE facility
13. Opposition to the proposed SHINE facility
14. Other comments outside the scope of NRC's environmental review.

5 In instances where a comment provided no environmental information, only a brief response is provided to the comment and no further evaluation will be performed.

The preparation of the EIS will take into account all of the relevant issues raised during th e scoping process. The NRC staff will issue a draft EIS for public comment in May 2015. That comment period will be the next opportunity for interested Federal, State, and local government agencies; Indian Tribal governments; local organizations; the applicant; and other members of the public to provide input to the NRC's environmental review process.

Comments received on the draft EIS will be considered in the preparation of the final EIS. The final EIS, along with the NRC staff's safety evaluation report, will provide much of the basis for the agency's decision on SHINE's application to construct the SHINE facility.

6 2 Proposed SHINE Medical Radioisotope Production Facility Scoping Comments and Responses

2.1 Accidents

Comments:

01-2: My only other concern would have to do with the issue of aircraft landing because the site is very close to the airport, planes coming in to land at Rock County airport.

It is important to make sure that the facility is built in such a way that nothing serious would happen in terms of any kind of radioactive release if the largest airplane that

's going to land at the airport were to crash right into the building.

So that is one of the important considerations there.

05-3: There is a matter that the FFA [FAA] may have concerns with the proximity, size, type & use of this proposed Shine building, considering the Southern Wisconsin Regional Airport and its runways being right across the street.

Even though its runways may not be directly in line with the proposed building, many airport crashes occur where the airplanes veer off the runway to either left or right of the runway.

Additional concerns would be the height of the proposed building possibly impeding line of s ight for pilots.

Would the proposed building withstand a large cargo or other large plane that could crash into it due to some malfunction, and cause release of contaminated material and cause environmental dangers?

05-13: The local citizens have concerns and possibly the FFA

[FAA] with the Shine building location, height and its uranium content being right across the street from the Southern Wisconsin Regional Airport and its runways. There are possibilities of an airplane crash and potential uranium exposure or contamination from a demolished building and its contents. Could there be an impediment to pilot's line of sight in evaluating their approach to land? Is the height of Shine's building too high and raise the risk of a plane strike when something goes wrong with the resulting environmental concerns?

05-15: The large Seneca Foods canning company and its processing of vegetables is located just to the North/East, down

-wind of the Shine site. There are hundreds of acres of farm crops that they harvest from this entire nearby area for their plant. Any accident, leakages, or contaminations to air, water, land could be very harmful to the editable crops, the entire food chain and to this business. The present environment could be greatly threatened.

07-1: Number one, the airport issue that was just brought up is how the building is going to be done, what protection are we going to have. What if we have some idiot wants to fly into it like we've had in other places, you know. I mean I've done helicopters when I was in Vietnam. Anything could happen. Anything. So even a plane motor can fall off and land into it and bust it all to pieces. What protection are we going to have from a leakage with that uranium because we've also got the farms out there. We also got Seneca right down the road here, which is less than a mile and a half from where we are sitting right now. They have fields across the highway.

They've got fields out towards the Blackhawk Tech and all this over here that if the fumes that would go over that would destroy those crops from being put in that particular time of need. So we've got to think about it.

Seneca also wants the addition over here.

Right, City Council members?

So we're going to have to worry about that because that is one thing that we are very concerned about.

7 11-7: The Draft EIS should discuss facility and system features to ensure safety and minimize off-site releases in the event of an accident or other unanticipated event.

Response

The above comments express concerns relating to potential accidents and can be found in Section 4 of this report.

The U.S. Nuclear Regulatory Commission (

NRC) staff will describe the regulatory limits to protect the public if an accident, such as a plane crash, were to occur at the proposed SHINE site in Janesville, WI

, in Chapter 3 of the EIS and will address the impacts to the public from the maximum hypothetical accident at the proposed SHINE facility in Chapter 4.

An expanded response to these comments will be included in Appendix A of the draft EIS. 2.2 Air Quality and Meteorology Comments: 03-3: A review regarding an air permit should be thoroughly examined by the project proponents.

The project involves the addition of at least one stationary source (the stand

-by emergency diesel generator).

SHINE is evaluating the eligibility of this stationary source for a Type A Registration Permit.

At this time, further review regarding the air permit applicability is required, per s.

NR 405, 406

, and 407 Wisconsin Administrative Code. 11-1: EPA notes that both diesel and natural gas are identified as fuel sources in the ER.

The draft EIS should include why two sources are necessary.

Further, we recommend SHINE consider the use of renewable energy sources either in lieu of or to supplement the proposed diesel and natural gas sources. If SHINE or NRC dismisses the use of alternative energy sources, the draft EIS should state why.

11-5: The draft EIS should describe how diesel emissions will be minimized throughout construction and decommissioning of the facility.

EPA suggests the following diesel emission reduction techniques be employed to further minimize impacts:

Using low

-sulfur diesel fuel (15 parts per million sulfur maximum) in construction vehicles and equipment.

Retrofitting engines with an exhaust filtration device to capture diesel particulate matter before it enters the construction site.

Positioning the exhaust pipe so that diesel fumes are directed away from the operator and nearby workers, thereby reducing the fume concentration to which personnel are exposed.

Using catalytic converters to reduce carbon monoxide, aldehydes, and hydrocarbons in diesel fumes. These devices must be used with low sulfur fuels.

Ventilating wherever diesel equipment operates indoors at the Meredosia an d injection well sites. Roof vents, open doors and windows, roof fans, or other mechanical systems help move fresh air through work areas. As buildings under construction are gradually enclosed, remember that fumes from diesel equipment operating indoors can build up to dangerous levels without adequate ventilation.

8 Attaching a hose to the tailpipe of diesel vehicles running indoors and exhaust the fumes outside, where they cannot re

-enter the workplace. Inspect hoses regularly for defects and damage.

Using enclosed, climate

-controlled cabs pressurized and equipped with high efficiency particulate air (HEPA) filters to reduce the operators' exposure to diesel fumes. Pressurization ensures that air moves from inside to outside. HEPA filters ensure that any incoming air is filtered first.

Regularly maintaining diesel engines, which is essential to keep exhaust emissions low. Follow the manufacturer's recommended maintenance schedule and procedures. Smoke color can signal the need for maintenance. For example, blue/black smoke indicates that an engine requires servicing or tuning.

Reducing exposure through work practices and training, such as turning off engines when vehicles are stopped for more than a few minutes, training diesel equipment operators to perform routine inspection, and maintaining filtration devices. Purchasing new vehicles that are equipped with the most advanced emission control systems available.

Using electric starting aids, such as block heaters, with older vehicles to warm the engine reduces diesel emissions.

Using respirators, which are only an interim measure to control exposure to diesel emissions. In most cases, an N95 respirator is adequate. Workers must be trained and fit

-tested before they wear respirators. Depending on work being conducted, and if oil is present, concentrations of particulates present will determine the efficiency and type of mask and respirator. Personnel familiar with the selection, care, and use of respirators must perform the fit testing. Respirators must bear a National Institute of Occupational Safety and Health (NIOSH) approval number. Never use paper masks or surgical masks without NIOSH approval numbers.

Response

The above comments express concerns relating to air quality and meteorology and can be found in Section 4 of this report

. The NRC staff will describe the environment on and around the proposed SHINE site in Janesville, WI as it relates to air quality and meteorology in Chapter 3 of the EIS and will address the impacts to air quality and metorology from construction, operations, and decommissioning of the proposed SHINE facility in Chapter 4.

An expanded response to these comments will be included in Appendix A of the EIS.

2.3 Alternatives Comments: 05-9: In British Columbia

, engineers and other experts have successfully developed medical isotopes using a cyclotron.

These isotopes for scans can be created by in hospital run cyclotrons, eliminating transportation dangers and the rush to hospital due to short use life.

Would not that be safer and healthier from production, to transportation, and to actual use on a patient and even for disposal?

Why would not the NRC curtail the unnecessary use of uranium for a better, cleaner

, and healthier environment?

Why would you even grant any medical 9 isotope licenses to any who would use uranium processed isotopes without fail safe methods and procedures all through the process?

The North Star isotope facility in Beloit, Wi., 12 miles from Janesville, will be producing medical isotopes with a different process within a year of two, from what I read.

Would it not make more sense to regionalize as to site locations of the four companies planning to produce isotopes in the U.S.? To not bunch them up?

Transportation and timing would be much more efficient.

So why would the NRC approve an already outdated process that Shine proposes?

The North Star site is ahead of Shine.

In my opinion, Shine took the wrong course in going the current uranium route. The Arizona proven process and North Star took the better route.

Don't feel sorry for Shine Medical Technologies, some technologies succeed, some do not.

05-19: Why have two medical isotope places (North star & Shine) within 12 miles of each other? With the processed products short life and needed short transportation times, would it not make more sense to allow four regional sites, spaced across the country, because I understand there are four isotope companies planning sites and operations now? Other sites that Shine had looked at would be much better & safer in my opinion.

07-7: They've got other sites they have looked at.

Now why didn

't they take one of those other sites? 08-1: Actually, I was coming across a comment on

-I saw an article in Popular Science. They were talking about using, in Canada, where they use these isotopes and make it [in] a hospital. And I thought is this going to be effective somewhere down the line, but when Mr.

Mackey actually explained to us, well, it's completely different, but it's just a point that is this facility, five years down the road, going to go bust. In other words, technologies change.

Response

The above comments express concerns relating to alternatives to the proposed construction of the SHINE facility at the Janesville, WI site and can be found in Section 4 of this report. The NRC staff will identify and evaluate reasonable alternatives to the proposed construction of the SHINE facility at the Janesville, WI site in Chapter 5 of the EIS. This includes the option of denying the construction permit, referred to as the "no

-action alternative."

Chapter 5 of the EIS will compare the impacts of construction, operation, and decommissioning of the proposed SHINE facility at the Janesville, WI site to the environmental impacts of alternatives, including alternative sites and alternative technologies

. An expanded response to these comments will be included in Appendix A of the EIS. 2.4 Ecological Resources Comment: 03-1: SHINE submitted an Endangered Resources Review (ER Log

  1. 12-020) request on January 19, 2012, to the WDNR Bureau of Natural Heritage Conservation (formerly known as the Bureau of Endangered Resources) for their proposed facility location in Janesville.

The purpose of the review is to obtain information on rare plants and animals

, including state and federally listed species, high quality natural communities

, and other endangered resources that may be impacted by the project.

The review also includes recommendations to help projects comply with Wisconsin

's Endangered Species Law (Wis. Stats. 29.604), the Federal Endangered Species Act, and other laws and regulations protecting endangered resources.

The review concluded that no action would be needed to avoid impacts to rare or sensitive species or communities.

The current condition of the property as an active agricultural field far 10 from any wetlands, water

, or buffer areas makes it unsuitable habitat for any listed species or natural communities located in the area.

Response

The above comment expresses concerns relating to ecological resources and can be found in Section 4 of this report.

The NRC staff will describe the ecological environment on and around the proposed SHINE site in Janesville, WI

, in Chapter 3 of the EIS and will address the impacts to ecological resources from construction, operations, and decommissioning of the proposed SHINE facility in Chapter 4.

An expanded response to this comment will be inclu ded in Appendix A of the draft EIS. 2.5 Geological Environment Comment: 05-7: How deep will the building excavation be? How much of the building be below ground level? Response:

The above comment expresses concerns relating to the geological environment and can be found in Section 4 of this report.

The NRC staff will describe the geologic environment on and around the proposed SHINE site in Janesville, WI

, in Chapter 3 of the EIS and will address the impacts to the geologic environment from construction, operations, and decommissioning of the proposed SHINE facility in Chapter 4.

An expanded response to thi s comment will be included in Appendix A of the draft EIS.

2.6 Historical and Cultural Resources Comment: 02-1: As this project occurs within Potawatomi ancestral and previously occupied lands, we would like to express our concerns with any impacts to historic and cultural properties located within the project area of potential effect for the project mentioned above.

We appreciate receiving results of an archival review, cultural resource investigation studies, and archaeological reports. Should there be an impact or effect to cultural or historic properties as a result of this project, we will request consultation pursuant to Section 106 of the National Historic Preservation Act, as amended.

Response

The above comment expresses concern relating to historical and cultural resources and can be found in Section 4 of this report.

The NRC staff will describe the cultural background and the known historic and cultural resources found on the proposed SHINE site in Janesville, WI

, in Chapter 3 of the EIS and will address the impacts to historic and cultural resources from construction, operations, and decommissioning of the proposed SHINE facility in Chapter 4. An expanded response to th is comment will be included in Appendix A of the EIS.

2.7 Human Health Comments: 05-2: This proposed site is less than ,06 [.06] of a mile South of a Trailer Court.

Potential Environmental risks causes those residents concern about any planned or unplanned release of any dangerous or contaminated airborne emissions from the site, and being carried by normal Southerly or S/W winds directly over the nearby trailer court

. There is also the potential risk of 11 fire or explosion or other accidents that could pose a danger to the nearby residents at the Trailer Court.

This location appears contrary to NRC desires that uranium facilities of all kinds be located outside of cities and in more remote areas to reduce dangers, hazardous exposures

, and protect the public from such exposures and more easily protect the environment and humans. 05-4: There are a number of other environmental concerns.

One involves nearby high quality agriculture land and its following food chain.

There is the large Macfarlane Pheasant farm and meat processing facility approximately less than a mile to the North.

Any releases of hazardous materials, particles

, or radiation emissions could cause great harm to his business and to those who may eat contaminated products before receiving knowledge of it.

There is also much high quality farm land to the East of the proposed Shine site, where hundreds of acres of corn and other crops are raised and harvested for & by the canning company Senica Foods.

They have a large nearby processing plant in town, just to the North/East, down wind of the proposed site.

Any leak of hazardous material or waste like uranium contaminated material or air particles could be a disaster to important food production, for who knows how long.

There could also be ground and ground water contamination from hidden or undiscovered leakage of hazardous materials, like radiation or uranium products or waste. 05-12: The occupied Trailer Court, is less than .06 of a mile down

-wind from the Shine site.

If there should be any fire, explosion, leaks or accident's with dangerous or contaminated airborne emission releases or other waste from the site, that could pose potential dangers and risks to those residing downwind in this nearby Trailer Court.

That's a potential environmental risk.

05-14: Other environmental concerns involve risks to the food chain. There is a large pheasant farm and it's meat processing plant less than a mile to the North and downwind of the Shine site. Release of hazardous materials, airborne harmful particles or radiation emissions could cause great harm to feed, pheasants, their business and loss of jobs, and potential contamination of the food supply for human consumption.

07-4: That's another thing we've got to worry about folks, our food chain. We also got the pheasant farm right across the road from there. That stuff gets on feathers. You think that man is going to be able to sell his pheasants? I don't think so. How do we know how much contamination? What does this give us, 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br />? Well, how do we know it's not already in their system? Now, I did have a hard thing up in Madison at the VA. I don't know what it was, but I know I was allergic to it. It caused me problems. But I didn't ask what it was. They told me it's similar to what this was and I said that's close to what this is and he says well, it's similar. I said well, you know something, if I'm allergic, how many more of these other people might be allergic to it accidentally?

Response

The above comments express concerns relating to human health and can be found in Section 4 of this report.

The NRC staff will describe the regulatory limits to protect workers and the public during construction, operations, and decommissioning of the proposed SHINE site in Janesville, WI

, in Chapter 3 of the EIS and will address the potential impacts to the health of workers and the public in Chapter 4. An expanded response to these comments will be included in Appendix A of the draft EIS

. To the extent that the above comments raise issues regarding accidents and land use, a response to those environmental issues are provided under Accidents, Section 2.1, and Land Use, Section 2.8.

12 2.8 Land Use Comments: 05-1: First, in your material on this, the NRC presented incorrect important information, on page 4, by stating the proposed Shine facility would be located approximately four miles south of Janesville, Wisconsin.

This site is within the Janesville cit y limits, on land purchased by the city and connected to other city tax incremental financing district land.

05-11: The NRC information mailed out was incorrect by stating the proposed Shine site would be located approximately 4 miles South of Janesville, WI. The fact is, it will be within the city limits of Janesville. I understood the NRC preferred sites that were away from population, animal, crops and food chain sources and operations, was I wrong?

07-8: How close is it? Now there's a pamphlet that we received from the NRC which I've already discussed with an individual here, that was this thing that said this thing was four miles outside of the City of Janesville. Well, it's not. It might be from the center of town four miles.

Response

The above comments express concerns relating to land use and can be found in Section 4 of this report.

The NRC staff will describe the land use on and around the proposed SHINE site in Janesville, WI

, in Chapter 3 of the EIS and will address the impacts to land use from construction, operations, and decommissioning of the proposed SHINE facility in Chapter 4. An expanded response to these comments will be included in Appendix A of the draft EIS.

To the extent that the above comments raise issues regarding alternatives, a response to those environmental issues are provided under Alternatives, Section 2.3.

2.9 Transportation

Comment: 11-6: The Draft EIS should identify any traffic management or infrastructure improvements to US Highway 51 that will be required to handle increased capacity of truck and employee traffic. Any improvements and resultant impacts should be considered connected actions.

The Draft EIS should indicate whether SHINE intends to use the adjacent Southern Wisconsin Regional Airport as a means of shipping and receiving materials. If yes, any improvements to the airport should be disclosed and considered connected actions.

Response

The above comment expresses concerns relating to transportation and can be found in Section 4 of this report.

The NRC staff will describe transportation infrastructure, traffic, and regulations to protect the public around the proposed SHINE site in Janesville, WI

, in Chapter 3 of the EIS and will address the impacts to transportation from construction, operations, and decommissioning of the proposed SHINE facility in Chapter 4.

An expanded response to this comment will be included in Appendix A of the draft EIS.

2.10 Water Resources Comments:

03-2: Wisconsin Department of Natural Resources Construction Site and Industrial Storm Water Discharge Permitting, NR 216, Wisconsin Administrative Code:

As described in Subchapter III of NR 216, Wis. Adm. Code, landowners of construction projects where one or more acres of land will be disturbed must obtain a WPDES

[Wisconsin Pollutant 13 Discharge Elimination System]

Construction Site Storm Water Discharge Permit.

A Water Resources Application for Project Permits (WRAPP)

(http://dnr.wi.gov/topic/stormwater/construction/forms.html) and applicable fee must be submitted to the Wisconsin Department of Natural Resources at least 14 working days before construction will begin.

Permittees must develop an Erosion and Sediment Control Plan and a Storm Water Management Plan describing the best management practices that will be implemented on

-site. Weekly on

-site inspections throughout the duration of the project and after storm water events are also required.

Additionally, industrial facilities that must obtain industrial storm water discharge permit coverage are listed in NR 216, Wis. Adm. Code, Subchapter II. The determination of whether an industrial facility must obtain storm water discharge permit coverage is based both on the facility's Standards Industrial Classification (SIC) code and whether or not the facility has the potential to contaminate storm water.

Permitted facilities must develop a site

-specific Storm Water Pollution Prevention Plan (SWPPP).

The goal of this plan is to encourage source

-area control through identification of a storm water pollution prevention individual, site

-specific best management practices, and implementation schedules to help decrease the amount of contaminated storm water runoff from a facility.

Some industrial facilities may also be required to conduct annual chemical monitoring for pollutants in runoff from their sites.

Facilities with discharges composed entirely of storm water and at which there is no exposure of industrial materials and activities to storm water, may qualify for a Conditional No Exposure Exclusion, as detailed in s. NR 216.21(3).

Industrial Notice of Intent and No Exposure Certification forms can be found online at http://dnr.wi.gov/topic/stormwater/industrial/forms.htm l and shall be submitted to the Wisconsin Department of Natural Resources at the same time as the construction site WRAPP (at least 14 working days prior to expected start of construction).

05-5: Water use concerns:

Senica [Seneca] Foods is in the process of enlarging and already using a very large unknown amount of water in million of gallons and will be using much more after enlarging their processing of vegetables production.

Now Shine alone, indicates it will use about 6600 gallons per day or 2,409,000 gallons per year.

Both of these businesses may threaten our well water &

pumping resources in the summer.

We have at least two city wells that have high levels of nitrates that can

't be used for drinking alone and in recent news Rock County has just experienced a huge increase of nitrate in wells throughout the County.

Where will we get good drinking water?

Last year many area wells went dry according to news reports.

We must preserve our water and other natural resources and address environmental concerns.

05-16: There are water use concerns. Shines indicates it would use approximately 6,600 gallons of water per day, that amounts to 2,409,000 gallons per year. The nearby Seneca Foods uses even much higher amounts of water as well, and will be expanding and using more water yet. The large water use may threaten our water resources and even pumping capacities during the hot summer. We need to preserve our drinking water resources.

07-2: Now our water. All the wells that we have here in this community are drinking water in this community. This is something that's also in here with Al's. We've got a well right across the little bit of a pond right here. We've got another one across the road. We've got another one right over here on the corner. And we've already had some problems with some nitrogen problems and everything with some of our water wells around here. Well, you know, we don't want no uranium problems because you don't know how far that thing is going to seep down in our ground.

14 The gentleman said where he was at said that 21 something that's supposed to have a water well up there. Well, wait a minute. Last we was told, there is no water well is now to be drilled up there. That would contaminate our water. Enough is enough is said about that. You want to contaminate our water?

07-6: Our water, our environmental.

They say that they

're not going to have to use our stormwater sewage. Well, where is that stuff going to go to if it

's on their property, it

's going to have to run somewhere?

It's sure not going to run and stay on their land.

You're going to have roads there.

It's going to be running down the roads right down through everything, right? How do we know they ain't going to leak?

Response

The above comments express concerns relating to water resources and can be found in Section 4 of this report.

The NRC staff will describe the water resources on and around the proposed SHINE site in Janesville, WI

, in Chapter 3 of the EIS and will address the impacts to water resources from construction, operations, and decommissioning of the proposed SHINE facility in Chapter 4.

An expanded response to these comments will be included in Appendix A of the draft EIS.

2.11 Waste Management Comments: 03-4: SHINE has indicated that they will submit a notification of exemption from State regulations regarding treatment, storage and disposal of hazardous waste under Wis.

Stats. 291, Wis.

Admin. NR 660 and Wis. Admin. NR 662 for waste generated and managed under an NRC license.

05-6: Now the second part, where will Shine

's hazardous waste and all those 2,409,000 gallons of salt brine/uranium waste water go, much of it contaminated water?

What kind of monitoring systems will be required for leaks and waste filtering and radon levels in all areas, including all waste products, as well as incoming uranium sources?

How can they filter out all the salt brine and the trace uranium from the waste water?

We can't drain all this inferior water into the Rock River and contaminate our sewage disposal system and underground water supplies.

Has a study been down on the depth and capacities of our underground water supply and aquifer levels? How far down beneath the building site does one reach the first water table?

How far down to the second water table?

Who is responsible for site clean up, should an accident take place and contaminate the entire site? What if Shine would just pick up and leave?

Can the site be cleaned up say after ten years use, so that the site can safely be used for any other purpose?

How much contaminated waste water or material can be accepted and stored on site and for how long?

Shine has said it will be using a salt brine in their accelerators in conjunction with uranium.

There is great concern that this will quickly cause great dangerous erosion/corrosion to all elements and cause further damage disposing waste salt water with uranium contaminated water.

These two products together presents and accelerates all the dangers resulting from corrosion caused by salt brine.

05-17: Shine's use of salt brine within the accelerators with uranium appears very risky, with the increased corrosion dangers of salt brine and expecte d leaks. Shine says they clean them every 5 1/2 days. How do they clean them and what products can they use to clean them? Where does all the waste water and salt brine water go?

How is that water safely cleaned or filtered?

15 07-3: What are we going to do with the water which is the

-this stuff is put into the accelerators which is done by a salt brine.

They're going to have tanks there to haul this stuff away.

It's my understanding they had some tanks similar to that up in Pennsylvania or Connecticut or somewhere just recently that NRC had to go and check on something about them leaking.

Well, these things will have to be hauled out of here.

They've got to be hauled down to Arizona and Texas. Wait a minute here, folks.

We got not only changes to worry about, we

've got this stuff being hauled all over across the country and where did it come from?

Janesville, Wisconsin.

11-2: The Draft EIS should describe how the facility will comply with Underground Storage Tanks (UST) regulations under the Resource Conservation and Recovery Act (RCRA) for underground storage of fuel.

11-4: The Draft EIS should describe the disposal facility options available in the event that an anticipated disposal or storage facility is no longer available. Waste stream and disposal facility availability should be reviewed on an annual basis to confirm knowledge of the waste streams relative to the disposal options available and to avoid a situation of accumulating waste without a disposal path. The availability of options for each solid and liquid waste stream should also be discussed.

Section 19.2.5.3.1 (Solid Radioactive Waste Handling System) discusses the generation and management of a used resin classified as Greater than Class C (GTCC) waste that would be shipped to Waste Control Specialists (WCS) of Texas for long-term storage.

The Draft EIS should acknowledge that currently there is not a permanent disposal option available for commercially-generated GTCC waste, hence the need for long

-term storage at WCS. The Draft EIS should evaluate whether it is possible to modify the system so that the used resin is generated as either Class A, B, or C low

-level radioactive waste, which currently have available disposal options.

The Draft EIS should provide information on the radionuclide inventory anticipated at the site during typical operations, with information on what would be considered process material, waste material temporarily stored on site for eventual off

-site transport and disposal, or other site

-specific material/product/waste designations. Radionuclide inventory limits under the NRC license should also be described.

Response

The above comments express concerns relating to radiological and nonradiological waste and can be found in Section 4 of this report.

The NRC staff will describe the management of radioactive and nonradiological waste at the proposed SHINE facility in Chapters 2 and 3 of the EIS and will address the impacts to radioactive and nonradioactive waste in Chapter 4 of the EIS. An expanded response to these comments will be included in Appendix A of the EIS.

2.12 Support for the Proposed SHINE Facility Comments: 01-1: I am not employed as a consultant for or employee of SHINE Medical Technologies. I speak only for myself.

That said, I am in favor of this project.

I recognize the importance of 16 developing domestic sources of molybdenum

-99 for medical diagnostic purposes and I'm confident that the safety issues involved in what SHINE is doing and what the NRC is monitoring are manageable and the proposal is both innovative and very likely to be successful. We're fortunate to have SHINE proposing to build this facility here in Rock County, an area that has not had the brightest of economic prospects in the past.

One additional thing I would say is that I am pleased to see that SHINE is planning to work with Blackhawk Tech for developing a training project so that of the 150 technical employees that they're planning to bring on board, that local people could be involved in that, not just imports of technical people from elsewhere.

As far as nuclear safety is concerned, I think it's worth pointing out that the SHINE facility is not one or more nuclear reactors of a critical sort in any way like power reactors that you're familiar with. It is a subcritical reactor and that is a much safer type of facility than a critical reactor.

As far as water and air monitoring are concerned, SHINE is planning to have monitoring stations all around their facility and also water monitoring, groundwater monitoring with wells on the site and there is radioactivity in our environment today.

We should all understand that there is radioactivity and the issue of safety is when you monitor is there any increase in radioactivity compared to the normal background. We live with the normal background.

We've lived with it for thousands of years and we can't do anything about it anyway, so we'll basically be just looking for any possible concern of increase.

The monitoring of radioactivity is much easier to do than monitoring of chemical releases or biological releases and it's much, much safer. People worry about nuclear concerns, about radioactivity. It is the easiest thing to detect and therefore the easiest to control.

06-1: I support the SHINE application and I also welcome the review that the NRC will provide, the safety and environmental protection for the citizens of Janesville and also the residents of Rock County as a whole.

This is an exciting and important economic addition to our community. It's got innovative technology that meets a growing need in a medical world at a time when the current providers, as I understand it, are winding down their projects with aging reactors which I believe would be a lot more unsafe than what SHINE is proposing.

So I support it on that regard. The application we were talking about, what's unique to this site, I believe we are very close to both the major cities of Madison, Milwaukee, and Chicago with the skills that they have and their education department and their research areas.

We have an interstate highway that is just starting to be revived with extra lanes for transportation that will be done just about the time SHINE comes on board.

We're very close to the airport for transportation.

They are separated from residents except for a few scattered ones that are in that area.

We have industrial and agricultural buffers on all sides of this project to safeguard our citizens. We also have a fairly new and well

-equipped fire department in Janesville just north of this site about two miles or so to the north.

Environmentally, right now, it's just basically existing farmland that's not being used to a very intensive use.

Partially, in anticipation of this project and also there's the existing airport flight path that goes over the top of it.

So I would basically welcome your review.

10-1: I would like to take a moment to mention how truly excited I am about SHINE coming to Janesville.

I need to caveat that I am a SHINE employee but my comments and opinions are based solely on being a resident of Janesville and a mom. Although I have only lived in Janesville for a little over a year I have spent a great deal of time here throughout the years 17 because of my family in the area.

I have seen the impact on the community since GM left and it has been very negative not only in a financial sense but also in an educational sense.

Right now Janesville is in a downturn educationally which has such a horrible impact on current and future generations.

The thought that a technologically advanced company would be willing to come into a town and provide the opportunity for jobs that require you to stay in school, do we ll in school and go to college is exciting.

Because even if they don't end up working at SHINE they now have opportunities they did not think they had before.

While idealistic, it is a simple truth to help our current and future generations you have to show them there is more than what they see now and right now they see nothing.

Seeing something as amazing as SHINE will be that kick in the butt that a lot of kids need to have a great future.

If the colleges around us see it and are already starting to adapt there programs of study in preparation that is amazing.

The next step is the high schools and so on.

There is such an amazing opportunity here.

And while the argument could be made that you have to have some super fancy degree to work there that is not true.... you just have to want it and have the opportunity to know that it is possible. Janesville has so many amazing minds, they just need a boost in the fight direction and I really think SHINE is that opportunity.

I also would like to make an additional comment on behalf of my grandfather Gordon Garske who passed away before he could see SHINE open.

My grandfather tracked every article about SHINE prior to my employment and especially after.

He is a former GM'er and was so excited that a company that made no sense to him would come into Janesville and bring it back to life. Every time I saw him he had to show me the latest article that was published and tell me how excited he was and how in the world did I get a job there and I better not mess it up.... He saw SHINE as a life saver so to speak to a town that was his home his entire life.

It made no sense to him that a bunch of kids could create something so amazing and they picked Janesville to make it happen but honestly anything that made that grumpy old man happy made me happy....

Response

The above comments express support for the proposed construction of the SHINE facility in Janesville, WI. The commenters cite the use of an innovative and safe technology, the benefit of providing a domestic supply of molybdenum

-99 for medical testing, SHINE's proposed environmental stewardship, the proximity of the proposed site to transportation infrastructure, and socioeconomic benefits

-including potential jobs and access to skilled workers near Janesville, as reasons for their support.

These comments express general support for the SHINE facility, but provide no substantive information relevant to the environmental review

. Therefore, these comments are outside the scope of the environmental review, and will not be addressed further in the development of t he EIS. The NRC staff will describe the environment around the proposed SHINE site as it pertains to the socioeconomic impacts from the proposed construction, operations, and decommissioning of the SHINE facility in Chapter s 3 and 4 of the EIS. The NRC staff will evaluate the costs and benefits of the proposed action and alternatives to the proposed action i n Chapter 5 of the draft EIS

. The purpose of the NRC's Federal action is to evaluate SHINE's proposal to construct a facility that would ultimately produce medical radioisotopes. The determination of need and the decision to produce radioisotopes are at the discretion of applicants or other medical radioisotope production decisionmakers. This definition of purpose and need reflects the NRC's recognition that, unless there are findings in the safety review required by the Atomic Energy Act of 1954, as amended, or findings in the environmental analysis under NEPA that would lead the NRC to reject a construction permit application, the agency does not have a role in planning decisions as to whether a particular medical radioisotope production facility should be constructed and operated

.

18 The U.S. Department of Energy (DOE) is a cooperating agency on the EIS (NRC 2015). If the NRC issues the required permits and licenses, the proposed Federal action for the DOE National Nuclear Security Administration is to decide whether to provide additional cost

-sharing financial support to SHINE under a cooperative agreement to accelerate the commercial production of medical radioisotopes without the use of highly enriched uranium. The funding would help accelerate activities such as construction, purchase of equipment, and initial operation using a subcritical fission process.

2.13 Opposition to the Proposed SHINE Facility Comments: 05-8: Will you seek separate environmental impact studies from the State of Wisconsin, the DNR, the EPA and Health & Safety Regulatory Agencies? Will they be furnished with the comments and questions I have listed here, so they address them from their perspectives, without your suggestions or results? Should not Shine be required to prefund a clean up account or be bonded for at least say, $10,000,000 to cover accident, harm or any possible negligence? What if a patient is harmed by a flawed product, which is new because it was created by a new process? Shine's process is fairly new so should not this whole process be scrutinized much closer in every respect, for safety?

Shine stated they will have to clean the accelerators every 5 &1/2 days. How will they b e

cleaned? What products will they use to clean the accelerators? How can uranium be cleaned? How much uranium can be at the site at any one time? Will they have a limit on how much they can bring on site and have on site? Will the facility be required to sign the site as to what it is and that there are hazardous materials? Who inspects the facility for compliance after operation begins and how often? Where can one find the inspection reports?

05-10: From what I read the Nation is trying to get away from over-abundant use of uranium in so many areas, because it poses both short term and long term dangers and with threats to humans, the environment and with the disposal difficulties.

Lets clean up the environment now and preserve our kids future and their health, by only approving super

-low nearly uranium free or uranium free medical isotopes.

This can be accomplished.

From the issues I indicated and commented on and raised questions on in this email/letter and possibly other factors, Janesville's site is not a good or desired location for this type of facility, in my opinion. These facilities should be located outside city limits and away from close

-by population, farm animals for meat, farm crops for human consumption and the nearby food processing facilities, away from water sources and not right next to an airport where airplanes are more apt to have problem s and crash, adding to already present risks and dangers. The total environment dangers and to danger to humans presented from such a facility are tremendous in this location in my opinion. I thought the NRC was opposed to locating these type of facilities that handle any type of uranium, where this one is proposed, and wanted them located in the open, unpopulated countryside

. 07-5: And they say the hospitals now will be able to do this within five to ten years? Again, the City of Janesville is offered so much money to invest in this building and this stuff. We have a property that we went out there and bought on a TIF. Now we're going to have to guarantee so much money. No, enough is enough.

07-9: Seneca, at an angle, is probably a mile and a tenth. Your pheasant farm is right across the road.

You got a trailer court less than one sixth of a tenth from that place. You got the airport, you got businesses on the other side.

Behind that you got housing. You got another 19 housing development over here on the other side. So wait a minute, folks, this thing is right in our City of Janesville. Let's look elsewhere to put this thing. Of course, I know the state wants it here because it's going to put 150 jobs in here.

How do we know for sure that these people are going to live here? You know, they've been offered to the site and everything else. Not a one of them has moved here as far as I know. They still got the thing up in Monona. It's time for this city to come together like we have on the south side of town here and said wait a minute. This is our side of town here. We're involved over here and over there. How do we know that that fumes is not going to go four and a half miles through the City of Janesville and elsewhere and get everywhere? We do not know. The unknown.

The umknown factor is what we're worried about here.

Uranium, no telling how far it's going to go and what's going to happen. They still have problems with uranium out West in old mines. So think about it befor e they offer this building permit because we still have problems with

-- how do we not know that somebody's aircraft is not going to hit that thing and cause more damage. And what are we going to do for the cleanup? Are they will to put $2 billion right now for a national cleanup on that building in case something hits it for an insurance?

Are you going

-- for your gardens and everything else, are you going to be able to protect all these businesses around that area? It's time for this building to be built elsewhere instead of where it is at. And I do thank you.

Response

The above comments express opposition to the proposed SHINE facility. The commenters cite the potential for accidents

-including those from an aircraft; the effects of radioactive releases during normal operations or during an accident to the public, farms, and to groundwater; environmental concerns related to the use of uranium, transportation of materials, potential leaks, and runoff from the site; potential impacts to drinking water; general safety concerns; security concerns; SHINE's financial viability to clean the site post

-operations or if an accident were to occur; and inspection procedures, as reasons for their opposition.

These comments express general opposition to the SHINE facility or disucss safety

-related concerns, but provide no substantive information relevant to the environmental review. Therefore, these comments are outside the scope of the environmental review, and will not be evaluated further in the development of the EIS. The NRC staff will evaluate the environmental impacts of the proposed action in Chapter 4 of the EIS, including some of impacts identified in the above comments, such as impacts to the health of workers and the public, water resources, or transportation, socioeconomic concerns, or impacts from potential accidents. The NRC staff will also independently evaluate the safety of the proposed action in its Safety Evaluation Report.

2.14 Other Comments Outside the Scope of NRC's Environmental Review Comment: 04-1: During the Wednesday, July 17, 2013 Scoping Meeting, newspaper articles and a compact disc

. were submitted to the NRC staff

Earnest B (Ed.).

"They're back: Manufacturers build, lease new space in Janesville." Life in Rock County: Great People, Great Stories. Summer. 2012: 32. Print.

Henning, R. 2012. "A Victim of Five." November 12, 2012.

Leute J. "Shining a light on safety: Medical isotope manufacturer says danger at facility, to community is minimal." The Gazette. 5 February. 2012: 1A. Print.

20 Leute J. "Council to consider SHINE agreement: Plan is costliest in recent memory." The Gazette. 9 February. 2012: 1A. Print.

Leute J. "Managing a waste stream: SHINE expects to produce truckload of radioactive waste each month." The Gazette. 23 June. 2013: 1A. Print.

Lichtenstein B. Docta N. Simmer L. As Goes Janesville. 371 Productions. 2012.

Compact Disc.

Rock County 5.0. Undated. "One Vision One Voice." Response:

The above comment is general in nature and provide s no substantive information relevant to the environmental review. As such, this comment will not be evaluated further in the development of the EIS.

The NRC staff will evaluate the environmental impacts of the proposed action in Chapter 4 of the EIS, including some of the impacts identified in the articles and compact disc, such as impacts to the health of workers and the public, land use, or transportation and socioeconomic or waste management concerns

. The NRC staff will also independently evaluate the safety of the proposed action in its Safety Evaluation Report.

Comment: 05-18: Who is responsible for site accident or contamination cleanup?

What if Shines just pulls out and leaves? Do they not have to be insured or have setaside reserves for site cleanup or designated bond funds of a few million to guarantee a clean environment for future uses of the site? Response:

The above comment questions the responsibility for clean up costs in the case of an accident and how the site would be restored for future uses. This comment is outside the scope of the environmental review. As such, this comment will not be evaluated further in the development of the EIS.

The NRC staff will evaluate the environmental impacts of the proposed action in Chapter 4 of the EIS, including impacts to land use and the health of workers and the public during an accident

. The NRC staff will also independently evaluate the safety of the proposed action in its safety evaluation report. In accordance with 10 CFR Part 50, a licensed production or utilization facility that permanently ceases operations shall submit a decommissioning report. The regulation at 10 CFR 50.33(k) requires that a report indicate how reasonable assurance will be provided that funds will be available to decommission the facility.

The NRC staff will evaluate the adequency of decommissioning funding in its review of the operating license application, if submitted by SHINE, as required by 10 CFR 50.33(k).

Comment: 11-3: The Draft EIS should include a "for official government use" document that provides details of proprietary information that is otherwise withheld from public disclosure, such as the details on "Waste generated by the target vessel solution cleanup process" described in Section 19.2.5.1.1 of the ER and information on the other waste streams.

Response

The above comment suggests that the draft EIS should include a "for official government use" document that provides details of proprietary information that is otherwise withheld from public disclosure.

The NRC staff will publish a public version of the draft EIS for review and comment by the public. Any Sensitive Unclassified Non

-Safeguards Information (SUNSI), such as proprietary information, in an EIS will be withheld from public disclosure, as 21 required by 10 CFR 2.390, "Public Inspections, Exemptions, Requests for Withholding,"

NRC Management Directive 3.4, "Release of Information to the Public" and NRC Management Directive 3.7, "NUREG

-Series Publications." A nonpublic version of the draft EIS will be retained within the agency and would be available for viewing by the U.S. Environmental Protection Agency, as defined in NRC's regulations and management directives.

In addition, the NRC published in the Federal Register a notice of hearing and opportunity to petition for leave to intervene, regarding the SHINE construction permit application that included an order

. The order contains instructions on how potential parties may request access to documents containing SUNSI for contention preparation and imposes procedures for handling such requests.

22 3 References 10 CFR 2.

Code of Federal Regulations, Title 10, Energy, Part 2, "Agency Rules of Practice and Procedures."

10 CFR 50. Code of Federal Regulations, Title 10, Energy, Part 50, "Domestic licensing of production and utilization facilities."

10 CFR 51. Code of Federal Regulations, Title 10, Energy, Part 51, "Environmental protection regulations for domestic licensing and related regulatory functions."

36 CFR 800.8. U.S. Code of Federal Regulations, "Coordination with the National Environmental Policy Act," Part 800.8, Title 36, "Parks, Forests, and Public Property."

50 CFR 402. U.S. Code of Federal Regulations

, "Interagency Cooperation

-Endangered Species Act of 1973," Part 402, Subchapter A, Title 50, "Wildlife and Fisheries."

78 FR 39343. U.S. Nuclear Regulatory Commission. "SHINE Medical Technologies, Inc.

-intent to prepare environmental impact statement and conduct scoping process; public meeting." Federal Register 78(126): 39343

-39344. July 1, 2013.

Atomic Energy Act of 1954, as amended. 42 U.S.C. §2011 et seq.

Endangered Species Act of 1973, as amended. 16 U.S.C. §1531 et seq.

National Environmental Policy Act of 1969, as amended (NEPA). 42 U.S.C. §4321 et seq.

National Historic Preservation Act of 1966. 16 U.S.C. §470 et seq. [NRC] U.S. Nuclear Regulatory Commission. 2009. NRC Management Directive 3.4, "Release of Information to the Public

." Washington, DC: NRC. February 6, 2009. Agencywide Documents Access and Mangement System (ADAMS) Accession No. ML080310417.

[NRC] U.S. Nuclear Regulatory Commission. 2012. Final Interim Staff Guidance Augmenting NUREG- 1537, Part 1, "Guidelines for Preparing and Reviewing Applications for the Licensing of Non- Power Reactors: Format and Content," for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors. Washington, DC: NRC. October 17, 2012. ADAMS Accession No. ML12156A069.

[NRC] U.S. Nuclear Regulatory Commission. 2013. "Summary of Public Scoping Meetings Conducted Related to the Review of the Proposed Shine Medical Technologies, Inc. Radioisotope Production Facility." Washington, DC: NRC. September 23, 2013. ADAMS Package Accession No. ML13260A294.

[NRC] U.S. Nuclear Regulatory Commission. 2014. NRC Management Directive 3.7, "NUREG

-Series Publications." Washington, DC: NRC.

March 24, 2014.

ADAMS Accession No. ML120650650.

[NRC] U.S. Nuclear Regulatory Commission. 2015. "Approval of Memorandum of Agreement between DOE and NRC on the Environmental Review Related to the Issuance of Authorizations to Construct Build and Operate SHINE Medical Technologies, Inc." Washington, DC: NRC. February 3, 2015. ADAMS Package Accession No. ML13304B666

[SHINE] SHINE Medical Technologies, Inc. 2013. Preliminary Safety Analysis Report (PSAR), Chapter 19

-Environmental Report. Monona, WI: SHINE. March 26, 2013. ADAMS Accession No. ML13172A324.

23 4 Comment Letters and Meeting Transcripts The following pages contain the comments, identified by commenter designation and comment number. The comments are from letters, emails, and the transcripts of the public scoping meetings.

The comments are presented in the following order:

Letters and Emails

1) Comment of Richard Henning
2) Comment of Al Lembrich
3) Comment of Kenneth Westlake (U.S. Envi ronmental Protection Agency)
4) Comment of Jamie Stout
5) Comment of Eric Heggelund (Wisconsin Department of Natural Resources)
6) Comment of Melissa Cook (Forest County Potawatomi Community)

Afternoon Transcripts

7) Comment of Douglas Marklein (Janesville City Council)
8) Comment of Dave Dobson
9) Comment of Richard Miller
10) Comment of Bill McCoy
11) Comment of Janet Piraino (District Director to Congressman Mark Pocan)

24 Comment of Richard Henning During the Wednesday, July 17, 2013 Scoping Meeting, the following articles and compact disc were submitted to the NRC staff:

Earnest B (Ed.). "They're back: Manufacturers build, lease new space in Janesville." Life in Rock County: Great People, Great Stories. Summer. 2012: 32. Print.

Henning, R. 2012. "A Victim of Five." November 12, 2012.

Leute J. "Shining a light on safety: Medical isotope manufacturer says danger at facility, to community is minimal." The Gazette. 5 February. 2012: 1A. Print.

Leute J. "Council to consider SHINE agreement: Plan is costliest in recent memory." The Gazette. 9 February. 2012: 1A. Print.

Leute J. "Managing a waste stream: SHINE expects to produce truckload of radioactive waste each month." The Gazette. 23 June. 2013: 1A. Print.

Lichtenstein B. Docta N. Simmer L. As Goes Janesville. 371 Productions. 2012.

Compact Disc.

Rock County 5.0. Undated. "One Vision One Voice."

04-1 25 Comment of Al Lembrich

26 27 28 29 30 31 Comment of Kenneth Westlake (U.S. Environ mental Protection Agency)

32 33 34 35 Comment of Jamie Stout

36 Comment of Eric Huggelund (Wisconsin Department of Natural Resources)

37 38 39 Comment of Melissa Cook (Forest County Potawatomi Community)

40 Afternoon Transcript

41 42 43 44 45 46 47 48 49 50 51 52 53