ML15201A575

Comment (8) of Kenneth A. Westlake on Behalf of the U.S. Environmental Protection Agency on Draft Environmental Impact Statement for the Construction Permit for the Shine Medical Radioisotope Production Facility, Janesville, Wisconsin - NUR

ML15201A575
Person / Time
Site:	SHINE Medical Technologies
Issue date:	07/02/2015
From:	Westlake K A Environmental Protection Agency
To:	Moser M R Rules, Announcements, and Directives Branch, Office of Nuclear Reactor Regulation
References
80FR27710 00008, E-19J, NUREG-2182 - CEQ
Download: ML15201A575 (9)

Text

Mendiola, Doris "7

Subject:

FW: SHINE Draft EIS -US EPA commentsAttachments:

20150133.pdf

//From: Poole, Elizabeth

[1]

Sent: Thursday, July 02, 2015 5:39 PMTo: Moser, MichelleCc: Bethaney Bacher-Gresock; Waldschmidt, Jay -DOT; 'Rosanne.Meer@dot.wi.gov';

alice.halp~in@wisconsin.g~ov; Ian Chidister; freitag~m@ci.ianesville.wi.us; smithr@ci.ianesville.wi.us; Randy.Howell@nnsa.doe.gov, Jim Costedio (Jim.Costedio@shinemed.com)

Subject:

[External_Sender]

SHINE Draft EIS -USEPA commentsHi Michelle, Attached you'll find USEPA's comments on the SHINE Draft EIS. Please let me know if you have anyquestions, or would like to schedule a call with our technical reviewers to discuss comments.

Hard copywent to NRC only.Thanks in advance,Elizabeth J :-7,r-TElizabeth Poole.....

, .. -- ,.-US EPA- RegionS 5 ,'.... C -)NEPA Implementation Section .... -. -Detailed to the Environmental Justice Program I..)J U-)3 12-353-2087 SUNSI Review CompleteTemplate

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-. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WEST7 JACKSON BOULEVARD

CHICAGO, IL 60604-3590 JUL 0 2 2015REPLY TO THE ATTENTION OF:E-19JMichelle MoserDivision of License RenewalNuclear Regulatory Commission Office of Nuclear Reactor Regulation Mail Stop 0-11F111555 Rockville PikeRockville, Maryland 20852Re: Draft Environmental Impact Statement for the Construction Permit for the SHINEMedical Radioisotope Production

Facility, Janesville, Wisconsin

-NUREG-2 183 -CEQ #2015O133

Dear Ms. Moser:

The U.S. Environmental Protection Agency has reviewed the Draft Environmental ImpactStatement (EIS) for the above-mentioned project prepared by the Nuclear Regulatory Commission (NRC). Our comments are: provided pursuant to the National Environmental PolicyAct (NEPA), the Council on Environmental Quality's NEPA Implementing Regulations (40 CFR1500-1508),

and Section 309 of the Clean Air Act.SHINE Medical 'Technologies, Inc. (the Applicant) applied to the NRC for a construction permitto build and operate a medical radioisotope production facility in Janesville, Wisconsin.

The U.S.Department of Energy (DOE) is a cooperating agency and must decide whether to provide cost-sharing financial support to the Applicant under a cooperative agreement, which will accelerate the commercial production of medical radioisotopes without the use of highly enriched uranium.The proposed preferred alternative is for NRC to issue the license.EPA acknowledges that mitigation measures that are unrelated to nuclear safety and securitycannot be included in the NRC license.

This includes, but is not limited to, diesel emissions reduction measures.

However, because we find these measures to be value-added, we continue torecommend them to the Applicant for any construction activities and include them in ourcomment letters.

We encourage the Applicant to incorporate mitigation measures irnto theproject, wherever possible.

Based on the information

provide, EPA assigns a rating of EC-t, Environmental Concerns

-Adequate Information.

However, we have identified some areas where additional information should be provided in the Final EIS and mitigation measures that would reduce environmental impacts.

Our summary ~of ratings is enclosed.

RecycledlRecyciable o Printed wilh Vegetable.

Oil Based inks on 100% Recycled Paper (100% Post-Consumer)

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 wereserve the right to provide additional comments or recommendations under other permitting stages. 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. Westl eChief, NEPA Implementation SectionOffice of Enforcement and Compliance Assurance Cc (via email):Enclosure (2):Randy Howell, Department of EnergyJim 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 SystemAlice Halpin, Department of Agriculture, Trade, and Consumer Protection Detailed CommentsSummary of Ratings Definitions 2

EPA's Detailed Comments on the Draft ETS for the Construction Permit for the SHINEMedical Radioisotope Production

Facility, CEO #20150133 July 2015Radiation EPA has reviewed the Draft EIS and cited reference materials regarding radioactive solid wastes.Table 11.2-1 "Waste Stream Summary" (reference SHINE 2013 a Chapter 11 -Radiation Protection Program and Waste Management of the Preliminary Safety Analysis Report)provides the destinations of the solid, resin, and liquid wastes. Zeolite Beds and anotherproprietary waste stream are said to be generated as greater-than-class-C (GTCC) with WasteControl Specialists listed as a destination.

Waste Control Specialists has GTCC storagecapability, but not GTCC disposal capability.

The Draft EIS states that if a disposal pathway forGTCC waste does not exist, the Department of Energy (DOE) will be responsible for its safestorage and disposal in accordance with the American Medical Isotopes Production Act of2012'. There is currently no disposal path for GTCC waste and DOE is currently evaluating alternatives for GTCC disposal2.Recommendation:

The Final ETS should clarify whether DOE or the Applicant will beresponsible for the storage of the facility's GTCC wastes at Waste ControlSpecialists.

The Final EIS should state that once DOE establishes a disposal pathway forGTCC, it should promptly facilitate the disposal of the Applicant's GTCC wastes. EPAalso recommends that the Applicant clarify whether a radioisotope production processcan be engineered so as to eliminate the generation of GTCC waste for which there is nocurrent disposal path, and otherwise reduce or limit the generation of other waste streamsto Class A levels.IJREX process raffinate is listed as a Class B liquid waste with Energy Solutions as thedestination.

Energy Solutions is not authorized to receive Class B and Class C waste according toits waste acceptance criteria document3.Recommendation:

The Final EIS should clarify how Energy Solutions can be adestination for Class B UREX process raffinate waste.The Draft EIS lists three isotopes currently slated for production at the facility (molybdenum-99, iodine- 131, and xenon- 133). The Draft EIS is unclear if the Applicant anticipates needing to addadditional isotopes to the facility's production capabilities (based on market conditions ortechnological advancements, for example).

Recommendation:

The Final EIS should clarify whether the Applicant anticipates needing to add additional isotope production capabilities (other than the ones listed).

Ifthe Applicant anticipates needing additional production capabilities, the Final EIS shouldidentify potential expansion locations and resultant

impacts, including anticipated management of waste streams associated with additional isotope production.

1 42 U.S.C. 2065(c)(3XA)(ii)

-https://www.law.comnell

.eduluscode/text/42/2065 2 http://www.ktcceis.an1.aov

.7 http 14/1 1/B WF-WAC-Rev-93

.pdf The Draft EIS includes several determinations about whether a potential impact is based onmodels. In most instances, the name of the model and specifics about model inputs andassumptions are not included in the Draft EIS. EPA is aware that this information could beproprietary or included in other documents.

Recommendation:

EPA recommends that the Final EIS include the name of the models,inputs, and assumptions identified in the Draft EIS for the following determinations, withlocations in the Draft EIS given in parentheses.

If this information is provided elsewhere, please provide specific locations.

Or, if this information is proprietary, please contact usto discuss comment resolution in the Final EIS.*Estimate values for gaseous radioactive effluents and determination for exposurepotential to an individual(s) off site. (Table 2-2, page 2-16);*Determining compliance with regulatory requirements for public exposure toradiation (Section 3.8.1.2, page 3-54, lines 1-5; Section 4.8.2.1, page 4-36 lines 44-46and page 4-37, lines 1-2; Section 4.11.1, page 4-47, lines 18-25; Section 4.13.8, page4-70, lines 38-46; Section 5.2.2.13, page 5-46 lines 21-47 and page 5-47, lines 1-2;Section 5.2.3.8, page 5-71, lines 5-10; Section 5.2.3.13, page 5-91, lines 28-44);The Applicant will employ three separate water treatment processes:

a demineralization process,a cooling water treatment

process, and a facility heating water treatment process.

Rock County,Wisconsin is a Zone One Radon County4, meaning there are relatively high concentrations of naturally occurring radiation in the soil and groundwater in this area. Water treatment anddemineralization will have a tendency to concentrate naturally occurring radioactive materials.

Recommendation:

The Final ETS should address plans for monitoring and subsequent handling and disposal of wastewater and wastewater treatment residuals should highconcentrations of radium or other radionuclides be encountered during the production process.Agreement States and NRC regulated facilities are to keep all exposures of the public to as lowas reasonably achievable (ALARA).

In order for EPA to rescind regulation of airborne doseexposure from NRC-licensed or Federal facilities, NRC and any delegated program would meetthe requirements of Title 40 of the Code of Federal Regulations Part 61, Subpart I requirements, as outlined in the 1998 Memorandum of Understanding between NRC and EPA.Recommendation:

The Final ELS should clarify how the Akpplicant plans to achieveALARA to the airborne dose exposure to radionuclides as agreed to between NRC andEPA in the 1998 MOU regarding 40 CFR Part 61, Subpart I, prior to the rescission.

The facility will produce more than 500,000 Curies per year of radioactive material.

EPArecognizes that the probability of an accident is low, given the type of technology used at thefacility.

However, given the large amount of radioactive material produced and since this is the4http://www.epa.gov/radon/zonemap.html 2

first of its kind in the area, the section detailing accidents and response should be strengthened (Section 4.11 Accidents,).

Recommendation:

EPA recommends the Applicant provide additional details onaccident preparedness pians. We recommend including reference to any agreements withlocal, state, or Federal emergency responders.

We also recommend the Final EIS includedetails of public outreach specifically related to emergency response (such as handoutssent to adjacent property owners).Green Infrastructure The Draft UIS details the locations of pennanent structures, buildings, and roads required for thefacility, including an estimate of the type and amount of construction materials required.

Structures and building includes an administrative

building, water and fuel tanks, production

facility, and other various support buildings.

This site would also include an entrance road andparking lots. Overall, approximately 41 acres would be disturbed, of which 15 acres would betemporary.

EPA commends the Applicant for already identifying several ways to reduce environmental

impacts, such as committing to conversion of unused, temporarily disturbed lands to nativeprairies.

EPA has several recommendations regarding immediate site land use planning andgreen infrastructure.

Please note that we are aware of NRC's limited ability to include thefollowing recommendations in the license;

however, we find these measures to further reduceenvironmental impacts and would encourage the Applicant to incorporate them into siteplanning.

• The Final EIS should clarify to what extent the DOE (as a cooperating agency andprospective provider of funding to the Applicant under a cooperative agreement) wouldrequire energy efficiency

measures, greenhiouse gas reductions, and other sustainability

measures, per Executive Order 13693.* Any locations on the site which are not planned for operations should be considered forconversion to native habitats, increasing the area which can be beneficially used forwildlife, infiltration or stormwater retention, and aesthetics, among other functions.

• The Final BIS should include more information on the sources of the requiredconstruction materials, as listed in Table 2-1 (Estimated Construction MaterialRequirements).

Please outline whether this material can be made of second-sourced material (i.e., reclaimed aggregate).

EPA understands there are specific safety codes thatmay prevent this; however, we recommend that any auxiliary buildings, new roads, andother non-safety related structures be constructed with materials that are recycled, ifpossible.

If you need more information about this, please see our website aboutenvironmentally responsible purchasing at www~epa..gov/epp.

• Any roads, parking lots, sidewalks, or other surfaces slated for driving or walking shouldbe constructed using permeable pavement to reduce runoff,, EPA recommends staggering construction schedules of the new facilities so that no* additional undisturbed land is permanently disturbed.

This could mean having onetemporary laydown area (that is ultimately slated for a permanent use) serving theconstruction of new permanent facilities.

3

• EPA encourages the Applicant to construct all buildings to Leadership in Energy andEnvironmental Design (LEED) standards.

If LEED standards are pursued, thisinformation should be included in the Final EIS. Any potential use of Energy Starappliances, EPA's WaterSense

program, or other similar programs should be identified inthe Final EIS. In lieu of including this commitment in the license, the Applicant shouldreport to EPA once these measures have been implemented, if applicable.

Climate Chang~e and Greenhouse GasesOn December 18, 2014, the Council on Environmental Quality released revised draft guidancefor public comment that describes how Federal departments and agencies should consider theeffects of greenhouse gas (GHG) emissions and climate change in their NEPA reviews.

Therevised draft guidance supersedes the draft GHG and climate change guidance released by CEQin February 2010. This guidance explains that agencies should consider both the potential effectsof a proposed action on climate change, as indicated by its estimated GHG emissions, and theimplications of climate change for the environmental effects of a proposed action.Recommendation:

As discussed above under "Green Infrastructure,"

EPA recommends

• that the Applicant identify opportunities to minimize GHG emissions associated withconstruction and operation of the facility to the extent feasible.

For example, clean energyoptions, such as energy efficiency and renewable energy, can be considered in thepurchase of maintenance equipment, new equipment and vehicles.

We also recommend any measures that may reduce the facility's carbon dioxide (C02) footprint, particularly from fuel combustion during the life of operations.

Finally, EPA recommends that theapplicant consider the need to develop adaptation measures to address impacts fromclimate change on the facility, such as increased intensity and frequency of storm andflood events.EPA notes that our diesel emissions reduction

measures, as recommended in our August 14,2013 scoping letter, were included in the Draft ELS. EPA commends NRC for including thislanguage and continues to encourage the Applicant to incorporate these measures into theirconstruction planning.

Transportation The Draft EIS states that the Beloit-Janesville Express operates weekdays between Beloit andJanesville (Section 3.9.1 -Roads); the closest stops to the facility are Kellogg Ave (to the north)and Sunny Lane (to the south). At this time, there are no plans to include a new stop on this routeserving the facility.

Recommendation:

EPA recommends the Applicant and the Janesville Transit Systemdetermine whether a stop at the facility would benefit employees of the facility and helpto alleviate potential degradation to traffic patterns along U.S. Highway 51:The Applicant anticipates an additional 1000 vehicle trips daily associated with the facility (or anapproximately 11% increase from current conditions) in traffic volumes on U.S. Highway 51during construction activity (Section 4.10.1 Transportation-Construction).

EPA commends theApplicant for already committing to staggered work schedules during construction anddemolition, during which an increase in the number of trucks and vehicles would be highest.

We4 also commend the Applicant for planning to implement a carpooling program for employees during operation to minimize worker vehicle emissions.

Recommendation:

EPA recommends on-going coordination with local traffic authorities to ensure levels of service remain appropriate and that users of the road are kept updatedof closures and delays. Any anticipated system or infrastructure upgrades deemednecessary as a result of the facility should be identified in the Final EIS.Editorial The Draft EIS states that the Applicant does not intend to treat or permanently store hazardous wastes on site, meaning it will not require a hazardous waste treatment or storage permit underthe Resource Conservation and Recovery Act (RCRA) (Section 2.7.2 Nonradioactive Waste,page 2-17, lines 38-42).Recommendation:

EPA recommends this section be clarified to indicate that Wisconsin Department of Natural Resources is the permitting authority for hazardous wastetreatment and storage per RCRA.To facilitate the review, EPA continues to recommend figures be provided in color, whereappropriate and where color gradient is used in analyzing the information.

EPA continues to recommend clear and objective metrics or thresholds be identified for the threesignificance levels (SMALL, MODERATE, and LARGE), particularly for where there areranges.5

• SUMMARflY OF RATING DEFINITIONS AN]) FOLLOW U1? ACTION*Environmental Impact of the ActionLCD-Lack of Objections

• The EPA review has not identified any potential environmental impacts requiring substantive changes to theproposal.

The review may have disclosed opportunities for application of mitigation measures that could beaccomplished with no more than minor changes to the proposal.

EC-Envirormedntal ConcernsThe EPA review has identified environmental impacts that should be avoided in order to fully protect theenvironment.

Corrective measures may require changes to the preferred alternative or application of mitigation" measures that can reduce the environmental impacts.

EPA would like to work with the lead agency to reduce theseimpacts.EQ-Environmental Objections The EPA review has identified significant environmental impacts that must be avoided in order to provide adequateprotection for the environment.

Corrective measures may require substantial changes to the preferred alternative orconsideration of some other project alternative (including the no action alternative or a new alternative).

EPAintends to work with the lead agency to reduce these impacts.EU-Environmentally Unsatisfactory The EPA review has identified adverse environmental impacts that are of sufficient magnitude that they areunsatisfactory fr'om the standpoint of public health or welfare or environmental quality.

EPA intends to work withthe lead agency to reduce these impacts.

If the potential unsatisfactory impacts are not corrected at the final EIS -stage, this proposal will be recommended for referral to the CEQ.Adequacy of the Impact Statement Category' 1-Adequate The EPA believes the draft EIS adequately sets forth the environmental impact(s) of the preferred alterative andthose of the alternatives reasonably available to the project or action. No further analysis or data collecting isnecessary, but the reviewer may suggest the addition of cl~arifying language or information.

Category_

2-Insufficient Inafor-mation The draft EIS does not contain sufficient, information for the EPA to fully assess the environmental impacts thatshould be avoided in order to fully protect the environment, or the EPA reviewer has identified new reasonably available alternatives that are within the spectrum 9f alternatives analyzed in the draft EIS, which could reduce theenvironmental impacts of the action.*

The identified additional information, data, analyses, or discussion should beincluded in the final EIS.Catezory 3-Inadequate EPA does not believe that the draft fiTS adequately assesses potentially significant environmental impacts of theaction, or the EPA reviewer has identified new, reasonably available alternatives that are outside of the spectrum ofalternatives analyzed in the dra~ft EIS, which should be analyzed in order to reduce the potentially signmificant environmental impacts.

EPA believes that the identified additional information, data analyses, or discussions are ofsuch a magnaitude that they should have fuall public review at a draft stage. EPA does not believe that the draft EIS isadequate for the purposes of the NEPA and/or Section 309 review, and thus should be formally revised and madeavailable for public comment in a supplemental or revised draft EIS. On the basis of the potential significant impacts involved, this proposal could be a candidate for referral to the CEQ."From EPA Manual 1640 Policy and Procedures for the Review of the Federal Actions Impacting the Environment