 Well, I'll call this hearing to order on a more serious event, but it let first let me get my script out Since we do need to go through a number of things as before we begin this Begin this hearing. I want to welcome the audience and those who may be Viewing this remotely online Welcome to the applicant to the staff members of the public and The commission is here today to conduct an evidentiary hearing and the shine medical technologies application for a construction permit for a medical radio isotope production facility in Janesville, Wisconsin This hearing is required under section 189a of the Atomic Energy Act of 1954 as amended and the commission will also be reviewing the adequacy of the NRC staff's environmental impact analysis under the National Environmental Policy Act of 1969 which many of us refer to as NEPA This is the third so-called mandatory or uncontested hearing that the commission has held this year But unlike the two previous ones this one is for a construction permit not for a combined license But the requirements for therefore the the necessity of a hearing on a construction permit is required as I noted under section 189a During the hearing shine and the staff will provide Testimony and witness panels that will provide an overview of the application as well as address safety environmental issues associated with review and Commission questions will follow each panel and there will be a rotation of the commissioners and From panel to panel and commissioners may allocate their total time among the panels as the commissioner each commissioner sees fit In order to issue a construction permit the commission must make certain Specific safety and environmental findings on the safety side the commission will determine whether In accordance with 10 CFR 50 point 35 subsection a Whether the applicant has described the proposed design of the facility including the principal architectural and engineering criteria for the design and whether the applicant has identified the major features or Components incorporated therein for the protection of the health and safety of the public Also such further technical or design information as may be required to complete the safety analysis and Which can be and those which can be reasonably left for later consideration will be supplied to be supplied in the final safety analysis report Whether safety features or components if any that require research and development have been described by the applicant And the applicant has identified and there will be conducted a research and development program reasonably designed to resolve any safety questions associated with such features or Components and whether on the basis of the foregoing there is reasonable assurance that one such safety questions will be Satisfactory resolved at or before the latest state stated in the application for completion of the construction of the proposed facility and To taking into consideration the site criteria contained in 10 CFR part 100 The proposed facility can be constructed and operated at the proposed location Without undue risk to the health and safety of the public in making these findings the commission will also be guided by the considerations in 10 CFR section 50 point 40 Which include the commission's opinion as to whether the issuance of the construction permit Will not be inimical to this common defense and security or to the health and safety of the public With respect to environmental matters the commission will determine whether the requirements of NEPA sections 102 to a C and e and the applicable regulations in 10 CFR part 51 have been met It will the commission will independently consider the final balance among conflicting factors contained in the record of the Ceeping with a view to determining the appropriate action to be taken Determine after weighing the Environmental economic technical and other benefits against environmental and other costs and considering reasonable alternatives Whether the construction permit should be issued denied or appropriately conditioned to protect environmental values and Determine whether the NEPA review conducted by the staff has been adequate This meeting is open to the public and we do not anticipate the need to close the meeting to discuss Non-public information But if a party believes that a response to a question may require a reference to non-public information Then I would ask the party to answer the question to the best of its ability and Practicality with with information that is on the public record and file any non-public response Promptly after the hearing on the non-public docket Before proceeding to my fellow commissioners have anything they'd like to add Then we'll proceed With the swearing in of witness will start with first with shine and ask counsel for shine to introduce himself Good morning. This is Steven Burdick from Morgan Lewis and Bacchus also joined by my colleague Paul busette. We are counsel for shine Okay, I'll ask you to raise your right hand Do you swear or affirm that the testimony you will provide in this proceeding is the truth? The whole truth and nothing but the truth Did any please inform me if any of you declined to take the oath? Okay, you may be seated and I present is there any objection to Including a witness list the objection. Okay So proceed to the mission of the evidence on behalf the nrc staff Are there any edits at its counsel to your exhibit list? There are no edits Would you read the range of numbers on the list of exhibits to be admitted staff exhibits run from nrc? 001 through nrc 013 Okay, and I presume you would move to include the admit those exhibits and into Evidence we would like to move to admit them into there. Are there any objections objection. Okay, and seeing no objection the Exhibits are admitted. So thank you for those. We got through the preliminaries I think at this point. We're ready to Have the overview panel for shine And for this portion of the proceeding will have the overview panel from shine and I believe then we have the questions Of this on the overview panel, and then we'll have the staff panel. So thank you counsel And again that this is an overview panel for Opportunity for the applicant to provide us overview of the application and the proposed project I would remind the witnesses that you remain under oath You could may assume that the Commission is familiar with the pre-hearing filings On behalf of of the applicant is as well of the staff and I would then ask the panelists to introduce themselves I'll start here. Are you still my name is Greg Piper. I'm the founder and CEO of shine medical My name is Bill Hennessey. I'm the manager of engineering for shine My name is Jim Castillo on the licensing manager for shine My name is Eric van Abel. I'm an engineering supervisor for shine. Okay. Thank you gentlemen And you may proceed with your presentation So once again, my name is Greg Piper and I want to thank Commission commissioners mr. Chairman for your consideration in this very important matter Started off. I'd like to give you guys a little bit of background on shine and our mission as a company Shine medical technologies is dedicated to being the world leader in the production of clean affordable production of medical tracers and cancer treatment Elements commonly known as medical isotopes by the medical community We recognize fully that in order to run this business successfully our highest priority needs to be on safety And reliability of the processes used to produce these isotopes at the end of the day These products will serve the needs of approximately 100,000 patients per day around the globe Making this a very very significant endeavor in terms of health care of patients Of course, we can't operate the plant at all if we're not focused on safety in our own house And so those are the highest sort of values within the company Also interesting is that we come with this technology to the market at a very interesting time when there is a tremendous amount of Transition happening in the existing supply chain for these medical isotopes Currently the only producer in the western hemisphere of any significant volume will be leaving the market permanently in 2018 And the products have a 66 hour half-life the most the most commonly used product has a 66 hour half-life And that creates substantial challenges for us patients here if we need to bring all of our medical isotopes from overseas next slide please Just a little bit more background on the primary medical isotope That the world uses molybdenum 99 Decays into a daughter technetium 99 M and is used in about 85 percent of the nuclear medicine scans performed globally Technetium 99 M is extremely versatile its chemistry allows itself to attach itself to a very wide variety of drugs Where it acts as a tracer and essentially allows doctors to see what that drug is doing It has a six hour half-life And so it is very difficult to distribute as technetium, but because it's a daughter of molybdenum 99 Which has a 66 hour half-life you can distribute it around the globe fairly easily Collectively these procedures make up about 40 million doses on an annual basis So very very high volume and very important to patients all around the world the US being approximately half of those doses The pie chart included on slide 3 shows a breakdown of the Procedures primarily that use technetium 99 M I'm just going to call your attention to two of the slices the largest slice is labeled myocardial perfusion Myocardial perfusion is just a way of saying looking at blood flow through the heart muscle And in fact is commonly known as a stress test If a doctor wants to know where to put a stent if a patient's having chest pain They'll do this if they want to see if the heart's been damaged by a heart attack They'll do this test and so very very useful when you look at the number one killer of human beings in the United States It's cardiac disease and the number two use is for something called a bone scan, which is used to stage cancer And and that is the number two killer of people in this country And so very important products very widely used today, and it's very important that the supply chain remain robust For many many years to come next slide, please However, you know it is not clear that the supply chain will remain resilient on the current track without new production In fact, it looks like it will not be able to meet the needs the growing needs of the globe in terms of medical isotope production I mentioned the Canadian reactor is exiting the market permanently in March of 2018 And they actually plan to decommission that reactor at which time the Western Hemisphere will not have a source Barring barring new entrance coming in and this is not going to create just a problem over here But it's going to create a global problem and that in fact the nuclear energy Agency as part of the Organization of Economic Cooperation and Development has been performing studies on exactly this situation for the last several years And we've included a small bit of data from the most recent study Which shows currents demand growth in the green line and current production capacity In the orange ish line as you see that it kind of dips down when Canada leaves I'll note that this demand graph does include something called outage reserve capacity and so You know it there's a little buffer on what's actually required, but that's important That's what the market needs in order to operate reliably and ensure that patients can get the products They need and manage it the occasional outage because the supply chain is On the order of 50 to 60 years old in most cases the research reactors producing this isotopes so it's it's very very I Think stressful situation for the medical community right now not knowing where their answers are going to lie in the long term And that that problem creates an opportunity For new technology to come in and sort of change the way we've been making medical isotopes in this country And and really do it in a better way And that's that's what we believe we've done here You're going to hear a lot more about how we plan to do that as the day goes on But when we develop this technology we've been working on it since about 2006 We had some core values as a company when we founded the company that that really are embodied by the technological approach You're going to hear about And obviously as I mentioned in the beginning We believe at the very highest level that it is impossible to run this company Without protecting the health and safety of our workers the public and the environment And so these have been factors in our consideration from day one When we were looking at what technologies to choose and what approach to go forward on On top of that we need to ensure based on the short half-life of these products that we can get the product out regularly on time every time again with 66 hours You know, there's really no forgiveness for substantial delays It just means that patients aren't going to get the products they need if you can't deliver And that's unfortunate if a patient presents with chest pains and a doctor's concerned They may have had a heart attack and it has to tell them to come back, you know Maybe in a week and hope you make it Or has to give them an alternative isotope that'll leave them radioactive for weeks They just keep stay away from small children for quite some time. That's just not good for the patient So we need to get this out every single time We also needed to ensure cost effectiveness. We had to ensure an approach that would allow us to make medical isotopes that can be bought You know, it's a time when reimbursement is generally across the board decreasing in the United States And it's important that a cost-effective technology be developed so that this doesn't become prohibitive in terms of cost for patient access And finally something that's been very strong in our minds since the beginning Is that it's it's not necessary to use highly enriched uranium to make Medical isotopes, however, it is commonly used around the globe today And so we designed our process to eliminate the need for highly enriched uranium And in fact use only low enriched uranium as part of our process the risk posed to the US public by the proliferation of highly enriched uranium is extremely high if there were to be an event the consequences would be disastrous and we fully support the US government's initiatives to Remove highly enriched uranium from the supply chain and in fact stop shipping it around the world to ensure that we have appropriate medical tracers So these are all things that drove our mission and drove our values or drove our technology rather And so I'm going to just give you a high-level View of the technology and how it reflects those values Fundamentally the biggest protection that we have is that these systems have been designed to be small And I'm talking about small in terms of thermal power equivalent When you look at a shine production unit or radiation unit you'll hear more about this throughout the day The thermal power of one of these systems is on the order of 100 kilowatts When it's producing at full tilt if you were to compare this to a reactor like the NRU Which is also producing medical isotopes today that reactors thermal power equivalent is 135 megawatts So there's about a factor of 1000 difference in thermal power from a shine based system to a reactor based system And that has tremendous safety benefits for us Including low source term and very low decay heat if we shut one of our systems off within hours Just a few hours. We're down to about a kilowatt of decay heat And so we're talking about something that's less than a hairdryer And so you don't have a lot of the concerns you would have with loss of power in in much larger facilities in addition to the safety benefits just from the lower source term and Lower decay heat, of course, we're producing less radionuclides overall Than a much larger reactor would do and that allows us to use commercial disposal for much if not all of our disposal path It's a great economic benefit and certain certainty benefit in terms of final disposition of waste products Secondly, we developed a low enriched uranium target that is not only novel in terms of being aqueous The target is in a liquid form, but it's also the first target that I'm aware of that is Reusable and the reusability of our target actually gives us a substantial economic advantage Currently in the supply chain metal targets are used solid targets are placed next to a reactor core They're irradiated much of the uranium does not fission They're dissolved and the medical isotopes are extracted out and the rest of the uranium is essentially thrown away Well, in fact since it's highly enriched uranium in most of these cases it's thrown into tanks and very carefully monitored But the reusable target for us is a major major improvement And finally the system is driven by a low energy electrostatic accelerator. I say low energy That's about 300 kilovolts 300 kiloelectron volts beam energy And if you were to compare that to a cyclotron that would be found in a pharmacy today That makes isotopes such as fluorine 18. Those are on the order of 10 Mev mega electron volts. So it's it's a much lower much simpler accelerator that we're using to drive this This target and that also allows us to operate below criticality Some liquid reactors have been operated in the past and they operate at criticality with control rods We've chosen for a number of reasons to eliminate criticality altogether and use this accelerator system to drive the liquid target And that gives us again Substantially less waste by eliminating the need for a reactor as the primary neutron source It is also proven demonstrated in fairly cost-effective technology That actually people can come and see if they'd like it's in our lab in Bonona. So that is I guess that concludes my presentation I'm going to turn the rest of the overview over to Jim Castedio Good morning next slide, please The the shine facilities located on a previously undeveloped 91 acre parcel on the southern boundaries of the city of Jamesville and Rock County, Wisconsin If you look at the map the area outlined in red on the southern boundary is Rock County Next slide, please The shine facility layout consists of an irradiation facility or the IF in a radio isotope production facility or the RPF The area outlined in blue is the irradiation facility which houses the irradiation units And the area outlined in red is a radio isotope production facility which houses the hot cells The facility is relatively small compared to the size of the parcel It's a 91 acre parcel and the facility is above 55,000 square feet centered approximately in the middle of the parcel Next slide, please The shine IF consists of eight subcritical irradiation units, which are comparable in thermal power level and safety considerations to existing non-power reactors licensed at a 10 CFR part 50 However, due to subcriticality the irradiation units did not meet the existing definition of utilization facility in 10 CFR 50.2 To align the licensing process with the potential hazards the NRC issued a direct final rule Modifying 10 CFR 50.2 definition of utilization facility to include the shine irradiation units And irradiation unit consists of a subcritical assembly a neutron driver and supporting systems Next slide, please The radio isotope production facility is a portion of the shine facility used for preparing target solution extracting purifying and packaging molly 99 and the recycling and cleaning of target solution Based on the batch size of greater than a hundred grams the RPF meets the definition of a production facility as defined in 10 CFR 50.2 Next slide, please Shine submitted a construction permit application in two parts pursuant to an exemption from 10 CFR 2.101 Part one of the application was submitted on March 26, 2013 Which included PSR chapter 2 on psych characteristics PSR chapter 19 for the environmental review and general and financial information Part 2 of the application was submitted May 31st 2013, which provided the remaining PSR chapters and then a discussion of preliminary plans for coping with emergencies in accordance with 10 CFR 50.34 810 Was provided September 25th, 2013 The shine facility will be licensed under 10 CFR part 50 domestic licensing of production and utilization facilities Next slide, please Shine used for regulatory guidance and acceptance criteria shine use new rate 1537 Guidelines for preparing and reviewing applications for licensing and non-power reactors and these in the interim staff guidance augmenting new rate 1537 parts 1 and 2 The ISG Incorporated relevant guidance from new rate 1520 the standard review plan for the review of a licensed application for a fuel cycle facility Shine also used additional and gardens additional guidance such as regulatory guides and ANSI standards and developing the application Now that is my presentation. I'll now turn it over to Eric van able to discuss the shine technology Okay, next slide, please. Good morning I want to give a brief overview of the process and technology that shine plans on using As in this slide as Jim showed there. There's two main areas of the production facility building There's an irradiation facility in IF and a radio isotope production facility in RPF I'm going to go through the processes in those two areas in the next few slides Next slide, please Here's a general schematic of the overall shine process overview Just to orient you relative to the last figure The TSP and irradiation UN cell on the left there is part of the irradiation facility and the other components on this diagram Are all part of the RPF So we begin our process in the bottom there at the target solution preparation step In that process we dissolve uranium in sulfuric acid and produce what we call target solution That target solution is then moved to a whole tank, which is number two on the figure there There's one of these whole tanks for each of our eight irradiation units. So there's eight whole tanks Those whole tanks are staging areas prior to the irradiation cycle So in that whole tank will measure the uranium concentration the pH ensure that the parameters are correct to begin the irradiation cycle And then once we're ready to begin we'll start pumping that solution over to the TSV in discrete batches We'll fill up the TSV to the proper level and then once the TSV is at the proper level We begin the irradiation process by energizing the neutron driver, which is our accelerator that Greg mentioned That accelerator runs for approximately five and a half days We irradiate the solution produce a medical isotopes of interest in the solution and then we once we're done with the irradiation process We drain that solution to a dump tank Located right in the radiation unit cell So the solution is held there for a short period to decay And then once we're ready to process it we Transfer it over to the supercell which is number four on the figure there The supercell is just a larger hot cell that has several processes inside of single hot cell In the first part of that process is the extraction process and that's where we actually separate out the Mali 99 from the other isotopes in the solution and Then most of the time that uranium solution just goes right on to the recycled tank Which is number five in the figure And there it's just recycled back into the process and it goes in a loop goes to another whole tank to another irradiation cycle Occasionally, we also send it to the urex process, which is item six in the figure there And that's where we periodically clean up the solution We remove the uranium from the other fission products using solvent extraction technology urex And we recover the uranium and recycle that back into the process So we just send that back to the target solution preparation steps and recreate target solution again next slide please In the irradiation facility shine has a a system that couples fusion and fission technology So we have a an accelerator that's fusion-based to terium tritium fusion-based accelerator coupled to a fission-based subcritical assembly The prostitl diagram on the right there shows a schematic of that process in the accelerator We accelerate to terium ions into a tritium gas target and that results in the production of fusion neutrons 14 MeB fusion neutrons Those neutrons and pass through a component. We call the neutron multiplier in that multiplier they The yield of neutrons is increased and then the neutrons are transferred into the target solution The target solution is where the uranium is is actually located In the target solution there is subcritical multiplication So the fission occurs it causes more fission, but in a subcritical process And then that that fission yields the radioisotopes of interest directly in the solution for ready extraction from the solution There are additional supporting systems Including a light-water pool system the entire system is located in a pool similar to a research reactor The target solution vessel off-cast system as I'll mention in a few slides here manages is manages to gas products from the fission process The primary close-up cooling system cools the TSV during the radiation process And there's a tritium purification system that supplies clean gases to the accelerator for the irradiation It's important to note that this process is done at essentially atmospheric pressure. It's a low temperature low pressure process These aren't highly pressurized high-temperature systems like a power reactor would be The target solution at the end of the irradiation cycle is simply drained to a dump tank as I mentioned Right in the irradiation unit cell. That's a passively cooled safe by geometry tank to store the solution And that's drained through redundant fail-open dump valves The TSV itself is just an annular simple annular vessel constructed of zircaloi a Widely used alloy in the nuclear industry and there's no pumping of the solution while we're radiating it It's just naturally convected inside of the vessel This slide shows the Just a rendering of the subcritical assembly The outer vessel in the center there is the subcritical assembly support structure the SAS This is a secondary vessel that surrounds the TSV The TSV is internal to that along with the neutron multiplier SAS is just there in case that there's a leak in the TSV that solution would be contained inside of that The dump tank is located directly below it there and there are dump and overflow lines from the TSV to the dump tank to connect it next slide please so we were just looking at the components and read on this figure Directly above that is the accelerator and the accelerator sits on a grating above the pool And the accelerators in yellow in this picture It's an electrostatic accelerator a simple accelerator technology As Greg pointed out before It generates fusion neutrons from DT fusion That drive the fission process when we shut down the accelerator the fission process terminates because the subcritical assembly is never at critical The tritium purification system is not shown in this figure But it's also in the radiation facility and that system Separates gases from the accelerators of the accelerators. It's operating. It's mixing deuterium and tritium together The tritium purification system separates those back apart and resupplies the purified tritium back to the accelerator for continued operation And the tritium lines for that system and the processing equipment are in gloveboxes and double walled pipe Next slide, please The TSV off gas system is shown in green on the figure here That system is directly adjacent to the radiation unit cells That system contains the fission product gases that are generated in the TSV during a radiation It removes iodine from the gas stream and also its its major function is to recombine hydrogen and oxygen So as we irradiate the solution Radialysis of the water generates hydrogen and oxygen and this system sweeps sweep gas air Over the target solution vessel to the dilute the hydrogen and send it to a recombiner and then recombine the water and return that water Back to the TSV such as the closed loop The subcritical assembly as I mentioned before is immersed in a light water pool that pool provides significant radiation shielding and decay heat removal Next slide for the irradiation process When we're ready to begin the irradiation We measure the relevant parameters of the target solution such as uranium concentration and pH and any other Chemical parameters that we need to determine and then we begin Moving a solution in discreet batches over into the target solution vessel. We measure the count rate at each step there and From that we can do the the 1 over m process that's used in Reactors all over the world to predict the critical state of the assembly and the difference with us is that we Increase volume we predict for the critical state is and we never go there. We stop 5% by volume below critical And that's our highest reactivity point for the system And during that process there's there are automatic safety systems That are monitoring and will initiate a shutdown on high new jump flux or primary cooling temperature should The operators not stop the system before that and that would prevent a criticality Next slide please Once we begin the irradiation process we isolate that batch of uranium solution in the TSV So it's a fixed target fixed batch of solution We close the the fill valves the redundant fill valves and isolate the fill pump from the system We energize the accelerator and then we began slowly supplying tritium to the accelerator and that causes the output of the accelerator accelerator to gradually increase And that increase in the neutron output accelerator results in increased fission power in the TSV That fission power results in increased temperature and void fraction in the TSV Which the system has very strong inherent negative feedback coefficients So though that increase in temperature and void fraction causes the reactivity to drop significantly in the system And we don't do anything to compensate for their activity dropped we lot the system drive further subcritical We do this for approximately five and a half days and then following shutdown we drain the solution into that dump tank where it's passively cooled Normally we're maintaining the temperature of that pool, but should we lose off say power or active cooling for any reason of the pool There's sufficient heat capacity in the pool For a temperature rise of only 12 degrees after 90 days without cooling So it's a large body of water. There's very little decay heat because this is such a small system Next slide please In the radio ISO production facility once we're ready we transfer that solution over to the RPF and there we extract them the Mali 99 We have a purification process that it then goes to and this is the leu modified cynic M process Where it's a laboratory scale Glassware process that's done in a hot cell just to purify the product and then we package it and get ready for shipment to customers The in the RPF. There's also a noble gas removal system the NGRS This system collects those off gases from the TSV off gas systems to a TSV off gas system stores them Holds them for decay for 40 days Prior to sampling and then a filtered monitor discharge to our process vessel event system Also in the RPF is the processes for recycling and cleaning up the target solution the Eurex process That's a as I mentioned before it's solve an extraction process that separates the fission products and plutonium from the uranium The uranium is recovered And for reuse in the process Next slide please In the shine facility we use engineered safety features to protect public health and safety and these are principally confinement The it's important to note that our inventory in any one of these confinement areas is approximately 10,000 times less than the radio-nuclide inventory in a power reactor. So they're Lower much lower inventory which reduces the risk and also these are low temperature low pressure processes So there's not a lot of stored energy to encourage dispersal So there's there's lower dispersion forces, which of course reduces releases The confinement functions themselves are provided by the biological shielding. There's Over most of processes. There's thick reinforced concrete biological shielding usually several feet thick concrete Isolation valves on the piping systems Ventilation systems play an important role in the confinement features as shown on the figure on the right there That shows you some of our cascaded ventilation zones From zone one to zone four. There's a pressure gradient with zone one being at the lowest pressure so the any potential contamination is Reduced outside of those areas in zone one where radiological materials are normally stored And in any accident scenario those areas and read on the figure there are the areas where Isolation would principally occur and contain that material should a accident occur And also there are of course at instrumentation and control systems that actuate the confinement features Next slide, please right So as described in shines PSIR we have a preliminary design That shows that we can construct this facility to meet the applicable regulatory requirements We've identified robust engineered and administrative controls to ensure that we can protect public health and safety the environment and our workers and we are Certainly designing this plant with safety as our primary criterion And that concludes my presentation That concludes the presentations Thank you