ML15356A133
| ML15356A133 | |
| Person / Time | |
|---|---|
| Site: | Northwest Medical Isotopes |
| Issue date: | 12/08/2015 |
| From: | Martinez N Division of License Renewal |
| To: | |
| Nancy Martinez 415-2719 | |
| Shared Package | |
| ML15356A096 | List: |
| References | |
| NRC-2059 | |
| Download: ML15356A133 (38) | |
Text
Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION
Title:
Public Scoping Meeting for Northwest Medical Isotopes, LLC Docket Number:
50-609 Location:
Columbia, Missouri Date:
Tuesday, December 8, 2015 Work Order No.:
NRC-2059 Pages 1-37 NEAL R. GROSS AND CO., INC.
Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 (202) 234-4433
1 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 UNITED STATES OF AMERICA NUCLEAR REGULATORY Commission
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PUBLIC MEETING TO DISCUSS THE CONSTRUCTION PERMIT PROCESS AND ENVIRONMENTAL SCOPING FOR THE NORTHWEST MEDICAL ISOTOPES, LLC RADIOISOTOPE PRODUCTION FACILITY APPLICATION
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TUESDAY DECEMBER 8, 2015
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The Public Meeting was convened at the Holiday Inn East, 915 Port Way, Columbia, Missouri at 6:00 p.m., Cheryl Hausman, Facilitator, presiding.
PRESENT:
CHERYL HAUSMAN, Facilitator MICHAEL BALAZIK, Office of Nuclear Reactor Regulation NANCY MARTINEZ, Office of Nuclear Reactor Regulation
2 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 P R O C E E D I N G S 1
(6:00 p.m.)
2 MS. HAUSMAN: Good evening, everyone.
3 I'd like to welcome you and thank you for participating 4
in the environmental public scoping meeting this 5
evening and providing comments on the NRC's 6
Environmental Impact Statement to evaluate the 7
environmental impacts for the construction, operation, 8
and decommissioning of the proposed Northwest Medical 9
Isotopes radioisotope production facility in Columbia, 10 Missouri.
11 My name is Cheryl Hausman, and I'm going 12 to be the facilitator for the meeting this evening. My 13 role as a facilitator is to help the meeting run 14 smoothly, to ensure that everyone who wishes to speak 15 has an opportunity to do so, and to try to keep us on 16 time.
17 At this time I would like to introduce Al 18 Adams. Al Adams is the NRC chief of research and test 19 reactor licensing. His branch is responsible for 20 review of medical isotope production facilities.
21 MR. ADAMS: Thank you. Good evening.
22 I'd like to also add my welcome. Thanks for coming out 23 tonight, taking time out of your schedule at this busy 24 time of year to spend part of your evening with us.
25
3 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 A couple of things we hope to accomplish 1
tonight. One is we want you to hear about our safety 2
and environmental reviews that we're doing for 3
Northwest Medical facility. Also to give you a brief 4
introduction to Northwest's technology for producing 5
medical isotopes. Plus, the most important part of 6
tonight is hearing from you. Public input is an 7
important part of the NRC licensing process, and we hope 8
that you will take the opportunity to tell us what you 9
consider to be important environmental aspects of the 10 review that we've started on.
11 So, with that, I'll return it to Cheryl.
12 Thank you for coming.
13 MS. HAUSMAN: We'll have two presenters 14 this evening. Michael Balazik. Mike is a safety 15 project manager for Northwest's application. He is in 16 the division of policy and rulemaking, research and 17 test reactor licensing branch. Mike will be 18 presenting an overview of the safety review of the 19 applications.
20 Nancy Martinez.
Nancy is the 21 environmental project manager for Northwest's 22 application. She is in the division of license 23 renewal, environmental review and guidance update 24 branch. Nancy will be presenting an overview of the 25
4 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 environmental review.
1 And there are a few other NRC staff.
2 There are -- I'd like for them to introduce themselves.
3 MS. MOSER: Good evening. My name's 4
Michelle Moser. I'm the ecologist working on this 5
project.
6 MR. FOLK: Kevin Folk. I'm an 7
environmental technical reviewer hydrologist in the 8
environmental review branch for NRC.
9 MS. MITLYNG: I'm Viktoria Mitlyng, 10 public affairs officer for the NRC Region III.
11 MS. HAUSMAN: Thank you.
12 This is a Category 3 public meeting to 13 encourage active participation and information 14 exchange with the NRC and members of the public to 15 obtain comments for the EIS. The NRC invites and 16 encourages members of the public to present oral and 17 written comments on the appropriate scope of issues to 18 be considered in and the content of the EIS.
19 Before we begin, I'd like to go over a few 20 ground rules for the meeting this evening. This 21 meeting is being transcribed, so I ask that you keep 22 any background noise to a minimum so the transcriber 23 can produce an accurate recording of the meeting.
24 There are two security officers present 25
5 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 this evening for everyone's safety, and that is 1
standard practice.
2 Please be respectful of others during the 3
meeting so that all participants who have a question 4
or want to make a comment can be heard and have the time 5
to do so.
6 Please turn off all electronic devices or 7
put them on vibrate. If you need to take a phone call, 8
I ask that you step outside the meeting room to take 9
the call so that the audience can hear the proceedings 10 and the transcriber can obtain an accurate recording.
11 There are two exits for the room, one on 12 each side of the room. And the restrooms are down the 13 hall to the left. If we have to evacuate for any 14 reason, please follow the direction of the security 15 officers.
16 The agenda for the meeting include the 17 presentations by NRC staff to present an overview of 18 the NRC's role and mission and a summary of the 19 environmental review process.
Following the 20 presentation, we will take time to answer questions 21 from the audience and then open up the floor for 22 comments. Please keep your questions and comments 23 relevant to the topic.
24 Hopefully everybody got signed in and 25
6 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 received copies of the agenda and presentation slide 1
and a feedback form. If you haven't signed in, before 2
you leave, would you please do so at the registration 3
table.
4 When speaking please use the microphone.
5 If you have a question or a comment, you can step up 6
to the podium or raise your hand and I'll bring the 7
microphone to you.
8 And, finally, the NRC is always looking 9
to improve our meetings, and your feedback is important 10 to us. There are some postage-paid public meeting 11 feedback forms available on the table outside, and you 12 can fill it out today and give it to any NRC staff member 13 or drop it in the mail.
14 Any questions about the logistics of the 15 meeting this evening?
16 Okay. With that, I would like to turn the 17 meeting over to Michael for the first slide 18 presentation. Please hold your questions and comments 19 until we begin the Q and A session.
20 Thank you.
21 MR. BALAZIK: Thank you, Cheryl.
22 Good evening. My name is Mike Balazik.
23 I'm a project manager with the Division of Policy and 24 Rule Making at the NRC and coordinating the staff's 25
7 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 review of the Northwest Medical Isotopes construction 1
permit application.
2 Thank you for all taking -- taking time 3
out today to attend this meeting.
4 This evening we'll provide an overview of 5
the construction permit review process, which includes 6
both a safety review and an environmental review.
7 We'll also describe ways in which the public can 8
participate in the Northwest Medical Isotopes 9
construction permit review process.
10 I'd like to reiterate that the most 11 important part of tonight's meeting is receiving any 12 comments that you may have on the scope of the 13 environmental review. We'll also give you information 14 on how you can submit comments, if you prefer not to 15 speak at this meeting. I hope the information that we 16 provide you will help you better understand the 17 construction permit review process and the role that 18 you have in that process.
19 Before discussing the construction 20 permit review process, I'd like to first talk about the 21 regulatory oversight and the mission of the NRC. The 22 NRC is a federal agency that regulates the civilian use 23 of nuclear material. Statutory regulatory authority 24 has been granted to the NRC, primarily by the Atomic 25
8 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Energy Act of
- 1954, as amended; the Energy 1
Reorganization Act of 1974, as amended; and the Energy 2
Policy Act of 2005. From this authority the NRC has 3
promulgated the regulations contained in Title 10 of 4
the Code of Federal Regulations, also known as 10 CFR. 5 Another law, the National Environmental 6
Policy Act of 1969, or otherwise known as NEPA, 7
established the national policy for considering the 8
impact of federal decision making on the human 9
environment. Nancy will discuss these in greater 10 detail during her presentation.
11 The NRC mission is to ensure adequate 12 protection of public health and safety and to promote 13 the common defense and security. NRC regulations that 14 implement NEPA also protect the environment.
15 NRC accomplishes these goals through a 16 combination of regulatory programs and processes such 17 as establishing rules and regulations, reviewing 18 license applications, conducting inspections, and 19 issuing enforcement actions and assessing licensee 20 performance. We also evaluate operating -- operating 21 experience from existing nuclear facilities across the 22 country, as well as internationally.
23 Now I'd like to move into a discussion of 24 content and format of a
construction permit 25
9 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 application. The NRC received Northwest's application 1
for construction permit in two parts. The first part 2
was submitted on February 5th, 2015, and it consisted 3
of general information in an environmental report.
4 The second part was submitted on July 20th, 2015 that 5
con-- that considered Northwest's preliminary safety 6
analysis report for its proposed facility.
7 The entire application is available 8
online in the NRC's Agency Document Access Management 9
System, otherwise known as ADAMS. The accession 10 number from the application is noted on this slide.
11 The first accession number is associated with the 12 environmental report, and the second accession number 13 is associated with the preliminary safety analysis 14 report.
15 The NRC staff will conduct environmental 16 safety reviews concurrently and expect each 17 one -- review to take approximately 18 to 24 months, 18 depending on the quality of the application.
19 The next several slides I'll provide an 20 overview of the overall construction permit review 21 process, as well as go into additional detail on the 22 review of the preliminary safety analysis report.
23 This flow chart highlights the safety 24 environmental review for a construction permit 25
10 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 application. This is 10 CFR Part 50 review about 1
entering separate aspects of the construction permit 2
application.
3 The chart also indicates that there are 4
other items that precede the Commission's decision on 5
whether or not to grant the construction permit. One 6
of these items is an independent review performed by 7
the Advisory Committee on Reactor Safeguards, commonly 8
referred to as ACRS. Mandated by the Atomic Energy Act 9
the 1954, the ACRS is an independent group of scientists 10 and nuclear safety experts who advise the Commission 11 on safety issues. The ACRS reviews the construction 12 permit application and the NCR staff's safety 13 evaluation. The ACRS reports its findings and 14 recommendations directly to the Commission.
15 As part of the environmental review, the 16 staff consults with local, state, federal, and tribal 17 officials. The staff also holds public meetings like 18 this to receive comments on the draft Environmental 19 Impact Statement. Additionally, a mandatory hearing 20 will be conducted by the Commission. The Commission 21 considers information presented at the hearing in its 22 decision on whether or not to issue a construction 23 permit.
24 Next I'll describe the construction 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 permit review process in a little bit more detail, 1
starting with the safety review. The first step of the 2
construction permit application review process is to 3
perform an acceptance and sufficiency review of the 4
application. The purpose of this review is to 5
determine if the Applicant has provided all the 6
information required by regulations so that the 7
application can be docketed. Some of the information 8
required to be in a construction permit application 9
include a summary description of the facility, the 10 preliminary design of the facility, and a preliminary 11 analysis and evaluation of the proposed design and 12 performance of structured system and components of the 13 facility.
14 As I stated before, the application also 15 includes an environmental report, which is the 16 Applicant's assessment of the environmental impacts of 17 the proposed facility.
18 If the application has the required 19 information, then it is considered acceptable for 20 docketing, and the staff will begin its technical 21 review of the application. In the case of Northwest's 22 two-part application submittal, separate docketing 23 acceptance reviews are performed for each part of the 24 application.
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 NRC staff has completed its docketing 1
acceptance review of part one of Northwest Medical 2
Isotopes' application, which I
stated earlier 3
primarily consists of the environmental report. The 4
staff found this portion of the application acceptable 5
for docketing and has begun a detailed review of this 6
part of the application.
7 The staff is currently performing its 8
acceptance review of Northwest Medical Isotopes' 9
preliminary safety analysis report provided in part two 10 of the construction permit application.
11 Now I would like to quickly discuss the 12 technology that Northwest proposes to use here in 13 Columbia, Missouri. Northwest is proposing to 14 manufacture low-enriched uranium target at its 15 facility. In the case of Northwest, a target means 16 material subject to neutrons in a nuclear reactor to 17 elicit particulate reaction for the production of 18 molybdenum-99, which is the isotope of interest.
19 Once fabricated, these targets will be 20 transported to existing universities' nuclear reactors 21 for irradiation. Currently Northwest is proposing to 22 use the University of Missouri and Oregon State 23 University research reactors to irradiate its target.
24 After irradiation, the target will be transported back 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 to Northwest's facility for processing to separate the 1
molybdenum-99 from other isotopes.
2 Additionally, I'd like to add, for each 3
research reactor that would irradiate these targets 4
would need to get NRC approval via license amendment 5
request. Such amendment requests are not part of the 6
Northwest application permit and would be submitted 7
separately by those research reactors for NRC's 8
consideration.
9 Here's a flowchart of the Northwest 10 proposed activities for molybdenum-99. If a license 11 to construct, operate, and receive nuclear material is 12 granted to Northwest, the blue activity would occur at 13 the proposed Northwest facility and the green activity 14 would occur at the nuclear research reactor facility.
15 This flowchart show the three main activities at the 16 proposed facility; target fabrication, target 17 disassembly and dissolution, and molybdenum-99 18 separation.
19 Starting in the lower left corner, 20 low-enriched uranium target material will be 21 fabricated using both fresh uranium and recovered 22 uranium. The target material will be encased in a 23 metal cladding to manufacture a low-enriched uranium 24 target. These targets will be packaged and shipped to 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Oregon State University and the University of Missouri 1
research reactor and potentially a third research 2
reactor.
3 After irradiation, targets will be 4
shipped back to the Northwest Medical Isotopes facility 5
for processing. The irradiated low-enriched uranium 6
target would be mechanically disassembled and 7
dissolved in solution processing. The dissolved 8
low-enriched uranium solution would be processed to 9
recover and purify the molybdenum-99. The purified 10 molybdenum-99 would be packaged and shipped to a 11 radiopharmaceutical distributor. The low-enriched 12 uranium solution would be treated to recover uranium 13 and be cycled back to step one of this flowchart.
14 If the NRC staff determines that the 15 remainder of the Northwest Medical Isotopes 16 construction permit application meets all the material 17 parts for docketing, then staff will docket the 18 application and begin a detailed review. Following 19 the initial review of the application, the staff may 20 issue requests for additional information to Northwest 21 to ensure that staff has all necessary technical 22 information to develop a safety evaluation report. The 23 NRC did request additional information for the 24 Environmental Impact Statement.
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 The safety evaluation report documents 1
the staff's review of the construction permit 2
application and states the bases for the staff's 3
recommendation to either grant or deny the application.
4 The safety evaluation report summarizes the 5
application, the regulatory standards under which the 6
review is being conducted, and the technical evaluation 7
on how the application does or does not meet NRC 8
regulations.
9 As discussed on the previous slide, 10 following the completion of the safety evaluation 11 report, the ACRS reviews the construction permit 12 application and the staff safety evaluation, and then 13 the ACRS reports its findings and recommendations 14 directly to the Commission.
15 Prior to the decision to either grant or 16 deny the construction permit application, a mandatory 17 Commission hearing will be held on the application.
18 The date of the hearing and the explanation of the 19 hearing procedures, including opportunities for the 20 public participation, will be announced with at least 21 30 days notice in a future Federal Register Notice after 22 the full construction permit application has been 23 accepted for docketing.
24 Finally, the Commission will make a 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 decision to either grant or deny the construction 1
permit based on the NRC staff's safety evaluation 2
report, the recommendation from the ACRS, and the 3
Environmental Impact Statement.
4 More details on the environmental review 5
will be discussed by the environmental project manager, 6
Nancy Martinez.
7 Thank you for your time.
8 MS. MARTINEZ: Thank you, Michael.
9 Good evening. My name is Nancy Martinez.
10 I am the environmental project manager, and I will 11 discuss the environmental review process.
12 The environmental review for the 13 Northwest application will be performed in accordance 14 with the National Environmental Policy Act of 1959, 15 commonly known as NEPA. NEPA requires federal 16 agencies to follow a systematic approach in evaluating 17 potential environmental impacts of the proposed 18 actions and also to assess alternatives to those 19 actions.
The NEPA process involves public 20 participation and public disclosure.
21 NRC's environmental regulations 22 implemented in NEPA are contained in 10 CFR Part 51.
23 Our environmental review considers the impact of 24 construction, operation, and decommissioning of the 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Northwest facility.
1 We will also consider the impact of 2
alternatives to the proposed action, including 3
alternative sites, alternative technology, and the 4
impact of not issuing a construction permit. We 5
document the review in an Environmental Impact 6
Statement, which is made publicly available.
7 Ultimately the purpose of the 8
environmental review is to take a detailed hard look 9
at the environmental impact of construction, 10 operation, and decommissioning of the Northwest 11 facility, and after balancing the benefits versus the 12 impacts of the proposed project, make a recommendation 13 to the Commission on whether or not to issue the 14 construction permit.
15 This slide presents a high-level overview 16 of NRC's environmental review process, which begins 17 with scoping. Scoping is a process by which the NRC 18 staff identifies the specific impacts and significant 19 issues to be considered in the preparation of the 20 Northwest Environmental Impact Statement.
21 An important part of the scoping process 22 is public involvement. Information that we gather 23 from you today and in the next few weeks will be 24 considered in the development of the Environmental 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Impact Statement. Following the scoping process, the 1
NRC staff will prepare a draft of the Environmental 2
Impact Statement for the proposed Northwest facility 3
and issue the draft for public comment. This is the 4
next opportunity for you and other members of the public 5
to participate in the environmental review process.
6 Comments received on the draft will be considered 7
before the NRC staff issues a final Environmental 8
Impact Statement.
9 The Environmental Impact Statement will 10 be available at NRC's website. As you came in, you were 11 asked to fill out a registration card at our reception 12 table. If you included your address on that card, we 13 will mail you a CD copy of the draft and final EIS to 14 you. Once issued, the Northwest Environmental Impact 15 Statement will help to inform the decision on whether 16 or not to issue the construction permit for the 17 Northwest facility.
18 The proposed facility site is located at 19 the Discovery Ridge Research Park in Columbia, 20 Missouri. The site, identified by the red rectangle 21 here, is approximately four-and-a-half miles south of 22 U.S. Interstate 70 and just north of U.S. Highway 63.
23 The site is 7.4 acres and contains no existing 24 structures.
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 This is a photo of the site taken by the 1
NRC staff during its environmental site visit. The 2
photo was taken looking in a northeast direction of the 3
site. The Discovery Ridge site is a research 4
development and office park. The site is a section of 5
Columbia South Farms, which is primarily agriculture.
6 For an Environmental Impact Statement, 7
the NRC environmental staff looks at a wide range of 8
potential impacts, including potential impacts to air 9
and water resources, land use, human health, fish and 10 wildlife, and environmental justice. As part of the 11 process, the NRC staff consults and coordinates with 12 various federal, state, and local officials, as well 13 as leaders of tribal nations, including the U.S. Fish 14
& Wildlife Service, Environmental Protection Agency, 15 Missouri Department of Natural Resources, Missouri 16 State Historic Preservation Office, and Tribal Nations 17 with historic ties to the site. Consultation helps to 18 make sure that current information that these groups 19 may have is identified and considered in our analysis.
20 The scoping period started on November 21 18th when the notice of intent to prepare an 22 Environmental Impact Statement and conduct scoping was 23 published in the Federal Register. The NRC will accept 24 comments on the scope of the environmental review until 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 January 4th, 2016. In general, the NRC staff is 1
looking for information about the environmental 2
impacts of construction, operation, and 3
decommissioning of the proposed Northwest facility.
4 You can assist this process by telling us, for example, 5
what aspects of your local community we should focus 6
on; what local environmental, social, and economic 7
issues the NRC should examine during our review; what 8
other major projects are in progress or planned in the 9
area; and what reasonable alternatives are most 10 appropriate for this region. These are just some 11 examples of the information NRC staff seeks. Because 12 you are more familiar with your community than we are, 13 your comments tonight will help us facilitate a 14 thorough NRC staff review.
15 Public comments are an important part of 16 the environmental review process. You may wonder how 17 we collect and use your comments. First I will discuss 18 how we review your comments, and then how you can 19 provide comments. We consider each comment as part of 20 the environmental review. The formal scoping summary 21 report will address comments collected during the 22 scoping period, and comments are used to determine the 23 scope of the Environmental Impact Statement. The 24 Environmental Impact Statement is one of the factors, 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 as well as several others shown here, that influence 1
the Commission's decision to issue the construction 2
permit.
3 Now I will discuss how to submit comments.
4 Today you can turn in written comments at the 5
registration table or you can provide verbal comments 6
later on in this meeting. A court reporter is here to 7
record all comments provided verbally. In addition to 8
providing verbal and written comments at this meeting, 9
there are other ways that you can submit comments. You 10 can submit comments online using the Federal Rulemaking 11 website, as identified on the slide and with the ID 12 provided. This is a screenshot of the regulations.gov 13 website. You just enter the ID, and this will give you 14 a list of Federal Register Notices. There's an icon 15 on the right-hand side to submit comments.
16 Please note that comments will not be 17 edited to remove any identifying or contact 18 information, such as a phone number or address. Do not 19 include any information in comments that you do not want 20 publicly disclosed.
21 You can also provide written comments by 22 mail at the address provided on this slide. All 23 comments must be submitted by January 4th, 2016.
24 If you are interested in reviewing the 25
22 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 environmental report that Northwest submitted as part 1
of its construction permit, a hard copy can be found 2
at the Daniel Boone Regional Library. Additionally, 3
electronic copies of the environmental report can be 4
viewed on NRC's website, as identified on this slide.
5 Michael and I are the primary points of 6
contact for the NRC for the Northwest application 7
review. Our contact information is provided on this 8
slide.
9 This concludes my presentation. If 10 anyone has questions pertaining to the safety 11 environmental review information provided during this 12 presentation, Michael and I are happy to address them.
13 Thank you.
14 MS. HAUSMAN: Thank you, Michael and 15 Nancy.
16 Does anybody have any questions about the 17 presentation that you've just seen?
18 Okay. Seeing none, no hands raised.
19 Okay. Next we'll move into the public 20 comment period of the meeting. This is the part of the 21 meeting where you have an opportunity to give your 22 comments on the scope and content of the EIS.
23 There are a number of things we can all 24 do to ensure this part of the meeting runs smoothly.
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23 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 First, as I mentioned earlier, we are transcribing the 1
meeting. So please keep any sidebar conversations 2
down and avoid background noise. In addition, 3
comments can only be heard if you speak into a 4
microphone. Please do not make comments from the 5
audience, because we won't be able to transcribe them 6
accurately.
7 If you have written comments, you can 8
leave them with me or an NRC staff before you leave this 9
evening.
10 And, finally, for those making comments, 11 please step up to the podium and begin by identifying 12 yourself with your name. And, if you would like to 13 mention any organization or who you represent, please 14 do that as well. In addition, if you can be as succinct 15 as possible, we should be able to get to everyone's 16 comments and conclude the meeting in a time -- include 17 the meeting in a timely manner.
18 If you wish to make a comment outside the 19 scope of this meeting, NRC staff will be available 20 following the meeting to answer questions.
21 And if you filled out a yellow comment 22 card, I'll call you up by name. When those comments 23 are finished, I will open up the meeting for any 24 other -- anybody else who has a comment this evening.
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24 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 First I would like to invite Karen Miller 1
to the podium.
2 MS. MILLER: Good evening. My name's 3
Karen Miller, and an I'm associate commissioner here 4
in Boone County. I am here to testify in support of 5
Northwest Medical Isotopes, LLC's proposed project.
6 Because of our wide array of community assets, we 7
believe that Boone County is an excellent location for 8
the proposed facility.
9 One of our community's premier assets is 10 the University of Missouri's nuclear reactor. The 11 physical proximity of the reactor, as well as its 12 history of excellence in performance, combine to make 13 this a perfect partnership between the University of 14 Missouri and Northwest Medical Isotopes.
15 Through this partnership we will 16 be -- which will produce 99-MO, cancer patients 17 throughout the United States will have more 18 opportunities for a better outcome. The proposed 19 location of the facility at University of Missouri's 20 Discovery Ridge Park will provide access to 21 Mid-Missouri Regional Airport. This too is an 22 enormous benefit to the project, since reducing the 23 time between production of the drug and delivery to 24 healthcare professionals will effectively increase the 25
25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 efficacy of the drug needed by the patients and doctors 1
throughout the United States.
2 Another asset that our community brings 3
to the table is Boone County's ability to utilize our 4
economic development tool, as Chap -- known as Chapter 5
100 Bond. With this tool, in cooperation with our 6
taxing entities, we can make this project successful.
7 This is a community-wide partnership, 8
which has the potential to grow ever stronger through 9
the collaboration created by effectively utilizing our 10 community assets, the University's research reactor, 11 Mid-Missouri Regional Airport, and our ability to 12 utilize the economic tool Chapter 100 Bond.
13 Our community directly benefits from this 14 partnership because this project will bring 15 good-paying jobs and capital investment, and it creates 16 the possibility of pharmaceutical companies joining 17 the research hub of Discovery Ridge, with that enhanced 18 tax base benefiting all citizens.
19 Please accept this testimony made on 20 behalf of the Boone County Commission in support of the 21 Northwest Medical Isotopes, LLC facility location.
22 Thank you.
23 MS. HAUSMAN: Thank you.
24 Next I would like to invite Bob McDan 25
26 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 (sic).
1 MR. MCDAVID: Thank you. My name is Bob 2
McDavid. I'm mayor of the City of Columbia. I 3
appreciate the opportunity to testify before the NRC 4
in support of the Northwest Medical Isotopes proposal.
5 This is an important initiative for 6
obviously several different reasons. One is that we 7
have a highly-skilled workforce in Boone County and can 8
easily support the 80-plus jobs that will be required 9
in the production of Technetium.
10 Secondly, obviously for Boone County, the 11 1,600 workers that will be required to construct the 12 building is very important to the economy here in 13 Mid-Missouri and in the whole state of Missouri.
14 Second -- next, you know, I have -- in my 15 former life I was a physician and have been on staff 16 of both the University of Missouri Hospital and Boone 17 Hospital; and I know how important, you know how 18 important the use of radioisotopes is to the healthcare 19 community, to the men and women who do diagnostic and 20 therapeutic intervention, and you know how important 21 this tool is to continue. And it's -- it's -- I know 22 there are a lot of healthcare providers that are 23 uncomfortable with the prospect that Technetium may be 24 in short supply in the pending near future.
25
27 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 And, last, and really most important in 1
my opinion is the fact that so many of us may be 2
requiring this tool. You know, whether there's -- of 3
the 18 million doses of Technetium a year, which, 4
obviously, do the math, is 50,000 a day, many of us will 5
need this diagnostic tool for heart disease, bone, 6
skin, and other emerging technologies. And it means 7
so much if we're able to bring the production of this 8
very essential radioisotope back into the United States 9
where we can produce it here and deliver it to the 10 300-plus citizens of the United States who continue to 11 need this and will need this in the future.
12 Thank you for your consideration.
13 MS. HAUSMAN: Thank you.
14 Next, Matt McCormick.
15 MR. DOWELL: Actually, Matt is on his 16 way. So I'm going to speak on behalf of our 17 organization, if that's all right.
18 MS. HAUSMAN: Sure. No problem.
19 MR. DOWELL: I'm Jerry Dowell. I'm the 20 director of government affairs for the Columbia Chamber 21 of Commerce, and I wanted to put on record the Columbia 22 Chamber of Commerce's support of the Northwest Medical 23 Isotopes application.
24 I wanted to highlight a couple of items 25
28 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 that we are supportive of. Missouri and Columbia is 1
the home to world-class medical research resources, and 2
Columbia is at the strategic central location of that 3
access point, and it accesses to other critical markets 4
across the country. So we're supportive of that 5
effort.
6 Also, the Discovery Ridge site utilizes 7
the proximity nourished Missouri and its proximity to 8
transport access at the intersections of two major 9
highways and our access to a regional airport. Also, 10 we have an ample workforce available for the 11 construction phase through the decommissioning phase 12 of this facility.
13 So, once again, the Columbia Chamber of 14 Commerce wants to be on record in support of the 15 Northwest Medical Isotopes application.
16 MS. HAUSMAN: Thank you.
17 David Griggs.
18 MR. GRIGGS: I must say that a third of 19 my speech has already been given, so I'm going to spare 20 you in giving it.
21 My name is David Griggs. I reside at 6420 22 North Highway VV in Columbia. Tonight I'm here to 23 represent Regional Economic Development, or REDI, 24 about this great project.
25
29 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Just a little bit of background on where 1
I'm coming from. I'm a former Boone County 2
Commissioner, a past president of the Columbia Chamber 3
of Commerce, two-time former chair of REDI, and I've 4
operated a business in Columbia for over 40 years. I 5
mention that simply to reinforce the point that this 6
project, Northwest Medical Isotopes, has from the start 7
been the perfect example of a private-public or a 8
public-private partnership. Much like REDI, which is 9
also a public-private partnership, this project is a 10 prime example of a company in the city of Columbia, 11 county of Boone, state of Missouri, and our great native 12 University working together to do whatever's necessary 13 to bring a great project to fruition.
14 You will hear some more and have heard 15 from several folks tonight about more specific 16 information relating to this project. My role is to 17 discuss the overall economic pro-- economic impact of 18 the project and how it will impact our community and 19 state.
20 REDI's worked with Northwest for over two 21 years by assisting Northwest and bringing together the 22 right organizational leadership to help move this 23 project to this point. I mentioned many of them just 24 a second ago, but must stress the critical role of the 25
30 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 University and the University team at the research 1
reactor. This is simply an amazing opportunity for 2
Columbia, the University, Missouri and, in fact, the 3
United States and our citizens.
4 There are approximately 50,000 doses of 5
this drug that will be produced at this proposed 6
facility administered every day in North America.
7 There's no other producer in the United States for this 8
credible diagnostic medical pharmaceutical. Our 9
research reactor, in collaboration between Northwest 10 and the University, are the critical components for 11 this project.
12 It's estimated that construction of this 13
$70 million radioisotope production facility in fully 14 operational state will require over 180 full-time 15 skilled construction personnel from Central Missouri 16 and take longer than a year. When the facility's in 17 operation, it's estimated to employ 98 full-time 18 employees. I will tell you those positions will range 19 from extremely highly-skilled technical jobs to those 20 tasked with maintenance of equipment in the facilities.
21 I make that point to note the variety of employment 22 opportunities this project brings to our community.
23 Not included in these construction and 24 operational employment and cost estimates are the 25
31 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 ancillary jobs this project will create. Obviously 1
these radiopharmaceuticals require very rapid delivery 2
to the medical facilities that administer them around 3
the country.
4 This project will be located at 5
University's Discovery Ridge Research Park on 7.4 6
acres. Discovery Ridge is another great example of 7
great public-private partnerships, as it houses ABC 8
Laboratories, which is an environmental testing 9
organization serving the pharmaceutical industry, and 10 other clients like IDEXX, a bioscience company serving 11 veterinary and the animal health research industry.
12 This site is critically located within a 13 few miles of Interstate Highway 70, sets immediately 14 adjacent to U.S. Highway 63. This location provides 15 critical north, south, east, west transportation 16 assets from the center of the United States and is only 17 about six miles from Columbia Regional Airport.
18 All necessary utilities and street 19 infrastructures, including an adjacent overpass 20 providing access to Highway 63, is already in place at 21 the lot line for a fast timeline for this project. That 22 fact simply demonstrates our community's long-term 23 commitment to support this very type of development at 24 Discovery Ridge.
25
32 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 In addition to the investment and 1
employment opportunities I've mentioned, it's also 2
anticipated over the life of this project this project 3
will produce over $76 million in tax revenues to support 4
our school, our city, our county, and our state.
5 In closing, on behalf of REDI and myself, 6
our community, our county, our state, and the thousands 7
of U.S. citizens whose lives will be positively 8
impacted by this project on a daily basis, I give our 9
support and approval. And thank you very much.
10 MS. HAUSMAN: Thank you, David.
11 Terry Maglich.
12 MR. MAGLICH: Good evening. I'm Terry 13 Maglich. I am a project manager with the Department 14 of Economic Development with the State of Missouri.
15 The role of myself and the Department is to provide 16 assistance to business and communities that create 17 opportunities. The opportunities that we look forward 18 to are those that allow for the growth of employment 19 as well as investment.
20 We're very, very pleased to have provided 21 an assistance proposal to Northwest Isotopes 22 approximately a year and a half ago that does just that; 23 creates a number of great jobs, a great deal of 24 investment in one of our targeted industries of life 25
33 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 sciences. It also does something that I consider very 1
important; it creates an opportunity to save lives.
2 Thank you for allowing me to testify.
3 MS. HAUSMAN: Thank you, Terry.
4 Next, Dan Brague.
5 MR. BRAGUE: Thank you. My name is Dan 6
Brague. I'm the vice president and general manager of 7
global medical imaging for Mallinckrodt 8
Pharmaceuticals. I'm responsible for the commercial 9
activities for Mallinckrodt's nuclear medicine 10 business globally, and I a have keen interest in the 11 supply of moly-99.
12 Mallinckrodt is the world's largest 13 producer of technetium generators for use of nuclear 14 medicine. These generators use moly-99 with a three-day 15 half-life to provide
- sterile, pyrogen-free 16 technetium-99 medicine with a six-hour half-life.
17 Mallinckrodt has generator manufacturing 18 operations in Missouri, as well as the Netherlands, 19 which rely on a steady supply of moly-99. Technetium 20 is used in roughly 80 percent of all nuclear medicine 21 procedures nearly 30 million times each year globally 22 to diagnose heart disease, diagnose and stage cancer, 23 and examine organ functions in kidneys, lungs and 24 brain. More than 100 diagnostic procedures are 25
34 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 available to patients using technetium-99 1
radiopharmaceuticals.
2 Large-scale production of moly-99 is 3
currently only completed at five facilities worldwide.
4 Moly-99 has not been produced domestically since 1991.
5 These five facilities rely on aging research reactors, 6
which are periodically subject to planned and unplanned 7
maintenance. Some of these unplanned maintenance 8
outages have led to shortages of moly-99, frequently 9
impacting patient access to technetium for these 10 important diagnostic procedures.
11 Mallinckrodt is also a major producer of 12 moly-99 at our facility in the Netherlands, so we are 13 very familiar with what is needed to produce commercial 14 quantities of this isotope. As the world's largest 15 consumer of moly-99, Mallinckrodt closely follows new 16 efforts to produce this critical isotope and supports 17 construction of new facilities for its production. We 18 are very familiar with Northwest Medical Isotopes' plan 19 to license and construct a facility in Columbia, 20 Missouri for the production of moly-99 and the 21 recycling of their target material. As we understand 22 it, they intend to utilize a network of two to three 23 university research reactors and build a new moly-99 24 production facility, all of which should provide 25
35 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 additional moly-99 capacity.
1 We believe their technology offers 2
distinct advantages because it is based on the 3
well-proven fission method of moly-99 production and 4
uses existing reactors.
Their operation
- will, 5
importantly, also be based upon low-enriched uranium, 6
which meets the objectives of the U.S. Government's 7
nonproliferation policy, as stated at the 2012 Nuclear 8
Security Summit in Seoul, South Korea and in 2014 in 9
the Netherlands.
10 Nuclear medicine procedures performed in 11 the U.S. consume half of the world's supplies of 12 moly-99. A domestic moly-99 production facility will 13 reduce radioactive decay losses in transit from the 14 current suppliers in Europe, South Africa, and 15 Australia. A U.S. supply, if robust enough to supply 16 the entire market, will also eliminate or reduce 17 transport problems we've had in the past relying on 18 shipments from Europe, incidents including volcanic 19 activity in Iceland and flood destructions due to 20 terrorist concerns. Discussions leading up to the 21 passage of the American Medical Isotope Production Act 22 of 2012 cited all of these issues as a reason to 23 encourage domestic production of moly-99.
24 Mallinckrodt applauds Northwest Medical 25
36 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Isotopes' efforts to build its facility in Columbia and 1
encourages the NRC to provide the necessary resources 2
for an expedient review of their construction permit 3
and operating license applications.
4 Thank you for the opportunity to provide 5
these comments today.
6 MS. HAUSMAN: Thank you, Dan.
7 Does anybody else have a comment that they 8
would like to make this evening?
9 Okay. Going once, twice.
10 We would like to thank everyone for coming 11 to and participating in the meeting this evening, for 12 openness and transparency.
13 The transcript of this meeting will be 14 available publicly on NRC's web page. And the NRC 15 staff will be available for a short time after. If you 16 have questions or comments for us, we will be here.
17 Thank you.
18 (Whereupon, at 6:45 p.m., the proceedings 19 went off the record.)
20 21 22 23 24 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 1
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4 5
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10 11 12 13 14 15
Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION
Title:
Public Scoping Meeting for Northwest Medical Isotopes, LLC Docket Number:
50-609 Location:
Columbia, Missouri Date:
Tuesday, December 8, 2015 Work Order No.:
NRC-2059 Pages 1-37 NEAL R. GROSS AND CO., INC.
Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 (202) 234-4433
1 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 UNITED STATES OF AMERICA NUCLEAR REGULATORY Commission
+++++
PUBLIC MEETING TO DISCUSS THE CONSTRUCTION PERMIT PROCESS AND ENVIRONMENTAL SCOPING FOR THE NORTHWEST MEDICAL ISOTOPES, LLC RADIOISOTOPE PRODUCTION FACILITY APPLICATION
+++++
TUESDAY DECEMBER 8, 2015
+++++
The Public Meeting was convened at the Holiday Inn East, 915 Port Way, Columbia, Missouri at 6:00 p.m., Cheryl Hausman, Facilitator, presiding.
PRESENT:
CHERYL HAUSMAN, Facilitator MICHAEL BALAZIK, Office of Nuclear Reactor Regulation NANCY MARTINEZ, Office of Nuclear Reactor Regulation
2 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 P R O C E E D I N G S 1
(6:00 p.m.)
2 MS. HAUSMAN: Good evening, everyone.
3 I'd like to welcome you and thank you for participating 4
in the environmental public scoping meeting this 5
evening and providing comments on the NRC's 6
Environmental Impact Statement to evaluate the 7
environmental impacts for the construction, operation, 8
and decommissioning of the proposed Northwest Medical 9
Isotopes radioisotope production facility in Columbia, 10 Missouri.
11 My name is Cheryl Hausman, and I'm going 12 to be the facilitator for the meeting this evening. My 13 role as a facilitator is to help the meeting run 14 smoothly, to ensure that everyone who wishes to speak 15 has an opportunity to do so, and to try to keep us on 16 time.
17 At this time I would like to introduce Al 18 Adams. Al Adams is the NRC chief of research and test 19 reactor licensing. His branch is responsible for 20 review of medical isotope production facilities.
21 MR. ADAMS: Thank you. Good evening.
22 I'd like to also add my welcome. Thanks for coming out 23 tonight, taking time out of your schedule at this busy 24 time of year to spend part of your evening with us.
25
3 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 A couple of things we hope to accomplish 1
tonight. One is we want you to hear about our safety 2
and environmental reviews that we're doing for 3
Northwest Medical facility. Also to give you a brief 4
introduction to Northwest's technology for producing 5
medical isotopes. Plus, the most important part of 6
tonight is hearing from you. Public input is an 7
important part of the NRC licensing process, and we hope 8
that you will take the opportunity to tell us what you 9
consider to be important environmental aspects of the 10 review that we've started on.
11 So, with that, I'll return it to Cheryl.
12 Thank you for coming.
13 MS. HAUSMAN: We'll have two presenters 14 this evening. Michael Balazik. Mike is a safety 15 project manager for Northwest's application. He is in 16 the division of policy and rulemaking, research and 17 test reactor licensing branch. Mike will be 18 presenting an overview of the safety review of the 19 applications.
20 Nancy Martinez.
Nancy is the 21 environmental project manager for Northwest's 22 application. She is in the division of license 23 renewal, environmental review and guidance update 24 branch. Nancy will be presenting an overview of the 25
4 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 environmental review.
1 And there are a few other NRC staff.
2 There are -- I'd like for them to introduce themselves.
3 MS. MOSER: Good evening. My name's 4
Michelle Moser. I'm the ecologist working on this 5
project.
6 MR. FOLK: Kevin Folk. I'm an 7
environmental technical reviewer hydrologist in the 8
environmental review branch for NRC.
9 MS. MITLYNG: I'm Viktoria Mitlyng, 10 public affairs officer for the NRC Region III.
11 MS. HAUSMAN: Thank you.
12 This is a Category 3 public meeting to 13 encourage active participation and information 14 exchange with the NRC and members of the public to 15 obtain comments for the EIS. The NRC invites and 16 encourages members of the public to present oral and 17 written comments on the appropriate scope of issues to 18 be considered in and the content of the EIS.
19 Before we begin, I'd like to go over a few 20 ground rules for the meeting this evening. This 21 meeting is being transcribed, so I ask that you keep 22 any background noise to a minimum so the transcriber 23 can produce an accurate recording of the meeting.
24 There are two security officers present 25
5 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 this evening for everyone's safety, and that is 1
standard practice.
2 Please be respectful of others during the 3
meeting so that all participants who have a question 4
or want to make a comment can be heard and have the time 5
to do so.
6 Please turn off all electronic devices or 7
put them on vibrate. If you need to take a phone call, 8
I ask that you step outside the meeting room to take 9
the call so that the audience can hear the proceedings 10 and the transcriber can obtain an accurate recording.
11 There are two exits for the room, one on 12 each side of the room. And the restrooms are down the 13 hall to the left. If we have to evacuate for any 14 reason, please follow the direction of the security 15 officers.
16 The agenda for the meeting include the 17 presentations by NRC staff to present an overview of 18 the NRC's role and mission and a summary of the 19 environmental review process.
Following the 20 presentation, we will take time to answer questions 21 from the audience and then open up the floor for 22 comments. Please keep your questions and comments 23 relevant to the topic.
24 Hopefully everybody got signed in and 25
6 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 received copies of the agenda and presentation slide 1
and a feedback form. If you haven't signed in, before 2
you leave, would you please do so at the registration 3
table.
4 When speaking please use the microphone.
5 If you have a question or a comment, you can step up 6
to the podium or raise your hand and I'll bring the 7
microphone to you.
8 And, finally, the NRC is always looking 9
to improve our meetings, and your feedback is important 10 to us. There are some postage-paid public meeting 11 feedback forms available on the table outside, and you 12 can fill it out today and give it to any NRC staff member 13 or drop it in the mail.
14 Any questions about the logistics of the 15 meeting this evening?
16 Okay. With that, I would like to turn the 17 meeting over to Michael for the first slide 18 presentation. Please hold your questions and comments 19 until we begin the Q and A session.
20 Thank you.
21 MR. BALAZIK: Thank you, Cheryl.
22 Good evening. My name is Mike Balazik.
23 I'm a project manager with the Division of Policy and 24 Rule Making at the NRC and coordinating the staff's 25
7 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 review of the Northwest Medical Isotopes construction 1
permit application.
2 Thank you for all taking -- taking time 3
out today to attend this meeting.
4 This evening we'll provide an overview of 5
the construction permit review process, which includes 6
both a safety review and an environmental review.
7 We'll also describe ways in which the public can 8
participate in the Northwest Medical Isotopes 9
construction permit review process.
10 I'd like to reiterate that the most 11 important part of tonight's meeting is receiving any 12 comments that you may have on the scope of the 13 environmental review. We'll also give you information 14 on how you can submit comments, if you prefer not to 15 speak at this meeting. I hope the information that we 16 provide you will help you better understand the 17 construction permit review process and the role that 18 you have in that process.
19 Before discussing the construction 20 permit review process, I'd like to first talk about the 21 regulatory oversight and the mission of the NRC. The 22 NRC is a federal agency that regulates the civilian use 23 of nuclear material. Statutory regulatory authority 24 has been granted to the NRC, primarily by the Atomic 25
8 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Energy Act of
- 1954, as amended; the Energy 1
Reorganization Act of 1974, as amended; and the Energy 2
Policy Act of 2005. From this authority the NRC has 3
promulgated the regulations contained in Title 10 of 4
the Code of Federal Regulations, also known as 10 CFR. 5 Another law, the National Environmental 6
Policy Act of 1969, or otherwise known as NEPA, 7
established the national policy for considering the 8
impact of federal decision making on the human 9
environment. Nancy will discuss these in greater 10 detail during her presentation.
11 The NRC mission is to ensure adequate 12 protection of public health and safety and to promote 13 the common defense and security. NRC regulations that 14 implement NEPA also protect the environment.
15 NRC accomplishes these goals through a 16 combination of regulatory programs and processes such 17 as establishing rules and regulations, reviewing 18 license applications, conducting inspections, and 19 issuing enforcement actions and assessing licensee 20 performance. We also evaluate operating -- operating 21 experience from existing nuclear facilities across the 22 country, as well as internationally.
23 Now I'd like to move into a discussion of 24 content and format of a
construction permit 25
9 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 application. The NRC received Northwest's application 1
for construction permit in two parts. The first part 2
was submitted on February 5th, 2015, and it consisted 3
of general information in an environmental report.
4 The second part was submitted on July 20th, 2015 that 5
con-- that considered Northwest's preliminary safety 6
analysis report for its proposed facility.
7 The entire application is available 8
online in the NRC's Agency Document Access Management 9
System, otherwise known as ADAMS. The accession 10 number from the application is noted on this slide.
11 The first accession number is associated with the 12 environmental report, and the second accession number 13 is associated with the preliminary safety analysis 14 report.
15 The NRC staff will conduct environmental 16 safety reviews concurrently and expect each 17 one -- review to take approximately 18 to 24 months, 18 depending on the quality of the application.
19 The next several slides I'll provide an 20 overview of the overall construction permit review 21 process, as well as go into additional detail on the 22 review of the preliminary safety analysis report.
23 This flow chart highlights the safety 24 environmental review for a construction permit 25
10 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 application. This is 10 CFR Part 50 review about 1
entering separate aspects of the construction permit 2
application.
3 The chart also indicates that there are 4
other items that precede the Commission's decision on 5
whether or not to grant the construction permit. One 6
of these items is an independent review performed by 7
the Advisory Committee on Reactor Safeguards, commonly 8
referred to as ACRS. Mandated by the Atomic Energy Act 9
the 1954, the ACRS is an independent group of scientists 10 and nuclear safety experts who advise the Commission 11 on safety issues. The ACRS reviews the construction 12 permit application and the NCR staff's safety 13 evaluation. The ACRS reports its findings and 14 recommendations directly to the Commission.
15 As part of the environmental review, the 16 staff consults with local, state, federal, and tribal 17 officials. The staff also holds public meetings like 18 this to receive comments on the draft Environmental 19 Impact Statement. Additionally, a mandatory hearing 20 will be conducted by the Commission. The Commission 21 considers information presented at the hearing in its 22 decision on whether or not to issue a construction 23 permit.
24 Next I'll describe the construction 25
11 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 permit review process in a little bit more detail, 1
starting with the safety review. The first step of the 2
construction permit application review process is to 3
perform an acceptance and sufficiency review of the 4
application. The purpose of this review is to 5
determine if the Applicant has provided all the 6
information required by regulations so that the 7
application can be docketed. Some of the information 8
required to be in a construction permit application 9
include a summary description of the facility, the 10 preliminary design of the facility, and a preliminary 11 analysis and evaluation of the proposed design and 12 performance of structured system and components of the 13 facility.
14 As I stated before, the application also 15 includes an environmental report, which is the 16 Applicant's assessment of the environmental impacts of 17 the proposed facility.
18 If the application has the required 19 information, then it is considered acceptable for 20 docketing, and the staff will begin its technical 21 review of the application. In the case of Northwest's 22 two-part application submittal, separate docketing 23 acceptance reviews are performed for each part of the 24 application.
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 NRC staff has completed its docketing 1
acceptance review of part one of Northwest Medical 2
Isotopes' application, which I
stated earlier 3
primarily consists of the environmental report. The 4
staff found this portion of the application acceptable 5
for docketing and has begun a detailed review of this 6
part of the application.
7 The staff is currently performing its 8
acceptance review of Northwest Medical Isotopes' 9
preliminary safety analysis report provided in part two 10 of the construction permit application.
11 Now I would like to quickly discuss the 12 technology that Northwest proposes to use here in 13 Columbia, Missouri. Northwest is proposing to 14 manufacture low-enriched uranium target at its 15 facility. In the case of Northwest, a target means 16 material subject to neutrons in a nuclear reactor to 17 elicit particulate reaction for the production of 18 molybdenum-99, which is the isotope of interest.
19 Once fabricated, these targets will be 20 transported to existing universities' nuclear reactors 21 for irradiation. Currently Northwest is proposing to 22 use the University of Missouri and Oregon State 23 University research reactors to irradiate its target.
24 After irradiation, the target will be transported back 25
13 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 to Northwest's facility for processing to separate the 1
molybdenum-99 from other isotopes.
2 Additionally, I'd like to add, for each 3
research reactor that would irradiate these targets 4
would need to get NRC approval via license amendment 5
request. Such amendment requests are not part of the 6
Northwest application permit and would be submitted 7
separately by those research reactors for NRC's 8
consideration.
9 Here's a flowchart of the Northwest 10 proposed activities for molybdenum-99. If a license 11 to construct, operate, and receive nuclear material is 12 granted to Northwest, the blue activity would occur at 13 the proposed Northwest facility and the green activity 14 would occur at the nuclear research reactor facility.
15 This flowchart show the three main activities at the 16 proposed facility; target fabrication, target 17 disassembly and dissolution, and molybdenum-99 18 separation.
19 Starting in the lower left corner, 20 low-enriched uranium target material will be 21 fabricated using both fresh uranium and recovered 22 uranium. The target material will be encased in a 23 metal cladding to manufacture a low-enriched uranium 24 target. These targets will be packaged and shipped to 25
14 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Oregon State University and the University of Missouri 1
research reactor and potentially a third research 2
reactor.
3 After irradiation, targets will be 4
shipped back to the Northwest Medical Isotopes facility 5
for processing. The irradiated low-enriched uranium 6
target would be mechanically disassembled and 7
dissolved in solution processing. The dissolved 8
low-enriched uranium solution would be processed to 9
recover and purify the molybdenum-99. The purified 10 molybdenum-99 would be packaged and shipped to a 11 radiopharmaceutical distributor. The low-enriched 12 uranium solution would be treated to recover uranium 13 and be cycled back to step one of this flowchart.
14 If the NRC staff determines that the 15 remainder of the Northwest Medical Isotopes 16 construction permit application meets all the material 17 parts for docketing, then staff will docket the 18 application and begin a detailed review. Following 19 the initial review of the application, the staff may 20 issue requests for additional information to Northwest 21 to ensure that staff has all necessary technical 22 information to develop a safety evaluation report. The 23 NRC did request additional information for the 24 Environmental Impact Statement.
25
15 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 The safety evaluation report documents 1
the staff's review of the construction permit 2
application and states the bases for the staff's 3
recommendation to either grant or deny the application.
4 The safety evaluation report summarizes the 5
application, the regulatory standards under which the 6
review is being conducted, and the technical evaluation 7
on how the application does or does not meet NRC 8
regulations.
9 As discussed on the previous slide, 10 following the completion of the safety evaluation 11 report, the ACRS reviews the construction permit 12 application and the staff safety evaluation, and then 13 the ACRS reports its findings and recommendations 14 directly to the Commission.
15 Prior to the decision to either grant or 16 deny the construction permit application, a mandatory 17 Commission hearing will be held on the application.
18 The date of the hearing and the explanation of the 19 hearing procedures, including opportunities for the 20 public participation, will be announced with at least 21 30 days notice in a future Federal Register Notice after 22 the full construction permit application has been 23 accepted for docketing.
24 Finally, the Commission will make a 25
16 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 decision to either grant or deny the construction 1
permit based on the NRC staff's safety evaluation 2
report, the recommendation from the ACRS, and the 3
Environmental Impact Statement.
4 More details on the environmental review 5
will be discussed by the environmental project manager, 6
Nancy Martinez.
7 Thank you for your time.
8 MS. MARTINEZ: Thank you, Michael.
9 Good evening. My name is Nancy Martinez.
10 I am the environmental project manager, and I will 11 discuss the environmental review process.
12 The environmental review for the 13 Northwest application will be performed in accordance 14 with the National Environmental Policy Act of 1959, 15 commonly known as NEPA. NEPA requires federal 16 agencies to follow a systematic approach in evaluating 17 potential environmental impacts of the proposed 18 actions and also to assess alternatives to those 19 actions.
The NEPA process involves public 20 participation and public disclosure.
21 NRC's environmental regulations 22 implemented in NEPA are contained in 10 CFR Part 51.
23 Our environmental review considers the impact of 24 construction, operation, and decommissioning of the 25
17 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Northwest facility.
1 We will also consider the impact of 2
alternatives to the proposed action, including 3
alternative sites, alternative technology, and the 4
impact of not issuing a construction permit. We 5
document the review in an Environmental Impact 6
Statement, which is made publicly available.
7 Ultimately the purpose of the 8
environmental review is to take a detailed hard look 9
at the environmental impact of construction, 10 operation, and decommissioning of the Northwest 11 facility, and after balancing the benefits versus the 12 impacts of the proposed project, make a recommendation 13 to the Commission on whether or not to issue the 14 construction permit.
15 This slide presents a high-level overview 16 of NRC's environmental review process, which begins 17 with scoping. Scoping is a process by which the NRC 18 staff identifies the specific impacts and significant 19 issues to be considered in the preparation of the 20 Northwest Environmental Impact Statement.
21 An important part of the scoping process 22 is public involvement. Information that we gather 23 from you today and in the next few weeks will be 24 considered in the development of the Environmental 25
18 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Impact Statement. Following the scoping process, the 1
NRC staff will prepare a draft of the Environmental 2
Impact Statement for the proposed Northwest facility 3
and issue the draft for public comment. This is the 4
next opportunity for you and other members of the public 5
to participate in the environmental review process.
6 Comments received on the draft will be considered 7
before the NRC staff issues a final Environmental 8
Impact Statement.
9 The Environmental Impact Statement will 10 be available at NRC's website. As you came in, you were 11 asked to fill out a registration card at our reception 12 table. If you included your address on that card, we 13 will mail you a CD copy of the draft and final EIS to 14 you. Once issued, the Northwest Environmental Impact 15 Statement will help to inform the decision on whether 16 or not to issue the construction permit for the 17 Northwest facility.
18 The proposed facility site is located at 19 the Discovery Ridge Research Park in Columbia, 20 Missouri. The site, identified by the red rectangle 21 here, is approximately four-and-a-half miles south of 22 U.S. Interstate 70 and just north of U.S. Highway 63.
23 The site is 7.4 acres and contains no existing 24 structures.
25
19 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 This is a photo of the site taken by the 1
NRC staff during its environmental site visit. The 2
photo was taken looking in a northeast direction of the 3
site. The Discovery Ridge site is a research 4
development and office park. The site is a section of 5
Columbia South Farms, which is primarily agriculture.
6 For an Environmental Impact Statement, 7
the NRC environmental staff looks at a wide range of 8
potential impacts, including potential impacts to air 9
and water resources, land use, human health, fish and 10 wildlife, and environmental justice. As part of the 11 process, the NRC staff consults and coordinates with 12 various federal, state, and local officials, as well 13 as leaders of tribal nations, including the U.S. Fish 14
& Wildlife Service, Environmental Protection Agency, 15 Missouri Department of Natural Resources, Missouri 16 State Historic Preservation Office, and Tribal Nations 17 with historic ties to the site. Consultation helps to 18 make sure that current information that these groups 19 may have is identified and considered in our analysis.
20 The scoping period started on November 21 18th when the notice of intent to prepare an 22 Environmental Impact Statement and conduct scoping was 23 published in the Federal Register. The NRC will accept 24 comments on the scope of the environmental review until 25
20 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 January 4th, 2016. In general, the NRC staff is 1
looking for information about the environmental 2
impacts of construction, operation, and 3
decommissioning of the proposed Northwest facility.
4 You can assist this process by telling us, for example, 5
what aspects of your local community we should focus 6
on; what local environmental, social, and economic 7
issues the NRC should examine during our review; what 8
other major projects are in progress or planned in the 9
area; and what reasonable alternatives are most 10 appropriate for this region. These are just some 11 examples of the information NRC staff seeks. Because 12 you are more familiar with your community than we are, 13 your comments tonight will help us facilitate a 14 thorough NRC staff review.
15 Public comments are an important part of 16 the environmental review process. You may wonder how 17 we collect and use your comments. First I will discuss 18 how we review your comments, and then how you can 19 provide comments. We consider each comment as part of 20 the environmental review. The formal scoping summary 21 report will address comments collected during the 22 scoping period, and comments are used to determine the 23 scope of the Environmental Impact Statement. The 24 Environmental Impact Statement is one of the factors, 25
21 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 as well as several others shown here, that influence 1
the Commission's decision to issue the construction 2
permit.
3 Now I will discuss how to submit comments.
4 Today you can turn in written comments at the 5
registration table or you can provide verbal comments 6
later on in this meeting. A court reporter is here to 7
record all comments provided verbally. In addition to 8
providing verbal and written comments at this meeting, 9
there are other ways that you can submit comments. You 10 can submit comments online using the Federal Rulemaking 11 website, as identified on the slide and with the ID 12 provided. This is a screenshot of the regulations.gov 13 website. You just enter the ID, and this will give you 14 a list of Federal Register Notices. There's an icon 15 on the right-hand side to submit comments.
16 Please note that comments will not be 17 edited to remove any identifying or contact 18 information, such as a phone number or address. Do not 19 include any information in comments that you do not want 20 publicly disclosed.
21 You can also provide written comments by 22 mail at the address provided on this slide. All 23 comments must be submitted by January 4th, 2016.
24 If you are interested in reviewing the 25
22 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 environmental report that Northwest submitted as part 1
of its construction permit, a hard copy can be found 2
at the Daniel Boone Regional Library. Additionally, 3
electronic copies of the environmental report can be 4
viewed on NRC's website, as identified on this slide.
5 Michael and I are the primary points of 6
contact for the NRC for the Northwest application 7
review. Our contact information is provided on this 8
slide.
9 This concludes my presentation. If 10 anyone has questions pertaining to the safety 11 environmental review information provided during this 12 presentation, Michael and I are happy to address them.
13 Thank you.
14 MS. HAUSMAN: Thank you, Michael and 15 Nancy.
16 Does anybody have any questions about the 17 presentation that you've just seen?
18 Okay. Seeing none, no hands raised.
19 Okay. Next we'll move into the public 20 comment period of the meeting. This is the part of the 21 meeting where you have an opportunity to give your 22 comments on the scope and content of the EIS.
23 There are a number of things we can all 24 do to ensure this part of the meeting runs smoothly.
25
23 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 First, as I mentioned earlier, we are transcribing the 1
meeting. So please keep any sidebar conversations 2
down and avoid background noise. In addition, 3
comments can only be heard if you speak into a 4
microphone. Please do not make comments from the 5
audience, because we won't be able to transcribe them 6
accurately.
7 If you have written comments, you can 8
leave them with me or an NRC staff before you leave this 9
evening.
10 And, finally, for those making comments, 11 please step up to the podium and begin by identifying 12 yourself with your name. And, if you would like to 13 mention any organization or who you represent, please 14 do that as well. In addition, if you can be as succinct 15 as possible, we should be able to get to everyone's 16 comments and conclude the meeting in a time -- include 17 the meeting in a timely manner.
18 If you wish to make a comment outside the 19 scope of this meeting, NRC staff will be available 20 following the meeting to answer questions.
21 And if you filled out a yellow comment 22 card, I'll call you up by name. When those comments 23 are finished, I will open up the meeting for any 24 other -- anybody else who has a comment this evening.
25
24 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 First I would like to invite Karen Miller 1
to the podium.
2 MS. MILLER: Good evening. My name's 3
Karen Miller, and an I'm associate commissioner here 4
in Boone County. I am here to testify in support of 5
Northwest Medical Isotopes, LLC's proposed project.
6 Because of our wide array of community assets, we 7
believe that Boone County is an excellent location for 8
the proposed facility.
9 One of our community's premier assets is 10 the University of Missouri's nuclear reactor. The 11 physical proximity of the reactor, as well as its 12 history of excellence in performance, combine to make 13 this a perfect partnership between the University of 14 Missouri and Northwest Medical Isotopes.
15 Through this partnership we will 16 be -- which will produce 99-MO, cancer patients 17 throughout the United States will have more 18 opportunities for a better outcome. The proposed 19 location of the facility at University of Missouri's 20 Discovery Ridge Park will provide access to 21 Mid-Missouri Regional Airport. This too is an 22 enormous benefit to the project, since reducing the 23 time between production of the drug and delivery to 24 healthcare professionals will effectively increase the 25
25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 efficacy of the drug needed by the patients and doctors 1
throughout the United States.
2 Another asset that our community brings 3
to the table is Boone County's ability to utilize our 4
economic development tool, as Chap -- known as Chapter 5
100 Bond. With this tool, in cooperation with our 6
taxing entities, we can make this project successful.
7 This is a community-wide partnership, 8
which has the potential to grow ever stronger through 9
the collaboration created by effectively utilizing our 10 community assets, the University's research reactor, 11 Mid-Missouri Regional Airport, and our ability to 12 utilize the economic tool Chapter 100 Bond.
13 Our community directly benefits from this 14 partnership because this project will bring 15 good-paying jobs and capital investment, and it creates 16 the possibility of pharmaceutical companies joining 17 the research hub of Discovery Ridge, with that enhanced 18 tax base benefiting all citizens.
19 Please accept this testimony made on 20 behalf of the Boone County Commission in support of the 21 Northwest Medical Isotopes, LLC facility location.
22 Thank you.
23 MS. HAUSMAN: Thank you.
24 Next I would like to invite Bob McDan 25
26 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 (sic).
1 MR. MCDAVID: Thank you. My name is Bob 2
McDavid. I'm mayor of the City of Columbia. I 3
appreciate the opportunity to testify before the NRC 4
in support of the Northwest Medical Isotopes proposal.
5 This is an important initiative for 6
obviously several different reasons. One is that we 7
have a highly-skilled workforce in Boone County and can 8
easily support the 80-plus jobs that will be required 9
in the production of Technetium.
10 Secondly, obviously for Boone County, the 11 1,600 workers that will be required to construct the 12 building is very important to the economy here in 13 Mid-Missouri and in the whole state of Missouri.
14 Second -- next, you know, I have -- in my 15 former life I was a physician and have been on staff 16 of both the University of Missouri Hospital and Boone 17 Hospital; and I know how important, you know how 18 important the use of radioisotopes is to the healthcare 19 community, to the men and women who do diagnostic and 20 therapeutic intervention, and you know how important 21 this tool is to continue. And it's -- it's -- I know 22 there are a lot of healthcare providers that are 23 uncomfortable with the prospect that Technetium may be 24 in short supply in the pending near future.
25
27 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 And, last, and really most important in 1
my opinion is the fact that so many of us may be 2
requiring this tool. You know, whether there's -- of 3
the 18 million doses of Technetium a year, which, 4
obviously, do the math, is 50,000 a day, many of us will 5
need this diagnostic tool for heart disease, bone, 6
skin, and other emerging technologies. And it means 7
so much if we're able to bring the production of this 8
very essential radioisotope back into the United States 9
where we can produce it here and deliver it to the 10 300-plus citizens of the United States who continue to 11 need this and will need this in the future.
12 Thank you for your consideration.
13 MS. HAUSMAN: Thank you.
14 Next, Matt McCormick.
15 MR. DOWELL: Actually, Matt is on his 16 way. So I'm going to speak on behalf of our 17 organization, if that's all right.
18 MS. HAUSMAN: Sure. No problem.
19 MR. DOWELL: I'm Jerry Dowell. I'm the 20 director of government affairs for the Columbia Chamber 21 of Commerce, and I wanted to put on record the Columbia 22 Chamber of Commerce's support of the Northwest Medical 23 Isotopes application.
24 I wanted to highlight a couple of items 25
28 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 that we are supportive of. Missouri and Columbia is 1
the home to world-class medical research resources, and 2
Columbia is at the strategic central location of that 3
access point, and it accesses to other critical markets 4
across the country. So we're supportive of that 5
effort.
6 Also, the Discovery Ridge site utilizes 7
the proximity nourished Missouri and its proximity to 8
transport access at the intersections of two major 9
highways and our access to a regional airport. Also, 10 we have an ample workforce available for the 11 construction phase through the decommissioning phase 12 of this facility.
13 So, once again, the Columbia Chamber of 14 Commerce wants to be on record in support of the 15 Northwest Medical Isotopes application.
16 MS. HAUSMAN: Thank you.
17 David Griggs.
18 MR. GRIGGS: I must say that a third of 19 my speech has already been given, so I'm going to spare 20 you in giving it.
21 My name is David Griggs. I reside at 6420 22 North Highway VV in Columbia. Tonight I'm here to 23 represent Regional Economic Development, or REDI, 24 about this great project.
25
29 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Just a little bit of background on where 1
I'm coming from. I'm a former Boone County 2
Commissioner, a past president of the Columbia Chamber 3
of Commerce, two-time former chair of REDI, and I've 4
operated a business in Columbia for over 40 years. I 5
mention that simply to reinforce the point that this 6
project, Northwest Medical Isotopes, has from the start 7
been the perfect example of a private-public or a 8
public-private partnership. Much like REDI, which is 9
also a public-private partnership, this project is a 10 prime example of a company in the city of Columbia, 11 county of Boone, state of Missouri, and our great native 12 University working together to do whatever's necessary 13 to bring a great project to fruition.
14 You will hear some more and have heard 15 from several folks tonight about more specific 16 information relating to this project. My role is to 17 discuss the overall economic pro-- economic impact of 18 the project and how it will impact our community and 19 state.
20 REDI's worked with Northwest for over two 21 years by assisting Northwest and bringing together the 22 right organizational leadership to help move this 23 project to this point. I mentioned many of them just 24 a second ago, but must stress the critical role of the 25
30 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 University and the University team at the research 1
reactor. This is simply an amazing opportunity for 2
Columbia, the University, Missouri and, in fact, the 3
United States and our citizens.
4 There are approximately 50,000 doses of 5
this drug that will be produced at this proposed 6
facility administered every day in North America.
7 There's no other producer in the United States for this 8
credible diagnostic medical pharmaceutical. Our 9
research reactor, in collaboration between Northwest 10 and the University, are the critical components for 11 this project.
12 It's estimated that construction of this 13
$70 million radioisotope production facility in fully 14 operational state will require over 180 full-time 15 skilled construction personnel from Central Missouri 16 and take longer than a year. When the facility's in 17 operation, it's estimated to employ 98 full-time 18 employees. I will tell you those positions will range 19 from extremely highly-skilled technical jobs to those 20 tasked with maintenance of equipment in the facilities.
21 I make that point to note the variety of employment 22 opportunities this project brings to our community.
23 Not included in these construction and 24 operational employment and cost estimates are the 25
31 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 ancillary jobs this project will create. Obviously 1
these radiopharmaceuticals require very rapid delivery 2
to the medical facilities that administer them around 3
the country.
4 This project will be located at 5
University's Discovery Ridge Research Park on 7.4 6
acres. Discovery Ridge is another great example of 7
great public-private partnerships, as it houses ABC 8
Laboratories, which is an environmental testing 9
organization serving the pharmaceutical industry, and 10 other clients like IDEXX, a bioscience company serving 11 veterinary and the animal health research industry.
12 This site is critically located within a 13 few miles of Interstate Highway 70, sets immediately 14 adjacent to U.S. Highway 63. This location provides 15 critical north, south, east, west transportation 16 assets from the center of the United States and is only 17 about six miles from Columbia Regional Airport.
18 All necessary utilities and street 19 infrastructures, including an adjacent overpass 20 providing access to Highway 63, is already in place at 21 the lot line for a fast timeline for this project. That 22 fact simply demonstrates our community's long-term 23 commitment to support this very type of development at 24 Discovery Ridge.
25
32 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 In addition to the investment and 1
employment opportunities I've mentioned, it's also 2
anticipated over the life of this project this project 3
will produce over $76 million in tax revenues to support 4
our school, our city, our county, and our state.
5 In closing, on behalf of REDI and myself, 6
our community, our county, our state, and the thousands 7
of U.S. citizens whose lives will be positively 8
impacted by this project on a daily basis, I give our 9
support and approval. And thank you very much.
10 MS. HAUSMAN: Thank you, David.
11 Terry Maglich.
12 MR. MAGLICH: Good evening. I'm Terry 13 Maglich. I am a project manager with the Department 14 of Economic Development with the State of Missouri.
15 The role of myself and the Department is to provide 16 assistance to business and communities that create 17 opportunities. The opportunities that we look forward 18 to are those that allow for the growth of employment 19 as well as investment.
20 We're very, very pleased to have provided 21 an assistance proposal to Northwest Isotopes 22 approximately a year and a half ago that does just that; 23 creates a number of great jobs, a great deal of 24 investment in one of our targeted industries of life 25
33 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 sciences. It also does something that I consider very 1
important; it creates an opportunity to save lives.
2 Thank you for allowing me to testify.
3 MS. HAUSMAN: Thank you, Terry.
4 Next, Dan Brague.
5 MR. BRAGUE: Thank you. My name is Dan 6
Brague. I'm the vice president and general manager of 7
global medical imaging for Mallinckrodt 8
Pharmaceuticals. I'm responsible for the commercial 9
activities for Mallinckrodt's nuclear medicine 10 business globally, and I a have keen interest in the 11 supply of moly-99.
12 Mallinckrodt is the world's largest 13 producer of technetium generators for use of nuclear 14 medicine. These generators use moly-99 with a three-day 15 half-life to provide
- sterile, pyrogen-free 16 technetium-99 medicine with a six-hour half-life.
17 Mallinckrodt has generator manufacturing 18 operations in Missouri, as well as the Netherlands, 19 which rely on a steady supply of moly-99. Technetium 20 is used in roughly 80 percent of all nuclear medicine 21 procedures nearly 30 million times each year globally 22 to diagnose heart disease, diagnose and stage cancer, 23 and examine organ functions in kidneys, lungs and 24 brain. More than 100 diagnostic procedures are 25
34 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 available to patients using technetium-99 1
radiopharmaceuticals.
2 Large-scale production of moly-99 is 3
currently only completed at five facilities worldwide.
4 Moly-99 has not been produced domestically since 1991.
5 These five facilities rely on aging research reactors, 6
which are periodically subject to planned and unplanned 7
maintenance. Some of these unplanned maintenance 8
outages have led to shortages of moly-99, frequently 9
impacting patient access to technetium for these 10 important diagnostic procedures.
11 Mallinckrodt is also a major producer of 12 moly-99 at our facility in the Netherlands, so we are 13 very familiar with what is needed to produce commercial 14 quantities of this isotope. As the world's largest 15 consumer of moly-99, Mallinckrodt closely follows new 16 efforts to produce this critical isotope and supports 17 construction of new facilities for its production. We 18 are very familiar with Northwest Medical Isotopes' plan 19 to license and construct a facility in Columbia, 20 Missouri for the production of moly-99 and the 21 recycling of their target material. As we understand 22 it, they intend to utilize a network of two to three 23 university research reactors and build a new moly-99 24 production facility, all of which should provide 25
35 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 additional moly-99 capacity.
1 We believe their technology offers 2
distinct advantages because it is based on the 3
well-proven fission method of moly-99 production and 4
uses existing reactors.
Their operation
- will, 5
importantly, also be based upon low-enriched uranium, 6
which meets the objectives of the U.S. Government's 7
nonproliferation policy, as stated at the 2012 Nuclear 8
Security Summit in Seoul, South Korea and in 2014 in 9
the Netherlands.
10 Nuclear medicine procedures performed in 11 the U.S. consume half of the world's supplies of 12 moly-99. A domestic moly-99 production facility will 13 reduce radioactive decay losses in transit from the 14 current suppliers in Europe, South Africa, and 15 Australia. A U.S. supply, if robust enough to supply 16 the entire market, will also eliminate or reduce 17 transport problems we've had in the past relying on 18 shipments from Europe, incidents including volcanic 19 activity in Iceland and flood destructions due to 20 terrorist concerns. Discussions leading up to the 21 passage of the American Medical Isotope Production Act 22 of 2012 cited all of these issues as a reason to 23 encourage domestic production of moly-99.
24 Mallinckrodt applauds Northwest Medical 25
36 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Isotopes' efforts to build its facility in Columbia and 1
encourages the NRC to provide the necessary resources 2
for an expedient review of their construction permit 3
and operating license applications.
4 Thank you for the opportunity to provide 5
these comments today.
6 MS. HAUSMAN: Thank you, Dan.
7 Does anybody else have a comment that they 8
would like to make this evening?
9 Okay. Going once, twice.
10 We would like to thank everyone for coming 11 to and participating in the meeting this evening, for 12 openness and transparency.
13 The transcript of this meeting will be 14 available publicly on NRC's web page. And the NRC 15 staff will be available for a short time after. If you 16 have questions or comments for us, we will be here.
17 Thank you.
18 (Whereupon, at 6:45 p.m., the proceedings 19 went off the record.)
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