ML18024A086
| ML18024A086 | |
| Person / Time | |
|---|---|
| Issue date: | 01/23/2018 |
| From: | NRC/SECY |
| To: | |
| References | |
| M180123 | |
| Download: ML18024A086 (106) | |
Text
SCHEDULING NOTE
Title:
HEARING ON CONSTRUCTION PERMIT FOR NORTHWEST MEDICAL ISOTOPES PRODUCTION FACILITY: SECTION 189A OF THE ATOMIC ENERGY ACT PROCEEDING (Public Meeting)
Purpose:
To receive testimony and exhibits regarding the application of Northwest Medical Isotopes, LLC, for a medical radioisotope production facility construction permit. The testimony will focus on unique features of the facility or novel issues that arose as part of the review process and other significant technical or policy issues associated with aspects of the staff's review that are important for the Commission to make its final decision. The Commission will determine whether the staff's review has been adequate to support the findings in 1O C.F.R. §§ 50.35(a), 50.40, 50.50, and 51.105(a).
Scheduled: January 23, 2018 9:00 am Duration: 1 day Location: Commissioners' Conference Room , 1st Floor OWFN NOTE: Chairman to provide opening remarks, admit exhibits, and swear 20 mins.
in witnesses.
Participants:
Presentation (Note: Witnesses seated at the table are listed, other staff available to answer questions will be seated in the well and reserved rows.)
Overview (Northwest Medical Isotopes, LLC) (9:20 am) 30 mins.*
At the table:
Nicholas Fowler, Chief Executive Officer, NWMI Carolyn Haass , Chief Operating Officer, NWMI Steven Reese, Irradiation Services Manager, NWMI Roy Brown, Vice President, Curium Pharma Topic: Overview Commission Q & A (round of questions; 6 minutes each) 18 mins.**
1
Overview (NRC Staff) 30 mins.*
At the table:
Michele Evans, Deputy Director for Reactor Safety Programs and Mission Support, Office of Nuclear Reactor Regulation (NRR)
Mary Jane Ross-Lee, Deputy Director, Division of Licensing Projects, NRR Joseph Donoghue, Deputy Director, Division of Materials and License Renewal (DMLR), NRR Brian Smith, Deputy Director, Division of Fuel Cycle Safety, Safeguards and Environmental Review, Office of Nuclear Material Safety and Safeguards (NMSS)
Topic: Overview of the staff's methodology for its review of the NWMI construction permit application and summary of key regulatory findings.
Commission Q & A (round of questions; 6 minutes each) 18 mins.**
BREAK 5 mins.
NOTE: For the remaining panels, the applicant is expected to discuss the contents of the construction permit application while the staff is expected to discuss its review process and regulatory conclusions. Each panel should include a discussion of any permit conditions associated with the subject matter of the panel.
Safety Panel 1 (11 :05 am)
Applicant 5 mins.*
At the table:
Carolyn Haass, Chief Operating Officer, NWMI Steven Reese, Irradiation Services Manager, NWMI Gary Dunford , Process Engineering Manager, NWMI (AEM Consulting , Inc.)
Michael Corum , Senior Technical Advisor, NWMI Staff 12 mins.*
At the table:
Alexander Adams, Jr., Chief, Research and Test Reactors Licensing Branch, NRR Michael Balazik, Project Manager, Research and Test Reactors Licensing Branch , NRR David Tiktinsky, Senior Project Manager, Fuel Manufacturing Branch (FMB), NMSS Steven Lynch , Project Manager, Research and Test Reactors Licensing Branch , NRR Topic: Sections of the application and the following chapters from 2
the Safety Evaluation Report:
Chapter 1, "The Facility, " and Chapter 4 "Radioisotope Production Facility Description ," including discussion of the unique licensing considerations; Colocation of Production Facility and Target Fabrication Area ,
and Quality Assurance Implementation.
Note that the panel will not have specific topics to discuss for the following chapters. If the Commission wishes to ask questions on these chapters , this panel would be the appropriate time.
o Chapter 2, "Site Characteristics" o Chapter 3, "Design of Structures, Systems, and Components" o Chapter 5, "Coolant Systems" o Chapter 6, "Engineered Safety Features" o Chapter 12, "Conduct of Operations"***
Commission Q & A (round of questions; 6 minutes each) 18 mins.**
BREAK (Lunch Break-Approx. 11:45-1:15 pm)
Safety Panel 2 (1:15 pm)
Applicant 5 mins.*
At the table:
Carolyn Haass , Chief Operating Officer, NWMI Steven Reese, Irradiation Services Manager, NWMI Gary Dunford , Process Engineering Manager, NWMI (AEM Consulting ,
Inc.)
Michael Corum , Senior Technical Advisor, NWMI Staff 12 mins.*
At the table:
Michael Balazik, Project Manager, Research and Test Reactors Licensing Branch, NRR April Smith, Reliability and Risk Analyst, Programmatic Oversight and Regional Support Branch , NMSS David Tiktinsky, Senior Project Manager, FMB, NMSS James Hammelman, Senior Chemical Engineer, FMB, NMSS Topic: Sections of the application and the following chapters from the Safety Evaluation Report:
Chapter 13, "Accident Analysis," including discussion of novel application of 10 CFR Part 70 accident analysis methodologies 3
for radiological and chemical exposure accidents.
Note that the panel will not have specific topics to discuss for the following chapters. If the Commission wishes to ask questions on these chapters, this panel would be the appropriate time.
o Chapter 7, "Instrumentation and Control Systems" o Chapter 8, "Electrical Power Systems" o Chapter 9, "Auxiliary Systems" o Chapter 11 , "Radiation Protection Program and Waste Management" o Chapter 14, "Technical Specifications" o Chapter 15, "Financial Qualifications" Commission Q & A (round of questions; 6 minutes each) 18 mins.**
Environmental Panel (1 :50 pm)
Applicant 10 mins.*
At the table:
Carolyn Haass , Chief Operating Officer, NWMI Steven Reese, Irradiation Services Manager, NWMI Staff 25 mins.*
At the table:
Benjamin Beasley, Chief, Environmental Review and NEPA Branch , NRR Nancy Martinez, Physical Scientist, NRR Michelle Moser, Biologist, NRR David Drucker, Senior Project Manager, NRR Topic: Final Environmental Impact Statement
- Provide a summary of the process for developing the Final Environmental Impact Statement (EIS) including:
o The decision to prepare an EIS o Scope and connected actions o The scoping process o The staff's independent review and analysis o Issuance of the Draft EIS , public meeting on the Draft EIS, and solicitation of stakeholder comments on the Draft EIS o The environmental impacts of the proposed action on the following resource areas: land use, visual resources, air quality and noise, water resources , ecological resources ,
historic and cultural resources, socioeconomics, human health, transportation , waste management, and environmental justice o Consultations with other Federal , State, and local agencies and Tribes 4
- Discuss the analysis of alternatives including; Range of reasonable alternatives, Alternative site, Alternative technologies, and the No-action alternative
- Summarize conclusions and recommendation including a summary of the. benefits and costs of the proposed action Commission Q & A (round of questions; 6 minutes each) 18 mins.**
BREAK 5 mins.
Closing (2:50 pm)
Closing Statement by Applicant 10 mins.*
Nicholas Fowler, Chief Executive Officer, NWMI Carolyn Haass, Chief Operating Officer, NWMI Roy Brown, Vice President, Curium Pharma Closing Statement by Staff 10 mins.*
Michele Evans , Deputy Director for Reactor Safety Programs and Mission Support, NRR Commission Q & A and Closing Statements 18 mins.**
- For presentation only and does not include time for Commission Q & A's.
- All Commissioners will have an opportun ity to ask questions after each panel. Commissioners will start the Q&A with their total time allotted to allocate as they see fit among the panels.
- Chapter 12, "Conduct of Operations, " of the staff's SER includes evaluations of NWMl's quality assurance program description and preliminary emergency plan .
5
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U.S. Nuclear Regulatorv Commission Commission Mandatorv Meeting Northwest Medical Isotopes, LLC Radioisotope Production Facilitv Overview Januarv 23, 2018
NWMI MISSIOD Assure a Domestic, Secure, and Reliable Supply of Molybdenum-99 (99Mo)
Irradiated targets Technetium 99mTc generators radiopharmaceuticals TARGET GENERATOR PROCESSING ANUFACTURING Irradiation FACILITY FACILITY 99mTc services Technetium End User supplier supplier generator supplier
...j** F,abricated Targets
~ Captive Network of University ~ Radioisotope Production Facility ~ Domestic 99 Mo Generator Research Reactors (RPF) Distributors
- Reliability/assurance of supply - Fabrication of LEU targets - Hold FDA Drug Master File
- Multiple shipments/week 99 Mo production
- - No changes to generators
- Uranium recycle and recovery - No changes to supply chain cur1uM*
LIFE FORWARD Oregon: State
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Pr1marv ASSUfflPIIODS j,., Single radioisotope production facility 7 RPF
- RPF includes target fabrication, 99 Mo production, and uranium recycle and recovery
- 99 Mo produced by a fission-based method using LEU
- Nominal capacity 3,500 6-day curies (Ci); surge capacity of 1,500 6-day Ci j,., Use network of university reactors
- Same target design used for all reactors
- Intellectual property obtained
- U.S., Australia, Russia, South Africa, Korea, Europe 7 Allowed Oreg ,nState
- I WUI IT T
- India, China 7 Pending j,., Fission product releases will comply with environmental release criteria j,., Generate Class A, B, and C wastes; no greater than Class C (GTCC) waste "I .........
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};,, Site located within Discovery Ridge Research Park 7 550 acre
- University of Missouri (MU)-owned research park in Columbia - Boone County, Missouri
};,, Discovery Ridge located in central Missouri
-125 miles east of Kansas City and
-125 miles west of St. Louis
- 4.5 miles south of lnterstate-70 and just to north of US Highway 63
- 3.5 miles to southeast of main MU campus 9.5 miles west of Missouri River
};,, RPF will be located on Lot 15 7 7.4-acre
- No existing structures
- Used for agriculture for past century
};,, NWMI "anchor" for radioisotope Rough estimate of Operations Boundary and Emergency Planning Zone c:::J Site boundary, area directly under the NRC Faahty Operating License ecosystem; two existing companies Controlled Area
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0 0.03 0.06
-==-==- -c:::==- -Miles 0.12 0.18 0.24
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~ License Request: NWMI has submitted a Construction Permit Application to obtain a license for a production facility under Title 10, Code of Federal Regulations, Part 50 (10 CFR 50), "Domestic Licensing of Production and Utilization Facilities"
- Using guidance in NUREG-1537, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors - Format and Content
~ Proposed Action: Issuance of an NRC license under 10 CFR 50 that would authorize NWMI to construct and operate a 99 Mo RPF at a site located in Columbia, Missouri
~ RPF will:
- Receive irradiated low-enriched uranium (LEU) targets (from a network of university research or test reactors)
- Process irradiated LEU targets for dissolution, recovery, and purification of 99 Mo
- Recover and recycle LEU to minimize radioactive, mixed, and hazardous waste generation
- Treat/package wastes generated by RPF process steps to enable transport to a disposal site
- Provide areas for associated laboratory and other support activities
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~ Additional RPF operational activities are subject to other NRC regulations
- 10 CFR 70, "Domestic Licensing of Special Nuclear Material," to receive, possess, use, and transfer special nuclear material
- Producing LEU target materials and fabrication of targets
- 10 CFR 30, "Rules of General Applicability to Domestic Licensing of Byproduct Material," to process and transport 99 Mo for medical applications
- Handling of byproduct material
~ University reactor(s) and Administration.
cask licensee(s) will amend and support area their current operating licenses 10 CFR70 10 CFR 50
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Proposeo scneou1e 1ca1enoar 1ear1
~ Start date of site preparation/construction 7 02 2018
~ End date of construction 7 03 2019
~ Start date of facility startup and cold commissioning (pre-operational) 7 04 2019
~ Date of hot commissioning and commercial operations 7 01 2020
~ Date of decommissioning: 2050
HPf opera11ng cnarac1er1s11cs Irradiated Target Disassembly Irradiate Targets in Reactor Target Fabrication and Dissolution ' 0 LEU target material is fabricated
' @ I : 0 ' (both fresh LEU and recycled U)
Target @ LEU target material encapsulated Un irradiated Target
- - Target'
-Irradiated Cladding to Solid Waste using metal cladding ~ LEU target Shipping to Shipping and Handling University Reactors Receiving 0 LEU targets are packaged and shipped to university reactors for irradiation 0 After irradiation, targets are shipped 0 i---- -------------,
I I
I I
back to RPF I
Uranium I Fresh Blended Recovery and I
I 0 Irradiated LEU targets disassembled Uranium Purified U Recycle lmpu.e U
- Solution I
Sotulion 0 Irradiated LEU targets dissolved into
* Fission Product Solution to a solution for processing Liquid Waste Handling Offgas treatment and release to stack via Primary G Dissolved LEU solution is processed Ventilation to recover and purify 99 Mo
@ Purified 99Mo is packaged/shipped Legend Product Cask to a radiopharmaceutical distributor
- Reactor Operations Shipments to Customer
- RPF Operations L------- ---------- 0 LEU solution is treated to recover U 99MO Production and is recycled back to Step 1
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},,, Ventilation System
- Ventilation system will be divided into four zones (Zone I, Zone II, Zone Ill, and Zone IV) ~
with airflow directed from lowest to highest potential for contamination
- Zone I ventilation system will be initial confinement barrier (e.g., gloveboxes, tank hot cell, processing hot cells, and Zone I exhaust subsystem)
},,, Biological Shield
- Provides an integrated system of features that protects workers from high-dose radiation generated during facility operations
- Will withstand seismic and other concurrent loads, while maintaining containment and shielding during a design basis event
- Primary function is to reduce radiation dose rates and accumulated doses in occupied areas to not exceed limits of 10 CFR 20 and RPF ALARA guidelines program
},,, Engineered Safety Features (ESF)
- Active or passive features designed to mitigate consequences of accidents and to keep radiological exposures to workers, the public, and environment within acceptable values
- Confinement is considered a general ESF
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Reagent, rronuct, ano waste summarv flow 01agram Reagents Gas Supply Chemical Supply
- Oxygen Irradiated tar ets New targets I
I 99 Mo product I
I I I t _______________________ ----------------------'
Waste Handling Legend:
- Inputs Output
- Process - Waste management rl
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>" First level footprint -52,000 square feet (ft2) >" High bay roof- 65 ft
- Target fabrication area
>" Mechanical area, second floor - 46 ft
- Hot cell processing area (dissolution , 99 Mo, and 235 U recovery)
- Waste management, laboratory, and utility areas >" Top of exhaust stack - 75 ft
>" Basement -2,000 ft2 (tank hot cell, decay vault) >" Loading dock (back) roof - 20 ft
>" Second level -17 ,000 ft2 (utility, ventilation, offgas equipment) ~ Support and admin (front) roof - 12 ft
>" Waste Management Building - 1,200 ft 2 >" Depth below grade for hot cell/high-integrity
>" Administration Building (outside secured RPF area) - 10,000 ft 2 container (HIC) storage - 15 ft I
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RPf consequences ano nao1onuc11oe 1nven1orv summarv
~ Primary consequences resulting from operation of RPF operations are radiological
- LEU target material production/fabrication
- Irradiated LEU target material processing (e.g., extract 99 Mo and recycle and recover 235 U)
- Radioactive waste materials processing
~ RPF radionuclide inventory is based on a weekly throughput < 40 hrEOI of irradiated targets
- MU RR 7 8 targets Legend
>100K Ci
- OSTR 7 30 targets >50K Ci
>10K Ci
~ Maximum radionuclide inventory ~ = <10KCi is based on accumulation in various systems dependent on process material decay times
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1ranspor1a11on
>"' Fresh LEU
- ES-3100 package (Certificate of Compliance No. 9315)
>"' Unirradiated targets
- ES-3100 or similar package
>"' Irradiated targets
- BEA Research Reactor cask or similar (Certificate of Compliance No. 9341)
>"' 99 Mo product
- Medical Isotope Depleted Uranium Shielded (MIDUS) Type B(U) container (Certificate of Compliance USA/9320/B(U)-96)
>"' Radioactive waste
- High-dose radioactive waste~ High integrity casks (e.g., Model 10-1608 cask)
- Low-dose radioactive waste ~ 208 liter (L) (55-gallon [gal]) waste drums
>"' Contact-handled waste
- Standard industrial waste drums or other appropriate [<2 millisievert (mSv)/hr (200 millirem [mrem]/hr) on contact and 0.1 mSv/hr (10 mrem/hr) at 1 meter (m) (3.3 ft)]
...; NW I
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uua111v assurance Program Plan
~ NWMI Quality Assurance Program Board of Managers President and CEO Plan (QAPP) describes policies and Chief Financial Officer requirements necessary to meet - General Counsel
- Finance applicable Federal regulations Chief Operating
- Human Resources Officer ANSI/ANS 15.8, Quality Assurance - Communications
- Procurement Program Requirements for Research - Project Controls Reactors Regulatory Guide 2.5, Quality Construcbon Manager Startup Manager I
Assurance Program Requirements for ---- - ---
Research and Test Reactors Project Managers 10 CFR 70.64(a)(1 ), Quality Standards Safety. Health and and Records .. *!i.
L1cens1ng Manager
~ QAPP applies to all nuclear, quality- Waste Safety, Security, Operations Radiation Management and Emergency Manager Protection Manager Preparedness related projects and activities that - Shift Supervisors/
Operators Manager Manager require conformance to a nuclear Procedures and - - MC&A Manager Nudear Criticality __.__
Safety Manager Licensing and Compliance Training Manager Manager quality assurance (QA) program NW\G-1202_r<M Le~nd Maintenance Executive Management
- Level 2 Manager Manager
- Level 1 Manager (NRC POC)
- Level 2 Manager
- Level 2 Manager (Pre-Operations) Level 3 Manager NWMI RPF Organization
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, U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Northwest Medical Isotopes Construction Permit Application Review
- Mandatory Hearing (Overview Panel)
- January 23, 2018
Panelists
- Deputy Director for Reactor Safety Programs and Mission Support, NRR
- MaryJane Ross-Lee
-Deputy Director, NRR/DLP
-Deputy Director, NRR/DMLR
- Deputy Director, NMSS/FCSE
99 Mo Overview
- 99 Mo decays to 99 mTc Mo-99
- _ 6 HOUR
- Effective diagnosis HA F'- IFE
-Minimal exposure T,o-99m I OUR
- - HA F'-LIFE
- 50,000 procedures daily
- No domestically-produced To-99
- _ 2 .000 R supply ' HALF lift Ruth nium-99
Establishing a Domestic Supply of 99Mo
- NRC supports U.S. policy objectives to establish domestic 99 Mo production
- First construction permit for domestic 99 Mo production issued to SHINE Medical Technologies in 201 6
- Northwest Medical Isotopes would produce 99 Mo by processing irradiated low enriched uranium targets
Conducting the NWMI Review
- Review of NWMI application supported by procedural efficiencies and previous licensing experience
- Two-part application submission
- Document templates
- Permit condition supporting quality
- assurance implementation
- Staff and contractors spent ~ 12,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> reviewing NWMI application
Authorizing Construction
- NWMI seeks authorization to construct 10 CFR Part 50 production facility
- Staff review based on preliminary design and analysis of facility
-Design details may be left for operating license application
- Target fabrication activities to be considered under a 10 CFR Part 70 application
Conducting the Safety Review Safety Review
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ACRS Review ,,
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Application r ' ""' / . . ....
Submitted to NRC Comm1ss1on Mandatory
~ Decision
\.. ,J Hearing
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Review
Tailoring Review Methodology
- Review accommodated unique aspects of the NWMI application
- Staff adapted existing guidance for research reactors, production facilities, and fuel cycle facilities
- Review focused on whether there was reasonable assurance that the final design would conform to design bases
Additional Information
- In response to staff requests, NWMI provided additional information
- In some cases, permit conditions were necessary to support findings
- Regulatory commitments track items for resolution in Final Safety Analysis Report
Environmental Requirements
- National Environmental Policy Act
- Informs Federal decision making
- Public disclosure
- NRC environmental regulations in 10 CFR Part 51
- NRC regulations implementing the National Environmental Policy Act
Environmental Review Process Environmental Report Draft Final Environmental Comment Environmental Environmental Site Audit Period
- Impact Impact Statement Statement Scoping *
- Opportunity for Public Request for Involvement Additional Information
Proposed Discovery Ridge Site
- Agricultural land
- Previously disturbed
- No surface water features
- No threatened or endangered species
- No historical or cultural resources
Statutory and Regulatory Basis for Construction Permit Issuance
- Commission authorized to issue permits by Atomic Energy Act, Section 103
- Applicable requirements in 10 CFR Parts 20, 50, and 51
- Performance requirements in 10 CFR Part 70 also considered
Construction Permit Findings
- Preliminary facility design described
- Further technical or design information may be left for FSAR
- Ongoing research and development identified
- Facility can be constructed and operated without undue risk
Construction Permit Considerations
- Construction will not endanger public health and safety *
- NWMI is technically and financially qualified
- Environmental requirements have been satisfied
Introducing the Review Panels Panel Number Discussion Topics Evaluation Areas Safety Panel 1 Licensing Safety Evaluation Considerations Report Chapters l, 4, and 12 Safety Panel 2 Accident Analysis Safety Evaluation Methodology Report Chapter 13 Environmental Panel
- Final Environmental Final Environmental Impact Statement Impact Statement Process
- Scope and Connected Actions
- Analysis of Alternatives
- NRR - Office of Nuclear Reactor Regulation
- OLP - Division of Licensing Projects
- DMLR - Division of Materials and License Renewal
- NMSS - Office of Nuclear Material Safety and Safeguards
- FCSE - Division of Fuel Cycle Safety, Safeguards, and Environmental Review
- 99Mo - molybdenum-99
- 99mTc - technetium-99m
- NRC - U.S. Nuclear Regulatory Commission
- NWMI - Northwest Medical Isotopes
- CFR - Code of Federal Regulations
- FSAR - final safety analysis report
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U.S. Nuclear Reuulatorv Commission Commission Mandatorv Hearing Saletv Panel 1Presentation Januarv 23, 2018 f" .
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Radioisotope Production Facilitv lRPFJ Proiect Overview Administration
_J and supportarea Irradiated target 0
receipt area 10 CFR 70 10 CFR 50 NWMl-040132'01
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~ Design based on applicable standards, guides, codes, and criteria and provides reasonable assurance that structures, systems, and components (SSC):
- Are built and function as designed and required per NWMl-2013-021, Construction Permit Application for Radioisotope Production Facility, Chapter 13.0, "Accident Analysis"
- Provide acceptable protection of public health and safety and the environment
- Protect against potential hydrological (water) and seismic damage
~ Defense-in-depth design philosophy 7 Applied from outset of facility design through completion of facility design/construction drawings
~ Certain systems and components are considered important-to-safety 7 Perform safety functions during normal operations or are required to prevent or mitigate consequences of abnormal operational transients or accidents
~ Safety-related is applied to items relied on to remain functional during or following a design basis event to ensure that the items provide a safety-related function
~ Technical specifications will be developed in the Operating License Application f *
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ssc sa1e1v- ano Non-sa1e1v ne1a1eo ue11n111ons c;;;AltltJH n rr 1m*vviJ*t;l
};;> SSCs are classified as safety-related and non-safety-related:
- Safety-related is a classification applied to items relied on to remain functional during or following a postulated design basis event to ensure:
- Integrity of facility infrastructure
- Capability to shut down the RPF and maintain the facility in a safe shutdown condition
- Capability to prevent or mitigate consequences of postulated accidents identified through accident analyses that could result in potential off-site and worker exposures comparable to applicable guideline exposures set forth in 10 CFR 70.61(b), 10 CFR 70.61(c), and 10 CFR 70.61 (d)
"Performance Requirements"
- Operation of RPF without undue risk to the health and safety of workers, the public, and environment to meet 10 CFR 20, "Standards for Protection Against Radiation ," normal release or exposure limits for radiation doses and applicable limits for chemical exposures
- Safety-related items relied on for safety (IROFS) - SSCs identified through accident analyses as required to meet the performance requirements of 10 CFR 70.61 (b), (c), and (d)
- Safety-related Non-lROFS - SSCs that provide reasonable assurance that the RPF can be operated without undue risk to the health and safety of workers, the public, and environment, and includes SSCs to meet 10 CFR 20 normal release or exposure limits
- Non-safety-related - SSCs related to production and delivery of products or services that are not in the above safety classifications
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~ Quality Level (QL) 1 will implement the full measure of the NWMI Quality Assurance Program Plan (QAPP) and will be applied to safety-related SSC IROFS, including items in which failure or malfunction could directly or indirectly result in a condition that adversely affects workers, the public, and/or environment, as described in 10 CFR 70.61
- Items to prevent nuclear criticality accidents (e.g. , preventive controls and measures to ensure that under normal and credible abnormal conditions, all nuclear processes are subcritical)
- Items credited to withstand credible design-bases external events (e.g., seismic, wind)
- Items to prevent degradation of structural integrity (e.g., failure or malfunction of facility)
~ QL 2 will be applied to non-QL 1 safety SSCs
- QAPP is important to acceptability and suitability of item or service to perform as specified (e.g. ,
SSCs to meet 10 CFR 20 normal release or exposure limits, fire protection systems, safeguards and security systems, material control and accountability systems)
~ QL 3 will include non-safety-related quality activities that are deemed necessary to ensure manufacture and delivery of highly reliable products and services to meet or exceed customer expectations and requirements
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>- SSCs identified as IROFS will be designed to satisfy general seismic criteria to withstand effects of natural phenomena without loss of capability to perform their safety functions
>- Seismic classification methodology used complies with ASCE 7, Chapter 11 (Seismic Design Criteria) and Regulatory Guide 1.29 (Seismic Design Classification)
- Demonstrates capability to function during and after vibratory ground-motion associated with safe-shutdown earthquake conditions
>- Methodology classifies SSCs into three categories:
- 1. Seismic Category I (C-1):
- Applies to IROFS and those SSCs required to support shut down of the RPF and maintain the facility in a safe shutdown condition from both functionality and integrity perspective
- 2. Seismic Category II (C-11):
- Applies to SSCs designed to prevent collapse under the safe-shutdown earthquake from an integrity perspective
- SSCs are classified as C-11 to preclude structural failure during a safe-shutdown earthquake, or where interaction with C-1 items could degrade the functioning of a safety-related SSC to an unacceptable level or could result in an incapacitating injury to occupants of the main control room
- 3. Non-seismic (NS):
- NS SSCs are those that are not classified seismic C-1 or C-11
.: 6
Svstem Safetv/Seismic Classification/QualilV level Sumffiarv""-vw-ry System Safety and Seismic Classification and Associated Quality Level Grou p System name (code) Highest safety classification Seismic classification Quality level group Facility structure (RPF) IROFS C-1 QL-1 Target fabrication (TF) IROFS C-1 QL-1 Target receipt and disassembly (TD) IROFS C-1 QL-1 Target dissolution (DS) IROFS C-1 QL-1 Mo recovery and purification (MR) IROFS C-1 QL-1 Uranium recovery and recycle (UR) IROFS C-1 QL-1 Waste handling (WH) IROFS C-1 QL-1 Criticality accident alarm (CA) IROFS C-1 QL-1 Radiation monitoring (RM) IROFS C-1 QL-1 Standby electrical power (SEP) IROFS C-1 QL-1 Normal electrical power (NEP) SR C-1 QL-1 Process vessel ventilation (PVV) IROFS C-1 QL-1 Facility ventilation (FV)c IROFS C-1/11 QL-1/2 Fire protection (FP) SR C-11 QL-2 Plant and instrument air (PA) NSR C-11 QL-2 Emergency purge gas (PG) IROFS C-1 QL-1 Gas supply (GS) NSR C-11 QL-2 Process chilled water (PCW) IROFS C-1 QL-1 Facility chilled water (FCW) NSR C-11 QL-2 Facility heated water (HW) NSR C-11 QL-2 Process steam IROFS C-1 QL-1 Demineralized water (DW) NSR C-11 QL-2 Chemical supply (CS) IROFS C-1 QL-1 Biological shield (BS) IROFS C-1 QL-1 Facility process control (FPC) SR C-11 QL-2 IROFS = items relied on for safety. RPF Radioisotope Production Facility.
NSR = non-safety related . SR = safety-related (not IROFS).
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U-tY\1'1-IIAIAAIU 1/(U/JY::J r.SUOIIS8DII NRC-011 U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Northwest Medical Isotopes Construction Permit Application Review
- Mandatory Hearing (Safety Panel 1)
- January 23, 2018
Panelists
- Alexander Adams, Jr.
- Chief, Research and Test Reactors Licensing Branch, NRR
-Project Manager, NRR
-Senior Project Manager, NMSS 1
-Project Manager, NRR
Licensing Process
- NWMI seeks a permit to construct a 10 CFR Part 50 production facility
- Licensing process for NWMI production facility similar to that for other non-power Part 50 facilities
- Unique licensing considerations
Advisory Committee on Reactor Safeguards Review
- Staff presented at subcommittee and full committee meetings
- Staff performed additional independent analysis
- ACRS recommended issuance of construction permit
- Staff documented the NWMI commitments in Safety Evaluation Report
Production Facility Licensing
- Production facility will process irradiated special nuclear material and separate byproduct material
- Special nuclear material batches contain greater than 100 grams of uranium-235
- Processes similar to those at existing fuel cycle facilities
- NUREG-1537, Interim Staff Guidance Augmenting NUREG-1537, NUREG-1520
Unique Licensing Considerations
- Two processes described within a
- single facility
-Production facility licensed under 10 CFR Part 50
- Target fabrication licensed under 10 CFR Part 70
- Understanding the interface between the two processes
Relationship Between Production Facility and Target Fabrication
- Both processes described in construction permit application
- Review focused on interface, shared systems, and impact
- Permit would authorize construction of 10 CFR Part 50 production facility
Proposed Permit Conditions
- Construction permit does not constitute approval of the safety of any design feature or specification
- Permit conditions
-Criticality Safety
-Quality Assurance
-Site Characteristics
Criticality Safety Conditions
- Criticality accident alarm system
- Su bcritical limit
- Conditions are confirmatory
- Termination of conditions
Quality Assurance Condition Similar to requirements of 10 CFR 50.55(f),
condition would support
-Adequate implementation of commitments in design, procurement, and construction
- Maintenance of documentation
-Approval of certain QAPP changes
- Correction of deficiencies
Geotechnical Condition
- NWMI committed to performing site-specific geotechnical investigation
- Since results could impact design bases, Staff recommends NWMI
- Identify sinkhole potential, soil characteristics, and liquefaction potential
-Submit design changes based on findings
- Results inform construction inspection
- CFR - Code of Federal Regulations
- NRR - Office of Nuclear Reactor Regulation
- NMSS - Office of Material Safety and Safeguards
- NWMI - Northwest Medical Isotopes
- QAPP - Quality Assurance Program Plan
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U.S. Nuclear Reuulatorv Commission Commission Mandatorv Meeting Saletv Panel 2 Presentation Januarv 23, 2018
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>- NUREG-1537, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, requirements
- Used integrated safety analysis (ISA) methodologies (per 10 CFR 70 Subpart H, "Additional Requirements for Certain Licensees Authorized to Possess a Critical Mass of Special Nuclear Material," and NUREG-1520, Standard Review Plan for Fuel Cycle Facilities License Applications)
- Applied radiological and chemical consequence and likelihood criteria ~dentified in the performance requirements of 10 CFR 70.61
- Designated items relied on for safety (IROFS) and established management measures to demonstrate adequate safety for the Radioisotope Production Facility (RPF)
>- Evaluated RPF in systematic integrated examination, including processes, equipment, structures, and personnel activities, which ensured that all relevant hazards that could result in unacceptable consequences were adequately evaluated and appropriate protective measures were identified
>- Evaluated special nuclear material areas through development of criticality safety evaluations (CSE) to identify double contingencies controls to maintain subcriticality
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~ RPF was evaluated using an ISA process
- Completed process hazards analysis (PHA)
- Developed quantitative risk assessments (QRA) to address events and hazards identified in PHA as requiring additional evaluation
~ Evaluated accident sequences (qualitatively) to identify likelihood and severity using event frequencies and consequence categories consistent with regulatory guidelines
~ Assessed each event with an adverse consequence (involving licensed material or its byproducts) for risk using a risk matrix that enables user(s) to identify unacceptable intermediate- and high-consequence risks
- Developed IROFS to prevent or mitigate consequences of events
- Reduced risks acceptable frequencies through preventive or mitigative IROFS
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Integrated Safetv Analvsis Methodology (continued] '-AIIIUU nmr,,-vvv~n
~ Used event trees analysis (certain circumstances)
- Provided quantitative failure analysis data (failure frequencies)
- Quantitatively analyzed an event from its basic initiators to demonstrate that quantitative failure frequencies are highly unlikely under normal standard industrial conditions (i.e., no IROFS required)-
~ Identified management measures to ensure that the IROFS failure frequency used in the analysis was preserved and IROFS are able to perform intended function(s) when needed
~ Translation of IROFS (10 CFR 70) to technical specifications (10 CFR 50) will be developed in the Operating License Application
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1n1egra1eo satetv AD8IVS1S H8SUIIS
~ Evaluated accident sequences using both qualitative and quantitative techniques
- Most of quantitative consequence estimates are for releases to an uncontrolled area (public)
- Worker safety consequence estimates are primarily qualitative
- As facility final design matures, quantitative worker safety consequence analyses will be performed
~ Accidents for operations with special nuclear material (including irradiated target processing, target material recycle, waste handling, and target fabrication), radioactive materials, and hazardous chemicals were analyzed
~ Initiating events for analyzed sequences include*operator error, loss of power, external events, and critical equipment malfunctions or failures
~ Shielded and unshielded criticality accidents assumed to have high consequences to worker if not prevented
~ Updated frequency (likelihood) and worker and public quantitative safety consequences will be provided in Operating License Application r,
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~ Completed PHA on eight "systems;" Qualitative Risk Assessment Documents 107 nodes were evaluated Radioisotope Production Facility Preliminary Hazards Analysis (PHA tables -300 pages) Radioisotope Production Facility Integrated Safety Analysis Summary Chemical Safety Process Upsets
~ -140 accident sequences were Process Upsets Associated with Passive Engineering Controls Leading to Accidental Criticality Accident Sequences identified for additional evaluation; Criticality Accident Sequences that Involve Uranium Entering a System 75 accident sequences were Not Intended for Uranium Service evaluated in QRAs Criticality Accident Sequences that Involve High Uranium Content in Side Waste Stream
~ 8 QRAs were completed, covering Facility Fires and Explosions Leading to Uncontrolled Release of Fissile Material, High- and Low-Dose Radionuclides 75 accidents; one ORA addressed Radiological Accident Sequences in Confinement Boundaries chemical accidents (including Ventilation Systems)
Administratively Controlled Enrichment, Mass, Container Volume, and Interaction Limit Process Upsets Leading to Accidental Criticality Accident Sequences Receipt and Shipping Events Evaluation of Natural Phenomenon and Man-Made Events on Safety Features and Items Relied on for Safety I
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~ Monte Carlo N-Particle Transport Code: MCNP 6.1, Continuous Energy ENDF/8- Vll.1 Cross-Section
~ Define operation/process to identify range of parameters to be validated
~ 92 criticality safety experiments were selected that adequately match uranium enrichment, geometry, moderator, reflector, and neutron energy
~ Define area of applicability (AoA) of the validation
~ Analyzed data
- Determined bias and bias uncertainty
- Identified trends in data 7 No trends were identified
- Test for normal or other distribution and select statistical method for data treatment
- Identify and support subcritical margin - Margin of subcriticality (MoS) of 0.05 Ilk
- Calculate USL - 0.9240
L.J1.111uu n "" ,r11*vvv:n cr111ca111v AD8IVS1S
>"' Used "first principles" as bases for equipment Criticality Safety Evaluation Documents design and process area layouts Irradiated Target Handling and Disassembly Irradiated Low-Enriched Uranium Target Dissolution Geometry constraints (e.g., pencil tank diameters)
Molybdenum-99 Recovery Tank array spacing (conservative)
Low-Enriched Uranium Target Material Production Transition from "safe-geometry" process equipment Target Fabrication Uranium Solution Processes to less-restricted waste staging and processing Target Finishing equipment was considered Target and Can Storage and Carts
>"' Evaluations and analysis Hot Cell Uranium Purification Liquid Waste Processing MCNP code validation and upper subcritical limits for Solid Waste Collection , Encapsulation , and Staging all areas of applicability
- Defined operation/process to identify range of parameters Offgas and Ventilation
- 92 criticality safety experiments Target Transport Cask and Drum Handling
- Defined area of applicability Analytical Laboratory Project-specific single-parameter criticality limits for Calculations U enrichment, forms, and basic geometries
- Single Parameter Subcritical Limits for 20 wt% 235U - Uranium Metal, Uranium Oxide, and Homogenous Water Mixtures
>"' Criticality safety evaluations (CSE)
- Irradiated Target Low-Enriched Uranium Material Dissolution
- 55-Gallon Drum Arrays Normal operating conditions described
- Single Parameter Subcritical Limits for 20 wt% 235U -
Low-Enriched Uranium Target Material Criticality hazard evaluation
- Target Fabrication Tanks, Wet Processes, and Storage Contingency analysis
- Tank Hot Cell Double contingency controls
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1cc1oen1 sequences 1va1ua1eo ano uruan1za11on 1..A111uu n rr ,r11*vvv:n Accident Sequences Evaluated Accident-Initiating Events
- Spill and Spray Accidents .... Radiological - Criticality accident and Criticality (Section 13.2.2)
- Loss of electrical power
- Dissolver Offgas Accidents --
- External events (meteorological, Radiological (Section 13.2.3) seismic, fire, flood)
- Leaks into Auxiliary Systems -
- Critical equipment malfunction Radiological and Criticality (Section 13.2.4) - Operator error
- Loss of Electrical Power Accidents - Facility fire (including explosion)
(Section 13.2.5) - Any other event potentially related to
- Natural Phenomena Accidents unique facility operations (Section 13.2.6)
- Other Accidents (Section 13.2. 7)
- Accidents with Hazardous Chemicals (Section 13.3)
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NRC-012 U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Northwest Medical Isotopes Construction Permit Application Review
- Mandatory Hearing (Safety Panel 2)
- January 23, 2018
- Panelists
- Project Manager, NRR
- Reliability and Risk Analyst, NMSS
- Senior Project Manager, NMSS
- Senior Chemical Engineer, NMSS
Accident Analysis Methodology
- NWMI used an ISA methodology for its accident analyses
- IROFS and management measures to be selected to demonstrate safety
- Consistent with the ISG Augmenting NUREG-1537, radiological and chemical hazards evaluated against consequence criteria in
ISA Methodology
- Northwest submitted an ISA Summary of the accident analysis of radiological and chemical hazards
- ISA Summary contains:
- Hazard analyses results
- Qualitative assessment of likelihood, consequences, and risk category
- Identification of accident sequences
ISA Methodology ( continued)
- ISA methodology found adequate to identify IROFS to prevent or mitigate accidents and prevent an inadvertent Cri ti Ca Ii ty
- Management measures to assure availability and reliability of IROFS will be reviewed in the OL application
- Staff found that ISA process adequate to support identification of hazards and mitigation or prevention of accidents
. . I Radiological and Criticality Safety
- PSAR/ISA Summary presented multiple accident sequences involving liquid spills, sprays and leaks with impacts to radiological and criticality safety
- Staff evaluated engineered safety f ea tu res including items relied on for safety
- Analysis provides reasonable assurance that credible accident sequences have been identified
Chemical Safety
- Staff reviewed the design, accident analysis, and proposed safety features
- Staff conducted independent analyses of chemical hazards
- NWMI identified additional chemical safety research and development related to ion exchange system
- Staff concludes that the chemical hazards can be adequately managed
Summary of Accident Analysis Findings
- Northwest adequately assessed risks to public health and safety for issuance of a construction permit
- IROFS - Items relied on for safety
- ISA - Integrated safety analyses
- PSAR - Preliminary Sat ety Analysis Report
- NMSS - Office of Nuclear Material Safety and Safeguards
- NRR - Office of Nuclear Reactor Regulation
- NWMI - Northwest Medical Isotopes
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U.S. Nuclear Reuulatorv Commission Commission Mandatorv Meeting Environmental Panel Januarv 23, 2018 ff~
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ueve1opmen1011nv1ronmen1a1 Report
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>- Granted an exemption to submit the Construction Permit Application in two parts
[Published in Federal Register (FR) on October 24, 2013 (78 FR 63501 )]
>- NRC conducted an independent evaluation of Part One of the Construction Permit Application and developed potential impacts of NWMl's proposed action
>- Environmental Impact Statement Development Milestones
- NWMI submitted Part One of Construction Permit Application: February 5, 2015
- NRC acknowledged receipt: April 21, 2015 (80 FR 22227)
- NRC published Notice of Docketing: June 8, 2015 (80 FR 32418) (ADAMS Accession No. ML15125A048)
- Environmental Site Audit/Scoping Meeting: December 8 & 9, 2015 (Columbia, MO)
- Draft EIS public comment period: November 1 - December 29, 2016 (Public meeting on December 6, 2016 in Columbia, Missouri)
Final EIS published May 31, 2017 7 NUREG-2209, Final Environmental Impact Statement for the Construction Permit for the Northwest Medical Isotopes Radioisotope Production Facility (ADAMS Accession No. ML17130A862)
Proposeo ACIIOD
~ Decide whether to issue a construction permit under 10 CFR 50 that would allow construction of the NWMI medical radioisotope production facility (RPF)
~ If a construction permit is granted by NRC, NWMI could build the proposed facility at the 3 hectare (7.4-acre) Discovery Ridge Research Park (Discovery Ridge) site, in Boone County, Columbia, Missouri
~ NWMI RPF activities include:
- Fabricating low-enriched uranium (LEU) targets (including uranium recycle and recovery)
- Shipping targets to university research reactors
- Irradiating LEU targets at university research reactors
- Returning targets to RPF
- LEU target dissolution
- Molybdenum-99 (99 Mo) recovery and purification
consu11a11ons .."'""" ****nu VVI - , \
>"' Advisory Council on Historic Preservation
>"' Boone County Government Center COLUMBIA, MO WHAT YOU UN[XP£.CT
>"' City of Columbia, Missouri
>"' Mid-Missouri Regional Planning Commission
>"' Missouri Department of Conservation
>"' Missouri Department of Health and Senior Services
>"' Missouri Department of Natural Resources
>"' Missouri Department of Public Safety
>"' Missouri Department of Transportation
>"' U.S. Fish and Wildlife Service
>"' U.S. Department of Energy
>"' Tribal Nations 7 31 MISSOURI II N'ATURAL RESOURCES
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111ernat1ve site Locations 1va1ua1eo nv NWMI - . A l IIWI I I WW9' IHI VY I - , '
~ University -of Missouri Research Reactor (MURR) - Columbia, MO
~ Discovery Ridge Research Park - Columbia, MO
~ Oregon State University (OSU) - Corvallis, OR
~ McClellan Business Park (McClellan)- Davis, CA
- University of California at Davis (UC Davis) Research Reactor located at McClellan
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Phasing Plan Phue I 139 0 Ac Phae II 54 9 Ac Phele Ill 143.5 Ac Future 212.6 Ac
~ RPF will be located on Lot 15 7 7.4-acre
- No existing structures
- Used for agriculture for past century
~ NWMI "anchor" for radioisotope ecosystem; two existing companies
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MUHH Hrf l8VOUI Preliminary RPF Layout Current MURR Layout
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Alternative Technologies/Alternatives Evaluated hv NRC Alternative Technologies Alternatives Evaluated
)"' Neutron capture technology )"' No-action alternative
)"' Aqueous homogenous reactor )"' NWMI RPF at University of Missouri technology Research Reactor site (alternative site)
)"' Selective gas extraction technology )"' Linear accelerator-based facility at Discovery Ridge site (Alternative
)"' Uranium fission technology Technology No. 1)
)"' Linear accelerator-based )"' Subcritical fission-based facility at technology Discovery Ridge site (Alternative Technology No. 2)
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I LEGEND University of t'issouri
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University Research Reactors Chosen University Research Reactors Being Evaluated NWMI Radioi~otope Production Facility Prospective Trans port Routes
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~ Few facility modifications will be required
~ No exterior construction anticipated for any reactor
~ No changes in land use
~ Minimal changes in staffing
~ Authorization for possession and use of targets will be promulgated under the license amendment process for each facility
- MURR 7 early 2018
- OSU 7 early 2019
~ Third facility has been selected but not socialized
tnv1ronmen1a1 impact summarv ._I\.IIIUII IW"JIIWII VVI - , \
Environmental Impact Summary Linear Accelerator-Based Subcritical Fission-Based NWMI RPF NWMI RPF Technology Technology at Discovery Ridge at MURR at Discovery Ridge at Discovery Ridge No Action Construction
- SMALL impacts to all
- SMALL to MODERATE
- SMALL impacts to all
- SMALL impacts to all
- SMALL impacts to Impacts resource categories impacts to all resource resource categories resource categories all resource
- No historic properties categories
- No historic properties
- No historic properties categories affected
- Potential adverse affected affected
- No historic effect to historic properties affected properties Construction * -100 jobs (on average) * -100 jobs (on average) * -100 jobs(on average) * -100 jobs (on average) None Benefits
- Annual tax payment of
- Annual tax payment of
- Annual tax payment of
- Annual tax payment of
$2.5M $2.5M $2.5M $2.5M Operation
- SMALL impacts to all
- SMALL impacts to all
- SMALL impacts to all
- SMALL impacts to all
- SMALL impacts to Impacts resource categories resource categories resource categories resource categories all resource categories Operation * -125jobs * -125 jobs * -125 jobs * -125jobs None Benefits
- Reliable source of
- Reliable source of 99Mo
- Reliable source of 99Mo
- Reliable source of 99Mo 99Mo for medical uses for medical uses for medical uses for medical uses
- Annual tax payment of
- Annual tax payment of
- Annual tax payment of
- Annual tax payment of
$2.5M $2.5M $2.5M $2.5M w,
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\ r"_ J 1\1\-IIAI * * & I 11NII IV-, r.SUOIIS8DII NRC-013 U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Northwest Medical Isotopes Construction Permit Application Review
- Mandatory Hearing (Environmental Panel)
- January 23, 2018
Panelists
- Chief, Environmental Review and NEPA Branch, NRR
- Nancy Martinez
- Physical Scientist, NRR
- Biologist, NRR
- Senior Project Manager, NRR
Environmental Review
- National Environmental Policy Act
- Environmental review process
- 10 CF R Pa rt 51
- Interim Staff Guidance Augmenting NUREG-1537 for Licensing Radioisotope Production Facilities and Aqueous Homogenous Reactors
Scope of the Review: Proposed Action and Connected Actions Actions are connected if they:
- Automatically trigger other actions that may require environmental impact statements; or
- Cannot or will not proceed unless other actions are taken previously or simultaneously; or
- Are interdependent parts of a larger action and depend on the larger action for their justification
Proposed Action and Connected Actions
- Construction, operations, and decommissioning of the 10 CFR Part 50 production facility
- Construction, operations, and decommissioning related to target fabrication
- Transportation of targets to/from research reactors and irradiation of targets at research reactors
Environmental Impact Statement (EIS)
- 10 CFR 51 .20
- Project-specific decision
- Operation of the proposed Northwest facility would include target fabrication and scrap recovery
- Environmental assessment might not support a finding of no significant impact
Scoping Process
- Public meeting in Columbia, Missouri
- Six oral commenters
- Eight comment letters or emails
- Environmental Review Areas Air Quality Socioeconomics and Environmental Terrestrial Justice Resources Human Health Water Soils Resources Historic and Cultural Resources
Environmental Impacts Resource Area Impact Land Use and Visual Resources SMALL Air Quality and Noise SMALL Geologic Environment SMALL Ecological and Water Resources SMALL Historic and Cultural Resources SMALL Socioeconomics SMALL Human Health and Waste SMALL Transportation SMALL
Consultations Determination Endangered Species Act, No .Effect Section 7 National Historic No Adverse Preservation Act, Effect Section 106
Alternatives
- No-action alternative
- Alternative site
- Alternative technologies
Alternative Technologies
- Neutron capture
- Aqueous homogenous reactor
- Selective gas extraction
- Linear-accelerator-based
- Analyzed in depth
- Subcritical fission
- Analyzed in depth
Costs and Benefits
- Purpose
- Inform recommendation to the Commission
- Costs
- Environmental and financial
- Benefits
- Societal,
- medical, and economic
Draft Environmental Impact Statement
- Public meeting in Columbia, Missouri
- Seven oral commenters
- Five comment letters or emails
Staff.Conclusion and Recommendation
- Benefits (societal, medical, and economic) outweigh the costs (environmental, economic)
- Considered reasonable alternatives
- Recommend issuance of the construction permit
Future NEPA Analyses
- Application for an operating license
- Application for a license to possess and use special nuclear material for target fabrication and scrap recovery
- License amendment requests from research reactors
- EIS - Environmental Impact Statement
- NEPA - National Environmental Policy Act
- NRR - Office of Nuclear Reactor Regulation