ML18016A964
| ML18016A964 | |
| Person / Time | |
|---|---|
| Site: | Northwest Medical Isotopes |
| Issue date: | 01/23/2018 |
| From: | Northwest Medical Isotopes |
| To: | NRC/OGC |
| SECY RAS | |
| References | |
| 50-609-CP, Construction Permit Mndtry Hrg, RAS 54171 | |
| Download: ML18016A964 (15) | |
Text
Exhibit NWMI-004-R U.S. Nuclear Regulatory Commission Commission Mandatory Meeting Northwest Medical Isotopes, LLC Radioisotope Production Facility Overview January 23, 2018 11
Exhibit NWMI-004-R NWMI Mission Assure a Domestic, Secure, and Reliable Supply of Molybdenum-99 (99Mo)
Irradiated targets Technetium 99mTc generators radiopharmaceuticals 99Mo Irradiation 99mTc services 99Mo Technetium End User supplier supplier supplier generator supplier Fabricated Targets Captive Network of University Radioisotope Production Facility Domestic 99Mo Generator Research Reactors (RPF) Distributors
- Reliability/assurance of supply - Fabrication of LEU targets - Hold FDA Drug Master File
- Multiple shipments/week - 99Mo production - No changes to generators
- Uranium recycle and recovery - No changes to supply chain 2
Exhibit NWMI-004-R Primary Assumptions Single radioisotope production facility RPF
- RPF includes target fabrication, 99Mo production, and uranium recycle and recovery
- 99Mo produced by a fission-based method using LEU
- Nominal capacity 3,500 6-day curies (Ci); surge capacity of 1,500 6-day Ci Use network of university reactors
- Same target design used for all reactors
- Intellectual property obtained
- U.S., Australia, Russia, South Africa, Korea, Europe Allowed
- India, China Pending Fission product releases will comply with environmental release criteria Generate Class A, B, and C wastes; no greater than Class C (GTCC) waste 3
Exhibit NWMI-004-R Site Location and Description Site located within Discovery Ridge Research Park 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 Interstate-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 7.4-acre
- No existing structures
- Used for agriculture for past century NWMI anchor for radioisotope ecosystem; two existing companies 4
Exhibit NWMI-004-R Licensing Approach 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 99Mo 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 99Mo
- 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 5
Exhibit NWMI-004-R Additional RPF Licensing Activities 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 99Mo for medical applications
- Handling of byproduct material University reactor(s) and cask licensee(s) will amend their current operating licenses 6
Exhibit NWMI-004-R Proposed Schedule (Calendar Year)
Start date of site preparation/construction Q2 2018 End date of construction Q3 2019 Start date of facility startup and cold commissioning (pre-operational) Q4 2019 Date of hot commissioning and commercial operations Q1 2020 Date of decommissioning: 2050 7
Exhibit NWMI-004-R RPF Operating Characteristics Irradiated Target Disassembly Irradiate Targets in Reactor Target Fabrication and Dissolution LEU target material is fabricated (both fresh LEU and recycled U)
Target Irradiated Target Target Cladding to LEU target material encapsulated Packaging Unirradiated Target Irradiated Target Shipping and Disassembly Solid Waste using metal cladding LEU target Shipping to Handling Receiving University Reactors LEU targets are packaged and shipped to university reactors for Encapsulation irradiation After irradiation, targets are shipped back to RPF LEU Target Uranium Mo Recovery Fresh Blended Material Recovery and and Target Irradiated LEU targets disassembled Purified U Impure U Dissolved Dissolution Uranium Production Recycle Purification Solution Solution Targets 2013-021_010r4 Irradiated LEU targets dissolved into Purified 99Mo a solution for processing Fission Product Solution to Liquid Waste Handling Solution Mo Product Offgas treatment and release to stack via Primary Dissolved LEU solution is processed Packaging Ventilation to recover and purify 99Mo Purified 99Mo is packaged/shipped Legend Product Cask to a radiopharmaceutical distributor Reactor Operations Shipments to RPF Operations Customer LEU solution is treated to recover U 99Mo Production and is recycled back to Step 1 8
Exhibit NWMI-004-R RPF Operating Characteristics (continued)
Ventilation System
- Ventilation system will be divided into four zones (Zone I, Zone II, Zone III, 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 9
Exhibit NWMI-004-R Reagent, Product, and Waste Summary Flow Diagram 10
Exhibit NWMI-004-R RPF Description First level footprint ~52,000 square feet (ft2) High bay roof - 65 ft
- Target fabrication area
- Hot cell processing area (dissolution, 99Mo, and 235U recovery)
Mechanical area, second floor - 46 ft
- 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 ft2 Depth below grade for hot cell/high-integrity Administration Building (outside secured RPF area) ~10,000 ft2 container (HIC) storage - 15 ft 11
Exhibit NWMI-004-R RPF Consequences and Radionuclide Inventory Summary Primary consequences resulting from operation of RPF operations are radiological
- LEU target material production/fabrication
- Irradiated LEU target material processing (e.g., extract 99Mo and recycle and recover 235U)
- Radioactive waste materials processing RPF radionuclide inventory is based on a weekly throughput < 40 hr EOI of irradiated targets
- MURR 8 targets Legend
- OSTR 30 targets >100K Ci
>50K Ci Maximum radionuclide inventory >10K Ci
<10K Ci is based on accumulation in various systems dependent on process material decay times
> 40 hr EOI 12
Exhibit NWMI-004-R Transportation 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) 99Mo 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 10-160B 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)]
13
Exhibit NWMI-004-R Quality Assurance Program Plan NWMI Quality Assurance Program Plan (QAPP) describes policies and requirements necessary to meet applicable Federal regulations
- ANSI/ANS 15.8, Quality Assurance Program Requirements for Research Reactors
- Regulatory Guide 2.5, Quality Assurance Program Requirements for Research and Test Reactors
- 10 CFR 70.64(a)(1), Quality Standards and Records QAPP applies to all nuclear, quality-related projects and activities that require conformance to a nuclear quality assurance (QA) program NWMI RPF Organization 14
Questions?
Exhibit NWMI-004-R 15