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| | issue date = 09/01/2016 | | | issue date = 09/01/2016 |
| | title = Northwest Medical Isotopes, LLC, Response to Environmental Request for Additional Information - Additional Clarification on POSA3-1A, POSA3-2A, POSA3-3A, NOI3-IB, and PA3-1 | | | title = Northwest Medical Isotopes, LLC, Response to Environmental Request for Additional Information - Additional Clarification on POSA3-1A, POSA3-2A, POSA3-3A, NOI3-IB, and PA3-1 |
| | author name = Haass C C | | | author name = Haass C |
| | author affiliation = Northwest Medical Isotopes | | | author affiliation = Northwest Medical Isotopes |
| | addressee name = Drucker D M | | | addressee name = Drucker D |
| | addressee affiliation = NRC/Document Control Desk, NRC/NRR/DLR | | | addressee affiliation = NRC/Document Control Desk, NRC/NRR/DLR |
| | docket = 05000609 | | | docket = 05000609 |
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| {{#Wiki_filter:Northwest Medical Isotopes, LLC l 815 NW 9th Ave, Suite 256 l Corvallis, OR 97330 September 1, 2016 NWMI-LTR-2016-009 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk 11555 Rockville Pike Washington, DC 20555 Mr. David Drucker, Senior Project Manager Division of License Renewal Office of Nuclear Reactor Regulation RE: Docket No. 50-609, Northwest Medical Isotopes, LLC Responses to the U.S. Nuclear Regulatory Commission Environmental Request for Additional information (Letter dated June 16, 2016) Additional Clarification on POSA3-1A, POSA3-1B, POSA3-2A, POSA3-3A, NOI3-1B, and PA3-1 | | {{#Wiki_filter:September 1, 2016 NWMI-LTR-2016-009 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk 11555 Rockville Pike Washington, DC 20555 Mr. David Drucker, Senior Project Manager Division of License Renewal Office of Nuclear Reactor Regulation RE: Docket No. 50-609, Northwest Medical Isotopes, LLC Responses to the U.S. Nuclear Regulatory Commission Environmental Request for Additional information (Letter dated June 16, 2016) - Additional Clarification on POSA3-1A, POSA3-1B, POSA3-2A, POSA3-3A, NOI3-1B, and PA3-1 |
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| ==References:== | | ==References:== |
| : 1. Northwest Medical Isotopes, LLC Letter NWMI-LTR-2016-007 to U.S. Nuclear Regulatory Commission, dated July 18, 2016, Docket No. 50-609, Responses to Request for Additional Information dated June 16, 2016 (ADAMS Accession No. ML16210A305) 2. U.S. Nuclear Regulatory Commission letter to Northwest Medical Isotopes, LLC, dated June 16, 2016, Docket No. 50-609, Request for Additional Information for the Environmental Review of the Northwest Medical Isotopes, LLC Construction Permit Application (ADAMS Accession No. ML16176A114) (TAC Nos. MF6134 and MF 6135) 3. Northwest Medical Isotopes, LLC Letter NWMI-LTR-20 15-006 to U.S. Nuclear Regulatory Commission, dated July 20, 2015,NRC Project No. 0803 - Northwest Medical Isotopes, LLC, Submittal Part 2 Construction Permit Application for a Radioisotope Production Facility (ADAMS Accession No. ML16056A122) 4. Northwest Medical Isotopes, LLC Letter to U.S. Nuclear Regulatory Commission, dated February 5, 2015 (ADAMS Accession No. ML14349A501) Environmental Report and Associated Part One Submittal (ADAMS Accession Nos. ML14349A501, ML15210A123, ML15210A128, ML15210A129, and ML15210A131) | | : 1. Northwest Medical Isotopes, LLC Letter NWMI-LTR-2016-007 to U.S. Nuclear Regulatory Commission, dated July 18, 2016, Docket No. 50-609, Responses to Request for Additional Information dated June 16, 2016 (ADAMS Accession No. ML16210A305) |
| | : 2. U.S. Nuclear Regulatory Commission letter to Northwest Medical Isotopes, LLC, dated June 16, 2016, Docket No. 50-609, Request for Additional Information for the Environmental Review of the Northwest Medical Isotopes, LLC Construction Permit Application (ADAMS Accession No. ML16176A114) (TAC Nos. MF6134 and MF 6135) |
| | : 3. Northwest Medical Isotopes, LLC Letter NWMI-LTR-20 15-006 to U.S. Nuclear Regulatory Commission, dated July 20, 2015,NRC Project No. 0803 - Northwest Medical Isotopes, LLC, Submittal Part 2 Construction Permit Application for a Radioisotope Production Facility (ADAMS Accession No. ML16056A122) |
| | : 4. Northwest Medical Isotopes, LLC Letter to U.S. Nuclear Regulatory Commission, dated February 5, 2015 (ADAMS Accession No. ML14349A501) Environmental Report and Associated Part One Submittal (ADAMS Accession Nos. ML14349A501, ML15210A123, ML15210A128, ML15210A129, and ML15210A131) |
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| ==Dear Mr. Drucker:== | | ==Dear Mr. Drucker:== |
| Northwest Medical Isotopes, LLC (NWMI) is providing additional clarification on POSA3-1A, POSA3-1B, POSA3-2A, POSA3-3A, NOI3-1B, and PA3-1 and to the response to the U.S. Nuclear Regulatory Commission request for additional information (RAI) dated June 16, 2016. These clarifications are provided in Attachment 1. NWMI submitted their original response the above referenced RAIs on July 25, 2016. NWMI is submitting these clarifications to the NRC in accordance with 10 CFR Affirmation,10 CFR Communications Mr. Michael Balazik Page 2 I solemnly declare and affirm that the foregoing information is true and correct under the penalty of perjury. Executed on September 1, 2016. If you have questions, I can be reached at (509) 430-6921 or carolyn.haass@nwmedicalisotopes.com. Sincerely, Carolyn C. Haass Chief Operating Officer | | |
| | Northwest Medical Isotopes, LLC (NWMI) is providing additional clarification on POSA3-1A, POSA3-1B, POSA3-2A, POSA3-3A, NOI3-1B, and PA3-1 and to the response to the U.S. Nuclear Regulatory Commission request for additional information (RAI) dated June 16, 2016. These clarifications are provided in Attachment 1. NWMI submitted their original response the above referenced RAIs on July 25, 2016. |
| | NWMI is submitting these clarifications to the NRC in accordance with 10 CFR 50.30(b), Oath or Affirmation, and 10 CFR 50.4, Written Communications. |
| | Northwest Medical Isotopes, LLC l 815 NW 9th Ave, Suite 256 l Corvallis, OR 97330 |
| | |
| | Mr. Michael Balazik Page 2 I solemnly declare and affirm that the foregoing information is true and correct under the penalty of perjury. |
| | Executed on September 1, 2016. |
| | If you have questions, I can be reached at (509) 430-6921 or carolyn.haass@nwmedicalisotopes.com. |
| | Sincerely, Carolyn C. Haass Chief Operating Officer |
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| ==Enclosures:== | | ==Enclosures:== |
| Attachment 1 cc: Mr. Michael Balazik Research and Test Reactors Branch A Office of Nuclear Reactor Regulation Mr. Alexander Adams Research and Test Reactors Branch A Office of Nuclear Reactor Regulation ATTACHMENT 1 Northwest Medical Isotopes, LLC Response to the U.S. Nuclear Regulatory Commission Request for Additional Information Regarding Chapters 4, 13, and 19 of the Preliminary Safety Analysis Report and Environmental Review of the Northwest Medical Isotopes, LLC Construction Permit Application Docket No. 50-609 Clarification to July 25, 2016 Submission on Request for Additional Information POSA3-1A, POSA3-1B, POSA3-2A, POSA3-3A, NOI3-1B, and PA3-1 This page intentionally left blank. | | Attachment 1 cc: Mr. Michael Balazik Research and Test Reactors Branch A Office of Nuclear Reactor Regulation Mr. Alexander Adams Research and Test Reactors Branch A Office of Nuclear Reactor Regulation |
| A-1 Clarification Response to POSA3-1A: Northwest Medical Isotopes, LLC (NWMI) is continuing to evaluate chemical release accidents and will establish preventative or mitigative controls for chemical release accidents with U.S. Nuclear Regulatory Commission (NRC)-licensed material or for chemical accidents that involve processing of licensed radioactive material with high consequences for workers, members of the public, and/or the environment (as determined by the criteria in 10 CFR 70.61, Performance Requirements). The set of ication, Chapter Accident Analysisother controls that NWMI may develop, will either reduce the accident likelihood to highly unlikely or reduce the accident consequences to be intermediate or low consequences. Clarification Response to POSA3-1B: NWMI is continuing to evaluate chemical release accidents and will establish preventative or mitigative controls for chemical release accidents with NRC-licensed material or for chemical accidents that involve processing of licensed radioactive material with intermediate consequences for workers, members of the public, and/or the environment (as determined by the criteria in 10 CFR 70.61). The set of controls set of controls identified in along with other controls that NWMI may develop, will either reduce the accident likelihood to unlikely or reduce the accident consequences to be low consequences. Clarification Response to POSA3-2A: NWMI is continuing to evaluate radiological accidents and will establish preventative or mitigative controls for radiological accidents with high consequences for workers, members of the public, and/or the environment (as determined by the criteria in 10 CFR 70.61). The set of controls identified in ruction Permit Application, Chapter 13.0, will either reduce the accident likelihood to highly unlikely or reduce the accident consequences to be intermediate or low consequences. Clarification Response to POSA3-3A: Clarification to this response was discussed at the non-public portion of a meeting held between NWMI and the NRC on August 11, 2016. In summary, the Radioisotope Production Facility (RPF) bounding radiological source term is based on the number of low-enriched uranium (LEU) targets irradiated at the nearby research reactor (MURR). Each irradiated MURR LEU target has nominally four times the radioactivity of an irradiated OSTR (or the hypothetical third reactor) LEU target. Even if the LEU targets from both MURR and OSTR (or the hypothetical third reactor) were both processed in a single week, the OSTR (or hypothetical third reactor) LEU target would dilute the radiological source term in the RPF. Clarification Response to NOI3-1B: The nearest resident used in noise modeling is nearest to both U.S. Highway 63 and to the proposed RPF. The approximate distance to the residence from U.S. Highway 63 is 85.3 meters (m) [280 feet (ft)], and the distance to the proposed RPF site is 792.5 m (2,600 ft). The noise receptor used in the noise model is 85.3 m (280 ft). Clarification Response to PA3-1: Off-specification uranium can be generated during target fabrication in the target fabrication system. The off-specification uranium is anticipated to be generated intermittently. The general approach to deal with off specification uranium is for it to be recycled and processed into fresh LEU target material. The exception is if the uranium is not suitable for LEU target material production (e.g., the enrichment is too low). Any LEU material with low enrichment will be stabilized, packaged for secured storage, and then returned to DOE per the Uranium Lease and Take-Back contract. For the RPF preliminary design, the off-specification uranium operations will be sized to accommodate 25 percent of the total throughput. An allowance has been made in the mass balance for the generation of off-specification uranium. There are three potential areas in the target fabrication system that off-specification uranium may be recovered including: Uranium that has been irradiated, recovered during irradiated target processing, and recycled into new LEU target material may eventually be unacceptable for continued 99Mo production due to the burnup of 235U and buildup of unwanted uranium isotopes. This material, which is recovered as uranyl nitrate, will be converted into a stable form for disposition, packaged for secured storage, and returned to DOE.
| | |
| A-2 If uranium is identified as being off-specification due to the presence of chemical impurities, the material will be recycled to the uranium recycle system within the hot cells. The purified uranyl nitrate will then be recycled to the target fabrication process. If LEU target material is identified as being off-specification after being produced (e.g., does not meet process requirements), the material will be recycled to the uranium dissolution step in the target fabrication system.}} | | ATTACHMENT 1 Northwest Medical Isotopes, LLC Response to the U.S. Nuclear Regulatory Commission Request for Additional Information Regarding Chapters 4, 13, and 19 of the Preliminary Safety Analysis Report and Environmental Review of the Northwest Medical Isotopes, LLC Construction Permit Application Docket No. 50-609 Clarification to July 25, 2016 Submission on Request for Additional Information - |
| | POSA3-1A, POSA3-1B, POSA3-2A, POSA3-3A, NOI3-1B, and PA3-1 |
| | |
| | This page intentionally left blank. |
| | Clarification Response to POSA3-1A: Northwest Medical Isotopes, LLC (NWMI) is continuing to evaluate chemical release accidents and will establish preventative or mitigative controls for chemical release accidents with U.S. Nuclear Regulatory Commission (NRC)-licensed material or for chemical accidents that involve processing of licensed radioactive material with high consequences for workers, members of the public, and/or the environment (as determined by the criteria in 10 CFR 70.61, Performance Requirements). The set of controls identified in NWMIs Construction Permit Application, Chapter 13.0, Accident Analysis, along with other controls that NWMI may develop, will either reduce the accident likelihood to highly unlikely or reduce the accident consequences to be intermediate or low consequences. |
| | Clarification Response to POSA3-1B: NWMI is continuing to evaluate chemical release accidents and will establish preventative or mitigative controls for chemical release accidents with NRC-licensed material or for chemical accidents that involve processing of licensed radioactive material with intermediate consequences for workers, members of the public, and/or the environment (as determined by the criteria in 10 CFR 70.61). The set of controls set of controls identified in NWMIs Construction Permit Application, Chapter 13.0, along with other controls that NWMI may develop, will either reduce the accident likelihood to unlikely or reduce the accident consequences to be low consequences. |
| | Clarification Response to POSA3-2A: NWMI is continuing to evaluate radiological accidents and will establish preventative or mitigative controls for radiological accidents with high consequences for workers, members of the public, and/or the environment (as determined by the criteria in 10 CFR 70.61). The set of controls identified in NWMIs Construction Permit Application, Chapter 13.0, will either reduce the accident likelihood to highly unlikely or reduce the accident consequences to be intermediate or low consequences. |
| | Clarification Response to POSA3-3A: Clarification to this response was discussed at the non-public portion of a meeting held between NWMI and the NRC on August 11, 2016. In summary, the Radioisotope Production Facility (RPF) bounding radiological source term is based on the number of low-enriched uranium (LEU) targets irradiated at the nearby research reactor (MURR). Each irradiated MURR LEU target has nominally four times the radioactivity of an irradiated OSTR (or the hypothetical third reactor) LEU target. Even if the LEU targets from both MURR and OSTR (or the hypothetical third reactor) were both processed in a single week, the OSTR (or hypothetical third reactor) LEU target would dilute the radiological source term in the RPF. |
| | Clarification Response to NOI3-1B: The nearest resident used in noise modeling is nearest to both U.S. |
| | Highway 63 and to the proposed RPF. The approximate distance to the residence from U.S. Highway 63 is 85.3 meters (m) [280 feet (ft)], and the distance to the proposed RPF site is 792.5 m (2,600 ft). The noise receptor used in the noise model is 85.3 m (280 ft). |
| | Clarification Response to PA3-1: Off-specification uranium can be generated during target fabrication in the target fabrication system. The off-specification uranium is anticipated to be generated intermittently. The general approach to deal with off specification uranium is for it to be recycled and processed into fresh LEU target material. The exception is if the uranium is not suitable for LEU target material production (e.g., the enrichment is too low). Any LEU material with low enrichment will be stabilized, packaged for secured storage, and then returned to DOE per the Uranium Lease and Take-Back contract. |
| | For the RPF preliminary design, the off-specification uranium operations will be sized to accommodate 25 percent of the total throughput. An allowance has been made in the mass balance for the generation of off-specification uranium. There are three potential areas in the target fabrication system that off-specification uranium may be recovered including: |
| | * Uranium that has been irradiated, recovered during irradiated target processing, and recycled into new LEU target material may eventually be unacceptable for continued 99Mo production due to the burnup of 235U and buildup of unwanted uranium isotopes. This material, which is recovered as uranyl nitrate, will be converted into a stable form for disposition, packaged for secured storage, and returned to DOE. |
| | A-1 |
| | * If uranium is identified as being off-specification due to the presence of chemical impurities, the material will be recycled to the uranium recycle system within the hot cells. The purified uranyl nitrate will then be recycled to the target fabrication process. |
| | * If LEU target material is identified as being off-specification after being produced (e.g., does not meet process requirements), the material will be recycled to the uranium dissolution step in the target fabrication system. |
| | A-2}} |
Letter Sequence Request |
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Initiation
- Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request
- Acceptance...
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MONTHYEARML16344A0552015-08-29029 August 2015
NWMI-2015-CSE-008, Nwmi Preliminary Criticality Safety Evaluation: Hot Cell Uranium Purification (Recovery and Recycle) (Rev. a) (Public Version)
Project stage: Other
ML16048A5542016-02-17017 February 2016
Rev 9 Mo-99 Overview and Status Slides No Notes
Project stage: Request
ML16083A1062016-02-18018 February 2016
Transcript of Public Meeting with Northwest Medical Isotopes on February 18, 2016, Pages 1-176
Project stage: Request
ML16083A1072016-03-29029 March 2016
February 18, 2016 Summary of Public Meeting with Northwest Medical Isotopes
Project stage: Meeting
ML16123A1192016-04-25025 April 2016
Northwest Medical Isotopes, LLC - Responses to the NRC Environmental Request for Additional Information - Letter Dated March 28, 2016
Project stage: Request
ML16210A3052016-07-18018 July 2016
Northwest Medical Isotopes, LLC, Response to Request for Additional Information Regarding Chapters 4, 13, and 19 of the Preliminary Safety Analysis Report and Environmental Review
Project stage: Response to RAI
ML16270A3772016-09-0101 September 2016
Northwest Medical Isotopes, LLC, Response to Environmental Request for Additional Information - Additional Clarification on POSA3-1A, POSA3-2A, POSA3-3A, NOI3-IB, and PA3-1
Project stage: Request
ML16344A0522016-11-28028 November 2016
Northwest Medical Isotopes, LLC - Responses to the U.S. Nuclear Regulatory Commission Regarding the Preliminary Safety Analysis Report Request for Additional Information
Project stage: Request
ML16344A0532016-11-28028 November 2016
Northwest Medical Isotopes, LLC - Response to the U.S. Nuclear Regulatory Commission Request for Additional Information Regarding the Preliminary Safety Analysis Report and Environmental Review
Project stage: Request
ML16344A0542016-11-28028 November 2016
NWMl-2014-RPT-006, Northwest Medical Isotopes, LLC - MCNP 6.1 Validations with Continuous Energy ENDF/B-VII.1 Cross-Sections (Rev. 0) (Public Version)
Project stage: Other
ML17093A6612017-03-0606 March 2017
Northwest Medical Isotopes, LLC Responses to the U.S. Nuclear Regulatory Commission Environmental Request for Additional Information - Letter Dated January 25, 2017
Project stage: Request
ML17069A4082017-03-29029 March 2017
Northwest Medical Isotopes, LLC Request for Additional Information Regarding Application for Construction Permit
Project stage: RAI
ML17128A0662017-04-28028 April 2017
Northwest Medical Isotopes, LLC Response to the NRC Regarding the Request for Additional Information Regarding Application for Construction Permit (Letter Dated March 29, 2017)
Project stage: Request
ML17128A0672017-04-28028 April 2017
NWMI-2017-RAI-002, Rev. 0, Response to the U.S. Nuclear Regulatory Commission Northwest Medical Isotopes, LLC - Request for Additional Information Regarding Application for Construction Permit (TAC MF6138).
Project stage: Request
ML17157B4112017-06-0202 June 2017
Northwest Medical Isotopes, LLC, Transmittal of Revision 2 of NWMI-2014-RPT-006, MCNP 6.1 Validations with Continuous Energy ENDF/B-VIL.1 Cross-Sections
Project stage: Request
ML17221A2012017-08-0505 August 2017
Attachment 3 to NWMI-2013-021, Rev. 2, Chapter 6.0 - Engineered Safety Features Construction Permit Application for Radioisotope Production Facility to Chapter 11.0 - Radiation Protection and Waste Management
Project stage: Request
ML17265A0472017-09-19019 September 2017
Response to the U.S. Nuclear Regulatory Commission, Northwest Medical Isotopes, LLC - Request for Additional Information Regarding Preliminary Safety Analysis Report, Construction Permit Application
Project stage: Request
ML17265A0462017-09-19019 September 2017
Northwest Medical Isotopes, LLC Response to U.S. Nuclear Regulatory Commission Request for Additional Information Regarding Application for Construction Permit
Project stage: Request
ML17262A1112017-09-21021 September 2017
Northwest Medical Isotopes, LLC Request for Additional Information Regarding Application for Construction Permit
Project stage: RAI
ML17283A1092017-09-28028 September 2017
Northwest Medical Isotopes, LLC Response to U.S. Nuclear Regulatory Commission Request for Additional Information Regarding Application for Construction Permit (TAC No. MF6138), Docket No. 50-609, Dated September 18, 2017
Project stage: Request
2016-09-01
[Table View] |
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Category:Letter
MONTHYEARML22147A1572022-07-11011 July 2022
Northwest Medical Isotopes, LLC - Termination of Construction Permit CPMIF-002
ML22084A0042022-02-0707 February 2022
Northwest Medical Isotopes, LLC (Nwmi), Request for Termination of Construction Permit No. CPMIF-002
ML19315A0132019-11-11011 November 2019
Northwest Medical Isotopes, LLC (Nwmi) Periodic Report Required by the License Conditions in Construction Permit No. CPMIF-002 (Docket No. 50-609), November 11, 2019
ML18163A0612018-11-16016 November 2018
Letter: Approval of Request for Exemption from Requirements of Title 10 of the Code of Federal Regulations, Paragraph 70.21 (F)
ML18318A3052018-11-0909 November 2018
Northwest Medical Isotopes, LLC (Nwmi) - Periodic Report Required by the License Conditions in Construction Permit No. CPMIF-002
ML18113A5042018-05-17017 May 2018
Letter to L. Tippet-Mosby Missouri Department of Natural Resources Request for Comments on North West Medical Isotopes Draft Environmental Assessment
ML18037A3082018-05-0909 May 2018
Northwest Medical Isotopes, LLC - Transmittal Letter Regarding Issuance of Construction Permit for a Medical Radioisotope Production Facility
ML18110A6072018-04-26026 April 2018
Acceptance for Review of Request for Exemption from Requirements of 10 CFR 70.21(F) for the Target Fabrication Portion of the Northwest Medical Isotopes Radioisotope Production Facility
ML18088A1752018-03-12012 March 2018
Supplemental Information Request - Exemption Request Pursuant to 10 CFR 70.17, from Requirement of 10 CFR 70.21(F), Filing, for Northwest Medical Isotopes, LLC Radioisotope Production Facility
ML17355A5292017-12-21021 December 2017
RIC Invitation Letter External Speaker 2018 Haass
ML17362A0402017-12-18018 December 2017
Northwest Medical Isotopes, LLC - Exemption Request Pursuant to 10 CFR 70.17, from Requirement of 10 CFR 70 21(F), Filing.
ML17353A0982017-12-18018 December 2017
Letter from Missouri Department of Natural Resources Regarding Northwest Medical Isotopes, LLC Application for Construction Permit
ML17349A1732017-12-14014 December 2017
Letter to Chairman Kristine Svinicki from Senators Ron Wyden and Claire Mccaskill Regarding Northwest Medical Isotopes, LLC Application for Construction Permit
ML17324A4122017-12-0808 December 2017
LTR-17-0431-1 - Report on Safety Aspects of the Construction Permit Application for Nwmi Medical Radioisotope Production Facility
ML17339A1972017-11-27027 November 2017
11-27-17 Ltr to Maurice Graham, Et Al., from Annette Vietti-Cook Notifying Him of That the Commission Is Convening an Evidentiary Hearing on the Construction Permit Application Associated with the Proposed Northwest Medical Isotopes Facilit
ML17332A6802017-11-24024 November 2017
11-24-17, Ltr to the Honorable Eric Greitens Et Al., Governor of Missouri from Denise Mcgovern Notifying Him of an Evidentiary Hearing for the Construction Permit Application Associated with Proposed Northwest Medical Isotopes Facility in C
ML17331B4452017-11-22022 November 2017
11-22-17 Letter to Bill Anoatubby Et Al, Governor, Chickasaw Nation from Annette Vietti-Cook Notifying Him of the Evidentiary Hearing for the Construction Permit Application Associated with the Proposed Northwest Medical Isotopes Facility i
ML17310A3662017-11-16016 November 2017
Transmittal Letter of Safety Evaluation Report for the Northwest Medical Isotopes, LLC, Constuction Permit Application
ML17310B5112017-11-0606 November 2017
Report on the Safety Aspects of the Construction Permit for Northwest Medical Isotopes, LLC, Radioisotope Production Facility
ML17283A1092017-09-28028 September 2017
Northwest Medical Isotopes, LLC Response to U.S. Nuclear Regulatory Commission Request for Additional Information Regarding Application for Construction Permit (TAC No. MF6138), Docket No. 50-609, Dated September 18, 2017
ML17283A1082017-09-28028 September 2017
Responses to Advisory Committee on Reactor Safeguards Questions on Docket No. 50-609, Northwest Medical Isotopes, LLC, NWMl-2013-021, Construction Permit Application for Radioisotope Production, at Meeting on September 21, 2017
ML17262A1112017-09-21021 September 2017
Northwest Medical Isotopes, LLC Request for Additional Information Regarding Application for Construction Permit
ML17265A0462017-09-19019 September 2017
Northwest Medical Isotopes, LLC Response to U.S. Nuclear Regulatory Commission Request for Additional Information Regarding Application for Construction Permit
ML17265A0482017-09-18018 September 2017
Responses to Advisory Committee on Reactor Safeguard Questions on Docket No. 50-609, Northwest Medical Isotopes, LLC, NWMI-2013-021, Construction Permit Application/Or Radioisotope Production, at Meetings on June 19, 2017; July 11, 2017; &
ML17268A3032017-09-15015 September 2017
Ltr from Missouri Dept of Natural Resources Dtd Sep 15, 2017, to Nwmi, Issuing 401 Water Quality Certification
ML17221A1992017-08-0707 August 2017
Transmittal of Revision 1 of Chapters 10.0, 11.0, 12.0 (Including Appendices 12A, 12b and 12C) and 14.0 and Revision 2 of Chapters 2.0, 3.0, 6.0, 7.0, 8.0 and 13.0 of NWMI-2013-021, Construction Permit Application for Radioisotope Productio
ML17193A4252017-07-0606 July 2017
Northwest Medical Isotopes, LLC - Transmittal of Revision 1 of Chapters 3.0, 6.0, 7.0, 8.0, 9.0, and 13.0 of NWMI-2013-021, Construction Permit Application for Radioisotope Production
ML17158B2672017-06-0303 June 2017
Northwest Medical Isotopes, LLC - Transmittal of Revision 1 of Chapters 1.0, 2.0, 4.0, and 5.0 of NWMl-2013-021, Construction Permit Application for Radioisotope Production Facility
ML17157B4112017-06-0202 June 2017
Northwest Medical Isotopes, LLC, Transmittal of Revision 2 of NWMI-2014-RPT-006, MCNP 6.1 Validations with Continuous Energy ENDF/B-VIL.1 Cross-Sections
ML17111A7252017-05-30030 May 2017
Maintenance of Reference Materials at the Daniel Boone Regional Library for the Environmental Review of Northwest Medical Isotopes, LLC Construction Permit Application
ML17086A5822017-05-30030 May 2017
Letter from NRC to Nwmi Carolyn Haass Transmitting Nwmi Final EIS
ML17132A3912017-05-24024 May 2017
Notice of Availability of the Final Environmental Impact Statement for the Proposed Northwest Medical Isotopes, LLC Radioisotope Production Facility Construction Permit
ML17096A1832017-05-23023 May 2017
Notice of Availability of the Final Environmental Impact Statement for the Northwest Medical Isotopes, LLC, Medical Radioisotope Production Facility Construction Permit Application (CAC No. MF6135) to N. Fowler
ML17114A2532017-05-22022 May 2017
Final EIS for Nwmi Construction Permit and Response to Comments on the Draft EIS from EPA
ML17121A3562017-05-22022 May 2017
Final Environmental Impact Statement for the Northwest Medical Isotopes, LLC, Medical Radioisotope Production Facility Construction Permit Application and Response to Comments on the Draft Environmental Impact Statement
ML17128A0652017-04-28028 April 2017
Northwest Medical Isotopes, LLC Responses to the NRC Environmental Request for Additional Information - Letter Dated January 25, 2017
ML17128A0662017-04-28028 April 2017
Northwest Medical Isotopes, LLC Response to the NRC Regarding the Request for Additional Information Regarding Application for Construction Permit (Letter Dated March 29, 2017)
ML17069A4082017-03-29029 March 2017
Northwest Medical Isotopes, LLC Request for Additional Information Regarding Application for Construction Permit
ML17061A1592017-03-22022 March 2017
Proprietary Determination Regarding Northwest Medical Isotopes Presentation November 10, 2016
ML17093A6612017-03-0606 March 2017
Northwest Medical Isotopes, LLC Responses to the U.S. Nuclear Regulatory Commission Environmental Request for Additional Information - Letter Dated January 25, 2017
ML17048A2712017-02-27027 February 2017
Northwest Medical Isotopes, LLC - Proprietary Determination Regarding Request for Information Responses Dated November 28, 2016
ML16344A0522016-11-28028 November 2016
Northwest Medical Isotopes, LLC - Responses to the U.S. Nuclear Regulatory Commission Regarding the Preliminary Safety Analysis Report Request for Additional Information
ML16305A2442016-11-10010 November 2016
Maintenance of Reference Materials at the Daniel Boone Regional Library for the Environmental Review of Northwest Medical Isotopes, Llc Construction Permit Application
ML16294A1352016-11-0707 November 2016
Notice of Availability of the Draft Environmental Impact Statement for the Construction Permit for the Proposed Northwest Medical Isotopes, LLC Radioisotope Production Facility
ML16293A8812016-11-0707 November 2016
Notice of Availability of the Draft Environmental Impact Statement for the Construction Permit for the Proposed Northwest Medical Isotopes, LLC Radioisotope Production Facility
ML16308A4342016-11-0707 November 2016
Notice of Availability of the Draft Environmental Impact Statement for the Northwest Medical Isotopes, Llc Radioisotope Production Facility Construction Permit Application (Cac No. MF6135)
ML16295A1292016-11-0404 November 2016
Notice of Availability of Nwmi DEIS-Tribal
ML16272A2942016-11-0101 November 2016
NRC to FWS Availability of the NWMI Draft EIS and Concurrence with ESA Determinations
ML16294A4792016-11-0101 November 2016
Letter to Nicholas Fowler, Nwmi, Transmitting the Draft Environmental Impact Statement for the Northwest Medical Isotopes, LLC, Medical Radioisotope Production Facility Construction Permit Application
ML16292A7242016-11-0101 November 2016
Notice of Availability of the Draft Environmental Impact Statement for the Northwest Medical Isotopes, LLC, Medical Radioisotope Production Facility Construction Permit Application
2022-07-11
[Table view]
Category:Response to Request for Additional Information (RAI)
MONTHYEARML17283A1092017-09-28028 September 2017
Northwest Medical Isotopes, LLC Response to U.S. Nuclear Regulatory Commission Request for Additional Information Regarding Application for Construction Permit (TAC No. MF6138), Docket No. 50-609, Dated September 18, 2017
ML17265A0462017-09-19019 September 2017
Northwest Medical Isotopes, LLC Response to U.S. Nuclear Regulatory Commission Request for Additional Information Regarding Application for Construction Permit
ML17265A0472017-09-19019 September 2017
Response to the U.S. Nuclear Regulatory Commission, Northwest Medical Isotopes, LLC - Request for Additional Information Regarding Preliminary Safety Analysis Report, Construction Permit Application
ML17265A0482017-09-18018 September 2017
Responses to Advisory Committee on Reactor Safeguard Questions on Docket No. 50-609, Northwest Medical Isotopes, LLC, NWMI-2013-021, Construction Permit Application/Or Radioisotope Production, at Meetings on June 19, 2017; July 11, 2017; &
ML17128A0672017-04-28028 April 2017
NWMI-2017-RAI-002, Rev. 0, Response to the U.S. Nuclear Regulatory Commission Northwest Medical Isotopes, LLC - Request for Additional Information Regarding Application for Construction Permit (TAC MF6138).
ML17128A0662017-04-28028 April 2017
Northwest Medical Isotopes, LLC Response to the NRC Regarding the Request for Additional Information Regarding Application for Construction Permit (Letter Dated March 29, 2017)
ML17128A0652017-04-28028 April 2017
Northwest Medical Isotopes, LLC Responses to the NRC Environmental Request for Additional Information - Letter Dated January 25, 2017
ML17093A6612017-03-0606 March 2017
Northwest Medical Isotopes, LLC Responses to the U.S. Nuclear Regulatory Commission Environmental Request for Additional Information - Letter Dated January 25, 2017
ML16344A0532016-11-28028 November 2016
Northwest Medical Isotopes, LLC - Response to the U.S. Nuclear Regulatory Commission Request for Additional Information Regarding the Preliminary Safety Analysis Report and Environmental Review
ML16270A3772016-09-0101 September 2016
Northwest Medical Isotopes, LLC, Response to Environmental Request for Additional Information - Additional Clarification on POSA3-1A, POSA3-2A, POSA3-3A, NOI3-IB, and PA3-1
ML16210A3052016-07-18018 July 2016
Northwest Medical Isotopes, LLC, Response to Request for Additional Information Regarding Chapters 4, 13, and 19 of the Preliminary Safety Analysis Report and Environmental Review
ML16124A5102016-05-26026 May 2016
Summary of Telephone Conference Call Held on April 21, 2016, Between the U.S. Nuclear Regulatory Commission and Northwest Medical Isotopes, LLC Concerning Clarifications on Responses to Request for Additional Information for the Environment
ML16123A1192016-04-25025 April 2016
Northwest Medical Isotopes, LLC - Responses to the NRC Environmental Request for Additional Information - Letter Dated March 28, 2016
ML16053A2042016-02-12012 February 2016
Northwest Medical Isotopes, LLC - Responses to the U.S. Nuclear Regulatory Commission Environmental Request for Additional Information - Letter Dated January 19, 2016
ML15328A0712015-11-20020 November 2015
Northwest Medical Isotopes, LLC - Response to the U.S. Nuclear Regulatory Commission Request for Additional Information, Environmental Review of the Construction Permit Application, Including Document No. NWMI-2015-RAI-001. Part 1 of 14
ML15328A0702015-11-20020 November 2015
Northwest Medical Isotopes, LLC - Responses to the U.S. Nuclear Regulatory Commission Environmental Request for Additional Information - Letter Dated November 2, 2015
2017-09-28
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Text
September 1, 2016 NWMI-LTR-2016-009 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk 11555 Rockville Pike Washington, DC 20555 Mr. David Drucker, Senior Project Manager Division of License Renewal Office of Nuclear Reactor Regulation RE: Docket No. 50-609, Northwest Medical Isotopes, LLC Responses to the U.S. Nuclear Regulatory Commission Environmental Request for Additional information (Letter dated June 16, 2016) - Additional Clarification on POSA3-1A, POSA3-1B, POSA3-2A, POSA3-3A, NOI3-1B, and PA3-1
References:
- 1. Northwest Medical Isotopes, LLC Letter NWMI-LTR-2016-007 to U.S. Nuclear Regulatory Commission, dated July 18, 2016, Docket No. 50-609, Responses to Request for Additional Information dated June 16, 2016 (ADAMS Accession No. ML16210A305)
- 2. U.S. Nuclear Regulatory Commission letter to Northwest Medical Isotopes, LLC, dated June 16, 2016, Docket No. 50-609, Request for Additional Information for the Environmental Review of the Northwest Medical Isotopes, LLC Construction Permit Application (ADAMS Accession No. ML16176A114) (TAC Nos. MF6134 and MF 6135)
- 3. Northwest Medical Isotopes, LLC Letter NWMI-LTR-20 15-006 to U.S. Nuclear Regulatory Commission, dated July 20, 2015,NRC Project No. 0803 - Northwest Medical Isotopes, LLC, Submittal Part 2 Construction Permit Application for a Radioisotope Production Facility (ADAMS Accession No. ML16056A122)
- 4. Northwest Medical Isotopes, LLC Letter to U.S. Nuclear Regulatory Commission, dated February 5, 2015 (ADAMS Accession No. ML14349A501) Environmental Report and Associated Part One Submittal (ADAMS Accession Nos. ML14349A501, ML15210A123, ML15210A128, ML15210A129, and ML15210A131)
Dear Mr. Drucker:
Northwest Medical Isotopes, LLC (NWMI) is providing additional clarification on POSA3-1A, POSA3-1B, POSA3-2A, POSA3-3A, NOI3-1B, and PA3-1 and to the response to the U.S. Nuclear Regulatory Commission request for additional information (RAI) dated June 16, 2016. These clarifications are provided in Attachment 1. NWMI submitted their original response the above referenced RAIs on July 25, 2016.
NWMI is submitting these clarifications to the NRC in accordance with 10 CFR 50.30(b), Oath or Affirmation, and 10 CFR 50.4, Written Communications.
Northwest Medical Isotopes, LLC l 815 NW 9th Ave, Suite 256 l Corvallis, OR 97330
Mr. Michael Balazik Page 2 I solemnly declare and affirm that the foregoing information is true and correct under the penalty of perjury.
Executed on September 1, 2016.
If you have questions, I can be reached at (509) 430-6921 or carolyn.haass@nwmedicalisotopes.com.
Sincerely, Carolyn C. Haass Chief Operating Officer
Enclosures:
Attachment 1 cc: Mr. Michael Balazik Research and Test Reactors Branch A Office of Nuclear Reactor Regulation Mr. Alexander Adams Research and Test Reactors Branch A Office of Nuclear Reactor Regulation
ATTACHMENT 1 Northwest Medical Isotopes, LLC Response to the U.S. Nuclear Regulatory Commission Request for Additional Information Regarding Chapters 4, 13, and 19 of the Preliminary Safety Analysis Report and Environmental Review of the Northwest Medical Isotopes, LLC Construction Permit Application Docket No. 50-609 Clarification to July 25, 2016 Submission on Request for Additional Information -
POSA3-1A, POSA3-1B, POSA3-2A, POSA3-3A, NOI3-1B, and PA3-1
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Clarification Response to POSA3-1A: Northwest Medical Isotopes, LLC (NWMI) is continuing to evaluate chemical release accidents and will establish preventative or mitigative controls for chemical release accidents with U.S. Nuclear Regulatory Commission (NRC)-licensed material or for chemical accidents that involve processing of licensed radioactive material with high consequences for workers, members of the public, and/or the environment (as determined by the criteria in 10 CFR 70.61, Performance Requirements). The set of controls identified in NWMIs Construction Permit Application, Chapter 13.0, Accident Analysis, along with other controls that NWMI may develop, will either reduce the accident likelihood to highly unlikely or reduce the accident consequences to be intermediate or low consequences.
Clarification Response to POSA3-1B: NWMI is continuing to evaluate chemical release accidents and will establish preventative or mitigative controls for chemical release accidents with NRC-licensed material or for chemical accidents that involve processing of licensed radioactive material with intermediate consequences for workers, members of the public, and/or the environment (as determined by the criteria in 10 CFR 70.61). The set of controls set of controls identified in NWMIs Construction Permit Application, Chapter 13.0, along with other controls that NWMI may develop, will either reduce the accident likelihood to unlikely or reduce the accident consequences to be low consequences.
Clarification Response to POSA3-2A: NWMI is continuing to evaluate radiological accidents and will establish preventative or mitigative controls for radiological accidents with high consequences for workers, members of the public, and/or the environment (as determined by the criteria in 10 CFR 70.61). The set of controls identified in NWMIs Construction Permit Application, Chapter 13.0, will either reduce the accident likelihood to highly unlikely or reduce the accident consequences to be intermediate or low consequences.
Clarification Response to POSA3-3A: Clarification to this response was discussed at the non-public portion of a meeting held between NWMI and the NRC on August 11, 2016. In summary, the Radioisotope Production Facility (RPF) bounding radiological source term is based on the number of low-enriched uranium (LEU) targets irradiated at the nearby research reactor (MURR). Each irradiated MURR LEU target has nominally four times the radioactivity of an irradiated OSTR (or the hypothetical third reactor) LEU target. Even if the LEU targets from both MURR and OSTR (or the hypothetical third reactor) were both processed in a single week, the OSTR (or hypothetical third reactor) LEU target would dilute the radiological source term in the RPF.
Clarification Response to NOI3-1B: The nearest resident used in noise modeling is nearest to both U.S.
Highway 63 and to the proposed RPF. The approximate distance to the residence from U.S. Highway 63 is 85.3 meters (m) [280 feet (ft)], and the distance to the proposed RPF site is 792.5 m (2,600 ft). The noise receptor used in the noise model is 85.3 m (280 ft).
Clarification Response to PA3-1: Off-specification uranium can be generated during target fabrication in the target fabrication system. The off-specification uranium is anticipated to be generated intermittently. The general approach to deal with off specification uranium is for it to be recycled and processed into fresh LEU target material. The exception is if the uranium is not suitable for LEU target material production (e.g., the enrichment is too low). Any LEU material with low enrichment will be stabilized, packaged for secured storage, and then returned to DOE per the Uranium Lease and Take-Back contract.
For the RPF preliminary design, the off-specification uranium operations will be sized to accommodate 25 percent of the total throughput. An allowance has been made in the mass balance for the generation of off-specification uranium. There are three potential areas in the target fabrication system that off-specification uranium may be recovered including:
- Uranium that has been irradiated, recovered during irradiated target processing, and recycled into new LEU target material may eventually be unacceptable for continued 99Mo production due to the burnup of 235U and buildup of unwanted uranium isotopes. This material, which is recovered as uranyl nitrate, will be converted into a stable form for disposition, packaged for secured storage, and returned to DOE.
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- If uranium is identified as being off-specification due to the presence of chemical impurities, the material will be recycled to the uranium recycle system within the hot cells. The purified uranyl nitrate will then be recycled to the target fabrication process.
- If LEU target material is identified as being off-specification after being produced (e.g., does not meet process requirements), the material will be recycled to the uranium dissolution step in the target fabrication system.
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