ML15187A237
| ML15187A237 | |
| Person / Time | |
|---|---|
| Site: | University of Missouri-Columbia |
| Issue date: | 04/27/2015 |
| From: | Steven Lynch Research and Test Reactors Branch B |
| To: | |
| Lynch S, NRR/DPR, 301-415-1524 | |
| Shared Package | |
| ML15187A33 | List: |
| References | |
| Download: ML15187A237 (18) | |
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Providing quality nuclear research, education and service to a global community University of Missouri Research Reactor, Nordion and General Atomics Collaborating to Develop a New and Reliable Supply of Mo-99 for the Future A Canadian-US partnership has been announced to create a "new, reliable supply" of medical isotopes for use worldwide.
The MURR research reactor (Image: University of Missouri)
Canada's Nordion and its US parent company Sterigenics International signed partnership agreements on 20 February with the USA's General Atomics (GA) and the University of Missouri Research Reactor Center (MURR).
This meeting segment is to present and discuss the approach to NRC licensing at MURR related to this project April 27, 2015
Providing quality nuclear research, education and service to a global community 2
GA SGE Technology Licensing Approach
- Goals for todays and follow-up discussion(s):
- 1. Identify the most appropriate licensing approach for this project to support the national Mo-99 supply need;
- 2. Obtain a mutual understanding of the clear and concise requirements such that a high quality licensing submittal maybe accomplished;
- 3. Maintain frequent communication with the NRC; and
- 4. Understand the timeline for obtaining NRC approval of licensing approach.
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Providing quality nuclear research, education and service to a global community 3
Licensing Approach:
Testing facility as per Definition 10 CFR 50.2 - Testing facility means a nuclear reactor which is of a type described in § 50.21(c) and for which an application has been filed for a license authorizing operation at:
(1) A thermal power level in excess of 10 megawatts; or (2) A thermal power level in excess of 1 megawatt, if the reactor is to contain:
(i) A circulating loop through the core in which the applicant proposes to conduct fuel experiments; or (ii) A liquid fuel loading; or (iii) An experimental facility in the core in excess of 16 square inches in cross-section.
This project does not meet the definition of a testing facility. The project will not require a fueled experiment with a circulating loop through the primary coolant pressurized boundary of the reactor core, nor does it require a liquid fuel loading or a experimental facility in the core in excess of 16 square inches in cross-section.
MURR will continue to operate at a maximum thermal power level of 10 MW.
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Licensing Approach:
Option 1 Submit amendment to current Part 50, Class 104(c) license (R-103) with no change in utilization facility classification Decision Factors Include:
No construction of new buildings or expansions to existing buildings Project requires installing typical, standard equipment that currently exists at MURR - such as hot cells, heat exchangers, pumps, etc.
Irradiating targets in MURRs graphite reflector region is common AND is outside the primary pressure boundary No processing (dissolution) of SNM After SGE, chemistry steps are standard and well within MURRs staff experience Example of typical hot cells currently at MURR Morgan Lewis LLP 2015 MURR Part 50; 104(c) Utilization License Add Mo-99 Capability Does the LA involve a material alteration of the facility?
Construction permit required prior to NRC processing license amendment request.
License amendment (LA) request invokes 10 C.F.R. §§ 50.90-50.92 Process Public notice.
Opportunity for pre-issuance hearing on constr. permit.
NRC processes license amendment request.
If successful hearing, NRC issues construction permit after NRC staff review.
If NSHC determination, NRC issues license amendment (after NRC staff review).
No Yes Post-issuance hearing, if requested.
No NSHC determination; opportunity for pre-approval hearing.
Pre-issuance hearing successful =
issue license amendment.
Mandatory hearing (even if uncontested) per AEA § 189.
Option 1 Submit amendment to current Part 50; 104(c) license with no change in utilization facility status.
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Licensing Approach:
Options 2 and 3 Are variations of applying production facility classification Production Facility Definition per 10 CFR 50.2 means:
(1)
Any nuclear reactor designed or used primarily for the formation of plutonium or uranium-233; or (2)
Any facility designed or used for the separation of the isotopes of plutonium, except laboratory scale facilities designed or used for experimental or analytical purposes only; or (3)
Any facility designed or used for the processing of irradiated materials containing special nuclear material, except (i) laboratory scale facilities designed or used for experimental or analytical purposes, (ii) facilities in which the only special nuclear materials contained in the irradiated material to be processed are uranium enriched in the isotope U-235 and plutonium produced by the irradiation, if the material processed contains not more than 10-6 grams of plutonium per gram of U-235 and has fission product activity not in excess of 0.25 millicuries of fission products per gram of U-235, and (iii) facilities in which processing is conducted pursuant to a license issued under parts 30 and 70 of this chapter, or equivalent regulations of an Agreement State, for the receipt, possession, use, and transfer of irradiated special nuclear material, which authorizes the processing of the irradiated material on a batch basis for the separation of selected fission products and limits the process batch to not more than 100 grams of uranium enriched in the isotope 235 and not more than 15 grams of any other special nuclear material.
Morgan Lewis LLP 2015 MURR Part 50; 104(c) Utilization License Option 3 Convert the MURR Part 50; 104(c) utilization license to a production facility license.
Option 2 Amend the MURR Part 50 license to add a production facility function to the existing utilization facility function.
Add Mo-99 Capability Submit license amendment maintaining RTR status, but noting that production is a much more significant part of licensed activities. Potential impacts on FSAR, risk analysis, consequence analysis, level of NRC oversight, security, EP, TS, financial assurance, etc.
Does the LA involve a material alteration of the facility?
Construction permit required prior to NRC processing license amendment request.
License amendment (LA) request invokes 10 C.F.R. §§ 50.90-50.92 Process Public notice.
Opportunity for pre-issuance hearing on constr. permit.
NRC processes license amendment request.
If successful hearing, NRC issues construction permit after NRC staff review.
Submit a license amendment to add second type of license to existing Part 50 license. Potential impacts on FSAR, risk analysis, consequence analysis, level of NRC oversight, security, EP, TS, financial assurance, etc.
No known precedent.
If NSHC determination, NRC issues license amendment (after NRC staff review).
Obtain authori issuance cons C.F.R. § 50.10 No Yes Post-issuance hearing, if requested.
No NSHC determination; opportunity for pre-approval hearing.
Pre-issuance hearing successful =
issue license amendment.
Mandatory hearing (even if uncontested) per AEA § 189.
No known precedent.
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Providing quality nuclear research, education and service to a global community 7
Licensing Approach:
Definition Excerpts from 10CFR50 Apply?
(1) Any nuclear reactor designed or used primarily for the formation of plutonium or uranium-233 No (2) Any facility designed or used for the separation of the isotopes of plutonium No (3) Any facility designed or used for the processing of irradiated materials containing special nuclear material No*
Would implementation of the proposed GA SGE technology at MURR meet the definition of a production facility?
- 10 CFR 50 does not contain a definition for processing. In producing Mo-99 from uranium, it seems that the industry implied definition is the disassembly and/or chemical dissolution of uranium targets that have been irradiated and then removed from the reactor into separate facilities for processing - chemical separation of Mo-99 from the dissolved uranium target.
In the case of the GA SGE technology, the uranium targets are not removed from the reactor and are never disassembled nor chemically dissolved. Furthermore, the GA SGE technology does not separate uranium or plutonium from the target assembly; thus, does not appear to meet the definition of a production facility.
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Licensing Approach:
Option 2 Amend the MURR Part 50 license to add a production facility function to the existing utilization facility classification Decision Factors Include:
With implementation of this project, MURR still does not appear to satisfy any of the production facility definition in 10 CFR 50 We are unaware of any precedence for establishing a production facility within a utilization facility Requires maintaining two separate Class 104(c) licenses; thus requiring separate NRC oversight and inspections?
Submit a license amendment to add a second type of license to existing Part 50 license No known precedent Morgan Lewis LLP 2015 MURR Part 50; 104(c) Utilization License Option 2 Amend the MURR Part 50 license to add a production facility function to the existing utilization facility function.
Add Mo-99 Capability Does the LA involve a material alteration of the facility?
Construction permit required prior to NRC processing license amendment request.
License amendment (LA) request invokes 10 C.F.R. §§ 50.90-50.92 Process Public notice.
Opportunity for pre-issuance hearing on constr. permit.
NRC processes license amendment request.
If successful hearing, NRC issues construction permit after NRC staff review.
Submit a license amendment to add second type of license to existing Part 50 license. Potential impacts on FSAR, risk analysis, consequence analysis, level of NRC oversight, security, EP, TS, financial assurance, etc.
No known precedent.
If NSHC determination, NRC issues license amendment (after NRC staff review).
Obtain a issuan C.F.R. § No Yes Post-issuance hearing, if requested.
No NSHC determination; opportunity for pre-approval hearing.
Pre-issuance hearing successful =
issue license amendment.
Mandatory hearing (even if uncontested) per AEA § 189.
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Providing quality nuclear research, education and service to a global community 9
Licensing Approach:
Option 3 Change the MURR Part 50; Class 104(c) utilization facility license to a production facility license Submit license amendment maintaining RTR status, but reclassifying to a production facility No known precedent Decision Factors Include:
With implementation of this project, MURR still does not appear to satisfy the production facility definition in 10 CFR 50 We are unaware of any precedence for converting an existing utilization facility into a production facility Morgan Lewis LLP 2015 MURR Part 50; 104(c) Utilization License Option 3 Convert the MURR Part 50; 104(c) utilization license to a production facility license.
Add Mo-99 Capability Submit license amendment maintaining RTR status, but noting that production is a much more significant part of licensed activities. Potential impacts on FSAR, risk analysis, consequence analysis, level of NRC oversight, security, EP, TS, financial assurance, etc.
Does the LA involve a material alteration of the facility?
Construction permit required prior to NRC processing license amendment request.
License amendment (LA) request invokes 10 C.F.R. §§ 50.90-50.92 Process Public notice.
Opportunity for pre-issuance hearing on constr. permit.
NRC processes license amendment request.
If successful hearing, NRC issues construction permit after NRC staff review.
If NSHC determination, NRC issues license amendment (after NRC staff review).
Obtain authorization for pre-issuance construction (10 C.F.R. § 50.10 or §50.12(b).
No Yes Post-issuance hearing, if requested.
No NSHC determination; opportunity for pre-approval hearing.
Pre-issuance hearing successful =
issue license amendment.
Mandatory hearing (even if uncontested) per AEA § 189.
No known precedent.
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Providing quality nuclear research, education and service to a global community 10 Licensing Approach:
Option 4 Request a stand-alone production facility license Invoke process for licensing a new facility but reclassifying to a production facility Decision Factors Include:
There are no new buildings nor expansions to existing buildings being constructed There is no processing of SNM Requires maintaining two separate Class 104(c) licenses; thus requiring separate NRC oversight and inspections Morgan Lewis LLP 2015 MURR Part 50; 104(c) Utilization License Option 4 Request a stand-alone production facility license.
Add Mo-99 Capability Construction permit required prior to NRC processing license amendment request.
Public notice.
Opportunity for pre-issuance hearing on constr. permit.
NRC processes license amendment request.
If successful hearing, NRC issues construction permit after NRC staff review.
If NSHC determination, NRC issues license amendment (after NRC staff review).
Obtain authorization for pre-issuance construction (10 C.F.R. § 50.10 or §50.12(b).
Post-issuance hearing, if requested.
No NSHC determination; opportunity for pre-approval hearing.
Pre-issuance hearing successful =
issue license amendment.
Mandatory hearing (even if uncontested) per AEA § 189.
Invoke process for licensing a new facility, including:
Construction permit.
Mandatory hearing (even if uncontested)
New technical specifications Separate FSAR, QA Plan, security requirements, TS, etc.
Multiple points of possible intervention Separate license fees.
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Providing quality nuclear research, education and service to a global community 11 (a) In determining whether an amendment to a license, construction permit, or early site permit will be issued to the applicant, the Commission will be guided by the considerations which govern the issuance of initial licenses, construction permits, or early site permits to the extent applicable and appropriate. If the application involves the material alteration of a licensed facility, a construction permit will be issued before the issuance of the amendment to the license,.
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§ 50.92(a) Issuance of Amendment
§ 50.23 Construction Permits A construction permit for the construction of a production or utilization facility will be issued before the issuance of a license if the application is otherwise acceptable, and will be converted upon completion of the facility and Commission action, into a license as provided in § 50.56. However, if a combined license for a nuclear power reactor is issued under part 52 of this chapter, the construction permit and operating license are deemed to be combined in a single license. A construction permit for the alteration of a production or utilization facility will be issued before the issuance of an amendment of a license, if the application for amendment is otherwise acceptable, as provided in § 50.91.
Providing quality nuclear research, education and service to a global community 12 Does the LA involve a material alteration of the facility?
Construction permit required prior to NRC processing license amendment request.
License amendment (LA) request invokes 10 C.F.R. §§ 50.90-50.92 Process NRC processes license amendment request.
No Yes Licensing Approach:
Does the licensing action involve an alteration or material alteration to the facility?
The word alteration as used in § 50.23 and material alteration as used in
§ 50.92(a) are not defined in Part 50 12
Providing quality nuclear research, education and service to a global community 13 Licensing Approach:
No Material Alteration Decision Factors Include:
No construction of new buildings or expansions to existing buildings Project requires installing typical, standard equipment that currently exists at MURR - such as hot cells, heat exchangers, pumps, etc.
Irradiating targets in MURRs graphite reflector region is common AND is outside the primary pressure boundary No processing (dissolution) of SNM After extraction and collection using the GA SGE technology, chemistry steps are standard and well within MURRs staff experience MURR believes there is no alteration or material alteration to the facility MURR Part 50; 104(c) Utilization License Option 4 Request a stand-alone production facility license.
Option 3 Convert the MURR Part 50; 104(c) utilization license to a production facility license.
Option 2 Amend the MURR Part 50 license to add a production facility function to the existing utilization facility function.
Add Mo-99 Capability Submit license amendment maintaining RTR status, but noting that production is a much more significant part of licensed activities. Potential impacts on FSAR, risk analysis, consequence analysis, level of NRC oversight, security, EP, TS, financial assurance, etc.
Does the LA involve a material alteration of the facility?
License amendment (LA) request invokes 10 C.F.R. §§ 50.90-50.92 Process Public notice.
NRC processes license amendment request.
Submit a license amendment to add second type of license to existing Part 50 license. Potential impacts on FSAR, risk analysis, consequence analysis, level of NRC oversight, security, EP, TS, financial assurance, etc.
If NSHC determination, NRC issues license amendment (after NRC staff review).
No Post-issuance hearing, if requested.
No NSHC determination; opportunity for pre-approval hearing.
Pre-issuance hearing successful =
issue license amendment.
Option 1 amendment to current 104(c) license with no e in utilization facility status.
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Providing quality nuclear research, education and service to a global community 14 MURRs Proposed Licensing Approach Option 1 MURR to submit an amendment to the current Part 50, Class 104(c) license with no change in utilization facility status Implementation of GA SGE technology at MURR is not considered an alternation or material alteration to the facility and thus does not require a construction permit 14
Providing quality nuclear research, education and service to a global community 15
- Part 50 License Amendment Justification -
- 1. Appears to be the most straight forward and applicable;
- 2. Historical basis for clear and concise regulatory requirements; and
- 3. Provides the most expeditious pathway to begin meeting U.S. patient needs.
MURRs Proposed Licensing Approach 15
Providing quality nuclear research, education and service to a global community 16
- Reactor power level is determined using a power calorimetric and a secondary heat balance as a double check.
- Calculation includes power (heat) generated by the reactor core and also conservatively includes heat generated in the reflector regions by experiments, structural materials, stored irradiated fuel etc. - (Primary coolant delta-T x flow)
+ (Pool coolant delta-T x flow).
- GA SGE coolant loop will be instrumented (flow and temperature) such that power (heat) generated by target assembly will be known.
- MURR feels that power generated by SGE target should not be included in licensed power level determination.
MURR Licensed Power Level - 10 MWth 16
Providing quality nuclear research, education and service to a global community 17
- Implementation of GA SGE technology does not reclassify MURR from a research reactor to a testing facility.
- Option 1 appears to be the most straightforward and applicable licensing approach.
- No guidance on what a alteration or material alternation means.
- Unaware of what the implications are of being reclassified from a utilization facility to a production facility.
- Unaware if a facility can be classified as both a utilization and production facility.
- Heat generated by SGE target assembly should not be included in the MURR licensed power level.
Summary 17
Providing quality nuclear research, education and service to a global community Thanks for your attention, questions?
Thanks for your attention, questions?