ML17264A903

Licensing Novel Technologies within the U.S. Nuclear Regulatory Commissions Existing Regulatory Framework

ML17264A903
Person / Time
Issue date:	10/31/2017
From:	Steven Lynch NRC/NRR/DPR/PRLB
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Lynch S
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ML17264A901	List: ML17264A903
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Download: ML17264A903 (18)

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Licensing Novel Technologies within the U.S. Nuclear Regulatory Commissions Existing Regulatory Framework Steven Lynch Office of Nuclear Reactor Regulation U.S. Nuclear Regulatory Commission October 2017

Non-power Reactor Licensing

• Types of non-power reactor licenses

- Research and test reactors

- Commercial facilities

• Applicable regulatory requirements and guidance

• Licensing process

• Current reviews involving novel technologies 2

Classes of Non-Power Reactors

• Pursuant to the Atomic Energy Act (AEA), the NRC licenses production and utilization facilities

• All current reactors, both power and non-power, are licensed as utilization facilities

• Two primary classes of non-power reactor licenses:

- Section 103 Commercial Licenses

- Section 104 Medical Therapy and Research and Development Licenses 3

Section 104 Medical Therapy and Research and Development Licenses

• Three subsets of Section 104 licenses in AEA:

- 104(a) - Medical therapy

- 104(b) - Early industrial and commercial demonstration

- 104(c) - Research and development

• All NRC-licensed research and test reactors licensed pursuant to Section 104(c) of the AEA

• One facility also holds a 104(a) license 4

Research and Test Reactors

• AEA directs Commission to impose minimum amount of regulation of 104(c) licensees necessary to fulfill Commissions obligations

• NRC licenses research and test reactors under regulations in Title 10 of the Code of Federal Regulations, Part 50, Domestic Licensing of Production and Utilization Facilities 5

Definitions

• Research reactor: a nuclear reactor licensed under subsection 104c of the AEA for operation at 10 megawatts or less, and is not a testing facility

• Testing facility: a nuclear reactor licensed under subsection 104c of the AEA for 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 for 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 6

Section 103 Commercial Licenses

• A facility is deemed commercial if more than 50 percent of the annual cost of owning and operating is devoted to sale of materials, products, energy, or services

• Examples of non-power facilities licensed pursuant to Section 103 of the AEA

- Medical radioisotope facilities proposing to produce molybdenum-99 (99Mo)

- Prototype plants 7

Licensing Comparison

• Test Reactors

- Occupational dose requirements: 10 CFR 20.1201

- Public dose requirements: 10 CFR 20.1301

- Accident dose requirements: 10 CFR 100.11

- Require Environmental Impact Statement (EIS),

hearing, and ACRS Review

• Research Reactors

- Occupational dose requirements: 10 CFR 20.1201

- Public dose requirements: 10 CFR 20.1301

- Accident dose guidance: NUREG-1537

- No EIS, hearing, or ACRS review required 8

Applicable Regulatory Guidance

• NUREG-1537, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors

• Regulatory Guides

- Division 2, Research and Test Reactors

- Division 5, Materials and Plant Protection

- Guidance on technical specification development, quality assurance program requirements, and emergency planning

• ANS/ANSI Research Reactor Standards ANS 15 Series (15.1, 15.2, 15.4, 15.8, 15.11, 15.16) referenced by guidance 9

10 CFR Part 50 Licensing Process Applications contain both general and technical information Construction permit application

- Environmental report

- Preliminary safety analysis report (PSAR)

Operating license application

- Update to environmental report, as necessary

- Final safety analysis report (FSAR)

- Physical security plan

- Safeguards contingency plan

- Protection against unauthorized disclosure May submit applications separately or together Testing facilities and commercial facilities may request limited work authorization to allow certain construction activities prior to the issuance of a construction permit 10

Test Reactor Construction Permit Review Environmental Review Review by ACRS*

Mandatory hearing Application submitted to NRC Commission Decision on Permit Possible contested hearing Safety Review

• Advisory Committee on Reactor Safeguards 11

Test Reactor Operating License Review Environmental Review Review by ACRS*

Possible hearing Application submitted to NRC Commission Decision on License Safety Review

• Advisory Committee on Reactor Safeguards 12

Medical Isotope Licensing Reviews

• Majority of proposals involve low enriched uranium fission

- Reactor and non-reactor technologies

- Solid clad and aqueous solution targets

- New and existing facilities

- Hot cells for separation of fission products

• Most facilities licensed under 10 CFR Part 50

- Target irradiation performed by utilization facilities

- Fission product separation in production facilities 13

Addressing Novel Technology Through Regulatory Guidance

• Interim Staff Guidance (ISG) Augmenting NUREG-1537

- Radioisotope production facilities

- Aqueous homogeneous reactors

- Incorporates relevant non-reactor guidance from NUREG-1520, Standard Review Plan for the Review of a License Application for a Fuel Cycle Facility, Rev. 1 14

SHINE Medical Technologies, Inc.

• Proposes to produce 99Mo from fission of low enriched uranium target solution in 8 irradiation units 99Mo recovered through irradiated target solution processing in 3 hot cells

• Direct final rule issued modifying definition of utilization facility to include SHINE irradiation units

• Construction permit issued in February 2016 month application review from time of docketing 15

Northwest Medical Isotopes, LLC

• Proposes to manufacture low enriched uranium targets for irradiation at existing research reactors

• 99Mo recovered through hot cell processing of irradiated targets

• Target irradiations performed by existing research reactors

• Construction permit application review ongoing 16

Ongoing 99Mo Infrastructure and Support Activities

• Developing construction and operation inspection programs

• Reviewing regulations and guidance

• Coordinating technical and licensing expertise through inter-office working group

• Maintaining communication with stakeholders

- Federal government

- State and local governments

- Public 17

Getting Started: Pre-Application Interactions

• For novel technologies, early interaction supports efficient application processing and review

• Public Meetings

- Promote engagement between NRC and potential applicant

- Inform the development of high-quality applications

- Inform budgeting and resource allocation

- Inform public of NRC process 18