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At least 19 records

AMMT-Regulatory Development Collaboration Scoping Project

This project was initiated by the Regulatory Development (RD) Program to identify potential collaborations in work scope between the Advanced Materials and Manufacturing Technologies (AMMT) Program and the Regulatory Development Program. During Fiscal Year 2025, RD Program staff met with members of the AMMT Program, including the national technical director and multiple technical area leads to discuss ongoing work and areas where regulatory interactions with the Nuclear Regulatory Commission (NRC) would increase the efficiency to get new materials and manufacturing technologies approved for industry use. RD staff would like to thank the AMMT staff for their participation in these interactions to identify areas of potential collaboration.

11 - NUCLEAR FUEL CYCLE AND FUEL MATERIALS↗

Overview of DOE Regulatory Development

This is the overview of DOE Regulatory Development Program under the Advanced Reactor Demonstration Program. This will be a presentation for the NRC Advanced Reactor Stakeholder Meeting on March 27, 2024.

99 GENERAL AND MISCELLANEOUS↗

Regulatory Development & Support for Advanced Reactor Technology Program

During 2012, the Department of Energy (DOE) instituted an Advanced Reactor Concepts Technical Review Panel process to evaluate viable reactor concepts from industry and identify research and development needs. Early in the process, the Technical Review Panel members and advanced reactor designers noted the need to develop a regulatory framework for non-light water advanced reactors to reduce risk and uncertainty to the industry. Concurrently, and in response to Congressional direction, the Nuclear Regulatory Commission (NRC) provided a report to Congress on advanced reactors. In this report, NRC noted that several reactor vendors also identified the need for regulatory guidance for advanced non-light water reactor designs.

11 NUCLEAR FUEL CYCLE AND FUEL MATERIALS↗

Regulatory Development Challenges and Opportunities for the Safe and Secure Transport of Radioactive Materials

Drafting regulations for transport safety and transport security achieve two separate objectives, which can lead to divergent outcomes. With transport safety, the principle goal is to protect the public and the environment from the effects of ionizing radiation, while in contrast, the principle goal of transport security is to protect the material from malicious actors. While many Member States may have transport safety regulations for radioactive materials, transport security regulatory development is still in its nascent stages globally. Trying to develop harmonized transport safety and transport security regulations could lead to challenges ranging from differences in terminology used in transport safety versus terminology uses in transport security, roles and responsibilities for the variety of stakeholders involved in transport, and finally, the possible role of multiple competent authorities in governing the transport of dangerous goods, which includes radioactive material. While the International Atomic Energy Agency (IAEA) is currently developing a process of a methodology for drafting transport security regulations, any process must address both safety considerations and security requirements. (As the most vulnerable part of the life cycle of radioactive materials, the need for harmonized transport safety/transport security regulations is essential.) This paper investigates the regulatory elements of the safety-security interface for nuclear and other radioactive material in transport. Examining challenges including use of terms, the role of multiple competent authorities, and practical challenges involved in the safe and secure transport of radioactive material, the paper analyzes the need for integrated regulatory development for the safe and secure transport of these materials.

Anderson, Kimberly↗

Assessment of Sodium Fast Reactor Specific Consensus Standards and Recommendations for Future Regulatory Development for Standards Activities

The U.S. has designed, constructed, and operated several sodium fast reactors (SFRs). To support these efforts and to document best practices, activities associated with the development of standards and consensus standards were carried out, however, the vast majority of those SFR standards are currently in a withdrawn or inactive status. Consensus standards are useful during design and licensing of reactors, as is evident in the current nuclear power generation fleet. Consensus standards provide certainty and predictability between stakeholders during licensing and other regulatory interactions. These standards offer guidance, reflect expert positions, and establish effective practices for a wide range of topics. Consensus standards are developed by committees with representation from a broad cross-section of industry, organizations, professional societies, and government agencies. However, most existing consensus standards applicable to nuclear power plants were developed specifically for light-water reactor (LWR) designs and may not adequately address specific advanced non-LWR design topics such as those related to SFRs.

21 SPECIFIC NUCLEAR REACTORS AND ASSOCIATED PLANTS↗

Regulatory Development for Advanced Manufacturing

Advanced Methods of Manufacturing (AMM) are new, novel manufacturing processes that have the potential to bring significant cost and schedule reductions to many industries, including the nuclear industry. These methods produce components faster and cheaper than many traditional methods. This includes replacing obsolete components at currently operating plants as well as manufacturing components of all sizes for advanced reactors.

11 NUCLEAR FUEL CYCLE AND FUEL MATERIALS↗

Regulatory Considerations Regarding Potential High Temperature Fluid Releases in Advanced Reactor Designs

The current effort is supported by the U.S. Department of Energy (DOE), Advanced Reactor Demonstration Program (ARDP) Regulatory Development, Regulatory Framework Modernization area, which seeks to address potential regulatory challenges for advanced reactor vendors that are currently or will soon be initiating the licensing process. In pursuit of this goal, this effort seeks to aid the advanced reactor industry and regulatory bodies in understanding and addressing the potential occurrence of high-temperature fluid releases in advanced reactor designs as part of licensing and regulatory oversight of operation. Improving the awareness and understanding of the behavior and potential consequences associated with high-temperature fluid release events can ensure that they are appropriately considered and addressed.

22 GENERAL STUDIES OF NUCLEAR REACTORS↗

Advanced Reactor Regulatory Framework Development Activities for Fiscal Year 2023

This report provides an end-of-year summary that reflects the progress and status of Idaho National Laboratory’s (INL) activities concerning the development of advanced reactor (AR) regulatory framework and its implementation in the United States (U.S.). The report also summarizes some general updates on important topics in regulatory development. This work was completed in Fiscal Year 2023 (FY-23) and was supported by the U.S. Department of Energy (DOE) Regulatory Development sub-program. These activities are managed by INL on behalf of DOE.

29 ENERGY PLANNING, POLICY, AND ECONOMY↗

Summary Status of FY21 Regulatory Framework Development Activities and Associated Progress.

This report provides an end-of-year summary that reflects the progress and status of Idaho National Laboratory’s activities concerning advanced reactor regulatory framework development and implementation in the U.S. This work was done in FY 2021 and supported regulatory development for the U.S. Department of Energy (DOE) Advanced Reactor Technologies Program. These activities are managed by Idaho National Laboratory on behalf of the U.S. DOE.

11 NUCLEAR FUEL CYCLE AND FUEL MATERIALS↗

Regulatory Framework Modernization Program

This presentation discusses the work performed/being performed under the DOE Regulatory Development-Regulatory Framework Modernization Area in FY24

99 GENERAL AND MISCELLANEOUS↗

Considerations for Developing a Regulatory Roadmap for Distributed Energy Resource (DER) Integration in Colombia

The USAID-NREL Partnership in Colombia, in conjunction with SURE and USEA, selected four action plan teams from the Young Professionals Leadership Program to receive tailored NREL technical assistance to support action plan implementation. The four plans selected represent various aspects associated with planning for the efficient integration of DERs, including electric mobility, residential and commercial energy applications, distributed generation modeling, and regulatory considerations. In response to national grid modernization, decentralization, digitalization, and electrification trends, CREG is looking to update Colombia's electric distribution code, with an emphasis on the integration of electric vehicles and charging stations, but also energy storage systems, non-conventional sources of renewable energy, and other distributed energy resources (DERs). CREG aims to establish the general steps that must be carried out to update the distribution code for the integration of DERs, with a view to the design and development of new markets. The objective of the TA provided to CREG was to support them in identifying and outlining the general processes and approaches to consider when updating Colombia's distribution code for the integration of electric vehicles, distributed renewable energy systems, and energy storage systems, with a view to the design and development of new markets.

24 POWER TRANSMISSION AND DISTRIBUTION↗

Status Quo in V2G/V2H: Closer Look at CA's Progress

This presentation will guide participants through the progress of V2G interconnection, using California's regulatory development as a case study. The focus will be on utility-side considerations rather than EVs themselves, and as such, EV-EVSE interactions will not be covered. Since V2G DC is already accommodated within the existing grid interconnection process, the majority of the discussion will center on V2G AC, particularly the regulatory and standards development.

24 POWER TRANSMISSION AND DISTRIBUTION↗

A call to standardize metrics for monitoring baleen whales near marine construction activities

Effective monitoring is necessary to protect marine mammal species during the construction of offshore infrastructure. The tools for detecting or monitoring marine mammals span traditional (e.g., visual observers, optical cameras), to newer (e.g., passive acoustic monitoring, infrared cameras, tags), and emerging (e.g., satellite imagery, environmental DNA, dimethyl sulfide concentration) technologies. Some are better suited for use during offshore development; however, peer-reviewed literature does not typically evaluate and report on the performance of these various technologies. We define a minimum set of metrics related to efficacy (i.e., confusion matrix, precision and recall, probability of missed mitigation), detection range (i.e., maximum and reliable detection range, spatial resolution), and data delivery (i.e., detection latency, system reliability, temporal resolution) that we recommend are needed to assess the utility of monitoring technologies for this purpose. Following a literature review of relevant studies, we highlight which publications reported these metrics and used multiple technologies to compare relative performance. We also emphasize the benefits of multi-modal approaches and recommend performance assessments through modeling or large-scale collaborative field testing. These metrics will standardize data collection, reporting, and analysis; promote consistent and comparable results; and foster collaboration among developers, regulatory agencies, and scientists. This may lead to the co-development of technology that achieves multiple goals, has greater application, and can answer research questions while collecting data to fulfill permitting requirements. These metrics may also inform decisions on what systems regulatory agencies might consider using and reduce monitoring costs, which is critical to support the marine sector's rapid growth alongside marine mammal conservation.

32 ENERGY CONSERVATION, CONSUMPTION, AND UTILIZATI↗

Evaluation of ASCE 4-16 and AISC 43-18 (Draft) for use in the Risk-Informed Performance-Based Seismic Design of Nuclear Power Plant Structures, Systems, and Components

This report describes the assessment of ASCE Standards 4-16 and 43-18 (Draft) for use in the Risk-Informed Performance-Based (RIPB) seismic design of structures, systems, and components (SSCs) at nuclear power plants. This work was performed for the U.S. Nuclear Regulatory Commission (NRC) Office of Regulatory Research (RES), to support potential endorsement of these industry standards for the design of nuclear power plants based on the RIPB approach. Currently, the NRC endorses a deterministic design approach for demonstrating the design adequacy of SSCs based on the Standard Review Plan (NUREG-0800) and NRC Regulatory Guides. In the RIPB approach, the design criteria are developed to achieve a target performance goal, which is defined by the annual frequency of occurrence of the design basis earthquake (i.e., Seismic Design Category) and the acceptable level of structural performance (i.e., Limit State) for the SSCs. ASCE 4-16 provides methods for performing a seismic analysis of structures to obtain the seismic response of these structures (e.g., building displacements, accelerations, in-structure response spectra) which are used in the design of the SSCs. It also provides methods for performing seismic analysis of SSCs to determine the seismic demands (e.g. member forces and displacements) needed to design individual SSCs. ASCE 43-18 (Draft) provides the criteria for the seismic design of SSCs using the seismic demands developed in ASCE 4-16. The use of ASCE Standard 43-18 (Draft), along with ASCE 4-16, provides the criteria for the seismic design of the SSCs. ASCE 43-18 (DRAFT) relies on other consensus codes and standards such as ACI 349 for reinforced concrete, AISC/N690 for steel structures, ASME Section III for pressure-retaining mechanical components and Containments, and IEEE-344 for Class 1E equipment. The goal of this technical review was to assess the adequacy of the provisions in these standards for use by the NRC in developing regulatory guidance for design of SSCs in nuclear power plants, based on the RIPB approach. The research reported herein describes the basis for acceptance of the new standards and identifies areas where additional staff guidance is needed for the seismic design of SSCs at nuclear power plants. This technical review has determined that ASCE 4-16 and ASCE 43-18 (Draft) provide an appropriate framework for the seismic design of SSCs at nuclear power plants using a Risk-Informed Performance-Based approach. However, some of the criteria therein warrant exceptions, qualifications, and/or clarifications.

42 ENGINEERING↗

Clinical pharmacology information in regulatory submissions and labeling: A comparative analysis of orphan and non-orphan drugs approved by the FDA

Clinical pharmacology is an integral discipline supporting the development, regulatory evaluation, and clinical use of drugs for the treatment of both common and rare diseases. Here, we evaluated the recommendations and information available from select clinical pharmacology studies in the therapeutic product labeling of new molecular entities (NMEs) approved from 2017 to 2019 for both common and rare diseases. A total of 151 NMEs, including 72 orphan and 79 non-orphan drugs, were analyzed for recommendations and information available related to food–drug interaction, drug–drug interaction, renal impairment, hepatic impairment, QT assessment, and human radiolabeled mass balance studies using data collected from the original labeling and other regulatory documents. The analysis showed no statistically significant difference in the recommendations between orphan and non-orphan drugs except for renal impairment related recommendations in section 8 of the labeling. Although not significant, fewer hepatic impairment labeling recommendations were available for orphan drugs when compared with non-orphan drugs. At the time of initial approval, 79 postmarketing requirements (PMRs) and postmarketing commitments (PMCs) for 33 orphan drugs and 39 PMRs and PMCs for 19 non-orphan drugs were established; with most difference observed for drug–drug interaction, hepatic impairment, and QT assessment. Overall, although there was a trend for more labeling recommendations and fewer postmarketing studies and clinical trials for non-orphan drugs, there appeared to be no substantial differences in how these select clinical pharmacology studies are leveraged during the development and approval of orphan and non-orphan drugs.

60 APPLIED LIFE SCIENCES↗

Phase II Field Demonstration at Lansing Smith Generating Plant, Southport, Florida (Final Report)

The Final Technical Report: Field Test Design and Pressure Management Strategies for Phase II Field Demonstration of Optimal Pressure Control, Plume Management, and Produced Water Strategies presents the culmination of multi-year efforts under the U.S. Department of Energy’s Brine Extraction and Storage Test (BEST) program, led by EPRI in partnership with Gulf Power at the Plant Smith site near Panama City, Florida. The project was designed to evaluate and demonstrate the technical feasibility of managing subsurface pressures and fluid movement associated with large-scale CO₂ injection, using low-salinity water as a proxy fluid. Through a combination of field injection testing, reservoir modeling, and optimization studies, the research team developed and refined active and passive brine extraction strategies aimed at controlling injection-induced pressure buildup, mitigating risks of fault activation, and managing plume migration. The field demonstration incorporated a new injection well (TIW-2), a new monitoring/extraction well (TEMW-A), and an existing well (TIW-1) repurposed for passive pressure relief. Complementary geophysical monitoring was designed to track plume development and evaluate the effectiveness of pressure management strategies. The report details the integrated workflow encompassing wellfield development, regulatory permitting, model calibration, and survey design. It includes a comprehensive electromagnetic (EM) modeling and inversion study used to develop a cost-effective, time-lapse geophysical monitoring plan capable of imaging the evolving low-salinity plume within the highly saline Lower Tuscaloosa formation. Reservoir simulation results guided the design of the 17-month injection program and the timing of active extraction to maintain formation pressures below a hypothetical fault reactivation threshold. Supporting analyses evaluated potential injectivity risks related to clay fines migration and geochemical incompatibility, identifying practical mitigation measures such as salinity and pH control. The final design recommends a series of crosswell EM surveys—conducted before, during, and after injection—as the most effective and economical approach for plume imaging, supplemented by continuous downhole pressure and flow monitoring. Collectively, the study provides a field-ready framework for cost-effective pressure management and monitoring in support of future CO₂ storage projects.

01 COAL, LIGNITE, AND PEAT↗