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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↗

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and consensus standards were carried out, however, the vast majority of those SFR standards are currently in a withdrawn or inactive status.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 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↗

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↗

Long-Term Time Series of Remote Sensing Observations for Development of Regulatory Water Quality Standards

Water quality standards in the U.S. consist of: designated uses (the services that a water body provides; e.g., drinking water, aquatic life, harvestable species, recreation) . criteria that define the environmental conditions that must be maintained to support the uses For estuaries and coastal waters in the Gulf of Mexico, there are no numeric (quantitative) criteria to protect designated uses from effects of nutrients. This is largely due to the absence of adequate data that would quantitatively link biological conditions to nutrient concentrations. The Gulf of Mexico Alliance, an organization fostering collaboration between the Gulf States and U.S. Federal agencies, has identified the development of the numeric nutrient criteria as a major step leading to reduction in MODIS Products Figure 6. Map of the Mobile Bay with a yellow patch indicating the Bon Secour Bay area selected in this study for averaging water clarity parameters retrieved from MODIS datasets. nutrient inputs to coastal ecosystems. Nutrient enrichment in estuaries and coastal waters can be quantified based on response variables that measure phytoplankton biomass and water clarity. Long-term, spatially and temporally resolved measurements of chlorophyll a concentration, total concentration of suspended solids, and water clarity are needed to establish reference conditions and to quantify stressor-response relationships.

Blonski, Slawomir↗

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↗

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↗

Investigation and Demonstration of Reliability Target Allocation to Support Reliability and Integrity Management Program

Nuclear energy is the most reliable and environmentally sustainable energy source available today. In the United States (U.S.), nuclear-generated power accounts for approximately 20% of total electricity and over 55% of clean energy. New advanced reactors have enormous potential to help further decarbonize the energy market, enhance grid resiliency, create new jobs, and build a stronger economy. More than 50 new reactors are being developed in the U.S., and the federal government realizes an urgent need to deploy nuclear technologies to meet the country’s energy, environmental, and national security goals. As such, the U.S. Department of Energy (DOE) launched multiple programs to support advanced reactor deployment. The research described in this report explores implementation strategies for the Reliability and Integrity Management Program that directly supports the DOE goal to enable the near-term deployment of the advanced reactor technologies. The project is conducted under the Regulatory Development Program for advanced reactors sponsored by the DOE.

22 GENERAL STUDIES OF NUCLEAR REACTORS↗

Review of Canadian mobile satellite systems institutional arrangements policy

Development of institutional arrangements policy for maritime, land, and aeronautical mobile satellite systems (MSS) is an integral part of the Canadian telecommunications policy process. An ongoing activity in that process is fitting of MSS institutional arrangements policy within the confines of the 1987 Canadian Telecom Policy Framework. Making sure the fit is correct is a major task at present because technology seems to be driving service demand at rapid growth rates, particularly in the case of land MSS. This growth is stimulating policy and regulatory development efforts to keep pace. In Canada, this is happening in four planned MSS applications areas: Canada-US transborder (immediate), aeronautical MSS (1990/94), Telesat Mobile Inc. EMDS via INMARSAT (1990), and MSAT (1993/94). The need for an up-to-date MSS policy in these areas is emphasized by related developments in the US and elsewhere. It arises because of the growing number of market initiatives proposing North American rather than Canada-only or US-only coverage, such as INMARSAT, Geostar, OmniTRACS, and Starlink.

Gilvary, David↗

Reliability and Integrity Management Program Implementation Approach

Nuclear energy is the most reliable and environmentally sustainable energy source available today. In the United States, nuclear-generated power accounts for approximately 20% of total electricity and over 55% of clean energy. New advanced reactors have enormous potential to help further decarbonize the energy market, enhance grid resiliency, create new jobs, and build a stronger economy. More than 50 new reactors are being developed in the United States, and the federal government realizes an urgent need to deploy nuclear technologies to meet the country’s energy, environmental, and national security goals. As such, the U.S. Department of Energy launched multiple programs to support advanced reactor deployment. The research described in this paper explores implementation strategies for the Reliability and Integrity Management Program that directly supports the U.S. Department of Energy goal to enable the near-term deployment of the advanced reactor technologies. The project is conducted under the Regulatory Development Program for advanced reactors sponsored by the U.S. Department of Energy.

22 GENERAL STUDIES OF NUCLEAR REACTORS↗

Research Lasers and Air Traffic Safety: Issues, Concerns and Responsibilities of the Research Community

The subject of outdoor use of lasers relative to air traffic has become a diverse and dynamic topic. During the past several decades, the use of lasers in outdoor research activities have increased significantly. Increases in the outdoor use of lasers and increases in air traffic densities have changed the levels of risk involved. To date there have been no documented incidents of air traffic interference from research lasers; however, incidents involving display lasers have shown a marked increase. As a result of the national response to these incidents, new concerns over lasers have arisen. Through the efforts of the SAE G-10T Laser Safety Hazards Subcommittee and the ANSI Z136.6 development committee, potential detrimental effects to air traffic beyond the traditional eye damage concerns have been identified. An increased emphasis from the Federal Aviation Administration (FAA), the Center for Devices and Radiological Hazards (CDRH), and the National Transportation Safety Board (NTSB) along with increased concern by the public have resulted in focused scrutiny of potential hazards presented by lasers. The research community needs to rethink the traditional methods of risk evaluation and application of protective measures. The best current approach to assure adequate protection of air traffic is the application of viable hazard and risk analysis and the use of validated protective measures. Standards making efforts and regulatory development must be supported by the research community to assure that reasonable measures are developed. Without input, standards and regulations can be developed that are not compatible with the needs of the research community. Finally, support is needed for the continued development and validation of protective measures.

Nessler, Phillip J., Jr.↗