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At least 271 records · Page 15

Regulatory Physiology

As noted elsewhere in this report, a central goal of the Extended Duration Orbiter Medical Project (EDOMP) was to ensure that cardiovascular and muscle function were adequate to perform an emergency egress after 16 days of spaceflight. The goals of the Regulatory Physiology component of the EDOMP were to identify and subsequently ameliorate those biochemical and nutritional factors that deplete physiological reserves or increase risk for disease, and to facilitate the development of effective muscle, exercise, and cardiovascular countermeasures. The component investigations designed to meet these goals focused on biochemical and physiological aspects of nutrition and metabolism, the risk of renal (kidney) stone formation, gastrointestinal function, and sleep in space. Investigations involved both ground-based protocols to validate proposed methods and flight studies to test those methods. Two hardware tests were also completed.

Lane, Helen W.↗

Purification and stability characterization of a cell regulatory sialoglycopeptide inhibitor

Previous attempts to physically separate the cell cycle inhibitory and protease activities in preparations of a purified cell regulatory sialoglycopeptide (CeReS) inhibitor were largely unsuccessful. Gradient elution of the inhibitor preparation from a DEAE HPLC column separated the cell growth inhibitor from the protease, and the two activities have been shown to be distinct and non-overlapping. The additional purification increased the specific biological activity of the CeReS preparation by approximately two-fold. The major inhibitory fraction that eluted from the DEAE column was further analyzed by tricine-SDS-PAGE and microbore reverse phase HPLC and shown to be homogeneous in nature. Two other fractions separated by DEAE HPLC, also devoid of protease activity, were shown to be inhibitory to cell proliferation and most likely represented modified relatives of the CeReS inhibitor. The highly purified CeReS was chemically characterized for amino acid and carbohydrate composition and the role of the carbohydrate in cell proliferation inhibition, stability, and protease resistance was assessed.

Non-NASA Center↗

Discovering the Regulatory Considerations of the Federal Aviation Administration: Interviewing the Aviation Rulemaking Advisory Committee

Maintenance Resource Management (MRM) training for aviation mechanics has become mandatory in many industrialized countries since 1998. Yet, to date, MRM training remains optional in the U.S. Interestingly, a similar safety discipline, namely Crew/Cockpit Resource Management (CRM), is mandatory for pilots, flight engineers, flight attendants, and dispatchers and is regulated in the Federal Aviation Administration s (FAA) Federal Aviation Regulations (FARs). If MRM training is important to enhance aviation technicians working behavior, the rationale to not regulate it opens a window for study. This research aims to inductively investigate the FAA s regulatory rationale concerning MRM training based on direct inputs from the FAA s Aviation Rulemaking Advisory Committee (ARAC) members. Delphi methodology associated with purposive sampling technique was adopted. The result revealed that the FAA cannot regulate MRM because the aviation industry is strongly opposed to it due to the lack of training budgets, the need of a quantifiable cost-effect analysis, concern over the FAA s inspection workforce, an ongoing voluntary alternative called the Air Transportation Surveillance System (ATOS), the government s lower priority on maintenance after 9/11, and the airlines tight embracement of operational flexibility without regulation.

Lu, Chien-tsung↗

Human System Integration: Regulatory Analysis

This document was intended as an input to the Access 5 Policy Integrated Product team. Using a Human System Integration (HIS) perspective, a regulatory analyses of the FARS (specifically Part 91), the Airman s Information Manual (AIM) and the FAA Controllers Handbook (7110.65) was conducted as part of a front-end approach needed to derive HSI requirements for Unmanned Aircraft Systems (UAS) operations in the National Airspace System above FL430. The review of the above aviation reference materials yielded eighty-four functions determined to be necessary or highly desirable for flight within the Air Traffic Management System. They include categories for Flight, Communications, Navigation, Surveillance, and Hazard Avoidance.

Source record↗

Can Regulatory Bodies Expect Efficient Help from Formal Methods?

In the context of EDEMOI - a French national project that proposed the use of semiformal and formal methods to infer the consistency and robustness of aeronautical regulations through the analysis of faithfully representative models- a methodology had been suggested (and applied) to different (safety and security-related) aeronautical regulations. This paper summarizes the preliminary results of this experience by stating which were the methodology s expected benefits, from a scientific point of view, and which are its useful benefits, from a regulatory body s point of view.

Lopez Ruiz, Eduardo R.↗

Regulatory response to a hybrid ancestral nitrogenase in Azotobacter vinelandii

Biological nitrogen fixation, the microbial reduction of atmospheric nitrogen to bioavailable ammonia, represents both a major limitation on biological productivity and a highly desirable engineering target for synthetic biology. However, the engineering of nitrogen fixation requires an integrated understanding of how the gene regulatory dynamics of host diazotrophs respond across sequence-function space of its central catalytic metalloenzyme, nitrogenase. Here, we interrogate this relationship by analyzing the transcriptome of Azotobacter vinelandii engineered with a phylogenetically inferred ancestral nitrogenase protein variant. The engineered strain exhibits reduced cellular nitrogenase activity but recovers wild-type growth rates following an extended lag period. We find that expression of genes within the immediate nitrogen fixation network is resilient to the introduced nitrogenase sequence-level perturbations. Rather the sustained physiological compatibility with the ancestral nitrogenase variant is accompanied by reduced expression of genes that support trace metal and electron resource allocation to nitrogenase. Our results spotlight gene expression changes in cellular processes adjacent to nitrogen fixation as productive engineering considerations to improve compatibility between remodeled nitrogenase proteins and engineered host diazotrophs.

nitrogen fixation↗

Air Pollutant Emissions and Regulatory Implications of Co-Processing Raw Bio-Oil in U.S. Petroleum Refineries

Pyrolysis oil, often referred as bio-oil or biocrude, has attracted considerable attention because it has higher energy density and carbon content compared to the raw biomass. Using pyrolysis oil derived from low cost and underutilized biomass to produce renewable hydrocarbon fuels provides a viable link between the agriculture/forestry and (petro-) chemical industry. Co-processing bio-oil with vacuum gas oil (VGO) in petroleum refinery is appealing due to the relatively low capital requirement to retrofit refinery and the compatibility of fuel products with existing infrastructure. In order to implement co-processing, a petroleum refinery would need to consider several process modifications and therefore could be subject to varying levels of air permitting requirements based on bio-oil co-processing ratio, co-processing capacity in existing units, the amount of regulated pollutants expected to be emitted, among other factors. This analysis considers co-processing 5% (by weight) of raw bio-oil with VGO in the fluidized catalytic cracking (FCC) unit(s) in a petroleum refinery. We estimate the potential increase in emissions of regulated air pollutants resulting from the modifications required to implement bio-oil co-processing and evaluate the regulatory and permitting implications for three FCC size categories in the U.S. refineries, which could co-processes raw bio-oil to produce partially renewable transportation fuels. We also assess technically feasible emission control options petroleum refineries could adopt to avoid being subject to major source permitting requirements if the estimated increase in regulated air pollutant emission exceeds the applicable threshold for major modifications. Insights from our analysis can help overcome challenges and risks associated with timely obtaining air permits required to implement bio-oil co-processing in existing refineries. Our analysis also provides needed information for decision makers (e.g., local air quality agencies) to understand the potential air quality implications for retrofitting refineries to co-process bio-oil, particularly in areas with high concentration of petroleum refineries.

09 BIOMASS FUELS↗

Regulatory and Policy Considerations for the Reuse and End-of-Life Management of Solar and Batteries in the U.S.

The demand for solar photovoltaics (PV) and lithium-ion batteries (LIB) is expected to continue in the U.S. as the call for solar is projected to quadruple by 2030 to meet renewable energy and decarbonization goals. The expected demand for PV and LIB brings supply chain concerns and a growing need for a circular economy for PV and LIB materials. Domestic reuse and recycling is one potential circular economy solution for PV and LIB. This presentation explores the current U.S. law and regulatory landscape for the reuse and recycling of PV and LIB materials, and how certain policy frameworks impact reuse and end-of-life management decisions for PV and LIB materials.

batteries↗

ADDITIVE MANUFACTURING AND REGULATORY TESTING OF CANISTERS FOR SPENT NUCLEAR FUEL MANAGEMENT

The back end of the fuel cycle focuses on the interim storage, transportation, and final disposition of the spent nuclear fuel from nuclear reactors. Commercial light water nuclear power stations across the United States operate with fuel assemblies being irradiated for up to 6 years (planned) in the reactor pressure vessel. After their planned irradiation, the fuel assemblies are moved to a spent fuel pool within the facility complex. After the spent nuclear fuel is removed from the fuel pool, it is typically inserted into a welded metal canister that can be transferred between overpacks for storage, transportation and possibly disposal. Most dry storage systems being used by industry today use dual purpose canisters (DPCs), designed for use in storage and transportation overpacks, but not specifically designed for disposal. Triple purpose-canisters, designed for disposal in addition to storage and transportation, have also been researched. Traditional manufacturing methods for spent fuel canisters involve fusion welding along the length or circumference of the canister which results in high tensile residual stresses in the joint weld zone (WZ) and heat affected zone (HAZ). In this paper, spent fuel canister designs were printed by wire arc additive manufacturing (AM) using the 316L SS welding wire to demonstrate: 1. Feasibility of spent nuclear fuel canister fabrication using this advanced manufacturing method, 2. Dynamic response of the additive manufacture canister design when subjected to the federally mandated Normal Conditions of Transport (NCT) and Hypothetical Accident Conditions (HAC) physical tests for Type B packages. This paper will focus on the canister printing design and structural tests. The AM 3D printed design, regulatory testing, and post-test evaluation of the canister tested to the 10 CFR 71.71 and 10 CFR 71.73 requirements will be presented. One AM canister design was subjected to the penetration, free drop, and puncture test. Before and after the dynamic structural tests, the AM canister design was scanned with a handheld scanner to capture a 3D CAD geometry to compare to the 3D printed canister design in the deformed shape. The scanned geometry was sectioned in areas with deformation and the cross-section profile was measured to determine accurate and repeated results of the deformed shape of the AM canister design.

Martinez, Oscar↗

Legal and Regulatory Aspects Related to Unmanned Aerial Systems (UAS) for Safeguards Implementation

The International Atomic Energy Agency (IAEA) is exploring the use of innovative technologies such as Unmanned Aerial Systems (UAS) to address safeguards verification challenges such as difficulties in accessing nuclear material in high radiation environments, and remotely located installations, as well as to increase the efficiency of safeguards implementation by automating repetitive and time-consuming tasks. As UAS continue to advance and their use becomes more frequent in high security conscious industries such as nuclear, their advantages in contributing to greater safety and security may weigh in favor of their use. However, as the IAEA begins to use these technologies, the legal, policy, and operational considerations associated with these advanced technologies will also need to be considered to identify any key opportunities, challenges, or areas of concern for the IAEA and its Member States. This paper will explore these areas and identify important considerations for the IAEA and its Member States to consider as the use of UAS is explored further for safeguards applications. It will also provide a series of recommendations for anticipating and addressing legal, regulatory, and policy challenges related to the use of UAS for safeguards implementation.

Siserman-Gray, Ioana-Cristina↗

Synergies Between Nuclear Security and Critical Infrastructure: National Legal and Regulatory Frameworks

Nuclear reactors and other nuclear facilities are part of a nation's critical infrastructure assets. Key cross-sector interdependencies, in relation to energy, transportation systems, communications, emergency services, water, information technologies and others, result in inevitable synergies between legal frameworks for the security of nuclear facilities and legal frameworks for the protection of critical infrastructure. The protection of nuclear facilities against sabotage and other malicious acts is paramount in ensuring energy security and thus ensuring uninterrupted energy supply. The protection of other sectors, such as uninterrupted communications, secure water supply, and others, supports a safe and secure operation of nuclear facilities. Some countries rely on broader critical infrastructure frameworks to impose security requirements on nuclear facilities, or to achieve robust cybersecurity systems. This paper will analyze the interdependencies and synergies between the legal and regulatory frameworks for critical infrastructure protection and nuclear facilities' security by comparing various national frameworks. The paper will also propose modalities to leverage the best practices and requirements from each framework towards energy security goals and stronger national nuclear security regimes.

Man, Madalina-Anca↗

Rational design and testing of abiotic stress‐inducible synthetic promoters from poplar cis ‐regulatory elements

Summary Abiotic stress resistance traits may be especially crucial for sustainable production of bioenergy tree crops. Here, we show the performance of a set of rationally designed osmotic‐related and salt stress‐inducible synthetic promoters for use in hybrid poplar. De novo motif‐detecting algorithms yielded 30 water‐deficit (SD) and 34 salt stress (SS) candidate DNA motifs from relevant poplar transcriptomes. We selected three conserved water‐deficit stress motifs (SD18, SD13 and SD9) found in 16 co‐expressed gene promoters, and we discovered a well‐conserved motif for salt response (SS16). We characterized several native poplar stress‐inducible promoters to enable comparisons with our synthetic promoters. Fifteen synthetic promoters were designed using various SD and SS subdomains, in which heptameric repeats of five‐to‐eight subdomain bases were fused to a common core promoter downstream, which, in turn, drove a green fluorescent protein (GFP) gene for reporter assays. These 15 synthetic promoters were screened by transient expression assays in poplar leaf mesophyll protoplasts and agroinfiltrated Nicotiana benthamiana leaves under osmotic stress conditions. Twelve synthetic promoters were induced in transient expression assays with a GFP readout. Of these, five promoters (SD18‐1, SD9‐2, SS16‐1, SS16‐2 and SS16‐3) endowed higher inducibility under osmotic stress conditions than native promoters. These five synthetic promoters were stably transformed into Arabidopsis thaliana to study inducibility in whole plants. Herein, SD18‐1 and SD9‐2 were induced by water‐deficit stress, whereas SS16‐1, SS16‐2 and SS16‐3 were induced by salt stress. The synthetic biology design pipeline resulted in five synthetic promoters that outperformed endogenous promoters in transgenic plants.

09 BIOMASS FUELS↗

Disrupting the ArcA Regulatory Network Amplifies the Fitness Cost of Tetracycline Resistance in Escherichia coli

There is an urgent need for strategies to discover secondary drugs to prevent or disrupt antimicrobial resistance (AMR), which is causing >700,000 deaths annually. Here, we demonstrate that tetracycline-resistant (Tet R ) Escherichia coli undergoes global transcriptional and metabolic remodeling, including downregulation of tricarboxylic acid cycle and disruption of redox homeostasis, to support consumption of the proton motive force for tetracycline efflux. Using a pooled genome-wide library of single-gene deletion strains, at least 308 genes, including four transcriptional regulators identified by our network analysis, were confirmed as essential for restoring the fitness of Tet R E. coli during treatment with tetracycline. Targeted knockout of ArcA, identified by network analysis as a master regulator of this new compensatory physiological state, significantly compromised fitness of Tet R E. coli during tetracycline treatment. A drug, sertraline, which generated a similar metabolome profile as the arcA knockout strain, also resensitized Tet R E. coli to tetracycline. We discovered that the potentiating effect of sertraline was eliminated upon knocking out arcA, demonstrating that the mechanism of potential synergy was through action of sertraline on the tetracycline-induced ArcA network in the Tet R strain. Our findings demonstrate that therapies that target mechanistic drivers of compensatory physiological states could resensitize AMR pathogens to lost antibiotics.

59 BASIC BIOLOGICAL SCIENCES↗

Networked Microgrid Optimal Design and Operations Tool: Regulatory and Business Environment Study

Microgrids aim to increase the resilience of the electric supply to the loads within the microgrid through the ability to disconnect from the distribution utility in the event of a power outage and by supplying power to the microgrid loads from a combination of multiple power generation assets and storage systems. Microgrids can also improve reliability at the distribution level by reducing the load on the system under stress conditions. Networking two or more microgrids has the potential to increase reliability and resilience at a reduced cost by taking advantage of economies of scale and increasing the diversity of the generation assets and loads. This report is part of a collaborative effort among several U.S. Department of Energy national laboratories to develop a networked microgrid (NMG) Optimal Design and Operations (OD&O) tool. This tool addresses the goal defined in the Grid Modernization Multi-Year Program Plan to develop a suite of tools that addresses functional requirements for system optimal design and the operations of NMGs.

24 POWER TRANSMISSION AND DISTRIBUTION↗