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441,568 result(s) for "Federal regulations"
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Phage therapy redux — What is to be done?
Bacteriophage biology should move beyond a model system to support human health Phage therapy is the use of bacteriophages—viruses that infect and replicate within a bacterium—to treat pathogenic bacteria. This approach had a short history in the premolecular era of Western medicine, but it died out before the mid-20th century mainly as a result of justly critical reports from the American Medical Association and the development of chemical antibiotics ( 1 ). Now, the global antibiotic resistance crisis and a new appreciation for the importance of the human microbiota have led to a resurgence of interest in phage therapy, not only in the classic sense of treating bacterial infections ( 2 ) but also for its potential role in modulating microbiota ( 3 ). A landmark 2015 meeting ( 4 ) on phage-based therapeutics hosted by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) included not only phage biologists but also participants from private companies, public and governmental research organizations, clinicians, and the federal regulatory community. Opinions on the practicality of phage applications replacing traditional antibiotic regimens ranged from full-speed ahead, mostly from the biotechnology industry, to overt skepticism on the part of some physicians. In any case, participants left the meeting convinced that a “Phage Therapy 2.0” is on its way.
RegBR: A novel Brazilian government framework to classify and analyze industry-specific regulations
Government transparency and openness are key factors to bring forth the modernization of the state. The combination of transparency and digital information has given rise to the concept of Open Government, that increases citizen understanding and monitoring of government actions, which in turn improves the quality of public services and of the government decision making process. With the goal of improving legislative transparency and the understanding of the Brazilian regulatory process and its characteristics, this paper introduces RegBR, the first national framework to centralize, classify and analyze regulations from the Brazilian government. A centralized database of Brazilian federal legislation built from automated ETL routines and processed with data mining and machine learning techniques was created. Our framework evaluates different NLP models in a text classification task on our novel Portuguese legal corpus and performs regulatory analysis based on metrics that concern linguistic complexity, restrictiveness, law interest, and industry-specific citation relevance. Our results were examined over time and validated by correlating them with known episodes of regulatory changes in Brazilian history, such as the implementation of new economic plans or the emergence of an energy crisis. Methods and metrics proposed by this framework can be used by policy makers to measure their own work and serve as inputs for future studies that could analyze government changes and their relationship with federal regulations.
An economic evaluation of the Whole Genome Sequencing source tracking program in the U.S
The U.S. Food and Drug Administration (FDA) created the GenomeTrakr Whole Genome Sequencing (WGS) Network in 2013, as a tool to improve food safety. This study presents an analysis of Whole Genome source tracking implementation on potential food contamination and related illnesses through theoretical, empirical, and cost benefit analyses. We conduct empirical tests using data from FDA regulated food commodity outbreaks garnering FDA response from 1999 through 2019 and examine the effect of the National Center for Biotechnology Information (NCBI) Pathogen detection program of source tracking WGS isolates collected in the U.S. on outbreak illnesses for three pilot pathogens ( E . coli , Listeria , and Salmonella ). Empirical results are consistent with the theoretical model and suggest that each additional 1,000 WGS isolates added to the public NCBI database is associated with a reduction of approximately 6 illnesses per WGS pathogen, per year. Empirical results are connected to existing literature for a Monte Carlo analysis to estimate benefits and costs. By 2019, annual health benefits are estimated at nearly$500 million, compared to an approximately $ 22 million investment by public health agencies. Even under conservative assumptions, the program likely broke even in its second year of implementation and could produce increasing public health benefits as the GenomeTrakr network matures.
Looking backward to move regulations forward
Rigorous ex post analyses can improve regulatory policies Research-based evidence is critical for understanding and improving the impact of government regulation on society. Positions promoted by the Trump Administration question the effectiveness of many regulations, making their rigorous analysis all the more critical. Yet such research is relatively rare, especially for environmental rules, the most costly type of federal regulation in the United States ( 1 ). The principal source of information on costs, benefits, and distributional consequences of major regulations are ex ante studies such as regulatory impact analyses (RIAs) routinely conducted on proposed rules by U.S. federal agencies. Despite their rigor and complexity, RIAs are developed at “the point when the least is known and any analysis must rest on many unverifiable and potentially controversial assumptions” ( 2 ). By contrast, retrospective analysis can reaffirm (or question) the effectiveness of rules and the accuracy of RIAs and thereby aid the rational allocation of societal resources. Despite this advantage, many obstacles prevent widespread development of such ex post analyses. We discuss approaches to ex post analysis and suggest steps to broaden its use.
Online sale of small turtles circumvents public health regulations in the United States
In the United States (U.S.), pet turtles have been associated with outbreaks of salmonellosis, a serious and sometimes-fatal intestinal illness caused by Salmonella bacteria, with nearly 300,000 people being infected in some years. Children are particularly susceptible because of their propensity to put items, including small turtles, in their mouths. In 1975, a U.S. federal regulation prohibited the sale of turtles <4 inches (101.6 mm) in size, except for the purposes of export, scientific, or educational purposes. This regulation was established to reduce the incidence of salmonellosis, particularly in small children. Previous research has not evaluated the availability of turtles <4 inches in size on websites selling wildlife. We monitored 16 websites in 2021 and quantified listings of small turtles. We determined whether information on Salmonella , the 1975 federal regulation, or related state regulations were provided on the websites and determined legality of sales of small turtles by state regulations. We found that all 16 websites openly advertised and sold turtles <4 inches in size, but only half of these websites provided information about Salmonella and/or the federal regulation. These websites required buyers to confirm that they were not purchasing a turtle as a pet, thereby putting the onus on the consumer to adhere to the regulation. We documented 515 listings of turtles <4 inches in size, including 47 species and one hybrid. Our study has demonstrated that internet sales of small turtles currently represent part of the thriving online pet trade in the U.S. Enforcement of the federal regulation faces jurisdictional challenges in most states. Therefore, we recommend continued public education campaigns by public health agencies in the U.S. to help reduce the risk that pet turtle ownership presents.
The larger attachment glycoprotein of respiratory syncytial virus produced in primary human bronchial epithelial cultures reduces infectivity for cell lines
Respiratory syncytial virus (RSV) infects the upper and lower respiratory tracts and can cause lower respiratory tract infections in children and elders. RSV has traditionally been isolated, grown, studied and quantified in immortalized cell lines, most frequently HEp-2 cells. However, in vivo RSV infection is modeled more accurately in primary well differentiated human bronchial epithelial (HBE) cultures where RSV targets the ciliated cells and where the putative RSV receptor differs from the receptor on HEp-2 cells. The RSV attachment (G) glycoprotein in virions produced by HEp-2 cells is a highly glycosylated 95 kDa protein with a 32 kDa peptide core. However, virions produced in HBE cultures, RSV (HBE), contain an even larger, 170 kDa, G protein (LgG). Here we show that LgG is found in virions from both subgroups A and B lab-adapted and clinical isolates. Unexpectedly, RSV (HBE) virions were approximately 100-fold more infectious for HBE cultures than for HEp-2 cells. Surprisingly, the cause of this differential infectivity, was reduced infectivity of RSV (HBE) on HEp-2 cells rather than enhanced infectivity on HBE cultures. The lower infectivity of RSV(HBE) for HEp-2 cells is caused by the reduced ability of LgG to interact with heparan sulfate proteoglycans (HSPG), the RSV receptor on HEp-2 cells. The discovery of different infectivity corresponding with the larger form of the RSV attachment protein when produced by HBE cultures highlights the importance of studying a virus produced by its native host cell and the potential impact on quantifying virus infectivity on cell lines where the virus entry mechanisms differ from their natural target cell.
Greenhouse gas reporting data improves understanding of regional climate impact on landfill methane production and collection
A critical examination of the US Environmental Protection Agency’s (US EPA’s) Greenhouse Gas Reporting Program (GHGRP) database provided an opportunity for the largest evaluation to date of landfilled waste decomposition kinetics with respect to different US climate regimes. In this paper, 5–8 years of annual methane collection data from 114 closed landfills located in 29 states were used to estimate site-specific waste decay rates (k) and methane collection potentials (L c ). These sites account for approximately 9% of all landfills required to report GHG emissions to the US EPA annually. The mean methane collection potential (L c ) for the sites located in regions with less than 635 mm (25 in) annual rainfall was significantly (p<0.002) lower than the mean methane collection potential of the sites located in regions with more than 635 mm (25 in) annual precipitation (49 and 73 m 3 methane Mg -1 waste, respectively). This finding suggests that a fraction of the in-place biodegradable waste may not be decomposing, potentially due to a lack of adequate moisture content of landfills located in arid regions. The results of this evaluation offer insight that challenges assumptions of the traditional landfill methane estimation approach, especially in arid climates, that all methane corresponding to the total methane generation potential of the buried solid waste will be produced. Decay rates showed a significant correlation with annual precipitation, with an average k of 0.043 year -1 for arid regions (< 508 mm (20 in) year -1 ), 0.074 year -1 for regions with 508–1,016 mm (20–40 in) annual precipitation, and 0.09 year -1 in wet regions (> 1,016 mm (40 in) year -1 ). The data suggest that waste is decaying faster than the model default values, which in turn suggests that a larger fraction of methane is produced during a landfill’s operating life (relative to post-closure).
Caramel Color in Soft Drinks and Exposure to 4-Methylimidazole: A Quantitative Risk Assessment
Caramel color is added to many widely-consumed beverages as a colorant. Consumers of these beverages can be exposed to 4-methylimidazole (4-MEI), a potential carcinogen formed during its manufacture. California's Proposition 65 law requires that beverages containing 4-MEI concentrations corresponding to exposures that pose excess cancer risks > 1 case per 100,000 exposed persons (29 μg 4-MEI/day) carry warning labels. Using ultrahigh-performance liquid chromatography-tandem mass spectrometry, we assessed 4-MEI concentrations in 12 beverages purchased in California and a geographically distant metropolitan area (New York) in which warning labels are not required. In addition, we characterized beverage consumption by age and race/ethnicity (using weighted means calculated from logistic regressions) and assessed 4-MEI exposure and resulting cancer risks and US population cancer burdens attributable to beverage consumption. Data on beverage consumption were obtained from the National Health and Nutrition Examination Survey, dose-response data for 4-MEI were obtained from the California Environmental Protection Agency Office of Environmental Health Hazards Assessment, and data on population characteristics were obtained from the U.S. Census Bureau. Of the 12 beverages, Malta Goya had the highest 4-MEI concentration (915.8 to 963.3μg/L), lifetime average daily dose (LADD - 8.04x10-3 mg/kgBW-day), lifetime excess cancer risk (1.93x10-4) and burden (5,011 cancer cases in the U.S. population over 70 years); Coca-Cola had the lowest value of each (4-MEI: 9.5 to 11.7μg/L; LADD: 1.01x10-4 mg/kgBW-day; risk: 1.92x10-6; and burden: 76 cases). 4-MEI concentrations varied considerably by soda and state/area of purchase, but were generally consistent across lots of the same beverage purchased in the same state/area. Routine consumption of certain beverages can result in 4-MEI exposures > 29 μg/day. State regulatory standards appear to have been effective in reducing exposure to carcinogens in some beverages. Federal regulation of 4-MEI in caramel color may be appropriate.
How do federal regulations affect consumer prices? An analysis of the regressive effects of regulation
This study is the first to measure the impact of federal regulations on consumer prices. By combining consumer expenditure and pricing data from the Bureau of Labor Statistics, industry supply-chain data from the Bureau of Economic Analysis, and industry-specific regulation information from the Mercatus Center’s RegData database, we determine that regulations promote higher consumer prices, and that these price increases have a disproportionately negative effect on low-income households. Specifically, we find that the poorest households spend larger proportions of their incomes on heavily regulated goods and services prone to sharp price increases. While the literature explores other specific costs of regulation, noting that higher consumer prices are a probable consequence of heavy regulation, this study is the first to provide a thorough empirical analysis of that relationship across industries. Irrespective of the reasons for imposing new regulations, these results demonstrate that in the aggregate, the negative consequences are significant, especially for the most vulnerable households.
Understanding Small Water System Violations and Deficiencies
A 2014 study determined why small water systems were failing to comply with drinking water regulations; from the results, providers can target training and technical assistance to help small systems comply with the regulations.