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Predictive Bayesian microbial dose-response assessment based on suggested self-organization in primary illness response: Cryptosporidium parvum.

The probability of illness caused by very low doses of pathogens cannot generally be tested due to the numbers of subjects that would be needed, though such assessments of illness dose response are needed to evaluate drinking water standards. A predictive Bayesian dose-response assessment method was proposed previously to assess the unconditional probability of illness from available information and avoid the inconsistencies of confidence-based approaches. However, the method uses knowledge of the conditional dose-response form, and this form is not well established for the illness endpoint. A conditional parametric dose-response function for gastroenteric illness is proposed here based on simple numerical models of self-organized host-pathogen systems and probabilistic arguments. In the models, illnesses terminate when the host evolves by processes of natural selection to a self-organized critical value of wellness. A generalized beta-Poisson illness dose-response form emerges for the population as a whole. Use of this form is demonstrated in a predictive Bayesian dose-response assessment for cryptosporidiosis. Results suggest that a maximum allowable dose of 5.0 x 10(-7) oocysts/exposure (e.g., 2.5 x 10(-7) oocysts/L water) would correspond with the original goals of the U.S. Environmental Protection Agency Surface Water Treatment Rule, considering only primary illnesses resulting from Poisson-distributed pathogen counts. This estimate should be revised to account for non-Poisson distributions of Cryptosporidium parvum in drinking water and total response, considering secondary illness propagation in the population.

Animals↗

Inactivation of enteric adenovirus and feline calicivirus by ozone.

Little information is available regarding the effectiveness of ozone on the inactivation of caliciviruses and enteric adenoviruses. Inactivation experiments were conducted with feline calicivirus (FCV), closely related to the human caliciviruses based on nucleic acid organization and capsid architecture, and adenovirus type 40 (AD40). Experiments were carried out in buffered disinfectant demand free water at pH 7 and 5 degrees C. Ct values; concentration of ozone multiplied by contact time with virus; were determined from application of the efficiency factor hom (EFH) model. Ct values for 4-log (99.99%) ozone inactivation at 5 degrees C and pH 7 ranged from 0.07 to 0.60 mg/l min for AD40 and <0.01 to 0.03 mg/l min for FCV. Ct values listed in the US environmental protection agency "Guidance Manual for Compliance with Filtration and Disinfection Requirements for Public Water Systems Using Surface Water Sources" were higher than Ct values generated by this study. Very low ozone residuals (<0.01(mg/l) substantially inactivated FCV and AD40 under the studied conditions.

Adenoviruses, Human↗

Evaluating public participation in environmental decision-making: EPA's superfund community involvement program.

This article discusses an 8-year, ongoing project that evaluates the Environmental Protection Agency's Superfund community involvement program. The project originated as a response to the Government Performance and Results Act, which requires federal agencies to articulate program goals, and evaluate and report their progress in meeting those goals. The evaluation project assesses how effective the Superfund community involvement program is in promoting public participation in decisions about how to clean up hazardous wastes at Superfund sites. We do three things in the article: (1) share our experience with evaluating an Agency public participation program, including lessons learned about methods of evaluation; (2) report evaluation results; and (3) address a number of issues pertaining to the evaluation of public participation in environmental decision-making. Our goal is to encourage more environmental managers to incorporate evaluation into their public participation programs as a tool for improving them. We found that written mail surveys were an effective and economical tool for obtaining feedback on EPA's community involvement program at Superfund sites. The evaluation focused on four criteria: citizen satisfaction with EPA information about the Superfund site, citizen understanding of environmental and human health risks associated with the site, citizen satisfaction with opportunities provided by EPA for community input, and citizen satisfaction with EPA's response to community input. While the evaluation results were mixed, in general, community members who were most informed about and involved in the cleanup process at Superfund sites generally were also the most satisfied with the community involvement process, and the job that EPA was doing cleaning up the site. We conclude that systematic evaluation provides meaningful and useful information that agencies can use to improve their public participation programs. However, there need to be institutionalized processes that ensure evaluation results are used to develop and implement strategies for improvement.

Community-Institutional Relations↗

Risk assessment and risk management of noncriteria pollutants.

Noncriteria air pollutants are synonymous with hazardous air pollutants (HAPs), air toxics or toxic air pollutants (TAPs). The term noncriteria pollutants refers to all air pollutants except for the criteria pollutants (SOx, PM, NOx, CO, O3, and Pb). Air toxics are pervasive in our environment worldwide in varying degrees. Uses of these chemicals are varied and numerous; their emissions are ubiquitous, and they include organic compounds such as chlorinated hydrocarbons, dioxins, aldehydes, polynuclear aromatic hydrocarbons, and heavy metals such as chromium, nickel, cadmium, and mercury. There are more than 70,000 chemicals that are in use commercially in the United States, and we know relatively little about their ambient concentrations, persistence, transport and transformation as well as their effects on health and the environment, many of which take decades to emerge. The United States Environmental Protection Agency, under the authority of Section 112 of the Clean Air Act, is mandated to regulate any air pollutant which, in the Administrator's judgment, "causes, or contributes to, air pollution which may reasonably be anticipated to result in an increase in serious irreversible or incapacitating reversible illness." For such regulatory decision-making, EPA's Office of Health and Environmental Assessment (OHEA) provides scientific assessment of health effects for potentially hazardous air pollutants. In accordance with risk assessment guidelines developed by OHEA over the years, Health Assessment Documents (HADs) containing risk assessment information were prepared and were subjected to critical review and careful revision to produce Final Draft HADs which serve as scientific databases for regulatory decision-making by the Office of Air Quality Planning and Standards (OAQPS) in its risk management process. EPA developed databases such as the Integrated Risk Information System (IRIS) and the National Air Toxics Information Clearinghouse (NATICH) and a technical assistance response system called the Air Risk Information Support Center (AIR RISC), in addition, to help in implementation of the National Air Toxics Program by state and local regulators.

Air Pollutants↗

Food Quality Protection Act: its impact on the pesticide industry.

Enacted into law by Congress in August 1996, the Food Quality Protection Act (FQPA) is the most significant piece of federal pesticide legislation since the 1988 amendments to the Federal Insecticide, Fungicide and Rodenticide Act. FQPA was hastily drafted and approved towards the end of the 1996 Congressional session. The new law was advertised as resolving some long-standing problems; however, it is clear now that it has also created some new ones. Since the FQPA's passage, the U.S. Environmental Protection Agency has issued numerous rules and regulations that are being used to evaluate and judge the safety of pesticide use on foods. This article discusses some of the major provisions of the new law and their impact to the U.S. pesticide industry.

Child↗

Federal regulatory assessment approach at the U.S. EPA.

For this presentation the data package on acrylonitrile was used as an example of the processes by which risk assessment evaluations would be performed for chemicals regulated by the Environmental Protection Agency, Office of Drinking Water. The discussion spans both regulatory and non-regulatory aspects of regulation. Developing risk assessments for EPA regulatory purposes is similar in all offices and in that context the considerations as well as the methods of assessing risks apply generally to regulatory considerations by other offices within the EPA.

Animals↗

Industrial emissions of 1,3-butadiene.

Sources of industrial emissions of 1,3-butadiene are discussed both by process (production, consumers) and type (equipment leaks, point sources). Quantification of the emissions are presented, as reported by the U.S. Environmental Protection Agency in 1986. The reported emissions attributed to equipment leaks (also known as fugitive emissions) range from about 50 to 95% of the total, depending on the specific production process used. The methods by which these emissions were estimated are discussed, with particular emphasis on the fugitive sources. Industry studies to better quantify the fugitive emissions are described.

Air Pollutants, Occupational↗

Inhalation exposure and risk from mobile source air toxics in future years.

Modeling of inhalation exposure and risks resulting from exposure to mobile source air toxics can be used to evaluate impacts of reductions from control programs on overall risk, as well as changes in relative contributions of different source sectors to risk, changes in contributions of different pollutants to overall risk, and changes in geographic distributions of risk. Such analysis is useful in setting regulatory priorities, and informing the decision-making process. In this paper, we have conducted national-scale air quality, exposure, and risk modeling for the US in the years 2015, 2020, and 2030, using similar tools and methods as the 1999 National-Scale Air Toxics Assessment. Our results suggest that US Environmental Protection Agency emission control programs will substantially reduce average inhalation cancer risks and potential noncancer health risks from exposure to mobile source air toxics. However, cancer risk and noncancer hazard due to inhalation of air toxics will continue to be a public health concern.

Air Pollutants↗

Toxic chemical release inventory information.

As part of a U.S. government effort to inform the public about toxic or hazardous chemicals released into the environment, the National Library of Medicine (NLM) and the Environmental Protection Agency (EPA) are jointly producing the TRI (Toxic Chemical Release Inventory) databanks which consist of two separate files, TRI87 and TRI88. Both files reside on NLM's TOX-NET system. The files contain geographic information about reporting facilities and land, air, and water release data for approximately 300 listed chemicals.

Databases, Factual↗

Comparison of commercially available Escherichia coli enumeration tests: implications for attaining water quality standards.

Many states are replacing microbiological water quality standards based on "fecal" or thermotolerant coliforms (ThCs) with new standards that employ Escherichia coli as the indicator organism. Implicit in these new standards are assumptions about the equivalence of E. coli enumeration tests and the E. coli levels that will provide protection equivalent to former ThC standards. To investigate these assumptions, E. coli levels in split samples (tests conducted on portions of the same grab sample) collected from small urban streams were determined using enzyme-specific media (Colilert, m-ColiBlue24, and nutrient agar with MUG) and compared to levels determined with conventional culture media (m-FC and m-TEC). Although levels observed with all tests were highly correlated, significantly fewer E. coli were enumerated with m-TEC than with enzyme-specific media (paired Student's t-test, alpha>99%). In addition, E. coli were found to comprise a larger fraction (84-104%, depending on the test) of the total presumptive ThC concentration than that suggested by the United States Environmental Protection Agency (63%). Both of these observations (1) the improvement in E. coli yields observed with enzyme-specific media, and (2) the greater proportion of ThC organisms that are E. coli, indicate that more water quality violations will occur when enzyme-specific media are used for testing than if conventional culture media are used.

Colony Count, Microbial↗

Ion abundance criteria for gas chromatographic/mass spectrometric environmental analysis.

Mass and intensity calibration of gas chromatograph/mass spectrometer (GC/MS) responses is an important quality assurance issue for chemical analysis. Ion abundance calibration with decafluorotriphenylphosphine (DFTPP) was applied in 1975 to standardize quadrupole spectra to resemble the ion abundances that were obtainable from magnetic sector mass spectrometers. Modern quadrupole mass spectrometers provide significantly greater high-mass sensitivity than allowed under the 1975 study. Thus, those recommendations were reevaluated with 2 approaches. First, an interlaboratory study was conducted using 15 different gas chromatography/mass spectrometry (GC/MS) systems. Second, the U.S. Environmental Protection Agency Contract Laboratory Program (EPA-CLP) quality assurance data base was searched and over 6500 DFTPP tune results were plotted and evaluated. Based on these approaches, updated ion abundance criteria recommendations have been developed, which contemporary instruments can meet, and which meet data quality objectives regarding identification and quantitative analysis of analytes.

Chemical Phenomena↗

Development of the method and U.S. normalization database for Life Cycle Impact Assessment and sustainability metrics.

Normalization is an optional step within Life Cycle Impact Assessment (LCIA) that may be used to assist in the interpretation of life cycle inventory data as well as life cycle impact assessment results. Normalization transforms the magnitude of LCI and LCIA results into relative contribution by substance and life cycle impact category. Normalization thus can significantly influence LCA-based decisions when tradeoffs exist. The U. S. Environmental Protection Agency (EPA) has developed a normalization database based on the spatial scale of the 48 continental U.S. states, Hawaii, Alaska, the District of Columbia, and Puerto Rico with a one-year reference time frame. Data within the normalization database were compiled based on the impact methodologies and lists of stressors used in TRACI-the EPA's Tool for the Reduction and Assessment of Chemical and other environmental Impacts. The new normalization database published within this article may be used for LCIA case studies within the United States, and can be used to assist in the further development of a global normalization database. The underlying data analyzed for the development of this database are included to allow the development of normalization data consistent with other impact assessment methodologies as well.

Air Pollutants↗

Subsurface agricultural irrigation drainage: the need for regulation.

Subsurface drainage resulting from irrigated agriculture is a toxic threat to fish and wildlife resources throughout the western United States. Studies by the U.S. Department of the Interior show that migratory waterfowl have been poisoned by drainwater contaminants on at least six national wildlife refuges. Allowing this poisoning to continue is a violation of the Migratory Bird Treaty Act under U.S. Federal law. Critical wetlands and waterfowl populations are threatened in both the Pacific and Central flyways. The public is also at risk and health warnings have been issued in some locations. Subsurface irrigation drainage is a complex effluent containing toxic concentrations of trace elements, salts, and nitrogenous compounds. Some of the contaminants are classified by the U.S. Environmental Protection Agency (EPA) as priority pollutants and they can be present in concentrations that exceed EPA's criteria for toxic waste. The on-farm drainage systems used to collect and transport this wastewater provide point-source identification as well as a mechanism for toxics control through the National Pollutant Discharge Elimination System (NPDES) permit process. A four-step approach is presented for dealing with irrigation drainage in an environmentally sound manner. This regulatory strategy is very similar to those commonly used for industrial discharges and includes site evaluation, contaminant reduction through NPDES, and compliance monitoring. The EPA must recognize subsurface irrigation drainage as a specific class of pollution subject to regulation under the NPDES process. Active involvement by EPA is necessary to ensure that adequate controls on this wastewater are implemented.

Agriculture↗

Linking environmental and health care databases: assessing the health effects of environmental pollutants.

The assessment of pollutant effects on health status requires the mergence and analysis of two different databases: pollution measurements and health care information. This paper compares two subsets of these data: Ohio Environmental Protection Agency data on ambient air pollutants and Ohio Medicare data on respiratory diseases. Small area analysis was performed to assess statewide variations in hospital admission rates for respiratory diseases. The ambient air pollutant levels for each small area were compared to the variations in respiratory disease rates. Five groups of diseases correlated with pollutant levels. In addition, pollutant levels were significantly associated with medical complications. This study demonstrates the feasibility and benefit of linking environmental and health care databases and suggests the need for a more comprehensive, automated analysis of more pollutants and diseases.

Air Pollutants↗

Development of the revised drinking water standard for chromium.

Comprehensive regulations are being developed to limit human exposure to contamination in drinking water by the United States Environmental Protection Agency (EPA) under the authority of the Safe Drinking Water Act (SDWA). These regulations are being developed in several phases and include synthetic organic chemicals, inorganic chemicals, microbiological contaminants and radionuclides. This paper addresses the fundamental concepts and approaches used by EPA in setting drinking water regulations and how EPA is using these concepts to revise the drinking water standard for chromium.

Carcinogens↗

Mechanistic data and cancer risk assessment: the need for quantitative molecular endpoints.

The cancer risk assessment process as currently proposed by the U.S. Environmental Protection Agency allows for the use of mechanistic data to inform the low-dose tumor response in humans and in laboratory animals. The aim is to reduce the reliance on defaults that introduce a relatively high level of uncertainty to the risk estimates. The types of data required for this purpose are those that help identify key events in tumor formation following exposure to environmental chemicals. Informative biomarkers of tumor responses could then be developed for describing the shape of a dose-response curve at low doses (i.e., a qualitative assessment) and for predicting tumor frequency at these low doses (i.e., a quantitative assessment). A number of recently developed molecular approaches could aid in the development of qualitatively and quantitatively informative biomarkers. An overview of these with examples of their use is presented. These methods include quantitative gene expression array techniques, quantitative proteomic assays, and the assessment of DNA alterations at the single gene level and at the genome level of detection. It is most likely that a combination of approaches at different levels of cellular organization (i.e., DNA, RNA, and protein) will be the most productive for biomarker development. The rapid progress that is being made will make this tool kit even more applicable for the cancer risk assessment process.

Biomarkers, Tumor↗

Molecular forensic profiling of Cryptosporidium species and genotypes in raw water.

The emerging concept of host specificity of Cryptosporidium spp. was exploited to characterize sources of fecal contamination in a watershed. A method of molecular forensic profiling of Cryptosporidium oocysts on microscope slides prepared from raw water samples processed by U.S. Environmental Protection Agency Method 1623 was developed. The method was based on a repetitive nested PCR-restriction fragment length polymorphism-DNA sequencing approach that permitted the resolution of multiple species/genotypes of Cryptosporidium in a single water sample.

Animals↗