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PubMed2001

Review of the methods of the US Environmental Protection Agency for bromate determination and validation of method 317.0 for disinfection by-product anions and low-level bromate.

In recent years several methods have been published by the United States Environmental Protection Agency (EPA) which specify bromate as a target analyte. The first of these was EPA Method 300.0. As technological improvements in ion chromatographic hardware have evolved and new detection techniques have been designed, method detection limits for bromate have been reduced and additional procedures have been written, including EPA Method 300.1, 321.8 and, most recently, EPA Method 317.0. An overview of the evolution of these bromate methods since 1989 is presented. The focus is specific to each of these respective procedures, highlighting method strengths, weaknesses, and addressing how these methods fit into EPA's regulatory agenda. In addition, performance data are presented detailing the joint EPA/American Society for Testing and Materials multilaboratory validation of EPA Method 317.0 for disinfection by-product anions and low-level bromate.

Anions↗
PubMed2005

Analysis of the 16 Environmental Protection Agency priority polycyclic aromatic hydrocarbons by high performance liquid chromatography-oxidized diamond film electrodes.

The capabilities of using boron-doped diamond (BDD) thin films as electrode materials for analysis of the 16 US Environmental Protection Agency (EPA) priority polyaromatic hydrocarbons (PAHs) after a liquid chromatographic separation were evaluated. The BDD electrode was able to detect all 16 PAHs with high sensitivity due to the low background current and wide potential window. The method provided detection limits ranging from 12-40 nM (3-10 ppb) and repeatable results over consecutive analysis. Calibration curves were linear up to at least 10 microM for all PAHs. The work shows the promising use of diamond as an amperometric detector in high performance liquid chromatography (HPLC), especially for PAHs and other hydrophobic aromatic compounds.

Boron↗
PubMed1989

U.S. Environmental Protection Agency procedures and policies to estimate risk of injury to the male reproductive system.

Risk assessment, as defined by the National Academy of Sciences in 1983, is comprised by the following components: hazard identification, dose-response assessment, exposure assessment, and risk characterization. The U.S. Environmental Protection Agency (EPA) has developed risk assessment guidelines which follow the NAS format for Program Offices to follow in evaluating the potential adverse effects of environmental agents on humans. Guidelines have been published in the Federal Register on cancer, mutagenicity, developmental toxicity, chemical mixtures, and exposure. Proposed guidelines are expected to be published shortly on female and male reproductive toxicity.

Animals↗
PubMed2000

Highly selective and efficient determination of US Environmental Protection Agency priority phenols employing solid-phase extraction and non-aqueous capillary electrophoresis.

Non-aqueous capillary electrophoresis has been used in the separation of a complete list of 26 priority phenols included in the 8041 US Environmental Protection Agency method and the 76/464/EEC European Union directive. A highly selective and efficient separation was obtained when the background electrolyte used was 150 mM ammonium acetate dissolved in N-methylformamide-acetonitrile (75:25). Solid-phase extraction was successfully assayed as an enrichment strategy for the analysis of low-concentration samples. A styrene-divinylbenzene functionalized cartridge provided excellent recoveries of phenols from water samples at neutral pH. The limits of quantification obtained permit the application of the proposed method to the determination of priority phenols in wastewater samples.

Electrophoresis, Capillary↗
PubMedDate not supplied

Environmental Protection Agency risk assessment--process and toxicologic pathology.

Risk assessment of a pesticide includes the identification of hazard, dose-response, exposure assessment, and risk characterization. Toxicology study reports undergo several levels of scientific and regulatory review in the Environmental Protection Agency's (EPA's) Office of Pesticide Programs. A Health Effects Division (HED) scientist reviews the reports. The resulting Data Evaluation Records are presented to several internal HED Peer Review committees to ensure consistency across chemicals in establishing which hazard end points to use when determining the reference dose and carcinogenicity potential for use in dietary and nondietary risk assessments. There may also be external reviews. The toxicologic pathologist can impact many steps in this process. The noncancer end points are just as important as the cancer end points when evaluating the hazard component of a pesticide. The toxicologic pathologist can assist in the hazard and risk characterization by being clear and concise, carefully defining terms and relating individual lesions to the animal, study, and database as a whole. The preceding will assist the HED in fulfilling EPA Administrator Carol Browner's guidance for risk characterizations that are transparent, clear, concise, and reasonable.

Animals↗
PubMed2006

US Environmental Protection Agency Method 314.1, an automated sample preconcentration/matrix elimination suppressed conductivity method for the analysis of trace levels (0.50 microg/L) of perchlorate in drinking water.

Since 1997 there has been increasing interest in the development of analytical methods for the analysis of perchlorate. The US Environmental Protection Agency (EPA) Method 314.0, which was used during the first Unregulated Contaminant Monitoring Regulation (UCMR) cycle, supports a method reporting limit (MRL) of 4.0 microg/L. The non-selective nature of conductivity detection, combined with very high ionic strength matrices, can create conditions that make the determination of perchlorate difficult. The objective of this work was to develop an automated, suppressed conductivity method with improved sensitivity for use in the second UCMR cycle. The new method, EPA Method 314.1, uses a 35 mm x 4 mm cryptand concentrator column in the sample loop position to concentrate perchlorate from a 2 mL sample volume, which is subsequently rinsed with 10 mM NaOH to remove interfering anions. The cryptand concentrator column is combined with a primary AS16 analytical column and a confirmation AS20 analytical column. Unique characteristics of the cryptand column allow perchlorate to be desorbed from the cryptand trap and refocused on the head of the guard column for subsequent separation and analysis. EPA Method 314.1 has a perchlorate lowest concentration minimum reporting level (LCMRL) of 0.13 microg/L in both drinking water and laboratory synthetic sample matrices (LSSM) containing up to 1,000 microg/L each of chloride, bicarbonate and sulfate.

Chromatography, Liquid↗
PubMed2000

U.S. Environmental Protection Agency's revised guidelines for carcinogen risk assessment: evaluating a postulated mode of carcinogenic action in guiding dose-response extrapolation.

There are new opportunities to using data from molecular and cellular studies in order to bring together a fuller biological understanding of how chemicals induce neoplasia. In 1996, the Environmental Protection Agency (EPA) published a proposal to replace its 1986 Guidelines for Carcinogen Risk Assessment to take advantage of these new scientific advances in cancer biology. The analytical framework within the new guidelines focuses on an understanding of the mode of carcinogenic action. Mode of action data come into play in a couple of ways in these new guidelines. For example, such information can inform the dose-response relationship below the experimental observable range of tumours. Thus, mode of action data can be useful in establishing more appropriate guidance levels for environmental contaminants. It is the understanding of the biological processes that lead to tumour development along with the response data derived from experimental studies that can help discern the shape of the dose-response at low doses (linear vs. nonlinear). Because it is experimentally difficult to establish "true thresholds" from others with a nonlinear dose-response relationship, the proposed guidelines take a practical approach to depart from low-dose linear extrapolation procedures when there is sufficient experimental support for a mode of action consistent with nonlinear biological processes (e.g., tumours resulting from the disruption of normal physiological processes).

Animals↗
PubMed2003

Modifications to United States Environmental Protection Agency methods 1622 and 1623 for detection of Cryptosporidium oocysts and Giardia cysts in water.

Collaborative and in-house laboratory trials were conducted to evaluate Cryptosporidium oocyst and Giardia cyst recoveries from source and finished-water samples by utilizing the Filta-Max system and U.S. Environmental Protection Agency (EPA) methods 1622 and 1623. Collaborative trials with the Filta-Max system were conducted in accordance with manufacturer protocols for sample collection and processing. The mean oocyst recovery from seeded, filtered tap water was 48.4% +/- 11.8%, while the mean cyst recovery was 57.1% +/- 10.9%. Recovery percentages from raw source water samples ranged from 19.5 to 54.5% for oocysts and from 46.7 to 70.0% for cysts. When modifications were made in the elution and concentration steps to streamline the Filta-Max procedure, the mean percentages of recovery from filtered tap water were 40.2% +/- 16.3% for oocysts and 49.4% +/- 12.3% for cysts by the modified procedures, while matrix spike oocyst recovery percentages ranged from 2.1 to 36.5% and cyst recovery percentages ranged from 22.7 to 68.3%. Blinded matrix spike samples were analyzed quarterly as part of voluntary participation in the U.S. EPA protozoan performance evaluation program. A total of 15 blind samples were analyzed by using the Filta-Max system. The mean oocyst recovery percentages was 50.2% +/- 13.8%, while the mean cyst recovery percentages was 41.2% +/- 9.9%. As part of the quality assurance objectives of methods 1622 and 1623, reagent water samples were seeded with a predetermined number of Cryptosporidium oocysts and Giardia cysts. Mean recovery percentages of 45.4% +/- 11.1% and 61.3% +/- 3.8% were obtained for Cryptosporidium oocysts and Giardia cysts, respectively. These studies demonstrated that the Filta-Max system meets the acceptance criteria described in U.S. EPA methods 1622 and 1623.

Animals↗
PubMed2002

Universal screening method for the determination of US Environmental Protection Agency phenols at the lower ng l(-1) level in water samples by on-line solid-phase extraction-high-performance liquid chromatography-atmospheric pressure chemical ionization mass spectrometry within a single run.

The applicability of a previously optimized method for the analysis of the US Environmental Protection Agency (EPA) regulations phenols, based on on-line solid-phase extraction coupled to liquid chromatography with mass spectrometric (MS) detection in different matrix loaded water samples is demonstrated. The comprehensive optimization of the mobile phase conditions and their influence on the ionization process in atmospheric pressure ionization is described in detail. In particular, MS detection of the weakly acidic phenols such as phenol, monochlorinated phenols and methylated phenols requires the absence of acidic mobile phase modifiers and buffers. Thus lower retention times and slight peak broadening of the more acidic dinitrophenols are obtained if the entire range of EPA phenols is analyzed within a single chromatographic run. The figures of merit for the method were determined and the applicability to real water samples was investigated. Limits of detection for phenols ranging from 40 to 280 ng l(-1) and relative standard deviations below 8% in SCAN mode are obtained for all phenols if only 10-ml river water samples with low dissolved organic carbon (DOC 5 mg C l(-1) concentrations are preconcentrated. The method was used to detect 2-nitrophenol and 4-nitrophenol in river water samples in the lower ng l(-1) range. The analysis of highly matrix-loaded samples (DOC 210 mg C l(-1)) requires a reduced enrichment volume resulting in decreased sensitivity. Still the method is capable of reaching excellent detection limits which demonstrates its excellent suitability for screening analysis.

Atmospheric Pressure↗
PubMed1996

Culture variability associated with the U.S. Environmental Protection Agency Tuberculocidal Activity Test Method.

Tuberculosis continues to be a major world health threat. The etiologic agent is among the vegetative organisms most resistant to chemical disinfection. Tuberculocidal efficacy testing for regulatory approval of chemical germicides has evolved considerably over the past decade. A method currently in use is the Environmental Protection Agency Tuberculocidal Activity Test Method, a suspension test using a Mycobacterium bovis culture grown under specific conditions and stored frozen until used. Differing tuberculocidal label claims on products with similar formulations have raised questions concerning the equivalence of test suspensions prepared by different laboratories. Five M. bovis suspensions from laboratories currently performing this test were compared against a battery of three disinfectants at a single test site. A significant difference between test cultures was found, with two of the five exhibiting a significant difference from the other three and also from each other. There was a significant culture-by-disinfectant interaction, indicating that the five cultures did not respond in a consistent manner across the different disinfectants used. However, these differences were due to cultures that were not prepared in accordance with the standard procedure or otherwise did not meet the test suspension criteria. In addition, a 0.55% sodium hypochlorite solution was found to be a sensitive indicator of culture variability. These data reinforce the need to adhere to published procedures and guidelines when growing and preparing a tuberculocidal test suspension and shed light on the variables associated with this type of testing.

Base Sequence↗
PubMed2000

Eliminating the chlorite interference in US Environmental Protection Agency Method 317.0 permits analysis of trace bromate levels in all drinking water matrices.

A post-column reagent (PCR) method for bromate analysis in drinking water with a method detection limit (MDL) and method reporting limit (MRL) of 0.1 and 0.5 microg/l, respectively, has been developed by the United States Environmental Protection Agency (EPA) for future publication as EPA Method 317.0. The PCR method provides comparable results to the EPA's Selective Anion Concentration (SAC) method used to support the laboratory analysis of Information Collection Rule (ICR) low-level bromate samples and offers a simple, rugged, direct injection method with potential to be utilized as a compliance monitoring technique for all inorganic Disinfectants/Disinfection By-Products (D/DBPs). It has superior sensitivity for bromate compared to EPA Method 300.1, which was promulgated as the compliance monitoring method for bromate under Stage 1 of the D/DBP rule. This paper addresses elimination of the chlorite interference that was previously reported in finished waters from public water systems (PWSs) that employ chlorine dioxide as the disinfectant. An evaluation of Method 317.0 for the analysis of bromate in commercial bottled waters is also reported.

Bromates↗
PubMed2001

Indirect exposure assessment at the United States Environmental Protection Agency.

In the early 1980s, exposures and subsequent health impact assessments from contaminants emitted into the air from stationary sources focused on the inhalation pathway. This 'direct' pathway of exposure was thought to be the most critical pathway, as it is for many contaminants. However, by the latter 1980s, the focus at the Environmental Protection Agency (EPA) shifted to contaminants that would persist in the environment and could bioaccumulate up the food chain. Consumption of impacted food products, and other 'indirect' pathways of exposure, such as soil-related exposures, were shown to result in exposures that exceeded inhalation exposures by two to up to four orders of magnitude. A historical background of indirect exposure assessment at EPA is provided in this paper, followed by an overview of modeling methodologies commonly used in indirect exposure assessments. These methodologies are demonstrated on a contaminant of primary focus for indirect exposure impact, dioxins. Two examples are provided. In the first, an air-to-beef model validation exercise is described. In the second, an indirect exposure assessment on a municipal solid waste incinerator in Ohio conducted by the EPA is summarized. This incinerator emitted very large amounts of dioxin, more than any single source known to EPA. Models were used to predict the movement of dioxins from the stack to a nearby hypothetical farm, where individuals in the farm family were exposed to dioxins from consumption of home-produced beef and milk. The predicted lifetime cancer risk of 2.8 x 10(-4) based on these food pathways was used by EPA's Region 5 to initiate regulatory activity on this incinerator.

Agriculture↗
PubMed2006

Apportionment of ambient primary and secondary pollutants during a 2001 summer study in Pittsburgh using U.S. Environmental Protection Agency UNMIX.

Apportionment of primary and secondary pollutants during the summer 2001 Pittsburgh Air Quality Study (PAQS) is reported. Several sites were included in PAQS, with the main site (the supersite) adjacent to the Carnegie Mellon University campus in Schenley Park. One of the additional sampling sites was located at the National Energy Technology Laboratory, located approximately 18 km southeast of downtown Pittsburgh. Fine particulate matter (PM2.5) mass, gas-phase volatile organic material (VOM), particulate semivolatile and nonvolatile organic material (NVOM), and ammonium sulfate were apportioned at the two sites into their primary and secondary contributions using the U.S. Environmental Protection Agency UNMIX 2.3 multivariate receptor modeling and analysis software. A portion of each of these species was identified as originating from gasoline and diesel primary mobile sources. Some of the organic material was formed from local secondary transformation processes, whereas the great majority of the secondary sulfate was associated with regional transformation contributions. The results indicated that the diurnal patterns of secondary gas-phase VOM and particulate semivolatile and NVOM were not correlated with secondary ammonium sulfate contributions but were associated with separate formation pathways. These findings are consistent with the bulk of the secondary ammonium sulfate in the Pittsburgh area being the result of contributions from distant transport and, thus, decoupled from local activity involving organic pollutants in the metropolitan area.

Air Pollutants↗
PubMed2003

Do U.S. Environmental Protection Agency water quality guidelines for recreational waters prevent gastrointestinal illness? A systematic review and meta-analysis.

Despite numerous studies, uncertainty remains about how water quality indicators can best be used in the regulation of recreational water. We conducted a systematic review of this topic with the goal of quantifying the association between microbial indicators of recreational water quality and gastrointestinal (GI) illness. A secondary goal was to evaluate the potential for GI illness below current guidelines. We screened 976 potentially relevant studies and from these identified 27 studies. From the latter, we determined summary relative risks for GI illness in relation to water quality indicator density. Our results support the use of enterococci in marine water at U.S. Environmental Protection Agency guideline levels. In fresh water, (Italic)Escherichia(/Italic) coli was a more consistent predictor of GI illness than are enterococci and other bacterial indicators. A log (base 10) unit increase in enterococci was associated with a 1.34 [95% confidence intervals (CI), 1.00-1.75] increase in relative risk in marine waters, and a log (base 10) unit increase in E. coli was associated with a 2.12 (95% CI, 0.925-4.85) increase in relative risk in fresh water. Indicators of viral contamination were strong predictors of GI illness in both fresh and marine environments. Significant heterogeneity was noted among the studies. In our analysis of heterogeneity, studies that used a nonswimming control group, studies that focused on children, and studies of athletic or other recreational events found elevated relative risks. Future studies should focus on the ability of new, more rapid and specific microbial methods to predict health effects, and estimating the risks of recreational water exposure among susceptible persons.

Diarrhea↗
PubMed1999

Assessment of the U.S. Environmental Protection Agency methods for identification of hazards to developing organisms, Part I: The reproduction and fertility testing guidelines.

BACKGROUND: Successful reproduction depends on the coordination of many processes, particularly the normal development and subsequent maturation of the sexual organs. The Food Quality Protection Act of 1996 mandates that the U.S. Environmental Protection Agency must protect infants and children from the effects of toxins, including those that affect the reproductive system. Therefore, the Agency finds itself at a critical juncture to make sure that the methods it requires for toxicity testing, the Health Effects Test Guidelines or Series 870 Guidelines, are adequate to determine possible toxicity to children. METHODS AND RESULTS: We found that two testing protocols included in the core guidelines assess toxicological effects on developing animals. This article aims to provide a detailed analysis of the protocols included in the Reproduction and Fertility Effects Test Guideline. An accompanying article assesses the Developmental Toxicity Testing Guideline. We conducted this analysis on the basis of whether the test would yield the information needed to adequately determine risk to infants and children. CONCLUSIONS: Our analysis concludes that given the limitations inherent in testing for reproduction and fertility effects during development, it is necessary to include a safety factor during risk assessment of chemicals. This action will fulfill the mandate expressed in the FQPA to protect infants and children from environmental hazards.

Animals↗
PubMed1983

The sex-linked recessive lethal test for mutagenesis in Drosophila melanogaster. A report of the U.S. Environmental Protection Agency Gene-Tox Program.

The test for sex-linked recessive lethals (SLRL) in Drosophila melanogaster has been used to detect induced mutations since 1927. The advantage of the test for both screening and hazard evaluation is its objectivity in testing for transmissible mutations in the germ cells of a eukaryote. Statistical criteria for both positive and negative mutagenicity at the highest concentration tested under a particular exposure condition were developed by the Work Group, and a recommended protocol for future testing was agreed upon. For 421 compounds there were sufficient data available in the literature for analysis; 198 compounds were found to be positive and 46 negative at the highest concentration tested. Most experiments had been done for objectives of pure research rather than for deliberately screening for mutagenicity, although many of the 421 chemicals were selected for testing because of suspected mutagenicity. Therefore, the statement of 198 positive and 46 negative should not be taken as an example of the proportion of mutagens in the environment. In three sets of experiments with D. melanogaster that were done specifically for screening, one involving 40 compounds for the Environmental Protection Agency (EPA), the others involving 13 for the Food and Drug Administration (FDA), only 6 mutagens were discovered. After completion of the classification of compounds according to their response in the SLRL test, the compounds were classified as to their carcinogenic response according to the list of Griesemer and Cueto (1980). There were 62 compounds that could be classified as positive or negative for both carcinogenesis and mutagenesis. Of the 62 compounds, there was agreement between the carcinogenesis and mutagenesis classification in 56 (50 positive and 6 negative), or 90% would have been correctly classified as to carcinogenesis from only the SLRL test. Because of inadequate sample size, 177 compounds could not be classified as positive or negative according to the statistical criteria established by the Work Group. This large number of inadequately tested compounds reflects the fact that many of the experiments were not done for screening. Further work is needed on the compounds with inadequate sample size.(ABSTRACT TRUNCATED AT 400 WORDS)

Animals↗