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PubMed2006

Animal carcinogenicity studies: 2. Obstacles to extrapolation of data to humans.

Due to limited human exposure data, risk classification and the consequent regulation of exposure to potential carcinogens has conventionally relied mainly upon animal tests. However, several investigations have revealed animal carcinogenicity data to be lacking in human predictivity. To investigate the reasons for this, we surveyed 160 chemicals possessing animal but not human exposure data within the US Environmental Protection Agency chemicals database, but which had received human carcinogenicity assessments by 1 January 2004. We discovered the use of a wide variety of species, with rodents predominating, and of a wide variety of routes of administration, and that there were effects on a particularly wide variety of organ systems. The likely causes of the poor human predictivity of rodent carcinogenicity bioassays include: 1) the profound discordance of bioassay results between rodent species, strains and genders, and further, between rodents and human beings; 2) the variable, yet substantial, stresses caused by handling and restraint, and the stressful routes of administration common to carcinogenicity bioassays, and their effects on hormonal regulation, immune status and predisposition to carcinogenesis; 3) differences in rates of absorption and transport mechanisms between test routes of administration and other important human routes of exposure; 4) the considerable variability of organ systems in response to carcinogenic insults, both between and within species; and 5) the predisposition of chronic high dose bioassays toward false positive results, due to the overwhelming of physiological defences, and the unnatural elevation of cell division rates during ad libitum feeding studies. Such factors render profoundly difficult any attempts to accurately extrapolate human carcinogenic hazards from animal data.

Animals↗
PubMed2006

Measurement of total polycyclic aromatic hydrocarbon concentrations in sediments and toxic units used for estimating risk to benthic invertebrates at manufactured gas plant sites.

The U.S. Environmental Protection Agency's (U.S. EPA) narcosis model requires the measurement of 18 parent and 16 groups of alkyl polycyclic aromatic hydrocarbons (PAHs) (so-called 34 PAHs) in sediments to calculate the number of PAH toxic units (TU) available to benthic organisms. If data for the 34 PAHs are not available, the U.S. EPA proposes estimating the risk by multiplying the TU for 13 parent PAHs by 11.5 (95% confidence interval) based on data from 488 sediments. This estimate is overly conservative for PAHs from pyrogenic manufactured gas plant (MGP) processes based on the analysis of 45 sediments from six sites. Parent PAHs contributed approximately 40% of the total concentrations and TU for MGP sediments. In contrast, parent PAHs from diesel fuel and petroleum crude oil contributed only 2 and 1%, respectively, of the PAH concentrations and TU, compared to approximately 98 to 99% contributed by the alkyl PAHs. Statistical comparison of the TU based on the measured 34 alkyl and parent PAHs and those based on only 13 parent PAHs demonstrated that a factor of 4.2 (rather than 11.5) is sufficient to estimate total TU within a 95% confidence level for MGP sites. Similarly, measurement of parent PAHs is sufficient to accurately estimate the total 34 alkyl and parent PAH concentrations for MGP-impacted sediments.

Animals↗
PubMed2006

Recent exposure to particulate matter and C-reactive protein concentration in the multi-ethnic study of atherosclerosis.

Ambient levels of particulate matter have been linked to cardiovascular disease. The mechanisms mediating these associations are poorly understood. One candidate mechanism is inflammation. Using data from the Multi-Ethnic Study of Atherosclerosis (2000-2002), the authors investigated the relation between exposure to particulate matter of less than or equal to 2.5 microm in diameter (PM2.5) and C-reactive protein concentration in 5,634 persons aged 45-84 years who were free of cardiovascular disease. Data from US Environmental Protection Agency monitors were used to estimate PM2.5 exposures for the prior day, prior 2 days, prior week, prior 30 days, and prior 60 days. Only the 30-day and 60-day mean exposures showed a weak positive association with C-reactive protein, and confidence intervals were wide: relative increases in C-reactive protein per 10 microg/m3 of PM2.5 adjusted for person-level covariates were 3% (95% confidence interval (CI): -2, 10) for a 30-day mean and 4% (95% CI: -3, 11.0) for a 60-day mean. The means of 7-day, 30-day, and 60-day exposures were weakly, positively, and nonsignificantly associated with the odds of C-reactive protein of greater than or equal to 3 mg/liter: adjusted odds ratios were 1.05 (95% CI: 0.96, 1.15), 1.12 (95% CI: 0.98, 1.29), and 1.12 (95% CI: 0.96, 1.32), respectively. Slightly stronger associations were observed in persons without other risk factors for elevated C-reactive protein, but this heterogeneity was not statistically significant. The authors' results are not compatible with strong effects of particulate matter exposures on population levels of C-reactive protein.

Aged↗
PubMed2001

Considerations necessary in gathering occurrence data for selected unstable compounds in the USEPA Unregulated Contaminant Candidate List in USEPA Method 526.

U.S. Environmental Protection Agency (EPA) Method 526 was developed for the analysis of target analytes that are subject to degradation by hydrolysis. Two technical hurdles that had to be overcome were preservation of the target analytes and selection of a suitable solid-phase extraction material. The target analytes were diazinon, disulfoton, fonofos, terbufos, prometon, 1,2-diphenylhydrazine, nitrobenzene, acetochlor, 2,4,6-trichlorophenol, 2,4-dichlorophenol, and cyanazine. Diazolidinyl urea was used for the first time as a microbial inhibitor in an EPA drinking water method. Experiment confirmed antimicrobial agents containing copper or mercury salts increased hydrolysis degradation rates. Trisodium ethylenediaminetetraacetic acid salt was added to chelate metal ions that may increase hydrolysis rates. A pH 7 buffer of tris(hydroxymethyl)aminomethane (Tris) and Tris hydrochloride was used to minimize rates of hydrolysis. The use of ascorbic acid prevented degradation of 2,4-dichlorophenol, terbufos, fonofos, diazinon, and disulfoton due to residual chlorine. Samples were extracted using a styrene divinylbenzene solid-phase material and analyzed by capillary column gas chromatography/mass spectrometry. A 21-day storage stability study, together with precision and accuracy studies, showed that this method has suitable sensitivity, accuracy, precision, and ruggedness for use in the EPA's Unregulated Contaminant Monitoring Rule drinking water occurrence survey.

Biodegradation, Environmental↗
PubMedDate not supplied

Applying mode-of-action and pharmacokinetic considerations in contemporary cancer risk assessments: an example with trichloroethylene.

The guidelines for carcinogen risk assessment recently proposed by the U.S. Environmental Protection Agency (U.S. EPA) provide an increased opportunity for the consideration of pharmacokinetic and mechanistic data in the risk assessment process. However, the greater flexibility of the new guidelines can also make their actual implementation for a particular chemical highly problematic. To illuminate the process of performing a cancer risk assessment under the new guidelines, the rationale for a state-of-the-science risk assessment for trichloroethylene (TCE) is presented. For TCE, there is evidence of increased cell proliferation due to receptor interaction or cytotoxicity in every instance in which tumors are observed, and most tumors represent an increase in the incidence of a commonly observed, species-specific lesion. A physiologically based pharmacokinetic (PBPK) model was applied to estimate target tissue doses for the three principal animal tumors associated with TCE exposure: liver, lung, and kidney. The lowest points of departure (lower bound estimates of the exposure associated with 10% tumor incidence) for lifetime human exposure to TCE were obtained for mouse liver tumors, assuming a mode of action primarily involving the mitogenicity of the metabolite trichloroacetic acid (TCA). The associated linear unit risk estimates for mouse liver tumors are 1.5 x 10(-6) for lifetime exposure to 1 microg TCE per cubic meter in air and 0.4 x 10(-6) for lifetime exposure to 1 microg TCE per liter in drinking water. However, these risk estimates ignore the evidence that the human is likely to be much less responsive than the mouse to the carcinogenic effects of TCA in the liver and that the carcinogenic effects of TCE are unlikely to occur at low environmental exposures. Based on consideration of the most plausible carcinogenic modes of action of TCE, a margin-of-exposure (MOE) approach would appear to be more appropriate. Applying an MOE of 1000, environmental exposures below 66 microg TCE per cubic meter in air and 265 microg TCE per liter in drinking water are considered unlikely to present a carcinogenic hazard to human health.

Animals↗
PubMed2002

Development of marine water quality criteria for the USA.

The US Environmental Protection Agency has developed guidelines for deriving numerical national water quality criteria for the protection of aquatic organisms and their uses. These guidelines provide the method for deriving water quality criteria, including minimum data base requirements, data evaluation procedures, and calculations. The guidelines have been in place for a long time, and states have used them to derive water quality standards for their water bodies. More recent efforts have been directed towards the development of technical guidance based on the concept that bioassessment and biocriteria programs for estuaries and near coastal waters are interrelated and are critical components of comprehensive water resource protection and management. This is a holistic approach to protection and management, integrating biological assessments into traditional chemical and physical evaluations and augmenting the established water quality criteria. The method for deriving water quality criteria and the approach for biocriteria development for marine systems are described.

Animals↗
PubMed2001

Statistical issues in the analysis of low-dose endocrine disruptor data.

UNLABELLED: The National Institute of Environmental Health Sciences (NIEHS) and the U.S. Environmental Protection Agency (U.S. EPA) recently cosponsored the Endocrine Disruptors Low-Dose Peer REVIEW: The purpose of this meeting was to examine data supporting the presence or absence of low-dose effects of endocrine disruptors in specific studies and then to evaluate the likelihood and significance of these and/or other potential low-dose effects for humans. All invited speakers agreed to provide their raw data in advance of the meeting to a Statistics Subpanel, which was asked to reevaluate the authors' experimental design, data analysis, and interpretation of experimental results. The purpose of this statistical reevaluation was to provide an independent assessment of the experimental design and data analysis used in each of the studies and to identify key statistical issues relevant to the evaluation and interpretation of the data. This paper presents a summary of the Statistics Subpanel's evaluation. Specific examples are presented to illustrate problems that arose in the experimental design and data analysis of certain studies. The statistical principles and issues that are discussed in this paper are not unique to endocrine disruptor studies and should provide important guidelines regarding appropriate experimental design and statistical analysis for other types of laboratory investigations.

Analysis of Variance↗
PubMed1994

Pesticide registration in the United States: overview and new directions.

This paper provides an overview of EPA's pesticide registration program and a discussion of recent activities. The registration of pesticides is the responsibility of the Office of Pesticide Programs, an office of the U.S. Environmental Protection Agency (EPA). EPA's pesticide regulatory authority derives from the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA). FIFRA governs the registration or licensing of pesticide products including insecticides, herbicides, fungicides, rodenticides, disinfectants, plant growth regulators, and biological agents. FFDCA governs pesticide residue levels in food and feed crops. FIFRA gives EPA authority for registering pesticides to ensure that when used according to label directions, they will not pose unreasonable adverse effects to the environment. FIFRA requires EPA to balance the risks and benefits of a pesticide in deciding whether or not to grant a pesticide registration. In a typical year EPA reviews over 5000 registration submissions that vary from routine label amendments to the review of a new active ingredient. About 20 applications for registration of a new active ingredient are received each year. Registration for a new active ingredient requires a significant investment in time and money by the registrant. Data development for a major agricultural chemical can cost 10 million dollars or more and take several years to complete. EPA is embarking on a number of new initiatives in the registration program designed to reduce the use of chemical pesticides, limit the regulatory burden on lower risk and reduced risk products, and streamline the review process generally.

Agriculture↗
PubMed1999

Statistical considerations in determining the health significance of constituents of airborne particulate matter.

Because of the U.S. Environmental Protection Agency's (EPA) new ambient air quality standard for fine particles, the need is likely to continue for more detailed scientific investigation of various types of particles and their effects on human health. Epidemiology studies have become the method of choice for investigating health responses to such particles and to other air pollutants in community settings. Health effects have been associated with virtually all of the gaseous criteria pollutants and with the major constituents of airborne particulate matter (PM), including all size fractions less than about 20 microns, inorganic ions, carbonaceous particles, metals, crustal material, and biological aerosols. In many of the more recent studies, multiple pollutants or agents (including weather variables) have been significantly associated with health responses, and various methods have been used to suggest which ones might be the most important. In an ideal situation, classical least-squares regression methods are capable of performing this task. However, in the real world, where most of the pollutants are correlated with one another and have varying degrees of measurement precision and accuracy, such regression results can be misleading. This paper presents some guidelines for dealing with such collinearity and model comparison problems in both single- and multiple-pollutant regressions. These techniques rely on mean effect (attributable risk) rather than statistical significance per se as the preferred indicator of importance for the pollution variables.

Air Pollution↗
PubMedDate not supplied

Comparison of five extraction methods for determination of incurred and added pesticides in dietary composites.

The National Exposure Research Laboratory of the U.S. Environmental Protection Agency conducts research to measure exposure of individuals to chemical pollutants through the diet. In support of this research, methods are being evaluated for the determination of pesticides in dietary composite samples. In the present study, Soxhlet, blender, microwave-assisted, pressurized fluid, and supercritical fluid extraction methods were compared for the determination of incurred and added pesticides in 4 dietary composites, which varied in fat and water content. Incurred pesticides were chlorothalonil, chlorpyrifos, DDE, dicloran, dieldrin, endosulfan I, malathion, cis- and trans-permethrin, and trifluralin. Added pesticides were alpha- and gamma-chlordane, hexachlorobenzene, and fonofos. Concentrations of the individual pesticides were between 0.2 and 20 ng/g composite. All 5 methods tested could extract pesticides from dietary composites. Most incurred pesticides were recovered from the dietary composites within the range of 59-140% of expected values. Recoveries of added pesticides were between 60 and 130%. Microwave-assisted extraction led to significantly higher concentrations of 7 pesticides. Blender extraction yielded significantly higher concentrations of chlorothalonil and fonofos. Water content was a significant factor in the recovery of chlorothalonil, and fat content was a significant factor in the recovery of fonofos. In designing an exposure study, the selection of the extraction method would be determined by number of samples to be extracted, analyte stability, and cost.

Diet↗
PubMed2002

Toxicity of methyl tert-butyl ether to marine organisms: ambient water quality criteria calculation.

In response to increasing concerns over the detection of methyl tert-butyl ether (MTBE) in groundwater and surface water and its potential effects in aquatic ecosystems, industry and the United States Environmental Protection Agency (USEPA) began to collaborate in 1997 to develop aquatic toxicity databases sufficient to derive ambient water quality criteria for MTBE consistent with USEPA requirements. Acute toxicity data for seven marine species, chronic toxicity data for an invertebrate, and plant toxicity data were developed to complete the saltwater database. The species tested were Cyprinodon variegatus, Gasterosteus aculeatus, Callinectes sapidus, Mytilus galloprovincialis, Palaemonetes pugio, Rhepoxynius abronius, Americamysis bahia, and Skeletonema costatum. The toxicity tests were conducted in accordance with USEPA and American Society for Testing and Materials testing procedures and Good Laboratory Practice guidelines. Data developed from this study were consistent with existing data and showed that MTBE has low acute and chronic toxicity to the marine species tested. Based upon measured MTBE concentrations, acute effects were found to range from 166 mg MTBE/l for the grass shrimp to 1950 mg MTBE/l for marine mussel. The no-observed effect concentration for the reproduction and growth of mysids was 26 mg MTBE/l during the life cycle test. The toxicity of MTBE to saltwater organisms is comparable to its toxicity to the freshwater species tested. Reported MTBE concentrations in coastal waters are several orders of magnitude lower than concentrations observed to cause effects in marine organisms.

Animals↗
PubMedDate not supplied

Dermal absorption of pesticides in the rat.

The Office of Pesticide Programs (OPP) of the Environmental Protection Agency has developed a standard protocol for evaluating the dermal penetration of pesticides in the rat. This protocol was formalized in 1994 as a guideline for Dermal Absorption Studies of Pesticides. To date, in excess of 263 studies on the dermal absorption of over 160 pesticide chemicals have been submitted to OPP as part of the pesticide registration and risk assessment processes. The majority of these studies has been performed according to the OPP standard protocol in the rat. These studies constitute the largest database in existence on the dermal absorption of a wide variety of chemicals using a standard protocol. From this standard protocol it is possible to describe, quantitatively with dose and time, the entrance of a chemical into and penetration through the mammalian epidermis into the systemic circulation, its concentration in blood and in the body, and its excretion in urine and feces. This article describes the experimental design of the standard protocol and presents examples of the types of pesticides studied: pesticides that are neither volatile nor damage the skin (the most common type), volatile pesticides, and pesticides that damage the skin. Examples are selected to illustrate differences in the pattern of dermal uptake and subsequent absorption into the systemic compartment among and within the three classes.

Animals↗
PubMed2001

The cost of developing site-specific environmental regulations: evidence from EPA's project XL.

The flagship of the Environmental Protection Agency's regulatory reinvention initiative, Project XL has been touted as a regulatory blueprint for a site-specific, performance-based pollution-control system, but widespread complaints about the costs of the program beg the question of whether the costs of tailoring regulations to individual facilities are manageable. To address this question, this paper presents original survey data on a sample of 11 XL projects. We find that the fixed costs of putting in place XL agreements are substantial, averaging over $450,000 per firm. While stakeholder negotiations are widely cited as the principal source for these costs, we find that they actually arise mainly from interaction between participating facilities and the EPA. Moreover, EPA management problems are perceived by our survey respondents as having inflated project development costs. Finally, we find that the key factors that explains differences in costs across XL projects are the scope and complexity of the project proposal. These findings suggest that Project XL favors large firms that can afford to pay significant project development costs, that EPA management problems must be resolved to reduce costs, and that there may be a significant economic bias against complex and innovative proposals--precisely the type of proposals that Project XL was designed to foster in order to improve the efficiency of the regulatory system.

Commerce↗
PubMedDate not supplied

Development of chronic aquatic water quality criteria and standards for silver.

U.S. Environmental Protection Agency (EPA) is updating its aquatic life ambient water quality criteria (aqAWQC) for a number of parameters, including silver. The silver aqAWQC was last issued in 1980. At that time only an acute aqAWQC was established. With the increased reliance on water quality criteria to drive and prioritize the United State's efforts to improve water quality, the scientific basis of new and modified water quality criteria must be both strong and transparent. Although few, if any, natural waters in the United States have suffered water quality impairments because of silver, the lack of valid silver chronic toxicity data in combination with the misapplication of the current U.S. EPA guidelines on deriving chronic aqAWQC could lead to derivation of chronic criteria (by U.S. EPA) and chronic standards (by states, tribes, etc.) that are not supported by scientific data. This misapplication could result in U.S. EPA and the states listing many waters as impaired by silver where, in fact, no silver-related water quality problem exists. This Research Note reviews available information on studies of both acute and chronic silver toxicity to aquatic organisms, as well as U.S. EPA's 1985 procedure for adopting chronic water quality criteria. It identifies existing gaps in the underlying research data base and identifies additional work necessary to derive valid chronic water quality criteria and standards for silver.

Animals↗
PubMed1998

Targeting lead in the multimedia environment in the continental United States.

The U.S. Environmental Protection Agency's (EPA) lead attainment strategy for air is being expanded to address geographic areas with the potential for multimedia, multipathway exposures to lead. Geographic Information Systems (GIS) technology is used to coordinate information from various databases to identify areas of potential concern. The data retrieval and decision processes used in identifying priority sources from each medium and in evaluating identified areas of concern are described in this paper. Only EPA databases with reliable locational information were used to facilitate accurate mapping and allow correlation with other data sources. The sources of lead loadings to air, water, and soils were mapped using either latitude and longitude or zip code, or county centroids for data lacking longitudinal and latitudinal coordinates (such as the drinking water data). A multimedia cluster of lead sources was identified at the county level, since all the facility data in the five databases could be mapped to this level. An impact factor and weighting system was devised to combine the information on the number of facilities and their relative size in developing a ranking of the multimedia lead clusters of concern in each region. The counties with the highest number of points were considered clusters of highest concern for multimedia lead sources. Two separate lists of the clusters were developed according to a point system. One identified 10 multimedia lead clusters in each of the 10 EPA regions, and the other identified the 100 clusters of highest concern in the country as a whole. The project is designed to be a first step in targeting future efforts to identify potential environmental problems associated with lead. The analyses presented in this paper provide a first look at the areas in the country where there is a potential for multimedia exposure to lead. A more refined analysis at the zip code level was subsequently developed to provide a good understanding of the issues pertaining to potential exposure at the neighborhood level. The results of this analysis will ultimately help the EPA and the states to target implementation and enforcement in areas of high potential lead exposures.

Databases, Factual↗
PubMed2005

Development of U.S. EPA method 527 for the analysis of selected pesticides and flame retardants in the UCMR survey.

Method 527 was developed to address the occurrence monitoring needs of the U.S. Environmental Protection Agency (EPA) under its second unregulated contaminant monitoring rule (UCMR 2). This method includes a wide range of semivolatile organic contaminants, including pesticides that were deferred during the first UCMR, flame retardants, and pyrethroid pesticides. This paper discusses the rationale for selection and inclusion of the various contaminants included in Method 527 and describes the challenges associated with developing analytical methods that will be used for the occurrence monitoring of such a diverse group of organic molecules. Method 527 employs solid-phase extraction with analysis by gas chromatography/ mass spectrometry (GC/MS). The final method preservation scheme requires the storage of samples in amber bottles buffered at pH 3.8 using citric acid to prevent degradation from acid-catalyzed hydrolysis and from UV light. Citric acid is also an effective antimicrobial reagent, preventing this mode of loss during storage. Ethylenediaminetetraacetic acid (EDTA) is added to remove transition metals such as copper, which was determined to degrade target analytes upon storage. Finally, free available chlorine (FAC), which is present in many finished waters and found to degrade a number of the targets, is removed using ascorbic acid. The final method meets all of the EPA UCMR survey requirements for sample storage, precision, accuracy, and sensitivity and will be proposed for use under the UCMR 2.

Data Collection↗
PubMed2006

Trichloroethylene cancer epidemiology: a consideration of select issues.

A large body of epidemiologic evidence exists for exploring causal associations between cancer and trichloroethylene (TCE) exposure. The U.S. Environmental Protection Agency 2001 draft TCE health risk assessment concluded that epidemiologic studies, on the whole, support associations between TCE exposure and excess risk of kidney cancer, liver cancer, and lymphomas, and, to a lesser extent, cervical cancer and prostate cancer. As part of a mini-monograph on key issues in the health risk assessment of TCE, this article reviews recently published scientific literature examining cancer and TCE exposure and identifies four issues that are key to interpreting the larger body of epidemiologic evidence: a) relative sensitivity of cancer incidence and mortality data ; b) different classifications of lymphomas, including non-Hodgkin lymphoma ; c) differences in data and methods for assigning TCE exposure status ; and d) different methods employed for causal inferences, including statistical or meta-analysis approaches. The recent epidemiologic studies substantially expand the epidemiologic database, with seven new studies available on kidney cancer and somewhat fewer studies available that examine possible associations at other sites. Overall, recently published studies appear to provide further support for the kidney, liver, and lymphatic systems as targets of TCE toxicity, suggesting, as do previous studies, modestly elevated (typically 1.5-2.0) site-specific relative risks, given exposure conditions in these studies. However, a number of challenging issues need to be considered before drawing causal conclusions about TCE exposure and cancer from these data.

Animals↗
PubMed2001

Field demonstration of pervaporation for the separation of volatile organic compounds from a surfactant-based soil remediation fluid.

As part of a Department of Defense project, the US Environmental Protection Agency was responsible for designing, building and field operating a pilot-scale pervaporation unit. The field site was an active dry cleaning facility on the grounds of Marine Corps Base Camp Lejeune in Jacksonville, NC. The overall goal of the project was to remove tetrachloroethylene (PCE) from the soil beneath the dry cleaning shop using a surfactant-based soil remediation fluid and to recycle/reuse the surfactant. In order to reinject the recovered surfactant, the pervaporation unit was required to achieve an average 95% removal of contaminants from the extracted fluid over the duration of the test period. PCE removal averaged 95.8% during peak surfactant levels and exceeded 99.9% in the absence of surfactant, thereby meeting the reinjection requirement. Removal of a group of secondary contaminants at the site, termed Varsol compounds, was monitored via concentrations of three Varsol marker compounds: decane, undecane and 1,3,5-trimethylbenzene. The pervaporation system processed 100,000 gal of groundwater and surfactant solution over a period of 70 days. In order to evaluate and validate process performance, a variety of process variables and properties were monitored over the course of the demonstration. Pervaporation costs are projected to be on the order of $20 per 1000 gal of surfactant solution treated for a moderate size system (10 gpm).

Decontamination↗