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PubMed2004

Human testing of pesticides: ethical and scientific considerations.

I reviewed ethical and scientific aspects of 6 human pesticide-dosing studies submitted to the Environmental Protection Agency (EPA) for consideration during the pesticide reregistration process. All had serious ethical or scientific deficiencies-or both-including unacceptable informed consent procedures, unmanaged financial conflicts of interest, inadequate statistical power, inappropriate test methods and endpoints, and distorted results. Given today's knowledge of the effects of pesticides, there is no assurance that any such study can be completely free of short-term risks, long-term risks, or both. Therefore, there is no basis for allowing pesticide studies to continue or for using them during the pesticide reregistration process. An EPA committee that is free from political and financial conflicts of interest should review this practice.

Analysis of Variance↗
PubMedDate not supplied

[The definitions and classifications of carcinogenesis, mutagenesis and teratogenesis used by national and international agencies and institutions].

Classifications of carcinogenesis, mutagenesis and teratogenesis used by the National Toxicological Advisory Committee in Italy (CCTN), the Commission of the European Communities (CEC), the Environmental Protection Agency in the USA (EPA), the International Agency for Research on Cancer (IARC), and the National Toxicology Programme in the USA (NPT) are examined and commented on, with a synopsis of several allocations made by the above organizations. However, the authors consider it advisable to redefine the categories and create 5 groups of substances (designated C1 to C5), on the basis of given definitions, with the aim of rendering the allocations comparable. This procedure is used solely for carcinogenesis and excludes the NTP. From such comparison, good agreement was found between CCTN and EPA and between CCTN and CEC, whereas agreement between IARC and other organizations was poor.

Abnormalities, Drug-Induced↗
PubMed2005

A novel approach for the determination of detection limits for metal analysis of environmental water samples.

Despite the widespread use of the USEPA method (U.S. Environmental Protection Agency, 40 CFR 136 Appendix B) for the determination of method detection limit (MDL), criticisms have been raised that the method does not account for measurement bias and outliers that subsequently lead to a common misunderstanding of the requirement for the determination of MDL. This paper demonstrates that it is difficult to follow the USEPA method for verifying the MDL for analysis involving multiple metals and proposes a precision and bias criterion for determining the MDL. A multiple-point fitted profile, based on the correlation between relative standard deviation (RSD) and concentration, is used to derive a robust MDL value. Representative examples of As, Ca, Cr, and Cu are used to illustrate this procedure. A procedure for identifying outliers is also discussed.

Arsenic↗
PubMed2002

VOCs, pesticides, nitrate, and their mixtures in groundwater used for drinking water in the United States.

Samples of untreated groundwater from 1255 domestic drinking-water wells and 242 public supply wells were analyzed as part of the National Water-Quality Assessment Program of the U.S. Geological Survey between 1992 and 1999. Wells were sampled to define the regional quality of the groundwater resource and, thus, were distributed geographically across large aquifers, primarily in rural areas. For each sample, as many as 60 volatile organic compounds (VOCs), 83 pesticides, and nitrate were analyzed. On the basis of previous studies, nitrate concentrations as nitrogen > or = 3 mg/L were considered to have an anthropogenic origin. VOCs were detected more frequently (44%) than pesticides (38%) or anthropogenic nitrate (28%). Seventy percent of the samples contained at least one VOC, pesticide, or anthropogenic nitrate; 47% contained at least two compounds; and 33% contained at least three compounds. The combined concentrations of VOCs and pesticides ranged from about 0.001 to 100 microg/L, with a median of 0.02 microg/L. Water from about 12% of the wells contained one or more compounds that exceeded U.S. Environmental Protection Agency drinking-water standards or human health criteria, primarily because of nitrate concentrations exceeding the maximum contaminant level in domestic wells. A mixture is defined as a unique combination of two or more particular compounds, regardless of the presence of other compounds that may occur in the same sample. There were 100 mixtures (significantly associated with agricultural land use) that had a detection frequency between 2% and 19%. There were 302 mixtures (significantly associated with urban land use) that had a detection frequency between 1% and <2%. Only 14 compounds (seven VOCs, six pesticides, and nitrate) contributed over 95% of the detections in these 402 mixtures; however, most samples with these mixtures also contain a variety of other compounds.

Data Collection↗
PubMed2002

Evaluating quantitative formulas for dose-response assessment of chemical mixtures.

Risk assessment formulas are often distinguished from dose-response models by being rough but necessary. The evaluation of these rough formulas is described here, using the example of mixture risk assessment. Two conditions make the dose-response part of mixture risk assessment difficult, lack of data on mixture dose-response relationships, and the need to address risk from combinations of chemicals because of public demands and statutory requirements. Consequently, the U.S. Environmental Protection Agency has developed methods for carrying out quantitative dose-response assessment for chemical mixtures that require information only on the toxicity of single chemicals and of chemical pair interactions. These formulas are based on plausible ideas and default parameters but minimal supporting data on whole mixtures. Because of this lack of mixture data, the usual evaluation of accuracy (predicted vs. observed) cannot be performed. Two approaches to the evaluation of such formulas are to consider fundamental biological concepts that support the quantitative formulas (e.g., toxicologic similarity) and to determine how well the proposed method performs under simplifying constraints (e.g., as the toxicologic interactions disappear). These ideas are illustrated using dose addition and two weight-of-evidence formulas for incorporating toxicologic interactions.

Dose-Response Relationship, Drug↗
PubMed1983

Legislative aspects of hazardous waste management.

In the fall of 1976 Congress enacted the Resource Conservation and Recovery Act, commonly referred to as RCRA. The objective of the statute is to create an orderly system for the generation, handling and disposal of hazardous waste by means of a comprehensive tracking and record keeping mechanism. RCRA does not regulate directly by statute so much as it delegates rule making authority to the U.S. Environmental Protection Agency. Pursuant to its mandate to develop regulations in accordance with the broad criteria of RCRA, EPA has published extensive regulations. These regulations address hazardous waste generation, transportation, treatment, storage and handling and its final disposal. The statute also offers remedies available to both EPA and the public at large to ensure enforcement of the provisions of RCRA and the EPA regulations. Additionally, it sets guidelines for states to implement their own hazardous waste management programs. This article is intended to introduce this complicated statutory/regulatory package to scientists and health professionals. It outlines the provisions of RCRA and the EPA regulations, abbreviates early judicial decisions interpreting these provisions and sets forth a brief description of various state approaches to hazardous waste management.

Government Agencies↗
PubMed1991

Comparison of risks from outdoor and indoor exposure to toxic chemicals.

Environmental Protection Agency TEAM (Total Exposure Assessment Measurement) Studies have measured exposures of about 800 persons to 25 volatile organic compounds (VOCs) and exposures of about 300 persons to 32 pesticides. These persons were selected to represent more than 1 million residents of industrial manufacturing cities such as Bayonne and Elizabeth, New Jersey, and Los Angeles, California; cities with light industry, such as Greensboro, North Carolina, and Baltimore, Maryland; rural areas such as Devils Lake, North Dakota; and cities with high pesticide use such as Jacksonville, Florida, as well as low-to-moderate pesticide use such as Springfield, Massachusetts. The TEAM data provide an opportunity to estimate the risks from airborne exposure to a number of suspected carcinogens for a substantial number of persons residing in a wide variety of urban, suburban, and rural areas. Because all of the TEAM Studies measured outdoor concentrations near the homes of the participants, it is possible to apportion the risks between outdoor and indoor sources. Upper-bound lifetime risks of cancer are calculated for both indoor and outdoor sources of 12 VOCs and about 23 pesticides measured in the TEAM Studies. These risk calculations are supplemented by calculations based on other studies for some additional pollutants, including radon and environmental tobacco smoke. The relationship of these upper-bound risk estimates to "best-guess" values is discussed. Sharper estimates of risk based on identifying population subgroups exposed to major sources are also discussed. Important gaps in our knowledge of exposure measurements are identified, e.g., particulates (including polyaromatic hydrocarbons); 1,3-butadiene, asbestos, chromium, cadmium, arsenic, vinyl chloride, methylene chloride, and most polar organics.

Air Pollution↗
PubMed2001

Collaborative study of EPA Method 317.0 for the determination of inorganic oxyhalide disinfection by-products in drinking water using ion chromatography with the addition of a postcolumn reagent for trace bromate analysis.

The development of the U.S. Environmental Protection Agency (EPA) Method 317.0 is initiated to provide a sufficiently sensitive and fundamental technique for the compliance monitoring of trace levels of bromate in drinking water. After a comparative evaluation of Method 317.0 and elimination of a chlorite interference, this method is tested by a collaborative study in order to determine the precision and bias of the method and evaluate its potential role as a future compliance-monitoring method for inorganic disinfection by-products (DBPs) and trace bromate. This technique provides a practical method for future compliance monitoring for all of the inorganic oxyhalide DBPs including trace concentrations of bromate.

Bromates↗
PubMed1985

A multi-route exposure assessment of chemically contaminated drinking water.

This report provides an example of how a single source of contamination could potentially contribute to all routes of exposure. A modeling approach was used to estimate multiple exposure routes in an attempt to assess the health significance of gasoline-contaminated drinking water supplies. This model consisted of a two-compartment, indoor air quality equation that calculates the contribution made by ambient and indoor air contaminated by a pollutant volatilized from drinking water to that pollutant's inhalation burden. In addition, the model uses the traditional equations for assessing a pollutant's oral and dermal burdens. Benzene, toluene and xylene were used as surrogates for gasoline contamination to determine the contribution of contaminated water to adult and child body burdens from indoor air, oral (drinking water and food) and dermal exposure routes. The contribution thus calculated for each chemical was compared to the EPA's Office of Drinking Water Health Advisories. In terms of acute exposure, the use of chemically contaminated water for showering purposes may generate vapor in the confined area of the bathroom at levels sufficient to cause or contribute to mucous tissue irritation, as commonly reported in affected homes. High temperatures and humidity may also contribute to these effects, especially in the bathroom. In terms of chronic exposure, the use of chemically contaminated water at EPA-recommended guideline amounts in an affected home may result in inhalation, oral and dermal exposures leading to cumulative doses exceeding adult and child total daily body burdens based on EPA's Health Advisories. Thus, this model indicates that the traditional standard/guidelines derivation processes should be reevaluated to consider the pollutant contribution from multiple routes of exposure. The New Jersey Departments of Health and Environmental Protection conducted a study in which concentrations of several pollutants including benzene in the breathing zone were measured during a 15-minute shower in homes with contaminated water. The findings suggest that the air quality model used in the present study may satisfactorily predict the airborne concentrations of pollutants in, at least, the bathroom after showering with contaminated water (Pearson rank correlation coefficient of 0.773 with p = 0.0012 for n = 14). The findings of the present study support the use of an adjustment factor for all exposure durations to account for exposures to other sources of the contaminant, i.e., urban, occupational, and food. A value of 20% seems appropriate based on the study's findings.(ABSTRACT TRUNCATED AT 400 WORDS)

Aerosols↗
PubMed1993

Drinking water health advisory program.

The US Environmental Protection Agency prepares Health Advisories (HA) for drinking water contaminants. The HA provide technical guidance to public health officials or other interested groups on many aspects concerning drinking water contamination. The HA contain information on the chemistry, health effects, analytical methods and treatment technologies for specific contaminants. In addition, the HA include a risk assessment section which provides concentrations of the contaminant in drinking water that are not anticipated to cause adverse, noncancer health effects for 1 or 10 days or for longer exposures. Because the HA include risk assessments for less than lifetime exposures, they are useful when accidental spills occur or when regulatory limits are temporarily exceeded. The guidance documents are updated when new information becomes available that would change the previous conclusions.

Risk Factors↗
PubMed2006

Governmental oversight of discharges from concentrated animal feeding operations.

As point sources of pollution in the United States, concentrated animal feeding operations (CAFOs) are subject to the National Pollution Discharge Elimination System permitting system requirements. Changes to federal regulations in 2003 and a 2005 court decision have increased the governmental oversight of CAFOs. Manure application to fields from "large CAFOs" that results in unpermitted discharges can be regulated under the Clean Water Act. The U.S. Environmental Protection Agency's interpretation of agricultural stormwater discharges was approved so that unpermitted discharges may arise if an owner or operator of a CAFO fails to apply manure correctly. Owners and operators do not, however, have a duty to secure governmental permits in the absence of a discharge. Turning to the federal provisions regarding nutrient management plans, a court found that they were deficient. Moreover, the federal government needs to reconsider requirements that would reduce pathogens from entering surface waters. Although these developments should assist in reducing the impairment of U.S. waters, concern still exists. Greater oversight of nutrient management plans and enhanced enforcement efforts offer opportunities to provide greater assurance that CAFO owners and operators will not allow a discharge of pollutants to enter surface waters.

Agriculture↗
PubMedDate not supplied

A review of the USEPA's single breath canister (SBC) method for exhaled volatile organic biomarkers.

Exhaled alveolar breath can provide a great deal of information about an individual's health and previous exposure to potentially harmful xenobiotic materials. Because breath can be obtained non-invasively and its constituents directly reflect concentrations in the blood, its use has many potential applications in the field of biomarker research. This paper reviews the utility and application of the single breath canister (SBC) method of alveolar breath collection and analysis first developed by the US Environmental Protection Agency (USEPA) in the 1990s. This review covers the development of the SBC technique in the laboratory and its application in a range of field studies. Together these studies specifically show how the SBC method (and exhaled breath analysis in general) can be used to clearly demonstrate recent exposure to volatile organic compounds, to link particular activities to specific exposures, to determine compound-specific uptake and elimination kinetics, and to assess the relative importance of various routes of exposure (i.e. dermal, ingestion, inhalation) in multi-pathway scenarios. Specific investigations covered in this overview include an assessment of exposures related to the residential use of contaminated groundwater, exposures to gasoline and fuel additives at self-service gas stations, swimmers' exposures to trihalomethanes, and occupational exposures to jet fuel.

Biomarkers↗
PubMed2001

Survival of fecal coliforms in dry-composting toilets.

The dry-composting toilet, which uses neither water nor sewage infrastructure, is a practical solution in areas with inadequate sewage disposal and where water is limited. These systems are becoming increasingly popular and are promoted to sanitize human excreta and to recycle them into fertilizer for nonedible plants, yet there are few data on the safety of this technology. This study analyzed fecal coliform reduction in approximately 90 prefabricated, dry-composting toilets (Sistema Integral de Reciclamiento de Desechos Orgánicos [SIRDOs]) that were installed on the U.S.-Mexico border in Ciudad Juárez, Chihuahua, Mexico. The purpose of this study was to determine fecal coliform reduction over time and the most probable method of this reduction. Biosolid waste samples were collected and analyzed at approximately 3 and 6 months and were classified based on U.S. Environmental Protection Agency standards. Results showed that class A compost (high grade) was present in only 35.8% of SIRDOs after 6 months. The primary mechanism for fecal coliform reduction was found to be desiccation rather than biodegradation. There was a significant correlation (P = 0.008) between classification rating and percent moisture categories of the biosolid samples: drier samples had a greater proportion of class A samples. Solar exposure was critical for maximal class A biosolid end products (P = 0.001). This study only addressed fecal coliforms as an indicator organism, and further research is necessary to determine the safety of composting toilets with respect to other pathogenic microorganisms, some of which are more resistant to desiccation.

Bacteriological Techniques↗
PubMed1997

Pesticide residues in food: investigation of disparities in cancer risk estimates.

Much of the public perceives that exposure to synthetic pesticide residues in the diet is a major cause of cancer. The National Research Council (NRC), in a 1987 report, Regulating Pesticides in Food: The Delaney Paradox, evaluated cancer risks for 29 pesticides that are rodent carcinogens and estimated that the risks for 23 were greater than one-in-a-million. In contrast, our group has ranked possible carcinogenic hazards from a variety of human exposures to rodent carcinogens using the HERP (Human Exposure/Rodent Potency) index, and found that dietary residues of synthetic pesticides ranked low. This paper evaluates the disparities in these analyses by examining the two components of risk assessment: carcinogenic potency in rodents and human exposure. Potency estimates based on rodent bioassay data are shown to be similar whether calculated, as in the NRC report, as the regulatory q1* or as TD50. In contrast, estimates of dietary exposure to residues of synthetic pesticides vary enormously, depending on whether they are based on the Theoretical Maximum Residue Contribution (TMRC) calculated by the Environmental Protection Agency vs. the average dietary residues measured by the Food and Drug Administration in the Total Diet Study (TDS). The TMRC is the theoretical maximum human exposure anticipated under the most severe field application conditions, which are far greater than dietary residues measured in the TDS. Several independent exposure studies suggest that the FDA dietary residues are reasonable estimates of average human exposures, whereas TMRC values are large overestimates. Using standard methodology and measured dietary residues in the TDS, the estimate of excess cancer risk from average lifetime exposure to synthetic pesticide residues in the diet appears to be less than one-in-a-million for each of the ten pesticides for which adequate data were available.

Animals↗
PubMed1997

Radon retesting and mitigation behavior among the U.S. population.

Relatively few data are available about how people comply with Environmental Protection Agency recommendations concerning retesting and mitigation after either an initial screening or long term test for radon gas. Using data from the 1990 and 1991 National Health Interview Surveys, we found that 40.7% (standard error 6.4%) of homes with radon levels above 148 Bq m(-3) in 1990 and 34.3% (standard error 4.9%) of homes with levels above 148 Bq m(-3) in 1991 were retested. Among homes that were retested and had either an initial screening or followup test above 148 Bq m(-3), 28.2% (standard error 6.4%) were mitigated in 1990 compared with 48.4% (standard error 14.4%) that did so in 1991. These results suggest that most people are not complying with current EPA recommendations for retesting and mitigation.

Air Pollutants, Radioactive↗
PubMed1990

Comprehensive waste regulation dumped. A limited demonstration project is all that remains.

When medical wastes started washing up along the Eastern Seaboard and the shores of the Great Lakes in 1988, healthcare providers became subject to close public scrutiny. Not only was the situation deplorable; the solution, they feared, would keep them entangled in red tape for years. Public outcry sent members of Congress scurrying to legislate medical waste regulation. But what many had predicted would be a comprehensive, nationwide regulation that tracked medical waste from cradle to grave turned out to be a demonstration project limited to Puerto Rico and four states in the Northeast. The Medical Waste Tracking Act of 1988 went into effect in June 1989. When it expires in June 1991, the Environmental Protection Agency (EPA) will report to Congress on the program's impact, presumably with an eye toward whether further legislation and continuing regulations are necessary. In the meantime, participating states must establish a system of tracking medical waste from its point of generation to its disposal by either incineration or burial in a landfill. Medical waste generators must separate it from other kinds of waste and place it in special labeled containers. They must also prepare a tracking form that accompanies the cargo and requires sign-off by generator, transporter, and disposal facility operator. The EPA has legal access to medical waste tracking forms and can inspect any site where medical wastes are located. Violators are subject to stiff civil and criminal penalties.

Facility Regulation and Control↗
PubMed1990

Failure of the STER-O-LIZER MD 200 to pass the EPA sporicidal test.

The U.S. Environmental Protection Agency (EPA) officially licenses and authorizes use of commercial gas and liquid sterilants. Products registered by the EPA include ethylene oxide gas, formalin-alcohol vapor, glutaraldehyde liquid, and chlorine dioxide liquid. One product that is exempted from EPA registration is the STER-O-LIZER MD 200, in which the active component is electropotentiated saline solution. The manufacturer of the STER-O-LIZER claims that the device sterilizes surgical instruments in 2 minutes. Sterilization claims for the product are based on a test selected by the manufacturer. The EPA, however, is not concerned about the use of the STER-O-LIZER because it is non-toxic to humans. This study tested the validity of the manufacturer's claim by using EPA standards.

Bacillus subtilis↗
PubMed2001

Uncertainties in the reference dose for methylmercury.

This paper critically examines the National Academy of Sciences and the National Research Council report on the toxicological effects of methyl mercury and the recently published US Environmental Protection Agency Reference Dose (RfD) for Methylmercury. Particular scrutiny is placed on the choice of the critical study and the underlining assumptions utilized in the selection of specific uncertainty factors (UFs) and the rationale for using a less-than-default factor of 10. The UFs that were utilized or considered by other agencies and organizations are also critically examined, explained and compared to one another. Based on these analyses, the authors suggest research that could be performed that would ameliorate the uncertainty of choosing a more precise partial UFor that may even provide completeness of database to allow for selecting of a UF for unity, thus improving the precision of the current published RfD.

Animals↗