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Organizational components and structural features of EPA's new Human Exposure Research Program.

Modern technology has brought about a dramatic increase in the production and consumption of man-made chemicals and in their resulting emissions. It is clear that these emissions and their by-products will likely affect our environment and have a health impact on the population exposed to them. Knowledge of exposure is required to document the impact of these emissions on human health. However, measuring, interpreting, and characterizing human exposures are extraordinarily complex processes because exposures may occur by multiple routes, multiple sources, and they are subject to a wide range of temporal, spatial, and source variations often from both anthropogenic and non-anthropogenic sources. The Environmental Protection Agency's approach to exposure research has often been insufficient to understand and mitigate these complex real-word exposures. For example, we do not know the population exposure distributions of most pollutants and the relative contributions of sources to these distributions. Without this knowledge as input into EPA's risk management process, EPA's may not be making the most effective environmental management decisions for reducing human health risks. The Human Exposure Research Program is a direct response to this need to understand how and to what extent humans are exposed to environmental pollutants.

Databases, Factual↗

Making cleanup decisions at hazardous waste sites: the clean sites approach.

This paper provides a summary of the results of an 18-month study conducted by Clean Sites, Inc. of Alexandria, Virginia. The study was designed to take a critical look at the way remedies are selected for abandoned hazardous waste sites that are cleaned up under the authority of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund) and to develop recommendations for improving that process. The recommendations were released in an October 1990 report entitled "Improving Remedy Selection: An Explicit and Interactive Process for the Superfund Program." Through a cooperative agreement with the U.S. Environmental Protection Agency, Clean Sites is working to test these recommendations. At two actual Superfund sites, Clean Sites will assist EPA in performing the remedy selection in accordance with the process Clean Sites has developed.

Hazardous Waste↗

Industry viewpoint on thresholds for genotoxic carcinogens.

Modern chemical control of pests has contributed to a dramatic improvement in public welfare since its introduction 50 years ago. Millions of lives have been saved through the control of disease vectors, and millions more have been improved by the use of chemicals to produce an inexpensive and abundant food supply. Hundreds of pesticidally active ingredients are in commercial use today, and among these are found genotoxic and nongenotoxic carcinogens. In the United States, the Environmental Protection Agency regulates carcinogens using threshold and nonthreshold approaches depending upon the outcome of a weight-of-evidence determination. More than one-half of all pesticides with some evidence of carcinogenic potential are regulated by the nonthreshold approach. The limitations on product use imposed by this approach have restricted the number of products available to growers and to the public. This restriction has had a direct impact on industry with respect to commercial success and financial returns on investment as well as an indirect impact on the industry's ability to fund the discovery and development of new compounds. This paper explores the question of how well regulation by the nonthreshold approach has achieved the goal of protecting public health, whether it does this better than the alternative use of the threshold approach, and whether the incremental protection it affords is a meaningful public benefit that justifies the aforementioned impacts on industry.

Carcinogenicity Tests↗

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↗

Residential arsenic and lead levels in an agricultural community with a history of lead arsenate use.

Lead arsenate (PbHAsO4) was used as an insecticide in Washington fruit orchards from 1905 to 1947. We examined exposure potential for children living in an agricultural community with historic PbHAsO4 use. Soil and housedust samples were collected from 58 residences. Families were asked about land use history, age of home, and remodeling activities. Median concentrations of arsenic were higher in housedust than in soil (9.0 and 4.2 microg/g, respectively; P=0.05), as were lead concentrations (129 and 46 microg/g, respectively; P=0.0001). Significant associations were observed between indoor and outdoor levels of each metal, indicating track-in as an important exposure pathway. Homes on or near land use for pear or apple production between 1905 and 1947 had significantly higher soil (P=0.005) and housedust (P=0.004) lead, and soil arsenic (P=0.04) than did the other homes. Homes more than 30 years old had significantly higher soil and housedust lead than did newer homes (P=0.01). Homes remodeled within the past two years had significantly higher soil (P=0.01) and housedust (P=0.04) lead. Child doses extrapolated from these data indicate that 36% of homes had soil or dust arsenic levels above the minimum risk level estimated by the Agency for Toxic Substances and Disease Registry. None of the measured lead levels exceeded current US Environmental Protection Agency guidelines. Public health education programs focused on residential hygiene would be of value in areas of historic PbHAsO4 use.

Adult↗

From health-based to technology-based standards for hazardous air pollutants.

The Clean Air Act Amendments of 1990 represent a major shift in regulatory emphasis for toxic air pollutants. Recognizing the immediate public health benefits that can be gained from the application of currently available and affordable control technologies, Congress has abandoned its insistence that health risks should be the only consideration in establishing emissions standards. Previously excluded concerns about economic costs and technological feasibility will now determine the initial level of pollution control required of toxic air pollution sources. In exchange for reducing the stringency of emissions limits, the newly amended act extends the scope of regulation by listing 189 toxic substances that must be controlled over the next decade. This exchange of regulatory depth for breadth occurs against a history of reluctance by the Environmental Protection Agency to implement the original health-protective language of the Clean Air Act. It mirrors earlier compromises under the Clean Water Act and the Occupational Safety and Health Act.

Air Pollutants↗

AHA responds to proposals on medical waste incineration.

Roger Olson, chairman of facilities operations for the Mayo Clinic, Rochester, MN, testified on behalf of the American Hospital Association before the U.S. Environmental Protection Agency's Office of Air Quality Planning and Standards on the EPA's proposed rules on medical waste incinerators. Here's what he had to say.

American Hospital Association↗

Formaldehyde. AMA Council on Scientific Affairs.

In response to Resolution 195 (A-87), the medical literature on the adverse health effects of formaldehyde was reviewed, and the potential cancer risk to anatomists and other related health professionals from exposure to the chemical is described. Though the evidence in humans is limited and controversial, both the Environmental Protection Agency and the Occupational Safety and Health Administration, in their consideration of available epidemiologic and toxicological studies, now regard formaldehyde as a possible human carcinogen and will regulate it accordingly.

Cohort Studies↗

Risk assessments of polychlorinated dibenzo- p-dioxins, polychlorinated dibenzofurans, and dioxin-like polychlorinated biphenyls in food.

The polychlorinated dibenzo-p-dioxins (PCDD), polychlorinated dibenzofurans (PCDF), and dioxin-like polychlorinated biphenyls (dioxin-like PCB) are ubiquitous in food of animal origin and accumulate in fatty tissues of animals and humans. The most toxic congener is 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD). The toxic responses include dermal toxicity, immunotoxicity, carcinogenicity, and reproductive and developmental toxicity. Toxic equivalency factors have been established for the other PCDD, PCDF and dioxin-like PCB relative to TCDD, and the combined toxicity of a sample can be expressed as toxic equivalent (WHO-TEQ). The EC Scientific Committee for Food evaluated these compounds in 2001. The assessment used the most sensitive adverse toxicological end-points of TCDD in experimental animals. These were developmental and reproductive effects in the male offspring of rats administered TCDD during pregnancy. Because of the large difference between rats and humans in the biological half-life of TCDD, the assessment used a body burden approach to compare across species and derived a tolerable weekly intake of 14 pg TCDD/kg of body weight (bw), which was extended to include all the 2,3,7,8-substituted PCDD and PCDF, and the dioxin-like PCB, and expressed as a group tolerable weekly intake of 14 pg WHO-TEQ/kg bw. The FAO/WHO Joint Expert Committee on Food Additives (JECFA) performed a similar assessment whereas the US Environmental Protection Agency (US EPA) has paid more attention to human data on carcinogenicity.

Adipose Tissue↗

Field testing of particulate matter continuous emission monitors at the DOE Oak Ridge TSCA incinerator. Toxic Substances Control Act.

A field study to evaluate the performance of three commercially available particulate matter (PM) continuous emission monitors (CEMs) was conducted in 1999-2000 at the US Department of Energy (DOE) Toxic Substances Control Act (TSCA) Incinerator. This study offers unique features that are believed to enhance the collective US experience with PM CEMs. The TSCA Incinerator is permitted to treat PCB-contaminated RCRA hazardous low-level radioactive wastes. The air pollution control system utilizes MACT control technology and is comprised of a rapid quench, venturi scrubber, packed bed scrubber, and two ionizing wet scrubbers in series, which create a saturated flue gas that must be conditioned by the CEMs prior to measurement. The incinerator routinely treats a wide variety of wastes including high and low BTU organic liquids, aqueous, and solid wastes. The various possible combinations for treating liquid and solid wastes may present a challenge in establishing a single, acceptable correlation relationship for individual CEMs. The effect of low-level radioactive material present in the waste is a unique site-specific factor not evaluated in previous tests. The three systems chosen for evaluation were two beta gauge devices and a light scattering device. The performance of the CEMs was evaluated using the requirements in draft Environmental Protection Agency (EPA) Performance Specification 11 (PS11) and Procedure 2. The results of Reference Method 5i stack tests for establishing statistical correlations between the reference method data and the CEMs responses are discussed.

Environmental Monitoring↗

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↗

Drinking water standards for radionuclides: the dilemma and a possible resolution.

The U.S. Environmental Protection Agency (EPA) is undertaking a revision of existing standards for radionuclides in drinking water. The Safe Drinking Water Act specifies that any revision "shall maintain or provide for greater protection of the health of persons." This provision appears to require that existing standards (maximum contaminant levels, MCLs) cannot be relaxed. Such a requirement presents a dilemma for two reasons. First, EPA has shown that the MCL for radium was not cost-effective. Second, MCLs for beta/gamma-emitting radionuclides incorporate outdated approaches to estimating dose from ingestion of radionuclides and, thus, appear to violate provisions of the Safe Drinking Water Act concerning the use of sound science in setting standards. We suggest that this dilemma can be resolved based on an argument that the standard for protection of public health mandated by the Safe Drinking Water Act is one of applying best-available technology for removal of contaminants from drinking water at a reasonable cost, not one of meeting previously established MCLs.

Humans↗

Health hazards by lead exposure: evaluation using ASV and XRF.

Globally, of many toxic heavy metals, lead is the most widely used for various purposes, resulting in a variety of health hazards due to environmental contamination. Lead in the workplace enters the workers through inhalation of lead-contaminated air, by ingestion, and sometimes through dermal exposure. Furthermore, exposure outside the workplace can occur from inhalation of lead-contaminated air, ingestion of lead-contaminated dust and soil, consumption of lead polluted water, lead adulterated food and lead supplemented medicine. In the present study, an evaluation of blood lead was carried out with the aid of a 3010 B lead analyser, based on the principle of anodic stripping voltametry (ASV), and environmental lead in paint, soil and dust samples by a field portable X-ray fluorescence (XRF) analyser. This revealed a high incidence of lead toxicity in most of the lead-based industrial workers in the four facilities tested in India and high levels of lead in the environmental samples. Developed countries have complied with the global standards for regulating environmental lead poisoning in the workplace, eliminating to some degree excessive exposure to lead. A developing country, such as India, can tackle this problem by implementing national and international policies. The US Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA) regulations, which are of prime importance, or similar regulations, can be adapted for use in India and implemented to minimize lead exposure and to reduce the resultant health hazards.

Developing Countries↗

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↗

Efficacy testing of disinfectants.

The U.S. Environmental Protection Agency's (EPA) Office of Pesticide Programs (OPP) has the responsibility for regulating antimicrobial products, including sporicides, used to treat and decontaminate inanimate surfaces. In response to the anthrax (Bacillus anthracis) attacks of 2001 and the associated need for verifying the performance of chemicals for building decontamination, the EPA initiated research in late 2003 to evaluate and improve efficacy test methods for sporicides. The OPP Microbiology Laboratory located at the Environmental Science Center, Ft. Meade, MD is the lead laboratory. Through funding provided by EPA's Office of Research and Development (Safe Buildings Program), a collaborative research plan has been established to address several key issues. Research is currently being conducted on 2 fronts: (1) the evaluation of quantitative methodology for assessing the efficacy of sporicides, and (2) the development and comparative testing of selected modifications to improve the AOAC Sporicidal Activity Test (AOAC Method 966.04). Future studies will include the evaluation of candidate surrogates of B. anthracis using a quantitative method, and a multilaboratory validation study of a quantitative method-surrogate combination. The General Referee is serving as the Principal Investigator for all research described in this report, and has the overall responsibility for the technical conduct of the projects. In cases where the General Referee has oversight of projects that involve official collaborative studies and validation support from AOAC INTERNATIONAL, AOAC officials and the Committee Chair will determine the appropriate mechanism for formal study review. The 2003 General Referee report provides the background on the development and direction of the research projects. The preliminary data, general conclusions, next steps, and recommendations are provided in this report.

Bacillus subtilis↗

Perspectives on the place of environmental health and protection in public health and public health agencies.

The field of environmental health and protection and the entire field of public health have repeatedly found themselves isolated from one another, unable to articulate the definition, mission, and goals of public health and the essential role for environmental health and protection in the provision of a healthy ecological and human environment. Environmental agencies often forget that they, too, are public health agencies; public health agencies that have had environmental health functions have divided and abdicated their environmental responsibilities, considering these to be "regulatory" rather than public health. This article reviews the history of environmental health and protection, its involvement within the field of public health, its eventual separation from other public health programs with resulting benefits and consequences, and what the future may hold for environmental health and protection activities as well as for the broader scope of public health of which these activities are a part.

Association↗

Water quality and poultry production.

Mineral and microbial content of water affects the performance of poultry. Because poultry production can adversely affect water quality, the Environmental Protection Agency monitors and regulates its impact. Management of nonpoint source water contamination is especially important. If properly managed, litter, a valuable secondary commodity associated with poultry production, can be used as fertilizer, food, or energy.

Animal Husbandry↗

Detection of human enteric viruses in stream water with RT-PCR and cell culture.

A multiplex RT-PCR method was used to measure virus occurrence at five stream water sites that span a range of hydroclimatic, water-quality, and land-use characteristics. The performance of the molecular method was evaluated in comparison with traditional cell culture and Escherichia coli membrane filtration assays. The study incorporated multiple quality controls and included a control for virus recovery during the sampling procedure as well as controls to detect potentially false-negative and false-positive data. Poliovirus recovery ranged from 16 to 65% and was variable, even in samples collected within the same stream. All five sites were positive for viruses by both molecular and cell culture-based virus assays. Enteroviruses, reoviruses, rotaviruses, and hepatitis A viruses were detected, but the use of the quality controls proved critical for interpretation of the molecular data. All sites showed evidence of faecal contamination, and culturable viruses were detected in four samples that would have met the US Environmental Protection Agency's recommended E. coli guideline for safe recreational water.

Base Sequence↗