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Asbestos removal, health hazards, and the EPA. Council on Scientific Affairs, American Medical Association.

Resolution 193 (A-90), which was adopted by the House of Delegates of the American Medical Association, called on the Council on Scientific Affairs to study the situation regarding asbestos abatement, the risks to health, and the appropriateness of Environmental Protection Agency regulations, policies, and control measures. This report reviews the current status of asbestos abatement as applied to schools and public buildings, which currently accounts for the major expenditure of public funds.

American Medical Association↗

Using science to assess environmental vulnerabilities.

Beginning in 1995, the U.S. Environmental Protection Agency (U.S. EPA), Office of Research and Development has focused much of its ecological research in the Mid-Atlantic as part of the Mid-Atlantic Integrated Assessment (MAIA). The goal of MAIA is to improve the assessability of scientific information in environmental decision-making. Following the Environmental Monitoring and Assessment Program (EMAP) whose goal is to guide monitoring that effectively reflects current ecosystem condition and trends, MAIA's second, current, phase of research under the Regional Vulnerability Assessment (ReVA) program is designed to target risk management activities using available data and models. The papers presented here are from a conference held in May 2003 that presented results of research in this second phase of MAIA. The conference was organized into the following topics: 1. Assessing Current Impacts and Vulnerabilities 2. Forecasting Environmental Condition and Vulnerabilities 3. Developing Management Strategies to Optimize the Future, and 4. Assessing and Responding to Environmental Vulnerability.

Environmental Monitoring↗

Chemical mixtures: considering the evolution of toxicology and chemical assessment.

The assessment of chemical mixtures is a complex topic for toxicologists, regulators, and the public. In this article the linkage between the science of toxicology and the needs of governmental regulatory agencies in the United States is explored through an overview of environmental regulations enacted over the past century and a brief history of modern toxicology. One of the goals of this overview is to encourage both regulators and scientists to consider the benefits and limitations of this science-regulatory relationship as they tackle existing issues such as chemical mixtures. It is clear that a) over the past 100 years chemical regulation and toxicologic research, have in large part, shared a common emphasis on characterization and regulation of individual chemicals. But chemical mixtures have been, and continue to be, evaluated at hazardous waste sites around the United States. For this reason the current U.S. Environmental Protection Agency guidelines for chemical mixtures assessment are also reviewed. These guidelines highlight the current practice of mixtures assessment, which relies primarily on the existing single-chemical database. It is also clear that b) the science and assessment of chemical mixtures are moving forward through the combined efforts of regulatory agencies and scientists from a broad range of disciplines, including toxicology. Because toxicology is at this exciting crossroads, particular attention should be paid to the forces (e.g., public demands, regulatory needs, funding, academic interests) that both promote and limit the growth of this expanding discipline.

Environmental Exposure↗

Enterococci as indicators of Lake Michigan recreational water quality: comparison of two methodologies and their impacts on public health regulatory events.

The frequency of poor-water-quality advisories issued in Milwaukee and Racine, Wisconsin, in the absence of identifiable sources of contamination brought into question the reliability of the present indicator organism, Escherichia coli. Enteroccoci have been suggested as an alternative to E. coli for freshwater monitoring due to their direct correlation to swimmer-associated gastroenteritis. The purpose of this research was threefold: (i) to explore enterococci as an alternative to E. coli for monitoring freshwater Lake Michigan beaches, (ii) to evaluate the impact of the two indicators on regulatory decisions, and (iii) to compare membrane filtration m-enterococcus agar with indoxyl-beta-D-glucoside to a chemical substrate technique (Enterolert) for the recovery of enterococci. Recreational water samples from Milwaukee (n = 305) and Racine (n = 153) were analyzed for the enumeration of E. coli and enterococci using IDEXX Colilert-18 and Enterolert. Correlation between the indicators was low (R(2) = 0.60 and 0.69). Based on U.S. Environmental Protection Agency bacterial indicator threshold levels of risk for full body immersion, using enterococci would have resulted in 56 additional unsafe-recreational-water-quality advisories compared to the total from using E. coli and the substrate-based methods. A comparison of the two enterococcal methods (n = 124) yielded similar results (R(2) = 0.62). This was further confounded by the frequent inability to verify enterococci from those wells producing fluorescence by the defined substrate test using conventional microbiological methods. These results suggest that further research is necessary regarding the use of defined substrate technology interchangeably with the U.S. Environmental Protection Agency-approved membrane filtration test for the detection of enterococci from fresh surface water.

Bacteriological Techniques↗

Mode of action and the assessment of chemical hazards in the presence of limited data: use of structure-activity relationships (SAR) under TSCA, Section 5.

Section 5 of the Toxic Substances Control Act (TSCA) requires that manufacturers and importers of new chemicals must submit a Premanufacture Notification (PMN) to the U.S. Environmental Protection Agency 90 days before they intend to commence manufacture or import. Certain information such as chemical identity, uses, etc., must be included in the notification. The submission of test data on the new substance, however, is not required, although any available health and environmental information must be provided. Nonetheless, over half of all PMNs submitted to the agency do not contain any test data; because PMN chemicals are new, no test data is generally available in the scientific literature. Given this situation, EPA has had to develop techniques for hazard assessment that can be used in the presence of limited test data. EPA's approach has been termed "structure-activity relationships" (SAR) and involves three major components: the first is critical evaluation and interpretation of available toxicity data on the chemical; the second component involves evaluation of test data available on analogous substances and/or potential metabolites; and the third component involves the use of mathematical expressions for biological activity known as "quantitative structure-activity relationships" (QSARs). At present, the use of QSARs is limited to estimating physical chemical properties, environmental toxicity, and bioconcentration factors. An important overarching element in EPA's approach is the experience and judgment of scientific assessors in interpreting and integrating the available data and information. Examples are provided that illustrate EPA's approach to hazard assessment for PMN chemicals.

Animals↗

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↗

Hazard identification for contaminants.

In recent years, the recognition of generation of large quantities of toxicants and their by-products due to the industrial and/or cultural activities and transport and their persistence in the environment and biological activities brings out the necessity and importance of their assessment of risk they pose to the ecosystems (e.g. aquatic environment-coastal waters, rivers, lakes and ground water). Indeed, understanding the impacts of contaminants on the environment, including the organisms which live in it, is rather complicated. Nevertheless, the need for protection of the scarce natural resources in the environment and wiser use of them brings the necessity and importance of focusing more attention to the issue. Accordingly the process of ecological risk assessment (ERA) has evolved rapidly since the Environmental Protection Agency (EPA) issued a framework for ecological risk assessment in 1992. The ecological risk assessment involves three stages in a continuous process: (1) problem formulation (problem identification-hazard identification), (2) the analysis of exposure and effects and (3) risk characterisation. Risk management follows the risk characterisation. Of these stages, problem identification is the most critical one which establishes the direction and scope of the ecological risk assessment. The stage involves identifying the actual environmental value(s) to be protected (assessment endpoints) and selecting ways in which these can be measured and evaluated (measurement endpoints). The accuracy of the risk estimation is largely based on the availability of the key information about the contaminant characteristics, ecosystem at risk and ecological effects and the less uncertainty associated with them. The key information required during this phase of the risk assessment process are as follows: (a) potential/actual contaminant of concern, (b) source of contaminant; current and historic use, (c) mode of action of the contaminant, (d) contaminant characteristics (e.g. physical/chemical properties and environmental behaviour, persistence in the ecosystem, transformation products and bioaccumulation), (e) ecosystem potentially at risk and (f) areas of uncertainty. Finally based on these information a conceptual model has to be developed to define the possible exposure and assessment scenarios. Herein, the aforementioned key issues concerning the problem-hazard identification stage of ecological risk assessment for contaminants have been briefly reviewed.

Chemical Phenomena↗

What industrial hygienists should know about TSCA.

Direct participation of industrial hygiene personnel in planning and implementing compliance with several pertinent sections of the Toxic Substances Control Act (TSCA) is warranted. TSCA is administered by the Environmental Protection Agency and there is a variety of areas in which industrial hygiene input is and will be required. Major sections of TSCA which require industrial hygiene participation include Testing, Premanufacture Notices (PMNs), Regulation of Hazardous Chemicals, and Reporting and Recordkeeping. The industrial hygiene input requires interaction with other groups such as Toxicology, Environmental, Government Regulations, Legal, Medical, Research and Development, Marketing and Manufacturing in order to provide a comprehensive response to and compliance with current and anticipated TSCA rules.

Chemical Industry↗

Naphthalene--an environmental and occupational toxicant.

For many years naphthalene had been considered as a non-carcinogenic polycyclic aromatic hydrocarbon (PAH). Airborne naphthalene concentrations have always been observed to be below the limit values of various national committees, such as the threshold limit value (TLV) of the American Conference of Governmental Industrial Hygienists (ACGIH) and the MAK of the Deutsche Forschungsgemeinschaft (DFG) (10 ppm). Since 2000, when the US National Toxicology Program revealed clear evidence of the carcinogenic activity of naphthalene in rats, international agencies [the International Agency for Research on Cancer (IARC), the US Environmental Protection Agency (US EPA), DFG] have reclassified naphthalene as a potential human carcinogen, and the European Union (EU) is currently preparing a new risk assessment report. It is presently unknown how to protect humans from health risks resulting from occupational and environmental naphthalene exposure. Knowledge about the external and internal exposure of humans serves as the key determinant in a comprehensive risk assessment. We review here ambient monitoring studies concerning the external naphthalene exposure that results from ubiquitous environmental sources (indoor and outdoor air, water, soil, food) and from a variety of critical workplaces (coking plants, creosote impregnation, distillation of coal tar and naphthalene, manufacture of refractories, graphite electrodes, aluminium and mothballs). Based on results of ambient monitoring studies published so far, a new hygiene-based exposure limit of 1.5 mg naphthalene per cubic metre of air (0.3 ppm) is proposed. Furthermore, results from biological monitoring studies are summarised in this article. The internal burden was almost exclusively determined by means of the urinary metabolites 1-naphthol and 2-naphthol, but it is currently not possible for one to evaluate a biological tolerance level (BAT) or a biological exposure index (BEI). Based on the toxicokinetics and metabolism of naphthalene, the central question on its carcinogenicity is briefly sketched. Naphthoquinones play an important role in this context. Their adducts with macromolecules may be the parameters of choice for the estimation of effects to human health.

Environmental Exposure↗

Application of pharmacokinetic data to the risk assessment of inhaled manganese.

There is increased interest within the scientific community concerning the neurotoxicity of manganese owing in part to the use of methylcyclopentadienyl manganese tricarbonyl (MMT) as a gasoline fuel additive and an enhanced awareness that this essential metal may play a role in hepatic encephalopathy and other neurologic diseases. Neurotoxicity generally arises over a prolonged period of time and results when manganese intake exceeds its elimination leading to increases in brain manganese concentration. Neurotoxicity can occur following high dose oral, inhalation, or parenteral exposure or when hepatobiliary clearance of this metal is impaired. Studies completed during the past several years have substantially improved our understanding of the health risks posed by inhaled manganese by determining exposure conditions that lead to increased concentrations of manganese within the central nervous system and other target organs. Many of these studies focused on phosphates, sulfates, and oxides of manganese since these are formed and emitted following MMT combustion by an automobile. These studies have evaluated the role of direct nose-to-brain transport of inhaled manganese and have examined differences in manganese toxicokinetics in potentially sensitive subpopulations (e.g., fetuses, neonates, individuals with compromised hepatic function or sub-optimal manganese intake, and the aged). This manuscript reviews the U.S. Environmental Protection Agency's current risk assessment for inhaled manganese, summarizes these contemporary pharmacokinetic studies, and considers how these data could inform future risk assessments of this metal following inhalation.

Animals↗

The risk of polychlorinated dibenzodioxins in human milk.

Recently, the news media have reported the presence of the carcinogenic compounds commonly called dioxins in human milk. Based on published Environmental Protection Agency (EPA) levels, the amounts of dioxins in human milk are below the level shown to have any toxic effect in test animals, but above the level recommended by the EPA as safe.

Carcinogens↗

Chlorpyrifos: an unwelcome pesticide in our homes.

Chlorpyrifos is an extensively used organophosphate insecticide having many urban and agricultural crop pest control uses. Studies conducted in indoor environments after termiticide, crack-and-crevice, broadcast, or fogger applications have shown that chlorpyrifos exposure can occur via inhalation of residual air concentrations, dermal or oral exposure from residues on floors and carpets, children toys, food, and dust. Not long ago the weight of scientific evidence supported safe indoor use, but recent studies support the possibility that when pregnant female rats are given the pesticide, chlorpyrifos causes brain damage in fetal rats. Moreover, the exposure of young rats to chlorpyrifos impairs early nervous system development. After finding that chlorpyrifos is an exposure risk especially to children, in June 2000 the United States Environmental Protection Agency and manufacturers agreed to voluntary measures that will reduce the exposure of children to chlorpyrifos-containing products. This action implies a search for less harmful new products to replace it and/or safer ways to control pests through basic hygiene. Whichever pest control method is selected, one should keep in mind that preventing environmental pesticide exposure in children is always better than treating the resulting disease.

Air Pollution, Indoor↗

Impact of current good manufacturing practices and emission regulations and guidances on the discharge of pharmaceutical chemicals into the environment from manufacturing, use, and disposal.

The current Good Manufacturing Practice (cGMP) and effluent emission (use and disposal) regulations of the U.S. Food and Drug Administration (FDA) and manufacturing effluent discharge and emission regulations of the U.S. Environmental Protection Agency (U.S. EPA) require contained manufacture, use, and disposal of pharmaceuticals with the goal of minimizing the release of pharmaceutical chemicals into the environment. However, debate has recently arisen in several scientific forums over whether these regulations adequately protect human and environmental health from the new pharmaceutical drugs introduced each year into the marketplace and the multitude of existing products, each with many distinct biochemical modes of actions. To address this issue, it is important to understand the relevance of current cGMP regulations and emission regulations that have a direct bearing on the releases of pharmaceutical chemicals into the environment during the manufacture, use, and disposal of active pharmaceutical ingredients (drug substances) and drug products. This knowledge may help us assess the quantity of residues that may be released into the environment. Additionally, the information on physical, chemical, and degradation and sorption properties of the pharmaceutical chemicals may help determine the net residue levels that could persist in the environment to evaluate if such residues have any bearing on human and environmental health. The scientific and regulatory aspects of issues related to the manufacture, use, and disposal of pharmaceutical chemicals are discussed in this article, with special emphasis on potential environmental exposure pathways during the life cycle of an active pharmaceutical ingredient or drug product. The mechanisms of degradation (transformation or depletion) and dilution of pharmaceutical residues that may be released into aquatic or terrestrial environmental compartments are described. Such degradation and dilution of pharmaceutical chemicals in the environment may significantly reduce the residues. It is important to evaluate whether such residue levels have any measurable impact on human and/or environmental health.

Drug Industry↗

Pesticides and public health: integrated methods of mosquito management.

Pesticides have a role in public health as part of sustainable integrated mosquito management. Other components of such management include surveillance, source reduction or prevention, biological control, repellents, traps, and pesticide-resistance management. We assess the future use of mosquito control pesticides in view of niche markets, incentives for new product development, Environmental Protection Agency registration, the Food Quality Protection Act, and improved pest management strategies for mosquito control.

Animals↗

Radon: counseling patients about risk.

Exposure to radon and its decay products has increased as the United States has changed from an outdoor society to a largely indoor society. Radon, which is found primarily in the soil, enters houses and buildings through cracks, holes and pipes in foundation walls and floors. Although radon is suspected of being a significant cause of lung cancer, comparisons with other risk factors cannot yet be made. Radon levels in the home can be measured with commercially available kits. Guidelines for reducing the amount of radon in a home are provided by the U.S. Environmental Protection Agency.

Counseling↗

Multimedia benchmarking analysis for three risk assessment models: RESRAD, MMSOILS, and MEPAS.

This paper is one in a series that describes results of a benchmarking analysis initiated by the Department of Energy (DOE) and the United States Environmental Protection Agency (EPA). An overview of the study is provided in a companion paper by Laniak et al. presented in this journal issue. The three models used in the study--RESRAD (DOE), MMSOILS (EPA), and MEPAS (DOE)--represent analytically-based tools that are used by the respective agencies for performing human exposure and health risk assessments. Both single media and multimedia benchmarking scenarios were developed and executed. In this paper, the multimedia scenario is examined. That scenario consists of a hypothetical landfill that initially contained uranium-238 and methylene chloride. The multimedia models predict the fate of these contaminants, plus the progeny of uranium-238, through the unsaturated zone, saturated zone, surface water, and atmosphere. Carcinogenic risks are calculated from exposure to the contaminants via multiple pathways. Results of the tests show that differences in model endpoint estimates arise from both differences in the models' mathematical formulations and assumptions related to the implementation of the scenarios.

Air Pollutants, Radioactive↗

Preparing for and handling the results of regulatory inspections of biomedical facilities.

Although there have been numerous presentations on how to conduct and survive a government inspection, it appears that these sessions do not always adequately include suggestions from those who have been the subjects of regulatory inspections. This paper will include comments from the experience of one of the regulated. Remarks apply to experience with U.S. regulatory authorities, principally the U.S. Food and Drug Administration (FDA) and the U.S. Environmental Protection Agency (EPA). This paper attempts to give guidance on how to prepare for an inspection and what to do at the debriefing and after the inspector(s) leave your facility.

Communication↗

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↗