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Chemical wastes, children's health, and the Superfund Basic Research Program.

Three to 4 million children and adolescents in the United States live within 1 mile of a federally designated Superfund hazardous waste disposal site and are at risk of exposure to chemical toxicants released from these sites into air, groundwater, surface water, and surrounding communities. Because of their patterns of exposure and their biological vulnerability, children are uniquely susceptible to health injury resulting from exposures to chemical toxicants in the environment. The Superfund Basic Research Program, funded by the U.S. Environmental Protection Agency and directed by the National Institute of Environmental Health Sciences, is extremely well positioned to organize multidisciplinary research that will assess patterns of children's exposures to hazardous chemicals from hazardous waste disposal sites; quantify children's vulnerability to environmental toxicants; assess causal associations between environmental exposures and pediatric disease; and elucidate the mechanisms of environmental disease in children at the cellular and molecular level.

Child↗

Implementation of EPA's Worker Protection Standard training for agricultural laborers: an evaluation using North Carolina data.

The US Environmental Protection Agency has promulgated a Worker Protection Standard which requires that farmworkers receive pesticide safety training. The implementation of these regulations has not been evaluated. Using data collected through personal interviews with 270 Hispanic farmworkers recruited from 35 labor sites in an eight-county area, the authors analyzed the extent to which farmworkers received pesticide safety training, characteristics of the training, and variations in knowledge and safety behavior. Approximately a third of the farmworkers reported having ever received information or training on pesticide safety, and 25.6% reported having received training in the year in which they were interviewed. Workers with H2A visas were significantly more likely to have received training than workers without these visas. The training received varied in location, duration, and language. Most included the use of a video, as well as verbal presentation, and most included printed materials. However, few workers knew the ways in which they could be exposed to pesticides or reported using any method to protect themselves from pesticide exposure.

Adult↗

The tobacco industry's political efforts to derail the EPA report on ETS.

Previously secret tobacco industry documents detailed a multifaceted approach of political strategies aimed to derail the 1993 Environmental Protection Agency (EPA) risk assessment on environmental tobacco smoke (ETS). These pervasive strategies included the following: (1) lobbying the first Bush Administration to approve an executive order that would impose new risk assessment standards for federal agencies, thus delaying the release of the EPA report; (2) having the first Bush Administration transfer jurisdiction over ETS from the EPA to Occupational Safety and Health Administration (OSHA), thus obviating the need for the release of the EPA report; and (3) applying enormous political pressure directly by alleging improper procedure and policy at EPA. Although some of the attempted strategies failed, the political pressure from Congressman Thomas Bliley (R-VA) was a success. This is the first report showing how a single member of Congress in conjunction with his staff, tobacco industry attorneys, and executives worked very aggressively to do the tobacco industry's bidding. These tactics successfully delayed the EPA risk assessment and placed a cloud over its validity that was not fully vindicated until December 2002 when the U.S. 4th Circuit Court of Appeals overturned the tobacco industry's suit against the EPA. The documents show that the industry will expend whatever effort is necessary to protect itself from public health policy that would adversely affect consumption of cigarettes and, therefore, profit.

Humans↗

Risk assessment under FQPA: case study with chlorpyrifos.

Key science policies have had significant impact on the evolving implementation of the Food Quality and Protection Act (FQPA) (PL 104-170, 1996) by the US Environmental Protection Agency (EPA). The impact offour of these policies will be examined using the risk assessment for chlorpyrifos as a case study. These policies are selection of a regulatory endpoint, use of animal data without consideration of human data for setting the reference dose, a 10 FQPA safety factor and use of the 99.9 percentile of modeled consumer exposure in the acute dietary assessment. Each of these policy decisions had individual impact that was then compounded as cumulative impact on the revised risk assessment for chlorpyrifos conducted by the US EPA in 2000 [Federal Register Notice 65(159) (2000) 49982]. But embedded within each science policy, there are assumptions which may be too conservative and which together have resulted in a very large multiplicative reduction in the allowable exposure limits for chlorpyrifos in the US. These new exposure limits are quite different from other regulatory standards around the world. There is third party opposition to many of these policies and many believe the understanding of the relationship between exposure and what is known about human and animal responses to chlorpyrifos has been clouded. These changes in policy insert a new level of conservatism into the scientific statement of risk and create confusion that threatens to weaken the credibility of the regulatory process.

Animals↗

Some scientific judgments in the assessment of the risk of environmental contaminants.

The assessment of risk due to environmental contaminants depends, in part, on scientific data. When such data are incomplete, as is usually the case, assumptions based on scientific judgments are made to analyze the consequences. Specifically, when health related data needed to assess the risk posed by environmental contaminants are missing or incomplete, it becomes necessary to make assumptions using scientific judgment to estimate the risk. Different scientists can and do make different assumptions, and the resulting differences in opinion can result in controversy. The present discussion presents a few of the consensus judgments of the Science Advisory Board (SAB) of the U.S. Environmental Protection Agency concerning the health effects and risk for such environmental contaminants as 1,2-dichloroethylene, dichloromethane, para-dichlorobenzene, polychlorinated biphenyls, perchloroethylene, and xylene, as well as the implications of the more likely cancer mechanisms, the exposure routes, and pharmacokinetics to the risk assessment process. In some of these examples, the scientific data have been developed to the extent that specific judgments by groups such as the SAB can result in greater confidence that one is correct in the assessment of risk. Because of the uncertainties in current scientific knowledge for many environmental contaminants, judgments differ and there is no right or wrong opinion.

Animals↗

Enhancing compliance at Department of Defense facilities: comparison of three environmental audit tools.

To enhance environmental compliance, the U.S. Department of Defense (DOD) recently developed and implemented a standardized environmental audit tool called The Environmental Assessment and Management (TEAM) Guide. Utilization of a common audit tool (TEAM Guide) throughout DOD agencies could be an effective agent of positive change. If, however, the audit tool is inappropriate, environmental compliance at DOD facilities could worsen. Furthermore, existing audit systems such as the U.S. Environmental Protection Agency's (U.S. EPA's) Generic Protocol for Conducting Environmental Audits of Federal Facilities and the International Organization for Standardization's (ISO's) Standard 14001, "Environmental Management System Audits," may be abandoned even if they offer significant advantages over TEAM Guide audit tool. Widespread use of TEAM Guide should not take place until thorough and independent evaluation has been performed. The purpose of this paper is to compare DOD's TEAM Guide audit tool with U.S. EPA's Generic Protocol for Conducting Environmental Audits of Federal Facilities and ISO 14001, in order to assess which is most appropriate and effective for DOD facilities, and in particular those operated by the U.S. Army Corps of Engineers (USACE). USACE was selected as a result of one author's recent experience as a district environmental compliance coordinator responsible for the audit mission at this agency. Specific recommendations for enhancing the quality of environmental audits at all DOD facilities also are given.

Environmental Pollutants↗

Nursing responses to environmental issues.

The government's White Paper, 'The Health of the Nation', has offered significant comment, but little practical advice, on dealing with environmental influences affecting health. This article explores two of the issues identified in the White Paper, the quality of air and drinking water, and questions the appropriateness of its responses to the problems. Nurses have a major role in persuading government and fellow health care professionals to take concrete environmental protection measures.

Environment↗

Differences between children and adults: implications for risk assessment at California EPA.

The California legislature enacted a law requiring the California Environmental Protection Agency (Cal/EPA) Office of Environmental Health Hazard Assessment (OEHHA) to evaluate whether our risk assessment methodologies are adequately protective of infants and children. In addition both OEHHA and the California Air Resources Board must examine whether the Ambient Air Quality Standards set for criteria air pollutants and the health values developed for air toxics are adequately protective of infants and children. We have initiated a program to look at potential differences in response to toxicants between children and adults. We are evaluating this issue from the perspective of exposure differences as well as toxicokinetic and toxicodynamic differences between children and adults. Data on specific chemicals are rather limited. As a result, we will be pooling information to determine whether there are generic differences between children and adults that may be applicable to risk assessment in general or to risk assessment of specific classes of compounds. This paper discusses the rationale for approaching the issue of determining whether our risk assessment methods are adequate for infants and children and includes a discussion of some of the available information on both qualitative and quantitative differences in response to toxicants between children and adults or immature and mature laboratory animals. We provide examples of differences between children and adults in absorption, metabolism, and excretion of toxicants as well as qualitative differences in toxic response.

Adult↗

Environmental hazard evaluation of amalgam scrap.

Amalgam scrap was subjected to two different Environmental Protection Agency (EPA) extraction procedures to determine if it presents an environmental hazard. The results indicate that concentrations of mercury and silver in the extracts do not exceed the EPA's maximum allowable concentrations. It was concluded that amalgam scrap is not a hazardous solid waste. Proper handling of amalgam scrap disposal by recycling is, however, highly recommended.

Copper↗

Operating room environment.

Sepsis after total joint replacement is related directly to environmental contamination. Therefore, to control the source of environmental contamination, and ultimately sepsis, it must be realized that the operating room personnel are the major source of the bacteria as evidence by the rise in the colony forming units per square foot per hour from 13 units in an operating room without people to greater than 400 units during actual surgery. The use of inclusive gowns, such as hooded body exhaust, is most helpful. However, all operating room personnel including anesthesia personnel, circulating nurses, visitors, and the operating room team must wear inclusive gowns. Face masks and head covers offer no environmental protection. Some type of an environmental control, such as laminar airflow or ultraviolet light, is the most helpful with greater than 90% reduction of airborne bacteria at the wound and 60% reduction of airborne bacteria in the operating room. Therefore, to reduce environmental bacteria contamination the number of personnel in the operating room and the length of time for the actual surgery should be reduced, because wound contamination occurs first by direct fall out from the environment and second by contaminated equipment and gloved hands that initially were contaminated by the environment.

Arthroplasty, Replacement↗

Review of procedures for protecting human subjects in recent clinical studies of pesticides.

Arguments have been made for and against the regulatory use of data from human subjects on both scientific and ethical grounds. One argument against the use of data from human clinical studies involving pesticides asserts that such data are obtained from studies that do not follow the Common Rule (40 CFR 26), which provides procedures for protecting human subjects in studies funded by federal agencies, including the U.S. Environmental Protection Agency (U.S. EPA). Although privately conducted studies using human subjects are not legally subject to or required to comply with the Common Rule, the protections of the Declaration of Helsinki and the International Conference on Harmonisation (ICH) Good Clinical Practice are commonly followed. We sought to answer the question of whether recent human clinical studies with insecticides performed according to Good Clinical Practice provided volunteers with the same protections as the Common Rule. All three sets of guidance have in common the intent to protect volunteer human subjects by providing standards for the conduct of studies in which they participate. This analysis compares the elements of the Common Rule with comparable elements from the Declaration of Helsinki and Good Clinical Practice to evaluate similarities and differences in procedural requirements. It then evaluates the documentation from 15 recent human studies of twelve insecticides conducted at four clinical laboratories in order to determine whether the conduct of those studies is consistent with the protections of the Common Rule. There were some cases for which we could not verify compliance with certain Common Rule elements; however, based on our evaluation it is apparent that the studies we reviewed were conducted in a manner substantially consistent with the fundamental protections of the Common Rule-voluntary participation, informed consent, and review by an ethical committee or institutional review board.

Clinical Trials as Topic↗

Research integrity: a government perspective.

What is research integrity? At the United States Environmental Protection Agency (U.S. EPA) research integrity can be defined as conducting and fostering research to define, anticipate, and understand environmental problems; and generating sound, appropriate, credible, and effective solutions to those problems. Whether in government, academia, or industry, integrity is required at all stages of research--from data generation to data analysis. What constitutes research integrity? Simply put, Did we do the right thing? Did we do it the right way? Did we honestly document what we did? This is especially important if the research is used as a basis for public policy. The extensive and intensive use of the results of science in EPA's standard setting, regulatory, and enforcement responsibilities means that scientific misconduct can lead to costly and inappropriate actions through unnecessary expenditure or inadequate protection. The soundness, effectiveness, and credibility of EPA's regulations ultimately rest on the scientific and technical bases for these actions. Careful attention to research record keeping can help ensure data quality and integrity. The U.S. Environmental Protection Agency, its research requirements, and the work of the National Health and Environmental Effects Research Laboratory are discussed below.

Environmental Monitoring↗

Influence of sampling depth on Escherichia coli concentrations in beach monitoring.

While the US Environmental Protection Agency's (EPA) Beaches Environmental Assessment and Coastal Health (BEACH) Act requires coastal and Great Lakes' states to implement plans for monitoring bacterial contamination of recreational beach water, exactly how this monitoring should occur has not been regulated. This study examined differences in concentration of Escherichia coli in water collected from different depths and from different horizontal locations across the beach. E. coli concentrations were significantly different (p<0.05), when water from different depths was compared. Sampling water at depths of 30, 60, and 120 cm resulted in significantly lower E. coli concentrations as depth increased. Had the State of Wisconsin chosen to collect beach water monitoring samples at a shallower or deeper depth, numbers of beach closures and the potential risk to public health would have changed substantially. These data imply that a revised and standardized protocol for monitoring beach water should be adopted by all states of a monitoring region to better compare microbial contamination of beaches and protect public health.

Bathing Beaches↗

Transforming an EPA QA/R-2 quality management plan into an ISO 9002 quality management system.

The Environmental Protection Agency's (EPA) Office of Emergency and Remedial Response (OERR) requires environmental data of known quality to support Superfund hazardous waste site projects. The Quality Assurance Technical Support (QATS) Program is operated by Shaw Environmental and Infrastructure, Inc. to provide EPA's Analytical Operations Center (AOC) with performance evaluation samples, reference materials, on-site laboratory auditing capabilities, data audits (including electronic media data audits), methods development, and other support services. The new QATS contract awarded in November 2000 required that the QATS Program become ISO 9000 certified. In a first for an EPA contractor, the QATS staff and management successfully transformed EPA's QA/R-2 type Quality Management Plan into a Quality Management System (QMS) that complies with the requirements of the internationally recognized ISO 9002 standard and achieved certification in the United States, Canada, and throughout Europe. The presentation describes how quality system elements of ISO 9002 were implemented on an already existing quality system. The psychological and organizational challenges of the culture change in QATS' day-to-day operations will be discussed for the benefit of other ISO 9000 aspirants.

Environmental Monitoring↗

Components of laboratory accreditation.

Accreditation or certification is a recognition given to an operation or product that has been evaluated against a standard; be it regulatory or voluntary. The purpose of accreditation is to provide the consumer with a level of confidence in the quality of operation (process) and the product of an organization. Environmental Protection Agency/OCM has proposed the development of an accreditation program under National Environmental Laboratory Accreditation Program for Good Laboratory Practice (GLP) laboratories as a supplement to the current program. This proposal was the result of the Inspector General Office reports that identified weaknesses in the current operation. Several accreditation programs can be evaluated and common components identified when proposing a structure for accrediting a GLP system. An understanding of these components is useful in building that structure. Internationally accepted accreditation programs provide a template for building a U.S. GLP accreditation program. This presentation will discuss the traditional structure of accreditation as presented in the Organization of Economic Cooperative Development/GLP program, ISO-9000 Accreditation and ISO/IEC Guide 25 Standard, and the Canadian Association for Environmental Analytical Laboratories, which has a biological component. Most accreditation programs are managed by a recognized third party, either privately or with government oversight. Common components often include a formal review of required credentials to evaluate organizational structure, a site visit to evaluate the facility, and a performance evaluation to assess technical competence. Laboratory performance is measured against written standards and scored. A formal report is then sent to the laboratory indicating accreditation status. Usually, there is a scheduled reevaluation built into the program. Fee structures vary considerably and will need to be examined closely when building a GLP program.

Accreditation↗

State pesticide regulatory programs: themes and variations.

State pesticide regulation varies with region, with the amount and type of agriculture, with pesticide use, and with political conditions that are sometimes volatile and unpredictable. Dr. Arne offers an overview of state regulatory programs and their connections to the U.S. Environmental Protection Agency.

Chemical Industry↗

[Reference values for indoor air: dearomatized hydrocarbon solvents (C(9)-C(14))].

To protect public health the German Joint Working Group on Indoor Guidelines of the Federal Environmental Protection Agency and the States' Departments of Health is issuing indoor air guideline values based on a fixed procedure published in 1996. Regarding dearomatized hydrocarbon solvents/white spirits (DAWS--CAS-No. 64742-47-8, 64742-48-9, 64742-88-7, 64741- 65-7) no human data are available. From animal studies, neurotoxicity, developmental toxicity and reproductive toxicity were identified as critical endpoints. For risk evaluation the Hass et al. (2001) study was used as the pivotal study. Based on effects at 4680 mg DAWS/m(3) for the endpoint developmental toxicity, the lowest adverse effect level for chronic exposure is assessed as 400 mg DAWS/m(3). By applying an interspecies factor of 10, an intraspecies factor of 10 and an additional factor 2 referring to the special physiology of children (higher breath rate compared to adults) a so-called health hazard value of 2 mg DAWS/m(3) indoor air and a so-called health prevention value of 0.2 mg DAWS/m(3) are obtained.

Air Pollutants↗

Determining optimal protective actions for nuclear incidents.

The U.S. Environmental Protection Agency is revising its Protective Action Guides (PAGs), which specify recommended dose levels at which actions should be taken to protect the public during an accident at a nuclear facility. The appropriateness of these PAGs depends on the health risks that could be avoided by the protective actions relative to both the costs and adverse health impacts of taking the actions. According to the optimization principle of radiation protection, the cost of measures designed to protect people from ionizing radiation should be commensurate with the risks avoided. This article evaluates the recommended protective actions with respect to the optimization principle. The evaluation is based on both recent radiation risk estimates and a derivation of the monetary value of a reduction in risk. It is estimated that evacuation of a population sector should be carried out only if the evacuation will reduce the collective dose equivalent to the population by 1 person-Sv or more for every U.S. +34,000 to +250,000 in net evacuation costs. Therefore, the decision to evacuate should be based on the dose that would be avoided by the evacuation and predetermined site-specific evacuation costs, rather than simply projected dose to the population. Findings further suggest that separate PAGs for the thyroid and skin are unnecessary for protecting against stochastic effects because use of the effective dose equivalent concept eliminates the need for these guides. Separate PAGs for specific organs need only ensure that significant nonstochastic effects are prevented.

Accidents↗