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The challenge of assessing children's residential exposure to pesticides.

In implementing the Food Quality Protection Act (FQPA) the U.S. Environmental Protection Agency (USEPA) has adopted a policy that the exposure factors and models used to assess and predict exposure to pesticides should generally be conservative. Some elements of exposure assessments for FQPA are screening level--they are both uncertain and conservative. If more realistic assessments are to be conducted, then research is required to reduce uncertainty associated with the factors and models used in the exposure assessments. To develop the strategy for conducting this research, critical exposure pathways and factors were identified, and the quality and quantity of data associated with default assumptions for exposure factors were evaluated. Then, based on our current understanding of the pathways that are potentially most important and most uncertain, significant research requirements were identified and prioritized to improve the data available and assumptions used to assess children's aggregate exposure to pesticides. Based on the results of these efforts, four priority research areas were identified: (1) pesticide use patterns in microenvironments where children spend time, (2) temporal and spatial distribution of pesticides following application in a residential setting, (3) dermal and nondietary ingestion exposure assessment methods and exposure factors, (4) dietary exposure assessment methods and exposure factors for infants and young children. The National Exposure Research Laboratory (NERL) research strategy in support of FQPA is designed to address these priority research needs.

Administration, Cutaneous↗

Inconsistency between workplace and spousal studies of environmental tobacco smoke and lung cancer.

In a risk assessment released at the end of 1992, the U.S. Environmental Protection Agency (EPA) concluded that environmental tobacco smoke (ETS) is a known human lung carcinogen. The Agency reached that conclusion primarily on the basis of epidemiologic studies of self-reported never-smoking women, in which the exposure index was marriage to a smoker. However, the use of the spousal smoking exposure surrogate introduces many potential confounding factors. Such confounding and bias due to denial of active smoking are likely explanations for weak and inconsistent reported ETS-lung cancer associations. This contention is supported by the results of 14 worldwide studies of lung cancer and ETS exposure in the workplace, which in combination indicated no risk elevation. Workplace ETS-lung cancer studies are not subject to the bias and confounding introduced by the spousal smoking exposure surrogate. The EPA ignored the workplace studies in its risk assessment and extrapolated the results of spousal smoking studies to workplace and other sources of ETS exposure. In its estimate of ETS-attributable lung cancer deaths in the United States, the EPA ascribed over 70% of the deaths to nonspousal ETS exposure, primarily workplace exposure. Considered in their entirety, the ETS-lung cancer epidemiologic data do not support a causal inference or provide a scientific basis for government regulation of smoking in the workplace.

Bias↗

Use of ecological regions in aquatic assessments of ecological condition.

Ecological regions are areas of similar climate, landform, soil, potential natural vegetation, hydrology, or other ecologically relevant variables. The makeup of aquatic biological assemblages (e.g., fish, macroinvertebrates, algae, riparian birds, etc.) varies dramatically over the landscape, as do the environmental stresses that affect the condition of those assemblages. Ecoregions delineate areas where similar assemblages are likely to occur and, therefore, where similar expectations can be established. For this reason, ecological regions have proven to be an important tool for use in the process of ecological assessment. This article describes four examples of the use of ecological regions in important aspects of environmental monitoring and assessment: (1) design of monitoring networks; (2) estimating expected conditions (criteria development); (3) reporting of results; (4) setting priorities for future monitoring and restoration. By delineating geographic areas with similar characteristics, ecological regions provide a framework for developing relevant indicators, setting expectations through the use of regional reference sites, establishing ecoregion-specific criteria and/or standards, presenting results, focusing models based on relationships between landscape and surface water metrics, and setting regional priorities for management and restoration. The Environmental Protection Agency and many state environmental departments currently use ecoregions to aid the development of environmental criteria, to illustrate current environmental condition, and to guide efforts to maintain and restore physical, chemical and biological integrity in lakes, streams, and rivers.

Ecology↗

Radio frequency radiation exposure standards: considerations for harmonization.

Radio frequency radiation exposure standards vary in origin, development process, legal status, and in the actual exposure limits. To identify the sources of differences in limits, we evaluated technical aspects of eight standards that included supporting information on the scientific data and rationale. Comparisons were made among the standards by examining the scope of the underlying database, the rationales for safety factors and other issues underlying exposure limits in the energy-deposition range (0.1 MHz to 10.0 GHz) and in the surface-heating range (about 10 or 15 GHz to 300 GHz). The framework for this assessment was based on the methods recommended by the scientific and regulatory organizations for developing health-based exposure limits. General guidelines for performing risk assessments for threshold acting agents have been developed by the U.S. Environmental Protection Agency, Health Canada's Environmental Health Directorate, and the International Program on Chemical Safety of the World Health Organization. This general methodology was applied to radiofrequency radiation for this assessment. Because these methods strive to identify scientific issues and separate them from risk management or policy, they provide a basis for evaluation of standards in this paper. This distinction can provide a foundation for the longer-term goal of global harmonization of radio frequency radiation standards. Each of the standards evaluated in the energy-deposition range was found to use the same basic restriction, based on biological data and a 10-fold safety factor, yet explanations reflect different interpretations of the underlying biological data. Rationales differ for the magnitude of the safety factor, for the circumstances of exposure, for the nature of sensitive populations, and for the presumed health status of the individuals for whom the basic restriction is applicable. In the surface-heating range, broad variability in exposure limits are seen in the limit itself, as well as in the approach to time averaging and frequency dependence. Averaging times differ among standards, as do tissue geometries for defining partial-body exposures. The differences in approaches to develop the standards do not completely explain differences among the exposure limits, and methods for computing exposure limits from basic restrictions are not always defined. This analysis suggests harmonization of standards will require more detailed review and coordination of biological and engineering data and of policy options.

Canada↗

Characterizing environmental harm: developments in an approach to strategic risk assessment and risk management.

Environmental policymakers and regulators are often in the position of having to prioritize their actions across a diverse range of environmental pressures to secure environmental protection and improvements. Information on environmental issues to inform this type of strategic analysis can be disparate; it may be too voluminous or even absent. Data on a range of issues are rarely presented in a common format that allows easy analysis and comparison. Nevertheless, judgments are required on the significance of various environmental pressures and on the inherent uncertainties to inform strategic assessments such as "state of the environment" reports. How can decisionmakers go about this type of strategic and comparative risk analysis? In an attempt to provide practical tools for the analysis of environmental risks at a strategic level, the Environment Agency of England and Wales has conducted a program of developmental research on strategic risk assessment since 1996. The tools developed under this program use the concept of "environmental harm" as a common metric, viewed from technical, social, and economic perspectives, to analyze impacts from a range of environmental pressures. Critical to an informed debate on the relative importance of these perspectives is an understanding and analysis of the various characteristics of harm (spatial and temporal extent, reversibility, latency, etc.) and of the social response to actual or potential environmental harm from a range of hazards. Recent developments in our approach, described herein, allow a presentation of the analysis in a structured fashion so as to better inform risk-management decisions.

Environment↗

Encouraging environmental awareness in renal units.

Humans have inhabited Earth for centuries, but unfortunately during the past two centuries we have caused untold damage and destruction to our planet, through pollution and waste of natural resources. Baxter Healthcare Ltd. is committed to a programme of environmental protection. The company adopted an Environmental policy in 1990 which applied to all Baxter operations world-wide. This policy stated that each area of the company would develop and implement its own environmental management programme.

Conservation of Natural Resources↗

[Centenary of the Health Council of the Netherlands. I. Introduction].

The Health Council of the Netherlands [Dutch name: Gezondheidsraad] is an independent, statutory advisory body whose task is to inform the Dutch government on the current level of knowledge with respect to public health issues. Its work covers the entire terrain of curative and preventive healthcare, environmental protection, nutrition, occupational hygiene and environmental hygiene. The Health Council has existed in one form or another since 1 August 1902. Its present form was established by the 1956 Health Act, which was amended in 1997. To perform its task, the Health Council brings together multidisciplinary committees of leading experts--nominated in a personal capacity--on specific topics both at the government's request and on its own initiative. About thirty committees are operative at any one time. The Health Council has published more than 2000 advisory reports during its 100 years of existence.

Financing, Government↗

Toxicological considerations in environmental audit studies.

Environmental auditing has emerged as a new industrial management tool in recent years. It involves a careful examination of the organization, management procedures, product development, and equipment for environmental protection. The purpose of an environmental audit, from the toxicological point of view, is to assure that the total risk to humans, material, and environment should not increase as a result of a chemical process. The criteria to be adopted for such a safety audit are outlined.

Conservation of Natural Resources↗

Genetic technologies. Bioengineered food--safety and labeling.

The safety and labeling of genetically engineered foods are two areas that have elicited considerable public concern and debate. This Policy Forum provides a legal analysis of these issues in the context of two bills that have been recently proposed in The U.S. Congress, the Genetically Engineered Food Safety Act and the Genetically Engineered Food Right to Know Act. Most transgenic components of foods currently on the market are plant-incorporated protectants or their inert ingredients. Therefore, they have been evaluated for safety by the Environmental Protection Agency (as well as the Food and Drug Administration), and their disclosure in labeling should not be required. If plant-incorporated protectants are considered safer than chemical pesticides, and chemical pesticides do not have to be disclosed in labels, then bioengineered foods should not be subject to stricter regulation, nor should they be required to be labeled. The two bills are inconsistent, in many respects, with well-established principles of food regulation.

Animals↗

Development of an eight-hour occupational exposure limit for beryllium.

This article recommends an 8-hour occupational exposure limit (OEL) for beryllium. It responds to growing concerns about the continuing incidence of chronic beryllium disease despite the long-standing OEL for beryllium: 2 micrograms of beryllium per cubic meter of air (microgram/m3), 8-hour time-weighted average (TWA). Current 8-hour TWA beryllium OELs are not based on chronic beryllium disease toxicology and an increasing number of studies report incidence of chronic beryllium disease at exposure levels apparently below 2 micrograms/m3. The experience of the beryllium-exposed population of Lorain, Ohio, in the late 1940s, and the ambient air regulatory standards derived from that event provide evidence that establishing a protective level is possible. These levels are used as the basis for a new recommended beryllium exposure standard. A correspondingly protective 8-hour TWA level of 0.1 microgram/m3 has been derived, which, for commonly encountered workplace conditions (in terms of geometric standard deviation and percent-compliance), should provide long-term mean exposure protection comparable to that received by the unaffected Lorain subpopulation and provided by the Environmental Protection Agency (EPA) ambient standard. It is concluded that an exposure limit of 0.1 microgram/m3 combined with exposure monitoring to assure a high rate of day-to-day compliance would provide better control of both long-term mean exposure levels and short-term levels than do current occupational exposure limits. The health data available, while certainly not conclusive, support further reductions in exposure levels to help minimize the incidence of chronic beryllium disease.

Air Pollutants, Occupational↗

Performance assessment of radioactive waste repositories.

The current plans for permanent disposal of radioactive waste call for its emplacement in deep underground repositories mined from geologically stable rock formations. The U.S. Nuclear Regulatory Commission and U.S. Environmental Protection Agency have established regulations setting repository performance standards for periods of up to 10,000 years after disposal. Compliance with these regulations will be based on a performance assessment that includes (i) identification and evaluation of the likelihood of all significant processes and events that could affect a repository, (ii) examination of the effects of these processes and events on the performance of a repository, and (iii) estimation of the releases of radionuclides, including the associated uncertainties, caused by these processes and events. These estimates are incorporated into a probability distribution function showing the likelihood of exceeding radionuclide release limits specified by regulations.

Evaluation Studies as Topic↗

What can research contribute to regulatory decisions about the health risks of multiple chemical sensitivity?

Multiple Chemical Sensitivity (MCS), which may not be caused by chemicals at all, is a serious medical problem of unknown origin and uncertain etiology that raises many fundamental science and policy questions. Regulators, for example, are confronted with a dilemma: what, if anything, should be done to protect people from the scientifically uncertain health risks of exposures to extremely low levels of environmental chemicals. Regulatory agencies, such as the Environmental Protection Agency, do not have the luxury of waiting until conclusive scientific evidence is available before making a decision; however, our present lack of scientific understanding about MCS is so acute that it is not possible to ascertain whether the cause of MCS-related symptoms is chemical, biological, physical, psychosocial, or some combination thereof. Nevertheless, many MCS sufferers and advocates for the chemically induced hypothesis are clamoring for regulatory action to reduce putative health risks from very-low-level exposures to chemicals in the environment. Unless steps are taken to improve the quantity and quality of the existing scientific data base, we cannot, with any acceptable degree of certainty, evaluate the extent to which regulatory decisions about MCS are either protective of public health or cost-effective. This article examines how research can strengthen the scientific basis for risk-related decisions about MCS, and proposes a framework for establishing research directions and priorities. It is argued that high-priority research on MCS is distinguishable by four attributes: (1) results are valuable for risk-related decisions; (2) findings significantly advance scientific knowledge and understanding; and the hypothesis being tested is both (3) biologically plausible and (4) readily testable.

Decision Making↗

Minimizing adverse environmental impact: how murky the waters.

The withdrawal of water from the nation's waterways to cool industrial facilities kills billions of adult, juvenile, and larval fish each year. U.S. Environmental Protection Agency (EPA) promulgation of categorical rules defining the best technology available to minimize adverse environmental impact (AEI) could standardize and improve the control of such mortality. However, in an attempt to avoid compliance costs, industry has seized on the statutory phrase "adverse environmental impact" to propose significant procedural and substantive hurdles and layers of uncertainty in the permitting of cooling-water intakes under the Clean Water Act. These include, among other things, a requirement to prove that a particular facility threatens the sustainability of an aquatic population as a prerequisite to regulation. Such claims have no foundation in science, law, or the English language. Any nontrivial aquatic mortality constitutes AEI, as the EPA and several state and federal regulatory agencies have properly acknowledged. The focus of scientists, lawyers, regulators, permit applicants, and other interested parties should not be on defining AEI, but rather on minimizing AEI, which requires minimization of impingement and entrainment.

Animals↗

Closer to a compromise on the direction of environmental research.

The Committee for the National Institute for the Environment (CNIE) was created in 1990 "to improve the scientific basis for making decisions on environmental issues," possibly through the establishment of a separate institute devoted to the environmental sciences. But while the goals proposed for the National Institute for the Environment were universally applauded, Congress was averse to adding a new agency to the federal bureaucracy. Recently, a compromise plan has been proposed that could expand the science base without having to create a new agency. On 29 July 1999, the National Science Board approved an interim report recommending an expanded program of environmental research and research planning, education, and scientific assessment with a funding target of an additional $1 billion over five years. The report stresses the importance of environmental research in formulating environmental protection programs and contains 12 recommendations intended to enhance and complement existing research activities in environmental sciences and engineering. If the National Science Foundation implements the recommendations in the report and if Congress appropriates funds for that purpose, the need for additional funding for new science activities identified by the CNIE should be satisfied.

Engineering↗

The Great Lakes Information Network: the region's Internet information service.

Communication is the cornerstone of ecosystem protection and sustainable development efforts in the binational Great Lakes region of North America. Great Lakes environmental protection, remediation, and pollution prevention efforts bring together individuals from across the public sector, business and industry, citizens groups, and academia. The region is now working to enhance communications between these groups and the rest of the world, through the Internet-based Great Lakes Information Network (GLIN). Diverse regional data, information, and human resources located at key agencies and organizations are accessible via GLIN. These online resources span environmental quality, human health effects and other research, resource management, transportation, demographic, and economic data, as well as other resources in the Great Lakes region of the United States and Canada. Federal, state, provincial, and regional agencies and a range of citizen, business, and research organizations are cooperating with the lead agency, the Great Lakes Commission, in developing GLIN into the region's shared Internet resource. GLIN resources are accessible to users of ubiquitous Internet research tools including World Wide Web and Gopher. Statistical information on usage and the region's response to ongoing efforts to build the GLIN system and solicit contributions of data and information indicate that we can continue to build GLIN into a truly regional resource which enhances communication among researchers, policy makers, students, and the general public.

Community-Institutional Relations↗

Genotoxicity risk assessment: a proposed classification strategy.

Recent advances in genetic toxicity (mutagenicity) testing methods and in approaches to performing risk assessment are prompting a renewed effort to harmonize genotoxicity risk assessment across the world. The US Environmental Protection Agency (EPA) first published Guidelines for Mutagenicity Risk Assessment in 1986 that focused mainly on transmissible germ cell genetic risk. Somatic cell genetic risk has also been a risk consideration, usually in support of carcinogenicity assessments. EPA and other international regulatory bodies have published mutagenicity testing requirements for agents (pesticides, pharmaceuticals, etc.) to generate data for use in genotoxicity risk assessments. The scheme that follows provides a proposed harmonization approach in which genotoxicity assessments are fully developed within the risk assessment paradigm used by EPA, and sets out a process that integrates newer thinking in testing battery design with the risk assessment process. A classification strategy for agents based on inherent genotoxicity, dose-responses observed in the data, and an exposure analysis is proposed. The classification leads to an initial level of concern for genotoxic risk to humans. A total risk characterization is performed using all relevant toxicity data and a comprehensive exposure evaluation in association with the genotoxicity data. The result of this characterization is ultimately used to generate a final level of concern for genotoxic risk to humans. The final level of concern and characterized genotoxicity risk assessment are communicated to decision makers for possible regulatory action(s) and to the public.

Animals↗

Proposal to boost children's health.

In a bid to provide better protection for children's health, U.S. Senators Barbara Boxer (D-California) and Frank Lautenberg (D-New Jersey) introduced the Children's Environmental Protection Act (CEPA), on 24 May 1999. CEPA is an amendment to the Toxic Substances Control Act of 1976 and seeks to protect children from exposures to hazardous substances such as toxic air pollutants and pesticides sprayed in schools. The act would also provide parents with the information necessary to make decisions about how to protect their children against such health threats.

Child↗

A brief targeted review of susceptibility factors, environmental exposures, asthma incidence, and recommendations for future asthma incidence research.

Relative to research on effects of environmental exposures on exacerbation of existing asthma, little research on incident asthma and environmental exposures has been conducted. However, this research is needed to better devise strategies for the prevention of asthma. The U.S. Environmental Protection Agency (EPA) and National Institute of Environmental Health Sciences held a conference in October 2004 to collaboratively discuss a future research agenda in this area. The first three articles in this mini-monograph summarize the discussion on potential putative environmental exposure; they include an overview of asthma and conclusions of the workshop participants with respect to public health actions that could currently be applied to the problem and research needs to better understand and control the induction and incidence of asthma, the potential role of indoor/outdoor air pollutants in the induction of asthma), and biologics in the induction of asthma. Susceptibility is a key concept in the U.S. EPA "Asthma Research Strategy" document and is associated with the U.S. EPA framework of protecting vulnerable populations from potentially harmful environmental exposures. Genetics, age, and lifestyle (obesity, diet) are major susceptibility factors in the induction of asthma and can interact with environmental exposures either synergistically or antagonistically. Therefore, in this fourth and last article we consider a number of "susceptibility factors" that potentially influence the asthmatic response to environmental exposures and propose a framework for developing research hypotheses regarding the effects of environmental exposures on asthma incidence and induction.

Asthma↗