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PubMed1985

The emerging role of benefit-cost analysis in the regulatory process at EPA.

Almost since its inception, the U.S. Environmental Protection Agency (EPA) has been using analytical techniques related to the concept of balancing benefits and costs. As a result of the Reagan Administration's Executive Order 12291, benefit-cost analysis is playing an increasingly important role in the EPA regulatory process. Benefit-cost analysis has assisted in organizing information and improving cost estimates. It has influenced the choice of regulatory criteria and aided in the developing degrees of stringency for environmental regulations. The usage of benefit-cost analysis is limited by interpretations of portions of the Clean Air Act and Clean Water Act that restrict consideration of costs or establish technology standards. Benefit analysis is only as reliable as the underlying scientific data in the health effects area. Work by epidemiologists on the relationships between pollutant exposures and adverse health effects will play a vital role in EPA's ability to value in dollars the health improvements attributable to pollution control. EPA's Office of Policy, Planning and Evaluation is currently conducting combined economic and epidemiology research to develop methods and estimates of the health benefits of pollution control.

Air Pollution↗
PubMed1991

Human exposure assessment and public health.

The scientific basis for public and private actions to ameliorate environmental health risks is the suspected or verified link between environmental exposures and human health effects. Exposure information is a key parameter, along with data on dose-response relationships, in determining which environmental health risks are unacceptable. Moreover, human exposures are the standard by which we judge the success of measures to prevent or reduce those risks that are deemed unacceptable. The concept of "total human exposure" has gained credence as a useful and viable framework by which to assess environmental exposures. It places exposures in the context of the continuum beginning with pollutant emissions to the environment and ending with human health consequences. The advent of biologic exposure markers, as well as effects and susceptibility markers, promises the opportunity to more accurately characterize total human exposures for environmental contaminants; thereby enhancing the quality of health risk assessments. The U.S. Environmental Protection Agency plays a significant role in the validation, application, and interpretation of biologic markers, with a lesser but important role in their development. Because the Agency is involved in virtually all phases of the biologic markers issue, EPA scientists have identified important research questions and developed plans to address those questions over the next several years. The EPA is positioned to promote the science necessary to bring biologic markers to bear on environmental issues and to interpret the results for risk assessment, risk management, and risk communication.

Biomarkers↗
PubMed2005

Lessons Learned for the Study of Childhood Asthma from the Centers for Children's Environmental Health and Disease Prevention Research.

The National Children's Study will address, among other illnesses, the environmental causes of both incident asthma and exacerbations of asthma in children. Seven of the Centers for Children's Environmental Health and Disease Prevention Research (Children's Centers), funded by the National Institute of Environmental Health Sciences and the U.S. Environmental Protection Agency, conducted studies relating to asthma. The design of these studies was diverse and included cohorts, longitudinal studies of older children, and intervention trials involving asthmatic children. In addition to the general lessons provided regarding the conduct of clinical studies in both urban and rural populations, these studies provide important lessons regarding the successful conduct of community research addressing asthma. They demonstrate that it is necessary and feasible to conduct repeated evaluation of environmental exposures in the home to address environmental exposures relevant to asthma. The time and staff required were usually underestimated by the investigators, but through resourceful efforts, the studies were completed with a remarkably high completion rate. The definition of asthma and assessment of disease severity proved to be complex and required a combination of questionnaires, pulmonary function tests, and biologic samples for markers of immune response and disease activity. The definition of asthma was particularly problematic in younger children, who may exhibit typical asthma symptoms sporadically with respiratory infections without developing chronic asthma. Medications confounded the definition of asthma disease activity, and must be repeatedly and systematically estimated. Despite these many challenges, the Children's Centers successfully conducted long-term studies of asthma.

Asthma↗
PubMed1993

Linking environmental and health care databases: assessing the health effects of environmental pollutants.

The assessment of pollutant effects on health status requires the mergence and analysis of two different databases: pollution measurements and health care information. This paper compares two subsets of these data: Ohio Environmental Protection Agency data on ambient air pollutants and Ohio Medicare data on respiratory diseases. Small area analysis was performed to assess statewide variations in hospital admission rates for respiratory diseases. The ambient air pollutant levels for each small area were compared to the variations in respiratory disease rates. Five groups of diseases correlated with pollutant levels. In addition, pollutant levels were significantly associated with medical complications. This study demonstrates the feasibility and benefit of linking environmental and health care databases and suggests the need for a more comprehensive, automated analysis of more pollutants and diseases.

Air Pollutants↗
PubMed1991

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↗
PubMed1996

Evaluation of the hazard quotient method for risk assessment of selenium.

Environmental contamination with selenium from industrial and agricultural sources has poisoned fish and wildlife at several locations in the United States. Monitoring and risk assessment activities are currently being conducted by many state and Federal agencies. The U.S. Environmental Protection Agency (EPA) recommends a hazard quotient (HQ) method (waterborne concentration divided by the national water quality criterion) to assess the toxic threat of individual waterborne elements, including selenium. An evaluation of the EPA HQ method was conducted by comparing it to a recently published protocol (Protocol) for selenium assessment. Hazard estimates obtained using HQ were found to be invalid because the EPA water quality criterion is outdated, and the procedure uses mean rather than maximum waterborne concentrations. The HQ method seriously underestimates hazard and could lead to risk management decisions that would not protect fish and wildlife from selenium toxicity. The Protocol method provides an accurate assessment because it evaluates hazard by examining multiple exposure pathways on a site-specific basis. Until a revised (lowered) national water quality criterion is available, the EPA HQ method should not be used for selenium. Even then, with the availability of the Protocol, HQ analysis should be restricted to data sets where water is the primary or sole source of information on environmental concentrations of selenium.

Environmental Monitoring↗
PubMedDate not supplied

Safety assessment programs for U.S. regulatory agencies: a perspective of requirements and compliance.

Regulatory agencies and components within agencies in the United States have been established at different times but with the same basic charge: to protect the health and welfare of the citizenry by regulating the manufacture and use of chemicals and devices that might constitute a threat to the environment or a health hazard for individuals, groups of individuals, or the population as a whole. The character of each agency differs because of the political climate in which it has evolved, the personalities of the leadership, and the internal philosophies concerning how the agency's charge under the letter of the law should be accomplished in keeping with the congressional intent for establishment of the agency. The current safety assessment program requirements/guidelines and some aspects of their interpretation and application are discussed for the Environmental Protection Agency and for components of the Food and Drug Administration, including the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Veterinary Medicine.

Animals↗
PubMedDate not supplied

An inventory of human exposure-related data bases.

An inventory of Federally-sponsored data bases, which either have been or could be used to estimate human exposures to environmental agents, was compiled through a joint effort by the Environmental Protection Agency (EPA), the National Center for Health Statistics (CDC-NCHS), and the Agency for Toxic Substances and Disease Registry (ATSDR). The inventory includes sixty-seven exposure-related data systems that meet the following criteria: cover a relatively large geographical area (e.g., national, state); provide reasonable access to information; and are supported, at least in part, by Federal funds. Findings allow for comparison of data bases according to 1) exposure estimators (e.g., emission estimates, environmental measurements), 2) sample types (e.g., air, water soil, food, human tissue), 3) measured/observed parameters (e.g., pesticides, PCBs, microorganisms), 4) geographic scope (e.g., national, regional, state), 5) sample collection frequency (e.g., yearly, quarterly, daily), and 6) sample location identifiers (e.g., latitude/longitude, zip code, county). Results indicate that existing data bases were established for a variety of reasons (e.g., regulatory compliance, research, monitor environmental conditions, legal requirements) and contain information which varies widely in terms of quality, relevance, and availability. Although the inventory identifies many potential sources of information, it also highlights significant shortcomings in the available systems, including an almost complete absence of data on contact between people and environmental agents (human exposure) and on the amount of the agent that is absorbed into the body (dose).

Data Collection↗
PubMed1988

Regulations of the Forest Law, 29 June 1988.

These Regulations set forth the administration and duties of various government departments under the Mexican Forest Law. They provide that the National Forest Administration is, among other things, to promote operations designed for the conservation, protection, and restoration of forest resources, especially with respect to disasters of any kind that affect forests, such as pestilence, fires, disease, floods, and acid rain, as well as other destructive and contaminating elements. Further provisions of the Regulations describe efforts to aid reforestation and silviculture to be undertaken by the Secretariat and activities with respect to use permits and forest management. In its efforts to aid reforestation, the Secretariat is to establish nurseries, give assistance to local bodies to establish nurseries, and support reforestation programs financially. Regulations of the General Law on Ecological Equilibrium and Environmental Protection with Respect to Environmental Impact of 6 June 1988 contain provisions requiring the Secretariat of Urban Development and Ecology to formulate general rules on the environmental impact involved in the use of forests. These rules are to set forth measures on prevention, improvement, preservation, restoration, and control. The Secretariat is also to issue ecological protection restrictions on the use of forest resources, which are to be relied on in the evaluation of proposed forest use projects. The Regulations also set forth procedures to be followed in examining use permit applications and information that must be included in such applications. See Diario Oficial, Vol. 417, No. 5, 7 June 1988, p. 28.

Americas↗
PubMed2006

Evaluation of repeated measurements of radon-222 concentrations in well water sampled from bedrock aquifers of the Piedmont near Richmond, Virginia, USA: effects of lithology and well characteristics.

Radon (222Rn) concentrations in 26 ground water wells of two distinct lithologies in the Piedmont of Virginia were measured to assess variation in ground water radon concentrations (GWRC), to evaluate differences in concentrations related to well characteristics, lithology, and spatial distributions, and to assess the feasibility of predicting GWRC. Wells were sampled in accordance with American Public Health Association Method 7500 Rn-B, with modifications to include a well shaft profile analysis that determined the minimum purge time sufficient to remove the equivalent of one column of water from each well. Statistically significant differences in GWRC were found in the Trssu (1482 +/- 1711 pCi/L) and Mpg (7750 +/- 5188 pCi/L) lithologies, however, no significant differences were found among GWRC at each well over time. Using multiple regression, 86% of the variability (R2) in the GWRC was explained by the lithology, latitudinal class, and water table elevation of the wells. The GWRC in a majority of the wells studied exceed US Environmental Protection Agency designated maximum contaminant level and AMCL. Results support modifications to sampling procedures and indicate that, in previous studies, variations in GWRC concentrations over time may have been due in part to differences in sampling procedures and not in source water.

Carcinogens, Environmental↗
PubMed1992

The role of the medical profession in the environmental arena.

Environmental agencies at both federal and state levels have enormous powers to control economic activities, yet these agencies must use these powers knowing very little about the actual effects of pollutants on human health or the environment. The author describes how this situation came about by reviewing (1) the history of the 19th-century sanitarians and how their traditions (especially of taking preventive action in the absence of definitive data, in order to ensure a margin of safety) later influenced the policies of the U.S. Public Health Service and, more recently, those of the Environmental Protection Agency (EPA); (2) the tradition of recovering damages from someone who harms your property or person; (3) the tradition of engineers to eliminate pollutants without concern for their effects; and (4) the value system of conservationists and ecologists. He then outlines four difficulties that these sometimes-conflicting traditions and values create for the EPA and other similar bodies. After reviewing the progress that has been made despite these difficulties, the author states the global nature of the environmental challenge that is upon us and how the public health tradition of prudent action will compel us to gather more data about global problems, which in turn will lead to more fine-tuned and appropriate actions. Finally, he states how important it is for health professionals to use their technical and scientific knowledge--especially their "habits of mind"--to help develop more intelligent and prudent environmental policies, and describes the crucial role of "citizen-health professionals" in the environmental arena of the future.

Allied Health Personnel↗
PubMed2006

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↗
PubMed1988

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↗
PubMed1999

Ethical review of regulatory toxicology guidelines involving experiments on animals: the example of endocrine disrupters.

The safety assessment of new chemicals (including medicines, pesticides, food additives, and industrial chemicals) relies on the results of animal experiments. Because the safety of those exposed to these products and the welfare of the experimental animals used are considered critically important, both testing requirements and the welfare of experimental animals are controlled by law. In the U.K., projects that propose to use animals for experimental purposes, including for the testing of chemicals, have been controlled by law for over a century, with the most recent legislation (Animals [Scientific Procedures] Act of 1986) requiring a cost/benefit assessment before it may proceed. New regulations introduced in 1998 will require an ethical review process for all projects from April 1999. Such ethical review will have to take account of the toxicity testing methods and schemes that are required by the legislation aimed at protecting human health. Neither national nor international proposals for toxicity testing methods and schemes are generally subjected to ethical review from the point of protecting animal welfare. The international nature of the chemical and pharmaceutical industry means that testing requirements from one of the major national regulatory agencies (USA, EU, or Japan) or the international organizations (Organization for Economic Co-operation and Development [OECD]or the International Conference on Harmonization [ICH]) have an impact on the testing carried out by industrial organizations in all countries. The recent proposals for screening and testing chemicals to identify endocrine disrupters (ED) from the Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC) of the U.S. Environmental Protection Agency (EPA) are used as an example of the interaction between regulatory proposals and animal welfare issues. The current proposals are the most extravagant in the use of animals. Between 0.6 and 1.2 million animals would be required for each 1000 chemicals tested. The EPA, before incorporating them into regulation, is subjecting the recommendations to further review. This will undoubtedly moderate the number of animals actually used from the worst-case calculation. The variables that have the greatest impact on the number of animals required for testing are the prevalence of ED chemicals in the chemicals to be tested, and the sensitivity and specificity of the testing methods. The modeling demonstrates, for example, that increasing the prevalence from 10 to 50% reduces the number of animals used to detect one ED from 10,000 to 2700. Knowledge of the prevalence of EDs in the chemicals to be tested would allow rational selection of tier one screening based on the sensitivity and specificity of the screening tests. The EDSTAC proposals are difficult to justify from an ethical perspective, as equally effective detection rates may be achieved with fewer animals. National and international regulatory testing proposals should be subjected to formal independent ethical review before they are finalized, with a view to improving animal welfare.

Animal Rights↗
PubMed2002

What to do at low doses: a bounding approach for economic analysis.

To quantify the health benefits of environmental policies, economists generally require estimates of the reduced probability of illness or death. For policies that reduce exposure to carcinogenic substances, these estimates traditionally have been obtained through the linear extrapolation of experimental dose-response data to low-exposure scenarios as described in the U.S. Environmental Protection Agency's Guidelines for Carcinogen Risk Assessment (1986). In response to evolving scientific knowledge, EPA proposed revisions to the guidelines in 1996. Under the proposed revisions, dose-response relationships would not be estimated for carcinogens thought to exhibit nonlinear modes of action. Such a change in cancer-risk assessment methods and outputs will likely have serious consequences for how benefit-cost analyses of policies aimed at reducing cancer risks are conducted. Any tendency for reduced quantification of effects in environmental risk assessments, such as those contemplated in the revisions to EPA's cancer-risk assessment guidelines, impedes the ability of economic analysts to respond to increasing calls for benefit-cost analysis. This article examines the implications for benefit-cost analysis of carcinogenic exposures of the proposed changes to the 1986 Guidelines and proposes an approach for bounding dose-response relationships when no biologically based models are available. In spite of the more limited quantitative information provided in a carcinogen risk assessment under the proposed revisions to the guidelines, we argue that reasonable bounds on dose-response relationships can be estimated for low-level exposures to nonlinear carcinogens. This approach yields estimates of reduced illness for use in a benefit-cost analysis while incorporating evidence of nonlinearities in the dose-response relationship. As an illustration, the bounding approach is applied to the case of chloroform exposure.

Carcinogens↗
PubMed2001

Lawmakers demand answers from EPA.

Washington, Oct. 6--Early this afternoon, lawmakers demanded answers from Environmental Protection Agency (EPA) Administrator Carol Browner. In a letter sent earlier today to Browner, House Science Committee Chairman F. James Sensenbrenner, Jr. (R-WI) demanded to know why her testimony and that of one of her deputies, Ramulo Diaz, at Wednesday"s Science Committee hearing conflicted with actions taken yesterday by the agency.

Environmental Health↗
PubMed1995

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↗
PubMed2006

Analysis of primary fine particle national ambient air quality standard metrics.

In accordance with the Clean Air Act, the U.S. Environmental Protection Agency (EPA) is currently reviewing its National Ambient Air Quality Standards for particulate matter, which are required to provide an adequate margin of safety to populations, including susceptible subgroups. Based on the latest scientific, health, and technical information about particle pollution, EPA staff recommends establishing more protective health-based fine particle standards. Since the last standards review, epidemiologic studies have continued to find associations between short-term and long-term exposure to particulate matter and cardiopulmonary morbidity and mortality at current pollution levels. This study analyzed the spatial and temporal variability of fine particulate (PM2.5) monitoring data for the Northeast and the continental United States to assess the protectiveness of various levels, forms, and combinations of 24-hr and annual health-based standards currently recommended by EPA staff and the Clean Air Scientific Advisory Committee. Recommended standards have the potential for modest or substantial increases in protection in the Northeast, ranging from an additional 13-83% of the population of the region who are living in areas not likely to meet new standards and thereby benefiting from compliance with more protective air pollution controls. Within recommended standard ranges, an optimal 24-hr (98th percentile)/annual standard suite occurs at 30/12 microg/m3, providing short- and long-term health protection for a substantial percentage of both Northeast (84%) and U.S. (78%) populations. In addition, the Northeast region will not benefit as widely as the nation as a whole if less stringent standards are selected. Should the 24-hr (98th percentile) standard be set at 35 microg/m3, Northeast and U.S. populations will receive 16-48% and 7-17% less protection than a 30 microg/m3 standard, respectively, depending on the level of the annual standard. A 30/12 microg/m3 standard suite also provides nearly equivalent 24-hr and annual control of PM2.5 distributions across the United States, thereby ensuring a more uniform and consistent level of protection than unmatched or "controlling" and "backstop" standards. This could occur even within EPA staff's recommended range of standard suites, where 22-43% of the monitors in the country could meet a controlling standard but fail to meet the combined backstop standard, resulting in inconsistent short- and long-term protection across the country. An equivalent standards combination of 30/12 microg/m3 would minimize the wide variation of protectiveness of 24-hr and annual PM2.5 concentrations. Furthermore, given recent associations of subdaily exposures and acute adverse health effects, in the absence of a subdaily averaging metric, a stringent 24-hr standard will more effectively control maximum hourly and multihourly peak concentrations than a weaker standard.

Air Pollutants↗