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PubMed1991

The Genetic Activity Profile database.

A graphic approach termed a Genetic Activity Profile (GAP) has been developed to display a matrix of data on the genetic and related effects of selected chemical agents. The profiles provide a visual overview of the quantitative (doses) and qualitative (test results) data for each chemical. Either the lowest effective dose (LED) or highest ineffective dose (HID) is recorded for each agent and bioassay. Up to 200 different test systems are represented across the GAP. Bioassay systems are organized according to the phylogeny of the test organisms and the end points of genetic activity. The methodology for the production and evaluation of GAPs has been developed in collaboration with the International Agency for Research on Cancer. Data on individual chemicals have been compiled by IARC and by the U.S. Environmental Protection Agency. Data are available on 299 compounds selected from volumes 1-50 of the IARC Monographs and on 115 compounds identified as Superfund Priority Substances. Software to display the GAPs on an IBM-compatible personal computer is available from the authors. Structurally similar compounds frequently display qualitatively and quantitatively similar GAPs. By examining the patterns of GAPs of pairs and groups of chemicals, it is possible to make more informed decisions regarding the selection of test batteries to be used in evaluating chemical analogs. GAPs have provided useful data for the development of weight-of-evidence hazard ranking schemes. Also, some knowledge of the potential genetic activity of complex environmental mixtures may be gained from assessing the GAPs of component chemicals. The fundamental techniques and computer programs devised for the GAP database may be used to develop similar databases in other disciplines.

Animals↗
PubMed1990

The COMPLY computer program for demonstrating compliance with national radionuclide air emission standards.

The Environmental Protection Agency (EPA) has proposed national radionuclide air emission standards for a number of source categories. One of these standards applies to Nuclear Regulatory Commission Licensees and non-Department of Energy facilities having the potential to release radionuclides to the atmosphere. Approximately 6000 facilities are subject to the standard, which limits the effective whole-body dose commitment to the maximally exposed individual from radionuclide releases to the atmosphere. A computer program to assist the regulated community in determining compliance has been developed by the EPA's Office of Radiation Programs. The computer program COMPLY calculates the dose to an individual residing outside the facility. The program considers dose from inhalation, ingestion of contaminated food, air immersion, and ground deposition. It is based on models developed by the National Council on Radiation Protection and Measurements (NCRP). Compliance procedures provided in COMPLY are designed to reduce the burden on the regulated community. The approach begins with simple-to-use methods that are very conservative in determining compliance. The methods become progressively less conservative but more complicated at succeeding levels. Each higher level requires the input of site-specific information, but allows a more realistic estimate of dose. This paper describes the COMPLY program, and provides estimates of the work required and the degree of conservatism in the dose computed at each level.

Air Pollution, Radioactive↗
PubMedDate not supplied

Risk assessment in the policy-making process: environmental health and safety protection.

This article examines the extent to which differences exist in the relative degree of discretion permitted by the statutory mandates under which health risk assessments are conducted as a basis for regulatory action. Attention is focused on the Environmental Protection Agency and the Food and Drug Administration, because they are the lead federal regulatory agencies on most environmental health matters. The statutes are found to define risk, consider effects, identify target populations, and use benefit-cost analysis in a flexible way. But the burden of proof of risk typically is assigned in a more direct and stringent fashion. Overall, however, agencies are found to have substantial discretion in the manner in which risk assessments are incorporated into the policy process. A number of examples of efforts to reduce this flexibility are outlined and their implications for the future of the analysis of risks are delineated.

Accident Prevention↗
PubMed2002

Inhibition of gap-junctional intercellular communication by environmentally occurring polycyclic aromatic hydrocarbons.

Polycyclic aromatic hydrocarbons (PAHs) are a broad class of ubiquitous environmental pollutants with known or suspected carcinogenic properties. Tumor promotion is a cell-proliferative step of cancer that requires the removal of cells from growth suppression via the inhibition of gap-junctional intercellular communication (GJIC). Inhibition of GJIC measured with an in vitro WB-F344 rat liver epithelial cell system was used to assess the relative potencies of 13 PAHs suggested by the U.S. Environmental Protection Agency (EPA) as the principal contaminants and 22 other PAHs, most of them identified in environmental samples. Maximal inhibition of GJIC was detected after 30 min of exposure, followed by a recovery in intercellular communication after an additional 30 min of exposure, suggesting a transient character of inhibition. Although microM concentrations of PAHs were required to reach the inhibition level equal to the model tumor promoter phorbol 12-myristate 13-acetate (IC50 = 8 nM), 12 of the PAHs under study were found to be strong inhibitors of GJIC (strongest effects were observed with fluoranthene, picene, 5-methylchrysene and nine additional PAHs). The other nine PAHs, including benzo[a]pyrene, inhibited GJIC only up to 50-75% of the control level. Interestingly, several high molecular weight PAHs with known strong carcinogenic properties possessed only weak (dibenzopyrenes) or no inhibition potency (dibenzofluoranthenes, naphtho[2,3-a]pyrene and benzo[a]perylene). Based on the IC50 values related to the reference PAH benzo[a]pyrene, we suggested arbitrary values of inhibition equivalency factors (GJIC-IEFs) ranging from 0 (noninhibiting PAHs) to 10.0 (strongest inhibitors), suitable for the purposes of environmental risk assessment.

Animals↗
PubMed2001

Harmonization of cancer and noncancer risk assessment: proceedings of a consensus-building workshop.

Significant advancements have been made toward the use of all relevant scientific information in health risk assessments. This principle has been set forth in risk-assessment guidance documents of international agencies including those of the World Health Organization's International Programme on Chemical Safety, the U.S. Environmental Protection Agency, and Health Canada. Improving the scientific basis of risk assessment is a leading strategic goal of the Society of Toxicology. In recent years, there has been a plethora of mechanistic research on modes of chemical toxicity that establishes mechanistic links between noncancer responses to toxic agents and subsequent overt manifestations of toxicity such as cancer. The research suggests that differences in approaches to assessing risk of cancer and noncancer toxicity need to be resolved and a common broad paradigm for dose-response assessments developed for all toxicity endpoints. In November 1999, a workshop entitled "Harmonization of Cancer and Noncancer Risk Assessment" was held to discuss the most critical issues involved in developing a more consistent and unified approach to risk assessment for all endpoints. Invited participants from government, industry, and academia discussed focus questions in the areas of mode of action as the basis for harmonization, common levels of adverse effect across toxicities for use in dose-response assessments, and scaling and uncertainty factors. This report summarizes the results of those discussions. There was broad agreement, albeit not unanimous, that current science supports the development of a harmonized set of principles that guide risk assessments for all toxic endpoints. There was an acceptance among the participants that understanding the mode of action of a chemical is ultimately critical for nondefault risk assessments, that common modes of action for different toxicities can be defined, and that our approach to assessing toxicity should be biologically consistent.

Animals↗
PubMed2003

Mass-selected resonance-enhanced multiphoton ionisation spectra of laser-desorbed molecules for environmental analysis: 16 representative polycyclic aromatic compounds.

Mass-selected gas-phase UV spectra of laser-desorbed molecules at room temperature have been measured via resonance-enhanced multiphoton ionisation (REMPI) and time-of-flight mass selection. The wavelength range of 260 to 320 nm is optimal for detection of polycyclic aromatic hydrocarbons (PAHs) using REMPI-mass spectrometry. A new laser desorption/laser ionisation source has been used which features a compact size and thermal equilibrium of the desorbed molecules. 16 PAHs have been investigated which have been selected by the US Environmental Protection Agency (EPA). These 16 EPA-PAHs are commonly used world-wide to characterise the PAH-load of environmental samples.

Environmental Monitoring↗
PubMedDate not supplied

[The definitions and classifications of carcinogenesis, mutagenesis and teratogenesis used by national and international agencies and institutions].

Classifications of carcinogenesis, mutagenesis and teratogenesis used by the National Toxicological Advisory Committee in Italy (CCTN), the Commission of the European Communities (CEC), the Environmental Protection Agency in the USA (EPA), the International Agency for Research on Cancer (IARC), and the National Toxicology Programme in the USA (NPT) are examined and commented on, with a synopsis of several allocations made by the above organizations. However, the authors consider it advisable to redefine the categories and create 5 groups of substances (designated C1 to C5), on the basis of given definitions, with the aim of rendering the allocations comparable. This procedure is used solely for carcinogenesis and excludes the NTP. From such comparison, good agreement was found between CCTN and EPA and between CCTN and CEC, whereas agreement between IARC and other organizations was poor.

Abnormalities, Drug-Induced↗
PubMedDate not supplied

Data quality objectives in environmental research planning.

This paper presents highlights of a Data Quality Objectives course relating the Environmental Protection Agency's (EPA) seven step research planning process to research efforts at the U.S. EPA National Health and Environmental Effects Research Laboratory, Mid-Continent Ecology Division, in Duluth, Minnesota. Introductory materials were derived from "Guidance for the Data Quality Objectives Process, EPA QA/G-4." Case studies illustrate decisions that were made during the systematic planning process and subsequent experimentation. This paper demonstrates how the Data Quality Objectives Process clearly links research goals and objectives with the final product. Application of the process to environmental research ensures that environmental research data are of known, credible, defensible and usable quality.

Animals↗
PubMedDate not supplied

Data and information quality strategic plan.

The Environmental Protection Agency's Strategic Plan was developed in response to internal and external concerns about the integrity, consistency, and accuracy of EPA's environmental data. This document explains why a Strategic Plan is needed and the methodology used in its development, cites Agency models of excellence, and presents the six recommendations of EPA's Data and Information Quality Strategic Plan.

Database Management Systems↗
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↗
PubMed1995

Using the EPC approach to develop health-based soil and water screening concentrations for environmental chemicals.

Reference doses (RfDs) and reference concentrations (RfCs) developed by the United States Environmental Protection Agency (USEPA) are typically used to assess the risk of potential adverse human health effects from exposure to environmental chemicals. For a large number of chemicals, however, USEPA RfDs or RfCs have not yet been determined. Thus, for risk assessments that involve a large number of chemicals, there may not be USEPA- or state-derived toxicity constants for all chemicals present at a particular site. A potential solution to this problem is to use estimated permissible concentrations (EPCs) to develop acceptable daily dosages from occupational exposure limits. The EPC is defined as the concentration of a chemical which, under continuous exposure conditions, is expected to be devoid of all acute and chronic toxicities. EPC values are based on allowable occupational exposure limits such as threshold limit values (TLVs), which are workplace exposure guidelines suggested by the American Conference of Governmental Industrial Hygienists. In the present analysis, the EPC method was used to develop interim toxicity constants for more than 30 chemicals which possess TLVs and which appear in the Appendix VIII Hazardous Constituents list, but for which the USEPA has not yet assigned a current RfD or RfC. Appendix VIII chemicals are commonly found at hazardous waste and other sites. Consequently, the development of toxicity constants for the more than 30 chemicals on this list would prove to be most useful for risk assessment purposes. These toxicity constants were then used, together with standard exposure assumptions, to develop acceptable human health-based soil and water concentrations for these chemicals. The use of these values as interim guidance would therefore allow individuals responsible for assessing human health effects posed by environmental contamination to address all site chemicals without performing extensive, chemical-specific toxicological analyses.

Adolescent↗
PubMed1987

An improved environmental pathway model for assessing high-level waste repository risks.

An environmental pathway model useful for assessing the postclosure radiological risks from high-level waste repositories has been developed. The model describes more fully than its predecessors the long-term build-up of radionuclides in the biosphere and is consequently better suited to the analysis of the prolonged radionuclide releases potentially associated with geologic waste repositories. The effect of incorporating the additional features is to alter, in some cases substantially, the predicted population risks associated with a given long-term release of particular radionuclides. The model has been used to evaluate certain assumptions underlying the environmental standard for high-level waste repositories recently issued by the U.S. Environmental Protection Agency.

Humans↗
PubMed1994

Environmental tobacco smoke. Health effects and prevention policies. Council on Scientific Affairs, American Medical Association.

The US Environmental Protection Agency report released in January 1993, Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders, has stirred considerable discussion and interest in the issues surrounding tobacco and health. The report addresses major health effects of environmental tobacco smoke (ETS), concluding (1) that ETS is causally associated with lung cancer in nonsmoking adults and should be classified as a group A, or known human carcinogen, with approximately 3000 excess deaths yearly; (2) that ETS produces an increased risk of development of acute lower respiratory tract irritation, asthma, and acute lower respiratory tract infections in children exposed in the home; and (3) that ETS is associated with an increase risk of sudden infant death syndrome. Other studies implicate ETS in between 35,000 and 40,000 premature deaths each year from cardiovascular disease. The Council on Scientific Affairs (CSA) agrees that ETS should be classified as a human carcinogen, and strongly supports the findings of other groups concerning both lung cancer and ETS-induced respiratory tract illnesses in children. The CSA concludes that exposure to passive smoke, whether in utero or during infancy, is associated with an increased risk of sudden infant death syndrome. The CSA agrees that the available evidence suggests that ETS exposure leads to increased risk for cardiovascular disease. It is clear that these morbidity and mortality estimates represent a significant public health threat that demands attention from the health community as well as government regulatory agencies involved with health protection.

Child↗
PubMed1994

The EPC approach to estimating safety from exposure to environmental chemicals.

Reference doses (RfDs) and reference concentrations (RfCs) developed by the United States Environmental Protection Agency (USEPA) are typically used in the quantitation of risk of potential adverse human health effects from exposure to environmental chemicals. For a large number of chemicals, however, USEPA RfDs and RfCs have not yet been determined. Thus, for risk assessments that involve a large number of chemicals, there is insufficient toxicity information with which to evaluate potential adverse human health effects for all chemicals present at a particular site. Due to this insufficiency, the risk assessor must either (1) ignore potential exposures on the assumption that omitting these exposures does not significantly alter decisions concerning the remediation of the site or (2) undertake a lengthy and costly analysis to generate the necessary RfDs or RfCs. A potential solution to this problem is to develop estimated permissible concentrations (EPCs), values which represent permissible environmental concentrations or related acceptable daily dosages derived from occupational exposure limits. In the present analysis, acceptable daily dosages determined using the EPC method were compared to USEPA RfDs or RfCs which were converted to dosages based on standard exposure assumptions. Based on a comparative analysis of EPCs and USEPA reference values for 103 chemicals, it was found that EPC daily dosages represent a reasonably conservative surrogate value when USEPA or state reference values are unavailable. Given that there are hundreds of chemicals with occupational exposure limits but no state or USEPA reference values, acceptance of the EPC methodology would provide an interim solution for the problem of insufficient toxicity information for a substantial number of environmental chemical contaminants.

Animals↗
PubMed2006

A review of scientific literature examining the mining history, geology, mineralogy, and amphibole asbestos health effects of the Rainy Creek igneous complex, Libby, Montana, USA.

This article reviews the past 90 yr of scientific research directed on multiple aspects of the unique geology and environmental health issues surrounding the vermiculite deposit found at Libby, MT. Hydrothermal alteration and extensive weathering of the ultramafic units resulted in the formation of a rich deposit of vermiculite that was mined for 67 yr and used in numerous consumer products in its expanded form. Later intrusions of alkaline units caused hydrothermal alteration of the pyroxenes, resulting in formation of amphiboles. Some of these amphiboles occur in the asbestiform habit and have been associated with pulmonary disease in former miners and mill workers. Identification of these amphibole asbestos minerals has received little attention in the past, but recent work shows that the majority of the amphibole mineral species present may not be any of the amphibole species currently regulated by government agencies. Epidemiological studies on former miners have, nevertheless, shown that the amphibole asbestos from the Rainy Creek igneous complex is harmful; also, a recent study by the Agency for Toxic Substances and Disease Registry shows that residents of Libby who had not been employed in the vermiculite mining or milling operations also appear to have developed asbestos-related pulmonary diseases at a higher rate than the general public elsewhere. Since November 1999, the U.S. Environmental Protection Agency has been involved in the cleanup of asbestos-contaminated sites in and around Libby associated with the mining and processing of vermiculite.

Aluminum Silicates↗
PubMed2005

Beverages: bottled water. Final rule.

The Food and Drug Administration (FDA) is amending its bottled water quality standard regulations by revising the existing allowable level for the contaminant arsenic. As a consequence, bottled water manufacturers are required to monitor their finished bottled water products for arsenic at least once each year under the current good manufacturing practice (CGMP) regulations for bottled water. Bottled water manufacturers are also required to monitor their source water for arsenic as often as necessary, but at least once every year unless they meet the criteria for the source water monitoring exemptions under the CGMP regulations. This final rule will ensure that the minimum quality of bottled water, as affected by arsenic, remains comparable with the quality of public drinking water that meets the Environmental Protection Agency's (EPA's) standards.

Arsenic↗
PubMed1999

Hazards for nearby residents and cleanup workers of waste sites.

This study weighs the risks to workers of cleaning up Superfund sites against the risks to residents if the sites were not cleaned up. Risks are measured by the number of deaths and disabilities due to injuries and diseases, as well as by the costs of these deaths and disabilities. We posit three methods to clean up the sites: one that is labor-intensive and two that are not. We posit 24 hypothetical sites, with varying numbers of residents and levels of cancer death and cancer disability rates. Depending on the cleanup method, the number of residents, and the rates, we find that the risks to workers frequently outweigh the risks to residents. We conclude that risks to workers should be accounted for in Environmental Protection Agency judgments regarding which and how Superfund sites should be cleaned up.

Cost-Benefit Analysis↗
PubMed1991

Chemical selection by the Interagency Testing Committee: use of computerized substructure searching to identify chemical groups for health effects, chemical fate and ecological effects testing.

Since 1977, the Interagency Testing Committee has convened over 300 meetings, issued 27 semi-annual reports to the Administrator of the US Environmental Protection Agency, screened about 26,000 chemicals, reviewed about 4,500 chemicals and recommended between 5000 and 7600 health effects, chemical fate or ecological effects tests for 114 chemicals and 27 chemical groups. The Committee has used three chemical selection processes to screen and identify chemicals for priority testing consideration. From 1977 to 1980, the Committee's processes consisted of examining large lists of chemicals and designating chemical categories that satisfied generic definitions. From 1980 to 1989, the Committee used sequential exposure and biological scoring processes followed by in-depth review. Since 1989, the Committee has used computerized processes to identify chemical groups that are associated with potentials to cause adverse health or ecological effects or that are likely to involve occupational or environmental exposure and that have common substructures, uses, testing information deficiencies, risk assessment uncertainties, etc. This paper focuses on use of the computerized processes to identify chemical groups containing common substructures that are associated with potentials to cause adverse ecological effects. The purpose of this paper is to describe how: (i) chemical substructures are selected, (ii) substructures are used to identify chemical groups, (iii) groups are processed, and (iv) reliability of the processes that were used to select chemical substructures are being assessed.

Animals↗