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This paper examines the effect of the U.S. Environmental Protection Agency's Cluster Rule on the product-mix decisions of plants in the pulp, paper, and paperboard industries. The Cluster Rule combines regulatory requirements from the Clean Air Act and Clean Water Act that are based on plants altering their production processes away from chlorine-based bleaching agents. In addition to, or instead of, altering production processes, plants may plausibly comply with the regulation by reducing output of bleached products or dropping some of these products entirely. Using a difference-in-difference-in-differences approach, we find evidence that plants facing both air and water Cluster Rule regulation (treatment group) are more likely to drop bleached products relative to unbleached products compared to plants facing only air Cluster Rule regulation (control group). Furthermore, we find evidence that plants in the control group alter their product mixes toward bleached products. [ABSTRACT FROM AUTHOR]

Abstract: This paper presents results from the first known population-based survey of recreational fishers in Louisiana (n=1774). The ultimate goal of this study was to obtain data in support of the development of regional advisories for a high exposure population with unique seafood consumption patterns. Between July and August of 2008, a survey was mailed to a random sample of licensed recreational fishers to characterize local fishing habits, sportfish consumption, and advisory awareness. Eighty-eight percent of respondents reported eating sportfish. Respondents ate an estimated mean of four fish meals per month, of which, approximately half were sportfish. Over half of all sportfish meals (54%) were caught in the Gulf of Mexico or bordering brackish areas. Sportfish consumption varied by license and gender; and was highest among Sportsman’s Paradise license holders (2.8±0.2 meals per month), and males (2.2±0.1 meals per month). The most frequently consumed sportfish species were red drum, speckled trout, catfish, bass, crappie and bream. Advisory awareness rates varied by gender, ethnicity, geographic area, license type, age and education; and were lowest among women (53%), African-Americans (43%), fishers from the southeast of Louisiana (50%), holders of Senior Hunting and Fishing licenses (51%), individuals between 15 and 19 years of age (41%), and individuals with less than a high school education (43%). Results were used to identify ways to optimize monitoring, advisory development and outreach activities. [Copyright &y& Elsevier]

Abstract: Traditionally, the No-Observed-Adverse-Effect-Level (NOAEL) approach has been used to determine the point of departure (POD) from animal toxicology data for use in human health risk assessments. However, this approach is subject to substantial limitations that have been well defined, such as strict dependence on the dose selection, dose spacing, and sample size of the study from which the critical effect has been identified. Also, the NOAEL approach fails to take into consideration the shape of the dose–response curve and other related information. The benchmark dose (BMD) method, originally proposed as an alternative to the NOAEL methodology in the 1980s, addresses many of the limitations of the NOAEL method. It is less dependent on dose selection and spacing, and it takes into account the shape of the dose–response curve. In addition, the estimation of a BMD 95% lower bound confidence limit (BMDL) results in a POD that appropriately accounts for study quality (i.e., sample size). With the recent advent of user-friendly BMD software programs, including the U.S. Environmental Protection Agency''s (U.S. EPA) Benchmark Dose Software (BMDS), BMD has become the method of choice for many health organizations world-wide. This paper discusses the BMD methods and corresponding software (i.e., BMDS version 2.1.1) that have been developed by the U.S. EPA, and includes a comparison with recently released European Food Safety Authority (EFSA) BMD guidance. [Copyright &y& Elsevier]

Abstract: The U.S. Environmental Protection Agency''s (EPA) Integrated Risk Information System (IRIS) Program develops assessments of health effects that may result from chronic exposure to chemicals in the environment. The IRIS database contains more than 540 assessments. When supported by available data, IRIS assessments provide quantitative analyses of carcinogenic effects. Since publication of EPA''s 2005 Guidelines for Carcinogen Risk Assessment, IRIS cancer assessments have implemented new approaches recommended in these guidelines and expanded the use of complex scientific methods to perform quantitative dose–response assessments. Two case studies of the application of the mode of action framework from the 2005 Cancer Guidelines are presented in this paper. The first is a case study of 1,2,3-trichloropropane, as an example of a chemical with a mutagenic mode of carcinogenic action thus warranting the application of age-dependent adjustment factors for early-life exposure; the second is a case study of ethylene glycol monobutyl ether, as an example of a chemical with a carcinogenic action consistent with a nonlinear extrapolation approach. The use of physiologically based pharmacokinetic (PBPK) modeling to quantify interindividual variability and account for human parameter uncertainty as part of a quantitative cancer assessment is illustrated using a case study involving probabilistic PBPK modeling for dichloromethane. We also discuss statistical issues in assessing trends and model fit for tumor dose–response data, analysis of the combined risk from multiple types of tumors, and application of life-table methods for using human data to derive cancer risk estimates. These issues reflect the complexity and challenges faced in assessing the carcinogenic risks from exposure to environmental chemicals, and provide a view of the current trends in IRIS carcinogenicity risk assessment. [Copyright &y& Elsevier]

Abstract: This paper presents Biomonitoring Equivalents (BEs) for inorganic arsenic. Biomonitoring Equivalents (BEs) are defined as the concentration or range of concentrations of a chemical or its metabolite in a biological medium (blood, urine, or other medium) that is consistent with an existing health-based exposure guideline, and are derived by integrating available data on pharmacokinetics with existing chemical risk assessments. This study reviews available health-based exposure guidance values for arsenic based on recent evaluations from the United States Environmental Protection Agency (US EPA), US Agency for Toxic Substances and Disease Registry (ATSDR) and Health Canada (HC). BE values corresponding to the Reference Dose (RfD) or risk-specific doses for cancer endpoints from these agencies were derived based on kinetic data (urinary excretion) from controlled dosing studies in humans. The BE values presented here provide estimates of the sum of inorganic arsenic-derived urinary biomarkers (inorganic arsenic, monomethylated arsenic, and dimethylated arsenic). The BE associated with the United States Environmental Protection Agency’s Reference Dose and the Agency for Toxic Substances and Disease Registry’s Minimal Risk Level is 6.4μg arsenic/L urine. The BEs associated with the various cancer risk assessments are significantly lower. These BE values may be used as screening tools for evaluation of biomonitoring data for inorganic arsenic in a public health risk context. [ABSTRACT FROM AUTHOR]

Perchlorate, an anion that originates as a contaminant in ground and surface waters, is both naturally occurring and manmade. Because of its toxicity, there has been increased interest in setting drinking water safety standards and in health effects when perchlorate is present at low (parts per billion (ppb)) levels. In January 2009, the EPA issued a heath advisory to assist state and local officials in addressing local contamination of perchlorate in drinking water. The interim health advisory level of 15 micrograms per liter (μg/L), or ppb, is based on the reference dose recommended by the National Research Council (NRC) of the National Academy of Sciences (NAS). This paper describes scope and extent of contaminant issues and a legal process of setting standards for perchlorate concentration in drinking water in the United States of America. [Copyright &y& Elsevier]

The “cradle to grave” concept of managing chemicals and wastes has been a descriptive analogy of proper environmental stewardship since the 1970s. The concept incorporates environmentally sustainable product choices—such as metal alloys utilized steel products which civilization is dependent upon. Manganese consumption is related to the increasing production of raw steel and upgrading ferroalloys. Nonferrous applications of manganese include production of dry-cell batteries, plant fertilizer components, animal feed and colorant for bricks. The manganese ore (high grade 35% manganese) production world wide is about 6million ton/year and electrolytic manganese metal demand is about 0.7million ton/year. The total manganese demand is consumed globally by industries including construction (23%), machinery (14%), and transportation (11%). Manganese is recycled within scrap of iron and steel, a small amount is recycled within aluminum used beverage cans. Recycling rate is 37% and efficiency is estimated as 53% [Roskill Metals and Minerals Reports, January 13, 2005. Manganese Report: rapid rise in output caused by Chinese crude steel production. Available from: http://www.roskill.com/reports/manganese.]. Environmentally sustainable management choices include identifying raw material chemistry, utilizing clean production processes, minimizing waste generation, recycling materials, controlling occupational exposures, and collecting representative environmental data. This paper will discuss two electrolytically produced manganese metals, the metal production differences, and environmental impacts cited to date. The two electrolytic manganese processes differ due to the addition of sulfur dioxide or selenium dioxide. Adverse environmental impacts due to use of selenium dioxide methodology include increased water consumption and order of magnitude greater solid waste generation per ton of metal processed. The use of high grade manganese ores in the electrolytic process also reduces the quantity of solid wastes generated during processing. Secondary aluminum facilities have reported hazardous waste generation management issues due to baghouse dusts from rotary furnaces processing selenium contaminated manganese alloys. Environmental impacts resulting from industry are represented by emission inventories of chemical releases to the air, water, and soil. The U.S. metals industry releases reported to EPA Toxic Release Inventory indicate the primary metals industry is the major source of metal air toxic emissions, exceeding electric utility air toxic emissions. The nonferrous metals industry is reported to be the Organization for Economic Co-operation and Development (OECD) most intensive airborne and land pollution source of bioaccumulative metals. However, total waste emissions from industries in the OECD countries have declined due to improving energy consumption. Emission registers and access are improving around the world. However, environmental databases for metal particulates have low confidence ratings since the majority of air toxic emissions are not reported, not monitored, or are estimated based on worst-case emission factors. Environmental assessments including biological monitoring are necessary to validate mandated particulate metal emission reductions and control technologies during metal processing. [Copyright &y& Elsevier]

Abstract: Traditional high resolution mass spectrometry (HRMS) analysis for polychlorinated dibenzo-p-dioxins and polychlorinated dibenzofurans (PCDD/Fs) can be time consuming and expensive. Consequently, alternative methods are of great interest to regulatory agencies and others characterizing contaminated sites. One factor that hinders acceptance of alternative methods is a lack of performance information that assesses the alternative method''s impacts on analytical results. The U.S. Environmental Protection Agency''s Superfund Innovative Technology Evaluation Monitoring and Measurement Technologies Program (EPA SITE MMT) encourages the development and implementation of innovative and alternative monitoring methods by providing performance information on site characterization technologies. This paper presents a comparison of the results obtained from laboratory-based alternative approaches for screening sediment and soil samples for dioxin toxicity equivalents (TEQD/F) to results obtained using traditional HRMS. The laboratory-based approaches included modifying the traditional HRMS analysis to make it more cost-effective (alternate 1613B), analyzing extracts that had been prepared for HRMS using low resolution mass spectrometry, and determining total organic carbon (TOC) content as an indicator of PCDD/F content. These comparisons demonstrated that TEQD/F values generated using toxicity equivalency factors proposed by the World Health Organization in 1998 applied to alternate 1613B and LRMS analyses have a strong linear correlation to the TEQD/F values derived in the same fashion from traditional HRMS analysis. These results would have placed >90% of the samples within the same concentration intervals using ranges of <0.05, 0.05–0.50, 0.50–5, and >5ngTEQ/g. Natural log transformed data for TOC had significantly weaker correlation to TEQD/F, indicating that TOC is not a reliable indicator of TEQD/F concentrations. [Copyright &y& Elsevier]

Abstract: This paper examines and compares the management practices and regulatory approaches used by the Mid-Atlantic States of Delaware, Maryland, New Jersey, and Pennsylvania for improving the quality of storm-water runoff. Such practices range from simple extended detention criteria in Pennsylvania through the BMP credit system used by Maryland, to the latest “green technology” methods promoted in Delaware and the recharge, quality and peak reduction approaches of New Jersey. All practices are designed to meet EPA requirements for total suspended solids (TSS) removal, but verification of performance is not required. More sophisticated methods of evaluating TSS removal that can be used for engineering design purposes are needed. [Copyright &y& Elsevier]

Abstract: This study was conducted to describe exposure prone behaviors of infants and toddlers in the farmworker community. Analysis of hand and mouth contact frequencies and durations aids understanding of how children interact with their environment and are exposed via contact with surfaces. All 23 participating children (8 female infants, 5 male infants, 5 female toddlers and 5 male toddlers) lived with at least one farmworker. Children were videotaped at home for 2–6h. Video footage was translated into micro-level activity time series (MLATS) for both hands and the mouth. MLATS were processed to calculate hourly duration in microenvironments, contact frequency, hourly contact duration and median contact duration. The median hourly duration spent indoors was 53min/h. The median hand-to-mouth frequency was 15.2events/h and the median object-to-mouth frequency was 27.2events/h. The hourly mouthing duration was 1.2 and 2.2min/h with the hands and objects, respectively. The median mouthing duration with hands and objects was 2s. The median contact frequency for both hands combined was 689.4events/h with an hourly contact duration of 100.5min/h and a median contact duration of 3s. Infants had higher mouthing frequencies with non-dietary objects while toddlers had higher mouthing frequencies with objects associated with pica (i.e., paper). Boys had higher contact frequencies while girls had longer contact durations. These sub-group differences indicate factors such as age and gender should be accounted for when conducting exposure assessments. Contact frequencies in this study are higher than current US EPA recommendations, questioning their protective value for infants and toddlers. [Copyright &y& Elsevier]

Abstract: On May 24–25, 2005 in Ann Arbor, Michigan, the US Environmental Protection Agency, the National Institute of Environmental Health Sciences, and the University of Michigan sponsored a technical workshop on the topic of connecting social and environmental factors to measure and track environmental health disparities. The workshop was designed to develop a transdisciplinary scientific foundation for exploring the conceptual issues, data needs, and policy applications associated with social and environmental factors used to measure and track racial, ethnic, and class disparities in environmental health. Papers, presentations, and discussions focused on the use of multilevel analysis to study environmental health disparities, the development of an organizing framework for evaluating health disparities, the development of indicators, and the generation of community-based participatory approaches for indicator development and use. Group exercises were conducted to identify preliminary lists of priority health outcomes and potential indicators and to discuss policy implications and next steps. Three critical issues that stem from the workshop were: (a) stronger funding support is needed for community-based participatory research in environmental health disparities, (b) race/ethnicity and socioeconomic position need to be included in environmental health surveillance and research, and (c) models to elucidate the interrelations between social, physical, and built environments should continue to be developed and empirically tested. [Copyright &y& Elsevier]

The U.S. Environmental Protection Agency (EPA) has conducted extensive reviews and analyses of health effects associated with exposures to 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) and related compounds. Because the carcinogenicity of TCDD has received considerable attention from EPA and others, this paper focuses on animal data for non-cancer health effects that sometimes appear to be almost as sensitive as cancer to TCDD exposures. Benchmark dose (BMD) methodology can be used to identify point-of-departure (POD) estimates for use in derivation of reference doses or evaluation of margins of exposure. However, selection of an appropriate BMD methodology for assessment of non-cancer data, which are usually continuous (non-quantal), needs to be considered. One option available for a benchmark dose is to use a small percentage change in the mean response relative to the estimated maximum effect of TCDD at large doses. The benchmark based on a change estimated to equal 1% of the estimated maximum change from background to the asymptotic response at large doses (denoted as the relative ED01) was used by EPA in a reassessment of TCDD health risks. A lower confidence limit (LED01) could serve as a point of departure for setting a reference dose (RfD). This is a somewhat arbitrary effect level, generally within the background range of variation among unexposed animals, with an unknown risk. An alternative approach is recommended in which the risk of abnormal levels can be estimated. For continuous-data effects, a low and/or high percentile (e.g., 1st and/or 99th) in unexposed control animals can be used to define abnormal (not necessarily adverse) levels. From a dose–response curve and the standard deviation, it is possible to estimate the excess risk (proportion) of animals with abnormal levels as a function of dose for normally distributed levels. With this approach, the risk-based benchmark dose (BMD01) represents the dose with an estimated excess risk of 1% of the animals in the abnormal range rather than an arbitrary change in the value of the measured endpoint. Values for the relative and risk-based benchmark doses are computed from published data for a variety of non-cancer health effects associated with exposure to TCDD. For the 30 cases investigated, the BMD01 tended to vary around the lowest experimental dose tested, whereas the relative ED01 tended to be about a factor of three below the lowest dose, and the BMD01 was more precisely estimated than the ED01 as reflected by narrower confidence intervals. The BMDL01 values were on average more than fivefold higher than the corresponding LED01 values. However, these values still provide a conservative assessment for POD assessment, because the BMDL01 tends to be about an order of magnitude lower (more conservative) than the no-observed-adverse-effect level. This analysis demonstrates the potential impact of alternative choices in benchmark dose methodology. In combination with selection of appropriate adverse health effect endpoint(s) and studies, use of the risk-based BMD results in identification of more valid and meaningful POD estimates for non-cancer effects compared to the use of the relative ED approach. [Copyright &y& Elsevier]

Abstract: In 1999, the US Environmental Protection Agency (EPA) published guidelines for product performance testing of skin-applied insect repellents, which provide guidance for topical insect repellent efficacy studies. EPA subsequently uses these sponsor-financed studies in their evaluation of proposed label claims. This paper reviews some of the statistical flaws in the proposed revisions to these guidelines and suggests possible improvements. This review is important because EPA’s revisions to the 1999 guidelines do not address these issues. [Copyright &y& Elsevier]