Risk Assessment for Carcinogens Under California''s Proposition 65

Risk assessments for carcinogens are being developed through an accelerated process in California as a part of the state's implementation of Proposition 65, the Safe Drinking Water and Toxic Enforcement Act. Estimates of carcinogenic potency made by the California Department of Health Services (CDHS) are generally similar to estimates made by the U.S. Environmental Protection Agency (EPA). The largest differences are due to EPA's use of the maximum likelihood estimate instead of CDHS' use of the upper 95% confidence bounds on potencies derived from human data and to procedures used to correct for studies of short duration or with early mortality. Numerical limits derived from these potency estimates constitute "no significant risk" levels, which govern exemption from Proposition 65's discharge prohibition and warning requirements. Under Proposition 65 regulations, lifetime cancer risks less than 10(-5) are not significant and cumulative intake is not considered. Following these regulations, numerical limits for a number of Proposition 65 carcinogens that are applicable to the control of toxic discharges are less stringent than limits under existing federal water pollution control laws. Thus, existing federal limits will become the Proposition 65 levels for discharge. Chemicals currently not covered by federal and state controls will eventually be subject to discharge limitations under Proposition 65. "No significant risk" levels (expressed in terms of daily intake of carcinogens) also trigger warning requirements under Proposition 65 that are more extensive than existing state or federal requirements. A variety of chemical exposures from multiple sources are identified that exceed Proposition 65's "no significant risk" levels.     

Improving the Regulation of Carcinogens by Expediting Cancer Potency Estimation1

The statutory language of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65; California Health and Safety Code 25249.5 et seq.) encourages rapid adoption of “no significant risk levels” (NSRLs), intakes associated with estimated cancer risks of no more than 1 in 100,000. Derivation of an NSRL for a carcinogen listed under Proposition 65 requires the development of a cancer potency value. This paper discusses the methodology for the derivation of cancer potencies using an expedited procedure, and provides potency estimates for a number of agents listed as carcinogens under Proposition 65. To derive expedited potency values, default risk assessment methods are applied to data sets selected from an extensive tabulation of animal cancer bioassays according to criteria used by regulatory agencies. A subset of these expedited values is compared to values previously developed by regulatory agencies using conventional quantitative risk assessment and found to be in good agreement. Specific regulatory activities which could be facilitated by adopting similar expedited procedures are identified.     

住房市场系统模型研究

从宏观层面建立了包含银行、地产商及消费者在内的住房市场系统模型,重点考虑了信贷对住房市场供需双方的金融支持,构建了住房市场系统的定量分析框架,该框架对于银行主导的住房市场具有一般性。通过中国住房市场的实证分析,证实了模型的有效性。     

Derivation of a Target Level of Lead in Soil at Residential Sites Corresponding to a De Minimis Contribution to Blood Lead Concentration1

Inability to define either a clear toxicologic threshold or a stochastic all-or-nothing (cancer-type) response model for the noncarcinogenic effects of lead (Pb) in young children has posed difficulties for derivation of risk-based target levels of Pb in residential soil. Approaches based on empirical relationships between Pb levels in blood (PbB) and Pb in soil suffer from inability to specify the numerous variables which mediate between these two quantities. Approaches based on achieving a toxicologically de minimis target PbB level (e.g., 10 μg/dl) are subject to large uncertainty in estimating the distribution of existing PbB levels in a specific exposed population and in estimating the relative contribution from nonsoil sources of Pb. The multisource contribution to the distribution of PbB makes this approach unsuited for determination of a target Pb level in a single medium. An alternative approach is presented based on achieving a de minimis contribution to PbB (ΔPbB) from soil. Contributions to Pb exposure from outdoor soil and indoor soil-derived dust (ISDD) are modeled and appropriate values are suggested for input parameters. This analysis predicts that chronic exposure of young children to 200 μg Pb/g (ppm) in residential soil will result in a ΔPbB of 2 μg Pb/dl blood. This concentration of Pb in soil may provide an appropriate target level for residential soil when other significant sources of Pb exposure are present. In other cases, this approach can be used to predict a soil concentration of Pb corresponding to an appropriate non-de minimisΔPbB.     

Assessment of Health Risk from Exposure to Contaminated Soil

The risk to human health posed by contaminated soil in a residential area depends on the potential extent of exposure to soil and on the toxic properties of the contaminants. A detailed soil exposure analysis is presented for young children, older children, and adults living in a house surrounded by contaminated soil. From this analysis, a lifetime exposure model is derived and used to assess chronic health risks.     

A Framework and Case Study for Exposure Assessment in the Voluntary Children''s Chemical Evaluation Program

A conceptual framework is presented for conducting exposure assessments under the U.S. EPA's Voluntary Children's Chemical Evaluation Program (VCCEP). The VCCEP is a voluntary program whereby companies that manufacture chemicals of potential concern are asked to conduct hazard, exposure, and risk assessments for the chemicals. The VCCEP is unique in its risk-based, tiered approach, and because it focuses on children and requires a comprehensive consideration of all reasonably foreseeable exposure pathways for a particular chemical. The consideration of all potential exposure pathways for some commonly used chemicals presents a daunting challenge for the exposure assessor. This article presents a framework for managing this complicated process, and illustrates the application of the framework with a hypothetical case study. The framework provides guidance for interpreting multiple sources of exposure information and developing a plausible list of exposure pathways for a chemical. Furthermore, the framework provides a means to process all the available information to eliminate pathways of negligible concern from consideration. Finally, the framework provides guidance for utilizing the tiered approach of VCCEP to efficiently conduct an assessment by first using simple, screening-level approaches and then, if necessary, using more complex, refined exposure assessment methods. The case study provides an illustration of the major concepts.     

Potential Exposure and Cancer Risk from Formaldehyde Emissions from Installed Chinese Manufactured Laminate Flooring

Lumber Liquidators (LL) Chinese‐manufactured laminate flooring (CLF) has been installed in >400,000 U.S. homes over the last decade. To characterize potential associated formaldehyde exposures and cancer risks, chamber emissions data were collected from 399 new LL CLF, and from LL CLF installed in 899 homes in which measured aggregate indoor formaldehyde concentrations exceeded 100 μg/m³ from a total of 17,867 homes screened. Data from both sources were combined to characterize LL CLF flooring‐associated formaldehyde emissions from new boards and installed boards. New flooring had an average (±SD ) emission rate of 61.3 ± 52.1 μg/m²‐hour; >one‐year installed boards had ∼threefold lower emission rates. Estimated emission rates for the 899 homes and corresponding data from questionnaires were used as inputs to a single‐compartment, steady‐state mass‐balance model to estimate corresponding residence‐specific TWA formaldehyde concentrations and potential resident exposures. Only ∼0.7% of those homes had estimated acute formaldehyde concentrations >100 μg/m³ immediately after LL CLF installation. The TWA daily formaldehyde inhalation exposure within the 899 homes was estimated to be 17 μg/day using California Proposition 65 default methods to extrapolate cancer risk (below the regulation “no significant risk level” of 40 μg/day). Using a U.S. Environmental Protection Agency linear cancer risk model, 50th and 95th percentile values of expected lifetime cancer risk for residents of these homes were estimated to be 0.33 and 1.2 per 100,000 exposed, respectively. Based on more recent data and verified nonlinear cancer risk assessment models, LL CLF formaldehyde emissions pose virtually no cancer risk to affected consumers.     

Health Risks of PCB Spills from Electrical Equipment

The Southern California Edison Company (SCE) has instituted a series of control strategies designed to minimize human exposure to polychlorinated biphenyls (PCBs) in electrical equipment used on its system. This paper describes a method of analyzing PCB risks using conservative estimates of human intake of PCBs originating from accidental spills from electrical equipment. The PCB releases from the Edison system were determined. The fate of these releases in soil, air, and water was analyzed to determine how much material reaches human receptors. The air and water pathways were determined to be the most likely candidates for the exposure and risk considerations. PCB intake via ingestion of soil at the spill site was neglected as an exposure pathway. Equipment spills without controls resulted in at the most 2 ng/day human intake of PCBs via the water exposure pathway. This was determined to be negligible in comparison with intake rates used in conjunction with the setting of food tolerance levels based on fish being the main dietary pathway of human exposure. The inhalation exposure of the hundred or so persons in the immediate vicinity of a spill was determined to equal the PCB intakes of the fish-eating subpopulation analyzed by the Food and Drug Administration for 2 ppm tolerance standard in the case of no controls or cleanup. Current cleanup procedures assure that even the persons in the immediate area are well below the intake of the subjects in the fish contamination analysis. All exposures were well below a "virtual safe dose" level estimated in the fish tolerance study.     

The Effect of Decisions About Spent Nuclear Fuel Storage on Residential Property Values

National, regional, state, and local surveys have revealed that people have intensely negative images of "nuclear" and "radioactive" technologies, activities, and facilities, as well as associated fears of stigmatization. In light of these perceptions, the debate over where to temporarily store or permanently dispose of spent nuclear fuel (at the reactor site, an interim storage facility, or a permanent repository) provokes immense concern among possible host jurisdictions. To address these concerns, one needs to know if people's subjective opinions conform with the choices they make and are therefore reflected in their economic behavior. Argonne National Laboratory researchers used a hedonic model to complete a study of residential property value dynamics over a 5-year period within a 15-mile radius of two California nuclear power plants. They tracked the economic ramifications of decisions about the spent nuclear fuel stored at those reactors. The study revealed that no significant negative effects on residential property values resulted from a decision to move spent nuclear fuel from wet storage to a dry-cask storage facility or from a request to extend the reactor operating permit (given future changes in the type of nuclear fuel storage facility that would accompany such an extension).     

A Probabilistic Arsenic Exposure Assessment for Children Who Contact CCA-Treated Playsets and Decks, Part 1: Model Methodology, Variability Results, and Model Evaluation

Concerns have been raised regarding the safety of young children who may contact arsenic residues while playing on and around chromated copper arsenate (CCA)-treated wood playsets and decks. Although CCA registrants voluntarily canceled the production of treated wood for residential use in 2003, the potential for exposure from existing structures and surrounding soil still poses concerns. The EPA's Office of Research and Development developed and applied the probabilistic Stochastic Human Exposure and Dose Simulation model for wood preservatives (SHEDS-Wood) to estimate children's absorbed dose of arsenic from CCA. Skin contact with, and nondietary ingestion of, arsenic in soil and wood residues were considered for the population of children in the United States who frequently contact CCA-treated wood playsets and decks. Model analyses were conducted to assess the range in population estimates and the impact of potential mitigation strategies such as the use of sealants and hand washing after play events. The results show predicted central values for lifetime annual average daily dose values for arsenic ranging from 10(-6) to 10(-5) mg/kg/day, with predicted 95th percentiles on the order of 10(-5) mg/kg/day. There were several orders of magnitude between lower and upper percentiles. Residue ingestion via hand-to-mouth contact was determined to be the most significant exposure route for most scenarios. Results of several alternative scenarios were similar to baseline results, except for the scenario with greatly reduced residue concentrations through hypothetical wood sealant applications; in this scenario, exposures were lower, and the soil ingestion route dominated. SHEDS-Wood estimates are typically consistent with, or within the range of, other CCA exposure models.     

Estimating Housing Infill Potential: Developing a Case for Floorspace Pooling in Ahmedabad,India

This paper demonstrates a rapid and inexpensive methodology (using minimal data) for estimating housing infill potential and develops the idea of residential floorspace pooling to deliver the infill. Estimates are based on surveying 11 km2 of the residential land in Ahmedabad. The analysis suggests that Ahmedabad has a huge potential for infill development, which could accommodate significantly more than its new housing requirements for 2031, within the existing footprint of the city. The second part of the paper discusses development of the idea of floorspace pooling as a tool to enable supply of the new housing infill floorspace in the market.     

Microenvironmental Analysis of Residential Exposure to Chromium-Laden Wastes in and Around New Jersey Homes

The purpose of this study was to identify the significant microenvironments that can lead to chromium exposure in Hudson County, New Jersey residential settings near or on soil contaminated with chromium waste. Measurements were made in indoor air, outdoor air, and house dust. Surface dust was found to be the best index of potential Cr exposure. The values of Cr in Hudson County household dust ranged from 3.25-320 ng/cm2 in wipe samples and 1.0-12 ng/cm2 in vacuum samples. Elevated Cr in household dust was found to be related to residential locations near large chromium waste sites, household cleaning habits, and house renovation activities. Outdoor Cr air levels were similar to those obtained in other urban areas at these seasons of the year, approximately 5-7 ng/m3. Comparisons with measurements of the Cr levels in urine found that the elevated Cr in dust was associated with elevated excretion of Cr. Site-specific Cr differences in household dust suggest different sources and routes of exposure. Within the total group of homes in the present study, Cr in household dust was the major influence on household exposure.     

Relative Contributions of Four Exposure Pathways to Influenza Infection Risk

The relative contribution of four influenza virus exposure pathways—(1) virus-contaminated hand contact with facial membranes, (2) inhalation of respirable cough particles, (3) inhalation of inspirable cough particles, and (4) spray of cough droplets onto facial membranes—must be quantified to determine the potential efficacy of nonpharmaceutical interventions of transmission. We used a mathematical model to estimate the relative contributions of the four pathways to infection risk in the context of a person attending a bed-ridden family member ill with influenza. Considering the uncertainties in the sparse human subject influenza dose-response data, we assumed alternative ratios of 3,200:1 and 1:1 for the infectivity of inhaled respirable virus to intranasally instilled virus. For the 3,200:1 ratio, pathways (1), (2), and (4) contribute substantially to influenza risk: at a virus saliva concentration of 10⁶ mL⁻¹, pathways (1), (2), (3), and (4) contribute, respectively, 31%, 17%, 0.52%, and 52% of the infection risk. With increasing virus concentrations, pathway (2) increases in importance, while pathway (4) decreases in importance. In contrast, for the 1:1 infectivity ratio, pathway (1) is the most important overall: at a virus saliva concentration of 10⁶ mL⁻¹, pathways (1), (2), (3), and (4) contribute, respectively, 93%, 0.037%, 3.3%, and 3.7% of the infection risk. With increasing virus concentrations, pathway (3) increases in importance, while pathway (4) decreases in importance. Given the sparse knowledge concerning influenza dose and infectivity via different exposure pathways, nonpharmaceutical interventions for influenza should simultaneously address potential exposure via hand contact to the face, inhalation, and droplet spray.     

Wildfire Risk Transmission in the Colorado Front Range,USA

Wildfires are a global phenomenon that in some circumstances can result in human casualties, economic loss, and ecosystem service degradation. In this article we spatially identify wildfire risk transmission pathways and locate the areas of highest exposure of human populations to wildland fires under severe, but not uncommon, weather events. We quantify varying levels of exposure in terms of population potentially affected and tie the exposure back to the spatial source of the risk for the Front Range of Colorado, USA. We use probabilistic fire simulation modeling to address where fire ignitions are most likely to cause the highest impact to human communities, and to explore the role that various landowners play in that transmission of risk. Our results indicated that, given an ignition and the right fire weather conditions, large areas along the Front Range in Colorado could be exposed to wildfires with high potential to impact human populations, and that overall private ignitions have the potential to impact more people than federal ignitions. These results can be used to identify high‐priority areas for wildfire risk mitigation using various mitigation tools.     

Group Buying,Buyer Heterogeneity,and Sellers' Bargaining Power*

Group buying enables collective bargaining opportunity that individual buyers lack to negotiate prices with sellers. This potential negotiation capability has two opposing effects. On the one hand, the prospect of the group being able to negotiate price with its rival forces each seller to lower its price offer, as too high a price will induce the group to give its rival an opportunity to undercut its price via negotiation, likely taking away all the buyers. On the other hand, the potential negotiation opportunity may also discourage sellers from competing aggressively in their price offers, as the benefit of charging a low price could be offset by competitors in negotiation, thus yielding overall higher prices for the buyers. In this study, we find that compared to individual purchase, buyers benefit from collective bargaining opportunity by group buying only if sellers’ bargaining power relative to the buyer group is low and/or buyers’ preferences toward the sellers are sufficiently differentiated. Given buyers’ strategic choice of group purchase, sellers may be worse off with a further increase in bargaining power, and so may social welfare.     

A Multilayered Box Model for Calculating Preliminary Remediation Goals in Soil Screening

In the process of screening a soil against a certain contaminant, we define the health-risk-based preliminary remediation goal (PRG) as the contaminant concentration above which some remedial action may be required. Thus, PRG is the first standard (or guidance) for judging a site. An overestimated PRG (a too-large value) may cause us to miss some contaminated sites that can threaten human health and the environment. An underestimated PRG (a too-small value), on the other hand, may lead to unnecessary cleanup and waste tremendous resources. The PRGs for soils are often calculated on the assumption that the contaminant concentration in soil does not change with time. However, that concentration usually decreases with time as a result of different chemical and transport mechanisms. The static assumption thus exaggerates the long-term exposure dose and results in a too-small PRG. We present a box model that considers all important transport processes and obeys the law of mass conservation. We can use the model as a tool to estimate the transient contaminant concentrations in air, soil, and ground water. Using these concentrations in conjunction with appropriate health-risk parameters, we may estimate the PRGs for different contaminants. As an example, we calculated the tritium PRG for residential soils. The result is quite different from, but within the range of, the two versions of the corresponding PRG previously recommended by the U.S. EPA.     

电子商务环境下合作采购效益分析

合作采购是一种重要的企业间电子商务应用模式,成功实施合作采购需要供应链成员的积极参与。本文针对供应商采取的两种批发价定价策略,比较分析了协调成本对买主间合作采购动力及其总体采购成本的影响。其结果表明,只要协调成本较小,买主便具有合作采购动力,且无论供应商采取固定价格策略还是采取数量折扣策略,都存在一个协调成本临界值,当协调成本小于该临界值时,合作采购将同时减少买主与供应商的总体成本;当协调成本大于该临界值时,则总有一方的总体成本在合作采购中增加。     

Development of a Unit Risk Factor for 1,3-Butadiene Based on an Updated Carcinogenic Toxicity Assessment

The Texas Commission on Environmental Quality (TCEQ) has developed an inhalation unit risk factor (URF) for 1,3-butadiene based on leukemia mortality in an updated epidemiological study on styrene-butadiene rubber production workers conducted by researchers at the University of Alabama at Birmingham. Exposure estimates were updated and an exposure estimate validation study as well as dose-response modeling were conducted by these researchers. This information was not available to the U.S. Environmental Protection Agency when it prepared its health assessment of 1,3-butadiene in 2002. An extensive analysis conducted by TCEQ discusses dose-response modeling, estimating risk for the general population from occupational workers, estimating risk for potentially sensitive subpopulations, effect of occupational exposure estimation error, and use of mortality rates to predict incidence. The URF is 5.0 × 10⁻⁷ per μg/m³ or 1.1 × 10⁻⁶ per ppb and is based on a Cox regression dose-response model using restricted continuous data with age as a covariate, and a linear low-dose extrapolation default approach using the 95% lower confidence limit as the point of departure. Age-dependent adjustment factors were applied to account for possible increased susceptibility for early life exposure. The air concentration at 1 in 100,000 excess leukemia mortality, the no-significant-risk level, is 20 μg/m³ (9.1 ppb), which is slightly lower than the TCEQ chronic reference value of 33 μg/m³ (15 ppb) protective of ovarian atrophy. These values will be used to evaluate ambient air monitoring data so the general public is protected against adverse health effects from chronic exposure to 1,3-butadiene.     

Issues Related to Time Averaging of Exposure in Modeling Risks Associated with Intermittent Exposures to Lead

Typical exposures to lead often involve a mix of long-term exposures to relatively constant exposure levels (e.g., residential yard soil and indoor dust) and highly intermittent exposures at other locations (e.g., seasonal recreational visits to a park). These types of exposures can be expected to result in blood lead concentrations that vary on a temporal scale with the intermittent exposure pattern. Prediction of short-term (or seasonal) blood lead concentrations arising from highly variable intermittent exposures requires a model that can reliably simulate lead exposures and biokinetics on a temporal scale that matches that of the exposure events of interest. If exposure model averaging times (EMATs) of the model exceed the shortest exposure duration that characterizes the intermittent exposure, uncertainties will be introduced into risk estimates because the exposure concentration used as input to the model must be time averaged to account for the intermittent nature of the exposure. We have used simulation as a means of determining the potential magnitude of these uncertainties. Simulations using models having various EMATs have allowed exploration of the strengths and weaknesses of various approaches to time averaging of exposures and impact on risk estimates associated with intermittent exposures to lead in soil. The International Commission of Radiological Protection (ICRP) model of lead pharmacokinetics in humans simulates lead intakes that can vary in intensity over time spans as small as one day, allowing for the simulation of intermittent exposures to lead as a series of discrete daily exposure events. The ICRP model was used to compare the outcomes (blood lead concentration) of various time-averaging adjustments for approximating the time-averaged intake of lead associated with various intermittent exposure patterns. Results of these analyses suggest that standard approaches to time averaging (e.g., U.S. EPA) that estimate the long-term daily exposure concentration can, in some cases, result in substantial underprediction of short-term variations in blood lead concentrations when used in models that operate with EMATs exceeding the shortest exposure duration that characterizes the intermittent exposure. Alternative time-averaging approaches recommended for use in lead risk assessment more reliably predict short-term periodic (e.g., seasonal) elevations in blood lead concentration that might result from intermittent exposures. In general, risk estimates will be improved by simulation on shorter time scales that more closely approximate the actual temporal dynamics of the exposure.     

A Methodology for Estimating Time-of-Day Variations in the Size of a Population Exposed to Risk

Consequence models for the risk assessment of man-made or natural disasters do not ordinarily take into account time-of-day variations in the size of the exposed population. Residential census population statistics are used instead. This paper proposes and illustrates a methodology for using metropolitan travel survey data to estimate the variations in question. Variations are computed from the Washington, D.C. area sample survey statistics on the number of trips taken in and out of different census tracts throughout each workday. Four principal patterns of population variation are identified, corresponding to four types of land use: commercial, residential, shopping/entertainment, and mixed use. Some general implications for consequence analysis are discussed.