Decisions,Science, and Values: Crafting Regulatory Alternatives Analysis

Emerging “prevention‐based” approaches to chemical regulation seek to minimize the use of toxic chemicals by mandating or directly incentivizing the adoption of viable safer alternative chemicals or processes. California and Maine are beginning to implement such programs, requiring manufacturers of consumer products containing certain chemicals of concern to identify and evaluate potential safer alternatives. In the European Union, the REACH program imposes similar obligations on manufacturers of certain substances of very high concern. Effective prevention‐based regulation requires regulatory alternatives analysis (RAA), a methodology for comparing and evaluating the regulated chemical or process and its alternatives across a range of relevant criteria. RAA has both public and private dimensions. To a significant degree, alternatives analysis is an aspect of product design; that is, the process by which private industry designs the goods it sells. Accordingly, an RAA method should reflect the attributes of well‐crafted product design tools used by businesses. But RAA adds health and environmental objectives to the mix of concerns taken into account by the product designer. Moreover, as part of a prevention‐based regulatory regime, it implicates important public values such as legitimacy, equity, public engagement, and accountability. Thus, an RAA should reflect both private standards and public values, and be evaluated against them. This article adopts that perspective, identifying an integrated set of design principles for RAA, and illustrating the application of those principles.     

Risk Assessment and Alternatives Assessment: Comparing Two Methodologies

The selection and use of chemicals and materials with less hazardous profiles reflects a paradigm shift from reliance on risk minimization through exposure controls to hazard avoidance. This article introduces risk assessment and alternatives assessment frameworks in order to clarify a misconception that alternatives assessment is a less effective tool to guide decision making, discusses factors promoting the use of each framework, and also identifies how and when application of each framework is most effective. As part of an assessor's decision process to select one framework over the other, it is critical to recognize that each framework is intended to perform different functions. Although the two frameworks share a number of similarities (such as identifying hazards and assessing exposure), an alternatives assessment provides a more realistic framework with which to select environmentally preferable chemicals because of its primary reliance on assessing hazards and secondary reliance on exposure assessment. Relevant to other life cycle impacts, the hazard of a chemical is inherent, and although it may be possible to minimize exposure (and subsequently reduce risk), it is challenging to assess such exposures through a chemical's life cycle. Through increased use of alternatives assessments at the initial stage of material or product design, there will be less reliance on post facto risk‐based assessment techniques because the potential for harm is significantly reduced, if not avoided, negating the need for assessing risk in the first place.     

Correlation of Noncancer Benchmark Doses in Short‐ and Long‐Term Rodent Bioassays

This study investigated whether, in the absence of chronic noncancer toxicity data, short‐term noncancer toxicity data can be used to predict chronic toxicity effect levels by focusing on the dose–response relationship instead of a critical effect. Data from National Toxicology Program (NTP) technical reports have been extracted and modeled using the Environmental Protection Agency's Benchmark Dose Software. Best‐fit, minimum benchmark dose (BMD), and benchmark dose lower limits (BMDLs) have been modeled for all NTP pathologist identified significant nonneoplastic lesions, final mean body weight, and mean organ weight of 41 chemicals tested by NTP between 2000 and 2012. Models were then developed at the chemical level using orthogonal regression techniques to predict chronic (two years) noncancer health effect levels using the results of the short‐term (three months) toxicity data. The findings indicate that short‐term animal studies may reasonably provide a quantitative estimate of a chronic BMD or BMDL. This can allow for faster development of human health toxicity values for risk assessment for chemicals that lack chronic toxicity data.     

Chemical Spill Exposure Assessment

POSSM, the PCB On-Site Spill Model, is a contaminant transport model developed to predict environmental concentrations associated with a chemical spill. The model predicts daily changes in chemical concentrations on a spill site (e.g., in soil and on vegetation) and losses of chemical due to volatilization, surface runoff/soil erosion, and leaching to groundwater. Spill areas consisting of soil/vegetation and/or an impervious surface (e.g., asphalt and concrete) can be analyzed, as can different spill cleanup practices. POSSM is used to analyze exposure levels associated with a hypothetical capacitor spill. While the model was developed for PCB spills, it is generally applicable to a number of organic compounds.     

家族企业可持续发展的路径选择研究

家族企业在全世界经济中占有重要地位。从各个不同角度研究家族企业可持续发展的理论问题,介绍家族企业可持续发展路径选择的SHEMP理论,并且探讨了此种路径选择与环境的关系:从宏观的角度进行家族企业可持续发展的PEST分析,进而提出在现有融资环境、诚信环境和职业经理人市场条件下,我国家族企业的选择路径。     

Evaluation of the Physical Hazards Associated with Two Remedial Alternatives at a Superfund Site

This study presents an evaluation of the risks due to the physical hazards associated with two remedial alternatives for a former chemical manufacturing facility in New Jersey. Both the on-site and off-site risk of work-related fatalities during remedy implementation and the risks of accident or accident-related fatalities during the off-site transport of site-related materials were evaluated. The two remedial alternatives evaluated were on-site containment and excavation with off-site incineration. The risk of at least one fatality due to a work-related accident was estimated for on-site activities associated with each remedial alternative, and for off-site incineration. The risks of at least one accident and of one accident-related fatality were calculated with accident and fatality data from the U.S. Department of Transportation. In addition, the risk of at least one accident that might potentially affect a natural resource (e.g., river, lake, or national park) was evaluated. This evaluation indicates that the risk of a work-related fatality is over an order of magnitude higher, and the risk of an accident or accident-related fatality is over three orders of magnitude higher, for the excavation/off-site incineration remedial alternative than for the on-site containment alternative. Overall, this study indicates that the physical hazards associated with excavation and off-site incineration are much greater than those associated with on-site containment for this site. Therefore, if a choice between the two remedial alternatives were to be made based solely on physical hazards and accident risk, the on-site containment alternative would be more protective of human health and the environment than the excavation/off-site incineration alternative.     

Aligning Chemical Assessment Tools Across the Hazard-Risk Continuum

With the growing number and diversity of hazard and risk assessment algorithms, models, databases, and frameworks for chemicals and their applications, risk assessors and managers are challenged to select the appropriate tool for a given need or decision. Some decisions require relatively simple tools to evaluate chemical hazards (e.g., toxicity), such as labeling for safe occupational handling and transport of chemicals. Others require assessment tools that provide relative comparisons among chemical properties, such as selecting the optimum chemical for a particular use among a group of candidates. Still other needs warrant full risk characterization, coupling both hazard and exposure considerations. Examples of these include new chemical evaluations for commercialization, evaluations of existing chemicals for novel uses, and assessments of the adequacy of risk management provisions. Even well-validated tools can be inappropriately applied, with consequences as severe as misguided chemical management, compromised credibility of the tool and its developers and users, and squandered resources. This article describes seven discrete categories of tools based on their information content, function, and the type of outputs produced. It proposes a systematic framework to assist users in selecting hazard and risk assessment tools for given applications. This analysis illustrates the importance of careful selection of assessment tools to achieve responsible chemical assessment communication and sound risk management.     

Chemical Health Effects Assessment Methodology for Airborne Contaminants

Chemical Health Effects Assessment Methodology (CHEM) is a new procedure for assessing hazardous properties of airborne toxic contaminants. CHEM evaluates substances for four major health effect categories: carcinogenicity, mutagenicity, reproductive/developmental toxicity, and toxic effects other than the first three. Three elements are considered in the assessment: weight of evidence, potency, and severity of effect. This approach produces a profile of toxic properties of chemicals which preserves their unique multidimensional character and highlights data gaps.     

The Discussion of Behavioral Principles in JOBM

Abstract

We addressed the inclusion of behavioral analyses in the research and case study articles published in the Journal of Organizational Behavior Management (JOBM) over the past 5 years (1992–1997). The amount of behavior analysis included in JOBM articles appears to be greater than that found in JABA in the early 1980s. However, the presence of such analyses in JOBM can still be increased. Further, a significant number of articles do not mention how the particular intervention was chosen to address a specific organizational problem. This lack of a functional assessment makes it difficult for readers to decide if a proposed intervention is applicable to a situation with which they might be dealing. Additionally, we reviewed articles and examined the range of those behavioral principles discussed and found little diversity among the principles used. This paper serves to address some of the problems and ramifications associated with this separation and to offer suggestions as to how this situation could be improved.     

Intuitive Toxicology: Expert and Lay Judgments of Chemical Risks

Human beings have always been intuitive toxicologists, relying on their senses of sight, taste, and smell to detect harmful or unsafe food, water, and air. As we have come to recognize that our senses are not adequate to assess the dangers inherent in exposure to a chemical substance, we have created the sciences of toxicology and risk assessment to perform this function. Yet despite this great effort to overcome the limitations of intuitive toxicology, it has become evident that even our best scientific methods still depend heavily on extrapolations and judgments in order to infer human health risks from animal data. Many observers have acknowledged the inherent subjectivity in the assessment of chemical risks and have indicated a need to examine the subjective or intuitive elements of expert and lay risk judgments. We have begun such an examination by surveying members of the Society of Toxicology and the lay public about basic toxicological concepts, assumptions, and interpretations. Our results demonstrate large differences between toxicologists and laypeople, as well as differences between toxicologists working in industry, academia, and government. In addition, we find that toxicologists are sharply divided in their opinions about the ability to predict a chemical's effect on human health on the basis of animal studies. We argue that these results place the problems of risk communication in a new light. Although the survey identifies misconceptions that experts should clarify for the public, it also suggests that controversies over chemical risks may be fueled as much by limitations of the science of risk assessment and disagreements among experts as by public misconceptions.     

Quantitative analyses of misclassification rates in the hazard classification of environmental chemicals: Evaluation of procedures for deriving predicted no-effect concentrations in the Chemical Substance Control Law in Japan

The quality of chemical management depends more or less on practical procedures used to assess chemicals. This study quantitatively assessed the efficacy of a derivation procedure for calculating no-effect concentrations for screening assessment of environmental hazards under the Chemical Substance Control Law in Japan. We first evaluated the derivation procedure by applying a series of test ecotoxicity datasets to the procedure and calculating the resulting misclassification rates of the hazardous class of chemicals. In this study, a chemical was deemed to have been misclassified if its classification differed from its classification based on the full dataset (chronic toxicity data for three trophic levels), which was defined as the correct assignment. We also calculated the effects of additional uncertainty factors to decrease the variance (i.e., to improve the consistency) of the misclassification rates among cases with different data availability in the derivation procedure. The results showed that the derivation procedure resulted in very high rates of misclassification when only particular sets of ecotoxicity data were available (e.g., only chronic toxicity data of algae were available). Our analyses also showed that the use of additional uncertainty factors improved the consistency of the misclassification rates within the derivation procedure. Our study presents a broadly applicable calculation framework for quantifying error rates in assessment procedures and serves as a case study for future development and reforms of chemical assessment processes and policies, while additional analyses using more extensive ecotoxicity data with various modes of actions are needed in the future.     

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.     

城市土地利用规划的交通影响评价建模研究

本文提出了一种基于投入产出关系和连续逼近方法的城市土地利用的交通影响评价模型。作为城市土地可持续利用规划模型的一个子模型,本模型已在桂林市的总体规划中得以实施。在本文中,先简要介绍了城市土地可持续利用规模模型,接着基于投入产出关系估算了分行业的单位产值对应的货物运输量,然后以交通熵和交通周转量作为评价指标,基于投入产出关系、连续逼近方法和Huff商区模式分别建立了货物运输、居民工作出行和居民购物出行交通影响评价模型。     

Assessing Major Accident Risks to Support Land‐Use Planning Using a Severity‐Vulnerability Combination Method: A Case Study in Dagushan Peninsula,China

Major accident risks posed by chemical hazards have raised major social concerns in today's China. Land‐use planning has been adopted by many countries as one of the essential elements for accident prevention. This article aims at proposing a method to assess major accident risks to support land‐use planning in the vicinity of chemical installations. This method is based on the definition of risk by the Accidental Risk Assessment Methodology for IndustrieS (ARAMIS) project and it is an expansion application of severity and vulnerability assessment tools. The severity and vulnerability indexes from the ARAMIS methodology are employed to assess both the severity and vulnerability levels, respectively. A risk matrix is devised to support risk ranking and compatibility checking. The method consists of four main steps and is presented in geographical information‐system‐based maps. As an illustration, the proposed method is applied in Dagushan Peninsula, China. The case study indicated that the method could not only aid risk regulations on existing land‐use planning, but also support future land‐use planning by offering alternatives or influencing the plans at the development stage, and thus further enhance the roles and influence of land‐use planning in the accident prevention activities in China.     

An Initial Assessment of Effective Preference Assessment Intervals Among Employees

Previous research has shown that employee preferences for tangible items may change significantly from one month to the next. Although a 1-month interval may be too long to wait between preference assessment administrations, no guidelines exist with regard to how often to assess employee preference. This study examined changes in preference as measured by two different preference assessments across four different time intervals. We measured preference stability by assessing changes in designations of high- and low-preference items from one assessment to the next. Only the 1-week interval indicated no changes in item designation from high preference to low preference or low preference to high preference. These data suggest that if tangibles are used, preferences may need to be assessed over time.     

Chronic Health Risks from Aggregate Exposures to Ionizing Radiation and Chemicals: Scientific Basis for an Assessment Framework

Very little quantitative analysis is currently available on the cumulative effects of exposure to multiple hazardous agents that have either similar or different mechanisms of action. Over the past several years, efforts have been made to develop the methodologies for risk assessment of chemical mixtures, but mixed exposures to two or more dissimilar agents such as radiation and one or more chemical agents have not yet been addressed in any substantive way. This article reviews the current understanding of the health risks arising from mixed exposures to ionizing radiation and specific chemicals. Specifically discussed is how mixed radiation/chemical exposures, when evaluated in aggregation, were linked to chronic health endpoints such as cancer and intermediate health outcomes such as chromosomal aberrations. Also considered is the extent to which the current practices are consistent with the scientific understanding of the health risks associated with mixed-agent exposures. From this the discussion moves to the research needs for assessing the cumulative health risks from aggregate exposures to ionizing radiation and chemicals. The evaluation indicates that essentially no guidance has been provided for conducting risk assessment for two agents with different mechanisms of action (i.e., energy deposition from ionizing radiation versus DNA interactions with chemicals) but similar biological endpoints (i.e., chromosomal aberrations, mutations, and cancer). The literature review also reveals the problems caused by the absence of both the basic science and an appropriate evaluation framework for the combined effects of mixed-agent exposures. This makes it difficult to determine whether there is truly no interaction or somehow the interaction is masked by the scale of effect observation or inappropriate dose-response assumptions.     

Exposure of Contractors to Chemical Pollutants During the Maintenance Shut-Down of a Chemical Plant

The exposure of employees of different contracting firms to chemical pollutants was assessed during the five-week biennial maintenance shut-down of an isocyanate (TDI) synthesis plant. This assessment was mainly based on personal sampling, but work-related constraints occasionally required that area samples be used instead. Many tasks were carried out during the shut-down procedure (dismantling of reactors, installation of insulation, refection of kilns, cleaning, painting, electricity, etc.), thereby causing the employees of the contracting firms to be exposed to different kinds of pollutants, including products used or manufactured in the process (solvents, TDI and its synthesis intermediates), and products specific to the contractors' activity (welding fumes, crystalline silica, mineral fibers of heat insulation). The highest level of exposure (mainly to TDI) was found for the mechanical engineering activities undertaken during the dismantling of reactors and for cleaning activities. It was demonstrated that there was much variability in day-to-day exposure levels, and occasionally in the exposure levels encountered during a given shift. Cases of concomitant exposure to TDI (mainly short-term exposures) and other pollutants due to simultaneous activities from different tasks in the same area (co-activity) were also observed. Both the need for, and limitations of personal protective equipment (mainly respiratory) are stressed. Special emphasis is put on the responsibility of the owner of the facilities in helping the contractors in the organization of a health and safety policy.     

Tools for Comparative Analysis of Alternatives: Competing or Complementary Perspectives?

A third generation of environmental policy making and risk management will increasingly impose environmental measures, which may give rise to analyzing countervailing risks. Therefore, a comprehensive analysis of all risks associated with the decision alternatives will aid decision-makers in prioritizing alternatives that effectively reduce both target and countervailing risks. Starting with the metaphor of the ripples caused by a stone that is thrown into a pond, we identify 10 types of ripples that symbolize, in our case, risks that deserve closer examination: direct, upstream, downstream, accidental risks, occupational risks, risks due to offsetting behavior, change in disposable income, macro-economic changes, depletion of natural resources, and risks to the manmade environment. Tools to analyze these risks were developed independently and recently have been applied to overlapping fields of application. This suggests that either the tools should be linked in a unified framework for comparative analysis or that the appropriate field of application for single tools should be better understood. The goals of this article are to create a better foundation for the understanding of the nature and coverage of available tools and to identify the remaining gaps. None of the tools is designed to deal with all 10 types of risk. Provided data suggest that, of the 10 types of identified risks, those associated with changes in disposable income may be particularly significant when decision alternatives differ with respect to their effects on disposable income. Finally, the present analysis was limited to analytical questions and did not capture the important role of the decision-making process itself.     

Major Chemical Accidents in Industrializing Countries: The Socio-Political Amplification of Risk

Accidents in the chemical industry, such as those that took place in Seveso (1976) and Bhopal (1984), may kill or injure thousands of people, cause serious health hazards and irreversible environmental damage. The aim of this paper is to examine the ever-increasing risk of similar accidents becoming a frequent ocurrence in the so-called industrializing countries. Using figures from some of the worst chemical accidents in the last decades, data on the Bhopal disaster, and Brazil's social and institutional characteristics, we put forward the hypothesis that present social, political and economic structures in industrializing countries make these countries much more vulnerable to such accidents and create the type of setting where–if and when these accidents occur–they will have even more catastrophic consequences. The authors argue that only the transformation of local structures, and stronger technical cooperation between international organizations, industrialized and industrializing countries could reduce this vulnerability.