The Precautionary Principle,Science and Human Health Protection

As technology advances rapidly, so do applications with potential adverse implications on human health. The possible threats include risks that can be substantial, far-reaching and irreversible, and currently available methods of investigation, designed to deal with direct exposure-disease associations, are not always suitable. Growing interest is being paid to health effects that may be the consequence of distal, “upstream” determinants. Considering the complex chain of events that links such determinants with health can be extremely difficult, and exposes severe limitations in science. Thus, there is often a mismatch between what is known and what would be required to inform rational, evidence-based decision making, which is increasingly called for. It has become apparent how production and use of scientific evidence in decision making must be accompanied by precaution, especially in those circumstances, more and more common in recent times, where there is an uncertain possibility that serious health consequences might take place. Several cautionary approaches have been proposed, but the Precautionary Principle (PP) has been the object of especially intense debate in recent years. Developed in the field of environmental health, the PP has been clarified, and has been applied or called for in several instances in public health. Although a unique definition is not available, the principle has been characterised, and criteria for its application have been proposed. However, many questions remain open on general as well as specific issues. In this paper, we address some of the questions that are relevant for the PP to support rational decision making in environment and health and more in general to strengthen its contribution towards human health protection.     

Finding Common Ground for Environmental Decisions: Public Health Principles as a Foundation for Better Choices

The history of environmental decision-making in the United States is primarily one of antagonism, conflict, and litigation. Four sectors of American society are typically at odds over why and how to solve environmental problems—government regulators, businesses proponents, environmental advocates, and members of affected communities. Dissimilar worldviews are at the heart of most environmental disputes, and people in the four sectors tend to have diverse perspectives and philosophies that affect how they interpret and respond to environmental issues. To promote integrated, cost-effective decisions, the public health paradigm (prevention first, intervention second, treatment third), as embodied in the Precautionary Principle and the concept of Sustainable Development, should be mutually adopted as a joint framework for prioritizing solutions to pressing environmental problems. The core public health principle of prevention first is a simple yet powerful tenet that can help foster better environmental choices that are more effective, efficient, and equitable.     

Implications of the Precautionary Principle: Is it a Threat to Science?

Scientific research is of proven value to protecting public health and the environment from current and future problems. We explore the extent to which the Precautionary Principle is a threat to this rôle for science and technology. Not surprisingly for a relatively simple yet still incompletely defined concept, supporters of the Precautionary Principle come from different viewpoints, including a viewpoint that is at least uneasy with the rôle of science, and particularly its use in risk assessment. There are also aspects of the Precautionary Principle that inherently restrict obtaining and using science. The Hazardous Air Pollutant (HAP) provisions in the US Clean Air Act Amendments are an example of the Precautionary Principle, which both shifted the burden of proof so that the onus is now on showing a listed compound is harmless, and required maximum available control technology (MACT) instead of a primarily risk-based approach to pollution control. Since its passage in 1990 there has been a decrease in research funding for studies of HAPs. Other potential problems include that once MACT regulations are established, it may be difficult to develop new technological approaches that will further improve air pollution control; that by treating all regulated HAPs similarly, no distinction is made between those that provide a higher or lower risk; and that there is a perverse incentive to use less well studied agents that are not on the existing list. As acting on the Precautionary Principle inherently imposes significant costs for what is a potentially erroneous action, additional scientific study should be required to determine if the precautionary action was successful. If we are to maximize the value of the Precautionary Principle to public health and the environment, it is crucial that its impact not adversely affect the potent preventive rôle of science and technology.     

Probabilistic Risk Assessment and Risk Mapping of Sediment Metals in Sydney Harbour Embayments

Sediment metal concentrations in embayments of Sydney Harbour, acquired from the literature and from samples collected for this study, were used to generate contaminant probability density distributions using AQUARISK. The sediment metal concentrations often exceeded Australia's interim sediment quality guidelines. Similarly, estuarine spiked sediment toxicity test literature provided adverse biotic effects concentration data to generate species sensitivity distributions using AQUARISK. Although the harbor is subject to other inorganic and organic contamination, we have used sediment metals to demonstrate an approach for ecological risk mapping and environmental management prioritization. Sufficient spiked sediment toxicity test data were found for only three metals—Cd, Cu, and Zn—and some tests were likely to overestimate toxicity. The estimates of the hazardous concentration to 5% of species (the 50th percentile of the 95% species protection level) were 5, 12, and 40 mg/kg DW of total sediment metal for Cd, Cu, and Zn, respectively. These values were generally low when compared with the interim sediment quality guidelines due to the overestimation of toxic effects in the literature data. The parameters for the species sensitivity distributions have been combined with the measured sediment metal concentrations in Homebush Bay to generate risk maps of the estimated species impact for each metal as well as for all three metals collectively assuming proportional additivity. This has demonstrated the utility of comparing contaminants on a consistent scale—ecological risk.     

Distribution of Daily Breathing Rates For Use in California's Air Toxics Hot Spots Program Risk Assessments

Data were combined from a study measuring breathing rates at various activities and two activity pattern studies to generate breathing rate distributions for children and adults. The children and adult breathing rate distributions were combined using a Monte Carlo technique to generate a breathing rate distribution for a lifetime spanning ages 0 to 70. The children's breathing rate distribution has a mean, standard deviation, median and 95^th percentile of 452, 67.7, 441, and 581 L/kg-day, respectively. The adult breathing rate distribution has a mean, standard deviation, median and 95^th percentile of 232, 64.6, 209, and 381 L/kg-day, respectively. The simulated 70-year distribution has a mean, standard deviation, median and 95^th percentile of 271, 57.9, 253, and 393 L/kg-day, respectively. The adult breathing rate distribution is based on 24-hour recall activity data that would not necessarily capture average activity patterns and therefore breathing rates. We utilized the human energy expenditure literature to validate the breathing rate distribution. We conclude that the breathing rate distribution is reasonable for chronic long-term risk assessment in California's Air Toxics Hot Spots program.     

Risk Assessment and Safety Evaluation Using Probabilistic Fault Tree Analysis

Risk assessment is an essential prelude to the development of accident prevention strategies in any chemical or petrochemical industry. Many techniques and methodologies such as HAZOP, failure mode effect analysis, fault tree analysis, preliminary hazard analysis, quantitative risk assessment and probabilistic safety analysis are available to conduct qualitative, quantitative, and probabilistic risk assessment. However, these methodologies are limited by: extensive data requirements, the length of study, results are not directly interpretable for decision making, simulation is often difficult, and they are applicable only at the operation or late design stage. Khan et al. (2001a) recently proposed a detailed methodology for risk assessment and safety evaluation. This methodology is simple, yet it is effective in safety and design-related decision making, and it has been applied successfully to many case studies. It is named SCAP, where S stands for safety, C and A stand for credible accident respectively, and P stands for probabilistic fault tree analysis. This paper recapitulates the SCAP methodology and demonstrates its application to a petrochemical plant.     

Safety,Health, and Environmental Risk Assessment of a Gas Power Plant: A Case Study from Southern Iran

This research was conducted to assess health, safety, and environmental risks of a gas power plant in southern Iran. In order to identify the subject risks of the power plant at operational phase a questionnaire was designed using the Delphi method. The questionnaires were put at the disposal of 99 electricity industry experts. Risk assessment was done using multicriteria decision-making methods such as technique for order of preference by similarity to ideal solution (TOPSIS), entropy, and Eigenvector technique. Following prioritization of risks at each power plant unit, top-priority risks were determined by one-way ANOVA. The obtained results indicated that the risk of working with medium voltage boards with a weight of 0.879 at the power plant's Electricity Unit is the most important safety and health risk in the studied power plant while risk of servicing the unit with fuel of gas weighting 0.807 and delivery of gas fuel with weight of 0.630 in the Exploiting Unit and work on liquid fuel clutch with weight of 0.603 in the Mechanical Unit are the most important environmental risks in the gas power plant. In conclusion, this study concludes that health, safety, and environmental risk assessment can be a structured and used as a systematic approach to plan for environmental protection and personnel health.     

Identifying Uncertainty in Environmental Risk Assessments: The Development of a Novel Typology and Its Implications for Risk Characterization

Environmental risk analysts need to draw from a clear typology of uncertainties when qualifying risk estimates and/or significance statements about risk. However, categorizations of uncertainty within existing typologies are largely overlapping, contradictory, and subjective, and many typologies are not designed with environmental risk assessments (ERAs) in mind. In an attempt to rectify these issues, this research provides a new categorization of uncertainties based, for the first time, on the appraisal of a large subset of ERAs, namely 171 peer-reviewed environmental weight-of-evidence assessments. Using this dataset, a defensible typology consisting of seven types of uncertainty (data, language, system, extrapolation, variability, model, and decision) and 20 related sub-types is developed. Relationships between uncertainties and the techniques used to manage them are also identified and statistically evaluated. A highly preferred uncertainty management option is to take no action when faced with uncertainty, although where techniques are applied they are commensurate with the uncertainty in question. Key observations are applied in the form of guidance for dealing with uncertainty, demonstrated through ERAs of genetically modified higher plants in the European Union. The presented typology and accompanying guidance will have positive implications for the identification, prioritization, and management of uncertainty during risk characterization.     

Health Risks of Metals in Soil,Water, and Major Food Crops in Hamedan Province,Iran

Food, drinking water, soil, and air are the main routes of exposure to trace metals, thus the assessment of the risks posed to humans by these elements is important. Wheat, potatoes, and maize are very important parts of the Iranian diet. The objectives of this study were to estimate the non-carcinogenic and carcinogenic health risks of Hg, Pb, Cd, Cr, Se, As, and Ni to adults and children via soil, water, and major food crops consumed in Hamedan Province, northwest Iran, using the total non-cancer hazard quotient (THQ) and cancer risk assessment estimates. Total non-cancer hazard of Ni and Hg, were greater than 1, and total cancer risk of As and Pb was greater than 1 × 10^?6. Food consumption was identified as the major route of human exposure to metals, and consuming foodstuff threatens the health of the studied population. In Hamedan Province, consumption of wheat is the main source of intake of metals from foodstuff for adults, and in children, the soil ingestion route is also important.     

Extrapolation in Human Health and Ecological Risk Assessments: Proceedings of a Symposium

A symposium was conducted in April 1998 by the U.S. Environmental Protection Agency's National Health and Environmental Effects Research Laboratory (NHEERL) to explore issues of extrapolation in human health and ecological risk assessments. Over the course of three and one half days, leading health and ecology experts presented and discussed research methods and approaches for extrapolating data among taxa and across levels of biological organization, through time, and across spatial scales. The intended result of this symposium was enhanced interaction among a diverse array of scientists, policymakers, and risk assessors to promote identification of approaches for reducing the uncertainties of extrapolation in risk assessment.     

A Risk-Based Approach to Health Impact Assessment for Input-Output Analysis, Part 1: Methodology (7 pp)

Goal, Scope and Background Incorporation of exposure and risk concepts into life cycle impact assessment (LCIA) is often impaired by the number of sources and the complexity of site-specific impact assessment, especially when input-output (I-O) analysis is used to evaluate upstream processes. This makes it difficult to interpret LCIA outputs, especially in policy contexts. In this study, we develop an LCIA tool which takes into account the geographical variability in both emissions and exposure and which can be applied to all economic sectors in I-O analysis, relying on screening-level risk calculations and methods to estimate population exposure per unit emissions from specific geographic locations. Methods We develop our analytical approach with reference to the case of increasing insulation for new single-family homes in the US. We quantify the public health costs from increasing insulation manufacturing and compare them with the benefits from energy savings, focusing on mortality and morbidity associated with exposure to primary and secondary fine particles (PM2.5) as well as cancer risk associated with exposure to toxic air pollutants. We use OpenLC to estimate the incremental economic outputs induced by increased insulation and reduced fuel consumption and calculate emissions from a sector-specific pollution intensity matrix. We calculate sector-specific intake fractions (dimensionless ratios between the amount of pollutant intake and the amount of a pollutant emitted) using previously-derived regression models and apply these values to the supply chain emissions of fiberglass and fuel sources. We refine the exposure estimates for selected emission sites and pollutants that contribute significantly to total health impacts, running site-specific air dispersion models. We estimate health impacts using concentration-response functions from the published literature and compare the costs and benefits of the program by assigning monetary values to the health risks. In the second part of this paper, we present the results of our case study and consider the implications for incorporating exposure and risk concepts into I-O LCA.     

Evaluating the Relationship Between Variance in Enzyme Expression and Toxicant Concentration in Health Risk Assessment

The replacement of default uncertainty factors with those based on chemical-specific data is a topic of interest to a growing number of government-based organizations and those in affiliated professional societies. The division of the uncertainty factors for animal-to-human extrapolation and human interindividual variance (UF_A and UF_H, respectively) into their pharmacodynamic (PD) and pharmacokinetic (PK) components invites additional and specific considerations. Where data are available, or substantiated PK models have been developed, the animal-to-human chemical-specific differences have been quantified and utilized to replace the PK component of the uncertainty factor. The increasing degree to which the genome is being characterized has stimulated additional interest in describing the impact of genetic polymorphisms on susceptibility. Frequently, proteins for which the genes are being evaluated are the group of xenobiotic metabolizing enzymes. In-depth understanding of the genetic polymorphisms of genes coding for Aldehyde dehydrogenase, glucuronyl transferase and cytochrome P450 enzyme forms has been combined with information on the bioactivation or detoxication of environmental contaminants. The preliminary conclusion of some of these considerations is that alterations in enzyme content or enzyme activity result in a de facto alteration of risk. While this may be true of the “all-or-none” genetic alterations, the impact of more subtle changes in enzyme content and/or activity are more difficult to predict. The hepatotoxicity of trichloroethylene (TCE) is dependent upon an initial, cytochrome P450 2E1 (CYP2E1)-mediated oxidative step. Variance of CYP2E1 content of human liver has been characterized from a bank of tissues from human organ donors and combined with data describing the in vitro Michaelis-Menten kinetic parameters in order to extrapolate the metabolic capacity (and variance thereof) from in vitro to in vivo and assess its impact on PK through incorporation in a physiologically based pharmacokinetic (PBPK) model. This presentation summarizes that work, and demonstrates and discusses why extremes of CYP2E1-mediated metabolic capacity in adult humans has virtually no impact on the PK metric most closely related to hepatotoxic injury from TCE exposure.     

A Risk-Based Approach to Health Impact Assessment for Input-Output Analysis, Part 2: Case Study of Insulation (8 pp)

Goal, Scope and Background In the first part of this paper, we developed a methodology to incorporate exposure and risk concepts into life cycle impact assessment (LCIA). We argued that both risk assessment and LCIA are needed to consider the impacts of increasing insulation for single-family homes in the US from current practice to the levels recommended by the 2000 International Energy Conservation Codes. In this analysis, we apply our model to the insulation case study and evaluate the benefits and costs of increased insulation for new housing. Results and Discussion The central estimate of impacts from the complete insulation manufacturing supply chain is approximately 14 premature deaths, 400 asthma attacks, and 7000 restricted activity days nationwide for one year of increased fiberglass output. Of the health impacts associated with increased insulation manufacturing, 83% is attributable to the supply chain emissions from the mineral wool industry, which is mostly associated with the direct primary PM2.5 emissions from the industry (98%). Reduced energy consumption leads to 1.2 premature deaths, 33 asthma attacks, and 600 restricted activity days avoided per year, indicating a public health “payback period” on the order of 11 years. Over 90% of these benefits were associated with direct emissions from power plants and residential combustion sources. In total, the net present value of economic benefits over a 50-year period for a single-year cohort of new homes is $190 million with a 5% discount rate, with 49 fewer premature deaths in this period. Conclusion Recommendation and Outlook. We have developed and applied a risk-based model to quantify the public health costs and benefits of increased insulation in new single-family homes in the US, demonstrating positive net economic and public health benefits within the lifetimes of the homes. More broadly, we demonstrated that it is feasible to incorporate exposure and risk concepts into I-O LCA, relying on regression-based intake fractions followed by more refined dispersion modeling. The refinement step is recommended especially if primary PM2.5 is an important source of exposure and if stack heights are relatively low. Where secondary PM2.5 is more important, use of regression-based intake fractions would be sufficient for a reasonable risk approximation. Uncertainties in our risk-based model should be carefully considered; nevertheless, our study can help decision-makers evaluate the costs and benefits of demand-side management policy options from a combined public health and life cycle perspective.     

Assessing the Human,Social, and Environmental Risks of Pervasive Computing

The vision of Pervasive Computing is built on the assumption that computers will become part of everyday objects, augmenting them with information services and enhanced functionality. This article reports on the approach we have used to assess potential side effects of this development on human health and the environment, and the major risks we identified. Social risks such as the risk of conflicts between users and non-users of the technology were also included because of their potential indirect adverse health effects. Assessing a technological vision before it has materialized makes it necessary to deal with two types of uncertainty: first, the uncertainty of how fast and to what extent the technology will be taken up and how it will be used; second, the uncertainty of causal models connecting technology-related causes with potential health or environmental effects. Due to these uncertainties, quantitative methods to evaluate expected risks are inadequate. Instead, we developed a “risk filter” that makes it possible to rank risks according to a set of qualitative criteria based on the Precautionary Principle. As the overall result, it turned out that Pervasive Computing bears potential risks to health, society, and/or the environment in the following fields: Non-ionizing radiation, stress imposed on the user, restriction of consumers' and patients' freedom of choice, threats to ecological sustainability, and dissipation of responsibility in computer-controlled environments.     

Risk Assessment of Tropospheric Ozone: Human Health,Natural Resources,and Ecology

Ozone is an unusual trace gas in the atmosphere, presenting a challenge for risk assessors and risk managers. The challenge can be traced to the gas’ complex chemistry in the atmosphere (exposure), toxicology in biological systems (response), and the fledgling enterprise of risk assessment for widely distributed, highly reactive pollutants. This paper addresses the (i) co-evolution of the scientific data underlying ozone risk assessment on human health, natural resources (crops and managed forests), and unmanaged ecosystems, (ii) similarities and differences in risk assessment among these receptors, and (iii) utility of indicators in risk assessment. The scientific community has developed a sound database to underpin the ozone risk assessment, although the breadth and depth differ markedly among the three receptors. There are similarities in ozone risk assessment among human health, natural resources, and ecology, including features of exposure (e.g., temporal variation), response of plants and humans (e.g., sensitive cohorts), and integration of exposure and response (e.g., importance of peak and cumulative exposures). Equally important are the notable differences, and the more prominent are scaling of exposure-response relationships, air quality monitoring, economic valuation, and models to complement more traditional experimental approaches. Of the three receptors, the status of indicators for conducting ecological ozone risk assessment is the weakest.     

Perspectives on the Conduct and Use of Economic Analysis in Federal Environmental Decisionmaking

This article lays out the broad rationale for conducting economic analyses of major environmental regulations—principally, benefit-cost analysis—as well as some of the pertinent critiques. What can public agencies expect to gain from such activities? What are the reasons to be wary of the results? The paper reviews the recent experience of the federal government in conducting such analyses, with particular reference to the relevant Presidential Executive Orders issued over the past three decades. Finally, the paper examines some of the key methodological issues, often involving interdiscripliary topics, critical to the conduct of such analyses. Overall, it is concluded that the economic analysis of proposed environmental regulations can help improve the allocation of society's resources while at the same time engendering an understanding of who benefits and who pays for any given regulatory action. Additionally, properly conducted economic analyses encourage transparency and accountability in the decisionmaking process, provide a framework for consistent data collection and identification of gaps in knowledge, and allow for the aggregation of many dissimilar effects (e.g., those on health, visibility, and crops) into one measure of net benefits expressed in a single currency.     

Genomics: Applications,Challenges, and Opportunities for the U.S. Environmental Protection Agency

Genomics information has great potential to enhance assessment of risks to human health and the environment. Although understanding genomic responses with respect to adverse ecological and human health outcomes is not, as yet, established, it is important to consider the likely future impacts of genomics technologies on risk assessment and decision-making. Four areas are identified as those likely to be influenced by the generation of genomics information within, and the submission of such information to, the U.S. Environmental Protection Agency (USEPA): risk assessment, prioritization of contaminants and contaminated sites, monitoring, and reporting provisions. For each of these risk assessment and regulatory applications, representative activities are presented to illustrate the application. Three major challenges for the USEPA associated with genomics are also identified in the areas of research, technical development, and capacity. The USEPA's initial activities to address these challenges are discussed. The Agency recognizes it must be prepared to use genomics information, and that many scientific, policy, ethical, and legal concerns will need to be addressed. The USEPA also recognizes it is essential to continue to collaborate with other federal agencies, academia, the regulated community, and other stakeholders in order to benefit from ongoing advances in genomics in the wider scientific and regulatory communities.     

Recent Developments in Nanotechnology and Risk Assessment Strategies for Addressing Public and Environmental Health Concerns

Nanotechnology is a novel emerging technology that allows the manipulation of materials at the scale comparable to the size of a single molecule (i.e., < 100 nm). There have been many new developments in this technology, resulting in complex exposure and health risk implications. Nanotechnology offers major benefits to humankind; however, there is growing concern regarding the potential adverse interactions of engineered nanoparticles at cellular or sub-cellular levels. The nanotech community is therefore experiencing growing calls for legislation to minimize or prevent exposure to nanoparticles. This article focuses on recent developments in nanotechnology including current manufacturing techniques, uses of nanoscale particles, and implications for particle toxicity and human exposure pathways. Current risk assessment methods are reviewed in the context of nanoparticle exposure routes and regulation for human and environmental health protection. This study provides a better understanding of the factors governing risks from nanoparticles and current strategies for protecting environmental and public health.     

Plan for an Integrated Human and Environmental Risk Assessment in the S. Domingos Mine Area (Portugal)

The need for the integration of the assessment of human and ecological risks in contaminated areas, such as derelict mines, widely increases. The risk assessment process is becoming a powerful tool to provide sound scientific bases for decision-making processes. In Portugal, the risk assessment process is in its early years and the lack of multidisciplinary teams of experts is frequently mentioned as the main obstacle to its implementation. Therefore, the majority of the reclamation actions are based on impact assessment studies that usually are characterized by few biological and toxicological considerations. In order to account for some of these constraints, the ecological risk assessment framework proposed by the U.S. Environmental Protection Agency was used to plan the assessment of human and ecological risks posed by the high concentrations of metals scattered in the vicinity of S. Domingos mine, a cuprous pyrite mine located in the Southeast Alentejo (Portugal). This study presents the problem formulation phase of the assessment. It includes all the scientific information available for the area, a conceptual model, and an analysis plan for the risk assessment process. Following a tiered approach, several tasks were planned in order to acquire chemical, toxicological, and ecological information, in order to compensate for the lack of toxicity data for site-specific species.     

Application of the Hazard Quotient Method in Remedial Decisions: A Comparison of Human and Ecological Risk Assessments

This paper evaluates the relative roles of the human health hazard index (HI) and the ecological risk assessment hazard quotient (HQ) in remedial decision-making. Through an analysis of HI outcomes drawn from Superfund Records of Decision, the reduced importance of the HI statistic in human health risk assessments is demonstrated, and the high visibility of the ecological risk assessment (ERA) HQ for terrestrial receptors (birds and mammals) is underscored. Three HQ method limitations common to both HHRA and ERA, deriving either from the mathematical construct of the HQ (a simple binary measure, indicating that an animal's exposure either exceeds its toxicity value or does not) or from dose-response outcomes in animal trials, are reviewed. Two additional HQ limitations unique to ERA (i.e., a propensity for the HQ to easily exceed its threshold value, and a propensity for it to assume values that are unreasonably high), and deriving from the complexities of estimating bird and mammal dietary intakes of contaminants and the availability of toxicological effects information, are also identified. The paper cautions of the potential to err in concluding that terrestrial site receptors are at risk when the HQ threshold is exceeded, and regardless of the toxicological information (NOAELs, LOAELs, etc.) used. It recognizes that because other methods of terrestrial assessment are presently unavailable, HQs are sometimes, out of necessity, used to justify a remedial action. The analysis and discussion are intended to remind ecological risk assessors that the HQ is a measure of a level of concern only and not a measure of risk