Science in Risk Assessment and Policy (SciRAP): An Online Resource for Evaluating and Reporting In Vivo (Eco)Toxicity Studies

(Eco)toxicity studies conducted according to internationally standardized test guidelines are often considered reliable by default and preferred as key evidence in regulatory risk assessment. At the same time regulatory agencies emphasize the use of all relevant (eco)toxicity data in the risk assessment process, including non-standard studies. However, there is a need to facilitate the use of such studies in regulatory risk assessment. Therefore, we propose a framework that facilitates a systematic and transparent evaluation of the reliability and relevance of (eco)toxicity in vivo studies for health and environmental risk assessment. The framework includes specific criteria to guide study evaluation, as well as a color-coding tool developed to aid the application of these criteria. In addition we provide guidance intended for researchers on how to report non-standard studies to ensure that they meet regulatory requirements. The intention of the evaluating and reporting criteria is to increase the usability of all relevant data that may fill information gaps in chemical risk assessments. The framework is publically available online, free of charge, at the Science in Risk Assessment and Policy (SciRAP) website: www.scirap.org. The aim of this article is to present the framework and resources available at the SciRAP website.     

The risk of establishment of aquatic invasive species: joining invasibility and propagule pressure

Invasive species are increasingly becoming a policy priority. This has spurred researchers and managers to try to estimate the risk of invasion. Conceptually, invasions are dependent both on the receiving environment (invasibility) and on the ability to reach these new areas (propagule pressure). However, analyses of risk typically examine only one or the other. Here, we develop and apply a joint model of invasion risk that simultaneously incorporates invasibility and propagule pressure. We present arguments that the behaviour of these two elements of risk differs substantially--propagule pressure is a function of time, whereas invasibility is not--and therefore have different management implications. Further, we use the well-studied zebra mussel (Dreissena polymorpha) to contrast predictions made using the joint model to those made by separate invasibility and propagule pressure models. We show that predictions of invasion progress as well as of the long-term invasion pattern are strongly affected by using a joint model.     

Ecological Risk Assessment Guidance and Procedural Documents: An Annotated Compilation and Evaluation of Reference Materials

The scientific approach toward ecological risk assessment (ERA) has advanced greatly during the 1990s. This growth has been accompanied by the development of ERA guidance by USEPA Headquarters, individual USEPA Regions, state environmental agencies, as well as international agencies. This compilation of ERA guidance and procedural documents identifies many of the existing ERA reference materials from the regulatory and/or governmental agency arena. In addition, this compilation provides annotations pertaining to the focus of each reviewed document, and compares/contrasts the approaches presented in the documents. As such, the evaluation provides insight into some of the qualities and levels of detail provided by each document. Examples of documents which are highlighted include recently published USEPA's “Guidelines for Ecological Risk Assessment;” USEPA's “Ecological Risk Assessment Guidance for Superfund;” the U.S. Army's “Procedural Guidelines for Ecological Risk Assessments;” and Environment Canada's “Ecological Risk Assessments Under the Canadian Environmental Protection Act.”     

Space use of a non-native species,the European hare (<Emphasis Type="Italic">Lepus europaeus</Emphasis>), in habitats of the southern vizcacha (<Emphasis Type="Italic">Lagidium viscacia</Emphasis>) in Northwestern Patagonia,Argentina

Two medium-sized herbivores with high trophic overlap coexist on rocky outcrops in the Patagonian landscape: the southern vizcacha (Lagidium viscacia), which is a native rock specialist, and the European hare (Lepus europaeus), which is a non-native species. We determined the patterns of space use related to distance from outcrops and analyzed spatial overlap between the two species. There were significant differences between the two species in the use of space adjacent to outcrops. The southern vizcacha mainly uses short and medium distances from the outcrop (up to 40 m), whereas the hare’s greatest activity was recorded at distances greater than 50 m. However, there is a partial overlap at medium distances (30–40 m) among both herbivores. Although, in general terms, there is no significant spatial overlap between hares and southern vizcachas, their biological characteristics and the high dietary overlap between the species allow us to predict that, if resources become scarce, the hare could extend its area of activity, as what happens elsewhere, and exploit food resources near outcrops, increasing the vulnerability of vizcacha colonies.     

Improving Risk Assessment: Priorities for Epidemiologic Research

The Epidemiology Work Group at the Workshop on Future Research for Improving Risk Assessment Methods, Of Mice, Men, and Models, held August 16 to 18, 2000, at Snowmass Village, Aspen, Colorado, concluded that in order to improve the utility of epidemiologic studies for risk assessment, methodologic research is needed in the following areas: (1) aspects of epidemiologic study designs that affect doseresponse estimation; (2) alternative methods for estimating dose in human studies; and (3) refined methods for dose-response modeling for epidemiologic data. Needed research in aspects of epidemiologic study design includes recognition and control of study biases, identification of susceptible subpopulations, choice of exposure metrics, and choice of epidemiologic risk parameters. Much of this research can be done with existing data. Research needed to improve determinants of dose in human studies includes additional individual-level data (e.g., diet, co-morbidity), development of more extensive human data for physiologically based pharmacokinetic (PBPK) dose modeling, tissue registries to increase the availability of tissue for studies of exposure/dose and susceptibility biomarkers, and biomarker data to assess exposures in humans and animals. Research needed on dose-response modeling of human studies includes more widespread application of flexible statistical methods (e.g., general additive models), development of methods to compensate for epidemiologic bias in dose-response models, improved biological models using human data, and evaluation of the benchmark dose using human data. There was consensus among the Work Group that, whereas most prior risk assessments have focused on cancer, there is a growing need for applications to other health outcomes. Developmental and reproductive effects, injuries, respiratory disease, and cardiovascular disease were identified as especially high priorities for research. It was also a consensus view that epidemiologists, industrial hygienists, and other scientists focusing on human data need to play a stronger role throughout the risk assessment process. Finally, the group agreed that there was a need to improve risk communication, particularly on uncertainty inherent in risk assessments that use epidemiologic data.     

Benchmark Dose Profiles for Joint‐Action Quantal Data in Quantitative Risk Assessment

Summary Benchmark analysis is a widely used tool in public health risk analysis. Therein, estimation of minimum exposure levels, called Benchmark Doses (BMDs), that induce a prespecified Benchmark Response (BMR) is well understood for the case of an adverse response to a single stimulus. For cases where two agents are studied in tandem, however, the benchmark approach is far less developed. This article demonstrates how the benchmark modeling paradigm can be expanded from the single‐dose setting to joint‐action, two‐agent studies. Focus is on response outcomes expressed as proportions. Extending the single‐exposure setting, representations of risk are based on a joint‐action dose–response model involving both agents. Based on such a model, the concept of a benchmark profile (BMP) – a two‐dimensional analog of the single‐dose BMD at which both agents achieve the specified BMR – is defined for use in quantitative risk characterization and assessment. The resulting, joint, low‐dose guidelines can improve public health planning and risk regulation when dealing with low‐level exposures to combinations of hazardous agents.     

WHO health risk assessment process for static fields

The World Health Organization (WHO) has a commitment to helping Member States achieve safe, sustainable and health-enhancing human environments, protected from biological, chemical and physical agents. The latter includes advising on the health impact of electromagnetic fields (EMFs) and radiation.

The results of the WHO/ICNIRP/NRPB workshop on static magnetic fields, published in this volume, provide a valuable and much needed contribution to the health risk assessment of exposure to static electric and magnetic fields, which is currently being coordinated by the WHO's International EMF Project. This WHO health risk assessment will be published as an environmental health criteria (EHC) monograph in early 2005.

This paper briefly gives an overview of the process of developing the WHO static fields EHC monograph, the criteria applied to studies that could contribute to the EHC, along with the ‘weight-of-evidence’ approach to health risk assessment. In addition, there is an increasing awareness of the need to account for uncertainty in the science database. This is traditionally addressed by further research, and the EMF project addresses these needs through the development of a ‘research agenda’. However, research programmes may take several years to complete, and the long latency associated with diseases such as cancer in people may also preclude a rapid outcome in some studies. The issue of current uncertainty is being addressed by the WHO EMF project through the development of a ‘precautionary framework’ in which precautionary measures will be applied to policy recommendations.     

A statistical simulation model for field testing of non‐target organisms in environmental risk assessment of genetically modified plants

Genetic modification of plants may result in unintended effects causing potentially adverse effects on the environment. A comparative safety assessment is therefore required by authorities, such as the European Food Safety Authority, in which the genetically modified plant is compared with its conventional counterpart. Part of the environmental risk assessment is a comparative field experiment in which the effect on non‐target organisms is compared. Statistical analysis of such trials come in two flavors: difference testing and equivalence testing. It is important to know the statistical properties of these, for example, the power to detect environmental change of a given magnitude, before the start of an experiment. Such prospective power analysis can best be studied by means of a statistical simulation model. This paper describes a general framework for simulating data typically encountered in environmental risk assessment of genetically modified plants. The simulation model, available as Supplementary Material, can be used to generate count data having different statistical distributions possibly with excess‐zeros. In addition the model employs completely randomized or randomized block experiments, can be used to simulate single or multiple trials across environments, enables genotype by environment interaction by adding random variety effects, and finally includes repeated measures in time following a constant, linear or quadratic pattern in time possibly with some form of autocorrelation. The model also allows to add a set of reference varieties to the GM plants and its comparator to assess the natural variation which can then be used to set limits of concern for equivalence testing. The different count distributions are described in some detail and some examples of how to use the simulation model to study various aspects, including a prospective power analysis, are provided.     

Urbanisation tolerance and the loss of avian diversity

Urbanisation is considered an important driver of current biodiversity loss, but the underlying causes are not fully understood. It is generally assumed that this loss reflects the fact that most organisms do not tolerate well the environmental alterations associated with urbanisation. Nevertheless, current evidence is inconclusive and the alternative that the biodiversity loss is the result of random mechanisms has never been evaluated. Analysing changes in abundance between urbanised environments and their non‐urbanised surroundings of > 800 avian species from five continents, we show here that although random processes account for part of the species loss associated with urbanisation, much of the loss is associated with a lack of appropriate adaptations of most species for exploiting resources and avoiding risks of the urban environments. These findings have important conservation implications because the extinction of species with particular features should have higher impact on biodiversity and ecosystem function than a random loss.     

Using the concept of Chou's pseudo amino acid composition for risk type prediction of human papillomaviruses

High-risk types of human papillomaviruses (HPVs) are the etiological agents in nearly all cases (99.7%) of cervical cancer, and the HPV E6 protein is one of the two viral oncoproteins which is expressed in virtually all HPV-positive cancers. Therefore, classifying the risk type of HPVs is very useful and necessary for diagnosis and remedy of cervical cancer. To predict and to classify the risk types of HPV by bioinformatics analysis, 96 E6 protein sequences from available databases were obtained. To investigate the risk type of these sequences, PseAAC server, ROC curves and statistical analysis were applied. Our classification was based on some characters of HPV E6 proteins, such as hydrophobicity, hydrophilicity, side chain mass, PK of the α-COOH group, PK of the α-NH3⁺ group and PI at 25 °C. Risk type of 4 unknown HPV types and 25 non-reported HPV types were also predicted. These results show that bioinformatics based theoretical approaches can direct and simplify experimental studies.