Although estimates vary, there is a broad agreement that invasive species impose major costs on the U.S. economy, as well as posing risks to nonmarket environmental goods and services and to public health. The domestic effort to manage risks associated with invasive species is coordinated by the National Invasive Species Council (NISC), which is charged with developing a science-based process to evaluate risks associated with the introduction and spread of invasive species. Various international agreements have also elevated invasive species issues onto the international policy agenda. The World Trade Organization (WTO) Sanitary and Phytosanitary (SPS) Agreement establishes rights and obligations to adhere to the discipline of scientific risk assessment to ensure that SPS measures are applied only to the extent required to protect human, animal, and plant health, and do not constitute arbitrary or unjustifiable technical barriers to trade. Currently, however, the field of risk assessment for invasive species is in its infancy. Therefore, there is a pressing need to formulate scientifically sound methods and approaches in this emerging field, while acknowledging that the demand for situation-specific empirical evidence is likely to persistently outstrip supply. To begin addressing this need, the Society for Risk Analysis Ecological Risk Assessment Specialty Group and the Ecological Society of America Theoretical Ecology Section convened a joint workshop to provide independent scientific input into the formulation of methods and processes for risk assessment of invasive species to ensure that the analytic processes used domestically and internationally will be firmly rooted in sound scientific principles.

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Toxicity reference values (TRVs) are essential in models used in the prediction of the potential for adverse impacts of environmental contaminants to avian and mammalian wildlife; however, issues in their derivation and application continue to result in inconsistent hazard and risk assessments that present a challenge to site managers and regulatory agencies. Currently, the available science does not support several common practices in TRV derivation and application. Key issues include inappropriate use of hazard quotients and the inability to define the probability of adverse outcomes. Other common problems include the continued use of no-observed-and lowest-observed-adverse-effect levels (NOAELs and LOAELs), the use of allometric scaling for interspecific extrapolation of chronic TRVs, inappropriate extrapolation across classes when data are limited, and extrapolation of chronic TRVs from acute data without scientific basis. Recommendations for future TRV derivation focus on using all available qualified toxicity data to include measures of variation associated with those data. This can be achieved by deriving effective dose (EDx)-based TRVs where x refers to an acceptable (as defined in a problem formulation) reduction in endpoint performance relative to the negative control instead of relying on NOAELs and LOAELs. Recommendations for moving past the use of hazard quotients and dealing with the uncertainty in the TRVs are also provided.

A joint workshop was convened by the Society for Risk Analysis Ecological Risk Assessment Specialty Group and the Ecological Society of America Theoretical Ecology Section to provide independent scientific input into the formulation of methods and processes for risk assessment of invasive species. In breakout sessions on (1) the effects of invasive species on human health, (2) effects on plants and animals, (3) risk analysis issues and research needs related to entry and establishment of invasive species, and (4) risk analysis issues and research needs related to the spread and impacts of invasive species, workshop participants discussed an overall approach to risk assessment for invasive species. Workshop participants agreed on the need for empirical research on areas in which data are lacking, including potential invasive species, native species and habitats that may be impacted by invasive species, important biological processes and phenomena such as dispersal, and pathways of entry and spread for invasive species. Participants agreed that theoretical ecology can inform the process of risk assessment for invasive species by providing guidelines and conceptual models, and can contribute to improved decision making by providing a firm biological basis for risk assessments.

This article summarizes a quantitative microbial risk assessment designed to characterize the public health impact of consumption of shell eggs and egg products contaminated with Salmonella Enteritidis (SE). This risk assessment's objectives were to: (1) establish the baseline risk of foodborne illness from SE, (2) identify and evaluate potential risk mitigation strategies, and (3) identify data gaps related to future research efforts. The risk assessment model has five modules. The Egg Production module estimates the number of eggs produced that are SE-contaminated. Shell Egg Processing, Egg Products Processing, and Preparation & Consumption modules estimate the increase or decrease in the numbers of SE organisms in eggs or egg products as they pass through storage, transportation, processing, and preparation. A Public Health Outcomes module then calculates the incidence of illnesses and four clinical outcomes, as well as the cases of reactive arthritis associated with SE infection following consumption. The baseline model estimates an average production of 2.3 million SE-contaminated shell eggs/year of the estimated 69 billion produced annually and predicts an average of 661,633, human illnesses per year from consumption of these eggs. The model estimates approximately 94% of these cases recover without medical care, 5% visit a physician, an additional 0.5% are hospitalized, and 0.05% result in death. The contribution of SE from commercially pasteurized egg products was estimated to be negligible. Five mitigation scenarios were selected for comparison of their individual and combined effects on the number of human illnesses. Results suggest that mitigation in only one segment of the farm-to-table continuum will be less effective than several applied in different segments. Key data gaps and areas for future research include the epidemiology of SE on farms, the bacteriology of SE in eggs, human behavior in food handling and preparation, and human responses to SE exposure.