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Regulatory Perspectives on the Significance of Ecological Changes as Reported in Ecological Risk Assessments

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A broad range of perspectives exists regarding the interpretation of potentially adverse ecological changes in ecological risk assessments conducted under Superfund and RCRA. While USEPA's Proposed Guidelines for Ecological Risk Assessment recommend determining whether predicted changes are adverse based on the nature of effects, intensity of effects, spatial scale, temporal scale, and potential for recovery, the guidelines do not provide specific stan dards for judging adversity. Hence, implementation of the proposed guide lines varies with each risk manager's subjective judgments regarding the relative importance of each of these five criteria. In an effort to increase consistency in the scientific interpretation of ecological risk assessments, the following practices are recommended. First, measures of effects should focus on levels of ecological organization that are more complex than the individual organ ism. Second, multiple lines of evidence should be evaluated for each assessment endpoint. Third, bioequivalence testing should be used in place of traditional statistical testing (e.g., Student t-test) because the goal of bioequivalence testing is to answer the biologically relevant question of whether measurements differ by, at most, a biologically small amount. Fourth, in defining biologically small differences, site-specific and species specific conditions should be considered to the greatest extent possible. Fifth, where the outcomes of multiple lines of evidence contradict one another, the risk assessor should employ a quantitative approach to weighing the evidence based on the scientific defensibility of each measure of effect.

Keywords: bioequivalence; de minimus; measures of effects; weight of evidence

Document Type: Research Article


Affiliations: ARCADIS Geraghty & Miller, Inc., Falmouth, ME 04105

Publication date: August 1, 1998


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