Data Quality, Reliability, and Relevance Standards for Ecological Risk Assessment: Recommendations for Improvements to Pesticide Regulation in Compliance with the Endangered Species Act

Risk assessment procedures used by the U.S. Environmental Protection Agency (EPA) for pesticides have been worked out over a period of years and are now well-established and well-known by the regulated community. Similarly, the nature of the database needed to support a standard EPA risk assessment for a pesticide is well-established and well-known. These procedures and data are used to make assessments for endpoints that are deemed relevant to the questions at hand for a particular pesticide. In contrast, no instructional guidelines for evaluating data reliability or relevance for the purpose of endangered species assessments for pesticides are in place. This circumstance has resulted in considerable confusion and uncertainty in the overall consultation process. In this paper, we begin with an overview of some methods used to ensure that high quality data are selected for a risk assessment and we then examine what criteria might be applied to whether data are in fact relevant for a given assessment. Finally, we provide examples of how improperly selected data can strongly influence the conclusions of an assessment, if such data are not of high quality or solid relevance. But we also provide guidance on how to decide which studies beyond guideline studies may (and should) be incorporated into the risk assessment. This paper concludes that no instructional guidelines for evaluating relevancy and reliability are in place, and shows that peer review does not always serve that purpose. Consequently, the risk assessor must use due diligence to consider risk assessment and protection goals in light of data reliability and relevance. Suggestions provided here on how a risk assessor might weigh data for use in a given risk assessment hopefully enhance the assessor's ability to utilize or question data and give it the proper role in the given risk assessment exercise.