Examination of EPA Risk Assessment Principles and Practices
Author:
The Risk Assessment Task Force
Date Published:
3/2004
Description:
EPA’s mission and statutes require that EPA protect human health and the environment, and ensure that EPA’s risk management decisions provide some “margin of safety” when risk assessment answers are uncertain or variable. The risk estimates provided in risk assessments and ultimately addressed in EPA decisions are driven by the uncertainty and variability inherent in practically all the information and methodologies EPA uses. This uncertainty stems to a large extent from the complex nature of the environment and the processes that interact with the stressor(s) to cause risk. It is clear that risk assessors best understand the basic elements of a risk assessment, in particular how to analyze the uncertainty and variability found in individual risk assessments. Risk managers, by taking into consideration the characterization of all the elements of a risk assessment — including the uncertainty and variability, provided by the risk assessors— should determine the appropriate degree of protection to ensure that risk is not underestimated and conversely, is not appreciably overestimated. Comments on EPA risk assessment principles and practices have been received over the years, more recently in response to the OMB Federal Register notice asking for such comments. An overarching position in the comments suggests that EPA inappropriately mixes policy and science: that, in generating risk assessments, risk assessors “decide” the degree of protection in a way that is not transparently characterized. Further, in more than a few instances, it is suggested that EPA’s current risk assessment practice compounds risk estimates to a protective position that is beyond reasonable. Also, in many instances, risk managers apparently are not aware of the degree of protection inherent in each risk assessment. Some other comments suggest that EPA risk estimates tend to underestimate risk, since a majority of the assessments tend to be single-stressor assessments and do not adequately take into account multiple stressors, multiple exposures, and susceptible populations.
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