Posted on October 29, 2012 by Angus Macbeth
The aim of this post is to encourage environmental lawyers to pay more attention to issues and developments in human health risk assessment.
Remedial clean ups under Superfund and RCRA are very largely driven by human health risk assessments carried out under EPA’s Integrated Risk Information System (IRIS) as applied to chemicals on the site. The health-protective regulations under the Clean Air Act also are typically the product of statutorily mandated human health risk assessments. Mass tort cases seeking medical monitoring and personal injury are often based on such assessments. Just as the cost of clean up and CAA compliance are driven by these assessments, so too are numerous corporate decisions on what chemicals to use in manufacturing and commercial activity.
Despite its centrality to so many important activities, IRIS is cordoned off from most of the legal system. It is not rooted in or governed by any statute. Its results are not reviewable except in the context of their application to a particular site – and if that site is governed by Superfund, review, as a practical matter, is available only at the end of the remedial process. Perhaps because of this structure and because human health risk assessments are an intensely scientific undertaking, the presence of lawyers is very little felt.
Nonetheless, environmental lawyers should be aware of some on-going efforts aimed at examining and reforming IRIS and similar systems.
First, the Administrative Conference of the United States commissioned Prof. Wendy Wagner of the University of Texas School of Law to undertake a study entitled “Science in the Administrative Process: A Study of Agency Decisionmaking Approaches.” Prof. Wagner details in 80 pages how the processes of EPA (including IRIS), the Fish and Wildlife Service (endangered and threatened species listing) and the Nuclear Regulatory Commission use science in regulatory decision-making. These useful guides are followed by almost 40 pages of recommendations and suggestions of best practices on issues such as the role of OMB in reviewing proposed agency actions with a major scientific component and the right of staff scientists to dissent from agency actions. Not surprisingly, given Prof. Wagner’s professional background, most of the topics on which she focuses are readily accessible to lawyers.
On September 10, 2012, the Administrative Conference held a workshop open to the public on many of Prof. Wagner’s ideas and proposals. It did not appear to me that very many environmental lawyers were on the stage or in the audience, despite the fact that issues and reforms discussed were central to their professional lives.
Second, in 2009, the National Academies published “Science and Decisions: Advancing Risk Assessment.” The volume focuses on EPA and IRIS. It is a thorough review of the issues and challenges of risk assessment from scientists who are, from time to time, called on to review EPA’s handiwork. Although some of the advice is merely editorial – be succinct and to the point, one chart or figure can be worth a thousand words – the authors address many of the major scientific issues in risk assessment, e.g. the selection of default values given the known sensitivity of a lab animal to a chemical, the probable sensitivity of humans has to be “calculated” or how to treat cumulative risks where there is exposure to two or more chemicals.
EPA is now working on implementing many of the suggestions set out in “Science and Decisions.” In September, 2012, the comment period closed on the draft of EPA’s “Framework for Human Health Risk Assessment to Inform Decision Making.” This document responds in large part to “Science and Decisions,” addressing “the recommendation that EPA formalize and implement planning, scoping, and problem formulation in the risk assessment process and that the agency adopt a framework for risk-based decision making.” EPA is not done absorbing “Science and Decisions” and the National Research Council is not done with EPA. The Council will continue to review how EPA implements IRIS. There will be an emphasis on EPA’s weight-of-evidence analyses and recommended approaches for weighing scientific evidence for chemical hazard and dose-response assessments. See Review of the IRIS Process, National Academies Current Projects.
The ongoing initiatives will provide the structure and the process for human health risk assessments in the future. The work of environmental lawyers will be shaped by what the scientists decide. Environmental lawyers should be engaged in these debates and arguments now.