Affiliation:
1. George Washington University
Abstract
Limited empirical evidence exists regarding the precise impact of stakeholder involvement on regulatory decision-making. Therefore, this research serves as a case study aimed at qualitatively characterizing how stakeholder participation impacts EPA's chemical toxicological assessments in its Integrated Risk Information System (IRIS). IRIS is considered the gold standard human health assessment database for the federal government, industry, and consumers. During EPA's lengthy 26-month IRIS review process, external peer reviewers and agencies have opportunities to comment on proposed human health risk values (HHRV). This research compares the draft and final HHRVs and analyzes the stakeholder comments for nine published chemicals. Our results show that EPA is responsive to stakeholder comments. We found that when a majority of external peer reviewers and agencies agree that a draft HHRV requires updates, EPA makes alterations in its final toxicological assessment to respond to these recommendations over 80% of the time. Furthermore, our research indicates that EPA is slightly more responsive to comments submitted by external peer reviewers as compared to comments offered by other federal agencies. This study also suggests future research should investigate whether the IRIS assessment process could be further streamlined. One possibility to explore is EPA's distribution of a general charge survey with a Likert scale at the beginning of each question. This delimited survey style would allow EPA to streamline the IRIS assessment process, simplify the comments to facilitate public comprehension, and preserve the opportunity for robust stakeholder commentary.