Chemical Assessments: Overview of EPA's Efforts to Produce Assessments

The Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program, which prepares human health toxicity assessments of chemicals, has made progress addressing historical timeliness and transparency challenges in the assessment process. Efforts to address timeliness include employing project management principles and specialized software to better plan assessments and utilize staff. To address the need for greater transparency in how the program conducts assessments, IRIS officials and the IRIS Program have implemented systematic review, which provides a structured and transparent process for identifying relevant studies, reviewing their methodological strengths and weaknesses, and integrating these studies as part of a weight of evidence analysis.

 

Since the process improvements were implemented, the program made progress toward producing chemical assessments through May 2018. In June 2018, the EPA Administrator’s office told IRIS officials that they could not release any IRIS-associated documentation without a formal request from EPA program office leadership. In August 2018, according to IRIS officials, program office leadership was asked to reconfirm which of 20 ongoing chemical assessments their offices needed. In late October 2018, prior to releasing results of the initial program and regional office survey, these offices were asked to limit their chemical requests further, to the top three or four assessments. At the same time—4 months after IRIS assessments were stopped from being released—28 of approximately 30 IRIS staff were directed to support implementation of the Toxic Substances Control Act of 1976 (TSCA), as amended, with 25 to 50 percent of their time, according to officials. When EPA leadership’s deliberations about the program’s priorities were completed, a memorandum was issued on December 4, 2018, that listed 11 chemical assessments that the IRIS Program would develop. Then on December 19, 2018, the Office of Research and Development publicly issued its IRIS Program Outlook, which provided an updated list of 13 assessments. Eleven of the 13 chemicals on the IRIS Program Outlook were requested by two EPA program offices. The memorandum issued earlier in December, gave no indication of when additional assessments could be requested or what the IRIS Program’s workflow would be in the near term.

EPA is responsible for reviewing chemicals in commerce and those entering the marketplace. Currently there are more than 40,000 active chemical substances in commerce, with more submitted to EPA for review annually. EPA’s IRIS database contains the agency’s scientific position on the potential human health effects that may result from exposure to various chemicals in the environment. EPA’s IRIS Program, which produces toxicity assessments, has been criticized in the past for timeliness and transparency issues. In response, the IRIS Program committed to making program improvements starting in 2011, which the National Academy of Sciences (NAS) recently commended. TSCA as amended in 2016 provides EPA with additional authority to review both existing and new chemicals and to regulate those that EPA determines pose unreasonable risks to human health or the environment.

 

This statement describes (1) the extent to which the IRIS Program has addressed identified challenges and (2) made progress toward producing chemical assessments. This statement summarizes our March 2019 report on EPA’s efforts to produce IRIS assessments.  We reviewed program documentation from 2012 through 2019 and applicable EPA guidelines and program NAS and EPA management practices. We interviewed IRIS officials, the leadership (as of October 2018) in EPA’s Office of Research and Development (ORD), and officials from EPA program and regional offices that request or use IRIS assessments on a regular basis. We interviewed representatives from an environmental stakeholder organization and an industry stakeholder organization that both have been involved in chemical regulatory policy and worked with or followed the IRIS Program for the past several years. Our March 2019 report contains a detailed overview of our scope and methodology. GAO reviewed NAS and EPA documents and interviewed officials from EPA and representatives from an environmental and an industry stakeholder organization.