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March 28, 2019

House Subcommittees Hold Hearing on EPA’s IRIS Program

Bergeson & Campbell, P.C.

On March 27, 2019, the House Science, Space, and Technology Subcommittee on Investigations and Oversight and Subcommittee on Environment held a hearing on “EPA’s IRIS Program:  Reviewing its Progress and Roadblocks Ahead.”  The hearing focused on issues with the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program, as described in two recent reports issued by the U.S. Government Accountability Office (GAO), Chemical Assessments:  Status of EPA’s Efforts to Produce Assessments and Implement the Toxic Substances Control Act (Chemical Assessments Report) and High-Risk Series:  Substantial Efforts Needed to Achieve Greater Progress on High-Risk Areas (High-Risk Report). 


As reported in our March 6, 2019, memorandum, “GAO Reviews EPA’s IRIS Assessment Efforts and Implementation of TSCA Reforms,” on March 4, 2019, GAO published the Chemical Assessments Report.  The Chemical Assessments Report describes the extent to which the IRIS Program has addressed identified challenges and made progress toward producing chemical assessments; and assesses whether EPA has demonstrated progress implementing the Toxic Substances Control Act (TSCA). 
GAO reports that, in June 2018, EPA leadership in the Office of Research and Development (ORD) reportedly told IRIS officials not to release any IRIS-associated documentation without a formal request from EPA program office leadership.  In August 2018, EPA program office leadership was asked to reconfirm which ongoing IRIS assessments their offices needed.  In late October 2018, leadership in ORD reportedly asked these offices to limit their requests further, to the top three or four assessments.  GAO states that at the same time, four months after IRIS assessments were stopped from being released, 28 of approximately 30 IRIS staff were directed to use 25 to 50 percent of their time to support TSCA implementation.
When EPA deliberations about the IRIS Program’s priorities were completed, a memorandum was issued on December 4, 2018, listing 11 chemical assessments that the IRIS Program would develop.  Although this was a reduction of the Program’s workflow from 22 assessments, GAO states that the memorandum “gave no reason for the reduction.”  GAO notes that it received this memorandum at the end of its review and did not have the opportunity to review the prioritization process that led to its drafting.
In its March 6, 2019, High-Risk Report, GAO included “Transforming EPA’s Process for Assessing and Controlling Toxic Chemicals” on a list of three areas that have regressed in their ratings against GAO’s criteria for removal from the High-Risk List.  GAO notes that since adding this area to its High-Risk List in 2009, it has made 12 recommendations to EPA related to the IRIS Program and TSCA.  According to GAO, while EPA has taken steps to manage chemicals that pose risks to human health and the environment, leadership and implementation challenges remain.  More information on the High-Risk Report is available in our March 8, 2019, memorandum, “EPA’s Process for Assessing and Controlling Toxic Chemicals Remains on GAO’s High-Risk List.”


The following opening statements are available online:

The first panel of witnesses included:

Members of the Committee and Subcommittees had a number of questions regarding the GAO’s finding that EPA leadership in ORD reportedly told IRIS officials not to release any IRIS-associated documentation without a formal request from EPA program office leadership.  Members also focused on the two surveys conducted to determine IRIS priorities:  the first, in August 2018, asking EPA program office leadership to reconfirm which ongoing IRIS assessments their offices needed; and the second, in late October 2018, asking these offices to limit their requests further, to the top three or four assessments.  On December 4, 2018, a memorandum was issued listing 11 chemical assessments that the IRIS Program would develop.  Gomez expressed concern about the increased involvement of political leadership in ORD, such as the directive that IRIS officials not release any IRIS documents without instruction from EPA program office leadership. 
Orme-Zavaleta stated that she was not involved in the discussions between the first and second surveys of the EPA program offices.  She noted that after receiving responses to the first survey, there was concern that the requests for 50 or so chemicals was too large for IRIS to manage.  For the second survey, she received “templates” that were signed off on by the assistant administrators for the offices, for a total of 11 chemicals.  The templates reported the priority chemical assessments that were needed and by when, and how the IRIS assessments were to be used by program offices.  Representative Paul Tonko (D-NY) asked about the responses submitted by the Office of Children’s Health Protection (OCHP).  According to Orme-Zavaleta, she received OCHP’s response to the second survey the day after the December 4, 2018, memorandum was issued.  Orme-Zavaleta stated that EPA will be sending another request to program offices this summer.
Questions also focused on the status of the IRIS handbook, which is expected to provide guidance for the development of IRIS assessments.  According to GAO’s Chemical Assessments Report, in early November 2018, IRIS officials informed GAO that EPA had almost completed internal review of the handbook, which was being prepared for public release.  During the hearing, Orme-Zavaleta stated that the government shutdown delayed work on reviewing and responding to internal comments on the handbook.  According to Orme-Zavaleta, although the handbook is not a final document, elements of the handbook have been used in recent IRIS assessments.
Members also addressed the status of the IRIS assessment for formaldehyde, which has reportedly been ready since the end of 2017 but was not included on the December 2018 list of priority chemicals and, according to GAO’s Chemical Assessments Report, its future is unknown.  Orme-Zavaleta stated that she believes the draft IRIS assessment will help EPA evaluate formaldehyde as a high-priority prioritization process candidate under TSCA.
Witnesses on the second panel included:

  • Dr. Bernard D. Goldstein, Professor Emeritus, Dean Emeritus, University of Pittsburgh Graduate School of Public Health;
  • Dr. Ivan Rusyn, Professor, Department of Veterinary Integrative Biosciences, Texas A&M University; Chair, Interdisciplinary Faculty of Toxicology; Director, Texas A&M Superfund Research Center;
  • Dr. Julie E. Goodman, Principal, Gradient; and
  • Ms. Wilma Subra, President, Subra Company; Technical Advisor, Louisiana Environmental Action Network.

Questions for the second panel from the Committee and Subcommittee members focused on the usefulness of the IRIS Program.  Goldstein stated that IRIS was intended to coordinate risk assessments throughout EPA, ensuring that the programs used the same science and minimizing the influence of political appointees.  When asked how Congress can support career staff at EPA, Goldstein recommended that Congress provide as much oversight as it can.  According to Rusyn, the IRIS Program is a leader in pushing risk assessment methodology forward, most recently in its implementation of systematic review.


The hearing was largely a recap of what was already known about the IRIS program, including EPA’s efforts to prioritize IRIS assessments as described by the recent GAO reporting.  Perhaps not surprisingly, IRIS came under criticism from both majority and minority members.  The issues raised included timeliness of outputs, IRIS’ long ongoing efforts to improve and strengthen its assessments and approach, the status of the IRIS assessment handbook, and the effect of EPA’s political leadership on the program. 
Apart from the delay and disruption of ongoing work, we can see the benefit of EPA leadership efforts to obtain clear written statements of the priorities as seen by program Assistant Administrators.  Perhaps this type of confirmation step will be an ongoing feature of the IRIS program into the future.