On May 21, 2009, U.S. EPA Administrator Lisa P. Jackson announced reforms to the agency’s Integrated Risk Information System (IRIS). IRIS is an electronic database that provides information on human health effects that may result from exposure to chemical substances in air, water, and land both from contaminated sites and from products.
U.S. EPA’s National Center for Environmental Assessment (NCEA) within the Office of Research and Development (ORD) maintains and prepares the database. Government and private entities in the United States and around the world use IRIS to help characterize public health risks of chemical substances in a site-specific situation and support risk-management decisions designed to protect public health. In West Virginia, for example, IRIS is used in risk-management decisions under the West Virginia Voluntary Remediation and Redevelopment Program. Other examples of risk management decisions relying upon IRIS include: deciding how much of a substance a company may discharge into a river, which substances may be stored at a hazardous waste disposal facility, and to what extent a hazardous waste site must be cleaned up; setting permit levels for discharge, storage, or transport; establishing levels for air emissions; and determining allowable levels of contamination in drinking water.
The reforms announced May 21, 2009, reverse changes to the IRIS process, including procedures formalized by the Bush EPA in an April 10, 2008, memorandum that U.S. EPA Administrator Jackson criticized as “reduc[ing] the transparency, timeliness, and scientific integrity of the IRIS process.” Administrator Jackson promised that the new process would be “more transparent and timely” and would also “ensure the highest level of scientific integrity.” While EPA will consider the scientific input of experts at other agencies and White House offices, EPA will manage the process and have “final responsibility” for the content of all IRIS assessments. The process will include the opportunity for public comment and rely on open and independent external peer review. EPA will provide a response to comments. The assessment development process will be shortened to 23 months and for fiscal year 2010, EPA resources for the IRIS program will be increased. President Obama’s 2010 fiscal year budget includes a request for an additional $5 million and 10 full-time equivalent employees for the IRIS program.
Before the development of the draft IRIS assessment for each chemical on the proposed agenda, EPA will conduct a scientific literature search and initiate a data call-in. For the scientific literature search, ORD will appoint a chemical manager for each chemical on the proposed agenda, and that chemical manager will then direct an EPA contractor to conduct and complete a comprehensive search of the scientific literature for the chemical. The results of that literature search will be posted on EPA’s web site. After the completion of the literature search for each chemical, EPA will publish a Federal Register notice notifying the public of the availability of the completed literature search on the IRIS web site. The notice will invite the public and other agencies to submit additional scientific information on the chemical and request information on new research that may be planned, underway, or in press.
After the literature search and data call-in are complete, EPA will begin development of the IRIS human health assessment. All IRIS human health assessments will undergo “rigorous, open, independent external peer review”. IRIS assessments considered being of major importance or high profile may be selected for peer review by panels of experts convened by EPA’s Science Advisory Board or by the National Academy of Sciences.
IRIS assessments are to be developed under a 7-step process. This seven-step process is expected to be completed within approximately 2 years from the Step 1 start date. Because of their complexity, large scientific literature base, or high profile, some IRIS assessments may take longer than 2 years.
· Step 1 – Development of Draft IRIS Toxicological Review: EPA develops and completes a draft IRIS Toxicological Review. An ORD assessment team will assess the data and the scientific literature and any information submitted as a result of the data call-in and develop a draft assessment for the chemical being assessed. The draft assessment will summarize potentially important health effects, information on potential modes of action, and information about potentially susceptible populations. The draft assessment will include a quantitative assessment, including application of certain factors, default approaches, mode of action information, and dose-response modeling. The draft assessment will also identify potential uncertainties that impact the qualitative and quantitative aspects of the assessment. The development and completion of the draft IRIS Toxicological Review is expected to take 345 days.
· Step 2 – Internal EPA Review: Once the draft IRIS Toxicological Review has been developed, ORD submits it for internal EPA review. Scientists from EPA programs and regions review the draft Toxicological Review and identify any scientific issues to determine the level of peer review, needed panel member disciplines, and the scope of the review. Internal EPA review is expected to take 60 days.
· Step 3 – Interagency Science Consultation: Following the internal EPA review, EPA initiates an Interagency Science Consultation on the draft IRIS Toxicological Review. EPA sends the draft IRIS Toxicological Review and draft external peer review charge to other federal agencies and White House offices for a science consultation. This science consultation is managed and coordinated by EPA. All written comments received during the Interagency Science Consultation become part of the record. Following receipt of written comments, ORD revises the draft assessment documents as appropriate, and science questions that arise may be included as part of a charge question to the peer review panel.
· Step 4 – External Peer Review, Public Review and Comment, and Public Listening Session: After the Interagency Science Consultation, EPA initiates an independent external peer review of the draft IRIS Toxicological Review, releases the draft IRIS Toxicological Review for public review and comment, and holds a public listening session. The external peer review, public review and comment, and public listening session are all announced in the Federal Register and are expected to take 105 days. EPA recently announced a listening session for the draft Toxicological Review of Pentachlorophenol (74 Fed. Reg. 27317; June 9, 2009), and a listening session and peer review workshop for the draft Toxicological Review of 1, 4-Dioxan (74 Fed. Reg. 27313; June 9, 2009).
· Step 5 – Revisions, IRIS Summary, and Response to Comments: Following the external peer review, public review and comment, and public listening session, ORD evaluates the report of the external peer review panel and all public comments. ORD revises the draft IRIS Toxicological Review, as appropriate, and develops the IRIS Summary. ORD also develops a disposition of peer reviewer and public comments and provides these as an appendix to the IRIS Toxicological Review. The revision process and response to comments is expected to take 60 days but the length of the process may depend on the complexity of the IRIS Toxicological Review and complexity and number of comments.
· Step 6 – Final Internal EPA Review and EPA-led Interagency Science Discussion: After development of the final drafts of the IRIS Toxicological Review and IRIS Summary and response to comments, ORD sends the final drafts of the IRIS Toxicological Review and IRIS Summary for final internal EPA review. This review is intended as a final check-in with Agency program and regions. Concurrent with the internal EPA review, EPA provides other agencies and White House offices with a final draft of the IRIS Summary and Toxicological Review and appendix describing disposition of peer review and public comments. Other agency and White House office scientists may provide written scientific feedback. EPA also hosts a meeting with other agencies and White House offices to discuss any scientific issues related to the final draft of the IRIS Summary and Toxicological Review and appendix. All written comments by other agencies and White House offices are documented in the record. Step 6 is expected to take 45 days.
· Step 7 – Completion of IRIS Toxicological Review and IRIS Summary: EPA completes the IRIS Toxicological Review and IRIS Summary. Step 7 is expected to take 30 days.
The reforms announced May 21, 2009, respond to criticism of the changes made to the IRIS process by the Bush EPA culminating in the April 10, 2008 memorandum. The 2008 process involved early involvement of other federal agencies and the public. In 2004, the White House directed EPA to begin routinely submitting draft assessments to the White House Office of Management and Budget (OMB) for review. Previously, the need for these reviews had been determined on a case-by-case basis. On April 10, 2008, EPA announced additional changes to the IRIS process which further involved OMB. This upset the scientific community because OMB’s staff is comprised mostly of policy analysts and economists. The 2008 IRIS process included asking other federal agencies whether an industrial chemical was critical to that agency’s mission. OMB then coordinated the agencies’ negotiations over “mission-critical” designations. If OMB and other agencies determined the chemicals in question to be “mission-critical,” then the other agencies had an opportunity to conduct their own research and to fill any identified data gaps or address any uncertainties. This prolonged the process and delayed the completion of IRIS assessments. Further, under the 2008 process, the communications during the consultations with other agencies and OMB were designated as “deliberative” and therefore not subject to a Freedom of Information Act request. The U.S. Government Accountability Office (GAO) was highly critical of an EPA’s 2008 IRIS process. In a May 21, 2008 report, GAO criticized the process as lacking transparency and limiting the credibility of IRIS assessments as well as placing the IRIS database at serious risk of becoming obsolete. GAO stated, “EPA has institutionalized a process that from the outset is estimated to take 6 to 8 years to complete.”
For additional information on 2009 reforms to the IRIS process, contact Gale Lea Rubrecht at galelea@jacksonkelly.com or 304-340-1200.
This article was authored by Gale Lea Rubrecht, Jackson Kelly PLLC. For more information on the author see here.
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