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1 1 (November 10, 2020)

handle is hein.crs/govdclu0001 and id is 1 raw text is: %Fnw C~l rEs ~rh$e November 10, 2020 U.S. Environmental Protection Agency's Integrated Risk Information System (IRIS): Toxicity Assessment of Chemicals The U.S. Environmental Protection Agency (EPA) established the Integrated Risk Information System (IRIS) program in 1985 to consolidate human health toxicity assessments that the agency had prepared in order to implement various pollution control statutes (e.g., Clean Air Act and Clean Water Act). Specific incidents, such as the 1984 leak of methyl isocyanate from a Union Carbide facility in Bhopal, India, reinforced the need for a better understanding of human health toxicity from exposure to various chemicals. Over time, findings from IRIS assessments have informed many different agency actions, including regulatory requirements that EPA has established under various pollution control statutes. Given that these actions may require regulated entities to incur significant compliance costs and determine the extent of health benefits, the process that EPA follows to conduct IRIS assessments and the findings of such assessments have received considerable attention. EPA's IRIS program is not authorized explicitly in statute, but multiple pollution control statutes include general research provisions intended for the agency to generate information that may be useful in the implementation of such statutes. Additionally, EPA continues to receive annual appropriations to its Science and Technology account that largely funds its research efforts, including the IRIS program. EPA maintains a public IRIS website that provides more than 560 assessments on a range of chemicals. EPA completed more than 80% of these assessments before 1995. However, assessments completed more than 25 years ago may still be relevant if no new information is available to warrant a revision of the existing assessment. EPA staff managing the IRIS program select chemicals for IRIS assessments through a prioritization process. This involves soliciting internal input from EPA program and regional offices on which assessments may be useful and evaluating the extent to which resources and expertise are available to complete the assessments. Changes in these and other factors may also lead EPA to withdraw an initiated assessment before it is completed. EPA began issuing an IRIS Program Outlook in December 2018 to provide periodic updates on the development of IRIS assessments. Given limited resources and many chemicals to assess, EPA has decided to focus on a select number of assessments at any given time. Assessments that examine multiple pathways of exposure (e.g., ingestion, inhalation, or direct contact) and potential health effects typically take many years to prepare. In some instances, EPA may decide to conduct an assessment with a more narrow scope, focusing on a specific pathway of exposure or health effect. This approach allows the agency to finalize an assessment more quickly. EPA's selection of which chemicals to assess has received scrutiny on occasion. For example, after some of EPA's announcements of upcoming IRIS assessments, observers have raised questions about whether the agency's plans reflect an appropriate assessment of high priorities. Since 2016, EPA has included a preamble in each IRIS assessment that summarizes the objectives and scope of the IRIS program, general principles and systematic procedures used in developing assessments, and the overall development process and document structure. The preamble is accompanied by the preface, which is chemical-specific and describes procedures in the assessment that differ from the general procedures described in the preamble. In the preamble of each IRIS assessment since 2016, EPA describes seven steps for developing IRIS assessments: Step 1. Draft development; Step 2. Agency review; Step 3. Interagency science consultation; Step 4. Public comment, followed by external peer review; Step 5. Assessment revision; Step 6. Final agency reviews and interagency science discussion; and Step 7. Post final assessment. EPA staff preparing IRIS assessments may revisit prior steps of the process based on input from program and regional offices, other agencies, peer reviewers, or the public. The process, from start to finish for assessments completed since 2013, has typically spanned at least five years, with the ethylene oxide carcinogenicity assessment taking 17 years. EPA now states that it aims to complete an assessment within three years. After selecting a chemical to assess and prior to developing a draft assessment, EPA generally prepares a series of documents that detail how the agency plans to develop the draft. EPA practice is to issue each of these documents for public comment, which may help to inform how the agency performs the assessment. The first document that EPA prepares for an assessment is the scoping document, which describes the chemical being assessed, potential routes and \\\\'\\ L N \ \I \M,\ \\ \ \ Q\\ \\\ \\\

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