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IRIS Process
Notice
[04/08] Update: EPA has announced an update to the current IRIS Process as described on the IRIS Process (2008 Update).
EPA's process for developing IRIS assessments consists of 4 steps, they include:
- Selection of Substances for Assessment Development
- Preparation of Draft Assessments
- Review
- Final Assessment
I. Selection of Substances for Assessment Development
On an annual basis, the IRIS Program requests nominations for new or updated IRIS assessments from EPA Program Offices and Regions and from the public. Substances are selected for assessment development based on one or more of the following factors: (1) Agency statutory, regulatory, or program implementation need; (2) the availability of new scientific information or methodology that might significantly change current IRIS information; (3) interest to other levels of government or the public; and (4) the availability of a scientific assessment completed while meeting other EPA requirements, and for which only modest additional effort is needed to complete the review and documentation for IRIS. Because of limited Agency resources, not all nominated substances are selected for IRIS assessment development.
A list of new starts is published in the Federal Register (FR) as part of the IRIS annual agenda. The FR notice asks for scientific input from the public on the substances beginning review.
II. Preparation of Draft Assessments
A health scientist, referred to as a Chemical Manager, is assigned to each substance. The Chemical Manager is responsible for developing the draft assessment and shepherding draft documents though the review process and final ORD/NCEA approval. Development of a draft assessment consists of a literature search and preparation of a draft Toxicological Review (or other background document) and an IRIS Summary. The Chemical Manager may work with a team of toxicologists, epidemiologists, and statisticians in reviewing and analyzing the available literature. EPA’s risk assessment guidelines form the basis for the analysis. This work is often supported by an EPA contractor.
III. Review
The draft IRIS assessment is subject to an extensive review process. Peer review for each assessment is conducted in accordance with Agency guidance on peer review.
Internal Peer Consultation. Internal (EPA) peer reviewers are selected to provide detailed scientific feedback on the draft assessment.
Agency Review. The draft assessment is reviewed by a standing group of senior health scientists representing EPA’s Offices and Regions and by selected senior health scientists with scientific expertise relevant to the substance under review. The purpose of the IRIS Agency Review is to provide expert internal peer review and Agency-wide consultation to Chemical Managers and to ORD on whether the draft assessment is ready for external peer review and what issues should be raised.
Interagency Review. The revised draft assessment is distributed through the Office of Management and Budget for review by other federal agencies.
External Peer Review. EPA obtains external peer review, typically via a panel meeting that is open to the public. At this time, the draft assessment is posted on the internet for public comment.
IV. Final Assessment
Upon general agreement by Agency Reviewers, Interagency Reviewers, and ORD/NCEA senior management that peer review comments have been appropriately addressed, the assessment is approved by the NCEA Center Director.
The final assessment is uploaded to the IRIS Web site at www.epa.gov/iris.
The central IRIS file and public reading room, located at the EPA Docket Center, is the repository for the peer review record for the assessment, copies of key references (documenting “principal studies” used in the assessment), any difficult-to-find reference material including unpublished studies, EPA reports, and foreign translations, and any public submissions pertinent to the assessment.