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IRIS Toxicological Review of Inorganic Arsenic (Interagency Science Consultation Draft, 2022)

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Abstract

In October 2023, the draft IRIS Toxicological Review of Inorganic Arsenic (Public Comment and External Review Draft) and the draft charge to external peer reviewers were released for a 60-day public review and comment period. The Toxicological Review and charge were reviewed internally by EPA and by other federal agencies and White House Offices before public release. Consistent with the May 2009 IRIS assessment development process, all written comments on IRIS assessments submitted by other federal agencies and White House Offices are made publicly available on this site.
Inorganic arsenic is used for hardening copper and lead alloys. It also is used in glass manufacturing as a decolorizing and refining agent, as a component of electrical devices, in the semiconductor industry, and as a catalyst in the production of ethylene oxide. Arsenic compounds are used as a mordant in the textile industry, for preserving hides, as medicinals, pesticides, pigments, and wood preservatives.

Arsenic is also found naturally in the environment and is typically present in soil and water at detectable levels. Sources of human exposure to inorganic arsenic include drinking water, diet, air, and soils (which can contain naturally occurring arsenic or contamination from anthropogenic sources). This draft IRIS health assessment addresses cancer and non-cancer human health effects that may result from chronic exposure to this chemical.

Impact/Purpose

This document presents a draft assessment plan for inorganic arsenic that will be the subject of an SAB/Chemical Assessment Advisory Committee meeting in 2022 and that will define the scope and approach of the IRIS assessment of this chemical.

Status

The toxicological review of inorganic arsenic was released for public comment in October 2023. After the public comment period, there will be an external peer review. The assessment will then be revised taking into consideration public and peer review comments.

Citation

U.S. EPA. IRIS Toxicological Review of Inorganic Arsenic (Interagency Science Consultation Draft, 2022). U.S. Environmental Protection Agency, Washington, DC, EPA/635/R-22/193, 2022.

History/Chronology

Date Description
01- 1988 EPA published the IRIS Health Hazard Assessment for Inorganic Arsenic.
02- 1999 NRC reviewed the 1988 IRIS assessment and the available health data for inorganic arsenic and made recommendations for updating the cancer assessment in Arsenic in Drinking Water.
03- 2001 NRC updated the NRC (1999) report and evaluated the toxicological risk and health effects of arsenic as relevant to the 2001 Arsenic Rule in Arsenic in Drinking Water – 2001 Update.
04- 2001 NRC reviewed the 2001 Primary Drinking Water Standard for inorganic Arsenic and made recommendations for applying epidemiologic data in the cancer health assessment.
05- 2003 EPA started a reassessment of the IRIS Toxicological Review.
06- Jul 2005 EPA released the draft IRIS inorganic arsenic assessment in July 2005 for public comment and peer review.
07- Jun 2007 Science Advisory Board (SAB) posted a response to the 2005 EPA reassessment of inorganic arsenic (cancer).
08- Oct 2008 Draft IRIS Toxicological Review for Inorganic Arsenic (Cancer) submitted to OMB for interagency review.
09- Jun 2009 EPA hosted an interagency science consultation on the draft IRIS Toxicological Review of Inorganic Arsenic (cancer).
10- Feb 2010 EPA released the revised draft IRIS inorganic arsenic assessment (cancer) for public comment and peer review, SAB announced public teleconference to conduct a quality review of the draft report to be held on November 22, 2010. [Federal Register Notice Oct 25, 2010], and SAB completed its review of the draft assessment.
11- Oct 2010 SAB announced a public teleconference to conduct a quality review of the draft report to be held on November 22, 2010. [Federal Register Oct 25, 2010]
12- 2011 Congress directed EPA to contract with the National Research Council (NRC) to review the draft assessment (cancer and noncancer).
13- Jan 2013 EPA held a public planning and scoping meeting for development of a new IRIS Toxicological Review of Inorganic Arsenic (cancer and noncancer).
14- 2013 EPA held eight science issues public webinars (Mar–July).
15- May 2013 EPA submitted a draft Assessment Development Plan (ADP) and preliminary assessment materials to NRC for review.
16- Nov 2013 NRC released the interim report, Critical Aspects of EPA’s IRIS Assessment of iAs and provided recommendations; NRC supported EPA’s plan.
17- Jun 2014 EPA held a public science meeting to present and encourage comments on the ADP, preliminary assessment materials, and key science issues.
18- Apr 2015 EPA released a revised ADP and other preliminary materials and held two public meetings (webinars).
19- Dec 2015 The National Academies of Science hosted a meeting on the review of EPA's IRIS Toxicological Assessment of Inorganic Arsenic (Preliminary Meeting Materials).
20- May 2019 EPA released the Updated Problem Formulation and Systematic Review Protocol for the IRIS inorganic Arsenic Assessment. EPA posted an errata sheet outlining an update that was made to the protocol and posted on this site on June 20, 2019. [Federal Register Notice May 28, 2019]
21- Jul 2019 EPA posted the summary of public comments document received on the IRIS inorganic arsenic protocol.
22- Nov 2022 EPA sent an interagency science consultation inorganic arsenic draft for review and comment.
23- Oct 2023 EPA release the draft IRIS Toxicological Review of Inorganic Arsenic for a 60-day public comment period and external peer review. EPA also released the interagency science consultation comments from reviewers. [Federal Register Notice: Oct 16, 2023]

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Last updated on October 16, 2023