Updated Problem Formulation and Systematic Review Protocol for the Inorganic Arsenic IRIS Assessment
U.S. EPA. Updated Problem Formulation and Systematic Review Protocol for the Inorganic Arsenic IRIS Assessment. U.S. Environmental Protection Agency, Washington, DC, EPA/635/R-19/049, 2019.
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.
|1988||EPA published the IRIS Health Hazard Assessment for Inorganic Arsenic.|
|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.|
|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.|
|2001||NRC reviewed the 2001 Primary Drinking Water Standard for inorganic Arsenic and made recommendations for applying epidemiologic data in the cancer health assessment.|
|2003||EPA started a reassessment of the IRIS Toxicological Review.|
|Jul 2005||EPA released the draft IRIS inorganic arsenic assessment in July 2005 for public comment and peer review.|
|Jun 2007||Science Advisory Board (SAB) posted a response to the 2005 EPA reassessment of inorganic arsenic (cancer).|
|Oct 2008||Draft IRIS Toxicological Review for Inorganic Arsenic (Cancer) submitted to OMB for interagency review.|
|Jun 2009||EPA hosted an interagency science consultation on the draft IRIS Toxicological Review of Inorganic Arsenic.|
|Feb 2010||EPA released the revised draft IRIS inorganic arsenic assessment 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.|
|2011||Congress directed EPA to contract with the National Research Council (NRC) to review the draft assessment.|
|Jan 2013||EPA held a public planning and scoping meeting for development of a new IRIS Toxicological Review of Inorganic Arsenic.|
|2013||EPA held eight science issues public webinars (Mar–July).|
|May 2013||EPA submitted a draft Assessment Development Plan (ADP) and preliminary assessment materials to NRC for review.|
|Nov 2013||NRC released the interim report, Critical Aspects of EPA’s IRIS Assessment of iAs and provided recommendations; NRC supported EPA’s plan.|
|Jun 2014||EPA held a public science meeting to present and encourage comments on the ADP, preliminary assessment materials, and key science issues.|
|Apr 2015||EPA released a revised ADP and other preliminary materials and held two public meetings (webinars).|
|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).|
|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]|
|Jul 2019||EPA posted the summary of public comments document received on the IRIS inorganic arsenic protocol.|
The IRIS Program will use the updated problem formulation and methods for conducting the systematic review and dose-response as described in the protocol to develop the draft assessment.
This download(s) is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency determination or policy.
- (176 pp, 2 MB, about PDF)
- (1 pp, 96 KB, about PDF)
- (3 pp, 309 KB, about PDF)
- (21 pp, 430 KB, about PDF)
If you have a disability and the format of any material on our web pages interferes with your ability to access the information, please reach out to us using the Contact us about IRIS form for assistance. To enable us to respond in a manner most helpful to you, please indicate the nature of the accessibility problem, the web address of the requested material, your preferred format in which you want to receive the material (electronic format (ASCII, etc.), standard print, large print, etc.), and your contact information.
Federal Register Notices
Comments on the assessment may be submitted and reviewed using the Docket ID EPA-HQ-ORD-2012-0830