IRIS Toxicological Review of Inorganic Arsenic (Cancer) (2010 External Review Draft)

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Report Information

EPA's Science Advisory Board (SAB) conducted a review of the scientific basis supporting the human health cancer hazard and dose-response assessment of inorganic arsenic that will appear on the Integrated Risk Information System (IRIS) database. EPA revised the assessment and is now returning the assessment to the SAB and releasing the document to the public for a focused review of EPA's responses to the SAB recommendations. Please refer to IRISTrack - Inorganic Arsenic (Cancer) for the latest schedule updates.

Reeder L. Sams

by phone at: 919-541-0661
by email at: sams.reeder@epa.gov

Background

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. Approximately 90% of the domestic consumption of arsenic is currently used with production of chromated copper arsenate (CCA), a wood preservative, the production of which is currently being phased out. 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 only cancer human health effects that may result from chronic exposure to this chemical. An assessment of noncancer health effects of inorganic arsenic will be released for external peer review and public comment at a later date.

History/Chronology

1999	NRC reviews the 1988 IRIS assessment and the available health data for inorganic arsenic and makes recommendations for updating the cancer assessment.
2001	NRC updated the NRC (1999) report and evaluated the toxicological risk and health effects of arsenic as relevant to the 2001 Arsenic Rule.
2001	NRC reviews the 2001 Primary Drinking Water Standard for inorganic Arsenic and EPA’s supporting risk assessment and makes recommendations for applying epidemiologic data in the cancer health assessment.
2003	EPA started a reassessment of the IRIS assessment for inorganic arsenic.
Jul 2005	EPA submitted the reassessment of cancer assessment for inorganic arsenic to EPA’s Science Advisory Board (SAB) for review (see related links under downloads).
Jun 2007	SAB posted a response to the 2005 EPA reassessment of inorganic arsenic (cancer). [See related links (below) or Link to the SAB Report and Review Panel Meetings]
Oct 2008	The draft IRIS Toxicological Review for Inorganic Arsenic (cancer) was submitted to OMB for interagency review.
Feb 2010	EPA released the draft IRIS Toxicological Review for Inorganic Arsenic (cancer) to SAB and simultaneously to the public for review and comment, focusing on EPA’s responses to the SAB (2007) report.
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]

Next Steps

This draft has been archived.

Supporting Documents: The file, Arsenic_Excel_Table 5-3.zip (ZIP, 195 Kb), provides the data and analyses EPA used to derive the cancer risk estimates as described in Table 5-3 in the Toxicological Review of Inorganic Arsenic (Cancer) (External Review Draft) 2010. An additional file (Arsenic_Excel_Appendix F.zip (ZIP, 143 Kb), ) provides the data and analyses EPA used to derive the results presented in Appendix F (Tables F-1 and F-2). Information regarding the files can be found on the first tab (labeled Directions) of each individual Excel® file.

Additional Information

Comments on the assessment may be submitted and reviewed using the e-Government Regulations.gov Web site. From the site, select Environmental Protection Agency and the key word EPA- HQ-ORD-2010-0123 (for the docket ID).

Citation

U.S. EPA. IRIS Toxicological Review of Inorganic Arsenic (Cancer) (2010 External Review Draft). U.S. Environmental Protection Agency, Washington, DC, EPA/635/R-10/001, 2010.

Downloads

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.

IRIS Toxicological Review of Inorganic Arsenic (Cancer) (External Review Draft) (PDF) (575 pp, 7 MB, about PDF)
Arsenic_ Excel_ Table 5-3.zip (ZIP, 195 Kb) (ZIP) (195 KB, about ZIP)
Arsenic_ Excel_ Appendix F.zip (ZIP, 143 Kb) (ZIP) (142 KB, about ZIP)
Charge to External Peer Reviewers (SAB) (PDF) (3 pp, 26 KB, about PDF)
SAB Report (PDF) (NA pp, 433 KB, about PDF)
Charge for the SAB Panel (PDF) (NA pp, 26 KB, about PDF)