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IRIS Toxicological Review of Methanol (External Review Draft; December 2009)
[Mar 2011] UPDATE: Following a report from the National Toxicology Program (NTP), EPA has placed the external peer review of the draft IRIS Methanol Toxicological Review on hold. The NTP report (referred to in EPA's June 15, 2010 press release) recommended that pathology reviews be carried out to resolve differences of opinion in the diagnoses of certain tumors reported in a methanol research study completed by the Ramazzini Institute. Therefore, EPA and the National Institute of Environmental Heath Sciences plan to jointly sponsor an independent Pathology Working Group (PWG) review of select studies conducted at the Institute. More information regarding the PWG work will be made publicly available in the near future.
Citation:
U.S. EPA. IRIS Toxicological Review of Methanol (External Review Draft; December 2009). U.S. Environmental Protection Agency, Washington, DC, EPA/635/R-09/013, 2010.
Impact/Purpose:
EPA is conducting a peer review of the scientific basis supporting the human health hazard and dose-response assessment of methanol that will appear in the Integrated Risk Information System (IRIS) database.
Description:
NOTE: The IRIS Toxicological Review of Methanol (external review draft; December 2009) was released for public comment and external peer review in January 2010 (Federal Register Notice Jan 12, 2010). The draft assessment was placed on hold in June 2010 (Press Release Announcement Jun 15, 2010) pending a review of certain underlying cancer studies. The non-cancer portion of the draft assessment was not impacted by the review of the cancer studies and was subsequently re-released for public comment and external peer review (Press Release Announcement Apr 11, 2011). The non-cancer methanol assessment peer review panel met in July 2011 and that panel’s report is available. The original draft assessment (December 2009) has been archived but is available on this web page for the sake of transparency.
In March 2012 EPA announced that it would no longer rely on certain data (Ramazzini update) that were utilized in the December 2009 draft assessment to characterize the carcinogenic potential of methanol.
URLs/Downloads:
IRIS Toxicological Review of Methanol (External Review Draft) with Notice (PDF, 491 pp, 5375 KB, about PDF)Charge to External Peer Reviewers (PDF, 5 pp, 29 KB, about PDF)
METHANOL - JAN 2010.ZIP
NEDO: Toxicological Research of Methanol as a Fuel for Power Station (Oct 1987) Scanned PDF (PDF, 289 pp, 12177 KB, about PDF)
Comments from Peer Reviewers on the NEDO Methanol Review (Jun 2009) (PDF, 109 pp, 436 KB, about PDF)