IRIS Toxicological Review of Tert-Butyl Alcohol (TBA) (Public Comment Draft, 2016)

Abstract

EPA is developing an Integrated Risk Information System (IRIS) assessment of tert-butyl Alcohol (tert-butanol or tBA) and has released the public comment draft assessment for public comment and external peer review. When final, the assessment will appear on the IRIS database.
tert-Butyl Alcohol (tBA) is used as a solvent; as a denaturant for ethanol and several other alcohols; in the manufacture of flotation agents, fruit essences, and perfumes; as an octane booster in gasoline; as a dehydrating agent; and as a chemical intermediate in the manufacture of methyl methacrylate. tBA's production for industrial uses may result in its direct release to the environment through various waste streams. tBA is also a likely degradation product of methyl tert-butyl ether (MTBE). Probable routes of human exposure to tBA include inhalation, ingestion, and skin or eye contact.

Impact/Purpose

This draft report is being released for public viewing and comment prior to a public meeting, providing an opportunity for the IRIS Program to engage in early discussions with stakeholders and the public on data that may be used to identify adverse health effects and characterize exposure-response relationships. EPA welcomes all comments on the draft literature search, preliminary evidence tables, and preliminary exposure-response arrays, such as remarks on the following: • the clarity and transparency of the materials; • the approach for identifying pertinent studies; • the selection of studies for data extraction to preliminary evidence tables and exposure-response arrays; • any methodological considerations that could affect the interpretation of or confidence in study results; and • any additional studies published or nearing publication that may provide data for the evaluation of human health hazard or dose-response relationships.

Status

Following public comment and external peer review, the assessment will be revised taking into consideration peer review and public comments. The assessment will then undergo a final EPA internal review and a review by other federal agencies and the Executive Office of the President. Once final, the assessment will be posted to the IRIS database.

Citation

U.S. EPA. IRIS Toxicological Review of Tert-Butyl Alcohol (TBA) (Public Comment Draft, 2016). U.S. Environmental Protection Agency, Washington, DC, EPA/635/R-16/079, 2016.

Date	Description
01- Aug 2013	EPA released Preliminary Assessment Materials (draft literature searches and associated search strategies, evidence tables and exposure response arrays) for discussion at an IRIS Public Science Meeting.
02- Dec 2013	EPA discussed tert-butanol at the December 2013 IRIS public science meeting.
03- Sep 2014	EPA sent an interagency science consultation draft for review and comment.
04- May 2016	EPA released the public comment draft for public review and comment. It is also a topic of discussion for the May 10, 2016 IRIS Public Science Meeting.
05- Jun 2016	EPA discussed the tBA (public comment draft) at the June 29-30, 2016 IRIS Public Science Meeting.
06- Jun 2017	EPA released the external review draft and charge to reviewers prior to the public peer review meeting.[SAB FR Notice Jun 16, 2017]

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.

• Toxicological Review of tert-Butyl Alcohol (Public Comment Draft) (PDF)  (140  pp, 2.9 MB, about PDF)
• Toxicological Review of tert-Butyl Alcohol - Supplementary Information (Public Comment Draft) (PDF)  (107  pp, 2.0 MB, about PDF)
• Draft Charge to the Science Advisory Board for the IRIS Toxicological Review of tert-Butyl Alcohol (PDF)  (5  pp, 168.0 KB, about PDF)
• ETBE kidney tables for the draft IRIS Assessment of tert-Butyl Alcohol (PDF)  (18  pp, 1.0 MB, about PDF)
• IRIS Public Science Meeting (Dec 2013)
• IRIS Public Science Meeting (Jun 2016)

Related Link(s)

• IRIS Toxicological Review of Tert-Butyl Alcohol (TBA) (Preliminary Assessment Materials, 2013)
• IRIS Toxicological Review of Tert-Butyl Alcohol (TBA) (Interagency Science Consultation Draft, 2014)
• IRIS Toxicological Review of Tert-Butyl Alcohol (TBA) (External Review Draft, 2017)

Docket

Comments on the assessment may be submitted and reviewed using the Docket ID EPA-HQ-ORD-2013-0111