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EPA/AR RIN: 2060-AM20 Publication ID: Spring 2010 
Title: Petition To Delist a Hazardous Air Pollutant From Section 112 of the Clean Air Act: Methyl Isobutyl Ketone (MIBK) 
Abstract: The Ketones Panel of the American Chemistry Council (ACC) has petitioned the Agency to remove methyl isobutyl ketone (MIBK) from the Clean Air Act (CAA) hazardous air pollutant (HAP) list. The ACC originally submitted the petition in April of 1997. EPA suspended review of the petition pending the completion of 2-generation reproductive effects study. That study is now complete. On October 17, 2003, the ACC submitted an addendum to the 1997 petition which includes: the results of the 2-generation reproductive effects study, a presentation of the updated EPA IRIS file for MIBK, updated air dispersion modeling, and an analysis of potential transformation products. Based on this new submission, the ACC requested that EPA reopen its review of the MIBK petition. EPA did reopen its review of the petition. However, since the last submittal by the petitioner, a 2-year MIBK bio-assay by the National Toxicology Program (NTP) has been completed. A draft report of this study was reviewed by the NTP Board of Scientific Counselors Technical Reports Review Subcommittee, which accepted unanimously the conclusions in the report that there is some evidence of carcinogenic activity of MIBK. EPA has notified the petitioner that further review of the petition will require that the petitioner submit information regarding the relevance of the NTP study and a risk characterization for the human risk of cancer from MIBK exposures, which would include the derivation of a cancer unit risk estimate. 
Agency: Environmental Protection Agency(EPA)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 40 CFR 63   
Legal Authority: 42 USC 7412   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Notice  07/19/2004  69 FR 42954   
Proposed Response  To Be Determined    
Additional Information: SAN No. 4849; EPA publication information: Notice - http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-16335.htm.
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Ken Hustvedt
Environmental Protection Agency
Air and Radiation
E143-01,
RTP, NC 27711
Phone:919 541-5395
Fax:919 685-3200
Email: Hustvedt.Ken@epamail.epa.gov