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EPA/OAR RIN: 2060-AU37 Publication ID: Spring 2019 
Title: ●National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Sterilizers Technology Review 

Maximum achievable control technology standards for commercial ethylene oxide (EtO) sterilizers were finalized on December 6, 1994 (59 FR 62585). The standards required controls for various sources of emissions depending on the amount of EtO used at a facility. On April 7, 2006, the EPA completed the residual risk and technology review for commercial EtO sterilizers (77 FR 17712). In December 2016, the carcinogenicity of EtO increased, causing substantial changes to risk from EtO sterilizers across the country. In this action, the EPA will propose a course of action for dealing with emissions from commercial EtO sterilizers.

Agency: Environmental Protection Agency(EPA)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
CFR Citation: 40 CFR 63   
Legal Authority: 42 U.S.C. 7412, Clean Air Act   
Legal Deadline:  None
Action Date FR Cite
NPRM  07/00/2019 
Final Rule  12/00/2019 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Sectors Affected: 311942 Spice and Extract Manufacturing; 325412 Pharmaceutical Preparation Manufacturing; 33911 Medical Equipment and Supplies Manufacturing 
RIN Data Printed in the FR: No 
Agency Contact:
Jon Witt
Environmental Protection Agency
Office of Air and Radiation
109 T.W. Alexander Drive, Mail Code E143-05,
Research Triangle Park, NC 27709
Phone:919 541-5645

Nick Hutson
Environmental Protection Agency
Office of Air and Radiation
109 T.W. Alexander Drive, Mail Code D243-01,
Research Triangle Park, NC 27711
Phone:919 541-2968
Fax:919 541-4991