2023-06676: National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review
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The U.S. Environmental Protection Agency (EPA) is proposing amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Commercial Sterilization Facilities source category. The EPA is proposing decisions concerning the risk and technology review (RTR), including proposing amendments pursuant to the technology review for certain point source emissions and proposing amendments pursuant to the risk review to specifically address ethylene oxide (EtO) emissions from point source and room air emissions from all commercial sterilization facilities. The EPA is also proposing amendments to correct and clarify regulatory provisions related to emissions during periods of startup, shutdown, and malfunction (SSM), including removing general exemptions for periods of SSM and adding work practice standards for periods of SSM where appropriate. Lastly, the EPA is proposing to revise monitoring and performance testing requirements and to add provisions for electronic reporting of performance test results and reports, performance evaluation reports, and compliance reports. We estimate that, if finalized, these proposed amendments would reduce EtO emissions from this source category by 19 tons per year (tpy) and reduce risks to public health to acceptable levels.
The agency’s own summary, as published.
What this changes
Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.
Rulemaking docket
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Supporting & Related Material December 12, 2019Meeting Minutes for Discussion with Representatives of the Ethylene Oxide Sterilization Association (EOSA) in March 2019
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Supporting & Related Material December 12, 2019Public Act 101-0022 and 101-0023
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Supporting & Related Material December 12, 2019Lower Explosive Limit (LEL) for Ethylene Oxide
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Supporting & Related Material December 12, 2019Meeting Minutes for Discussion with Representatives of STERIS in October 2019
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Supporting & Related Material December 12, 2019E-mail transmitting EPA responses to interagency comments on November 20, 2019 (revised)
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Supporting & Related Material December 12, 2019EtO Actual Use
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Supporting & Related Material December 12, 2019E-mail Series Regarding Interagency Review On November 26, 2019
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Supporting & Related Material December 12, 2019Outdoor Air Monitoring in the Willowbrook Community
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Supporting & Related Material December 12, 2019Draft Meeting Minutes for Discussion with Representatives of Cosmed in October 2019
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Proposed Rule December 12, 2019National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Commercial Sterilization and Fumigation Operations
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Supporting & Related Material December 12, 2019Memorandum to Docket ID No. EPA-HQ-OAR-2019-0178
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Supporting & Related Material December 12, 2019E-mail series arranging discussions between OMB and USEPA from November 21 to 22, 2019
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Supporting & Related Material December 12, 2019Ethylene Oxide Commercial Sterilization and Fumigation Operations NESHAP, Implementation Document
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Supporting & Related Material December 12, 2019CAA Section 112 Risk and Technology Reviews: Statutory Authority and Methodology
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Supporting & Related Material December 12, 2019E-mail Transmittal Of Slides For Ethylene Oxide Sterilizers ANPRM Discussions With OMB On October 31, 2019
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Supporting & Related Material December 12, 2019E-mail transmittal of follow-up interagency comments on Ethylene Oxide Sterilizers ANPRM on November 25, 2019
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Supporting & Related Material December 12, 2019Documentation of OMB Review Under Executive Order 12866
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Supporting & Related Material December 12, 2019E-mail Series Regarding Interagency Review Members. October 31, 2019
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Supporting & Related Material December 12, 2019E-mail series arranging discussions between OMB and USEPA from November 13 to 15, 2019
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Supporting & Related Material December 12, 2019E-mail series regarding Interagency Review comments from November 22 to 26, 2019
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Supporting & Related Material December 12, 2019Investigation Report: Sterigenics, Ontario, California. August 19, 2004
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Supporting & Related Material December 12, 20191910.1047 - Ethylene oxide, Occupational Safety and Health Administration
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Supporting & Related Material December 12, 2019E-mail arranging discussions between OMB and USEPA on November 18, 2019
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Supporting & Related Material December 12, 2019Meeting Minutes for Discussion with Representatives of Advanced Air Technologies in February 2019
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Supporting & Related Material December 12, 2019E-mail Series Arranging Discussions Between OMB And USEPA From October 29 To 30, 2019
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Supporting & Related Material December 12, 2019E-mail series regarding Interagency Review comments from November 22 to 26, 2019
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Supporting & Related Material December 12, 2019E-mail Series Regarding Interagency Review Comments From November 14 to 26, 2019
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Supporting & Related Material December 12, 201912866 Interagency Review: Draft National Emissons Standards for Hazardous Air Pollutants: Ethylene Oxide Commercial Sterilization and Fumigation Operations. Advance Notice of Proposed Rulemaking. Federal Register Notice...
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Supporting & Related Material December 12, 2019Meeting Minutes for Discussion with Representatives of STERIS in September 2019
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Supporting & Related Material December 12, 2019E-mail transmitting USEPA responses to interagency comments on November 20, 2019
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Supporting & Related Material December 12, 2019Revised Calculation of MACT Floors for Major Source Chamber Exhaust Vents at Ethylene Oxide Commercial Sterilization and Fumigation Operations; National Emissions Standards for Hazardous Air Pollutants (NESHAP)
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Supporting & Related Material December 12, 2019E-mail Transmittal Of Interagency Comments On Ethylene Oxide Sterilizers ANPRM On November 14, 2019
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Supporting & Related Material December 12, 2019Ethylene Oxide Emissions for Commercial Sterilization Fumigation Operations, Background Information for Proposed Standards
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Supporting & Related Material December 12, 2019Meeting Minutes for Discussion with Representative of LESNI in March 2019
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Supporting & Related Material December 12, 2019FDA webpage for Ethylene Oxide Sterilization for Medical Devices
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Supporting & Related Material December 12, 2019E-mail series regarding Interagency Review comments from November 14 to 25, 2019
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Supporting & Related Material December 12, 2019E-mail regarding Interagency Review comments on November 26, 2019
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Supporting & Related Material December 12, 2019EPA National Air Toxics Assessment
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Supporting & Related Material December 12, 2019Meeting Minutes for Discussion with Representatives of AdvaMed in July 2019
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Supporting & Related Material December 12, 2019Meeting Minutes for Discussion with Representatives of STERIS in August 2019
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Supporting & Related Material December 12, 2019Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide
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Supporting & Related Material December 12, 2019Preventing Worker Injuries and Deaths from Explosions in Industrial Ethylene Oxide Sterilization Facilities (Revised Edition)
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Supporting & Related Material June 12, 2020Supporting Statement for Public Comment, EPA ICR No. 2623.01, Information Collection Effort for Ethylene Oxide Commercial Sterilization Facilities
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Supporting & Related Material June 12, 2020Ethylene Oxide (EtO) Commercial Sterilization CAA Section 114 Information Collection Request (ICR)
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Notice June 12, 2020Agency Information Collection Activities; Proposals, Submissions, and Approvals: Effort for Ethylene Oxide Commercial Sterilization Facilities
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Supporting & Related Material May 10, 2021EtO 114ICR Supplement 2
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Supporting & Related Material May 10, 2021EtO 114ICR Supplement 3
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Supporting & Related Material May 10, 20212623t01
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Supporting & Related Material May 10, 2021EtO 114ICR Supplement 1
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Supporting & Related Material May 10, 2021EtO 114ICR Main
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Supporting & Related Material May 10, 2021EtO 114ICR Instructions Doc
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Supporting & Related Material May 10, 20212623ss01
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Notice May 10, 2021Agency Information Collection Activities; Proposals, Submissions, and Approvals: Ethylene Oxide Commercial Sterilization Facilities National Emission Standards for Hazardous Air Pollutants Technology Review
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Supporting & Related Material May 20, 20210062.5 EtO ICR FRN 1 RTC v.5
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Proposed Rule April 13, 2023National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Steritec, Inc. in Athens, TX
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Supporting & Related Material April 13, 2023Stack Test Report (12/27/2000) for Deroyal Industries, Inc. (New Tazewell, TN)
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Boulder BioMed in Boulder, CO
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Heartware in Miami Lakes, FL
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from STERIS AST South Plainfield NJ in South Plainfield, NJ
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Supporting & Related Material April 13, 2023Stack Test Report (03/17/2016) for Sotera Health (Atlanta, GA)
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Supporting & Related Material April 13, 2023Lemco (Ardmore, OK) 2017 Emissions Inventory Report
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Supporting & Related Material April 13, 2023September 2021 Section 114 ICR Letter to Ethylene Oxide Commercial Sterilization Facilities
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Supporting & Related Material April 13, 2023December 2019 Questionnaire Survey Instructions, Response Form, and Company Letters
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Supporting & Related Material April 13, 2023Stack Test Report (06/24/2013) for American Contract Systems Incorporated (Houston, TX)
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Supporting & Related Material April 13, 2023Memorandum - In-stack Method Detection Limits of Method 18/CARB 431 in Commercial Sterilization (11/4/2022)
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Supporting & Related Material April 13, 2023Sterigenics (Marion, AR) PUBLIC - Initial Air Permit Application for New Facility (06/05/2022)
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from KPR U.S., LLC dba Kendall Patient Recovery U.S., LLC in Augusta, GA
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Trinity Sterile in Salisbury, MD
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Boston Scientific Corporation in Coventry, RI
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Sterigenics US LLC Ontario in Ontario, CA
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Supporting & Related Material April 13, 2023LSOCA (Brea, CA) Application Form for Permit or Plan Approval
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Supporting & Related Material April 13, 2023Stack Test Report (11/17/2003) for Johnson & Johnson (San Angelo, TX)
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Supporting & Related Material April 13, 2023STERIS (Grand Prairie, TX) Air Permit No. 38690 Amendment Additional Information - Copyrighted
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Supporting & Related Material April 13, 2023Email from R.Nicolli, AAT, to G.Queiroz, EPA. Information on dry bed scrubbers. January 03, 2020.
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Supporting & Related Material April 13, 2023Meeting Minutes for Discussion with Medline Representatives on July 15, 2021
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Supporting & Related Material April 13, 2023OMB 2015. 2015 Report to Congress on the Benefits and Costs of Federal Regulations and Agency Compliance with the Unfunded Mandates Reform Act. (2015)
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Supporting & Related Material April 13, 2023ASTA 2009. Ethylene Oxide White Paper. (2009)
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Supporting & Related Material April 13, 2023EtO Compliance Report Draft Template - Summary Report
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Supporting & Related Material April 13, 2023Liu 2006. Price and income elasticity of the demand for health insurance and health care services: a critical review of the literature. (3/24/2006)
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Supporting & Related Material April 13, 2023AERMOD Implementation Guide
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Supporting & Related Material April 13, 2023Arrow et al. 2013. Benefit-Cost Analysis in Environmental, Health, and Safety Regulation. (1996)
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Supporting & Related Material April 13, 2023FDA 2019c. Center for Devices and Radiological Health Ethylene Oxide Sterilization Master File Pilot Program. (11/26/2019)
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Supporting & Related Material April 13, 2023Meeting Minutes for Discussion with AdvaMed Representatives on March 8, 2022
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Supporting & Related Material April 13, 2023Site Visit Report for Sterilization Services of Virginia facility in Richmond, VA
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Northborough in Northborough, MA
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from The Jackson Laboratory (JAX) Sacramento in Sacramento, CA
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from BD Medical Sandy in Sandy, UT
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from BD Medical Sandy in Sandy, UT
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Supporting & Related Material April 13, 2023Cosmed (San Diego, CA) Health Risk Assessment Review
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Baxter Healthcare Corporation in Mountain Home, AR
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Supporting & Related Material April 13, 2023Meeting Minutes for Discussion with AdvaMed Representatives on July 27, 2021
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Supporting & Related Material April 13, 2023Letter from M.Zhuang, EOSA, to M.Koerber, EPA. Inputs on emission fractions for fugitive/room air emissions. February, 08, 2022.
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Sterilization Services of Virginia in Richmond, VA
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Supporting & Related Material April 13, 2023Boston Scientific (Maple Grove, MN) Response to Request for Information from Minnesota Pollution Control Agency
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Supporting & Related Material April 13, 2023St. Jude Medical (Sylmar, CA) Permit to Operate G22028 (12/13/2012)
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Microvention in Aliso Viejo, CA
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Supporting & Related Material April 13, 2023Summary of EtO Facilities in Maryland
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Supporting & Related Material April 13, 2023Incorporation by Reference of materials associated with the development of the current EtO commercial sterilization standards (Docket ID No. EPA–HQ–OAR–2003–0197)
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Cook Inc. Ellettsville North Facility in Ellettsville, IN
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Elite Spice in Hanover, MD
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from STERIS AST in Temecula, CA
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Sterigenics US LLC, Los Angeles 50th St in Los Angeles, CA
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Cosmed Group Inc. dba ETO Sterilization in Linden, NJ
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Medtronic PLC (MPROC) - Villalba in Villalba, PR
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Sterigenics US LLC Santa Teresa in Santa Teresa, NM
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Physiological Research Laboratory in Coon Rapids, MN
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Rice Creek in Fridley, MN
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Supporting & Related Material April 13, 2023Stack Test Report (02/20/2020) for STERIS, Ltd. (Temecula, CA)
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Sterilization Services of Tennessee in Memphis, TN
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from BD Pharmaceuticals Systems in Columbus, NE
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Jacksonville in Jacksonville, FL
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Parter Sterilization Services in Carson, CA
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Supporting & Related Material April 13, 2023Stack Test Report (10/02/2018) for STERIS, Ltd. (Coon Rapids, MN)
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Supporting & Related Material April 13, 2023MDE Inspection of Trinity Sterile (Salisbury, MD) on 08/02/2010
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Supporting & Related Material April 13, 2023Section 114 Database and Documentation Memorandum
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Supporting & Related Material April 13, 2023Stack Test Report (10/06/2022) for American Contract Systems Inc. (Zelienople, PA)
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Supporting & Related Material April 13, 2023Executive Order 12866 Meeting Records - Proposed Rule Stage
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Elite Spice Inc. in Sparks, NV
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Supporting & Related Material April 13, 2023Supporting Statement and Burden Estimate for Subpart O rule proposal
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Supporting & Related Material April 13, 2023FDA 2019a. FDA Executive Summary Prepared for the November 6-7, 2019 Meeting of the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee on Reduction of Ethylene Oxide Sterilization E...
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Supporting & Related Material April 13, 2023Memorandum - In-stack Method Detection Limits of Optically Enhanced FTIR
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Supporting & Related Material April 13, 2023Stack Test Report (01/02/2013) for Sotera Health (Santa Teresa, NM)
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Supporting & Related Material April 13, 2023Stack Test Report (10/03/2006) for Parter Sterilization Services (Carson, CA)
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Supporting & Related Material April 13, 2023Air Pollution Emission Notice (Sept 19, 2018) for LivaNova PLC
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Supporting & Related Material April 13, 2023Stack Test Report (07/10/2015) for Johnson & Johnson (San Jose, CA)
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Supporting & Related Material April 13, 2023GEPD Comments on USEPA EtO Modeling Files
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Centurion Medical Products in YUMA, AZ
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Supporting & Related Material April 13, 2023Stack Test Report (11/08/2015) for Sotera Health (Ontario, CA)
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from International Sterilization Laboratory in Groveland, FL
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from B. Braun Medical Inc. Allentown in Allentown, PA
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Supporting & Related Material April 13, 2023Stack Test Report (07/11/2019) for Busse Hospital Disposables (Hauppauge, NY) - COPYRIGHTED
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Supporting & Related Material April 13, 2023Email from M. Biondi, AAT, to A. Hawkins, EPA. Information on control system media costs. November 8, 2018.
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Supporting & Related Material April 13, 2023FDA 2019b. Ethylene Oxide Sterilization for Medical Devices. (2019)
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Supporting & Related Material April 13, 2023Acute Dose-Response Values for Screening Risk Assessments (8/31/2021)
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Supporting & Related Material April 13, 2023Technical Support Document for Proposed Rule - Industry Profile, Review of Unregulated Emissions, CAA Section 112(d)(6) Technology Review, and CAA Section 112(f) Risk Assessment for the Ethylene Oxide Emissions Standards...
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Supporting & Related Material April 13, 2023User's Guide for the AMS/EPA Regulatory Model (AERMOD)
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Supporting & Related Material April 13, 2023OSHA 2002. OSHA fact sheet on ethylene oxide. (2002)
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Supporting & Related Material April 13, 2023Meeting Minutes for Discussion with Becton Dickinson Representatives on June 8, 2021
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Supporting & Related Material April 13, 2023Email from Banon, Y., EPA Region 2, to J.Witt, U.S. EPA. Release parameters for Long Island Sterilization facility. February 11, 2021. EtO Usage and stack parameters for Cosmed NJ facility and Steris NJ facility.
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Supporting & Related Material April 13, 2023Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide
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Supporting & Related Material April 13, 2023Memorandum to Project File. Declassification of Ethylene Oxide Emitted from Various Emission Points at Commercial Sterilization Facilities.
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Supporting & Related Material April 13, 2023GIPA 2017. A Comparison of Gamma, E-beam, X-ray and Ethylene Oxide Technologies for the Industrial Sterilization of Medical Devices and Healthcare Products. (8/31/2017)
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Supporting & Related Material April 13, 2023Genentech (South San Francisco, CA) Synthetic Minor Operating Permit Evaluation Report (12/04/2012)
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Supporting & Related Material April 13, 2023Initial Performance Test and CMS Performance Evaluation (August 2000) for Medtronic PLC (Villalba, PR)
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Stryker Sustainability Solutions in Phoenix, AZ
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from North Haven in North Haven, CT
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from El Paso I in El Paso, TX
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Midwest Sterilization Corporation in Jackson, MO
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Heartware in Miami Lakes, FL
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Supporting & Related Material April 13, 2023Sterigenics (Gifford Ave - Los Angeles, CA) Permit to Operate G44884 (02/08/2017)
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Arthrex Manufacturing Inc. Finishing Facility in Ave Maria, FL
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Supporting & Related Material April 13, 2023esponse to 2021 Section 114 ICR from Madison Sterilization in Madison, GA
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Supporting & Related Material April 13, 2023EPA 2005. Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens. (March 2005)
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Supporting & Related Material April 13, 2023Email from J.Witt, EPA, to G.Queiroz, EPA. Information on Midwest Sterilizers Corp. March 17, 2021.
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Supporting & Related Material April 13, 2023EPA 2016. Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide (CASRN 75-21-8) In Support of Summary Information on the Integrated Risk Information System (IRIS). National Center for Environmental Assessment, O...
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Supporting & Related Material April 13, 2023EPA 2018. Ethylene Oxide. Health Effects Notebook for Hazardous Air Pollutants. (December 2018)
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Supporting & Related Material April 13, 2023Emissions data for commercial ethylene oxide sterilization facilities located in California
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from The Jackson Laboratory in Ellsworth, ME
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Supporting & Related Material April 13, 2023Elite Spice (Sparks, NV) EtO Reno Scrubber Efficiency Calculations
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Royal Sterilization Systems in New Tazewell, TN
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Sterigenics US LLC Santa Teresa in Santa Teresa, NM
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Elite Spice Inc. in Jessup, MD
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Midwest Sterilization Corporation in Laredo, TX
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Centurion Medical Products in Salisbury, NC
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from STERIS AST in Coon Rapids, MN
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Sterigenics US LLC Atlanta in Atlanta, GA
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Covington Sterilization in Covington, GA
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Supporting & Related Material April 13, 2023Literature Search for Ethylene Oxide Commercial Sterilization Facilities
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Supporting & Related Material April 13, 2023OSHA 2005. Regulatory review of the Occupational Safety and Health Administration’s ethylene oxide standard [29 CFR 1910.1047]. (March 2005)
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Supporting & Related Material April 13, 2023Cost Memorandum Workbook
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Supporting & Related Material April 13, 2023EOSA 2018. The Benefits of Ethylene Oxide Sterilization. (2018)
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Supporting & Related Material April 13, 2023FDA 2022. Sterilization for Medical Devices (2022)
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Supporting & Related Material April 13, 2023ITA 2016. 2016 Top Markets Report – Medical Devices. (May 2016)
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Supporting & Related Material April 13, 2023Scoogins & Weinberg 2017. Healthcare Coinsurance Elasticity Coefficient Estimation Using Monthly Cross‐sectional, Time‐series Claims Data. (3/30/2016)
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Supporting & Related Material April 13, 2023Test Report - Sterigenics Willowbrook, IL (10/18/2018)
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Supporting & Related Material April 13, 2023CRS 2015. The Medical Device Excise Tax: Economic Analysis. (6/18/2015)
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Supporting & Related Material April 13, 2023Fuchs (Hampstead, MD) Emissions Certification Report (2018)
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Cosmed Group Inc., dba Cosmed of PA in Erie , PA
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Edwards Lifesciences Technology Sàrl in Añasco, PR
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from STERIS AST in Temecula, CA
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Cosmed Group Inc. in Franklin, NJ
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Cardiac Pacemakers Inc/Boston Scientific in Arden Hills, MN
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Sterigenics US LLC, Los Angeles - Gifford Ave in Los Angeles, CA
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from STERIS Corporation in El Paso, TX
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Sterigenics US LLC Charlotte in Charlotte, NC
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Sterigenics, LLC - Grand Prairie in Grand Prairie, TX
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Jacksonville in Jacksonville, FL
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Cosmed Group Inc., dba Cosmed of PA in Erie , PA
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Dynatec Scientific Laboratories in El Paso, TX
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Supporting & Related Material April 13, 20232021 ICR Letters
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Supporting & Related Material April 13, 2023Customed (Fajardo, PR) Permit to Operate (09/30/2016)
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Supporting & Related Material April 13, 2023Stack Test Report for the Cosmed Group, Inc. facility in Erie, PA
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Supporting & Related Material April 13, 202312866 Interagency Review Documentation - File Set 2 of 2: National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review. Not...
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Supporting & Related Material April 13, 2023E-mail between MPCA and USEPA from February 10, 2021
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Supporting & Related Material April 13, 2023Stack Test Report (03/07/2022) for American Contract Systems Inc. (Tiffin, OH)
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Supporting & Related Material April 13, 2023E-mail correspondence between USEPA and Medtronic from February 5 to 12, 2021
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Supporting & Related Material April 13, 2023Summary of 2021 EtO Emissions with New Control Equipment (STERIS Ltd)
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Supporting & Related Material April 13, 2023Emissions Data for the Terumo BCT, Inc. facility in Lakewood, CO
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Arrow International, Inc. - Asheboro in Asheboro, NC
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Supporting & Related Material April 13, 2023Small Business Advocacy Review Panel - Final Report
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Supporting & Related Material April 13, 2023EPA’s Air Toxics Risk Assessment Library. Volume 1, Appendix D Methodology for Identifying PB-HAP Compounds
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Supporting & Related Material April 13, 2023Sterigenics 2019. Ethylene Oxide Sterilization. (2019)
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Supporting & Related Material April 13, 2023Development of Ethylene Oxide Usage Fractions for Ethylene Oxide Commercial Sterilization - Proposal
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Supporting & Related Material April 13, 2023Emissions data for commercial ethylene oxide sterilization facilities located in Florida
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Supporting & Related Material April 13, 2023Meeting Minutes for Discussion with Sterigenics Representatives on April 8, 2021
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Supporting & Related Material April 13, 2023Site Visit Request Letter for Sterigenics in Charlotte, NC
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Supporting & Related Material April 13, 2023Aron-Dine et al. 2013. The RAND Health Insurance Experiment, Three Decades Later. (2013)
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from NovoSci in Conroe, TX
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Supporting & Related Material April 13, 2023IDEM Information on commercial ethylene oxide sterilization facilities located in Indiana
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Sterilization Services of Georgia in Atlanta, GA
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from STERIS AST in Coon Rapids, MN
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Midwest Sterilization Corporation in Laredo, TX
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Ethicon in San Angelo, TX
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from St. Jude Medical CRMD in Sylmar, CA
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Supporting & Related Material April 13, 2023Stack Test Report (10/01/2019) for Becton, Dickinson and Company (Covington, GA)
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Sterigenics US LLC Atlanta in Atlanta, GA
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Supporting & Related Material April 13, 2023Air Pollution Emission Notice (May 22, 2012) for Jorgensen Laboratories
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Supporting & Related Material April 13, 2023Permit Documents for the Abbott Laboratories facility in Arecebo, PR (01/15/2016)
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Supporting & Related Material April 13, 2023Engineering Studies Report (BD Georgia, 4/30/2020)
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Supporting & Related Material April 13, 2023Inspection report from SDDA for 3M (Brookings, SD) on 05/16/2019
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Supporting & Related Material April 13, 2023Stack Test Report (07/22/2020) for Becton, Dickinson and Company (Columbus, NE)
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Supporting & Related Material April 13, 20232020 TRI for Elite Spice Inc. (Jessup, MD)
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Medline North Point Services (NPS) in Waukegan, IL
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Supporting & Related Material April 13, 2023MDDI 1998. EtO sterilization: Principles of process design. (December 1998)
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Supporting & Related Material April 13, 2023Risk and Technology Review – Analysis of Demographic Factors for Populations Living Near Commercial Sterilization Facilities (12/11/2022)
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Supporting & Related Material April 13, 2023Schmalansee & Stavins 2011. A guide to economic and policy analysis of EPA’s Transport Rule. (March 2011)
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Supporting & Related Material April 13, 2023Sterigenics 2018. Stored Energy Device Safety Assessment for Ethylene Oxide Sterilization. (August 2018)
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Supporting & Related Material April 13, 20232018 Emissions Inventory for ACS (Chandler, AZ)
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Supporting & Related Material April 13, 2023Stack Test Report (09/17/2004) for Cosmed Group, Inc. (Franklin, NJ)
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Sterigenics Salt Lake City in Salt Lake City, UT
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Abbott Cardiovascular Systems in Temecula, CA
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Terumo BCT in Lakewood, CO
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Sterigenics US LLC
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Northborough in Northborough, MA
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Supporting & Related Material April 13, 2023NASA - Ames Research Center (Mountain View, CA) Synthetic Minor Operating Permit Evaluation Report
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Supporting & Related Material April 13, 20232021 ICR - Index of CBI Facilities
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from NASA Ames Research Center in Mountain View, CA
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from STERIS AST South Plainfield NJ in South Plainfield, NJ
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Supporting & Related Material April 13, 20232019 ICR - Index of CBI Facilities
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Sterigenics US LLC Ontario in Ontario, CA
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from BD Pharmaceuticals Systems in Columbus, NE
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Spartanburg in Spartanburg, SC
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Grand Prairie in Grand Prairie, TX
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Centurion Medical Products in Howell, MI
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Steri-Tech, Inc. in Salinas, PR
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Central Virginia Health Network in Richmond, VA
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Supporting & Related Material April 13, 2023Response to 2019 Section 114 ICR from Sterilization Services of Virginia in Richmond, VA
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Supporting & Related Material April 13, 2023Stack Test Report (07/29/2019) for Boston Scientific Corporation (Dorado, PR)
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Supporting & Related Material April 13, 2023Response to 2021 Section 114 ICR from Blue Line Sterilization Services in Novato, CA
Public comments
What people are saying
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Anonymous commenter 2026-10-08
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Anonymous commenter 2026-10-08
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Anonymous commenter 2026-10-08
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