UNITED STAT ES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460


### OCT 22 2015 MEMORANDUM SUBJECT: Completion ofTesting under an Enforceable Consent Agreement for the Hazardous Air Pollutant I ,2-Ethylene Dichloride 

### FROM: Maria 

### J. Doa, Directo l()fn 

## Uk-., Chemical Control Division,

## ~·**T** TO: Erika Sasser, Director Health and Environmental Impacts Division, OAQPS The purpose ofthis memorandum is to inform the Office of Air Quality Planning and Standards (OAQPS) that testing under the Enforceable Consent Agreement for Ethylene Dichloride (EDC) (CASRN 107-06-2) is now complete and the results are avai lable in docket EPA-HQ-OPPT2003 -0 010 for use by the Health and Environmental Impacts Division (HElD). At OAQPS' request, the Office of Pollution Prevention and Toxics (OPPTS) published a Proposed Test Rule for Hazardous Air Pollutants (HAPs) under section 4 of the Toxic Substances Control Act (TSCA) in the Federal Register 

### in June 1996 (61 FR 33 17 8, June 26 , 1996)
. The rule proposed testing fo r 21 chemicals, including EDC, that are listed as HAPs under section 1 12 of the Clean Air Act (CAA), and solicited proposals for enforceable consent agreements (ECAs). As a result, EPA and th e Hazardous Air Pollutant (HAP) Task Force entered into an ECA to test EDC for health effects relevant to conducting a residual risk assessment in support of the CAA. The testing program was complex in that it included development of pharmacokinetics and mechanistic data and a computational dosimetry model for route-to-route extrapo lations, which would allow the use of data from studies conducted by the oral route of exposure to predict the effects of inhalation exposures . The testing is described in the Federal Register notice issued on June 3 , 2003, announcing the ECA (68 FR 33125)
. Tier II HAPs testing described in the Federal Register notice was later modified to allow an extended onegeneration reproductive effects protocol with a neurotoxicity satellite to substitute for the reproductive and neurotoxicity testing protocols originally specified by the ECA. Documents that can be accessed in the docket that may be of particular interest to HElD include: 1) I,2-Ethylene Dichloride (EDC); Final Enforceable Consent Agreement and Testing Consent Order FEDERAL REGISTER NOTICE June 3 , 2003 (EPA-HQ-OPPT- 2003- 00 10-000 1 ); 2) 1,2

- Ethylene Dichloride Tier I Program Review Testing; Notice of Availability and Solicitation of Comment FEDERAL REGISTER NOTICE September 5 , 2006 (EPA

-HQOPPT-2003-00 1 0-0089) ;

Internet Address (URL) • http :/lwww

. epa.gov Recycled!Recyc l able • Printed with Vegetab le 011 Based Inks on 100% Postconsumer

. Process Chlorine Free Recycled Paper3) L2-Ethylene Dichloride; Completion of EPA Program Review FEDERAL REGISTER NOTICE July I 0, 2009 (EPA-HQ-OPPT-2003-001 0-0099); 4) Final Report; 1.2 Dichloroethane (EDC): Limited Pharmacokinetics and Metabolism Study in Fischer 344 Rats February 28, 2006 (February 28, 2006): 5) Final Report; Physiologically Based Pharmacokinetic Model Development and Simulations for Ethylene Dichloride ( 1.2-Dichloroethane) in Rats July 7, 2006 (EPA-HQOPPT-2003-001 0-0086); 6) Final Report; L2-Ethylene Dichloride (EDC): Acute Inhalation Toxicity with Bronchoalveolar Lavage and Histopathology/ Acute Inhalation Neurotoxicity Study in F344/DUCRL Rats (part I of 7) (letter and final study repoti

-- 7 pmts includes 6

attachmenls) June 2L 2006 (EPA-HQ-OPPT-2003-001 0-0087); 7) Final Report: Route-to-Route Extrapolation of 1,2-Dichloroethanc Studies from the Oral Route to Inhalation Using Physiologically Based Pharmacokinetic Models: Subchronic Toxicity in the Rat July 26, 2010 (EPA-HQ-OPPT-2003-0010-0112); 8) Final Reproductive Toxicity Report; An Extended One-Generation Drinking Water Reproductive Toxicity Study of Ethylene Dichloride in Rats August 24,2015 (EPA-HQOPPT-2003-00 1 0-0134); 9) Final Report; Final PBPK Modeling of Reproductive Study; Route--to--Route Extrapolation of 1.2--Dichloroethane Studies from the Oral Route to Inhalation Using Physiologically Based Pharmacokinetic Models: Extended One Generation Toxicity Study and Reproductive Toxicity Studies in the Rat July 30,2015 (EPA-HQ-OPPT-2003- 0010-0135). If you have any questions or need additional information, please contact John Schaeffer, the project manager for the EDC ECA, by telephone at (202) 564-8173 or email at schaeffer.john@epa.gov.