J~~-(ED ST,yT~S 

A YJ UNITED STATES ENVIRONMENTAL PROTECTION AGE 

WASHINGTON, D.C. 20460 

JUN 3 0 2009 

Dr. Peter Voytek 

HAP Task Force 

P.O. Box 331 

Milwood, VA 22646 

IIIVlillllllllllllll'llllllll!II!III'IIIIIIIlili4AP 

4 2 

RE : Completion of the EPA Program Review for EDC 

I am writing to thank the Hazardous Air Pollutant (HAP) Task Force for its completion of the 

EPA Program Review segment of the Enforceable Consent Agreement (ECA) for 1,2-ethylene 

dichloride (EDC). The pharmacokinetics studies and mechanistic data (PK/MECH) report and Tier I 

toxicity studies have been acceptably conducted according to the protocols specified in the appendices 

to the ECA, and the additional work on the physiologically-based pharmacokinetics (PBPK) model for 

EDC under the ECA has resulted in an appreciable improvement to prior PBPK models of EDC. 

In addition, I am writing to inform the HAP Task Force that the Tier 11 Testing and 

Extrapolation Reporting can proceed under an amended time schedule . The effective date for irj%tiating 

Tier 11 activities will be upon publication of the Federal Register notice announcing the completian of 

EPA's Program Review. The Addendum Modification to the EDC ECA, specifying the amended., time 

schedule is enclosed with this letter . The testing schedule corresponds closely to that originally -~ 

established in the Federal Register notice announcing the ECA and Order for EDC, but is modified to 

account for the additional time that has been required to complete the Program Review segment 'of the 

ECA. ' ` 

Your signature is needed on the Addendum indicating agreement with these changes. These 

modifications are considered minor changes for which public comment is not required . Please sign 

and return the enclosed "Addendum to the Enforceable Consent Agreement for 1,2-Ethylene 

Dichloride ." This signed document will be added to the official record for this ECA testing action 

(Docket OPPT-2003-0010). 

CQ~~~~~'S N 

Internet Address (URL) 0 http ://www .epa .gov 

Recycled/Recyclable 9 Printed with Vegetable Oil Based Inks on 100% Postconsumer, Process Chlorine Free Recycled Paper 

OFFICE OF 

PREVENTION, PEIggCIDES AND 

TOXIC SUBSF2~ICES 

a. :: 

l ' 1 9. .-- -3,Qo"7 
I look forward to the successful completion of the Tier Il testing and reporting activities . 

Please call John Schaeffer (202-564-5173) if you have any questions. 

Jim/VV' lis, Director 

Ch~xn'cal Control Division 

cc: Docket OPPT-2003-0010 

Francisca Liem (2225A) 

John Schaeffer (7405) 

Renee Kearney (7405) 

Caffey Norman (Patton Boggs, L.L.P.) 

Enclosure a/s 
ADDENDUM MODIFICATION 

TO 

ENFORCEABLE CONSENT AGREEMENT 

FOR 

1,2-ETHYLENEDICHLORIDE (EDC) 

CAS NO. 107-06-2 

DOCKET NO. 

OPPT-2003-0010 

Addendum Modification to Tier II Testing Schedule for Enforceable Consent 

Agreement for 1,2-ETHYLENEDICHLORIDE (EDC). 

We the undersigned agree to the "Deadline for final report" changes to the Enforceable Consent 

Agreement for 1,2-Ethylene Dichloride as described below: 
Table Modifications: 

From: the original language for Table l, Tier II Testing, of the ECA: 

Table 1 . --Required Testing, Test Standards, and Reporting Requirements for EDC 

Testing 

Segment* 

Required testing Test standard Deadline for 

final report\1\ 

(Months) 

Subchronic toxicity route-to-route ECA Appendix C.2 and C.6 36 

Tier II Testing extrapolation of dose-response (oral Tier II 

and/or testing to inhalation) of a study reported by 

Extrapolation Daniel, et al., (1994) 

Reporting 

Subchronic neurotoxicity (oral) 40 CFR §799.9620 (as 42 

annotated in ECA Appendix 

D.2) 

Subchronic neurotoxicity route-to-route ECA Appendix C3 and C.6 52 

extrapolation of dose-response (oral Tier II 

testing to inhalation) 

40 CFR §799.9380 (as 

Reproductive toxicity (oral) annotated in ECA Appendix 42 

D.3) 

Reproductive toxicity route-to-route ECA Appendix C.4 and C.6 52 

extrapolation of dose-response (oral data to 

inhalation, including Tier II testing and 

extant studies reported by Alumot, et al., ° 

(1976), Rao, et al., (1980), and Lane, et al., 

(1982)) 

\1 \Number of months after the effective date of the Order that incorporates this ECA when final report is due. Interim 

status reports , describing the status of all testing to be performed under this ECA, must be submitted by the Companies to 

EPA every 6 months beginning six months from the effective date of this ECA until the end of the ECA testing program 

(see Part VIII . E. and Part XIII of this ECA). 

*Table Footnotes 10, 11, 12 and 13 are unaffected by this addendum modification to the ECA testing schedule for EDC. 
FROM MS I . FR?S N0. :5408371602 Jul . 06 2009 11 : 32RM pp 15 

TO.' the new. amemded tanzua2c fartable~l ilrecames'Tabie4 (Amended-,I3.~lier R 's °=--~ . 

fi~e.F.~A: 

. 

Testing Req&dxed tegting Teststsniiard ' 

. 

Deadb1ze for 

final reparfUX 

~Montbs) 

subclunaiE mitny rouwto-row ECA Appendix C2 and C_6 12 Tier IE Testing extrapolation of do=-reqvne (oral Ties IE 

andlor ftstong to ini-lation) Of a stvdy vqporied by 

F=apolation I3auieJ, et al., (1994 . 

: Reporting . 

subduouic W=tMacity (oral) 40 cFx §799.962v (as i a 

aaobited in ECA Appeadix 

D.Z) 

' Subcinoaic nurvtoxieity :oute`to-route ECA Appendix C.3 and C.6 21 

a*apalaum of dQw-=qone (orat Tier 11 

testing to inhalation) 

40 CFR §7999380 (as 25 

. Reproduc .~tive taxiczty (orel) amotabd iw ECA Appendix 

D.3) . 

ECA Appmdix C.4 and C.6 28 

Regzvduc~ive hnEiciiyfoute-to-inute ' . . =raWUii.on of dose-zespam (oral data to 

k+balalfon, aichding Tier Ii testing 2 ~ 6d 

extent sceudzes reported by Alrxmo% et Qi?, . 

(1976), Rno, et al, (19$a~ and Lsu4, et a4 

(1982)} 

Ta6Ie 1. (Amaadect: *mm5rad.'Testiae. Test .-Standards and Renortin¢ Rewiir=-- , Far E' `C 

EYA Ym.mm Kevxew, when the i'ma! raooat s due-,_ .~",9:p er ~ 

dm eno of the ,1:i.;& tempg pmP,ra.ut, interim revorrs describing Me Sratas vfail LestiaQ to kC, pevfmwrl under la fs ELA mom be Subrmttaq by the CaIItDmmies to Em 

4Table Cootnotw i C+, i i, 12 end 1 3 are unaffe-cted bv this addeudurm modi$cation to the BCA USting schedule for WC. 

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PIQ6m voveek 

HAP Task Force sponsor RepreswTwrbve