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### UNITED STATES ENVIRONMENTAL PROTECTION AGE WASHINGTON, D.C. 20460



## JUN 30 2009

Dr . Peter Voytek HAP Task Force P.O . Box 331 Milwood, VA 22646 

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### RE : Completion of the EPA ProgramReview for EDC I am writing to thank the Hazardous Air Pollutant (HAP) Task Force for its completion of the EPA ProgramReview

segment ofthe 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 informthe 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 ProgramReview . The AddendumModification 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 ProgramReviewsegment 'of the ECA . '` Your signature is needed on the Addendumindicating agreement with these changes. These modifications are considered minor changes for which public comment is not required . Please sign and return the enclosed "Addendumto 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

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### 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



## AddendumModification 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 ECAAppendix C .2 and C .6 36 Tier II Testing extrapolation ofdose-response (oral Tier II and/or testing to inhalation) ofa study reported by Extrapolation Daniel, et al ., (1994) Reporting Subchronic neurotoxicity (oral) 40 CFR §799.9620 (as 42 annotated in ECAAppendix D .2) Subchronic neurotoxicity route-to-route ECAAppendix C3 and C .6 52 extrapolation ofdose-response (oral Tier II testing to inhalation) 40 CFR §799.9380 (as Reproductive toxicity (oral) annotated in ECAAppendix 42 D .3) Reproductive toxicity route-to-route ECAAppendix C .4 and C .6 52 extrapolation ofdose-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 ofthe Order that incorporates this ECAwhen 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 EPAevery 6 months beginning six months from the effective date ofthis ECA until the end ofthe ECAtesting program (see Part VIII . E

. and Part XIII of this ECA) . *Table Footnotes 10, 11, 12 and 13 are unaffected by this addendummodification to the ECAtesting schedule for EDC .FROM MS I . FR?S N0. :5408371602 Jul . 06 2009 11 : 32RM pp15



### 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 ECAAppendix C2and C_6 12 Tier IE Testing extrapolation ofdo=-reqvne (oral Ties IE andlor ftstong to ini-lation) Ofa stvdy vqporied by F=apolation I3auieJ, et al ., (1994 . :Reporting .



## subduouicW=tMacity (oral) 40cFx §799 .962v (as ia aaobited in ECAAppeadix D .Z) ' Subcinoaic nurvtoxieity :oute`to-route ECAAppendix C .3 and C .6 21 a*apalaum

ofdQw-=qone (orat Tier 11 testing toinhalation) 40CFR §7999380 (as 25

. Reproduc.~tive taxiczty (orel) amotabd iw ECAAppendix D .3) . ECA Appmdix C

.4and C .6 28 Regzvduc~ive hnEiciiyfoute-to-inute ' . . =raWUii .on ofdose-zespam (oral data to ~ k+balalfon, aichding Tier Ii testing 2 6d extent sceudzes reported by Alrxmo% etQi?, . (1976), Rno, et al, (19$a~ and Lsu4, et a4 (1982)} Ta6Ie 1 . (Amaadect: *mm5rad .'Testiae. Test .-Standards and Renortin¢ Rewiir=-- , Far E'`C

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.mm Kevxew, when the i'ma! raooat s due-,_ .~",9 :p er ~ dm eno of the ,1

:i . ;&tempg pmP,ra.ut, interimrevorrs describing Me Sratas vfail LestiaQto kC, pevfmwrl under la fs ELA mom be Subrmttaq bythe CaIItDmmies to Em 4Table CootnotwiC+, i i, 12 end 1 3 are unaffe-cted bv this addeudurm modi$cation to theBCAUSting schedule for WC .



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