Document YGw7bZKVrV6ZZ55Od20VJOMvy

IT08NEK S AI LAW m z a &_ * r r r "i:1.fl iI0: I ? 2550 M Street, N W W ashington, DC 20037-1350 202-457-6000 Facsimile 202-457-6315 w w w .pa ttonbo ggs .co m December 22, 2004 BY HAND DELIVERY P \(2 r Peter D. Robertson (202) 457-6320 probertson@pattonboggs.com Mr. Charles M. Auer Director Office o f Pollution Prevention and Toxics U.S. Environmental Protection Agency EPA East Building 1201 Constitution Avenue NW Washington, D C 20460 Re: Further DuPont Voluntary Response to EPA's November 4, 2004 Request Submission to AR-226 and TSCA 8(e) Office Epidemiology and Industrial Hygiene Air Monitoring Dear Charlie: The attached document production and information submitted with this letter represents DuPont's continued good faith effort to respond to EPA's November 4, 2004 request for voluntary submission o f certain material. kO (jO O Submission for December 22,2004 The documents submitted with this letter pertain to the submission requested by December 24, 2004. Specifically, this submission pertains to epidemiology and industrial hygiene air monitoring data/information. A summary o f the steps taken to collect the information requested by EPA for this submission, along with the guidelines used to assess responsiveness to the EPA request, is provided on Attachment 1 to this letter. A summary o f the contents o f this submission is provided in Attachment 2 to this letter. There is no confidential business information in this submission, although some documents have been redacted for privacy purposes. In addition to a cumulative index for this submission, each individual binder also contains an index for the contents o f the binder. W as h in gt on DC I Northern Virginia I Dallas Denver I Anchorage | Doha, Qatar I \M L 2 Q 2 Q IS - r PAON BOGGS usinas h un Mr. Charles M. Auer December 22, 2004 Page 2 TSCA 8(e) Office Submission DuPont does not believe that the information submitted with this letter triggers reporting obligations under TSCA section 8(e). However, in the course o f discussions with OPPT and the Office o f Regulatory Enforcement (ORE), it has become clear to DuPont that those two offices are applying standards o f reporting under TSCA section 8(e) that DuPont cannot anticipate. Accordingly, DuPont initially informed EPA that DuPont intended to submit all productions to both the AR-226 docket and the TSCA 8(e) office, as was done with the submission o f November 15, 2004. EPA has, however, informed counsel for DuPont that it is not necessary to make a duplicate, formal submission to the 8(e) office in order to discharge any reporting obligations that EPA might otherwise assert. Instead, EPA has asked that DuPont make only a single submission and advised that DuPont should indicate in this cover letter that the submission is intended for both the AR-226 docket and the TSCA 8(e) office. As such, DuPont states that the enclosed documents are intended to be a submission to both the AR-226 docket and, as a precaution, to the TSCA 8(e) office, notwithstanding DuPont's firm belief that the information does not trigger reporting obligations under that section of TSCA. This submission should not be construed as a direct or indirect admission that DuPont believes that any o f the enclosed information triggers such reporting obligations. We understand that O R E has agreed that DuPont's submission shall not prevent DuPont from asserting, in any proceeding, that section 8(e) did not require submission o f this information. Continued Activity After EPA has had the opportunity to review this letter and the documents, we are available at your convenience to discuss the documents in further detail to assist in your understanding. In the meantime, we will continue to gather materials for the remaining submissions, review and produce any additional documents that are located and are relevant to the topics that are the subject o f this submission, and create the electronic files you requested. Please contact me directly if you have any questions or need further clarification with respect to this submission. c- ' Peter D. Robertson & n io n m ii uf Mr. Charles M. Auer December 22, 2004 Page 3 Attachments Attachment 1 Attachment 2 - Summary o f submission (1 box, 2 volumes, no CBI) 3 11885939 Mr. Charles M. Auer December 22, 2004 Page 4 ATTACHMENT 1 The sections below provide a summary o f the steps taken to collect and produce the information requested in the particular category indicated. For each category, please note that DuPont does not maintain a comprehensive file o f all such information for the entire Company. The documents were collected either from the over one million pages o f documents collected for a class action lawsuit in West Virginia or from files o f individuals most likely to have documents responsive to EPA's request. Note that the documents collected for purposes of the West Virginia litigation are primarily related to PFOA. For purposes o f this document production, and in the interest o f attempting to make this production useful and purposeful to the Agency and to avoid redundancy, DuPont followed the guidelines provided below. Please note, however, that if the Agency wants DuPont to submit the type o f information that is indicated below as not being submitted herewith, please notify us and we will provide the requested information. G eneral Guidelines for D ecem ber 22nd Subm ission In reviewing documents for this submission, and following discussion with EPA concerning the content o f the prior submissions, DuPont focused on submitting final reports, draft reports where no final report is known to exist, and documents that contain data. This submission does not include the following types o f documents: Draft documents where it is known that a final version exists Documents known to be in the possession o f EPA (either at headquarters or an EPA Regional Office) Non-DuPont documents (includes documents from other companies, plaintiffs' counsel, etc.) Presentations and other documents that reference data that is in a report submitted to EPA Documents known to be publicly available Documents that are subject to attorney-client privilege Documents concerning work-in-progress (Note though that DuPont will provide periodic updates to EPA on work-in-progress, per the November 10, 2004 presentation to EPA, and will submit reports on such work to EPA when final. In addition, Volume 37 contains 2 protocols (see Tab 24 and Tab 26) that are related to on-going work.) Supporting reports/documents for data (e.g., lab analysis, lab notebooks, etc.) r - ------- 11868838 urnims ai u # Mr. Charles M. Auer December 22, 2004 Page 5 Sum m ary o f Collection P rocess for Specific C ategories o fR equested Inform ation The documents for this submission were collected from review of the documents produced in the class action litigation, along with collection o f documents from individuals in the Company most likely to possess such information. r U' HK S U UH Mr. Charles M. Auer December 22, 2004 Page 6 ATTACHMENT 2 Summary o fD ecem ber22, 2004 Subm ission There is no CBI in this submission, although some documents have been redacted for privacy purposes. Box no. 1 1 1 Volume 37 38 Part no. _ - - Topic Cumulative index for Vols. 37 and 38 Epidemiology Industrial Health --Air Monitoring DuPont Company VOL 37 37 37 37 37 37 37 37 37 37 TAB 1 2 3 4 5 6 7 8 9 10 DATE 9 /2 8 /7 8 9 /2 0 /7 8 8 /5 /9 6 1/15/81 1/28/81 1 /2 8 /8 3 11/3/93 9 /2 9 /0 3 4/13/81 6/8/81 DESCRIPTION M e m o from W . A. B ow er to J.C. Leitinger et al, e ntitle d "C -8 E xpo su re - M edical S urveillance" 'M em o from Y.L. P ow er, M D to W .A . Bow er, e n title d 'M e m o fro m Y .L. P ow er, M D to W illia m J. V ogler, entitled "C -8 S tudy" "S u m m a ry C h a rt "L iv e r S tu d y o f W a s h in g to n W orks E m ployees E xposed to C -8" "R e p o rt b y W illia m E. F a y e rw e a th e r e ntitle d "Liver Function S tudy o f W ashington W orks E m ployees E xposed to C -8" LV ra ft R e p o rt b y W illia m E. F a y e rw e a th e r entitled "U pdate o f 1/28/81 Liver F unction S tudy o f W ashington W orks E m ployees Exposed to C -8" 'M e m o from Y.L. Pow er, M D to B enjam in R am irez, M D entitled "R eview o f C-8 and R ecom m endations" '-fa b le entitled, "D uP ont C om pany, C ham bers W orks, P F O A R ecycle, Liver F unction Tests 'R e s e a rc h P roposal by W illiam E. F ayerw eather entitled "S tudy o f P regnancy 0 u tc o m e in W a sh in g to n W o rk s E m p lo ye e s" M e m o from R.D. Ingalls to N.J. Irsch e t al entitled "P regnancy O utcom e S tudy W ashington W o rks" CATEGORY W ashington W orks - M edical S urveillance W ashington W o rks - M edical S urveillance W ashington W o rks - M edical S urveillance W ashington W orks - Liver Function E v a lu a tio n W ashington W orks - Liver Function E v a lu a tio n W ashington W orks - Liver Function E v a lu a tio n W ashington W orks - Liver Function E v a lu a tio n C ham bers W orks - Liver Function W ashington W orks - P regnancy O utcom e W ashington W orks - P regnancy O utcom e Cumulative Index to Submission December 22, 2004 Voi. 37 and 38 7 LCI ^ Page 1 of 9 DuPont Company 37 11 2 /1 9 /8 2 M em o from B ruce W . K arrh, M D entitled W ashington W orks - P regnancy "Pregnancy O utcom e S tudy FC -143" O utcom e 37 12 undated 'R e p o rt by M aureen O 'Berg entitled "S tudy o f W ashington W orks - G eneral M yocardial Infarction at W ashington W orks E pidem iology P lant" 37 13 3/30/81 ''R ep o rt by W illiam E. F ayerw eather entitled W ashington W orks - G eneral "S tudy o f M yocardial Infarction Incidence and E pidem iology C oronary Fleart D isease M ortality R ates at W ashington W o rks" 37 14 10/31/85 'M e m o from M.T. O 'Berg to H.E. S erenbetz W ashington W orks - G eneral entitled "O bserved and E xpected Deaths E pidem iology A m ong E m ployees and P ensioners by Plant Site, 1957-1984, P olym e r P roducts D epartm ent" 37 15 12/14/89 iV le m o fro m H.A. S m ith to FI.V. B radley, e t al, W a sh in g to n W o rks - G en e ra l e ntitle d "W a s h in g to n W o rk s C a n ce r E pidem iology J ticid e n ce and O verall M ortality R ates" 37 16 2 /2 4 /8 9 C o v e r le tte r fro m W .E . F a y e rw e a th e r to FI.A. W a s h in g to n W o rk s - G e n e ra l Sm ith and report by Judy W a lra th and C herry E pidem iology B urke entitled "A n Investigation into the O ccurrence o f Leukem ia a t W ashington W orks" 37 17 12/31/91 T in a l R eport by M. E lizabeth K arns and W ashington W orks - G eneral W illia m E. F a y e rw e a th e r e n title d "A C a se - E pidem iology C ontrol S tudy o f Leukem ia at the W ashington W orks S ite" 37 18 8/28/92 R eport by Judy W alrath entitled " W ashington W orks - G eneral W ashington W orks - S urveillance Data, Epidem iology M ortality and C ancer Incidence" Cumulative Index to Submission December 22, 2004 Vol. 37 and 38 2 Page 2 of 9 DuPont Company 37 19 11/15/93 "IVIem o fro m A n th o n y J. P la y tis to J. W a lra th W a s h in g to n W o rk s - G e n e ra l e n title d "W o rk H isto rie s o f S p e c ific C a n c e r E pidem iology Cases 37 20 6 /3 0 /9 6 "D u P o n t E p id e m io lo g y S u rv e illa n c e R e p o rt W ashington W orks - G eneral from Judy W alrath to G erald A. P loeger E pidem iology entitled "M ortality and C ancer Incidence S urveillance at W ashington W o rks" 37 21 4/17/01 'M e m o from R obin C. Leonard to T o n y Playtis W ashington W orks - G eneral entitled "C ancer R egistry fo r W ashington E pidem iology W orks Laboratorians" 37 22 6/5/01 ''M em o fro m R obin C. Leonard to R.W . W ashington W orks - G eneral R ickard entitled "E pidem iology S urveillance E pidem iology at W ashington W orks" 37 23 1/27/03 Tvlem o fro m R obin C. Leonard to Paul W ashington W orks - G eneral B ossert et al entitled "C ancer Incidence E pidem iology R eport 1959-2001, All C ause M ortality R eport 1957-2000, W ashington W orks, Parkersburg, W est V irginia" 37 24 12/06/01 'P ro p o sa l fro m U niversity o f A berdeen and TFE Study the Institute o f O ccupational M edicine by John C herrie, Sean S em ple and A nne S outar entitled "An International C ohort M ortality S tudy o f W orkers w ith P otential exposure to T etrafluoroethylene: A P roposal to P rovide E xposure A ssessm ents to S upport the E pidem iological S tud y". T h is d o cu m e n t is the p ro to co l fo r th e study. T h e stu d y is on-going. 37 25 12/21/01 ''M em o fro m John W . G reen to R obin C. W ashington W orks - A nalysis o f C-8 Leonard entitled "S tatistical A nalysis of C8 E xp o su re Exposure Data" Cumulative Index to Submission December 22, 2004 9 Voi. 37 and 38 Page 3 of 9 DuPont Company 37 26 5 /2 7 /0 4 R e s e a rc h P rotocol, S tudy D irector Robin C. W ashington W orks - A nalysis o f C-8 L eo n ard, e n title d "A m m o n iu m E xp o su re P erfluorooctanoate: C ross-S ectional S urveillance o f C linical M easures o f G eneral Health S tatus R elated to a S erum B iom arker o f Exposure and R etrospective C ohort M o rta lity A n a lyse s in a P o lym e r P roduction P la n t". T h is stu d y is on-going. Cumulative Index to Submission December 22, 2004 Voi. 37 and 38 Page 4 of 9 DuPont Company VOL 38 38 38 38 38 38 38 38 38 38 TAB 1 2 3 4 5 6 7 8 9 10 DATE 10/30/81 3/16/82 7/20/87 7/18/01 6 /1 6 /0 4 1/2/92 U n d a te d 8 /2 /0 0 4/26/01 8/9/01 DESCRIPTION ^Analytical M ethod: D eterm ination o f P e rflu o ro o cta n o ic A cid (C -8 ) in A ir lyiethylene Blue M ethod D u P o n t Fibers P roducts - T eflon FC -143 A nalysis A n a ly tic a l M ethod: D eterm ination of P erfluorooctanoic A cid G as C hrom atographic M ethod A bsorption Tube Technique A n a ly tic a l M ethod: A m m onium ^e rflu o ro o c ta n o a te D e te rm in a tio n in A ir C ra ft M anuscript entitled "S am pling and D e te rm in a tio n o f P e rflu o ro o c ta n o ic A cid in A ir Using Liquid C h ro m a tog ra ph y with M ass S pectrom etry" 'C h a rt e ntitle d "A ir M o n ito rin g fo r W o rk e r Exposure to C -8" ^ a b le o f A ir M onitoring R esults w le m o fro m Y u-Ju C hen to M ike D aly e n title d "A ir M o n ito rin g R e su lts - C -8 " 'M e m o fro m Y u-Ju C hen to M ike Daly entitled "Exposure M onitoring R esults - C- y E n title d docum ent signed by W . Jam es Flarm an, Jr, John C oates and Shaw n M essinger CATEGORY A n a lytica l M e tho d s - P F O A in A ir A n a ly tic a l M e th o d s - P F O A in A ir A n a ly tic a l M e th o d s - P F O A in A ir A n a ly tic a l M e th o d s - P F O A in A ir A n a ly tic a l M e th o d s - P F O A in A ir G e n e ra l - P F O A in A ir C h a m be rs W o rks - P F O A in A ir C h a m b e rs W o rk s - P F O A in A ir C h a m b e rs W o rk s - P F O A in A ir C h a m b e rs W o rk s - P F O A in A ir IICumulative Index to Submission December 22, 2004 Vol. 37 and 38 Page 5 of 9 DuPont Company VOL 38 38 38 38 38 38 38 38 38 TAB 11 12 13 14 15 16 17 18 19 DATE 9/27/01 12/10/01 5/17/02 5/7/03 12/16/04 12/16/04 12/16/04 12/16/04 12/16/04 , DESCRIPTION -M em o from Yu-Ju Chen to Shawn M essinger entitled "E xposure M onitoring R esults - C 8" CATEGORY C h a m b e rs W o rk s - P F O A in A ir ''M em o from Y u-Ju C hen to S haw n C h a m be rs W o rks - P F O A in A ir M e s s in g e r e n title d "A ir M o n ito rin g Sum m ary Report - DFS1 " -/Memo from Y u-Ju C hen to Shaw n C h a m b e rs W o rk s - P F O A in A ir M essinger entitled "A ir M onitoring R esults -/D F S -1 " 'M em o from Y u-Ju C hen to Shaw n C h a m b e rs W o rk s - P F O A in A ir M essinger entitled "S um m ary o f A ir M onitoring R esults - P erfluorooctanoic A cis (P FO A )" rtro tS v O T a b le e n title d " D u P o n t C o m p a n y , P F O A in C h a m b e rs W o rk s - P F O A in A ir A ir, C ham bers W orks P erform ance C hem icals, A rea A ir S am ples" ^ T a b le e n title d " D u P o n t C o m p a n y , P F O A ^in* C h a m b e rs W o rk s - P F O A in A ir Air, C ham bers W o rks P erform ance C hem icals, P ersonal A ir S am ples" T a b le e n title d "D u P o n t C o m p a n y, P F O A in C h a m b e rs W o rk s - P F O A in A ir Air, C ham bers W orks S ecure Environm ental Treatm ent, A rea A ir Sam ples, P rocessing Parkersburg W a ste " T a b le e n title d "D u P o n t C o m p a n y , P F O A in C h a m b e rs W o rk s - P F O A in A ir Air, C ham bers W o rks S ecure E nvironm ental Treatm ent, Personal S am ples - P rocessing Parkersburg W aste" T a b l e e n title d " D u P o n t C o m p a n y , P F O A in C h a m b e rs W o rk s - P F O A in A ir Air, Jackson Lab, P ersonal A ir S am ples" Cumulative Index to Submission December 22, 2004 Voi. 37 and 38 Page 6 of 9 DuPont Company VOL 38 38 38 38 38 38 38 38 38 38 38 TAB 20 21 22 23 24 25 26 27 28 29 30 DATE 12/16/04 2 /1 8 /0 4 / DESCRIPTION "T a b le e n title d "D u P o n t C o m p a n y , P F O A in Air, Jackson Lab, A rea A ir S am ples / ^D ocum ent entitled "P relim inary R esults o f P F O A S am p lin g in 1205 B ldg D uring R em oval o f Lagging M aterial" CATEGORY C h a m b e rs W o rk s - P F O A in A ir Cham bers W orks - PFO A - A ir and W ipe 3 /1 7 /8 0 8 /1 7 /9 0 U n d a te d 11/18/2004 10/16/90 4 /4 /9 4 9 /1 2 /9 4 12/17/81 3/82 / 'M em o from R.A. B randenburg to J.W . R aines entitled "C -8 A ir M onitoring S am ples" M em o fro m R obert A. B eijleveldt to M artin E. K ooy entitled "O c c u p a tio n ^ Hygiene R eport o f T P & V sectie" 'table entitled "F ayetteville W o rks A P F O A rea A ir M onitoring D ata" ''Data S u m m a ry - F a y e tte v ille A ir IVIonitoring M arch - Ju ne 2 00 4 'Charts e n title d "O c c u p a tio n a l H ealth S tatus" m em o from Kazuaki Yokoyam a to Roger Zipfel entitled "C -8 P ersonnel M onitoring" 'C h a rts entitled "O ccupational Health s ta tu s at S him izu" 'M e m o from S.S. S tafford to M .A. Forte entitled "D eterm ination o f P e rfluo ro o cta n oa te in A q u e o u s A ir Ipipinger S am ples" '"R e p o rt e n title d " F C -1 4 3 in th e T e flo n D o rd re ch t - P F O A in A ir D o rd re ch t - P F O A in A ir F a yette ville - P F O A in A ir F a ye tte ville - P F O A in A ir S him izu - P F O A in A ir S him izu - P F O A in A ir S him izu - P F O A in A ir S p ru a n ce - P F O A in A ir S p ru a n ce - P F O A in A ir \3Cumulative Index to Submission December 22, 2004 Vol. 37 and 38 Page 7 of 9 DuPont Company VOL 38 38 38 38 38 38 38 38 38 TAB 31 32 33 34 35 36 37 38 39 DATE 1 1 /2 1 /0 ^ 12/15/04 12/15/04 12/15/04 12/15/04 9/16/97 12/12/01 3/20/80 12/14/04 DESCRIPTION P ro c e s s " Data S um m aries o f W ashington W orks F O A in A ir M o n itoring ^P rintout from W ashington W o rks Industrial H ygiene D atabase - Personal A ir M onitoring fo r C-8 10/23/79 - 8/12/81 / ''P rintout from W ashington W orks Industrial H ygiene D atabase - P ersonal A ir M onitoring fo r C -8 3/25/81 - 9/15/04 'P rin to u t fro m W ashington W o rks Industrial H ygiene D atabase - A rea A ir M onitoring fo r C-8 2/26/73 - 8/12/81 p rin to u t from W ashington W orks Industrial H ygiene D atabase - A rea A ir M onitoring fp r C-8 2/2/81 - 12/13/04 'R e p o rt by Jennifer N ichols entitled "S um m ary o f S pecial C-8 S am pling P roject" ^D uPont W ashington W orks R espiratory U se T able and C om pliance Plan CATEGORY W a sh in g to n W o rk s - P F O A in A ir W a sh in g to n W o rk s - P F O A in A ir W a sh in g to n W o rk s - P F O A in A ir W a sh in g to n W o rk s - P F O A in A ir W a sh in g to n W o rk s - P F O A in A ir W a sh in g to n W o rk s - P F O A in A ir W ashington W orks - PPE / 'M em o from C.E. S teiner/K .G . K ronberg to R.J. Z ipfel/J.R . B roadw ay entitled "Protective C lothing R ecom m endations for C-8 E xposure" 'T a b le "DuPont Com pany, Cham bers W orks Telom er, Area A ir M onitoring" W ashington W orks - PPE C ham bers W orks - Telom er A ir M onitoring Cumulative Index to Submission December 22, 2004 Voi. 37 and 38 Page 8 of 9 DuPont Company VOL 38 38 TAB 40 41 DATE 12/14/04 12/17/04 DESCRIPTION / 'T a b le "D uPont Com pany, Cham bers W orks Telom er, P ersonal A ir M onitoring T a b le " D u P o n t C o m p a n y, P F O A in A ir, C ham bers W orks Telom ers O perations" CATEGORY C ham bers W orks - T elom er A ir M onitoring C ham bers W orks - T elom er A ir M onitoring i Cumulative Index to Submission December 22. 2004 Vol. 37 and 38 Page 9 of 9