Document gaGk4MnXgqoLnX1Z9XvRN91g9
AR226-2553
To: Andrew S Hartten/AE/DuPont@DuPont Co: Subject: request for Information on perfluorochemicals
can you make a m eeting this afternoon at 3:15 at chestnut run 711 . . . . . . ---------------------Forwarded by Isidores J Zanikos/AE/OuPont on 04/20/2000 08:06 AM
Robert F Pinchot 04/20/2000 08:04 AM
To: Isidores J Zanlkos/AE/DuPont@DuPont ce: Subject: request for information on perfluorochemicals
S ee attached.
Rob -----------------------------Forwarded by Robert F Pinchot/DEV/AE/DuPont on 04/20/2000 08:04 A M ------------------------------------
Robert F Pinchot 04/10/2000 03:24 PM________________________________
To: cc: Subject:
Richard J Anglullo/AE/OuPont@DuPont, Timothy P Mecann/DuPont@DuPont, Maurice Astorga/AE/DuPont@DuPont, Michael 6 McCord/AE/DuPont@DuPont Robbiri Banerjee/AE/DuPont@DuPont, Oscar T Garza/AE/DuPont@DuPont, Gerald L
Kennedy/AE/DuPont@DuPont request for information on perfluorochemicals
Please see the attached.
C h arlie is the D irector fo r EPA's O ffice o f Pollution Prevention and Toxics (the office that administers T S C A ) and he is requesting a lot o f data on P F O A (C -8 ), P F O S (which w e don't handle in F L P R or D C S E ) and other "carboxylated or sulfonated perfluorochemicals." G erry was given a heads up by C harlie that this w as coming but w e w ere unaware o f the magnitude o f the request until Gerry received the letter today. C harlie told Gerry last w eek that the persistent functionalized fluorochemicals are a concern due to 3M 's recent T S C A 8(e) submission of reproductive effects at doses of <1mg/kg/day of PFOS.
Though we haven't had a chance to h a v e a group o f knowledgabie people look at this request in detail, the w ork to fulfill th e request Is enorm ous. N ot only are toxicity studies required but also data on emissions to the environm ent, and hum an monitoring and exposure data are required. A group is m eeting tomorrow afternoon to discuss our plan o f action. Though there are specific dates for submission in the letter, w e m ay h av e som e negotiation room if w e put in a good faith effort to get the data to the E P A in a tim ely manner.
M ore to come, Rob
-- - Forwarded by Robert F Pinohot/DEV/AE/DuPent on 04/19/2000 02:24 PM G erald L Kennedy
04/19/2800 02:06 PM
EID156168
To:
cc: Subject:
Andrea Malinowski/DPUDUP@DUP, Bernard J Reilly/AE/DuPont@DuPont, Stephen H
Korzeniowski/DuPontigDuPont, Jim E Pesek/AE/DuPont@DuPont, Robert C Buck/DuPont@DuPont,
Susan S Mileb/DuPont@DuPont, Robert F Plnehot/DEV/AE/DuPont@DuPont, Roger J ^
Zipfel/AE/DuPont@DuPont, Judy Stadler/AE/DuPont@DuPent, Robert W Rickard/AE/DuPont@DuPont
Gary W Jepson/AE/DuPont
^'
request for information on perfluorochemioals
f m ail from S P A (which w as also followed by a F A X ) which needs im m ediate action. W e need to Identify a work group and a point person to get this accomplished. Thanks.
-- Forwarded by Gerald L Kennedy/AE/OuPont on 04/19/2000 01:58 PM -- __________________
Auer.Charles@epamall.epa.gov on 04/19/2000 08;42:S4 AM
To: Gerald L Kennedy/AE/DuPont
cc:
Subject:
^ M r ^ ,S f ear^ epamaiUI a ' 30V` Pate|T iei|@epamail.epa.gov, Leczynski.Barbara@epamaii.epa.gov
request for information on perfluorochemicals
K3
Dear Gerry,
As discussed on April 13 by phone, E p a needs to review complete copies of final reports and any other relevant information in your possession or control on carboxylated and sulfonated perfluorochemicals; with initial focus on PFOA
K Cld) ' , r^uested information includes health effects studies {including pharmacokinetics), environmental effects studies,
s t u d i e r ^ H aL f ^ a HtUt:iieS a?dJinformation' " d hLTM an
environmental exposure
studies and information, including monitoring, if final reports are not
Zd
thf rU clarify the status of any ongoing studies with
regard to projected completion date and provide us with the latest and most
complete version of any preliminary reports in your possession or control.
?nnneqUeSC ta?t y? prYde us with the above information on PFOA by May 26, 2000. Regarding the sulfonated perfluorochemicals, our initial interest is
f
o n ,perfluorooctyl sulfonic acid (PFOS) and we request that you provide
the above information on PFOS by April 28, 2000.
y*
? the above information on other carboxylated or sulfonated
f
reque3t
by April 28, 2000, you initially identify
hZ ^
allow,U3 Co confirm our interest, and then provide the
requested information in your possession or control on other sulfonated
by,aay,i?A 20? and on other carboxylated perfluorochemicals ` by a week later, May 26, 2000. The information on these additional chemicals can
most usefully be provided in chemical specific increments as they are completed,
with completion of the full submissions by the dates requested,
'
A few points of clarification regarding this request:
mqraefli~?ed nb s u b m i t copies of studies already provided to EPA (e,g., under SCA 8(e), as FYIs, under FIFRA) although we do request that you provide a
againsteourVholdiigs9raPhy th* 3tUdieS a l M a d y 3ubmitted 30 we can check this
f acute.3y3temic toxicity studies can be limited to the key or critical
fordthe HPvd?hCbed the DaCa Adequacy and robust summary guidance developed f biblio!JrInhb 1{`etl?a Program. Under this approach all studies will be cited in * bibl9 X hc -ll3tlng although full copies'can be limited to studies which (1) serve to identify lowest (i.e., most toxic) lethal dose values by different fffLtb3 of <2> report observed effects which differ from those seen in studies (U3tng the same route) submitted under (1),
>skin and eye irritation studies can be handled in a manner consistent with that
EID156169
outlined for acute systemic toxicity (i.e., submit copies of the key or critical
studies whieh serve to set out the irritation potential of the chemical and
other irritation studies which show effects which differ from those reported in
submitted studies) .
>the initial request is generally limited to studies conducted during or after 1976. For studies conducted prior to 1976, we ask for a bibliography listing all studies and for full copies of studies in the following endpoint areas: genetic toxicity; subchronic toxicity; reproductive toxicity; developmental toxicity; immunotoxicity; uptake/metabolism; chronic toxicity/eareinogenicity; neurotoxicity.
regarding exposure information, we are most interested in receiving information and data of the types found in the U3e and Exposure Information Profile (UEIP; the UEIP has been used to support SIDS assessments in the US) and information on results of exposure or monitoring studies (human and environmental), including full copies of studies where available and including details on procedures and methods used for sampling and analysis. We are also interested in studies relating to the ultimate environmental fate and distribution of these chemicals.
In order to maintain the integrity of your submissions, please submit all
information on a given chemical as a separate "For Your Information" (FYI)
submission. You may also submit the information as supplements to any prior
submissions by your company under TSCA 8 (e) relating to these chemicals. As
always, any CBI must be submitted in accordance with applicable procedures. If
you have any questions with regard to the submission procedures, or you wish to
work out the arrangements in advance, please contact Terry Q?Bryan
.
(202-260-3483),
If you have any general questions regarding this request, please contact me by email or phone (202-260-3749). I thank you in advance for your cooperation.
Charles M. Auer, Director Chemical Control Division office of Pollution Prevention and Toxics/OPPTS/EPA
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