Document Ja3oeoZ35exnqXoLo9Erzdya

Message From: Sent: To: Subject: Gillay, David [David.Gillay@btlaw.com] 4/16/2018 4:32:15 PM Beck, Nancy [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=168ecb5184ac44de95a913297f353745-Beck, Nancy] RE: Harmonizing TCE Efforts Will d o a n d h op e to g e t it out to you later this evening or tom orrow ... 4/23 is rapidly a p p ro a ch in g . From: Beck, Nancy [mailto:Beck.Nancy@epa.gov] Sent: Monday, April 16, 2018 12:21 PM To: Gillay, David Subject: RE: Harmonizing TCE Efforts David, When its available, please share the workshop agenda and I can use that to see who the best participant from EPA may be. Thanks, Nancy Nancy B. Beck, Ph.D., DABT Deputy Assistant Administrator, OCSPP P: 202-564-1273 i Ex" 6 ! beck.nancy@epa.gov From: Gillay, David [mailto:David.Gillay@btlaw.com] Sent: Monday, April 16, 2018 12:19 PM To: Beck, Nancy <Beck.Nancy@epa.gov> Subject: RE: Harmonizing TCE Efforts Nancy - hope you had a nice weekend. Thanks so m uch for your follow up a n d I apologize for m y d e la ye d response (spring break w ith my senior son, etc.) It looks like w e are a g o for an initial m eeting in DC on 4/23. Do you have a senior staff or some one else you could d ele g a te to a tte n d or p articipate on 4/23? dave Ex. 6 Sierra Club v. EPA 18cv3472 NDCA Tier 12 ED 002061 00046322-00001 From: Beck, Nancy fmailto:Beck.Nancv@epa.aovl Sent: Friday, April 06, 2018 10:10 AM To: Gillay, David Subject: RE: Harmonizing TCE Efforts David, Thanks for thinking of me for this. I don't think that at this time it would be appropriate for me to be on the steering committee, but of course EPA will surely consider participation as appropriate in future workshop activities. Regards, Nancy Nancy B. Beck, Ph.D., DABT Deputy Assistant Administrator, OCSPP _P:.2Q2-5M-1223.. Ex. 6 beck.nancy@epa.gov From: Gillay, David [mailto:David.Gillay@btlaw.coml Sent: Thursday, April 5, 2018 8:20 AM To: Beck, Nancy < Beck.Nancy@epa.gov> Cc: 'amaier042@gmail.com' <amaier042@gmail.com>; 'Thompson, Rod B (rodnthom@iupui.edu)' <rodnthom @ iupui.edu>; 'Ed Pfau' <epfau@ hullinc.com >; 'Michael Dourson' <dourson@tera.org>; Clark, Becki <Clark. Becki@epa.gov> Subject: Harmonizing TCE Efforts Dr. Beck, g o o d m orning a n d I h op e you are having a nice w eek. In co o rd in a tio n w ith A ndy Maier, Mike Dourson, Rod Thompson, a n d Ed Pfau, w e w o u ld like to form ally invite you to p a rtic ip a te in a steering co m m itte e m eeting a n d workshop (at a d a te to b e d ete rm ine d soon, but hopefully in April) to d e ve lo p a c o o rd in a te d effort in co n n e c tio n w ith n o n -c a n c e r endpoints for TCE. We have prepared the following description to outline our thoughts, objectives, and path forward. Harmonizing Efforts to Address the Non-Cancer Regulation of Trichloroethylene in the United States Nationally, m any science and science policy efforts are underw ay atte m p tin g to im plem ent effective regulation of the n o n -c a n c e r endpoints of trichloroethylene (TCE). These efforts have illustrated the need for an e n h a n c e d understanding of n o n -c a n c e r toxico lo g ica l assessment, exposure q u a n tifica tio n a n d n o n -c a n c e r risk ch aracterization for purposes of risk m a n a g e m e n t. For exam ple, the p ra c tic a l a p p lica tio n of n o n -c a n c e r risk assessment science is being explored through a national effort to characterize a key a sp e ct of U.S. EPA's Reference C o n ce n tra tio n for TCE th a t includes " up to an order of m a g n itu d e u ncertainty," w h ich m ight define a " range" of a c c e p ta b le rem edial risk levels for risk m a n a g e m e n t decisions. Efforts are also u n d e rw a y to verify the findings of the Johnson et al. (2001) study a n d to dete rm ine the im plications of this study in the co n te xt of the existing n o n -c a n c e r toxicolog y d a ta b a se . These efforts m a y m ore fully ch aracterize the p ote ntia l risk of feta l heart m alform ations, or confirm o th e r studies th a t d o not show this e ffe ct, through inhalation exposures to TCE in am bient air under different exposure scenarios. In 2013, the A lliance for Risk Assessment (ARA) led an initiative to e va lu a te risk-based decision-m aking based on the Reference C o n ce n tra tio n for TCE finalized by U.S. EPA in 2011 a n d published in IRIS. This effort resulted in a Sierra Club v. EPA 18cv3472 NDCA Tier 12 ED 002061 00046322-00002 h alf-da y w e b c a s t w ith international participa tio n, a nd a g u id a n c e d o c u m e n t on the risk m a n a g e m e n t a t TCEc o n ta m in a te d sites.1 The evalua tio n also resulted in a published m anuscript (Dourson e t a l,, 2016)2 a n d m any o ther national, regional a n d local efforts to address the problem s associated w ith risk m a n a g e m e n t of TCE. Five years a fte r the ARA initiative, it appears th a t a renew al w o u ld support harmonizing ong o in g TCE-related risk science efforts to b e tte r understand a n d re gulate the risks of exposure. A proposed first step in this effort is to c o n ve n e a steering co m m itte e to plan future activities to support harmonizing TCE risk assessment a n d m a n a g e m e n t. Such activities m ight include o pe n workshops, e d u c a tio n sessions, te c h n ic a l p ro je ct d e ve lo p m e n t, a n d o th e r outreach. We solicit your involvem ent in this effort as a steering c o m m itte e p a rticip a n t w ith an a n tic ip a te d n ear term c o m m itm e n t of a tte n d in g a planning m eeting in the Law Offices of Barnes & Thornburg LLP in W ashington D.C. (with a w e b in a r option) a n d a h alf-da y workshop. The m ain g oa l of this steering co m m itte e workshop is to share inform ation on efforts underw ay am ong stakeholders, have a brief overview of the work currently being done, and form a steering co m m itte e action plan to help guide future efforts and avoid duplication. We are looking a t scheduling this planning m eeting a n d workshop on the w e e k of 4/16, 4/23, or 4/25. Please let us know your preferred d a te a n d tim e as soon as possible so w e ca n sync our schedules. O nce a d a te is confirm ed, w e will circulate a draft a g e n d a for input. 1 Alliance for Risk Assessment [ARA). G uidance for C ontam inated Sites: Trichloroethylene (TCE) Risk Assessment Case Study. April 15, 2013. 2 Dourson ML, G adagbui BK, Thompson RB, Pfau EJ, Lowe J. M anaging risks of noncancer health effects at hazardous waste sites: A case study using the Reference Concentration (RfC) of trichloroethylene (TCE). Regul Toxicol Pharmacol. 2016 O ct 80:125-33. Thanks in a d v a n c e for your tim e a n d willingness to p articip a te , dave h ve lo p m e n t dianapoiis, IN, 46204-3535 Ex. 6 Fax: 317-231-7433 i : : BTAHRONRENSB&URG Lu* Dallas | D elaw are j Indiana j Los Angeles j San Diego j M ichigan j M inneapolis I Ohio CONFIDENTIALITY NOTICE: This email and any attachments are for the exclusive and confidential use of the intended recipient. If you are not the intended recipient, please do not read, distribute or take action in reliance upon this message. If you have received this in error, please notify us immediately by return email and promptly delete this message and its attachments from your computer system. We do not waive attorney-client or work product privilege by the transmission of this message. CONFIDENTIALITY NOTICE: This email and any attachments are for the exclusive and confidential use of the intended recipient. If you are not the intended recipient, please do not read, distribute or take action in reliance upon this message. If you have received this in error, please notify us immediately by return email and promptly delete this message and its attachments from your computer system. We do not waive attorney-client or work product Sierra Club v. EPA 18cv3472 NDCA Tier 12 ED 002061 00046322-00003 privilege by the transmission of this message. CONFIDENTIALITY NOTICE: This email and any attachments are for the exclusive and confidential use of the intended recipient. If you are not the intended recipient, please do not read, distribute or take action in reliance upon this message. If you have received this in error, please notify us immediately by return email and promptly delete this message and its attachments from your computer system. We do not waive attorney-client or work product privilege by the transmission of this message. Sierra Club v. EPA 18cv3472 NDCA Tier 12 ED 002061 00046322-00004