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Gillay, David [David.Gillay@btlaw.com] 4/18/2018 1:47:15 PM Beck, Nancy [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=168ecb5184ac44de95a913297f353745-Beck, Nancy] RE: Harmonizing TCE Efforts
Nancy,
Thanks again for your quick reply. I am sure you schedule is packed and your ability to find any free time to respond to outside requests is remarkable and very much appreciated.
You are correct in this being a planning meeting and soliciting EPA's thoughts on steps forward would be valuable. This might be especially relevant to EPA since EPA is not consistent on its judgment of TCE toxicity (the public record shows that senior EPA scientists themselves argued against using the Johnson et al study and there continues to be divergent state approaches), nor in EPA's risk management of TCE at different regional offices. Moreover, during this planning meeting we will hopefully be getting an update of an industry attempt to replicate the Johnson et al study (the first attempt resulting in TCE concentrations not matching protocols). This attempt, if successful, will likely have a direct impact on the ongoing TCE assessment under the LCSA. If this attempt is not successful, then this obviously reduces confidence in the use of the Johnson et al study, since replication is the hallmark of science.
Let's stay connected and I would like to follow up after this planning meeting and as this unfolds.
Have a great week,
dove
David S. Gtitay lam es and Thornburg IIP
Chair. Rem ediation & R edevelopm ent 317-231-7474(0) ! .........E X. 6......... `
From: Beck, Nancy [ mailto:Beck.Nancy@epa.gov]
S e n t: Wednesday, April 18, 2018 8:18 AM
To: Gillay, David Subject: RE: Harmonizing TCE Efforts
David, While we could send someone to participate in a broad widely attended workshop, this has more of the feel of a smaller planning meeting. OCSPP will take a pass on participating. Thanks for thinking of us.
Nancy
Nancy B. Beck, Ph.D., DABT
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beck.nancy@epa.gov
From: Gillay, David [mailto:David.Gillay@btlaw.com] Sent: Wednesday, April 18, 2018 7:43 AM To: Beck, Nancy <Beck.Nancy@epa.gov> Subject: RE: Harmonizing TCE Efforts
Good morning - please find our proposed agenda for next Monday's meeting. If you have any questions or need any further information, please let me know, dave
Ex. 6
From: Beck, Nancy fmailto:Beck.Nancy@epa.qov1 Sent: Monday, April 16, 2018 12:21 PM To: Gillay, David
S u b je ct: 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
|........ Ex. 6 ........
L'b'ecicn3WcT@epa7gov
From: Gillay, David [mailto:David.Gillay@btlaw.com1 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.
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Thanks so much for your follow up and I apologize for my delayed response (spring break with my senior son, etc.)
It looks like we are a go for an Initial meeting In DC on 4/23. Do you have a senior staff or some one else you could delegate to attend or participate on 4/23?
dove
David I . Giiloy
Barnes an<J Thornburg UP
Chair, RernediatiQn.ik.Eadiiiyjp;p.Qi)<-ir!l'
31 7-231-7474 (o)
Ex. 6
From: Beck, Nancy fmailto:Beck.Nancy@epa.qov1 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 .:..702r.S 6A .J.7.7.3___
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b eck.n a ncy@e pa.go v
From: Gillay, David [mailto:David.Gillay@btlaw.com1 Sent: Thursday, April 5, 2018 8:20 AM To: Beck, Nancy <Beck.Nancy@epa.gov> Cc: 'amaier042@gmail.com1<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, good morning and I hope you are having a nice week.
In coordination with Andy Maler, Mike Dourson, Rod Thompson, and Ed Pfau, we would like to formally Invite you to participate In a steering committee meeting and workshop (at a date to be determined soon, but hopefully In April) to develop a coordinated effort In connection with non-cancer endpoints for TCE.
We have prepared the following description to outline our thoughts, objectives, and path forward.
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Harmonizing Efforts to Address the Non-Cancer Regulation of Trichloroethylene in the United States
Nationally, many science and science policy efforts are underway attempting to Implement effective regulation of the non-cancer endpoints of trichloroethylene (TCE). These efforts have Illustrated the need for an enhanced understanding of non-cancer toxicological assessment, exposure quantification and non-cancer risk characterization for purposes of risk management. For example, the practical application of non-cancer risk assessment science Is being explored through a national effort to characterize a key aspect of U.S. EPA's Reference Concentration for TCE that Includes "up to an order of magnitude uncertainty," which might define a "range" of acceptab le remedial risk levels for risk management decisions. Efforts are also underway to verify the findings of the Johnson et al. (2001) study and to determine the Implications of this study In the context of the existing non-cancer toxicology database. These efforts may more fully characterize the potential risk of fetal heart malformations, or confirm other studies that do not show this effect, through Inhalation exposures to TCE In ambient air under different exposure scenarios.
In 2013, the Alliance for Risk Assessment (ARA) led an Initiative to evaluate risk-based decision-making based on the Reference Concentration for TCE finalized by U.S. EPA In 2011 and published In IRIS. This effort resulted In a half-day webcast with International participation, and a guidance document on the risk management at TCEcontamlnated sites.1 The evaluation also resulted In a published manuscript (Dourson et al., 2016)2 and many other national, regional and local efforts to address the problems associated with risk management of TCE. Five years after the ARA Initiative, It appears that a renewal would support harmonizing ongoing TCE-related risk science efforts to better understand and regulate the risks of exposure.
A proposed first step In this effort Is to convene a steering committee to plan future activities to support harmonizing TCE risk assessment and management. Such activities might Include open workshops, education sessions, technical project development, and other outreach.
We solicit your Involvement In this effort as a steering committee participant with an anticipated near term commitment of attending a planning meeting In the Law Offices of Barnes & Thornburg LLP in Washington D.C. (with a webinar option) and a half-day workshop. The main goal of this steering committee workshop Is to share Information on efforts underway among stakeholders, have a brief overview of the work currently being done, and form a steering committee action plan to help guide future efforts and avoid duplication.
We are looking at scheduling this planning meeting and workshop on the week of 4/16, 4/23, or 4/25. Please let us know your preferred date and time as soon as possible so we can sync our schedules. Once a date Is confirmed, we will circulate a draft agenda for Input.
Alliance for Risk Assessment [ARA). Guidance for Contaminated Sites: Trichloroethylene (TCE) Risk Assessment Case Study. April 15, 2013. 2 Dourson ML, Gadagbui BK, Thompson RB, Pfau EJ, Lowe J. Managing risks of noncancer health effects at hazardous waste sites: A case study using the Reference Concentration (RfC) of trichloroethylene (TCE). Regul Toxicol Pharmacol. 2016 Oct 80:125-33.
Thanks in ad vance for your time and willingness to participate,
dave
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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 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.
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