Document daLo99dRv55e70Lr1g1v8BmRQ

Message From: Sent: To: CC: Subject: Conneely, Eileen [Eileen_Conneely@americanchemistry.com] 4/30/2018 7:30:57 PM Thayer, Kris [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=3ce4ae3fl07749c6815f243260df98c3-Thayer, Kri] Gibbons, Catherine [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=2ac775a35a0945718edc7e02f50e6cl2-Gibbons, Catherine]; Sasso, Alan [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=8cb867519abc4dcea88149dl2ef3e8e9-Sasso, Alan]; Yamada, Richard (Yujiro) [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=4c34ale0345e4d26b361b5031430639d-Yamada, Yuj]; Orme-Zavaleta, Jennifer [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=3c5allldc377411595e5b24b5d96146b-Orme-Zavaleta, Jennifer]; Bahadori, Tina [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=7da7967dcafb4c5bbc39c666fee31ec3-Bahadori, Tina]; Ohanian, Edward [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=fll9491e2ba8476381a39c57a456ac55-EOhanian] request to meet with IRIS staff concerning genomics dataset for Cr(VI) Dear Dr. Thayer, I appreciate your response. You noted that ERA expects to release a protocol on hexavalent chromium (Cr(VI)) this June or July and that ERA plans to convene a public webinar where ERA staff would summarize the protocol content and listen to public comment on the protocol. We appreciate the opportunity to present comments during the planned ERA webinar, but ten minutes would not be adequate to present an overview of the most recent SV10A research publications. We hope that additional time will be granted. Please also let: us know as soon as possible when you have set the date for the webinar, as many interested parties may have planned to be away on summer vacations. Additionally, we have questions on what full implementation of systematic review entails for the ERA IRIS program, especially since we have heard that the IRIS program has not fully considered the large toxicogenomics dataset funded by the Hexavalent Chromium Pane!. The SV1GA researchers communicated with Lyle Burgeon, formerly at ERA, from 2014 - 2016 concerning the Cr(VI) genomics dataset, and we would like to present an overview of events relevant to the Cr(VI) genomics data, an explanation for the number of microarrays available through different online data repositories, and a general findings comparison between published analyses (i.e. genomics data analysis methods and standards have evolved over time and yet general findings have remained consistent despite varying approaches). To ensure that ail of this important genomics data is being considered in the assessment process, we would like to schedule a meeting as soon as possible with you and the 1RiS staff working on the Cr(VI) assessment. Sincerely, Eileen Conneely Eileen ConneelyM.P.H. , J,D. |American Chemistry Council Director, Chemical Products St Technology Division eileen conneely@americanchemistry.com 700 2nd Street NE I Washington, DC 20002_______________ T:[ x. 6 |S F: (202) 330-5646 j C:j Ex. 6 Iwww.americanchemistry.com From: Thayer, Kris [mailto:thayer.kris@epa.gov] Sent: Thursday, March 29, 2018 5:08 AM Sierra Club v. EPA 18cv3472 NDCA Tier 2 ED 002061 00268342-00001 To: Conneely, Eileen <Eileen_Conneely@americanchemistry.com> Cc: Gibbons, Catherine <Gibbons.Catherine@epa.gov>; Sasso, Alan <Sasso.Alan@epa.gov>; Yamada, Richard (Yujiro) <yamada.richard@epa.gov>; Orme-Zavaleta, Jennifer <Orme-Zavaleta.Jennifer@epa.gov>; Bahadori, Tina <Bahadori.Tina@epa.gov>; Ohanian, Edward <Ohanian.Edward@epa.gov> Subject: RE: Draft IRIS Assessment of Hexavalent Chromium (Chromium VI) Eileen, Thanks again for reaching out. We appreciate your sharing the list of recent publications. We anticipate releasing a protocol on hexavalent chromium (Cr6) for public comment this June-July timeframe. The protocol will summarize the rationale for conducting the assessment, describe screening criteria to identify relevant literature, outline the approach for evaluating study quality, describe the process of evidence synthesis/integration, and dose-response methods. The protocol is a new document for the IRIS Program developed as part of its full implementation of systematic review (see presentation materials for the NAS Workshop " Review of Advances Made to the iRiS Process"). Obviously, the chromium assessment has been underway for some time now and release of this protocol should not be construed as a re-start. Rather, we are releasing the protocol so that the chromium assessment has similar public engagement steps as assessments started more recently. The protocol will include the list of studies currently included in the assessment. Given the high level of interest in the IRIS hexavalent chromium assessment, we are planning to convene a public science webinar concurrent with the public comment period on the protocol. The format of this webinar would be a presentation by EPA staff summarizing the protocol content, followed by a public comment session where the Hexavalent Chromium Panel could present the overview suggested in your note below during a 10-minute public comment period. It may be possible to extend the length of the oral comment period depending on the number of registered speakers. EPA scientists would respond to questions of clarification but would not be discussing scientific interpretation of the evidence at this point in our process. Written materials could also be submitted as part of the public comment period. We understand you may have questions on what full implementation of systematic review entails and how it integrates with the IRIS process. Although these topics are covered in the NAS presentation materials, we would be happy to schedule a meeting if you would like to discuss further. Sincerely, Kris Kristina Thayer, Ph.D. Director, Integrated Risk Information System (IRIS) Division National Center for Environmental Assessment, NCEA ORD, USEPA Mail Code: B243-01 Building: Bldg B (Room B211I) Research Triangle Park, NC 27711 (919) 541-0152 RTP (202) 564-1771 Ronald Reagan Building (room 51203) Skype: kristina.thayer thayer.kris@epa.gov Sierra Club v. EPA 18cv3472 NDCA Tier 2 ED 002061 00268342-00002 From: Conneely, Eileen [maiSto:Eileen Conneely@3 meric3 nchemistry.coml Sent: Thursday, March 22, 2018 8:24 PM To: Thayer, Kris <thayer.kris@epa.gov> Cc: Gibbons, Catherine <Gibbons.Catherine@epa.gov>; Sasso, Alan <Sasso.Aian@epa.gov>; Yamada, Richard (Yujiro) Orme-Zavaleta, Jennifer <Orme-Zavaieta.Jennifer@epa.gov>; Bahadori, Tina <8ahadon.Tina(5)epa.goy>; Ohanian, Edward <Ohanian.Edw3rd@ep3.gov> Subject: Re: Draft IRIS Assessment of Hexavalent Chromium (Chromium VI) Dear Dr. Thayer, Please see the attached letter written on behalf of the Hexavalent Chromium Panel of the American Chemistry Council requesting a stakeholder meeting with IRIS staff to present an overview of the most recent publications by the MOA study researchers, and to review important information relevant to the Cr(VI) genomics dataset that was communicated to Dr. Lyle Burgoon prior to his departure from EPA. Thank you, Eileen Conneely EUeen Conneeiy, M.P.H.J.D. 1American Chemistry Council Director, Chemical Products & Technology Division eileen conneelv@americanchemistry .com ^00_,2^_Steet_NE_J Washington. DC 20002 T :j Ex. 6 i| F: (202) 330-5646 | C: i Ex. 6 i wv-AV.americanchemistry.com +++++++++++++++++++++++++++++This message may contain confidential information and is intended only for the individual named. If you are not the named addressee do not disseminate, distribute or copy this email. Please notify the sender immediately by email if you have received this email by mistake and delete this email from your system. E-mail transmission cannot be guaranteed to be secure or error-free as information could be intercepted, corrupted, lost, destroyed, arrive late or incomplete, or contain viruses. The sender therefore does not accept liability for any errors or omissions in the contents of this message which arise as a result of email transmission. American Chemistry Council, 700 - 2nd Street NE, Washington, DC 20002, www,americanchemistry.tom +++++++++++++++++++++++++++++ This message may contain confidential information and is intended only for the individual named. If you are not the named addressee do not disseminate, distribute or copy this email. Please notify the sender immediately by email if you have received this email by mistake and delete this email from your system. E-mail transmission cannot be guaranteed to be secure or error-free as information could be intercepted, corrupted, lost, destroyed, arrive late or incomplete, or contain viruses. The sender therefore does not accept liability for any errors or omissions in the contents of this message which arise as a result of email transmission. American Chemistry Council, 700 - 2nd Street NE, Washington, DC 20002, www.americanchemi stry.com Sierra Club v. EPA 18cv3472 NDCA Tier 2 ED 002061 00268342-00003