To: Beck, Cc: Baptist, Schwab, From: Yamada, Richard (Yuiiro) Sent: Wed 1/31/2018 7:54:14 PM Subject: RE: For review - Draft EPA Testimony for House Science Hearing Yes, thanks this is helpful didn?t know about the intricacies of CBI ok, we will need to thread this one real tight! Thanks Nancy! From: Beck, Nancy Sent: Wednesday, January 31, 2018 2:51 PM To: Yamada, Richard (Yujiro) Cc: Baptist, Erik Schwab, Justin Subject: RE: For review - Draft EPA Testimony for House Science Hearing So for pesticide registrations, the regulation (part 158) requires a huge amount of data to be submitted to the agency?it costs companies millions of dollars to do these guideline studies. Guideline studies of this type are never put in journal publications?there is no audience for them. thus in IARCs eyes they are not published. IARC makes no efforts to use or collect them. Which is a maj or problem as these are very high quality standardized studies. My understanding is that these studies come in as CB1, but for a large majority of them, the CBI can be waived and the data can be made available (if requested). Making data available is very different than requiring a publication requirement. Such a requirement would be incredibly burdensome, not practical and you would need to create a whole new arm of the publishing industry to publish these types of studies that nobody is interested in. Note these full study reports are often hundreds of pages (they include extremely robust documentation) each. Nobody is interested in publishing these (nor having journal peer review conducted on them). EPA staff review them as part of the pesticide registration/re-registration process. This will also be a problem for TSCA where for many existing chemicals (thousands) for the EU registrations, companies conduct OECD guideline studies. Similar to my comments above, the studies get shared with ECHA but there is no incentive for anyone, anywhere, to publish them. It is likely that when we do TSCA risk evaluations, companies will provide us with these studies as CBI (to protect the costs/money they spent to do the testing- it?s a competitiveness issue). These data will be extremely valuable, extremely high quality, and NOT published. The directive needs to be revised. Without change it will jeopardize our entire pesticide registration/ re-registration review process and likely all TSCA risk evaluations. Let me know what more you may need from me to facilitate a change. Thanks, Nancy Nancy B. Beck, DABT Deputy Assistant Administrator, OCSPP P: 202-564-1273 M: 202-731-9910 beck.nancy@epa.irov From: Yamada, Richard (Yujiro) Sent: Wednesday, January 31, 2018 2:30 PM To: Beck, Nancy @epaaov> Cc: Baptist, Erik ; Schwab, Justin Subject: RE: For review - Draft EPA Testimony for House Science Hearing Ex. 5 - Deliberative Process From: Beck, Nancy Sent: Wednesday, January 31, 2018 2:24 PM To: Yamada, Richard (Yujiro) Cc: Baptist, Erik Schwab, Justin Subject: Re: For review - Draft EPA Testimony for House Science Hearing Ex. 5 - Deliberative Process Thanks. Nancy B. Beck, DABT Deputy Assistant Administrator, OCSPP P: M: 20%731m991l) Beengancx/@ena toy On Jan 31, 2018, at 2: 17 PM, Yamada, Richard (Yujiro) wrote: That?s fine with me as well and thanks for the catch 1 and - initiative needs work and won?t be ready for at least ~1-2 weeks before OGC review and then there will be more time taken for them to look at - thanks Nancy Sent from my iPhone On Jan 31, 2018, at 2:12 PM, Baptist, Erik wrote: Richard, For context, I suggested to Nancy that the following bullet from congressional testimony be deleted, giving the upcoming directive: Ex. 5 - Deliberative Process Ex. 5 - Deliberative Process Erik Baptist Senior Deputy General Counsel Of?ce of General Counsel US. Environmental Protection Agency 1200 Ave., NW Washington, DC 20460 (202) 564-1689 hantist.erikj@cna.iinv From: Beck, Nancy Sent: Wednesday, January 31, 2018 2:08 PM To: Baptist, Erik Schwab, Justin Cc: Yamada, Richard (Yujiro) amadarichard@ena.gev> Subject: RE: For review - Draft EPA Testimony for House Science Hearing Ok. this testimony will be Tuesday, Feb 6. Richard see chain below?I know you sent me something yesterday but I have not had a chance to review. What is the timing of your initiative?? Nancy B. Beck, DABT Deputy Assistant Administrator, OCSPP P: 202-564- 1273 M: 202-731-9910 hecknanc @cnavoy From: Baptist, Erik Sent: Wednesday, January 31, 2018 2:04 PM To: Beck, Nancy Schwab, Justin Subject: RE: For review - Draft EPA Testimony for House Science Hearing Richard Yamada should know the timing (1 do not). But he said he wants to work with you to ensure that there are no negative impacts. Erik Baptist Senior Deputy General Counsel Office of General Counsel US. Environmental Protection Agency 1200 Ave., NW Washington, DC 20460 (202) 564-1689 hautisteril; Schwab, Justin Subject: RE: For review - Draft EPA Testimony for House Science Hearing Ex. 5 - Deliberative Process Ex. 5 - Deliberative Process We need to have a further conversation. Whats the timing for this directive? I?m going to hold on making this change. Thanks. Nancy B. Beck, DABT Deputy Assistant Administrator, OCSPP P: 202-564-1273 M: 202-731?9910 From: Baptist, Erik Sent: Wednesday, January 31, 2018 1:26 PM To: Beck, Nancy Schwab, Justin Subject: RE: For review - Draft EPA Testimony for House Science Hearing Nancy, I have one suggested edit in the attachedi Ex. 5 - Deliberative Process x. 5 - Deliberative Process Erik Baptist Senior Deputy General Counsel Of?ce of General Counsel US. Environmental Protection Agency 1200 Ave., NW Washington, DC 20460 (202) 564-1689 From: Beck, Nancy Sent: Wednesday, January 31, 2018 9:49 AM To: Baptist, Erik Subject: Fwd: For review - Draft EPA Testimony for House Science Nancy B. Beck, Phil, DABT Deputy Assistant Administrator, OCSPP P: 202w564-12?3 M: 202??31-99 10 BeckyNarrev?enagov Begin forwarded message: From: "Kaiser, Sven-Erik" Date: January 31, 2018 at 9:45:56 AM EST To: "Beck, Nancy" "Bertrand, Charlotte? rov>, "Wise, Louise? ena rov>, "Keller, Kaitlin" "rov>, "Hanley, Mary" "Keigwin, Richard? , "Lovvit, Anna? , "Ringel, Aaron" , "Moody, Christina" "Linkins, Samantha?