Document 0qMR0D1or6K6eKNr5oEgDLD6b

Message From: Sent: To: CC: Subject: Bolen, Derrick [/0=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=1FFC58B0468C4DECA51A8BAD735B7D95-BOLEN, DERR] 11/17/2017 7:47:17 PM Juberg, Daland (DR) [DRJuberg@dow.com] Beck, Nancy [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=168ecb5184ac44de95a913297f353745-Beck, Nancy] RE: PMN meeting Daland- Below is the link for the 12/6 public meeting. https://www.epa.gov/assessing-and-managing-chemicals-untler-tsca/meetings-and-webinars-amendecl-toxicsubstances-control Thank you, Derrick Bolen From: Beck, Nancy Sent: Friday, November 17, 2017 7:18 AM To: Juberg, Daland (DR) <DRJuberg@dow.com> Cc: Bolen, Derrick <bolen.derrick@epa.gov> Subject: Re: PMN meeting Ok. FYI. We are having a big public meeting on new chemicals December 6. Derrick can send you the link to the meeting information and materials if you don't have it already. Nancy B. Beck, Ph.D., DABT Deputy Assistant Administrator, OCSPP P: 202-564-1273 M:i Ex. 6 Beck.Nancy@epa.gov On Nov 17, 2017, at 7:07 AM, Juberg, Daland (DR) <DRjuberg@dow.com> wrote: Nancy, 1 should have mentioned (and 1 can get specifics on date, OPPT staff) that the team here has had one meeting already, but probably 6 or more months ago relative to testing requested, consent order timelines, etc. Let me at least get date/names and that might provide more background from EPA's side. From: Beck, Nancy [mailto:Beck.Nancv@epa.gov1 Sent: Thursday, November 16, 2017 6:22 PM To: Juberg, Daland (DR) <DRJuherg@dow.com> Cc: Bolen, Derrick <boien.derrick@epa.gov> Subject: RE: PMN meeting Daland, Thanks for the note Let me circle back with OPPT staff and will let you know about what type of meeting we will want to set up. Sierra Club v. EPA 18cv3472 NDCA Tier 3/4 ED 002061 00040250-00001 Regards, Nancy Nancy B. Beck, Ph.D., DABT Deputy Assistant Administrator, OCSPP P: 202-564-1273 bec.k.nancy@epa.gov From: Juberg, Daland (DR) [maiito:DRJuberg@dow.com1 Sent: Thursday, November 16, 2017 8:51 AM To: Beck, Nancy <Beck.Nancy@epa.gov> Cc: Bolen, Derrick <boien.derrick@epa.gov> Subject: RE: PMN meeting Nancy, Derrick - this is the high-level situation for your review and suggested next steps. I left the two PMN identifiers on Nancy's VM. Below summary' is from the lead toxicologist on the team and based on your recommendation for next steps (30 min initial call, F2F meeting, etc.), I will then bring her/the team into this and let them lead from here with EPA. Many thanks. OPPT has requested the following testing for Rinskor PMNs: 1) Genotox (Ames and micronucleus) 2) Dermal Sensitization 3) OECD 422 via inhalation with TK and or micronucleus (this is repeat dose toxicity combined with reproductive and developmental screening which requires 800 rats) (only for one of the intermediate- depending on the resuits, it wili be triggered for other intermediate). DAS rationale for not requiring the testing for PMNs: A) Lack of Haiard potential for PMNs: 1) Rinskor (a new rice herbicide and the parent active) is considered as an appropriate surrogate or analog for these PMNs for read-across, Rinskor (Fiorpyrauxifen benzyl) was granted unconditional registration under FIFRA as rice herbicide in September, 2017. it was also granted a reduced risk designation based on it low human health risk profile. Based on lack of toxicity for Rinskor, no point of departures were selected and no quantitative risk assessments were conducted. 2) The basis to ask for OECD 42.2. for was OPPT's evaluation of Rinskor two-generation reproduction study results indicating that the changes in pup body weights at the highest dose of 300 mg/kg/day. However, this assessment is in contrast to what HED has concluded suggesting that there are no treatment related effects to the parent or offspring at any dose levels tested with Rinskor. 3) Rinskor is a weak dermal sensitizer, DAS is wiliing to take sensitization classification for PMNs as appropriate risk mitigation measures such as standard OSFIA required PPE are already in place for manufacturing workers. B) Lack of Exposure Potential for PMNs: 1) Both PMNs have low vapor pressure reducing exposure potential via inhalation Sierra Club v. EPA 18cv3472 NDCA Tier 3/4 ED 002061 00040250-00002 2) Gastro plus Simulation and EPA's MPPD models consistently predicted a lower inhalation absorption for both PMMs. 3) Both PMNs are predicted to exhibit sublinear kinetics similar to Rinskor. 4) Most importantly, it is a closed manufacturing system reducing exposure to workers and a. furthermore, workers wear PPE that minimizes both dermal and inhalation exposures i. Supplied air breathing hood, ii. Tyvek or PVC Suit, iii. nitrile under neoprene gloves taped to suit C) Pesticide intermediate is the only use for the PiViNs: 1) Patent protected until 2032 and beyond 2) Generic production unlikely for 12-15 years due to barrier to entry with data compensability under FIFRA statues 3) Complex synthetic route and no closely related analogs As per Lautenberg New Chemical Safety act requirement under Section 4 testing of chemicals by manufacturers, importers, and processors Is only required "where risks or exposures of concern are found" . Based on the above rationale for Rinskor PMN substances, since there is no hazard or exposure potential, there is no Risk, DAS believes Rinskor PMN substances do not trigger the criteria for any additional testing. From: Beck, Nancy [maiSto:Beck.Nancy@epa,gov1 Sent: Wednesday, November 15, 2017 9:00 AM To: Juberg, Daland (DR) <DRJubem@dow.com> Cc: Bolen, Derrick <boien.derrick@epa.gov> Subject: PMN meeting Daland, Got your message and I presume you are referring to a new chemical issue. Happy to have a 30 minute meeting (phone or in person). Derek can help get it on my calendar and if you tell me or him the PMN number we can ensure correct experts attend as well. You may not want to email the PMN number as it may likely be CBI. If you were referring to something else, just let me know the topic. Regards, Nancy Nancy B. Beck, Ph.D., DABT Deputy Assistant Administrator Office of Chemical Safety and Pollution Prevention P: 202-564-1273 M: ! Ex. 6 beck.nancy@epa.gov Sierra Club v. EPA 18cv3472 NDCA Tier 3/4 ED 002061 00040250-00003