Document evxDzXnVX6zZwYrvRzbz3Q0Nq

Message From: Sent: To: CC: Subject: Juberg, Daland (DR) [DRJuberg@dow.com] 11/30/2017 12:56:39 AM Beck, Nancy [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=168ecb5184ac44de95a913297f353745-Beck, Nancy] Bolen, Derrick [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=lffc58b0468c4deca51a8bad735b7d95-Bolen, Derr] RE: PMN meeting Hi Nancy -- my colleague, Sabitha, Papineni, who covers this issue for us is wondering if you have had a chance to suggest next steps relative to a possible meeting or phone call? My thanks. Daland DalandR. Juberg, Ph.D., Fellow, ATS Human Health Science Policy Regulatory Sciences Dow AgroSciences LLC 9330 Zionsville Road, Indianapolis, IN 46268 Office: [___ Ex. 6 ___ !DRJuberg@dow.com www.dowagro, com From: Juberg, Daland (DR) Sent: Thursday, November 16, 2017 6:27 PM To: 'Beck, Nancy1<Beck.Nancy@epa.gov> Cc: Bolen, Derrick <bolen.derrick@epa.gov> Subject: RE: PMN meeting Thank you. From: Beck, Nancy [mailto:Beck.Nancy@epa.gov] Sent: Thursday, November 16, 2017 6:22 PM To: Juberg, Daland (DR) <DRjuberg@dow.com> Cc: Bolen, Derrick <bQien.dernek@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 00039570-00001 Regards, Nancy Nancy B. Beck, Ph.D., DABT Deputy Assistant Administrator, OCSPP P: 202-564-1273 M:f Ex"~6 ! L__________________________________ I beck.nancy@epa.gov From: Juberg, Daland (DR) [mailto:DRJuberg@dGw.coml 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.*123 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 results, it will be triggered for other intermediate). DAS rationale for not requiring the testing for PMNs: A) Lack of Hazard 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 (Florpyrauxifen 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 iack of toxicity for Rinskor, no point of departures were selected and no quantitative risk assessments were conducted. 2) The basis to ask for OECD 422 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 willing to take sensitization classification for PM Ns as appropriate risk mitigation measures such as standard OSHA required PPE are aiready in place for manufacturing workers. B) Lack of Exposure Potential for PiViNs: 1) Both PMNs have iow vapor pressure reducing exposure potential via inhalation 2) Gastro plus Simulation and EPA's SV1PPD models consistently predicted a lower inhalation absorption for both PMNs, 3) Both PMNs are predicted to exhibit subiinear kinetics similar to Rinskor, Sierra Club v. EPA 18cv3472 NDCA Tier 3/4 ED 002061 00039570-00002 4) Most importantly, it is a dosed manufacturing system reducing exposure to workers and a, furthermore, workers wear PPE that minimizes both dermal and inhalation exposures i. Supplied air breathing hood, IL Tywek or PVC Suit, Hi. nitrile under neoprene gloves taped to suit C) Pesticide intermediate Is the only use for the PIVilMs: 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 [mailto:Bec.k.IMancy@epa.govl Sent: Wednesday, November 15, 2017 9:00 AM To: Juberg, Daland (DR) <DRJuberg@dow.com> Cc: Bolen, Derrick <bolen.derrick@epa.gQv> 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: I Ex. 6 I i________________________________i beck.nancy@epa.gov Sierra Club v. EPA 18cv3472 NDCA Tier 3/4 ED 002061 00039570-00003