### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WAS H! GTON D
.C
.. 20460 OFF I CE OF C ll EM I CAL SAFETY A D POLLUT I O PR EV E NT I ON PC Code: 090201 /090202 DP Barcode: D427773 Date: Jul y 15
. 2015 MEMORANDUM Subject:
To:

From: EFED R es po n se to Comments on the Problem Formulation for th e R egistratio n R eview of Carbox in/Oxycarboxin Dana Fri edman
. C hem i ca l R eview M a na ger Cathryn Britton. Team L eader K

ev in Costello. Branch C hi ef Ri s k M a nagement Bran c h 2 Pesticide R e-evaluation Division (7508P) C hu ck Peck, E nvironm e ntal Enginee r Catherine Aubcc. Sen i or Scientist Environme nt a l Ri s k Branch 4 Reviewed By: Jim Car l e to n. Ph
. D
.. Sen i o r Fate Sc i en ti st 

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# i~**7~rJ-2-0tC** Thr o u g h: Environmental Ri s k Branch 4 Jean H o lme s . D.Y.M
. . M.P.H. Bran ch Chief

# p.........__ Environmental Risk Bran ch 4 E

nvir o nm e nt a l Fa t e and Effects Division (7507P) The Environmenta l Fate and Effects Di vision (EFED) has reviewed commen t s sub mitLed by the FIFRA Endange red Spec i es Ta s k Fo r ce (FESTF. Docket umber EPA- H Q-OPP-20 15-0144-0 I0). Ma cDerm id Ag r icu l t u ra l So luti ons. In c. (Docket Nu mber EP A- 1I Q-OPP-2015-0144-0 I I ). th e Ce nter fo r Biological Divers i ty (C BD. Docket umber EPA- HQ-O PP -2015

- 0144-012)
. and the Ph ys icians Comm ittee for Re spo nsible Medic in e (Docket umber EPA-HQ-OPP-201 5-0144-014) in r e ponse to the EFED public rel ease of"Reg i s trati on R eview

- Prelimin ar y Probl em Form ul a tion for th e Dri nki ng Wat er and Eco l og i ca l Ri s k Asse ss ments of Carboxin and Oxyca rb oxin·· (PC Codes 09020 I and 090202). Comme nts from Ma cDcr mid Agr i c ultural So luti ons, Inc
. . the t ech ni ca l re g istr a nt for ca rb ox in and oxyca rb ox in. focused o n the data requirements di sc usse d in the problem fo rmul ation a nd proposal s fo r submitting additional data to fulfill the data requireme nt s or for waiving the requirements altogether. Data s ubmitted in su pp ort of the data requirement s w ill be reviewed a nd. if fo und to fulfill th e Agc ncy · s needs, may be u se d to fulfill o r waive the data requirement. Proposal s for data wa iv ers will be considered when s ubrnit1 ed after the data call-in submission ha s been finalized. MacDermid Agricultural Solutions. In c. also indicated their intent to amend the label for oxycarboxin to read "fo r use in e nclosed co mm erc i a l g r

een ho uses'', which wo uld e limin at e the n eed to cond uct m a n

y eco l og i ca l tox i c i

ty stud i es 

### fo r Page 1 of 2oxycarboxin. EFED agrees with this label language clarification and, if implemented , ' ill waive the r equ irement s fo r certain studies duri ng th e data call- in development. The comments from the Physician Committee for Re s po nsible Medicine focused on the conduct of the acute avian ora l toxicity s tud y for oxycarboxin and the acute toxicit y study for estuarine and marine fish for carboxi n and oxycarboxin. EFE D will co ns ider the se comment s when evaluating the s ubmitted protocols, data waiver s, and st udi es. The FES TF and CBD co mm ents dealt with eco logical assessment issues pertaining to ri s k s to listed spec i es. Th e EPA a l o ng w i th the U.S. Fish & Wi ldlife Service (USFWS), the National Marine Fisher ie s Service ( MFS) (collectively, th e Se rvic es), a nd the U.S. Department of Agriculture (USDA) , r e lea se d a s ummar y o f their implementation plan for a cssing ri s ks of pesticide s to li s ted s pecies ahead of a s takehold er workshop that wa s held o n ovc mber I S. 20 13. Thi s plan wa s developed in re s ponse to National Academy o f Sciences· (NAS) re co mmendation s, includin g developm ent of a common approach to ri sk as sess ment as a way of addressing sc i e ntific differences between EPA and the Services. Durin g the workshop. the agencies received feedback from the public on interim scientific approaches that were developed as part of an initial impl ementation of the AS rec ommendati ons. These approaches wi II be joint l y impl eme nted and vetted as pa r t of a p hased , i terat ive proce ss. O nce a full y-vetted process is in place. EPA will implement the approaches into the li s t ed spec i es effects determination portion of the ri sk ass essment for carboxin and oxycarboxin.

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