UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASH! GTON D.C .. 20460 

OFFICE OF 

CllEM ICAL SAFETY A D 

POLLUTIO PREV ENTION 

PC Code: 090201 /090202 

DP Barcode: D427773 

Date: July 15. 2015 

MEMORANDUM 

Subject: 

To: 

From: 

EFED Response to Comments on the Problem Formulation for the Registration Review of 

Carbox in/Oxycarboxin 

Dana Friedman. Chemical Review Manager 

Cathryn Britton. Team Leader 

Kevin Costello. Branch Chief 

Risk Management Branch 2 

Pesticide Re-evaluation Division (7508P) 

Chuck Peck, Environmental Engineer 

Catherine Aubcc. Senior Scientist 

Environmental Risk Branch 4 

Reviewed By: Jim Carleton. Ph.D .. Senior Fate Sc ientist =f-1<;- ~"S 

i~ 7~rJ-2-0tC Through: 

Environmental Risk Branch 4 

Jean Holmes. D.Y.M .. M.P.H. Branch Chief p.........__ 

Environmental Risk Branch 4 

Environmental Fate and Effects Division (7507P) 

The Environmental Fate and Effects Division (EFED) has reviewed comments submitLed by the FIFRA 

Endangered Species Task Force (FESTF. Docket umber EPA-HQ-OPP-20 15-0144-0 I 0). MacDermid 

Agricultural Solutions. Inc. (Docket Number EPA-1IQ-OPP-2015-0144-0 I I). the Center for Biological 

Diversity (CBD. Docket umber EPA-HQ-OPP-2015-0144-012). and the Physicians Committee for 

Responsible Medic ine (Docket umber EPA-HQ-OPP-201 5-0144-014) in re ponse to the EFED public 

release of"Registration Review - Preliminary Problem Formulation for the Drinking Water and 

Ecological Risk Assessments of Carboxin and Oxycarboxin·· (PC Codes 09020 I and 090202). 

Comments from MacDcrmid Agricultural Solutions, Inc .. the technical registrant for carboxin and 

oxycarboxin. focused on the data requirements discussed in the problem fo rmul ation and proposals for 

submitting additional data to fulfill the data requirements or for waiving the requirements altogether. 

Data submitted in support of the data requirements will be reviewed and. if found to fulfill the Agcncy·s 

needs, may be used to fulfill or waive the data requirement. Proposals for data waivers will be considered 

when subrnit1ed after the data call-in submission has been finalized. MacDermid Agricultural Solutions. 

Inc. also indicated their intent to amend the label for oxycarboxin to read "for use in enclosed commercial 

greenhouses'', which would eliminate the need to conduct many ecological toxicity studies for 

Page 1 of 2 
oxycarboxin. EFED agrees with this label language clarification and, if implemented, ' ill waive the 

requirements fo r certain studies duri ng the data call-in development. 

The comments from the Physician Committee for Responsible Medicine focused on the conduct of the 

acute avian oral toxicity study for oxycarboxin and the acute toxicity study for estuarine and marine fish 

for carboxin and oxycarboxin. EFED will consider these comments when evaluating the submitted 

protocols, data waivers, and studies. 

The FESTF and CBD comments dealt with ecological assessment issues pertaining to risks to listed 

species. The EPA along with the U.S. Fish & Wildlife Service (USFWS), the National Marine Fisheries 

Service ( MFS) (collectively, the Services), and the U.S. Department of Agriculture (USDA), released a 

summary of their implementation plan for a cssing risks of pesticides to listed species ahead of a 

stakeholder workshop that was held on ovcmber IS. 20 13. This plan was developed in response to 

National Academy of Sciences· (NAS) recommendations, including development of a common approach 

to risk assessment as a way of addressing scientific differences between EPA and the Services. During 

the workshop. the agencies received feedback from the public on interim scientific approaches that were 

developed as part of an initial implementation of the AS recommendations. These approaches wi II be 

jointly implemented and vetted as part of a phased, iterative process. Once a fully-vetted process is in 

place. EPA will implement the approaches into the listed species effects determination portion of the risk 

assessment for carboxin and oxycarboxin. 

Page 2 of 2