### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D

. C., 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

MEMORANDUM DATE: September 19,2014 SUBJECT: MCPA: PRD Response to Comments on Registration Review Preliminary Work Plan // 11 

### Khue Nguyen, Chemical Review Manager



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### Pesticide Re-evaluation Division (7508 P)



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### Neil Anderson, Branch Chief 

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. Risk Management and Implementation Bra nch 1 Pesticide Re-evaluation Division (7508P) TO: 

### MCPA Reg istration Review Docket Docket Number: EPA-HQ-OPP-2014-0180 www.regulations.gov On March 28, 2014, EPA opened a 60-day public comment period on the preliminary work plan (PWP) for the regi strati on review ofMCPA. The co mment period ended on May 27,2014. During the public comment period the Agency received 5 submissions. Comment s were submitted by the MCPA Task Force Three , the Center fo r B iological Diversity, the Central Valley Regional Water Quality Control Board (of California), the FIFRA Endan gered Species Task Force (FESTF), and a private citizen. Below are PRD 's re sponses to those comments pertaining to the preliminary work plan for MCPA, the use and usage ofMCPA, or pertaining to the general MCPA registration review program. Comments regarding the environmental fate or effects of MCPA have been addressed by the Environmental Fat e and Effects Division 's (EFED) document, 

### EFED Response to Public Comments on: Preliminary Problem Formulation for Environmental Fate and Ecological Risk, Endangered Species, and Drinking Water Assessments/or MCPA, dated August 14, 20 14. Comments regardi ng the human health assessment or human he alth data requirements have been addressed by the Health Effects Division 's (HED) document , 

### MCPA. Response to Comments Received Regarding Scoping Document in Support of Registration Review, dated September 4, 2014.

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### of 4Comments from t he MCPA Task Force Three in EPA - HQ - OPP - 2014 - 018 0- 0022 MCP A Task Force Comment: The Agency indicates that the registration review case for MCP A will include PC code 030506, the isooctyl ester of MCPA t hat is generally conside r ed an obsole t e form . Only one MC P A product is currently identified as containing P C code 030563: B r omoxynil + MCPA He r bicide, EPA registration number 66222-1 2 0. The Task Force believes that this product is er r oneously classified and should be corrected to PC code 030564 , the 2 - ethylhexyl esterform of M C PA . EPA Response: The Agency or i gi n ally i ncluded P C code 0 3 0 506 (MCPA i soocty l este r ) i n the re g ist r a t ion rev i ew case fo r MCP A beca u se the l abe l for registr:a t ion n u mber 66222- 1 20 (Bromoxynil + MCP A Herbicide) li sts this PC code as the act i ve i n g r edie n t. Upon close r examination of the d ocu m entat i o n for reg i str a tion number 66222 - 120, the Agency agrees tha t this produc t is erroneous l y classified and shou ld be reg i s t ered under PC code 030564, the 2 - et h yl h exyl este r form. T h e labe l for th i s produc t incorrect l y lists M CP A isooctyl ester as the active ingredient and should be amended to reflect MC P A 2 - ethy l hexyl ester as the ac t ive ingr e d ie n t. The s t a t ement on th e l a bel for numbe r of p o unds ae / ga l shoul d also b e corrected. The basic CSF fo r this p r oduct should also be updated w i th th e corr e ct so u rce reg i stra t ion numbe r to reflect the correc t act i ve ingre d ient. The registrant, A D AMA (forme rl y Ma k hteshim Agan ofNorth Amer i ca), shou l d e n sure tha t all c i ted/s u bm i tted data used t o support registra t ion numbe r 66222 -1 20 were conducted with t h e correct active ingredient. Once these cha n ges a r e made , the Agency will ensure t ha t PC code 030506 will n o t be i n cluded i n th e registration

re v i ew case for MCP A. M CPA Task Fo r ce Comment : T he summaries ofthe MCPA use sites listed in the Agency ' s registration review documents are incomplete. The MCP A RE D Appendix A , Use P atterns Subject to Reregistration for MCP A accurately list the comp r ehensive list of use sites . EPA Res p onse : The Agency intended the sum m ar i es ofMCPA use sites to be a hi g h level s u mmary

and not a complete comprehensive list of MCPA use sites. MCPA Task Fo r ce Comment : The Ag e ncy referenced MCPB and MR1Ds 45524105 and 47374801 in the MCP A problem formulation in co n nection with its rational for requesting additional information on dioxin!furan impuritie s in MCP A products. The Task F orce believes that EPA has access to more recent MCPA-specific information/rom MCPA technical registrants regarding this issue. EPA should

make spe c ific requests to t echnical regis t rants for additional data. EPA Response : The Tas k Force is co r rec t , recen t data on dioxin/furan impurit i es in MCPB p r od u cts

has p rom p t ed th e Agency to re qu i re these data o n M C P A p r od u cts. The Agency i s mod i fy i ng its li st of d a t a req u irements t o inc l ude guideline 8 3 0 . 1700 preliminary analysis i n order to confir m the presence / l evel of diox i n/fu r a n i m p ur i t i es in MCPA prod u cts using the most up- t o - date analyt i cal metho d s . M CP A Task Force Comment: The pr e liminary work plan states that MCP A was first regi s tered in 19 7 3 . The Task Force notes that forms of MCPA were registered as early as 1952 . 2 of 4

### EPA Response: The Agency listed 1973 as the date of first registration for MCPA in error. EPA 's records show that the first MCPA dimethylamine salt product was registered on May 13, 1953 (Weedone MCPA concentrate , EPA registration number 116 85-19). The Agency could not fi nd record of any MCP A product registered in 1952. 

### MCP A Tas k Force Comment: In the pr eliminary wo rkplan and BEAD chemicalprofile, EPA requested additional information on use of MCPA and its importance in non-agricultural use sites. EPA did not know why use on turf, golf courses , and institutiona l turf have increased so substantively. The Task Force provided information on why customers in certain secto r s prefer broadleaf herbicide mixtures not based on 2,4

-D , information on other herbicides typically combined with MCPA, and information on which specific target weeds each combination is meant to target
. EPA Response: The Agency thanks the MCPA Task Force for this information and will consid er it during the registration review of MCPA. 

### Comments from the Center for Biological Diversity in EPA-HQ-OPP-2014-0180-0020 Center for Biological Diversity Comment: The Cen ter for Biological Diversity's (CBD) comments focus on the E PA 's duty to consult with the 

### U.S. Fish and Wildlif e Service and the National Marin e Fisheries Se rvice (the Services) on the registration review of MCP A in accordance with the Endangered Species Act (ESA). The CBD comments mention various aspects of the risk assessment process, including use of the best available data to develop endangered species risk assessments, and evaluation of effects on endangered and threatened species and their designated critical habitat. CBD also expresses concern regarding the rigor of the Agency'spreliminary determinations regard ing the eff ects of MCP A on endangered and threatened (listed) species and their desig nated critical habitat for the MCP A registration review

. EPA Response : EPA has reviewed the comments fro m CBD o n the registration review docket opening for MCPA and plans to address many of the concerns raised by CBD as part ofthe implementati on plan for assessing the risk s of pes ticides to listed species based on the recommendations of the April 2013 National Academy of Sciences (NAS) report. EPA will address concerns speci fic to MCPA in connection with the development of its final registration review de cis ion for this pesticide. In November 2013, the EPA, along with the Services and the US DA, re leased a summary of theirjoint Interim Appro aches for assessing ri sks to endangered and threatened (li sted) species from pesticides. The Interim Approaches were developedjointly by the agencies in response to theNAS recommendations and reflect a common approac h to risk asse ssment shared by the agencies as a way of addressin g scientific differences between the EPA and the Services

. The NAS report outlines recomm endations on specific scientific and technical issue s re lated to the development of pestic ide ri sk assessments that EPA and the Serv ices must conduct in connection with their obligat ions under the ESA and FIFRA. The joi nt Interim Approaches were re leased prior to a stakeho lder workshop held on November 15, 2013. In addition , the EPA presented the joint Interim Approaches at the December 2013 Pesticide Program Di alo gue Committee (PPDC) and State-FIFRA Is s ues Research and Eval uation Group (S FI REG) meetings. The agenc ies also held a stakeholder works hop in April 20 14 , all owing additional opportunities for stakeholders to comment on the Interim Approaches. Additio nal workshops are

3 of 4planned to enhance stakeho l der invo l v e ment; the nex t workshop is schedu l ed fo r October 2014 . As p art of a phased, iterative process for d eve l oping the I n te r im A p p r oaches, t he agencies will also consider public commen t s on the Interi m App r oaches in connect i on with the development of upcoming registration r eview decisions. T he details of the j o i nt Interim Approaches are contained in the white**~'** Interim Approaches for National-Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the National Academy of Sciences April 2013 Report, dated November 1 , 2013. G i ven t hat t he agenc i es are conti n uing to develop and work toward i mp l ementat i on of the Interim Approaches to assess the potentia l risks of pest i c i des to listed species and their designated critical habitat, the ecolog i cal p r oblem formu l ation supporting this F i nal Work P l an for MCPA does no t describe t h e spec i fic ESA analysis, includ i ng effects determi n ations for specific listed species or des i gnated critical habi t at, t o be conducted dur i ng registration review. In t he ecologica l problem

fo r mu l ation document for MCPA, EPA described the screening-leve l r isk assessment to determine the poten t ial effects of MCPA on all taxa of non-target wild li fe a n d plants, which will assume that listed species and their designa t ed c r itica l habitats may be present in the vicin i ty of the application of MCPA . Th i s screen i ng

- level assessmen t w ill allow EPA to focus i ts future evaluations on the types of species where the poten t ial for effects exists once the scientific methods be i ng developed by t h e agencies have

been fully vetted. Whi l e the agencies con t inue to deve l op a commo n method for ESA analysis, the p l an n ed screening-level ris k assessment for the registration review of MCP A will describe the level of ES A ana l ys i s com p leted for th i s particular registration review case. O n ce the agenc i es have fully deve l o p ed and implemented the sc i ent i fic methods necessary t o complete risk assessments for endangered and threatened (l i sted) species and their designated cr i t i ca l habitats, these methods will be applied to s u bsequent analyses for MCP A as part of completing this reg i stration review. Comments from the FIFRA Endangered Species Task Force (FESTF) in EPA - HQ - OPP - 2014 - 0180-0019 FESTF Comment: FESTF commented t hat the MCP A technical registrants, Albaugh, Inc., Dow AgroSciences LLC, Nufarm UK Limited, Nufarm Platte PTY Ltd, and Nufarm America s, Inc. are all FEST F members and are entitled to rely o n FESTF data for endangered species assessment.

EPA Response: T h e Age n cy thanks FES T F for this information and will consider it during the r eg i stration review of MCP A. Comments from . an anonymous private citizen in EPA-HQ-OPP-2014 - 0180 - 0018 Citizen Comment: A private citizen commented in favor of banning MCP A and similar herbicides because of potential for bioaccumulation in the fatty tissues and possible endocrine disruption in animals and humans . EPA Response: The Agency is consideri n g the potential for bioaccum ul ation and endocrine disruption of MCPA d uring registration review . The Agency is requiring gu i deline 850 . 1730 aquatic o r gan i sms b i oavailab ili ty, b i omag n ificat i on, tox i c i ty (fish b i oconcentration fac t or) as part of the da t a requirements for the regis t ration review of MCP A. 4 of4