UNITED STATES ENV IR ONMENTAL PROTEC TION AGENCY WA S HINGTON D.C., 20460 OFFICE OF CHEMICAL SAFETY AND POLLUT ION PREVENTION

MEMORANDUM DATE: September 17 , 20 14 SUBJECT: MCPB : PRD Response to Comments on Registration Rev i ew Preliminary Work Plan 

### FROM: Khue Nguyen, Chemica l Re view Manag")i



# ~ ""'-./ Thomas Moriarty, Team Leader

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### 'f ' l.....,..._· "-"""'-- (f) Ri sk Management and I mpleme ntation Branch 1 P esticide Re-evaluatio n Division (7508P) THRO UGH : Neil Anderson, Branch Chief



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## A-... <Lt-.sRisk Man age ment and Implementatio n Branch 1 Pesticide R e-e valuation Divi s ion (7508P) TO: MCPB R egistration Review Docket Docket Number: EPA

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- OPP- 20 14-0181 www.regulations.gov On March 28, 2014, EPA open ed a 60-day public comm e nt period o n the preliminary work plan (PWP) for the regi strati o n review ofMCPB. The co mment period ended on May 27, 2014. During the pub li c comment period the Agency received 3 s ubmi ss ions. Comments w e re s ubmitted by the MCPB Task Force, the Center for Biological Diversity , a nd the FIFRA Endanger e d Spec i es Tas k Force (FESTF). Be low are PRD 's responses to those comments p ertain ing to the pr elimi n ary work plan for MCPB, the use and usage of MC PB , or pertaining to the ge ner al MCPB r egistrati on review program. Comments regarding the environmental fate or effects ofMCPB have been addressed by the Environmental Fate and Effects Division 's (EFED) document, EPA Response to Comments Related to the Preliminary Prob le m Fo rmulationfor Ecological Risk and Env ir onme ntal F at?, Endangered Spec ies, and Drinking Water Assessments/or MCPB and Its Salt , date d August 28, 2014. Comments regarding the human heal th assessment or human health data requirem e nt s have been addre ss ed by the Health Effects Division's (HED) doc um e nt , MCPB. Response t o Comme nt s Received Regarding Scoping Docum ent in Support of Registration Review, dated September 4, 2014.

1 of3Comments from the MCPB Task Force in EPA-HQ-OPP-2014-0181

- 0012 MCPB Task Force Comment: The MCPB Task Force made corrections to the MCPB LUIS report s and suggested that the LUIS reports should be rerun to incorporate new updates. EPA Response: The Agency acknowledges the se corrections. T he LUIS reports are up-to-date as of

the date the reports were genera t ed . The LUIS reports will be updated again when and if needed for

ri sk assessment, but as of this time the report s will not be rerun by the Agency. MCPB Task Force Comment: The MCPB Task Force stated that all formulations of MCPB are soluble concentrate and not emulsifi able concentrate. EPA Response: The Agency acknowledges this correction. MCPB Task Force Comment: The Task Force did not understand why an ecological incident naming MCP A was attributed to MCP B. EPA Response: The single terrestrial plant incident was actually attribut ed to MCPB. There was a typo in the problem formulation. Comments from the Center for Biological Diversity in EPA-HQ-OPP-2014

- 0181-0011 Center for Biological Diversity Comment: The Center for Biological Diversity's (CBD) comments focus on the EPA's duty to consult with the US Fish and Wildlife Service and the National Marine Fisheries Service (the Services) on the registration r eview of MCPB 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's preliminaty determinations regarding the effects of MCPB on endangered and threatened (listed) species and their designated critical habitat for the MCPB registration r ev iew. EPA Response: EPA has reviewed the comment s from CBD on the registration review docket opening for MCPB and plans to address many of the concerns raised by CBD as part of the implementation plan for assessing the risks of pesticides to listed species based on the recommendations ofthe April2013 National Academy of Sciences (NAS) report. EPA will address concerns specific to MCPB in connection with th e development of its final registration review decision for this **pesticid~.** In November 2013, the EPA, along with the Services and the USDA, released a summary of their joint Interim Approaches for assessing risks to endangered and threatened (listed) species from pesticides. The Interim Approaches were developed jointly by the agencie s in response to the NAS recommendations and reflect a common approach to risk assessment shared by the agencies as a way of addressing scientific differences between the EPA and the Services. Th e NAS r eport outlines recommendations on specific sc ientific and technical issues related to the development of pesticide ri sk assessments that EPA and the Services must conduct in connection with their obligations under the ESA and FIFRA. 2 of3The jo int In terim Approaches we re released pr i or to a stakeh older workshop he ld o n November 1 5, 2 0 13. ln additi on, th e EPA p resented the joi nt Inte ri m Approaches at the December 2013 Pes ti cide Program Dialogue Committee (PP D C) and State-FIFRA Issues Research and Eva luation Group (SFIREG) meetings. The agencies also held a stakeholder workshop in April 2014, allowing additional opportunities for stakeh olders to comment on the Inte rim Approaches. Ad ditio na l workshops are planned to enhance stakeholder invo lveme nt; the next workshop i s schedul ed for October 2014. As part of a phased , iterative process for develo pi ng the In teri m App r oaches, th e agencies will al so co n s ider pu blic comments on the In terim Approaches in connection wi th the deve lopment of upcom i ng registration revi ew decis ions. The details of the joint Interim Approaches are contained in the white

**~,Interim** Approaches for N ational-Level Pesticide Endangered Species Act Assessments Based on the Recomm e ndations of the National Academy of Sciences April 2013 Report, dated November 1 , 2013. Gi ven th at the agencies are contin uing to deve lop an d work to w ard imp lementation of th e Inter i m Approac hes to assess the potenti al risks of pesti cides to li sted species and their designated critical habitat, the ecological problem formulation supporting this Final Work Plan for MCPB does not describe the specific ESA analysis, including effects determinations for specific listed species or des ignated critical hab itat , to be conducted during registration review. In the eco logica l problem formulation document for MCPB, EPA described the screening-level ri sk assessment to determine the potent ial effec ts of MC PB on a ll taxa of n on-ta r ge t w ildli fe and plants, which w ill assume tha t li sted spec i es and the ir designated critical ha b itats may be present in the v ic inity of the app li catio n ofMCPB. This screening-level assessment will allow EPA to focus its future eva luations on the types of species where the potential for effects ex i sts once the scientific methods being developed by the agencies have been fully vetted. While the agencies continue to deve lop a common method for ESA analysis , the p l anned screening -l eve l risk assessment for the registration review of MC PB will describe the level of ESA analysis completed for this particu lar reg i stration review case . O n ce th e agenc i es have fu ll y developed and imp lem ented the sc i ent ifi c methods necessary to complete risk assessments for endangered and threatened (listed) species and their designated critical habitats, these methods will be applied to subsequent analyses for MCPB as part of complet ing th is registration review. 

### Com me nts from th e FIFRA Endan ge red S p ec ies T a s k Force (FESTF) in EPA

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- 0181 -0 010 FESTF Comme n t: FESTF commented that the MCPB technical registrants, Nufa rm Limited and Nuf arm Americas , Inc. , are both FESTF members and are entitled to rely on FESTF data for endangered spec ies assessment. 

### EPA Response: The Agency tha n ks FESTF fo r th is i n format i on a n d wi ll co ns i de r it dur in g the reg i strat ion review ofMCPB

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