### Do cket Number EPA-HQ-OPP-2015 -0 203 www.regulations.gov



# Acequinocyl Final Work Plan Registration Review

Case Number 7054

November 2015

Approved by:

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Date: Richard P. Keigwin, Jr. Director Pesticide R e-evaluation Division

### INTROD UCTIO N
This is the Environmental Protection Agency ' s (EPA or the Agency) Final Work Plan (FWP) for the reg i stration revi ew of acequinocy l. This work plan addresses public comments rece ived concerning the Pre limin ary Work Plan (PWP) , which was posted in the acequinocyl registration review docket (EPA

- HQ-OPP-2015-0203). Acequinocyl is a quinoline-type miticide currently registered for use in the U.S. on various food and ornamental plant crops for the control of mites. Acequinocyl is registered for use in greenhouses , shadehouses , and nurseries as well as in and around residences , businesses, public property, schools , interiorscapes , and other non-production
areas by commercial applicators and homeowners.
The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide , Fungic ide , and Rodenticide Act (FTFRA), and will review each regis tered pesticide every 1 5 years to determine whether it continues to meet the FIFRA standard for registration. Changes in science , public policy , and pesticide use practices occur over time. The registration review program is intended to make sure that , as the ability to assess risk evolves and
as policies and practices change , all registered pesticides continue to meet the statutory standard. The public phase of registration review begins when the initial docket is opened for each case. Inf ormation on this program is provided on the Agency's website. 1

The FWP begins with any updates since the PWP was iss ued. Next is a summary of substantive comments rec e ived during the public comment period for the PWP concerning anticipated data needs , expected risk assessments , or the estimated timeline identified in the PWP , and a summary ofthe Agency ' s responses to those comments. This section is followed by registration review planned data needs , risk assessments expected to be conducted , and the projected registration review timeline for acequinocyl. Lastly , there is a discussion of next steps.


### UPDATE S SINCE THE PWP WAS ISS UE D
There are no additional updates on acequinocy l s ince the PWP.


### SUMMARY O F C OMMENT S AND AGENCY RESPO NSES During the 60-day public comment period on the Acequinocyl Preliminar y Work Plan, which opened on June 24 , 2015 and closed on August 24 , 2015 , the Agency received one public comment from the Cent e r for Bio logical Diversity. In the PWP , EPA also solicited comments on the specific topics of environmental justice , water quality concerns , and trade irritants, but no comments or information were received on those issues.
S ummarized below i s the pub lic comment and response from E PA. Pub li c comments and EPA responses in their entirety are located in the docket, EPA

- HQ -OPP-20 15-0203.


### Co mment submi tted by the Center for Biolo gic a l Diversity in EPA-HQ-OPP-2015-0203- 0010

.

1 hnp: //www.epa.gov/oppsrrd I / reg istration

_ review/
2l. Comment: "EPA has an independent duty under the Endangered Species Act to consult with the U.S. Fish and Wildlife Service and National Marine Fisheries Service on the Reregi stration (s ic ) of acequinocyl" and its end- u se product labels including making
" defensible ' 'Not Likely to Adversely Affect " and " Lik ely to Adversely Affect " determinations as a prerequi s ite for defensible " Jeopardy " and "No Jeopardy " determinations , " assessing the "adverse impacts of acequinocyl in critical habitat," and following the new 

### Interim Approaches based on recommendations of the National Academy of Science that include a spa tial analysis at Step l and geographic restrictions on product labels to protect critical habitat at Steps 2 and 3. Response: EPA has reviewed the comments from CBD on the problem formulation for the regi stration review ofacequinocyl and plans to address many ofthe concern s raised by CB D 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 w ill address concerns specific to acequinocy l 

### in connect ion with the development of its regi stration review decision for acequinocyl.
The NAS report , available at http :/ /www.nap.edu/catalog.php?record

_ id= 18344http: / /www
.epa.gov/espp/20 1 3 /nas.html, outlines recommendations o n specific scientific and technical i ss u es related to the development of pesticide risk assessments that are compliant with the Endangered Species Act and the Federal Insecticide , Fungicide , and Rodenticide Act. In November, the EPA, along with the U.S. Fish & Wildlife Service (USFWS) , the National Marine Fisheries Service (NMFS) (collectively, the Service s) , and the U.S. Department of Agriculture (USDA) , released a summary of their joint Interim Approaches for assessing risks to listed species from pesticides. The Interim Approaches were developed jointly by the Agencies 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 EPA and the Services. Thejoint Interim Approaches were released prior to the stakeholder workshop held on November 15 , 20 13. EPA presented the joint Interim Approache s at the December 2013 PPD C and SFIREG meetings, allowing additional opportunities fo r stakeholders to comment on the Interim Approaches. The Agencies are considering public comments on the Interim Approaches prior to implementing them. The Agencies intend to jointly implement these approaches as part of a phased iterative process. EPA will refine its listed species risk assessments based on these interim approaches. The details of the joint Interim Approaches are contained in the white paper " Interim Approaches for National-Level Pesticide Endangered Species Act Assessments Based on the R ecommendations of the National Academy of Sciences April2013 Report , " dated November I, 2013 , available at http: // www.epa.gov/espp/20 13/nas.html.
EPA plans to follow the March 2013 stakeho lder engagement paper ( " Enhancing Stakeholder Input in the Pesticide Registration Review and ESA Consultation Processes and Development of Economically and Technologically Feasible Reasonable and Prudent Alternatives " ) to identify the appropriate time for initiation of consultation, e ither formal or informal , with the Services. The stakeho lder engagement paper, jointly developed by the EPA , USDA , and the Services and avai lable at http: // www.regulations.gov/# !documentDetail;D=EPA-HQ-OPP-2012 -044 2-0038 , allows for

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### early interaction with the Services under informal consultation. EPA and the Services acknowledge that early interaction as part of informal consultation may result in refinements to EPA 's effects determinations that can improve the efficiency of the E SA compliance process. For example, EPA may involve the Services at the earliest stages of registration review. In general, EPA plans to initiate formal ESA consultation , if necessary , at the fmal decision stage in the reg istration review process. Consulting later 

### in the process allows the EPA to develop more refined ecological risk assessments and to engage stakeholders in discussions that should result in more focused consultation packages that may include risk mitigation for listed species.



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### PLANNED DATA NEEDS
Table 1 below summarizes the p l anned data needs for acequinocyl based on the 

### Registration Review Problem Formulation for the Environmental Fate Ecological Risk, Endangered Species , and Drinking Water Assessments for Acequinocyl and the 

### Acequinocyl Human Health Assessment Scoping Document in Support of Registration Review

. The planned data needs have not changed from what was included in the PWP.


### Table 1 : P lanned Data Needs for the Aceq uinocyl Registration Review Estimated Guideline Study Title Timeframe Number Test Material (Months from receipt of DCI)
850.1025 Acute toxicity estuari ne and marine organisms- TGAI 12 oyster 850.1400 Fish earl y-li fe stage toxicity (freshwater) TGAl 12 850. 1400 Fish ear l y -li fe stage toxicity (saltwater) TGA I 12 850.2100 Avian acute oral toxicity3 TGAI 12 850.3040 Full

- field testing for pollinators4 TEP 12 850.4400 Aquatic vascular plant toxicity TEP 12 850.4500 Estuarine/ marine diatom toxicity te st using TEP 12 Skeletonomea costatum 850.4500 Freshwater diatom toxicity test using Navicula TEP 12 pefli c ulosa 850.4550 Cyanobacteria toxicity test usin g Anabaena jlos

- TEP 12 aquae Non- Whole sediment chronic invertebrates 5

- TGAI 12 Guideline freshwater midge Chironomus dilutus , freshwater amphipod Hyalella azteca, and estuarine/marine amphipod Leptocheirus plumulosus Non- Pollinator chronic oral toxic i ty, adult TGAI 12 Guideline Non- Pollinator acute oral toxicity, larvae TGAI 12 Guideline

2 On June 27,2012 , EPA announced certain revisions in harmonized guide line series 850- Ec ological Effec ts T ests

- including renumb ering and other de s ignations or changes for so me gu ideline studies. See "F inal Test Guidelines ; OCSPP 850 Series; Notice of Availability " 77 FR 38282 , June 27 , 2012. http: //www.r egu lations.gov/# !docume ntD etai I;D= E PA- HQ-OPPT -2009-0 154-0028 3 To be conducted w ith a passerine species. 4 The need for theses anticipated data requirements is contingent on res ult s of the tier I bee studies (includ in g acute oral toxicity to adult honey bees, acute oral toxicity to larval hon ey bees , chronic oral toxicity to adult honey bees , and chronic oral toxicity to larval hon ey be es)

. 5 EFED acknowledges that acequinocyl stability iss ues have bee n reported in estuarine / marine invertebrate tests that resulted in a wa iver for the chronic est uarin e/marine invertebrate study (USEPA, 20 I 0). If chemical stability is an issue during the chronic testing with a marin e/est uarine amphipod species, consulting with EFED scientists about other testing options may be possible. A protocol mu s t be provided for Agency review prior to initiation of the study

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### Table 1: Planned Data Needs for the Acequinocyl Registration Review
Estimated Guideline Timeframe Number Study Title Test Material (Months from receipt ofDCI)
Non- Po lli nator chronic ora l toxic ity , larvae TGAI 12 Guideline Non- Re sidues in pollen and nectar residue analysis4 TEP 24 Guideline Non

- Poll inator tier 2 semi -field toxicity testing TEP 24 Guideline (tunnel/enclosure or colony feeding) 4 TGAI = techmcal grade acuve mgredtent; TEP = typtcal end-use product; 4 The need for theses anticipated data r equirements is contingent on results of the tier I bee studies (inc luding acute oral toxicity to adult honey bees, acute oral toxici ty to larval honey bees, chronic oral toxicity to adult honey bees , and chronic oral toxicity to larval honey bees)

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### RISK ASSESSMENTS FOR REGISTRATION REVIEW During registration review, the Agency will conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all us es of acequinocyl. For human health, EPA will conduct revised dietary and occupationa l risk assessments during registration review. If toxicological endpoints or points of departure are revised based on the data that are required for registration review, the y will be considered in the new assessments , as well as any changes to the standard operating procedures or default exposure assumptions

. Table 2 below summarizes the planned registration review risk assessments based on the EFED Problem Formulation and HED Seeping Document and the planned assessments have not changed from what was included in the PWP.

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### Tab le 2: Planned Risk Assessments for th e Acequinocyl Registration Review Type of Risk Assessment Conduct? Notes

'£'..**·** ::- w .-. :.... · c.:.**~lF ate**  Comprehensive ecological 

### y The ecological dataset for acequinocyl is currently (species to be assessed incomplete. include terrestrial and aquatic organisms) , including endangered species Incidents Will check fo r No ecological incidents were recorded resulting from nnciMP.c:: the use of acequinocyl.

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### - Dietary 

# . Food 

### y A revised dietary-exposure analysis may be required to reflect the most recent dietary-exposure models and potential revised EDWCs (spec ifically, use ofPRZMGW). Drinking water 

### y The 2011 chronic dietary assessment did not utilize the latest dietary exposure model or consumption database. The impact of using the most up-to-date models and guidance at the time of the risk a ssess ment w ill need to be considered during RP.oic;tration Review.**o~~P**

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## .... 'll**~** Handlers (mixers, loaders , 

### y Updated occupational handler assessments will be applicators) required using current Agency policies to reflect all currently regi s tered uses and maximum application rates. Post-application 

### y Post-application exposure is anticipated since acequinocyl is appl i ed post-emergence as a foliar spray. Updated occupational assessments may be conducted to reflect all currently registered uses , using current Agency policies

. Residential ' Handlers 

### y An updated residential exposure assessment will be needed for acequinocyl during Registration Review to incorporate the 20 12 Residential Standard Operating Procedures (SOPs). Post-application 

### y An updated residential exposure assessment will be needed for acequinocy l during Regis tration Review to incoriJvld L \;; the 2012 Residential SOPs. Other Aggregate 

### y A revised aggregate exposure assessment may be needed to reflect a revised dietary-exposure ana l ysis and / or an updated residential P.xnnc::11re assessment. Cumulative N Not applicab le. Acequ inoc yl has not been identi fied as a member of a cumulative group that shares a common mechanism oftoxic i ty.



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### Tolerances 

### y EPA will consider harmonizing tolerances as appropriate. Incidents Will check for There were no incident cases reported for acequinocyl. updates The Agency will continue to monitor the incident information and if a concern is triggered , additional analysis wi ll be included in the risk assessment.


### TIMELINE
EPA has created the following estimated time line for the completion of the acequinocyl registration review in Table 3 below. The projected timeline has not changed since the PWP.



### Table 3: Registration Review for Acequinocy l- Projected Registration Review Timeline Activities Estimated Date Opening the Docket Open Docket and 60

- day Public Comment Period June 2015- Comp leted 

### Close Public Comment August 2015

- Comp leted 

### Case Development Final Work Plan November 2015

- Com_Qieted 

### Iss ue DCI Jan-March 20 16 

### Data Subm is sion Jan-March 20 18 

### 60-day Public Comment Period for Draft Risk Assessments 6 July-Sept 2020 

### Registration Review Decision 60-day Pub lic Comment Period for Proposed Registration Review Oct-Dec 2020 

### Decision Registration Rev iew Deci s ion and Begin Post-Decision Follow

-up 2021 

### Total (years) 6


### NEXT STEPS
As noted previously , the Agency plans to require several environmental fate, ecological effects , and human health studies for acequinocyl through a Data Call-In Notice, expected to be issued in 2016.

6 The regulations governing Reg istration Review generally require the Agency to provide a public comment period

of at least 30 calendar days for draft ri sk assessments; see 40 CFR Part 155.53(c)

. For conventional pesticides , the Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments. 

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