Docket Number EPA-HQ-OPP-2015-0203 

www.regulations.gov 

Acequinocyl Final Work Plan 

Registration Review 

Case Number 7054 

November 2015 

Approved by: cu_cl p v,.u_ ~ {~ 

Date: 

Richard P. Keigwin, Jr. 

Director 

Pesticide Re-evaluation Division 
INTRODUCTION 

This is the Environmental Protection Agency's (EPA or the Agency) Final Work Plan (FWP) for 

the registration review of acequinocyl. This work plan addresses public comments received 

concerning the Preliminary 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, Fungicide, and Rodenticide Act (FTFRA), and will review each registered 

pesticide every 15 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. 

Information on this program is provided on the Agency's website. 1 

The FWP begins with any updates since the PWP was issued. Next is a summary of substantive 

comments received 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 of the 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. 

UPDATES SINCE THE PWP WAS ISSUED 

There are no additional updates on acequinocyl since the PWP. 

SUMMARY OF COMMENTS AND AGENCY RESPONSES 

During the 60-day public comment period on the Acequinocyl Preliminary Work Plan, which 

opened on June 24, 2015 and closed on August 24, 2015, the Agency received one public 

comment from the Center for Biological 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. 

Summarized below is the public comment and response from EPA. Public comments and EPA 

responses in their entirety are located in the docket, EPA-HQ-OPP-20 15-0203. 

Comment submitted by the Center for Biological Diversity in EPA-HQ-OPP-2015-0203-

0010. 

1 hnp://www.epa.gov/oppsrrd I /registration _review/ 

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l. 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 

Reregistration (sic) of acequinocyl" and its end-use product labels including making 

"defensible ''Not Likely to Adversely Affect" and "Likely to Adversely Affect" 

determinations as a prerequisite 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 spatial 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 

registration review of acequinocyl 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 acequinocyl in connection with the development of its 

registration review decision for acequinocyl. 

The NAS report, available at 

http:/ /www.nap.edu/catalog. php?record _id= 18344http:/ /www.epa.gov/espp/20 13/nas.html, 

outlines recommendations on specific scientific and technical issues 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 Services), 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. 

The joint Interim Approaches were released prior to the stakeholder workshop held on 

November 15, 2013. EPA presented the joint Interim Approaches at the December 2013 

PPDC and SFIREG meetings, allowing additional opportunities for 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 Recommendations 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 stakeholder 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, either formal or 

informal, with the Services. The stakeholder engagement paper, jointly developed by the 

EPA, USDA, and the Services and available at 

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2012-0442-0038, 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 ESA 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 registration 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 planned 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: Planned Data Needs for the Acequinocyl Registration Review 

Estimated 

Guideline Study Title 

Timeframe 

Number Test Material (Months from 

receipt of DCI) 

850.1025 Acute toxicity estuarine and marine organisms- TGAI 12 

oyster 

850.1400 Fish early-life stage toxicity (freshwater) TGAl 12 

850. 1400 Fish early-life stage toxicity (saltwater) TGAI 12 

850.2100 A vi an 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 test using TEP 12 

Skeletonomea costatum 

850.4500 Freshwater diatom toxicity test using Navicula TEP 12 

pefliculosa 

850.4550 Cyanobacteria toxicity test using Anabaena jlos- TEP 12 

aquae 

Non- Whole sediment chronic invertebrates5 - TGAI 12 

Guideline freshwater midge Chironomus dilutus, freshwater 

amphipod Hyalella azteca, and estuarine/marine 

amphipod Leptocheirus plumulosus 

Non- Pollinator chronic oral toxicity, adult TGAI 12 

Guideline 

Non- Pollinator acute oral toxicity, larvae TGAI 12 

Guideline 

2 On June 27,2012, EPA announced certain revisions in harmonized guideline series 850- Ecological Effects Tests 

- including renumbering and other designations or changes for some guideline studies. See "Final Test Guidelines; 

OCSPP 850 Series; Notice of Availability" 77 FR 38282, June 27, 2012. 

http://www .regulations.gov/#! documentDetai I; D=EP A-HQ-OPPT -2009-0 154-0028 

3 To be conducted with a passerine species. 4 The need for theses anticipated data requirements is contingent on results of the tier I bee studies (including acute 

oral toxicity to adult honey bees, acute oral toxicity to larval honey bees, chronic oral toxicity to adult honey bees, 

and chronic oral toxicity to larval honey bees). 5 EFED acknowledges that acequinocyl stability issues have been reported in estuarine/marine invertebrate tests that 

resulted in a waiver for the chronic estuarine/marine invertebrate study (USEPA, 20 I 0). If chemical stability is an 

issue during the chronic testing with a marine/estuarine amphipod species, consulting with EFED scientists about 

other testing options may be possible. A protocol must 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 of DCI) 

Non- Pollinator chronic oral toxicity, larvae TGAI 12 

Guideline 

Non- Residues in pollen and nectar residue analysis4 TEP 24 

Guideline 

Non- Pollinator 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 requirements is contingent on results of the tier I bee studies (including acute 

oral toxicity to adult honey bees, acute oral toxicity to larval honey bees, chronic oral toxicity to adult honey bees, 

and chronic oral toxicity to larval honey bees). 

RISK ASSESSMENTS FOR REGISTRATION REVIEW 

During registration review, the Agency will conduct a comprehensive ecological risk assessment, 

including an endangered species assessment, for all uses of acequinocyl. For human health, EPA 

will conduct revised dietary and occupational risk assessments during registration review. If 

toxicological endpoints or points of departure are revised based on the data that are required for 

registration review, they 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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Table 2: Planned Risk Assessments for the Acequinocyl Registration Review 

Type of Risk Assessment Conduct? Notes 

'£'.. · ::-w.-. :....· c.:. ~lFate 

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 for No ecological incidents were recorded resulting from 

nnciMP.c:: the use of acequinocyl. . ......r.zr.!::_oi.._~ . .,..._. 1f211.. J; . :· . :•,· - - Dietary . 

Food y A revised dietary-exposure analysis may be required to 

reflect the most recent dietary-exposure models and 

potential revised EDWCs (specifically, 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 assessment will need to 

be considered during RP.oic;tration Review. 

o~~P ~ .... "'~"' .... 'll 

Handlers (mixers, loaders, y Updated occupational handler assessments will be 

applicators) required using current Agency policies to reflect all 

currently registered uses and maximum application 

rates. 

Post -application y Post-application exposure is anticipated since 

acequinocyl is applied 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 acequinocyl during Registration Review to 

incoriJvldL\;; the 2012 Residential SOPs. 

Other 

Aggregate y A revised aggregate exposure assessment may be 

needed to reflect a revised dietary-exposure analysis 

and/or an updated residential P.xnnc::11re assessment. 

Cumulative N Not applicable. Acequinocyl has not been identified as a 

member of a cumulative group that shares a common 

mechanism oftoxicity. 

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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 will be included in the risk assessment. 

TIME LINE 

EPA has created the following estimated timeline 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 Acequinocyl- Projected Registration Review Timeline 

Activities Estimated Date 

Opening the Docket 

Open Docket and 60-day Public Comment Period June 2015-Completed 

Close Public Comment August 2015 -

Completed 

Case Development 

Final Work Plan November 2015 -

Com_Qieted 

Issue DCI Jan-March 20 16 

Data Submission Jan-March 20 18 

60-day Public Comment Period for Draft Risk Assessments6 July-Sept 2020 

Registration Review Decision 

60-day Public Comment Period for Proposed Registration Review Oct-Dec 2020 

Decision 

Registration Review Decision 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 Registration Review generally require the Agency to provide a public comment period 

of at least 30 calendar days for draft risk 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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