Docket Numbe r EPA-HQ-OPP-2014-0133 www.regulations.gov



# Etoxazole Final Work Plan Registration Review

Case Number 7616
February 2015

Approved by:

**<;i'hu~P ~_,)l** 



### Date: Richard P. Keigwin, Jr. Director Pesticide Re-evaluation DivisionINTRODUCTION T hi s is the Environmen tal Protection Agency's (EPA or the Agency) Final Work Plan (FWP) for the registration review of etoxazole

. This work plan addresses p u blic comments receiv e d concerning the Preliminary Wo rk Plan (PWP ), which was posted in th e etoxazo l e registration rev iew docket (EPA-HQ

- OPP-2014-0133). Etoxazo le is a member ofthe diphenyloxazoline class of miticides/ ovicides. Products containing etoxazo le are registered fo r use to control mites on various a gr i cultural sites and ornamentals. There are currently no registered or pr oposed r esidential u ses of etoxaz ole. The Agency is imp lementin g the registration review program pursuant to Section 3(g) of the Federal Insecti c ide, Fungicide, and Rodenticid e Act (FIFRA), and will rev i ew each registered pesticide every 15 years to determine wh ether it co nt inues to meet the FI FRA standard for r eg i stration. Changes in scie nce, public po li cy, and pesticide use prac ti ces occur over time. Th e registration revi ew program is intended to make sure that, as the ability to assess ri s k evolves and as policies and practices change , all registered pesticides continue to meet the statutory standard

. Th e public phase o f reg istratio n review begins when the i nitial docket is opened for each case. In formati on on this program is provided on the Agency ' s web si te. 1 The FWP begins with any updates since the PWP was iss ued

. Next is a summary of s ubstanti ve comments received during the public comment period for the PWP co ncerning anticipated data needs , expected ri sk assessments, or the estimated t ime li ne identified in the PWP, and a s ummary of the Agency's responses to those comments. Thi s section is fo ll owed b y reg i stration rev i ew planned data needs, risk assessments expected to be conducted , and the projected registration r eview t ime line for etoxazole. Lastly , there i s a discussion of next steps. UPDATES SINCE THE PWP WAS ISS UED The E toxazole Preliminary Work Plan identified a 24 month timeframe to conduct the Honey Bee- Adult Chronic Oral Tox icity test for re g i stration review. T h e Agency upon further revi ew has determined that t he required timeframe to conduct this test is 1 2 month s. SUMMARY OF COMMENTS AND AGENCY RESPONSES During the 60-day public comment p eriod on the Etoxazole Preliminary Work Plan , which opened on September 24 , 20 1 4 and closed on November 24 , 2014 , the Agency received three pub li c commen ts. Comment s were submitted by Valent U.S.A. Corporation, the FIFRA Endangered Species Task Force (FES TF) , and the Ce nter for Biological Diversity (CB D)

. The comments from Valent U.S.A Corporation addresse d data requi rements, differences in interpretations of data , and u se and usage inform ation. The comments from FESTF identifi e d Valent U. S.A Corporation as a member oft h e T ask Force. CBD comments foc u se d on the EPA's duty to consult th e U.S. Fish and Wildlife Service and the National Marine Fisheries Service (th e Services) in accordance with the Endangered Species Act (ESA )

. None of the submitted comments address the timeline described in the PWP , but some do address the p lanned

1 http: //www.epa . gov / op p s rrd 1 /registration _rev iew/
2ecological and human health risk assessments and data requirements. EPA ' s re sponses to comments on the risk assessments and data need s, along with several other substantive comments, are provided in thi s document. In the PWP , EPA also so li cited comments on the specific topics of environmental justice, water quality concerns, and trade irritants, but no comments or information were received on tho se i ss ues. This section does not capture every comment mad e about the PWP and its s upporting d oc uments , nor all of the Age nc y's respon ses . S ummari z ed belo w are publi c comments that re sulted in chan ge s to the anticipated registration review data needs , ri sk assessments, or timeline , or are of a broader regulato ry nature
. Publi c comments and E PA res ponses in their e ntirety are located in the docket, EPA-HQ -OPP

- 20 14-0133. Summarized public comments and Age ncy respon ses re lated to the anticipated ecological risk assessment or da ta needs are in the Response to Public Co mments on Registration R evie w Problem Formulation for Ecological Risk Assessment and Drinking Water Exposure Assessment to be Conducted for Etoxazole (January 28, 20 15 ) while those r e l evant to t he anticipated human health ri sk asse ss m e nt or data needs are in the Etoxazole; Resp onse to Comments from Valen t R egarding H ED's Most Rece nt Human H

e alth Registration Review Scoping Docum ent for Etoxazole (Dec ember 23, 20 14). Comments relev ant to etoxazole u se /u sage information are in the BEA D R es ponse to Valent U. S.A. Corp oration Comments on Et oxazole Use and Usage Information in U.S. EPA ' s Etoxazole Reg i st

ration Re view Docket EPA-HQ-OPP-2014-0133 (December 16, 20 14). Comments submitted by Valent U.S.A. Corporation in EPA-HQ-OPP-20 14-0133 - 00 12. 1

. Comment: A waiver of the 90 -da y inhalation to xicity s tudy has been gra nt ed most recentl y for the greenhouse use pattern ( Decision No. 447295; DP Barcod e D388416)

. The datefor this wa iver docum ent is incorrectly indicated as 21 -Apr-201 0. The co rrect date is 21-Apr2011. The wa iver was granted on the basis of la rge MOE ' sfo r product packaged in water solu ble packa ges (all exceeding 1000) , low exposures and low acute toxicity of the Valent formulated and TGA1 material.

Re sponse: On May 24, 201 4 , the Hea lth Effects Division's (HED) Hazard Scie nce and Policy Council re-evaluated the earlier waiv er granted for etoxazole subchronic inhalation data based on th e c urrent policy of employin g a weight of evidence approach for such determinations (TXR # 0056977). Based on th at approach, HED recomm e nded that t he data be required. HED also has noted that the FQPA Safety Factor of 

### lOX w ill be retained for the inh a lation risk assessme nt in the absence o f these data or other su pp orting information. 2. Comment: Valent disputed the recomm endations of the Environm ental Fate and Effects Division (EFED) to require seve ral ecological toxicity studies, and indicat ed thatpollinator s tudies being conducted in response to EU data needs will be submitted to the Age ncy. Response: EFED expanded on the reasoning for its recommendations that the disputed data be required , and welcomed the submission of the E uropean bee data, reiterating that studies examining the toxicity of etoxazole t o honey bee brood are of particular interest s ince etoxazole i s known to inhibit chitin bi osy nth esis. It is noted that any d ata developed in response to EU d ata needs will be evaluat e d by E PA to determine its su itabili ty for use 

### in the Agency 's risk assessment.

33. Comment: 

### U nder " Use Sites" Valent requests to add the use of Popcorn and Field corn grownfor seed. The use sites of alfalfa and carrots should be specified as "alf alfa grownfor seed only" and "carrots grown for seed only

. " Response: BEAD has ame nd ed the BEAD Chemical Pro fil e (BCP) to add popcorn, field com, alfalfa , and carrots grown for seed. The amended BCP has been posted to the etoxazole registration review docket. Comments submitted by FESTF in EPA-HQ-OPP -2014 -0133-0011. 4. Comment: 

### Valent US.A. Corporation, the sole registrant of technical grade etoxazole, is a FESTF member and is entitled to rely on the FESTF data. Response: The Agency thanks FESTF for its comment, and wi ll consider the FESTF data during the etoxazole registration review. Comments subm itted by CBD in EPA-HQ-OPP-2014-0133-0010. 5. Comment: 

### The CBD ' s 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 review of etoxazole 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 preliminary determinations regarding the effects of etoxazole on endangered and threatened (listed) species and their designated critical habitat for the etoxazole registration review

. Response: EPA has reviewed the comments from CBD on the registration review docket opening for etoxazole and plans to address many of the concerns rais ed by CBD as part of the implementation plan for assessing the risks of pesticides to listed species based on the recommendation s ofthe Apri l2013 National Academy of Sciences (NAS) report. EPA will address concerns spec ific to etoxazole in connection with the developme nt of its final registration review decision for etoxazole. In November 2013, the EPA, along with the Services and the USDA , released a summary of their joint Interim Approaches for asses sing risks to endangered and threatened (listed) species from pe sticide s . The Interim Approaches were developed jointly by the agencies in response to the National Academy of Sciences' (NAS) recommendation s and reflect a common approach to risk assessment s hared by the agencies as a way of addressing scientific differences between the EPA and the Services. The NAS report2 outlines recommendations on specific scientific and technical issues related to the development of pesticide risk

2 http: // www.nap.edu/catalog.php?record

_ id = 18344

4assessments that E PA and th e Services mu st conduct in connection with t heir obligations under the ESA and F IFRA

. The joint Interim App roache s were released prior to a stakeholder workshop held on November 15 , 2013. In addition, the E PA pre se nted the joint Interim Approac hes at the December 2013 Pe s ticide Program Dialo g u e Committee (PPDC) and State-FIFRA Is sues Research and Evaluation Group (SF IRE G) mee ting s. The agencie s also h e ld stakeholder workshops in April and Octob e r 2014, allowing additional opportunities for s takeholders to comment on the Interim Approaches. Additional workshops are planned to enh ance s takeholder in volveme nt. As part of a phased, iterative process for d evelopi ng the Interim Approaches , the agencies w ill also cons ide r public comments on the Interim Approaches in connection with the development of upcoming Registration Review deci s ion s . The details of the joint Interim Approaches are contain ed in the white paper " Interim Approaches for National-Level Pe s ticide ES A Assessment s Base d on the Recomm e ndations of the National Acade m y of S cienc es Apr il2013 Report ," 3 dated November 1 , 20 1 3. Given that the agencies are continuing to develop and wo rk toward implementation of the Interim Approaches to assess the potential risks of pesticides to listed species and their de si gnated cr iti cal habitat , the ecolo g ical problem formu la tion supportin g this Fi nal Work Plan for E toxazole doe s not describe the sp ec ifi c ES A analysis , includin g effects determinations for sp ec ific listed species or d es ignated critical habitat, to be conducted during registration review. In the ecological problem fo rmulation document for etoxazole , EPA described th e sc reening-level ri sk assessment to determine the pot e ntial effects of Etoxazole on all taxa of non-target wildlife and plants, which will assume that listed species and their designated critical habitats may be present in the vicinity of the application of Etoxazole. This scree nin g -l evel asse ssment will allow EPA to f ocus it s future evaluation s o n the type s of spec ies w here the potential for effects exists once the scie ntifi c me thods being dev eloped by the agencies have been fully vetted. While the agencies continue to dev elop a common method for ESA analysis, the planned sc reening-level risk assessme nt for the registration revi ew of e to x azole will desc rib e the leve l ofESA analy s i s comp leted for this particular regi s tration rev iew case. Once the agencies have fully dev e l oped and implemented the scientific methods necessary to complete ri sk assessme nts for endangered and threatened ( li sted) species and their designated critical habitats, these method s will be app lied to subsequent analy ses fo r etoxazole as part of co mpleting this registration review. PLANNED DATA NEEDS Table 1 below summarizes the planned data n eeds for e to x azole based on th e Registration Review- Preliminar y Problem Formulationfor the Eco logical Risk Assessme nt and Drinking Water Exposure Assessment to Be Conducted for Etoxazole, Etoxa z ole. Human-Healt h Assessment Scoping Do cu m e nt in Support of Reg i s tration Review, Etoxazole; Res ponse to Co mment s from Valent Regarding HED 's Mo st Recent Human Health R egistra tion Review Scoping Docum en t for Etoxazole, BEAD Response to Vale nt US.A. Corporation Co mm e nt s on Etoxazole Use and Usage In fo rmation in US. EPA ' s Eto xazole Registration Review Dock et EPA -HQ-OPP- 2014-0133 , and the Response to Pub li c Comments on Regis tration R eview

3 http ://www.epa.gov/espp/20 13 / nas.html
5Problem Form ulation for Ecological Risk Assess ment and Drinking Wat er Exposure Assessment to be Co nduct ed for Etoxa z ole. The planned data needs have not changed fro m what was included in the PWP

. 

### Table 1: Planned Data Needs for the Etoxazole Registr ation Review Estimated Guideline Study Title Timeframe Number" Test (Months from Material receipt o f DCI) Planned Data Needs for Etoxazo le (parent) 835.4300 Aerobic Aquatic Metabolism (Two se diment TGAI 24 sys te m s should be tested) 835.4400 Anaerobic Aquatic Me taboli sm (Two se diment TGAI 24 systems s hou ld be tested ) 850.2100 Avian Acute Ora l To xicity Test (wit h p asse rine T GA I 12 species) 5 Field Testing for Pollinator s (Higher Tier 850.3040 To xicity Testin g under semi-field or field TEP 24 conditions) 6 • 7 850.4100 Seedling Emergence & Seedling Growth4 • 8 T EP 12 850.4 150 Vegetative Vigor 4 •8 TEP 12 850.4500 Al gal Toxicity (Freshwater green algae) 4 TGAI 12 850.4550 Cyanobacteri a Toxicity (A nabaena jlo s -aquae 

## t TGAI 12 En vironmental Che mi stry Methods and 850.6 1 00 Associated Independent Laboratory Validatio n s TGAI 12 in

**soi**

**~** water , and sed i ment Non- Honey Bee: 2 1-day , repeated dose , larval chro ni c TGAI 12 Guide line toxicity test 6• 7 Non

- Hone y Bee Toxicity: 1 0

- day Adult C hronic Oral TG AI 12 Guideline Toxicity Study 6• 7 Non

- Residu es in Pollen and Nectar (Higher Tier TEP 36 Guideline Te sting under semi -fi eld or field conditio n s) 6• 7 No nWhole sediment , chronic toxicity (60-Day) test to Guideline freshwater midge (Chironomus dilutus) 6 (ORD TGA I 24 Study Method: EPA 600/R-099-064) No nWhol e se dim ent , chronic toxicity (42-Day) test to Guide line freshwater amphipod (Hyalella azteca) 6 (ORD TGAI 24 Study Method EPA 600/R-099

- 064) 870.3465 90-Day inh a l atio n T oxicity9 T GA I 24



### 6Planned Data Needs for the Degradates R-8 and R-13 Estimated Guideline Timeframe Number' Study Title Test (Months from Material receipt of DCI) Environmenta l Chemistry Methods and R

- 8 and 850.6100 Associated Independent Laboratory Validations R-13 12 in soil , water , and sediment TGAI 

### = Techmcal grade of the acttve mgred1ent ; TEP 

### = Ty p1cal end-u s e product ; 4 On June 27 ,2012 , EPA announced certain revision s in harmonized g uideline series 850 -E cological Effects

Tests- including renumbering and/or removal of the tier designation for some guideline studies. See "Final Tes t Guidelines; OCSPP 850 Series ; Notice of Availabi lity" 77 FR 38282 , June 27, 20 12. htto: // www .regulations.gov /# !documen tDetai l :0
· EPA- HO

- O PPT -2009-0 154

- 0028 5 Data are recommended for a pas s erine species. A protocol does not need to be submitted provided that the

study adhere to the parameters outlined in the guidance available at: http ://www .epa . gov / pesticide s/ s cience/efed/policy _guidance/team

_ authors/ terrestrial

_ biology_ tech_ team/pa ss erine

_ oc s pp850

_ 2100

_ avian

_ oral_ tox.pdf 6 A protocol is expected to be submitted for review and approval by the Agency prior to initiation of this study. 7 on June 19 , 20 1 4, new pollinator risk assessment guidance was provided for evaluating the potential risk of pesticides to bees, particularly honey bees (Apis rnellif era). The Agency risk assessment guidance for bees can be found at: http: //www2.epa.gov/ pollinator-protection/pol l inator-risk-assessment

- guidance. 8 New studies are recommended at the highest maximum single application rate with TEP as te s t material instead

of the TGAI. 9 This data requirement can be fulfilled with a 28-day s tudy. 

### 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 etoxazole. For human health, EPA will conduct revised dietary , residential , 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 regi s tration review risk assessments based on the Registration Review- Preliminary Problem Formulation for the Ecological Ri s k Assessment and Drinking Water Exposure Assessment to Be Conducted for Etoxazole and Etoxazole. HumanHealth Assessment Scoping Document in Support of Registration Review. The planned assessments have not changed from what was included 

### in the PWP

.

7Table 2: Planned Risk Assessments for tbe Etoxazole Registration Review Type of Risk Assessment Conduct? Notes

**Eco~nGV.I** 

### and Eavironmental Fate Comprehensive ecological 

### y The risk assessment will include parent (species to be assessed include etoxazole and the degradates R

- 8 and R

- 13, terrestri al an d aqu ati c usin g th e total toxic res idue ap proac h

. o r ganisms) , including endangered species Incidents Will check For a discussion of reported ecological for updates incidents for etoxazole, see page 29 of the Problem Formulation. 

### Human Health Dietary Food 

### y A revised dietary exposure analysis may be needed to reflect the most recent dietary exposure model s and relevant new data. Drinking water 

### y The drinking water assessment will include the et oxazo l e parent and the degradates R-8 and R -13. The assessment will reflect potentially rev ised estimated drinking water concentrations (EDWCs) and any relevant new data, as needed. Occup ational H an dlers (mi xer s, l oaders , 

### y An updated occupational handler risk applicators) assessment will be conducted to reflect all currently registered uses , new po l icies , and any relevant new data, as needed. Post

- application 

### y An occupational post

- application risk assessment wi ll be conducted to reflec t all currently registered uses, new policies, and any relevant new data, as needed. Residential H andlers 

### N There are no proposed or current registrations for products containing etoxazole that allow residential use. P ost -app lication 

### y A bystander risk assessment for exposures from drift will be conducted. A screen will be conducted so that the need for a volatilization assessment can be determined. Other Agg regate 

### y Eval u ates th e combi n ed risk from d i etary and residential exposures. A new aggregate risk assessment will be required to incorporate a revised dietary risk assessment , 

### if needed.

8Table 

### 2: Planned Risk Assessments for the Etoxazole Registration Review Cumulative N EPA has not made a common mechanism of toxicity finding fo r etoxazole and any other substance s; and etoxazole do e s not appear to produce a toxic metabolite produced by other substances. Tolerances 

### y EPA will evaluate the possibility of harmonizing tolerances with Canada and Codex MRL s. Incident s Will check For a discus s ion of reported human incidents for updates for Etoxazole, see page 10 of the Scoping Document and the Etoxazole: Tier I Revi ew of Human Inc idents. TIMELINE EPA has created the following estimated timeline for the completion of the etoxazole registration review in Table 3 below

. The projected t ime line has not changed si nce the PWP. Table 3: Registration Review for Etoxazole- Projected Registration Review Timeline Activities Estimated Date O_pening the Docket Open Docket and 60-day Public Comment Period September 2014

- Completed Close Public Comme nt November 2014- Co mpleted Case Development Fin al Work Plan February 2015

- Completed I ssue DCI April- June 2015 Data Submission April

- June 2018 60-day Public Comment Period for Draft Risk AssessmentsY October- December 2019 Registration Review Decision 60-day Public Comment Period for Proposed Registration July- September 2020 Review Decision Registration Review Decision and Begin Po st-Decision 2021 Follow-up Total (years) 7 9The regulattons governing Re g tstration Revi ew generally require the A gency to provide a public co mment

period of at least 30 calendar day s for draft risk ass e ss ments ; see 40 CFR Part 155.53(c). For conventional pesticide s, the Agency plan s to provide a 60 calendar da y public comment period generall y f o r draft risk as se ss ments . NEXT STEPS As noted previously, the Agency plans to require several environmental fate, eco logica l effect s, and human health studies for etoxazole through a Data Call

- In Notice, expected to be issued between April and June 2015.

9