Do cket N umb er E PA -HQ-OPP- 2007-0437 www.regu lations.gov



# Fenoxaprop-p-ethyl Interim Registration Review Decision Case Number 7209

December 2015

Approved b y :

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# ,:O Richard P. Ke igwin, Jr. Director Pesticide Re-evaluation Division

Date :
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### Contents Fenoxaprop-p-ethyl Interim Decision Table of Contents

I. 

### INTRODUCTION

................................................................................... 3 II. USE AND USAGE

..................... .. . . .. .. . .. . .. . .. .. . .. . .. . .. . . .. . . ....... . . . . .. ... ............ ? III. SCIENTIFIC ASSESSMENTS

.. . .. . .................. . .. . .. . .......... . .. . . . . . ............. . . . . . . 8 A. Human Health

. .... . . .. . .... . ..................................................................... 8 I. Risk Conclusions

..................... .. .. . .. . .. . .. .. . .. . .. . .... . .. . . .... . . . . . .... . . .... ... . 8 2. Human Incidents

..... . .. . . . .. .. .............................................................8 3. Tolerances

.. ...... ..................... ....................................................... 9 B. Ecological

. ... .. . ... .. . ....................... ............ .......... ................ ............ ...9 1. Risk Conclusions

. . . .. . .. .. . .. . ... . .. .. ..................................................... . 9 2. Ecologica l Incidents

.... .. .................................................................. 12 3. Characterization ofEcological Risk

. .. ..... .. . .. . .. . .. . .. .... . . . .. . . .... . . . . . ............ . l2 C. Benefits Assessment

............................. . .. . .. . .. . .. . . .. . . .. . . . ....... . . . ...... . .. . ... . 13 D. Endangered Species Assessment

............ . .. .. . .. . .. . .. . . .. . ....... . . .. . . . . ...... ... ...... 13 E. Endoc rine Disrupter Screening Program

.................................................... 14 IV. INTERIM REGISTRATION REVIEW DECISION

. ....... ... . ....... . ........................ 15 V. NEXT STEPS AND TIME LINE

.............. . .. .................. . ...... .... ...... .... ... . . ..... 17 Appendix A: Summary of Actions Taken for Fenoxaprop-p-ethyl.

......... ................ . ..... . ... 18 Appendix B: Fenoxaprop-p-ethyl Label Table

... . ....................................................... 18

2

### I . INTRODUCTION
This document is the Environmental Protection Agency's (EPA or the Agency) Interim Registration Review Decision for Fenoxaprop -p- ethyl (FPE ) (case 7209. PC code 129092) and i s being issued pursuant to 40 C FR sections 155.56 and 155.58

. A regi stration review decision is th e Agency's determination whether a pesticide meet s, or do es not me e t, the standard for reg istration in the Federal Insecticide , Fungicide, and Rodenticide Act (Fl FRA). T he Age ncy may is sue , when it determines it to be appropr iate , an Interim Registration Review Decision before completing a reg istration review. Among other things , the Interim Registration Re view Decision may: 1) req uire new risk miti ga tion meas ures ; 2) imp ose interim risk m iti gation measures ; 3) identify additional data or other information required to complete the review ; and 4) include sche dul es for s ubmittin g the required data, conducting the new risk assessment , and comp leting the registration rev iew. For further inf orma tion o n FPE, additional documents can be found in EPA ' s public docket (EPA

- HQ-OPP

-2007-0437) at www.regulations.gov. FIFRA, as amended by the Food Quality Protection Act (FQPA) of 199 6, mandated the continuous review of existing pesticides. A ll pesticides distributed or so ld in th e U nited States generall y mu st be reg i stered by the E PA based on scientific data showing that they will not cause unreasonable risks to human health or to the environment when used as directed on produ ct labelin g. The registration revi ew p rogram is int ended to make s ure that , as t he ability to assess and reduce risk evolves and as policies and practices change , a ll registered pesticides continue to meet the stat utory standard of no unreasonable adverse effects. Changes in science , public po li cy, and pesticide u se practices will occur over time. Through the registration review program , the Agency periodically re - eva lu ates pestic ides to make sure that as the se changes occur, products in the marketplace can conti nue to be used safely. Informati on on this progran1 i s provided at www.epa.gov/ oppsrrdllregistration review /

. In 2006 , the Agency implemented the
regis tration review program pursuant to FIFRA sectio n 3(g) and will rev iew each r eg istered pesticide every 15 years to determine whether it continues to meet the FIFRA standar d for registration. EPA is i ssu in g an inlerim registration review decision for FPE so that it can (1) move forward with aspects of the registratio n review that are complete and (2) implement interim risk miti gation. The Agency is currently working with the U.S. Fi sh and Wildlife Service and the National Marine Fisheries Service (t he Services) to develop met hodolo g ies for co nducting national e ndangered species assessme nts for pesticides. Therefore , although EPA has not yet fully evaluated risks to threatened and endangered s pecie s , the Agency w ill complete its endangered spec ies assessment and any necessary consultat io n with the Serv ic es for FPE prior to completin g th e FPE registration review

. Likewise , the Agency w ill complete endocrine
screening for FPE , pursuant to the Federal Food , Drug , and Cosmetic Act (FFDCA) section 408(p) , before completing this registration review. Last, EPA will determine whether additional po ll inator expos ure and effec ts data are necessary to make a fina l regi stration re v iew decision for FPE and issue a data call-in (OC I) to obtain any s uch data prior to completing the FPE registration review.

FPE is a selective aryloxy phenoxy

-propionate he rbi cide re g istered for u se to control grass weeds after emergence. It is currently registered for agricultural use on barley , cotton , rice , 3soybeans, and wheat. It is also registered for non-agricultural use o n conservation reserves, orname nt a ls , rights-of-way , grass grown for seed (Washington , Oregon and Utah only), and turf. There are 16 FIFRA Section 3 registrations and several FIFRA 24 (c) Special Local Need registrations. A Reregistration Eligibility D eci sion (RED) was not conducted for FPE because the pesticide was registered afte r 1984 and , theref ore , was not subject to reregistration. Thi s document is organized in five sections: the Introduction , which includes this summary and a summary of public comments and EPA's response; Use and Usage , which describes how and why FPE i s u sed and summarizes data on its use; Scientific Assessments, which summarizes EPA ' s ri sk assessment, any revisions , and risk conclusions; the Interim Re gistratio n Review Deci s io n , wh ich describes the mitigation measures needed to address ri sks of concern and the regulatory rationale for EPA's registration rev iew deci s ion ; and , last, th e Next Steps and Tim el in e for completion of this registration revi ew. Pur suant to 40 CF R sect ion 155.50 , EPA formally initiated registration review for FPE (case 7209). The following summary highlights s i gnificant eve nts that hav e occurred during the registration review ofFPE and can be found in EPA ' s public docket , EPA-HQ -OPP-2007-0437 , accessed at www.regulations.gov:

• August 29 , 2007

- Publication of FPE Summary Document for a 90 -da y public comment period. The Summary Document included the Pre liminat y Work Plan ( PWP ) and was accompanied by the scoping document and problem formulation.

• February 29 , 2008- Final Work Plan (FWP) for FPE was i s sued. The Agency received comment s from two sources during the 90-day public comment period o n the PWP. The F I FRA Endang ered Species Task Fo rc e (FESTF) commented on data compensation i ss ues. B ayer , a technical registrant , submitted comments on FPE study res ults , revisions to FPE registrations, and details of the human health and eco lo gica l ri sk assessments. Bayer's comments and accompanying data s ubmi ss ion s res ulted in an adj ustment to the t ime li ne indicated in the PWP to accommodate the review of these data prior to issuance of a data call-in notice

• February 2 , 20 1 0

- Generic Data Call-In Notice (GDCI) fo r FPE was issued

.

• July 1, 2014- The Agency published the Preliminary /

Draft Ecological Risk Assessment for th e Registration Review of Fenoxaprop-p-ethyl and the R e gistration Review Prelimin01 y / Drafi Human Health Risk Assessment for F e noxaprop-p - ethyl for a 60-day public comment period. Comments were received from two sources, Bayer CropScience (Bayer) and the Center for Biologic al Diversity (CBD). Bayer clarified how FPE is typicall y used in agriculture , corrected typographical e rrors i n the human health risk assessment , and provided justification for using alternative endpoints in the non-target plant and chronic mammalian assessments. The Agency large ly concurred with Bayer's comment s and modified its assessments acco rdin gly. The CBD commented about the Age n cy ' s obligations under the Endang ered Spec ies Act (ESA)

.

4• August 2015

- T h e Agency p ub li s hed the Fenoxaprop-p-ethyl Propose d int e rim R egis tration R eview De cision for a 60- d ay public comment period. In add ition to that d oc ume nt, the Agency published th e following supporting documents: o EFE D Response t o Comm ent s on th e Environmental Fate and Ecological Risk Assessm ent for th e R egis trati on Rev iew of Fenoxaprop -p- e th yl. Chuck Peck, Sco tt Glaberman. Nove mber 3, 20 14 

### o F enoxaprop-p-ethyl: Res ponse to Registrant Co mments from Ba ye r Crop Science on th e Draft Preliminary Risk Assessment and Proposed New Use on Grass Grol-vnfor Seed. ShaJu Shelat , Chr i stopher Sc hl osser, Donald Wilbur. Decemb er 3 , 2014 o Addendum to th e Ecolog ica l Assessment fo r Fenoxap rop-p- ethyl. C hu ck Peck , Scott O laberman. June 4 , 20 1 5 o Fenoxaprop and Fenoxaprop-ethyl Usage Information/or Risk Assessment. B il l Chism, Jihad Alsadek, Michell e Ranville. May 8 , 2015 o Fenoxaprop and Fenoxaprop-ethyl Qualitati ve Benefits Assessmen t
. Bill Chism , M ichell e Ra nv ille. June 11 , 2015 During the 60-day co mment period on the FPE Propo se d Interim Regi s tration Re view D ec i s i on , which op en ed on Au gu st 8 , 2 015 and closed on October 9 , 2 015 , the Agency recei ve d comme nt s from Bayer and th e CBD, whic h are s ummarized b e low.

• December 2015

- The Agency i s no w publishing the Fenoxaprop-p-ethyllnterim R egistr ation Rev iew Dec is ion in the reg istration review docket (EPA- HQ-OPP-2007- 0437 ). C omm ents Recei ve d from Bayer CropScience (EPA-HQ-OPP-2007-0437-0028)
Comment: Bayer exp r essed ap pr ec iation fo r the Agenc y ' s consider ation of/heir comm ents on the draft ecological assessment for FPE andprovided additional co mm ents on t ech nical aspects ofthe Addendum to the Ecolog ica l Risk Assessment, which waspos ted a long with the FPE Proposed fnl e rim Regis tration Review De c is ion. Respon se: The Agency app rec iates Baye r 's co mments , agrees wit h the ty p ographical errors noted , and disag rees wi th other points suc h as the No Ob served Adverse Effect Level for tomato in a seedling e mergenc e s tud y. Bayer 's comment s do not affect the overall ri s k assessme nt conclus ion s for effects to no ntarge t p lants n o r the miti gation meas ures s pecifi ed for FPE. For additional d eta il s on B ayer's co mment s and the Age ncy 's response, please see R ev iew of Comments on A dd endum lo the Ecolog ical Ri sk Assessm ent for Fenoxaprop-p- ethy l , dated Novemb e r 1 3 , 2 015 , in the FPE registration rev iew docket. Comments Received from the Center for Biologica l Divers itv (EPA-HQ- OPP-2007-0437- 0033) Commen t: CBD opposes Ih e proposed reregistration of FPE at this time as premature because they assert that the Agenc y has dete rmin ed that FPE has th e po tential to cause adverse e ffec t s to species

. In CBD ' s comments on th e Proposed Interim Registra tion Rev iew Deci s ionfor Fenoxaprop-p-ethyl , th ey focus on EPA ·s duty to initiate co n s ultation with th e 

### U.S. Fish and 

### 5Wildlife Service and the National Marine Fisheries Service (the Services) prior to completion of the registration review process for FPE. CBD states that the reregistration of FP E cannot be completed in compliance with EPA ' s obligations under both FIFRA and the ESA until the EPA concludes that the continued use of FPE will have "no effect " on listed species or critical habitat or completes consultation. CBD also contends that there are readily available data and information sources that would allow EPA to complete Step 1 of the Interim Approaches/or National Level Endangered Species Assessments Based on the Recommendations of the National Academy ofScience

. CBD refers to their previous comments 1 on EPA ' s draft ecological risk assessment , which provided specific label language to implement the Bulletins Live! System, stating that this label language would enable EPA to comply with current and continuing ESA duties. (CBD incorporated these and all otherprevious comments on the draft ecological risk assessment by reference.) Last , they state that EPA must take a precautionGiy approach and enter into consultations with the Services on FP E as outlined in the Interim Approaches document. Response: As an initial matter, CBD ' s comments suggest that it may not fully appreciate the distinction between EPA's interim and fina l registration review decision

. Additionally, CBD seems to use "reregistration" interchangeably with " registration review." Both are separate programs mandated by FIFRA; FPE is currently undergoing Registration Review. As provided in EPA's registration review regulations at 40 CFR section 155.56 , EPA may , in its discretion, issue an interim decision before the comp let ion of registration review when, among other things, it determines that it cannot complete registration review because additional information is necessary to complete the Agency's assessment. In addition, section 155.56 also provides that EPA may require risk mitigation measures in an interim decision. Consistent with this provision , EPA is issuing this interim registration review decision for FPE in part so that it can move forward with aspects of the registration review decision that are complete while EPA continues to work with the Services on developing the interim approaches that will be used to complete its registration review endangered species assessment for FPE

. Under section 3(g) of FIFRA , EPA must complete the registration review of FPE by October I , 2022

. Whi le EPA**~ould ,**  therefore , choose not to comp l ete any aspect of the FPE registration review for several more years until it comp letes its endangered species assessment and any necessary consultation , EPA believes the public and the environment benefit from EPA's early action on the matters covered by this interim decision

- - including risk mitigation , such as use of spray nozzles limiting FPE droplet size and other drift reduction measures -- as described in Section IV of this document. EPA does not believe the Endangered Species Act compe l s a contrary result. Taking early action to address some risks now serves to benefit the environment and does not preclude EPA from taking any additional necessary actions to address effects to li sted species that EPA concludes are necessary as it works to complete registration review. Accordingly, EPA ' s previous response to CBD's comments on the draft eco logical risk assessment (in the Proposed Interim Decision) stated that EPA plans to address CBD's concerns with the development of its Final Registration Review Decision

. This i s still EPA's plan. EPA anticipates initiating consultation with the Serv ices after i ssuing the Interim Registration Review Decision, but prior to issuing the Final Registration Review Decision. Th is Interim Registration Review Dec ision , like the Proposed Interim Decision, states that EPA is not making a complete

1 Full CBD comments located on docket EPA-HQ-OPP-2007-0437-0033 

### 6endangered spec ies fmdin g , and that the Agency's F i nal Registration Rev iew D ecisio n for FPE wi ll depend upon the result of an ESA Section 7 consultation with the Services , an assessment of non-target exposure to bees , as we ll as the FFDCA Section 408(P) endocrine screen i ng requirements.
EPA is still in the process of developing the interim ap proache s based on the 2013 NAS Rep ort recommendations , includin g Steps 1 and 2 ofthe Biological Evaluation for listed spec ie s. CBD ' s previous co mment s provide refere nce to the availab le critica l habitat ; how ever , as CBD noted , not all spec ie s have critical habitat. Furthermore , critical habitat is just one piece of the species ' range. EPA is working with the Services to obtain the best avai lable species range information for all listed species. We are also working together to determine the appropriate pesticide use footprint. EPA w ill be taking pub li c comment on our interim approaches as deve loped and implemented for the three pilot chemica ls: chlorpyrifos , diazinon and malathion. As a result, EPA may develop a revised approac h for Steps I and 2 through work on the three pilot chemical s before completing Step l for FPE.
CBD ' s previous comments a lso provided label language referring pesticide applicators to EPA ' s Bulletins Live! System , and a statement that all product labels for FPE mu st contain this language. However , since there are no Bulletins for FPE in Bulletins Live! Two , it is unnecessary, at this point in time , to include this language on the label for FPE. Inclusion of a reference to Bullet i ns on the product label when no Bulletins exist is likely to result in confusion for pesticide app licators and g rowers . However , EPA is in agreement with CBD that Bulle tin s are the approp ri ate mechanism to implement any necessary geographica ll y - specific pesticide use limitations intended to protect li sted species. EPA plans to use Bulletins Live! Two to implement any Bulletins that would be generated as we complete the evaluation of potential risks ofFPE to li sted species and designated critical habitat. 

### II. USE AND USAGE
FPE is a post-emergence herbicide r eg i stered for u se to se lect ively control annual and perennial grass weeds in barley , cotton , soy beans , rice , and wheat. N' on-agricu ltural use s ites include rights

- of -way , ornamenta ls , grass grown for seed (Washington, Oregon and Utah only) , and turf. F P E inhibits acetyl CoA carboxylase enzy me (ACCase) (WSSA G roup 1) and interferes with meristematic tissue development. While most of this herbicide is used in wheat crops, it is also app lied to a relativ ely large percentage of barley and ric e crops in th e United States. Betwee n 2004 and 2012 , the average annual pounds active ingredient (a.i.) used are as follows: barley (20 , 000 lbs a.i /year) , rice ( 1 0 , 000 lbs a.i / year) , soybeans (20 , 000 lb s a .i /year) , and sprin g/ winter wheat (200,000 lbs a.i / year). Percent crop treated is app roximately 10 percent for barley , 5 perc ent for rice, 2.5 percent for soybeans, and 10 percent for wheat. EPA ' s analysis did not find any evidence of th e use ofF PE applications on an in-season (same calendar year) rotational crop in the same state. The majority of FPE usage over the years 2009-2013 was through ground application. Only two crops, barley and ric e, had a sign ificant percentage of treatment through aerial app li cation. Approximately e ight percent of the 10 percent of FPE-treated acres for barley are app lied aerially , and more than fifty percent of the five percent of FPE -tr eated acres for rice are applied aerially. The aerial applications for rice were apparently made to accommodate the large number 7of acres involved and not specifica ll y because of wet fields , since they were applied pre-flood and only a small number of acres were treated post-flood. The barley and wheat aerial app li cations were generally applied l ate post-emergence so that the large fields could be treated in a short amount of time when the weeds were most sensitive.See Fenoxaprop and Fenoxaprope th y l Us age Information for Risk Assessm ent , dated May 8 , 2015, for additional detail on FPE use and usage inf ormati on. 

### III . SCIENTIFIC ASSESSMENTS A. Hum an Health
A summary of the Agency ' s hum an health risk assessment is presented below. The Agency used the most recent Agency science policies and risk assessmen t methodologies to prepare a quantitat ive risk assessment in support of the registration review of FPE. For a detailed d isc u ssion of the human health assessment for FPE, see Fenoxaprop-p-ethyl Human Health Risk Assessment dated March 20 , 2014 and Fenoxaprop

- p-ethyl: Res ponse to Registrant Comments from Bayer Crop Science on the Draft Preliminary Risk Assessment and Proposed New Use on

Grass Grown for Seed dated D ecember 3 , 2014. Both of these documents are available in the public docket E PA-HQ-OPP-2007-0437 , which can be accessed at http: //www.regulations.gov /

. 1. Risk Conclusions EPA has n o d ietary risks of concern for FPE from exposure to resid ues in either food or drinking water. The Agency has no risk concerns for residential use of FPE on turf or ornamentals. Furthermore , EPA has no risk concern from aggregate exposure to FPE from food, drinking water, and residential/bystander exposure. EPA has not made a common mechanism of toxicity fmding as to FPE and any other substance and it does not appear to produce a toxic metabolite produced by other substances. Therefore , EPA has not assumed that FPE has a common mechanism of toxicity with other substances for this assessment. For pesticide handlers receiving occupational exposure to FPE , EPA has no risk concerns associated with dermal routes of exposure when handlers use chemical-resistant gloves, which are required personal protective equipment on all product labels. The Agency also evaluated exposure and risk to agricultural workers who enter areas treated with FPE after application. EPA determined that post app li cation exposures and risks were not of concern on the day of app li cation. 2. Human Incidents The Agency completed a review of FPE incidents in the OPP Incident Data Systems (IDS) , for the period covering January 1, 2008 to July 31, 2013 , and the Centers for Di sease Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIO SH) Sentinel Event Notification System for Occupational Risk-Pesticides (SEN SOR) database for th e period covering 19 98-2009. Based on the lo w frequency and severity of incident cases reported for FPE in both ID S and NIOSH SENSOR-Pestic ides , there does not appear to be a concern at this t ime that would warrant further investigation. The Ag ency will continue to monitor the incident information and , if a concern is 

### 8triggered , ad ditional analysis will be conducted. For additio nal detail , see Tier I Updated Re view of Human Incid ents for Preliminary Risk Assessment (0 416023 , Nove mber 1 3 , 2013) available in the pub li c docket EPA

- HQ-OPP-2007-0437 

### 3 . Tolerances Currently there are tolerances established for FPE based on previously-e stablished tolerances for fenoxaprop. Certain to lerances need re vis ion based on current Agency policy. The commodity definition for soybean will be changed from "soybean" to "soybean , see d " and the tolerance for " peanut hulls " will be revoked since this raw agricultural commodity is no longer cons id ered to be a s ignificant livestock feed item. 2 • The Agency is not aware of any international harmonization i ss ues related to the ex isting FPE tolerances. Furthe r details on necessary revisio ns to FPE tolerance can be found on page 10 of Fenoxaprop-p-ethyl: Regis tration R eview Pr ef

iminaTy Risk Assessment and Proposed New Grass Grown for Seed , which can be accessed on the public docket EPAHQ-OPP-2007-0437. 

### B. Ecolo gica l
A summary of the Agency's eco logical ri s k assessment is presented below. The Agency used the most updated Agency science po li cies and risk assessment methodologies to pr epare a quantitative risk assessment in support of the registration review of FPE. For a detailed discussion of the ecological assessment for FPE, see Environ mental Fate and Ecological Risk Assessment for Registration Rev iew of Fenoxaprop -p -ethyl dated Apr il 21, 20 14 , the Addendum to the Ecol_ogical Assessment for Fenoxaprop-p-ethyl dated June 4 , 20 15 , and the EFE D Response to Comment s on the Environm en tal F ate and Ecolog ical Risk Assessment for the Registration Review of Fenoxaprop-p-ethyl , dated Novembe r 3 , 20 I4. These documents are ava il able in the public docket E PA-HQ-OPP-2007-0437 , which can be accessed at http: //www.regu lations.gov/

. The Agency also completed a screening-level listed species assessment for FPE and identified potential risks to several taxa (terrestrial and semi

- aquatic monocot plants and mammals). The Agency is current ly work in g with it s federal partners and other stake hold ers to impl e ment an interim approach for assessing potential ri sk to listed species and their designated critical habitat s. Once the scientifi c methods necessary to complete risk assessments for listed species and their designated critical habitats are finalized , the Agency will complete its endangered spec ies assessment for FPE. As such, potential risks to li ste d spec ies will n ot be discussed further in this document. I. Risk Conclus ion s Terres trial Assessment Mammals- In the preliminary ri sk assessment for FPE, the Agency identified chronic risks of concern for mammals for all labeled uses except for g rass grown for seed. During the public comment period for the preliminary risk assessment, Bayer commented that the assessment included some incorrect app li cation rates for some uses. EPA

2 hllp : //www.regulations.gov/# !documc ntDetai I:D=E PA-110-0PPT

- 2009-0155-0003 9ve rifi ed the information provided by Bayer and th en revised the risk assess men t to reflect the correct use rates. As a res ult of Bayer ' s clarification of several application rate s , c hro ni c mammal ian ri sks are no longer of concern for the co n serva t io n reserve and the soy bean uses w h en three applicati ons a r e assumed. However, as noted in the risk assessment addendum , the chronic ri sk level of co ncern (LOC) for mamm als is still exceeded for seve ral u se s ites (risk quotients range from 0.0 I to 2.36). B ird s - There are no acute or chronic risks of concern to no n-target birds or to reptile s and terrestrial

- phase amphibians for which b ird s serve as s urrogates
. I nvertebrates

- Based on available data for yo un g adult bees, FPE is classified as practi cally non-toxic to non - target terrestrial inv e rte brate s on an acute contac t exposure ba s i s. S in ce the ac ute contact toxicity study for honeybees was non -definiti ve (i.e

. , the LD so was g reater than the hi g hest dose tested), ri sks were not assesse d for terres trial in ve rteb rates. T he re is s om e uncertainty r egardin g t ox icity of FPE to honey bee larvae s in ce no d a ta on this developmental stage were ava i la bl e at th e time of the assessment.
Whe n initially scoping the registration review for FPE , EPA did not identify the need for any add iti ona l studies to evaluate potential effects on pollinators. H owever, s ince th e iss uance of the June 2014 Guidance for Assessing Pesticid e Ri sks to B ees 3

, E PA has begu n to require these data w here applicable. EPA is c urrently determining w hether additional pollinator data ar e needed for active ingredi e nt s in reg istration review w h ose docke ts op e ned pri or to June 2014. For those activ e in g redients where EPA determ ine s that additi onal pollinator exposure and effects data are necessa r y to help make a fin a l regi s tration review decision , EPA intends to i ss ue a DC I to obta in these data. In the near future , EP A will pro v ide further informati o n and guidance on this effort. The pollinato r s tudi es that co uld be required are included in Tab le I be low. The Agency w ill require data it be li eves are nec ess ary to h e lp inform the pollinator risk assess ment.
T bl 1 P t f l P 11"

a e o e n ta o ma or DtR t a a eqmremen s 

### Guideline# Study J

, L 850. 3020* 1 Ac ute co n tact toxicity study wi th adu lt ho ney bees 850 .3030* 1 Honey bee toxici t y of residues on fo li age 850.3040** Fie ld testing for pollinators Non

- H o ne y bee adult acute oral toxicity Guide !in e* 1 ( OECD 213) No n- Guideline* H oney bee l arvae acute oral toxicity (OECD 237) No n- Gu idelin e* Honey bee adult chronic oral toxicity No n-Guid e line* Honey bee larvae chronic oral t oxic i ty No nR es idue s in pollen and n ec tar / field re s idu e ana lys is Gu id e line**

3

**http //**  **www2.~:na gov**  **/s it**  **sl production/lile**  **s/ 20**  1 4

-06/doc um e nt s/ pollin a tor ri s k assess ment g uidanc e 06 19 14 .pdf 10NonGuideline** (OECD 75 ) Semi-fie ld testing for pollinators (tunnel or colony feeding studies)

*Tier I (Laboratory-based s tudie s) ••Tier 2 and 3 (Semi-field and full field colony-level studies) The need for a higher tier test for pollinators will be determined b ased upon lower-tiered te sts a nd/or o ther lines of data and the need for a refined pollinator ri s k assess m e nt. 1

. Acce ptable data have already been s ulrnitted f o r FP E o r arc waived bas ed o n available information

. Plants

- Based on Ba yer's comments during the public comment period and the information ga in ed about application pract ices in a subse qu e nt meeting with FPE registrants 4

, the Agency revised several aspects of the risk assessment, including terrestrial plant endpo ints, risk estimates, and sp ray drift calc ul ations

. EPA agreed with B ayer that the initia l endpoints used for the plant assessment (i.e., root/radicl e measurements) are no longer specified in c urrent terrestri a l p lan t guide lin es and are s u bject to high variabi li ty. When root/radical endpoints were omitted from the assessment, plant ri sk estimates were greatly reduced. In addition, for the initial modeling assessment , the Agency assumed smal ler droplet s izes than are routine ly used , as FPE labels are inconsistent when referring to droplet s ize (e

. g. , medium size, mi cron range , or no size at all). The Agency initially used the American Society of Agricultural and Biological Engineers (ASABE) very fineto-fine droplet sizes to model ground applications and fine

- to-medium sizes to model aerial application s. Rev ised modeling included ASABE med ium- to-coarse droplet sizes for aerial applications, based on the registrants' commitment to amend product labe lin g to include this droplet s ize ran ge across labels. The terrestrial plant assessment pr esents estimates of how far off the treated field (i.e. , the effects distance) o ne might expect adverse effects to occur to non-target plants from spray drift. The initial assessment indicated effects

**dis~ances** of > I 000 feet for non-target monocotyledonous terrestrial p lants (monocots) for some use patterns. The revised assessment indi cates a 7 foot effects di s tanc e for g round applications (all u se sites) and a 7

- 43 foot effec ts distance for aeria l app li cations (varies by site) u s in g a medium-coarse droplet size. While the above rev tswns to the terrest rial p lant assessme nt re s ulted in a significant decrease in risk estimates, the overall risk conclusion that all labeled uses of FPE pose potential risks of concern to non - target monocots has not changed. Aquatic Assessment Risks of concern to fish and aquatic invertebrates are not expected from the labeled uses ofFPE. There i s so me Lmcertainty assoc iated with this finding s in ce there are no chron ic estuari n e/marine fish data avai l able nor benthic invertebrate sedim ent tox ic it y data. However , extrapo lating from chronic f re s hwater fish data, risks to estuarine/marine fish are not expected

. In addition, exposure to benthic invertebrat es is expected to be orders of magnitude below available aquatic t ox ic it y endpoints and, thus , risks of concern are not expected. FPE degrades rapidl y in the aquatic environment and benthic invertebrates would likely be exposed to FPE degradates , which appear to be less toxic to sedime nt4 See EPA, Bayer. Syngcnta. and Nufam1 Meeting on Fenoxaprop Registration Review. May 5. 20 15. located in the docket. 1 1dwelling organisms. Based on the available data , risks to aquatic plants are not expected from the currently registered uses of FPE.

2. Eco logical Inci d ents As of 2013 , the Agency has received 1 13 reports of adverse field effects to non-target p lants that have been linked to the use of FPE. All of these incidents involved damage to grain crops (bar ley, com, lenti l, rice , or wheat). The Agency cons i dered the cause and attribution to FPE to be uncertain in 75 cases because more than one herbicide was app lied to the crop. In the remaining 38 cases , the Agency considers FPE to be the probab le cause. Most of the incidents were reports of crop damag e that occurred following application of the herbicide directly to the crop, although four incidents occurred from carryover effects of applications made to another crop i n a previous growing season. None of the incidents involved damage to crops or other p lants outside the treatment site. For a detailed discussion of the eco logical incidents for FPE , see 

### Environmental Fate and Ecological RiskAssessment for Regis/ration Review of F enoxaprop-p-ethyl dated April 21 , 2014. 3. C h arac teri za ti o n o f Eco logica l Ris k The prel i m inary risk assessment and risk assessment addendum for FPE identified some risks that exceeded EPA ' s LOC for non-listed species. The Agency uses the LOC as an indicator of potential adverse effects to non - target organi sms. LOC exceedances are only one line of evidence used by EPA to describe the risks posed by a pesticide to non-target organisms. This risk characterization section i s an attempt to d e scribe other lines of evidence for FPE , and put the LOC exceedances into a broader context. 

### Mammals

- Whi le the LOC is exceeded for chron ic risk to mammals , EPA does not expect risk to mammals based on the following lines of evidence. Chronic risk estimates to mammals were calculated using data bridged from fenoxaprop

- ethyl (FE) , which appears to be more tox ic to mammals than FPE (see human health risk assessment). In addition, the endpoint used in the mammalian assessment is from a rat two

- generation study where the no adverse effect level was the highest concentration tested in the study , since no sign i ficant adverse effects were observed at any of the levels tested. Given the conservative nature of the assessment described herein , the Agency does not expect chronic risks to mammals from the use of FPE. 

### Terrestrial Plant s - This assessment indicates that all labeled uses of FPE pose potential risks of concern to non- target terrestrial plants (monocots) , which is supported by a series of incidents reported for grain crops treated with FPE

. The Agency ' s principa l concern is off

- target spray drift resulting from aerial applications. To address this concern , EPA and the FPE registrants have agreed to various label changes design e d to reduce off-target spray drift.

12C. Benefits Assessment FPE i s registered for use fo r selec tive post-emergence control of difficult to control annual and perennial grass specie s in barley , rice , soybeans , and winter and spring wheat. Approximately ten percent of the barley and wheat crop is treated with this herbicide , on average, indicating that FPE is important in controlling grass weeds in these crops. In California , o n barley and wheat , FPE is part of an Integrated Pest Management program for the control of several d ifficult to control grasses. As a post-emergence treatment , the grower can avoid making prophy l actic preemergence applications. In these crops , FPE is less expensive than several of the other availabl e alternative he rbi cides. FPE is ge nerally applied early to late postemergence to the crop and weeds using g rou nd eq uipm ent , with low booms. Aerial applications primarily occur in only two crops with 8% of total acres treated for barley and 53% percent of total acres treated for rice

. For additi onal detail on the qualitative benefits ofFPE, see Fenoxaprop and Fenoxaprop-ethyl Qualitative Benefits Assessment dated Jun e 11 , 20 15. D. Endangered Species Assessment
ln November 2013, the E PA, along with the Serv ices and the USDA , released a summary of their joint Interim Approaches for assessing risks to endangered and threatened (listed) species from pesticides. The Interim Approache s 5 were developed jointly by the agencies in response to the National Academy of Sciences' (NAS) recommendatio ns and refl ect a common approach to risk assessment shared by th e agencies as a way of address in g scientific diffe rences between the EPA and the Services. The NAS report 6 out lin es recommendations on specific scientific and technical issues related to the development of pesticide risk assessments th at EPA and the Services must conduct in connection with their obligations under the ESA and FIFRA.
The joint Interim Approaches were released prior to a stakeho lder workshop he ld on November 15 , 2013. In addition , the EPA presented the joint Interim Approach es at the December 2013 Pesticide Program Dialogu e Comm ittee (PP D C) and State -FIFRA Issues Research and Eva luation Group (SF I REG) meetings. The agencies also held stakeholder workshops- in April and October 2014, and in Ap ril 2015

- a llo w in g additional opportunities for stakeholders to comment on the In terim Approaches

. Additional workshops are planned to e nhance stakeholder in volve ment. As part of a phased , iterative process for developing the Interim Approaches , the age ncies will also consider public comments on the Interim Approaches in connection with the development of upcoming Registration Review decisions. The detai l s of the joint Interim Approaches are contained in the white paper Interim Approaches for Na tional-Level Pesticide Endangered Species Act (ESA) Assessments Based on the Recommendations of the National Academy of Sciences Ap ril 2013 Report 7

, dated November 1, 2013.

5 Inte rim Approaches for National-Level Pesticid e Endangered Species Act (ESA) Assessments Based on the R ecomm endations of the Nationa l Academ y ofSciences April2013 Repo rt. Available at hrro: //v. rww2 .epa.gov /endangered-species/interim-approaches-pesticide-endangered- s pecie s-ac t-as sess ments-ba sednas-report 6 Assessing Risks to Endangered and Threatened Speciesfrom Pesticides. National Acadamy of Sciences. 1983. Available from http: //www.nap.edu/ catalog.php?record id = 18344 7 Availab le at http : //www. epa.gov/ espp/ 20 13 / nas.html 13Given that the agencies are continuing to develop and work toward implementation of the Interim Approaches to assess the potential ri sks of pesticides to listed species and their designated critical habitat , the eco logical risk assessment supporting this Interim Decision for FPE does not contain a complete ESA analysis that includes effects determinations for specific listed species or designated critical habitat. Although EPA has not yet completed effects determinations for sp ecific species or habitats for thi s interim decision , EPA's evaluation assumed , for all taxa of non-target wildlife and plants , that listed spec ies and designated critical habitats may be present in the vicinity of the application of FPE. This assessment allows EPA to focus its future evaluations on the types of spec ie s where the potential for effec ts exists once the scie ntifi c methods being developed by the agencies have been fully vetted. Once the Agencies have fully developed and implemented the scientific methodology for evalu ating risks for listed spec ies and their d es i g nated critical habitats , these method s wi ll be applied to subsequent analyses for FPE as part of completing the final registration revi ew decis ion. 

### E

. E ndocrine Disruptor Screening Program
As required by F IFRA and FFDCA, EPA reviews numerous stud ies to assess potential adverse outcomes from exposure to chemicals. Collectively , these stud ies include acute , subchronic and c hronic toxicity , including assessments of carcinogenicity , neurotoxicity , developmental, reproductive , and ge neral or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence , including effects on endocrine target organ histopathology , organ weights , estrus cycl ic ity , sexual maturation, fertility , pregnancy rates , reproductive loss , and sex ra ti os in offspring. For ecological hazard assessments , EPA evaluates acute tests and chronic studies t h at assess growth , de velo pmental and reproductive effects in different taxonomic groups. As part of its most recent registration decision for FPE , EPA re viewed these data and se lected the mo st se nsitive endpoints for relevant ri sk assessment scenar ios from the exist in g hazard database. However, as required by FFDCA sect ion 408(p) , FPE is subject to the e ndocrine screen in g part of the Endocrine Disruptor Screening Program (EDSP).
EPA ha s developed the EDSP to determine whether certain s ub stance s (including pesticide active and other ingredients) may have an effect in humans or wild li fe simi l ar to an effect produced by a "na turally occurring estroge n, or other such endocrine effects as the Administrator may designate. " The EDSP employs a two-tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemica l subs tan ce to interact with the estrogen , androgen , or thyroid (E , A , or T) hormonal systems. C hemicals that go through Tier 1 scree nin g and are found to have the potential to interact withE , A , or T hormonal systems will proceed to the next stage of the EDSP where EPA will detennine whi c h , if any , of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine- re lated effec ts caused by the substance, and establish a dose-response relationship between the dose and the E , A , or T effect. Under FFDCA section 408(p) , the Agency must screen al l pesticide c hem icals. Between October 2009 and February 2010, EPA issued test orders /data call-ins for the fust group of67 chem ica ls , whic h contains 58 pesticide active in gredients and 9 inert ingredients. A second li st of che mi ca ls identifi ed for EDSP screening, which included FPE , was published on June 14,2013 8

8 Sec hn:p: //www . rcgulation s .gov /# !documentDetai i ;D = EPA-HO-OPPT-2009-0477

- 0074 for the final second li st of chemicals. 14and includes some pesticides sc heduled for Registration Review and chemicals found in water. Ne ither of these lists should be construed as a li st of known or lik e l y e ndo crine disrupters. For further information on the status of the EDSP , the policies and procedures , the lists of chemical s, future li sts , the test guidelines and the Tier 1 sc reening battery , please visit our website. 9
In this interim decision , EPA is making no human health or e n vironmental safety findings assoc iated with the EDSP sc ree ning ofFPE. Before completing this Regi strat ion Re v iew, the Agency will make an EDSP FFDCA sectio n 408(p) determination.


### IV. INTERIM REGISTRATION REVIEW DECISION A. Risk Mitigation and Regulatory Rationale Spray Drift Reduction As discu ssed in the ecological risk assessment sect ion of this document , FPE po ses a potential risk concern for non-target terrestrial (monocot) plants exposed to off-site spray drift from aeria l applications pri marily. FPE labels are inconsistent with regard to droplet s i ze (one of the main factors affecting spray drift) , w ith some referencing medium droplet size, micron size, or no spec ific reference to size. In addition , some labels reference wind speed restrictions or maximum release height w hil e others do not. To address spray drift concerns , the Agency and the FPE registrants have agreed to various label changes for FPE registrations. These label changes are intended to establish a baseline level of protection that is consistent across FPE labels. EPA believes this revised labeling , once in place , will reduce risks associated with drift without a s ig nificant reduction in product efficacy. The labe lin g lan g uage , described below , is to be incorporated on lab e ls of products used in agric ultura l, wide area, or rights-of-way setti n gs.

• Select nozzles and p ressur e that del iver medium or coarser spray droplets as indicated in no zz le manufacturer 's catalogs and in accordance with ASABE Standard S-572.
• Applicators may spray only when w ind spee d is between 3 and 10 mph.
• For ae rial applications , the release hei g ht must be no hi g her than 10 feet from the top of the crop canopy, unless a greater application height is required for pilot safety.
• For aerial applications , the distance of the o uter most nozzles on the boom should not exceed three -f ourths of the length of the wingspan or rotor diameter. To further reduce drift , use one -h a lf of the length of the wingspan or rotor diameter at the edge of a field. Herbicide-Resistance Management FPE belongs to a class of herbicides (ACCase inhibitors) that has the third highest numb er of resistant p lant species (>40) out of the most commo nl y used classes ofherbicides. 10 In addition, the majorit y of usage occurs in wheat, which is the crop with the highest number of resistant weed species (

- 71). The other crops o n which 

### FPE i s most commonly used (rice , winter wheat , barley , soybeans, and cotton) are also among the top ten crops with the greatest number of herbicide-resistant spec ies. In order to extend the useful life of FPE and slow the

9 htto: //www.cpa.gov/endo/ 10 Internati onal S urvey of Herbicide Res istant Weed s ( http: // weedscience.org/) 15development/expansion of FPE -res i stant weed spec ies, FPE reg i strants have agreed to include herbicide

- resistance management lan guage uni fo rm ly across their lab e l s. The Agency is requiring that all herbicid e products contai nin g FPE (excep t for those registered so lely for homeowner use) contain the fo ll ow ing minimum herbi cide -r esistance management elements on the ir lab el s . Th ese l abel require ments follow the reco mm endations of the Weed Sc ien ce Society of America (WSSA) publication , Reducing the Ri sks of Herbicide Res istance, Best Management Practices and Recommendations''· The Agency first pro vided g uidan ce o n resistance management labeling in Pe sticide Reg istration ( PR) Notice 20 01- 5 , Guidance for Pesticide Registrants on Resistance Management Labeling.

• Li sting of herbicide mechanism of ac tion , and/or WSSA h erb ic ide gro up numb er , at the top of the fir st page of eac h product l abel; • Instructions to alternate use of products containing FPE with other h erbicide s with different mechanisms of actio n ; • Recomme nd at io n s to sco u t for weeds before and after FPE application , to ensure proper identification of weeds and growth stage and to confirm product performance; and • Instructions to report h erbic ide fai lure to local exten s ion specialists , certified c rop advisors , and/or FPE registrants. EPA beli eves that the inclusion of herbicide

- resis tan ce management lan guage on FP E label s is important to slow t he deve lopment of resistance to thi s herb icide whi le maintaining fl exi bili ty for growers . Weed res istance is a co mp l ex issue and reg i strants play an important role in ens urin g effective resistance management. Educating all stakeholders on managing he rbicid e resistance is important and t he prod uct l abel is a critical piece of this effort. Us e Rate Clarifications In response to th e November 8, 20 1 2 EPA

- Registrant FPE Foc us Meetin g , Bayer and Syngenta sub mitted separate letters on November 30, 20 12 co mmittin g to clarify use patterns on product l abels (e.g

. , m axim um annual rates , retreatment intervals)

. Bayer rece ntl y noted one correction to the inf ormation co n tain ed in it s letter for applicatio ns to rice: the maximum seaso nal rate of 0.142 lbs a.i ./A is equi va lent to the maximum annual application rate (i .e. , for a g i ve n year, prior to growing rice and after the rice h as been harvested , no FPE can be applied to that field until the following year)

. B ayer and Syngenta have agreed to imp lem ent the use rate clarifications as specified in their commitment letters, along with B ayer's correction to the ri ce m axi mum annual application rate , after the Agency's iss uan ce of its registration review decision for FPE. T he N ovember 30 , 2012 commitment letters can b e foun d in E PA ' s public docket for the FPE r eg istra ti o n review (E PA -HQ-OPP- 2007-0437)

. B. To lerance Amendments A lthoug h EPA has d etermin ed that there are no adverse human health effects from all uses of FPE , th e Agency will purs ue the following changes to the tole rances for FPE , to reflect c urrent policies. E PA w ill revise th e followi n g es t a bli sh ed to leranc es in 40 CFR 

### § 180.430 (b) as follows :

1 1 N o rswo rth y e t a l. 20 1 2

. Weed Sc ien ce 20 1 2

. Sp eci a l Iss ue : 3 1

-62

. 16• The commodity definition for "s oybean " to be changed to "soybean, see d "

. • The tolerances for " peanut , hu ll " will be revoked since that commodity is no longer a regu lated raw agricu ltw-al commodity

.

C. Inte rim Regis tra tion Rev iew Decis ion
In accordance with 40 CFR Sections 155.56 and 155.58 , the Agency is issuing this Interim Registration Review Dec ision. Except for the E DSP , pollinator , and ESA components of this case, the Agency has made the following In terim Registration Review Decis io n : (1) wi th th e possib le exception of po lli nator studies listed in Sectio n IIIB of this docume nt , no ad di tional data are required at thi s t ime ; and (2) changes to the affected reg istra ti ons and t h eir label in g are needed at th i s time.
In this interim registratio n review decision , EPA is making no human hea lth or environmenta l safety fmdings associated with the ED SP screeni ng of FPE , nor is it making a complete endangered species finding or a complete assessment of effects to pollinators. The Agency's final registration review decision for FPE will depend upon the results of an ESA Section 7 cons u ltatio n wit h the Servi ces, an ED SP FFDCA section 408(p) determ ination , and an assessment of the non-targe t exposure to bees. 

### V . N E XT S T E PS AND TIMELINE
A. Regi s tratio n Rev iew D eci s ion
A final dec i sion on the FPE registration review case will occur after an ESA determinat ion and an EDS P FFDCA section 408(p) determination have been made, as well as completion of an assessme nt of the non - target expos ure to bees

. B . Impl em e ntation of Miti g ation M eas ures EPA is requiring re g i s trant s to submit amended labe ls that include the agreed-upon risk mitigation, described in Appendices A and B be low , to the Agency for approval within 60 days of the issuance of this Interim Registration Re v iew Decision.

1 7

### A-ppendix A: Summary of Actions Taken for Fenoxaprop

- p - ethyl

**~egistration** Rev i ew Case#: 72 09


# . 

# tc Code: 1 2 9092 C he mical Type: he r bicide C h emica l Family: Aryloxy Phe noxy Pro pioni c Ac id Mechan is m of Actio n : WSSA Grou p l Affected So ur ce of Route of Dura tio n of Ri s k( s) o f Action( s) K:;omme nt 

### r Population (s) Expos u re Ex pos ure Expo s ure Concern Taken

**~**

./ Terre strial ./ Aeria l ./ Fo l iar ./ Acute ./ Acu te ./ Require Plants Ap pli cation absorption t ox icity spray drift (monocots) reduction language ./ C la ri fy rice an nu a l maxi mum app li ca ti o n rate

Appendix B: F P E Label Table
S ummary o f Labe lin g C h a n ges f o r FPE D esc ripti o n Labeling L a ng u age f or F P E Prod u c t s P lacement on Lab e l SPRAY DR I FT Spray Drift Language 

### • Select nozzles and pressure that deliver medium or D irections for Use coarser spray droplets as indicated in nozzle manufacturer 's catalogs and in accordance with ASABE Standard S-572. 

### • Appl icators may spray only when wind speed is between 3 and I0 mph. 

### • For aerial applications , the maximum release heig ht must be no higher than I0 feet fTom the top of the crop canopy, unless a g r eater application hei g ht is required for pilot safety. 

### • For aeria l applications, the distance of the o uter most no zz l es o n the boom must not exceed three-fo UJ1h s of the l e ngth of the wingspan or rotor diame t e r . To further reduce drift, use one-ha l f of th e length of th e wingspan or rotor diameter at the edge of a field.
H E RBI C ID E R ES I STANCE MANAGEMENT

- Pro du c t s Labeled for Agricultural Use Herbicide Mechanism Front Panel, upper right of Action "G roup I HERBI C ID E" quadrant, surrounded by a black (or suitable co lor) rectangle Weed Re s is tance 

### • In structi o n s to alternate use of products containing Directions for Use , prior to

Management FPE with other herbicides wi th different directions for specific crops mechanisms of action; under the heading · ' WEED 

### • Recommendations to scout for weeds before and RESISTANCE after FPE application, to ensure proper identification MANAGEMENT' ' of weeds and growth stage and to confinn product perfonnance;

1 8S ummary of Labe l ing C hanges for FPE Description Labelin2: LanS?:uaS?:e f o r FPE Products Placement on Lab e l 

### • Instructions to report herbicide fa ilure to local extensio n s peciali s t s, ce rtifie d crop adviso rs, and/or FPE registrants. DIRE CT IO NS FOR USE Clarify use rates as 

### • F. or rice, the maximum seasonal rate of 0.142 lbs Directions for Use for Specific spec ified in Bayer 's a. i ./ A is equivalent to the maximum annual Crops 20 12 commitment letter application rate for a given field (with the exception of use on rice, which is corrected in this table) and in Syngenta's 20 1 2 comm itm ent lette r

19