Docket Number EPA-HQ

-OPP-2014

-0570 www.regulations.gov



## Fluroxypyr Fin I Work Plan Registratio Review

Case 

## Nurn IJ,er 

## 7248

. March 2015

Approved by:



## ~#

**.:h** Richard Il Keigwin, Jr. Director Pesticide Re-evaluation Division I
I 

### Date: 

# I ..8- /2_- r£}015INTRODUCTION This is the Environmental Protection Agency's (EPA or the Agency) Final Work Plan (FWP) for th e registration review of fluroxypyr. This work pla n addresses public comments received concerning the Preliminary Work Plan**(PWP~,** which was posted in the fluroxypyr registration review docket (EPA-HQ-OPP-2014-0570). Fluroxypyr is a pyrid i n e herb ici de registered for post-emergent selective control of broadleaf weeds. It is currently r eg istered for use on various grains, fruits, and agricultural areas, including wheat, barley , oats, millet, corn, sorghum, pome

fruits, fallow cropland, and range and**pastur ~**  grasses.

The Agency is implementing the registration review program pursuant to Section 3(g) of th e Federal Insecticide , Fungicide, and Rodentidde Act (FIFRA) , and will review each re g istered p estici de every 15 years to det ermine whether it continues to meet the FI FRA standard for re gistra tion. Cha nges in science, public policy, and pe stic ide use practices occur over time. The registration review program is intended to make sure that, as the ab ility to assess risk evolves and as policies and practices change, all regis tered 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 i s provided on the Agency's website. 1 The FWP begins with any updates since th e**~re liminary**  Work Plan (PWP) was issue d. Next is a s ummary of substantive comments received quring the public comment per iod for the PWP concerning anticipated data needs, expected risk assessments, or t he estimated timeline identified in the PWP, and a summary of the Agency's responses to tho se comments. This section is followed by r egistration review planned data needs, risk assessments expected to be conducted, and th e projected r egistrat ion review timeline for fluroxypyr. Las t ly , there is a discussion of next steps. UPDATES SINCE THE PWP WAS ISSUED • Due to comments received from Dow AgroSciences (availab le in the fluroxypyr registration review docket EPA-HQ-CDPP-201 4 -0570-0015) the requirement for GLN

850.3030 has been removed. • Additional pollinator data requirements have been added t o be cons istent with the Agency's new ri s k assessment procet for terrest rial in vertebrates and as a result the fluroxypyr regi st ra t ion re view projec d t imel i ne has been extended from 5 years to 6 years. The new data requirements are a result of the Agency recently finalizing its framework to assess risk to pollinators. EPA now requires a (Tier I) screening-level risk assessment be conducted for all pestidides that pose a reasonable potential for exposure to bees. Higher tier testi ng (Tier II and/or III) is co ntingent upon results of Tier I testing. Greater detail including justification for requesting non-guideline bee exposure and effec t s s tudie s is provided in the 201**~** document: Guidance on Exposure and Effects Testing for Assessing Ri sks to Bees which can be found at: http:/ /www2.epa.gov/sites/produc tio n/fi le s/20 14- 06/documents/pollinator ri sk assessment guidance 06 1 9 14.pdf. 1 http: // www.epa .gov / oppsrrd 1/registration _ review / 2SUMMARY OF COMMENTS AND AGENCY RESPONSES During the 60-day public comment period on the**fl~ '**  oxypyr Preliminary Work Plan, which opened on 9117114 and closed on 1 11 17/14, the Age cy received four public comments. Comments were submitted by Dow AgroSciences, e FIFRA Endangered Species Task Force, the Washington Association of Wheat Growers, an the Center for Biodiversity (CBD). The comments from Dow AgroSciences and the Agenc 's responses to those comments have resulted in changes to the anticipated data requirements. Alt ough the comments do not impact the time line described in the PWP, they do impact the lanned ecological and human health risk topics of environmental justice, water quality conce s, and trade irritants, but no comments or information were received on those issues. This section does not capture every comment made about the Preliminary Work Plan (PWP) nor all ofthe Agency's responses, but summarizes publ f c comments that resulted in changes to the anticipated registration review data needs, risk asse sments, or timeline, or are of a broader regulatory nature. Public comments and EPA respo ses in their entirety are located i n the docket, EPA-HQ-OPP-201 4-0570. Summarized public co ments and Agency responses related to the anticipated ecological risk assessment or data needs are in EFED ' s Response to Comments on the Problem Formulation for Fluroxypyr-MHE. One a icipated data requirement has been eliminated as a result of comments received from D w AgroSciences supporting the determination by the Agency that a "Honey Bee To icity ofResidues on Foliage" (GLN 850.3030) is not necessary. Comments submitted by Dow AgroSciences 

# LL1 in EPA-HQ-OPP-2014-0570-0015 Dow AgroSciences commented on the proposed dala requirements in the PWP. The comments and the Agency's responses to those conunents are ( eluded in the fluroxypyr-MHE docket. Comment submitted by FIFRA Endangered 

### Spei ies Task Force in EPA-HQ-OPP-2014- 0570-0012 Comment: FESTF identifies that Dow AgroScience f and Nufarm Limited , the technical registrants for fluroxypyr are members of FESTF a fd are entitled to rely on species proximity data developed by FESTF in response to he Agency ' s endangered species requirements

. . EPA Response: The Agency thanks FESTF for its fOmment and will consider appropriate information as it conducts registration review and makes its registration review decisions. Comments submitted by Washington Association of Wheat Growers in EPA-HQ-OPP2014-0570-0014 Comment: The Washington A ss ociation ofWheat rowers identifies several reasons why fluroxypyr should continue to be registered, includi g its importance as an herbicide to control

bedstraw, chickweed , kochia, and prickly lettuce as biotypes of these specific weeds have
3developed resistance to other herbicidal modes of action, including the acetolactate synthase I {ALS) inhibiting herbicides . It was also note 1 that fluroxypyr is an important herbicide in the higher rainfall producing areas of the state.

EPA Response : The Agency thanks the Washington Association ofWheat Growers for its comment. Comment submitted by Center for Biological diversity in EPA-HQ-OPP-2014-0570-0013 Comments: The Center for Biological Divers¢ty (CBD) comments focus on EPA's independent duty under the Endangered Species Act**(ESA ~**  to consult with the US. Fish and Wildlife Service and the National Marine and Fisheries Servi e (Services) on the registration review of fluroxypyr-MHE. Specifically, CBD opposes he proposed decision for jluroxypyr-MHE prior to completion of consultation with the Services . EPA Response: EPA has reviewed the co ents from CBD on the registration review docket opening for fluroxypyr-MHE and plans to**ad~ress** 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 of the April 2013 National Academy of Sciences (NAS) report. EPA will address concerns specific to fluroxypyr-MHE in connection with the development of its final registration review decision for fluroxypyr-MHE. Consistent with EPA's responsibility under**~e** Endangered Species Act (ESA), the Agency will evaluate risks to federally listed threatened aJ!ld endangered (listed) species from registered uses of pesticides in accordance with the Joint In t brim Approaches developed to implement the recommendations of the April 2013**Nationa~Academy** of Sciences (NAS) report, Assessing Risks to Endangered and Threatened Specie from Pesticides. The NAS report outlines recommendations on specific scientific and t chnical issues related to the development of I pesticide risk assessments that EPA and the Services must conduct in connection with their obligations under the ESA and FIFRA. EPA !will address concerns specific to fluroxypyr-MHE in connection with t he development of its finfll registration review decision for fluroxypyr-MHE. In November 2013, EPA, the U.S. Fish and Wildlife Service, Na t ional Marine Fisheries (the Services), and USDA released a whi te p aper f ontaining a summary oftheir joint Interim Approaches for assessing risks to listed speciles from pesticides. These Interim Approaches were

developed jointly by the agencies in**respons ~**  to the NAS recommendations, and reflect a

common approach to risk assessment shared pY the agencies as a way of addressing scientific differences between the EPA and the Servic1. Details of the joint Interim Approaches are con t ained in the November 1, 2013 white pa er, Interim Approaches for National-Level Pesticide Endangered Species Act Assessme 1 ts Based on the Recommendations of the National Academy ofSciences Apri/2013 Report. Given that the agencies are continuing to devielop and work toward implementation of the Interim Approaches to assess the potential r i sks of pesticides to l i sted species and their designated critical habitat, this Final Work Pfan for fluroxypyr-MHE does not describe the specific ESA analysis, including effects dete:nninations for specific listed species or designated

critical habitat, to be conducted during registration review. While the agencies continue to 4develop a common method for ESA analysis, the plfnned risk assessment for the registration review of fluroxypyr-M HE will describe the level 

# or ESA analysis completed for this particular registration review case . This assessment will**allo P** A to focus its future evalua tions on the types of species where the potential for effects exi*s, once the scientific methods being developed by the agencies have been fu lly vetted. nee the agencies have fully developed and implemented the scientific methods necessary to co plete risk assessments for listed species and their designated critical habita ts , these methods wil be applied to subsequent analyses of fluroxypyr-MHE as part of completing this**reg stra** **ion** review. PLANNED DATA N EEDS Table 1 below summarizes the planned data needs f pr fluroxypyr based on the Problem Formulat ion for the Ecological Risk and Drinking 'fater Exposure Assessments to be Conducted in Support of the Registration Review for Fluroxypyr-MHE and EFED ' s Response to Comments
I on the Problem Formulation/or Fluroxypyr-MH E

. [f he table has been updated since the PWP to reflect changes to the data needs , specifica lly the re rnoval of GLN 850.3030 and the addition of three non-guideline b ee studies

. Table 1: P lanned Data Needs for the l t'furoxypyr Registration Review Estimated Guideline Study Tit le3 Timeframe Number Test Material (Months from receipt of DCI)
850

. 3040 Field toxicity test with honeybee (MHE on/**J** TEP TBD 850.4100 Seedling Emergence and Seedling Growth (11**~H E**  onl y) T GAI 12 850.4150 Vegetative V igor (MHE only ) T GAJ 12 850.4500 Aquatic plant gro wth (algal toxicity)w / freshfvater TGAJ 12 diatom (MHE only) Environmental Chemistry Methods andAssociated 835.6100 Independent Laboratory validation for soil t d TG A1 12 water(MH E & Acid)
Dlss/panan Study I n C ampast ( MHE &

# Ac/ 4 Compos t Non- So urced from 12 Guideline Material treated with TEP Non- Pollinator Chronic Toxicity- honeybee larv e ( MH E TG AI 12 Guideline Only) Non- Pollinator Chronic Oral Toxicity

- honeybeJ adult TGAI 1 2 Guideline (MHE only ) 

### I Non

- Pollinator Acute Or a l T oxicity- honeybee a**ult** TGAI 12 Guideline ( MHEOnly)

2 On June 27 , 20 12, EPA announced certa in revisions in harm pnized guideline series 850

- Ecological Effects Tests

- including renumbering and other designations or changes f or some guideline studies. See "Fina l Test

0 0 Guidelines; OCSPP 850 Senes; Notice ofAvailability " 77**R** 38282 , June 27 , 2012

. h ://www .re ulations . ov/# !documentD etaii ·D =EPA-H OPPT

-2009-0154-0028 3 The need for this test is contingent upon results oflower tier poll inator tests. Protocol is required for this test. 5Table 1: Planned Data Needs fo lr the Fluroxypyr Registration Review Estimated Guideline Study Title 3 Timeframe Number Test Ma t erial (Months from receipt of DC I) Non- Pollinator Acute Oral Toxicity- hon f ybee larvae TGAI 12 Guideline (MHEOnly) Non- Semi-field test for pollinators 3 (MH EJ Only) TEP 24 Guideline Non- Residue analysis of nectar and**polle ~**  in flowering TEP 24 Guideline crops 3 (MHE Only) TGAI = techmcal grade active mgredrent ; TEP = typrcal end-use product; RISK ASSESSMENTS FOR REGISTRA l ON REVIEW During registration rev i ew, the Agency will l onduct a comprehensive ecologica l risk assessment, including an endangered species assessment, for all uses of fluroxypyr. For human hea l th, EPA w ill n ot conduct revised dietary, residential, d occupationa l risk assessments during registration review. If toxicological endpoint or points of departure are revised based on the data that are required for reg i strat i on review, they will be considered in the new assessments, as well

as any changes to the standard operating pro l edures or default exposure assumpt i ons. Table 2 below summarizes the planned**regis~ration** review risk assessments based on the EFED Problem Formu l at i on and HED Seeping Docrment and has been updated s i nce the PWP to reflect public comments which resulted in ch nges to the planned risk assessments. 6I 

### Table 2 : Planned Risk Assessments for

## t~e Fluroxypyr Registration Review Type of Risk Assessment Conduct?

## Note**~** Eeo· 

### · -• aacl En'riromnental Fate I Comprehensive ecologica l 

### y The**gency's** ecological analysis will include both (species to be assessed fluro**ypyr** MHE and it's degradate fluroxypyr acid. include terrest rial and aquatic organisms), including endangered species Incidents 

### y Will pheck for updates. 

### Haman Health Dietary Food 

### N In th Agency's most recent dietary assessment for fluro xypyr, (20 12), no acute dietary assessment was

### cond**cted** (no acute endpoint was identified in the toxic ty database) and chronic dietary risks were beJO'

### lv the Agency's level of concern. Therefore, a revis**~d** dietary risk assessment is not anticipated for regis ration review

. Drinking water N The t\gency's most recent drinking water assessment (20 1 ) was conducted on rice and is considered cons r\rative fo r all current uses of fluroxypyr. Ther**~fore,** the Agency does not anticipate the need to upda e its drinking water assessment for registration revie**~-** Occupat ional Handlers (mixers, loaders, N Occt: pational assessments reflect current policies and applicators) adeq**~ate** toxicity and exposure data. The need for Post

-application N upda ed occupational handler exposure assessments is not apticipated as part ofregistration review. Residential Handlers 

### N The 1\gency's most recent residential assessment for Post-application 

### N fluro**~ypyr** (2012), utilized current policies and 

### me;do logies including policy changes for body weig t assumptions. Therefore, the Agency does not antic pate updating its residential assessment. Other Aggregate 

### N WiH no anticipated changes to either the dietary or resid**~ntial** analysis for fluroxypyr, the Agency does not a lnticipate updating its aggregate assessment for this c 1ompound. Cumulative N Flurc ,xypyr has not been identified as a member of a cum**~lative** group that shares a common mechanism ofto**~icity,** therefore a cumulative risk assessment is notalnticipated.



### 7Tolerances y The Agency will review t he fluroxypyr tolerance to hannonize with N o rth America and CODEX MRL's where possible. Incidents N Based on the low fr equency and severity of human health inc i dent ca s e s repm1ed for both fluroxypyr in

both IDS and SE N SOR - Pesticides , there does not appear to be a c on c ern at this time that would warrant further investigat i on . TIME LINE

EPA has created the fo ll owing estimated tim**~line** for the comple t ion of the fluroxypyr registration review in Table 3 below. The p r**~jected** time l ine has not changed since the PWP. Table 3 : Registration Review for**Fluro~ypyr-** Projected R egistration Review Timeline Activities Estimated Date Opening the Docket Open Docket and 60 - day Public Comment**~eriod** September 20 14 - Comp l eted C l ose Public Comment I November 2014 - Completed Case Development F i nal Work Plan March 2015- Completed Issue DCI April- June 2015 Data Subm i ssion Oct. - D e c . 20 1 7 60 - day Public Comment Period for Draft Ri sk Assessments 4 Mar.- May 2019 Registration Review Decision 60 - day Public Comment Period for Propose r Registration Review May- J uly 20 1 9 Decision Registration Review Decision and Begin Pest-Decision Fo ll ow-up 2020 Tota l (years) 6 NE X T ST E PS As noted previously, the Agency plans to req**~ire** several . environmental f ate and eco l og i ca l effects studies for fluroxypyr

- MHE through Data Ca ll- In Notice, expected to be issued in May

2015 overnin rail re uire the A enc to rovide a ublic comment eriod 4 The re ulatio n s Re istration Review em g g gg g yq g y p p p of at leas t 30 ca l endar days for draft risk**assessmen t~** **;** see 40 CFR Part 155 . 5 3( c ) . F or conventional pesticides , the Agency plans to provide a 60 calendar day public co hun ent per i od generally for draft r isk as s e s sm e nt s . 8