Docket Number EPA-HQ-OPP-2014-0570 

www.regulations.gov 

Fluroxypyr Fin I Work Plan 

Registratio Review 

Case N urn IJ,er 7248 

. March 2015 

Approved by: ~# .:h Richard Il Keigwin, Jr. 

Director 

Pesticide Re-evaluation Division I 

I 

Date: 

I ..8- /2_- r£}015 
INTRODUCTION 

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

the registration review of fluroxypyr. This work plan 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 pyridine herbicide registered for 

post-emergent selective control of broadleaf weeds. It is currently registered 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 the 

Federal Insecticide, Fungicide, and Rodentidde Act (FIFRA), and will review each registered 

pesticide every 15 years to determine whether it continues to meet the FIFRA standard for 

registration. Changes in science, public policy, and pesticide use practices occur over time. The 

registration review program is intended to make sure that, as the ability to assess risk evolves and 

as policies and practices change, all registered pesticides continue to meet the statutory standard. 

The public phase of registration review begins when the initial docket is opened for each case. 

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

The FWP begins with any updates since the ~reliminary Work Plan (PWP) was issued. Next is a 

summary of substantive comments received quring the public comment period for the PWP 

concerning anticipated data needs, expected risk assessments, or the estimated timeline identified 

in the PWP, and a summary of the Agency's responses to those comments. This section is 

followed by registration review planned data needs, risk assessments expected to be conducted, 

and the projected registration review timeline for fluroxypyr. Lastly, there is a discussion of next 

steps. 

UPDATES SINCE THE PWP WAS ISSUED 

• Due to comments received from Dow AgroSciences (available in the fluroxypyr 

registration review docket EPA-HQ-CDPP-2014-0570-0015) the requirement for GLN 

850.3030 has been removed. 

• Additional pollinator data requirements have been added to be consistent with the 

Agency's new risk assessment procet for terrestrial invertebrates and as a result the 

fluroxypyr registration review projec d timeline 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 testing (Tier II and/or III) is contingent upon results of Tier I testing. 

Greater detail including justification for requesting non-guideline bee exposure and 

effects studies is provided in the 201 ~ document: Guidance on Exposure and Effects 

Testing for Assessing Risks to Bees which can be found at: 

http:/ /www2.epa.gov/sites/production/files/20 14-

06/documents/pollinator risk assessment guidance 06 19 14.pdf. 

1 http://www.epa.gov/oppsrrd 1/registration_review/ 

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SUMMARY 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 11117/14, 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 publfc 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 in the docket, 

EPA-HQ-OPP-2014-0570. 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 of Residues 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 Speiies Task Force in EPA-HQ-OPP-2014-

0570-0012 

Comment: FESTF identifies that Dow AgroSciencef and Nufarm Limited, the technical 

registrants for fluroxypyr are members of FESTF af d 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 Association 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 

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developed resistance to other herbicidal modes of action, including the acetolactate synthase I 

{ALS) inhibiting herbicides. It was also note1 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 Intbrim 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 the development of its finfll registration review decision for fluroxypyr-MHE. 

In November 2013, EPA, the U.S. Fish and Wildlife Service, National Marine Fisheries (the 

Services), and USDA released a white paperf 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 

contained in the November 1, 2013 white pa er, Interim Approaches for National-Level 

Pesticide Endangered Species Act Assessme1ts 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 risks of pesticides to listed 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 

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develop a common method for ESA analysis, the plfnned risk assessment for the registration 

review of fluroxypyr-MHE will describe the level or ESA analysis completed for this particular 

registration review case. This assessment will allo P A to focus its future evaluations on the 

types of species where the potential for effects exi*s, once the scientific methods being 

developed by the agencies have been fully 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 habitats, these methods wil be applied to subsequent analyses of 

fluroxypyr-MHE as part of completing this reg stra ion review. 

PLANNED DATA NEEDS 

Table 1 below summarizes the planned data needs fpr fluroxypyr based on the Problem 

Formulation for the Ecological Risk and Drinking 'fater Exposure Assessments to be Conducted 

in Support ofthe Registration Review for Fluroxypyr-MHE and EFED 's Response to Comments I 

on the Problem Formulation/or Fluroxypyr-MHE. [fhe table has been updated since the PWP to 

reflect changes to the data needs, specifically the re rnoval of GLN 850.3030 and the addition of 

three non-guideline bee studies. 

Table 1: Planned Data Needs for the l t'furoxypyr Registration Review 

Estimated 

Guideline Study Title3 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 ~HE only) TGAI 12 

850.4150 Vegetative Vigor (MHE only) TGAJ 12 

850.4500 Aquatic plant growth (algal toxicity)w/ fresh fvater TGAJ 12 

diatom (MHE only) 

Environmental Chemistry Methods and Associated 

835.6100 Independent Laboratory validation for soil t d TGA1 12 

water(MHE & Acid) 

Dlss/panan Study In Campast (MHE & Ac/4 

Compost 

Non- Sourced from 12 Guideline Material treated 

with TEP 

Non- Pollinator Chronic Toxicity- honeybee larv e (MHE TGAI 12 Guideline Only) 

Non- Pollinator Chronic Oral Toxicity - honeybeJ adult TGAI 12 Guideline (MHE only) I 

Non- Pollinator Acute Oral Toxicity- honeybee a ult TGAI 12 Guideline (MHEOnly) 

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

- including renumbering and other designations or changes for some guideline studies. See "Final Test 0 0 Guidelines; OCSPP 850 Senes; Notice of Availability" 77 R 38282, June 27, 2012. 

h ://www.re ulations. ov/#!documentDetaii·D=EPA-H OPPT-2009-0154-0028 

3 The need for this test is contingent upon results oflower tier pollinator tests. Protocol is required for this test. 

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Table 1: Planned Data Needs fo lr the Fluroxypyr Registration Review 

Estimated 

Guideline Study Title3 Timeframe 

Number Test Material (Months from 

receipt of DC I) 

Non- Pollinator Acute Oral Toxicity- honfybee larvae TGAI 12 

Guideline (MHEOnly) 

Non- Semi-field test for pollinators3 (MHEJ Only) TEP 24 

Guideline 

Non- Residue analysis of nectar and polle~ in flowering TEP 24 

Guideline crops3 (MHE Only) 

TGAI = techmcal grade active mgredrent; TEP = typrcal end-use product; 

RISK ASSESSMENTS FOR REGISTRAl ON REVIEW 

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

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

will not conduct revised dietary, residential, d occupational risk assessments during 

registration review. If toxicological endpoint 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 prol edures or default exposure assumptions. 

Table 2 below summarizes the planned regis~ration review risk assessments based on the EFED 

Problem Formulation and HED Seeping Docrment and has been updated since the PWP to 

reflect public comments which resulted in ch nges to the planned risk assessments. 

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Table 2: Planned Risk Assessments for t~e Fluroxypyr Registration Review 

Type of Risk Assessment Conduct? Note~ Eeo· · -• aacl En'riromnental Fate I 

Comprehensive ecological y The gency's ecological analysis will include both 

(species to be assessed fluro ypyr MHE and it's degradate fluroxypyr acid. 

include terrestrial 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 

fluroxypyr, (2012), 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 

(201 ) was conducted on rice and is considered 

cons r\rative for all current uses of fluroxypyr. 

Ther ~fore, the Agency does not anticipate the need to 

upda e its drinking water assessment for registration 

revie ~-

Occupational 

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 a pticipated as part of registration review. 

Residential 

Handlers N The 1\gency's most recent residential assessment for 

Post-application N fluro ~ypyr (2012), utilized current policies and 

me;dologies 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 alnticipate updating its aggregate assessment for 

this c

1 ompound. 

Cumulative N Flurc , xypyr has not been identified as a member of a 

cum ~lative group that shares a common mechanism 

of to ~icity, therefore a cumulative risk assessment is 

nota lnticipated. 

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Tolerances y The Agency will review the fluroxypyr tolerance to 

hannonize with North America and CODEX MRL's 

where possible. 

Incidents N Based on the low frequency and severity of human 

health incident cases repm1ed for both fluroxypyr in 

both IDS and SENSOR-Pesticides, there does not 

appear to be a concern at this time that would warrant 

further investigation. 

TIME LINE 

EPA has created the following estimated tim ~line for the completion of the fluroxypyr 

registration review in Table 3 below. The pr ~jected timeline has not changed since the PWP. 

Table 3: Registration Review for Fluro~ypyr- Projected Registration Review Timeline 

Activities Estimated Date 

Opening the Docket 

Open Docket and 60-day Public Comment ~eriod September 20 14 -

Completed 

Close Public Comment 

I 

November 2014 -

Completed 

Case Development 

Final Work Plan March 2015-

Completed 

Issue DCI April- June 2015 

Data Submission Oct. - Dec. 2017 

60-day Public Comment Period for Draft Ri sk Assessments4 Mar.- May 2019 

Registration Review Decision 

60-day Public Comment Period for Proposer Registration Review May-July 20 19 

Decision 

Registration Review Decision and Begin Pest-Decision Follow-up 2020 

Total (years) 6 

NEXT STEPS 

As noted previously, the Agency plans to req ~ire several .environmental fate and ecological 

effects studies for fluroxypyr-MHE through Data Call-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 g ulations g gg Re istration Review g em yq g y p p p 

of at least 30 calendar days for draft risk assessment~ ; see 40 CFR Part 155 .53( c). For conventional pesticides, the 

Agency plans to provide a 60 calendar day public cohunent period generally for draft risk assessments. 

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