### Table of Contents

**Contents**

I. Introductio n

............................................................................................................................. 3

II. Use and Usage/Background

. .............................................................................................. .. . .. 6

III. Scientific Assess m ent s

....................................................................................................... . . .. 6

A. Hu m an Health Assess m ent

.................................................................................................... 6

Hazard Characterization and Risk

.......................................................................................... 6

Food Tolerance s

.............................................................................................................. . ....... .7

Hu m an Incidents

.............................................................................................................. . ...... 8

B. Environ m ental Assess m ent

................................................................................................... 8

Ecological Risk Characterizatio n

............................................................................................ 8

Ecological Risk Assess m ent Uncertainties

............................................. ............................... 10

Ecological Incident s

......................................................................................................... . .... 11

Endangered Species Assess m ent

.......................................................................................... 11

C. Endocrine Disr uptor Screening P rogram

............................................................................. 12

IV. I nterim Registration Review Decision

............ ............................................................... 13

V. Next Steps and Ti m eline

.................................................................................................... 17

A. Registration Review Decision ..............................................................................................17

B. Implementation of Mitigation Measures......................

. .................................... ..... ........ 17

Appendix A: Summary of Proposed Actions Taken for Flutolanil

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

Appendix B: Fluto l anil Label Table

............................................................ ............................... 19

Appendix C: Risk Quotient Ranges

............................................................. ............................... 20

2

### I. Introduction

This document is the Environ m ental Pro t ection A gency’s (E P A or the Agency) Interim Registration Review Decision for flutolanil and is being issued pursuant to 40 CFR sections 155.56 and 155.58. A registration review decision is the Agency ' s deter m ination whether a pesticide m eets, or does not m eet, the standard for registration in the Federal Insecticide, Fungicide, and Rodenticide Act (FI F RA). The Agency m ay issu e, when it deter m ines it to be appropriate, an interim registration review decision before co m pleting a registration review. Among other th i ngs, the interim registration review deci s i on m a y requi r e n e w risk m itigation

m easures, i m pose inte r i m risk m itigation m easures, identify data or infor m ation required to

c o m plete the review, and include schedules for sub m itting the required data, conducting t h e new risk a s ses s m ent and completing t h e regi s t ration review. For further infor m ation on f l utola n il,

ad d i tio n al doc u m ents can be found in EPA’s public docket (E PA

- HQ

- OPP

- 2008

- 0148) at www.regulations.go v

.

FIFRA, as a m ended by t he Food Quality Protection Act (FQPA) of 1996, m andated the

continuous review of existing pes t icides. All pesticides distributed or sold in the United States

gener a lly must be re g i st ered by t h e EPA based on scie n ti f ic data showi n g that they will not cau s e unreasonable risks to hu m an health or to the environ m ent when used as directed on product labeling. The registration review program is intended to m ake sure that, as the ability to assess and reduce risk evolves and as policies and practices change, all registered pesticides continue to

m eet the statutory standard of no unreasonable ad verse effects. Changes in science, public policy, and pesticide u s e practices will occ u r o ver ti m e. Through the registration review progra m , the Agency periodically reevaluates pesticides to m ake sure t h at as these changes occur, prod u cts in

the m arket p l ac e can continue to be used safely. Information on this program is provided as

www.epa.g o v/oppsrrd1/registration_review/

.

In 2006, the Agency i m ple m ented the regis t ration review program pursuant to FIFRA section 3(g) and will review each re gi stered p esti c ide ev e ry 15 years to d eter m ine whether it

continues to m eet the FIF R A standard for registration.

Flutola n il is a syste m ic fungicide

, first re g i stered by EPA in 1993. Because it was registered after Nove m b er 1984, flutolanil was not s ubject to reregistration. It is registered for use to control fungal diseases in both food crops (peanuts, potatoes, rice, Cole crops, turnip greens, and seed piece treat m ents on potato, c o tton, sugar bee t and soybean) and non

- food sites (turf, greenhouse, field

- grown and potted orna m e ntals). Fluto l anil for m s a protective b arrier on the plant, enters the plant, and m oves upward in the xyle m . Flutolanil has both protective and

cur a tive acti v ity.

Pursuant to 40 CFR section 155.50, EPA fo r m a lly initiated registration review for flutolanil (case # 7010). The following highlights sign i ficant events that h a ve occurred during the registration review of flutolanil:

• Septe m ber 15, 2008

– Publication of Flutolanil Summary D o cument for a 60

- day public comment period. The Summary Do cu m ent inc l uded the Preli m inary W o r k Plan (PWP)

and was acco m panied by the scoping docu m ent and problem fo r m ulation.

3• February 5, 2009

- Final Work Plan ( F W P) for f l u t o l an i l was issued. One public co mm ent was received during the 60

- day c o m m ent period for the flutolanil P W P but it did not change the risk assess m e nts needed, data nee d s o r the ti m eline in the P W P. The F W P did modify the P W P to r e move the analytical standar d s data re q uire m ent f or m etabolites and

to add the U V /Visible light absor p tion data r eq u ire m ent.

• April 7, 2010

– Generic Data Call

- In Notice (GDCI) for flutolanil iss u ed.

• March 28, 2014

– The Agency published the Draft Preliminary Environmental Fate and Ecological Risk Assessment for t h e Registr a tion Review Combined with the Environmental Fate and Ecological Risk A ssessment for Proposed Amendments to Certain Labels for F l utolanil

, and the Flutolanil

– Preliminary Human Health Risk Assessment for Registr a tion Review a nd Human Health Risk Assessment for Label Amendments for Brassica (Col e ) Leafy Vegetables (Crop Group 5 ) , Turnip Greens, Rice, and Turf in Addition to Banded Applic a tions on Peanuts for a 60

- day public com m e nt period. One com m ent was rece i ved from the Center for Biological Diversity (CBD) on the ecological risk assessment regarding consultation requirements under the Endangered Species Act (ESA), which did not result in any revisions to the assessment.

• Septe m ber 2014

– The Agency published the Flutolanil Proposed Interim Registr a tion

Review Decision in docket nu m ber EPA

- HQ

- OPP

- 2008

- 0148 for a 60

- day public

co mm ent period. One comment was received from the CBD

, similar to the comment

received on the dr aft ecolo gical risk assessment. The comment is summarized below with the Agency’s response.

Comment: The Center for Biological Diversity’ s ( CBD) 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 flutolanil 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 flutolanil on endangered and threatened (listed) species and their designated critical habitat for the flutolanil registration review.

Response: EPA has reviewed the comments from CBD on the Proposed Re gistration Review

Decision for flutolanil and plans to address many of the concerns raised by CBD as part of the implementation plan for assessing the risks of pesticides to listed species based on the recommendations of the April 201 3 National Academy of Sciences (NAS) report. EPA will address concerns specific to flutolanil in connection with the development of its final registration review decision for flutolanil

.

In November 2013, the EPA, along with the Services and the USDA, rel eased a summary of their joint Interim Approaches for assessing risks to endangered and threatened (listed) species from pesticides. The Interim Approaches were developed jointly by the agencies in response to the National Academy of Sciences' (NAS) recomm endations and reflect a common approach to risk assessment shared by the agencies as a way of addressing

4scientific differences between the EPA a nd the Services. The NAS report 1 outlines recommendations on specific scientific and technical issues related t o the development of pesticide risk assessments that 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 stakeholder workshop held on November 15, 2013. In a ddition, the EPA presented the joint Interim Approaches at the December 2013 Pesticide Program Dialogue Committee (PPDC) and State

- FIFRA Issues Research and Evaluation Group (SFIREG) meetings. The agencies also held stakeholder workshops in April and Octob er 2014, allowing additional opportunities for stakeholders to comment on the Interim Approaches. Additional workshops are planned to enhance stakeholder involvement. As part of a phased, itera tive process for developing the Interim Approaches, the agencie s will also consider public comments on the Interim Approaches

in connection wi th the development of upcoming registration r eview decisions. The details of the joint Interim Approaches are contained in the white paper "Interim Approaches for National

- Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the National Academy of Sciences April 2013 Report 2 , dated November 1, 2013.

Given that the agencies are continuing to develop and work toward implementation of the Interim Appr oaches to assess the potential risks of pesticides to listed species and their designated critical habitat, the risk assessment supporting this Interim Decision for

flutolanil does not include a complete ESA analysis, including effects determinations for

s pecific listed species or designated critical habitat. This screening

- level risk assessment determined the potential effects of flutolanil on all taxa of non

- target wildlife and plants, assuming that listed species and their designated critical habitats ma y be present in the vicinity of the application of flutolanil . This screening

- level assessment will allow EPA to focus its future evaluations on the types of species where the potential for effects exists once the scientific methods being developed by the agencies have been fully vetted. Once the agencies have fully developed and implemented the scientific methods necessary to complete risk assessments for endangered and threatened (listed) species and their designated critical habitats, these methods will be applied to subsequent analyses for

flutolanil as part of completing this registration review.

• March 2015

- The Agency is now publishing the Flutolanil Interim Registration Review

Decision in EPA’s public docket, EPA

- HQ

- OPP

- 2008

- 0148, accessed at www.regulations.go v

.

1 http://www.nap.edu/catalog/18344

2 http://www.epa.gov/espp/2013/nas.html 5

### II. Use and Usage/Bac k g round

Flutolanil is a fungicide registered for the control of fungal diseases on peanuts

, potatoes,
rice and other crops (such as leafy vege tab l es, cole crops, and seed treat m ent for cotto n
, sugar beets, and soybean), turf, greenhouses, and orna m entals. Peanuts and potatoes are the pro m inent use sites for flutolanil, accounting for m ore than 99% of flutolanil usage in the U.S. between

2008

- 2012. The rice use is the least, with percent crop treated (PCT) with flutolanil less than 1%. For the period 2008

- 2012

, the average PCT w it h flutolanil for peanuts a n d potatoes (foliar) was 15% and 1 0 %, resp e cti v el y
, while fo r potato seed tre a t m ent PCT was 5% percent.

When co m p ared with other re g i ster e d fungic ide s , flutolanil i s a viable alterna t i ve for

contr o l of white m old (caused by Sclerotium sp.) and lim b /

pod rot (caused by Rhizoctonia sp.) on

peanu t s
, Rhizoctonia d i s eases (scurf and blight) o n potatoes ( s eed a nd fo l i ar treat m ent), and
Rhizocto n i a diseases on turf and orna m entals. For turf and orna m enta l uses of flutolanil as a succinate dehydrogenase inhibitor ( SDHI) fungicide is conside r ed a useful partner th a t m ay be

alt e rnated with ot h er fung icide chemist r ies (such as de m ethylation inhibitors (DMI) and quinone

outside inhibitor ( QoI) fungicides) to provide e f f ective r esi s tance m anage m ent as well as

effective di s ease co n t rol. Fl uto la n il u se on turf and orna m entals is typic a lly li m ited to tre a t m ent
for Rhizoctonia diseases and as s u ch is hi g hl y dependent on d i sease p re s sure in a g i v en season as well as typi c a l use p a tt er ns that involve spot treat m ents where pockets of disease m ay b e observed or anticipated.



### III. Scientific Assessments

A. Human Health Assessment

A sum m ary of the Agency’s hu m an health r i sk assess m ent is presented b elow. The Agency used the HED scoping docu m ent, its supporting docu m ents, and the m ost updated Agency science policies and risk assess m ent m ethodologies to prepare a qualitative risk

assess m ent, inclu d ing a quantitative chronic d i e t ary assessment, in support of the registration

review of flutola n il. T h e m ost recent hu m an health risk assess m ent was c onducted in February 2014. For a detailed discussion, see the Flutola nil

– Preliminary Human Health Risk Assessment for Registration Review and Human Health Risk Assessment for Label Amendments for Brassica (Col e ) Leafy Vegetables (Crop Group 5 ) , Turnip Greens, Rice, and Turf in Addition to Banded Applications on Peanuts

, published on March 28, 2014 in the public docket EPA

- HQ

- OPP

- 2008

- 0148, which can be accessed on http://www.regulations.gov/ . The Agency did not receive any

comments on the risk assess m ent.

Ha z ard Characteri z ation and Risk

There are no dietary, reside n tial, occupational, or agg r egate risks of concern for flutolanil. Flutolanil has few biologically significant toxicological effects, which are m ainly in

the liver and gastr o int e stinal (GI) syste m

. The flutolanil data do not indicate that it is neurotoxic, or that it targets the immune system, fetal dev e lop m ent, or reproduction. No der m a l effects were observed, and the subchronic inhalation study was waived based on a weight

- of

- evidence approach; th erefore

, no toxicological endpoints w ere established for any der m al or inhalation

6exposure d u ration. No hazard was i d entified for inc i dental oral exposure. The only e n dpoint t h at could be identified was for chronic dietary expo s ure. The chronic dietary exposure esti m ates for food and drinking water are below the level of concern for the general U.S. population and for infants (<1 year), the most exposed subgroup.

No der m al, incidental oral, or inhalation toxicological endpoin t s attributable to short

- or inter m ediate

- term exposures have been identified, and long term residential exposure and chronic occupational exposure are n ot expected. Therefore, q uant i tative residential handler and

post

- application exposure assessments , occupational handler and post

- application exposure

assessments , and short

- and inter m e diate term aggregate assess m ents were not required. Chronic aggregate exposure (food and drinking water) was assessed but the resultant risk

esti m ates were not of concern, as stated abo v e.

It has not been deter m ined that flutolanil shares a common m echa n ism of toxicity w ith

other c h e m i cal s ; therefore a cu m ulative risk a ssess m ent was also not re q uired. Fl u t o l anil is further characterized as “not likely to be carcinogenic to hu m ans.”

Food Tolerances

Tolerances for flutolanil a r e established in 40 CFR §180.484 for residues of flutolanil, N

- (3

- ( 1

- m ethylethoxy) phenyl)

- 2

- (trifl u oro m ethyl) benza m ide, including its m etabolites and degradates, in or on commodities. T o lera n ces are esta b lished [ 40 CFR §180. 484(a)] on rice straw and hulls but are no longer required

, beca u se they are no longer considered significant feedstuffs for any livestock ( Table 1 Feedstuffs , June 2008) and should be re m oved. Based on

the OECD tolera n ce calculat i on procedures on peanut hay, including residues from both band and broadcast applications, the established tolerance of 15.0 ppm for peanut hay should be increased to 20.0 pp m . The tolerance of 0.1 ppm on turnip greens and the B rassica (cole) leafy vegetable group 5 should be increased to 0.20 pp m ; this is a reconsideration of previous

recom m endations, because detecta b le residues of parent were found in one field trial on m ustard

greens.

The US tolerance expression har m onizes with the Codex tolerance expression for

live s tock c o mmodities

, b ut not f or plants. The US tole r ance expres s i on f or pla n t and live s tock

commoditi e s is f l utolanil and its m etabolites c o n verted to 2

- ( t ri f l u o ro m ethyl) benz o i c acid and

calc u lated as flutola n il, whereas t h e Codex tol e rance expression for plants is flutolanil. For

ani m al commodities, t h e Codex tolerance ex p re s s i on is fl u t olanil and its transfor m ation products containing the 2

- (trifluoro m e thyl) benzoic acid moiety.

There are no Codex, Canadian, or Mexican M R Ls for peanuts, turnip greens, or the

Brassica (cole) leafy vegetables. Codex MRLs are established on rice grain, bran, and straw.

Codex and US tolerance levels are the sa m e for rice b ran a n d rice s t raw, but are d i fferent for ri c e grain, i.e., 7.0 ppm in the US co m pared to 2.0 for husked rice grain and 1.0 for polished rice grain for Codex. For livestock commodities, m ost C odex tole r ance le v els a re the s a m e as the US

tol e rance l e vels. However, the US t o lera n ces fo r the livestock liver and kidney are higher than

the Codex MRLs and cannot be harmonized.

7Human Incidents

The incide n t analyses of the Main a n d A ggregate Incide n t Data System (IDS) was updated in July 2013 to include the ti m e period January 1, 2008 to May 8, 2013, where there was one

incident reported that involved flutolanil that was part of a lawsuit and was not considered in this update. There were three incidents identified in Aggregate I D S that involve flutolanil, which were

cl a ssi fi ed as m i nor severity. T h e inci d ent a n alysis of t h e Nation al In s tit u te of Occupation a l Sa f ety
and Health Sentinel Event N oti f ic a tion S ystem for Occupational Risks (NIOSH SENSOR) was updated in July 2013 to include the ti m e period from 1998 to 2009. One incident was identified in SENSOR involving flutola n il. This case occurred in N ew York in 2006,

involved m ulti p le acti v e ingre d ients, and was m o derate in se v erity.

The curre n t incide n t analysis is consistent with the p r evious analysis. Based on the continued low frequency and severity of incident cases re ported for flutolanil, there does not appear to be a concern at this ti m e that wou l d warrant f u r t her investigati o n. The Agency will

continue to monitor the incide n t in fo r m ation a nd if a concern is triggered, additional analysis

will be con d ucted.

B. Env ironmental As s essment

The risk assess m ent evaluates risks to spec i es that are not subject to the E ndangered Species Act (ESA) and provides a screening level assess m ent for pote n tial risks to listed species

under the E SA. A sum m ary of the Agency’s env i ron m ental risk assess m ent for flutolanil is presented below. For detailed discussions of all aspects of the environ m ental risk assess m ent,
see the Draft Preliminary Environmental Fate and Ecological Risk Assessment for the Registration Review Combined with the Environmental Fate and Ecological Risk Assessment for Proposed Amendments to Certain Labels for F l utolanil published on March 28, 2014 in the public docket EPA

- HQ

- OPP

- 2008

- 0148, which can be accessed on http://www.regulations.gov/

. The Agency received one c o mm ent on the risk assess m en t from the Center for Biological Diversity (CBD) regarding consultation requirements under the Endangered Species Act (ESA), which did not result in any revisions to the assessment.

Ecological Risk Characteri z ation

Acute and chronic risk q uotie n t s exceeded l e vels of concern (LOC) for several taxa from

the use of flutolanil on a nu m ber of different use sites in accordance with current labels. In particular, acute and c h ronic LOCs were excee d ed for freshwater fish and estuarine/ m arine pelagic (in the water c o lu m n) a nd benthic invertebrates, as w e ll a s f or a q uatic no n

- v a scular plants and terrestrial d i c o t pla n t s.

Acute risk is below the level of concern (LOC) for estuarine/ m arine fish. However, there is uncertainty as to whether exposure could e x ceed the chronic LOC for estuarine/ m arine fish,

the ac u te a n d chronic LO Cs for freshwater pelag i c and benthic invertebrates, and the acute and

chronic L O Cs for birds and m a mm a ls. These u n certainties arise because definiti v e e n dpoints

were not reached in the relevant t oxicity studies due to lack of e f fects, and the true No Observed

Adverse Effect Concentrat i ons (NO AEC) fall so m e where above the highest treat m e n t
concentration. Esti m ated Environ m e ntal Co n centrations (E E C’s) m ay be above the non

definiti v e e n dpoint and s o there is t h e potential to exceed t h e LOC. These risks are explained in

8more detail below. The ran ge of risk quotie n t s ( R Q’s) for differ e nt s cenarios are pro v ided for each taxon in Appendix C.

Risk to Aquatic Organisms

Acute LOCs were exceeded for listed and non

- listed freshwater fish and aquatic phase

a m phibians for nursery uses and on orna m ental s

. The acute LOC was exceeded for o nly li s ted freshwater fish and aquatic phase amphibians for the turf use, and f or aeri a l application to peanuts and rice. Chro ni c risk LOCs were excee d ed for freshwater fish and aquatic p hase

a m phibians for rice and nursery and orna m entals uses, based on the chronic toxicity study which

showed red u ctions in le n gth, but no s i gnifica n t p h ysical/beha v ioral abnor m alities.

Acute and chronic risk LOCs were exceeded f o r listed and non

- list e d estuarine/ m arine pelagic and benthic invertebrates for most uses, including peanuts, rice, turf, and nurseries and

orna m entals. Flutolanil was shown to be at least one order of m agnitude more toxic to

estuarine/ m a rine inverte b rates than to freshwater inverte b rates on an acute and chronic basi s. It is highly ac u tely toxic to mysid shri m p, with 90% a nd 100% m o rtality seen at the two hi g hest test

concentrations. In the chronic shri m p study, a reduction in survival, weight, and the number of young was seen. Acute LOCs were also exceeded for listed estuarine/ m arine pelagic and benthic invertebrates for potatoes and s oybean; the listed and non

- listed chronic LOC was also exceeded for potatoes and soybean.

The LOC for acute listed and non

- listed fre s hwater inverte b rates is potentially e x ceeded

for nu rsery and orna m entals uses, and potentially exceeded f o r li s ted fres hw ater in v ertebrates for rice. In the acute pelagic test an EC 5 0 was not re ac hed at t h e li m it of solubility f or f l ut o l anil, resulting in non

- definitive endpoints. However, mortality did reach 45% at that concentration. In the chronic pelagic toxicity study, length, ti m e to first brood, and nu m b e r young were all significa n tly reduce d ; t h e LOC f o r listed and no n

- li s ted c h ro n i c freshwater invertebrates was

exceeded f o r rice and n u rseries and o rna m entals. No effects were seen in b enthic fres hw ater
invertebrate acute studies and endpoints were non

- definitive; however, the m agnitude the EECs for nursery and orna m ental uses is s u ch that a potential LOC exceedan c e could be po s sible. The

LOCs for risks to chronic benthic invertebrates is also exceeded when using pore water EECs for nursery and orna m ental uses.

No m ortality was observed in the acute study f o r estuarine and m arine fish, but sublethal

effects were seen at the two highest test concentrations. A chronic study is not available; however, a potential for chronic risk exists f or es tua r ine/ m arine fish based on behavioral effects in the acute study and the esta b lish m ent of a chronic NOAEC in t h e freshwater chronic study.

Risk to Ter r estri a l Org a nisms

Flutola n il is practic a lly n on

- toxic to birds on acute oral and subacute dietary basis. The

oral toxicity and dieta r y studies in bobwhite and m allard s howed no m ortality, no other effects,

and had non

- definitive endpoints. H owever, the m agnitude of the screen i ng

- level EECs for turf and nursery uses is g reat enough that these exposu r es have t h e potential to exceed listed and non

listed LOCs if there would be m orta lity to birds at exposures greater than the highest tested in the acute toxicity studies. T here are chronic RQ exceedances of the listed a n d non

- listed LOC for turf

and nur s ery uses. T h ere is a definiti v e NOAEC from the bobwhite reproduction s t udy showing

9no effects other than a slight reduction in nu m ber of eggs laid, which is biologically m eaningful.

The m allard reproduction study showed a statistically sign i ficant reduction in eggshell thickness

at the highest c oncentration tested. Birds also serve a s a surrog a te for reptiles and terrestrial phase amphibians, to which these results also apply.

Flutola n il is practic a lly n on

- toxic to m a mmals on an oral acute ba s is, and there were no reproductive effects. Endpoints were non

- definitive, but as with b i rds, the screening

- level EECs for turf and nursery and orna m entals were great enough that there is a potential that acute and

chronic L O Cs could be exceeded.

Flutolanil is practically non

- toxic to insects, based on an a cute contact toxicity study with adult honeybees. However, data are not available to evaluate the potential effects to larvae, or

chronic risk to adult insects.

Risk to Plants

For terrestrial pla n ts, t h e seedling eme r gence study showed significant effect s on

e m ergence, survival, and height, with dicots being slightly more sensitive than m ono c ots.

However so m e species tested showed pro m otion of e m ergence. The vegetative vigor study also generally showed pro m otion of survival and height, and weight in so m e species or no reduction

in survi v al f or dic o ts, a n d therefore n o definiti v e endpoint c o uld be deter m ined based on lack of toxicity. For m onocots there were effects at the lowest and highest treatment concentrations and so a definitive endpoint could not be deter m ined, and risk could not be esti m ated. EPA’s LOC is

exceeded f o r listed and nonlisted terrestrial pla n ts from the use on turf a n d nursery stock.

For aquatic vascular and non

- vascular pla n ts, the endpoints w ere non

- d efiniti v e for all species tested. There were sign i ficant reductions in frond/cell c ounts at a single concentration exposure that was greater than the solubility li m it for flutolanil, used in all studies except the

freshwater diato m . However, the EECs for listed aquatic nonvascular plants potentially exceed the acute LOC for at least rice and nursery uses, and potentially for other uses as well. There

were no LOC exceedances for listed a q uatic v ascular pla n ts, b u t so m e uncertai n ty due to

scree n ing

- level EECs greater t h an the non

- definiti v e endp o ints. There are no LOC exceedances

for nonlisted aquatic vascular plants.

Ecological Risk Asses s ment Unce r tainties

Exposure

Exposure to aquatic ani m als and plants in a q uatic environ m ents were m o deled with the

P esti c ide R oot Z one M odel and E x posure A nalysis M odeling S ystem (PRZM/EXAMS) and the Pesticides in Flooded Applications Model (PFAM) to provide esti m ated environ m ental

c o ncent r atio n s (EECs) which were compared to toxicity v a lues to calculate risk. A number of

conservative assu m ptions w ere included in this T i er 1 risk assess m ent. EECs are based on

m aximum labeled single use rates, which are likely lower based on typical use infor m ation (BEAD, 8 / 8/2014). For exa m ple, t h e ave r a g e a p p lic a t ion rate for peanuts is 0.4 pounds of active ingred i ent (lbs a .i

. ) per a c re
, 0.5 l bs. a .i . for potatoes ( f oliar and seed) and 0.3 lbs. a.i. for r i ce (2008

- 20 12, EPA Propri e tary Data) . For aquatic m odeling, the risk assess m ent assu m ed between

0.742

- 2.00 lbs a.i/acre for peanuts, 0.36 (see d )

- 0.77 lbs a.i./acre for potatoes, and 0.490

- 0.980 lbs

10a.i./acre for rice. A l so, since t h e che m ical shows m edium to high pest resi s t a n ce (as indicated by Fungicide Resistance Action Com m ittee for che m icals in Group 7), it m ay not be applied every year to rice as simulated in the exposure model

.

Also, field dissipation studies with flutolanil point towards lower persistence than noted

from the results of PRZM/EXAMS. Since there is only one, instead of two, sedi m ents in the aquatic m etabolism study, and th e study only exa m i n es short ti m e durations, the results were

extrap o l ate d , introd u cing a 3X uncertainty fact o r into the aq ua tic m odeling results. Fi n ally, the standard pond used in P RZM/EXAMS does not include flow or turnover, a m ong other things,

which m ay r e m ove part of the flutolanil received in the pond.

The bioavailability of flutola n il in a q uatic m edia is unce r t a in due to low to m oderate

recoveries of the test m aterial and precipitate observed in so m e studies; this could underesti m ate risk to aquatic organis m s.

Nursery Use

The risks calculated from use of flutolanil on nursery stock are likely overesti m ated. It is

lik e l y th a t f or the nu r sery scena r io, t h ere is lower persistence than what was m odeled using the standard input para m eters. Considering lower per s iste n ce, t h e FL nursery (soil d renc h ) scena r ios yield acute and chronic RQs t h at are approxi m ately 2.3 fold less than those derived from standard input para m eters. Acute and chronic r i sk to est u ari ne / m arine inv e rteb r at e s r e m ains above the listed and nonlisted LOC for both uses including these m odified para m eters, but acute and

chronic risk to all oth e r assessed taxa falls below the nonlisted level of concern.

Turf Use

As a refin e m ent for the turf use for risk to est ua rin e / m arine inve r t ebr a t e s, the sp r ay dri f t value was decreased considering the buffer zone of 100 feet towards freshwater bodies of water for ground applications currently on most labels, decreasing EECs. The buffer m ay also decrease

EEC’s further due to reducti ons in runoff, which cannot be quantified. However when co m pared

to the a v ailable ac u te a n d chronic t o xicity d a ta f or estuarine/ m arine pelagic and benthic invertebrates, the refined scenari o s of exposure resulted in R Q s that were very si m ilar to those

tha t were esti m ated without the use of a buffer zone.

Ecological Incidents

An October 2013 search of OPP’s E c ological Incident Information System of all years of available data up until October 2013 resulted in one incident of yellowing and stunting of oats, which was classified as “unlikely” to be due to flutolanil exposure. No incidents were found in

the Incident Database S y ste m , of all years of available d ata up until Octo b er 2013. There were

no bird incidents in the Avian Incident Monitoring System d atabase maintained by the A m erican Bird Conservancy , of all years of ava i lable data up until O ctober 2013.

Endangered Species Assessment

Consistent with EPA’s responsibility under the Endangered Species Act (ESA), the Agency will evaluate risks to federally listed threatened and endangered (listed) species from registered uses of pesticides in accordance with the Joint Interim Approaches de veloped to implement the

11recommendations of the April 2013 National Academy of Sciences (NAS) report, Assessing Risks to Endangered and Threatened Species from Pesticides

. The NAS report 3 outlines recommendations on specific scientific and technical issues related to the development of 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 flutolanil in connection with the development of its final registration review decision for flutolanil

.

In November 2013, EPA, the U.S. Fish and Wildlife Service, National Marine Fisheries Services (the Services), and the U.S. Department of Agriculture released a white paper containing a summary of their joint Interim Approaches for assessing risks to listed species from pesticides. These Interim Approaches were developed jointly by the agencies in response to the NAS recommendations, and reflect a comm on approach to risk assessment shared by the agencies as a way of addressing scientific differences between the EPA and the Services. Details of the joint Interim Approaches are contained in the November 1, 2013 white paper

, Interim Approaches for

Nationa l

- Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the National Academy of Sciences April 2013 Report. 4

Given that the agencies are continuing to develop and work toward implementation of the Interim Approaches to assess the potential risks of pesticides to listed species and their designated critical habitat, the ecological risk assessment supporting this Interim Registration Review Decision for flutolanil does not contain a complete ESA analysis, including effects determ inations for specific listed species or designated critical habitat. While the agencies continue to develop a common method for ESA analysis, the preliminary risk assessment for the registration review of

flutolanil describes the level of ESA analysis com pleted for this particular registration review case. This assessment will allow EPA to focus its future evaluations on the types of species where the potential for effects exists, once the scientific methods being developed by the agencies have been fully vetted. Once the agencies have fully developed and implemented the scientific methods necessary to complete risk assessments for listed species and their designated critical habitats, these methods will be applied to subsequent analyses of flutolanil as pa rt of completing this registration

review.

C. Endocrine Disruptor Screening Program

As required by FIFRA a nd FFDCA, EPA reviews nu m erous studies to assess potential

adverse outco m es from e xposure to che m icals. Collectively, these studies include acute,

subchronic and chronic toxic i ty, including assess m ents of carcinogenicity, neurotoxicity, develop m ental, reproductive, and general or sys t e m ic toxicity. These studies include endpoints

which m ay be susceptible to endocrine influen c e, including effects on endocrine target organ histopathology, organ weights, e s trus cyclicity, sexual m aturation, fertility, pregnancy rates, reproductive loss, and sex ratios in o f fspring. For ecological h azard ass e ss m ents, EPA

evaluates acute tests and chronic studies that as sess growth, develop m e n tal and reproductive

effects in different ta x ono m i c gro u ps. As part of its m ost recent regi s t ration deci s i o n for flutolanil, EPA reviewed these data and selec t ed the m ost sensitive endpoints for relevant risk

assess m ent scenarios fr om the existing hazard database. However, as required by F FDCA section 408(p), flutolanil is subject to the endocrine screening part of the Endocrine Disruptor

3 http://www.nap.edu/catalog/1834 4

4 http://www.epa.gov/espp/2013/nas.html 12Screening Program (EDSP).

EPA has developed the EDSP to deter m ine whether certain substances (including pesticide active and other ingredi e nts) m ay have an effect in h u m ans or wildli f e s i m i lar to an effect produced by a “naturally occurring est r ogen, or other such endocrine effects as the

Ad m i nistrator m ay designate.” The EDSP e m p l oys a two

- tiere d approach to m aking the statutorily required deter m inations. Tier 1 consists of a battery of 11 screening assays to identify the pote n tial of a che m ical substance to interact w ith the estrogen, androgen, or thyroid (E, A, or T) hor m onal syste m s. Che m ical s that go through Tier 1 screening and are found to have the potential to inter a ct with E, A, or T hor m onal syste m s will proceed to the next stage of the EDSP

where EPA will deter m ine which, if any, of the T i er 2 tests are neces s ary based on the available data. Tier 2 testing is designed to identify any adverse endoc r ine

- r el a ted eff ects caus e d by the substance, and establish a dose

- r e sponse relationship between the do s e and the E, A, or T effect.

Under FFDCA section 408(p), the Agency m ust screen all pesti cide che m icals. Between October 2009 and February 2010, EPA issued test orders/data call

- ins for the first group of 67

che m icals, which contains 58 pes t icide active ingredients and 9 inert ingredients. A second list of

che m icals identified for EDSP sc r een ing was published on June 14, 2013 1 and includes so m e pesticides scheduled for r eg i stration r eview and che m icals found in water. For further

infor m ation on the status of the EDSP, the policies and procedures, the lists of che m icals, future
lists, the test guidelines and the Tier 1 screening battery, plea s e visit our website

. 2

Flutolanil is on List 1 for whi c h EPA has re c eived all the req u ired Tier 1 assay data. The Agency is currently reviewing all of the assay d a ta received for the ap p r o priate Li s t 1 che m icals and planning to m ake the conclusions of those reviews available during 2015.

In this interim decision, EPA is m aking no hu m an health or environ m ental safety

findi n gs associated with the ED SP screening of flutolanil. Before co m pleting this

r egist r ation r eview, the Agency will m ake an EDSP FFDCA section 4 0 8(p) deter m ination.



### IV. Interim Registration Review Decision

In acc o rda n ce with 40 C FR Sections 155.56 and 155.58, the Agency is issuing this

interim registration review decision docu m ent for flutolanil. Except for the EDSP and ESA

co m ponents of the flutolanil registration review case, t h e Agency has m ade the following

1 See h tt p :// w w w .reg u l ati on s. g o v /#! do c u m en t D etail; D =EP A

- H Q

- O PPT

- 2 0 09

- 04 7 7

- 007 4 for t h e f i n al sec o nd list o f

che m icals.

2 h tt p ://www.epa.g ov /e n d o /

13i n terim decisi o n: (1) no a d ditio n al data are required at t h is ti m e; and (2) c h anges are required

to f l utolanil product labels.

Pending consideration under the Endocrine D is r u ptor Screening Progra m , the Agency has

identified no hu m an dietary, residential, oc c upational, or aggregate risks of concern for flutolanil.

T he qualitative risk assess m ent per f or m ed in support of the re gistration review of flutolanil supports this concl u sion in co m pliance with the m ost updated Agency science policies and hu m an health risk assess m ent methodologies. As a result, no revision of fluto lanil labels is currently necessary to address a ny hu m an health risk concerns.

The proposed m itigation focuses on ecological ri s k to est u ari n e and m arine invertebrates,

the taxon for which there were the m ost ac u te a n d chronic risk exceedances, and also on risk to freshwater fish. Peanuts and potat o es are t h e p r o m inent use sites for flutolanil, accounting for more than 99% of flutolanil usage in the U.S. between 2008

- 2012. These uses also had the lowest RQ’s and LOC exceedances. The rice u se is the lea s t pro m inent, with PCT with flutola n il

less than 1%.

For the peanut use, the predo m inant use of f l utolanil, RQs are at t h e acute LOC from drift and runoff for listed freshwater fish (acute), and above the LOCs for listed and non

- listed

estuarine/ m a rine inverte b rates (ac u te and chron i c) in the water colu m n and the benth o s. The highest RQs correspond to aerial applications, and the LOC e x ceedance for listed freshwater fish is only for aerial application. However, 95% of t h e applied flutolanil to peanuts was via ground application, with only 5% applied aerially (BEAD, 8/8/2014). According to the registrant, the aerial application is used when the fields are too wet to apply flutolanil via ground application.

Acute and chronic RQ s also exceed LOCs for estu a r ine/ m arine inv e rte br ates in the w ater
colu m n and the benthos for potato and soybean uses, although these exc e edances are m arginal.

The acute LO C exceedances are for listed e s tuarine/ m arine i n verte b rates only, while the chronic

LOC exceedances are for bot h listed and non

- listed estuarine/ m arine invertebrates. Acute and chronic RQs for listed and non

- listed freshwater fish, and for listed and nonlisted estuarine and

m arine invertebrates in the water colu m n and b e nthos, were also exceeded for turf, rice, and

nursery uses.

In order to reduce offsite exposure f rom spray drift, the registrant with all of the flutolanil turf and nursery use registrations, Bayer Environ m ental Science, has agreed to change their labels

to r e q uire ap p li c ators to use a Medium drople t size spect r um or coarser for all uses of flutolanil, as defined by the A m erican Socie t y of Agricultural a nd Biological Engineers (ASABE) standard 572. Nichino, the registrant with all of the peanut use registrations, has agreed to this droplet size

restriction for the ae r ial appli c ation to peanuts. The highest RQs are f or aeri a l a p plic a tions, w hich

accou n ts for 5% of flutolanil applic a tion to peanuts, with 95% of the applied flutolanil to pe a nuts was via ground applicatio n

. The proposed label changes requiring at least a Medium droplet size

spectrum should reduce t h e m ass of flutolanil that m i ght drift from applications to all use sites and should reduce the pot e ntial for risk to all non

- target organis m s off of treated fields.

14In addition to the spray drift restrictions described above, Bayer Environ m ental Science has agr e ed that all t u rf labels f or f l utolanil will i n clude a 10 0

- f oot bu ff er from turf applic a tions to

estuarine or m arine habitat, and to ditches, drainage tiles, or o t her water w ays that drain directly into (within 1⁄2 m ile of) estuaries and m arine habitats. Such language is currently on so m e of the flutolanil turf use labels, but so m e are currently m i ssing this languag e . The ecological risk

assess m ent considered the effe ct a 100

- foot buffer would have on spray

- drift exposure to

estuarine a n d m arine in v erte b rates, b ut was not able to quantify the resulting reduction of

f l utolanil tr a nsport in ru n o ff . It is cle a r, however, that extendi n g this m itig a tion to all t u rf labels

should reduce to so m e extent the overall m ass of flutolanil reaching estuaries from use on turf.

Si m ilarly, t h e rice use had so m e of the highest predicted exposure for aquatic organis m s of all registered uses of flutolanil. However, cur r ent label language prohibits the use of flutolanil appli c ation within 3 m iles of any estuarin e / m arine waterway or watershed, which was not

accounted f or quantitatively in calculating RQs. EECs are likely overesti m ated and so all RQs

that e x ceeded the LOCs for the use o n ric e are also likely to b e overesti m ated. Althou g h flutolanil does not degrade readily under m ost t e sting conditions, field studies did not show very high persistence overall. Aquatic m etabolis m , dilution, and binding to sedi m ents and particulate

in the course of a 3

- m ile travel to encounter an estuarine/ m arine body of water will contribute to the dissipation of flutolanil. In addition, b a sed on usage infor m ation over the years 2008

- 2012, the use on rice has decreased sig n ificantly, to only <1% of PCT w it h flutolanil. Therefore, EPA is not prop o sing any f urther m itigation f or the u s e of f l utola n il on r i ce.

Finally, Bayer Environ m ental Science has agreed that a ll of t h eir f l ut o l anil labels with

uses on orna m ental nursery stock will only allow four applications per year. This language is currently m i ssing from one of their orna m ental nursery

- use labels. The nursery uses had the large s t LOC exceedances for m ost taxa in the ri s k assess m ent, but EECs can be refi n ed when considering nursery practice . For example, if the m ax i m u m rate w e re u s ed f or f oliar a p plic a tion

then a m aximum annual application would be 2.1 lb; for container nurseries, there could be 2.93 lb ai per acre if all pots were treated (BEAD 8/8/2014). This is co m pared to use rates of 9.78 lbs (ground application) to 21.5 lbs (soil drench) used in the risk assess m ent. In addition, as described above, the calculated exposure from the nursery use m ay have b e en overesti m ated due to the persistence of flutolanil si m ulated in e xposure m odeli ng. As a result, the Agency is not pursuing a d ditio n al m itigation for u s e of flutola n il in n u rseries beyond th o se described above.

The Agency does not propose additional changes to flutolanil labels at this ti m e to address p o t e nti a l risk to bir d s and m ammals. The ecolo g i cal risk a s sess m ent in d i cated that a potential for LOC exceedances re m a ined due to high screening

- lev e l EECs for turf and nursery stock. However, the RQs that suggest this possi b ility for acute and chronic risk to m am m als and

acute risk to birds are deriv e d from st udies in which no tox i c effects were observed, w hich

m akes the potential for risk highly uncertain.

Screenin g

- level chro n i c RQs for birds exceeded the LOC for several t u rf uses and for use in nurseries, but the potential for and extent of possible risk is uncerta i n. T he m ag nitude of the RQs is less than twice the LOC for most of these uses, and so our modeling suggests exposures of concern would not extend beyond the treated field, and that RQs calculated with ty pical

instead of m ax i m u m screening E ECs would be below the level of concern for m o s t uses. In addition, the highest of the RQs which exceed t h e chronic LOC are for s m all birds consu m ing only short g rass, which would represent a very s m all portion of potential l y exposed birds.

15Final l y, birds would not likely derive all of their food from so m e of the use sites mod e led, such as golf tees, greens and aprons, and nurseries. Nonetheless, the spray droplet

- s ize restrictions that are proposed to be incorporat ed on flutolanil product labels should reduce off

- site transport of flutolanil, and should reduce the potential for chronic risk to birds.

The Agency does not propose additional changes to flutolanil labels at this ti m e to address p o t e nti a l risk to terre s t r i al p l a nts. The sc re ening le v el r i sk ass e ss m ent res u lted in risk quotients for non

- listed, se m i

- aquatic plants at t h e LOC of 1.0 for golf

- cou r se fairways and the highest calculated application rate for nurseries. As indicated above, this m axi m u m r ate use d in

the risk assess m ent m ay not refle c t actual nursery practices, suggesting that the risk quotient at

the LOC m a y well be an overesti m ate. In addition, the m odel used to esti m ate potential exposure

to se m i

- aquatic p l ants o nly consi d ers areas d i rectly a d jace n t to the tre a ted area, ass u m i ng a set

a m ount of r unoff that does not take local soil a n d weather c o nditions into account. Finally, the RQ at the non

- listed plant LOC was based on t h e most sensitive pla n t tested, and m ay not

repre s ent all plants well; flutolanil actually e nha n ced see d ling e m ergence and vegetative vigor in

a nu m ber of plant species tested. Nonetheless, the spray droplet

- size restrictions and buffer from aquatic features for turf applications that are proposed to be incorporated on flutol anil product

labels should reduce off

- site transport of fluto l anil, which will further reduce the potential for

risk to se m i

- aquatic plants. These m easures cou l d also reduce the potential for exposure to listed plants, for w hich the risk assess m ent indicated s o m e LOC exceedances. T he exte n t to which any listed pla n ts m i ght be exposed will b e deter m ined in future consultation on flutolanil with the

Fish and W i ldli f e Ser v i c e.

The Agency also does n ot propose additio n al c h ang e s to flutolanil labels at t h is ti m e to address p o t e nti a l risk to aquat i c plants. Most vascular and non

- vascular plants tested had no toxicity endpoint established at co nc entrations t h at in d i cate n o r i sk at the screening level. There

is unce r t a inty associ a t ed with RQs f o r the m o st s e nsiti v e aqu a tic pla n t t e st e d, a f reshwater

diato m . However, while these RQs were based on a study in which some effects to the diato m s were observed, the effects were not sufficient to establish a toxicity endpoint for the risk

assess m ent. Nonetheless, as with other aquatic taxa, the spray droplet

- size restrictions and buffer

from aquatic features for turf applications that are proposed to be incorporated on flutolanil product labels should reduce off

- site transport of flutolanil, which should f urther reduce the potential for risk to aqu a tic p l ants.

In the interim, EPA is making no hu m an h ealth or environ m ental safety findings

associated w ith the EDSP screening of flutolanil. W hile the risk assess m e nt supporting this

Interim Registration Review Decisi on evaluates risks to species that are not subject to the ESA, it is pre m ature to m ake ef f ects d e ter m inations f or li s ted spe c ies u ntil the i n te r i m approaches developed in response to the National Acade m y of Science (NAS) April 2013 report are vetted;

there fore, E P A has not completed effects d e ter m inations f or li s ted spe c ies a ssoci a t ed with the registered u ses o f flutolanil. Therefore, consultation w ith the Fi s h and W ildli f e Service and National Marine Fisheries Service (the Serv i ces) on t h e p otential risk of f l utolanil to li s ted species will be necessar y

. In addition, risk to pollinators has not been assessed.

The Agency is iss ui ng a n interim registration re v i ew decision pending the evaluation of potential endocrine disruptor risk, c onsultation with the Services , and an assessment of risk to pollinators . Be f ore completing this r egist r ation r eview, the Agency will m ake an EDSP FFDCA

section 408(p) deter m ination and an endangered species effects deter m ination under the ESA.

16The Agency is issuing a n Interim Registration Review Decision pen d ing co m pletion of the ESA

and EDSP assess m ents, as well as an assessment of non

- target exposure to pollinators. As the Age ncy works toward implementing its Guidance for Assessing Pesticide Risks to Bees http://www2.epa.gov/pollinator

- protection/pollinator

- risk

- assessment

- guidance , additional data may be required for flutola nil to assess non

- target exposure to bees.



### V. Next Steps and Timeline

A. Registration Review Decision

A final decision on the flutolanil registration review case will occur after an ESA and

EDSP FFDCA section 408(p) determination have been made.

B. Implementation of Mitigation Measures

Registrants will need to su b m it proposed a m ended labels that i n clude t h e a g reed

- upon end use product risk m iti g ation and sub m it them to the Age n cy wit h in 6 0 days of issuance of the

Interim Registration Review Decision. The m itigation m easures and label a m end m ents are
d escri b ed in Appendix A and B.

17Appendix A: Summa r y of Pr o posed Actions Taken for Flutolanil

Registration Review Case# : 7010

P C Code: 128975

Chemical Ty p e: F u ngicide

Chemical F a mily: phenyl

‐ benz a mide (benzanil i de)

M o de o f Action: succinat e

‐ dehydrog en ase respiration inhibitor ( S DHI)

Affected Population( s ) Source o f E xpo sure Route o f Exposure Duration of
Exposure Risk( s ) o f Concern Action(s) Ta k en Comments

Freshwater fish Water (dir e ct cont a ct, no n

‐ dietary) Ingestion

Dermal absorption Acute

Chronic Acute Tox i city

Chronic to x ic i ty

‐ growth Buffer

Specify Med i um or larger dropl e t size

Restri c t nu m ber of applications Buffer o n T u rf

uses for estuary
and mari n e habitats.

Med i um

‐ large droplet size to
reduce spray drift to aquatic

habitats on turf, ornamental,

and aerial

peanut applications

.

Restri c t applications per

year to
ornamental planti n gs. Aquat i c Inve r tebrates

estuarine/m a rine Water (dir e ct cont a ct, no n

‐ dietary) Ingestion

Dermal absorption Acute

Chronic Acute Tox i city

Chronic to x ic i ty

‐ reproduction

18Appendix B: Flutolanil Label Table

Sum m a ry o f Pro p osed L ab eling C h a ng e s f o r Fl u to l anil Uses

Descr i p ti o n Lab e ling L an gu a ge f o r F l utolanil Turf and Ornamental End Use Pr o d ucts Place m ent o n Label

Use Restric tions

– Prod u cts la b eled for turf

a n d or n a m e n t a ls “F o r use rates ov e r 3 oz. p e r 1 00 0 s q ft, do not ap ply wit h i n 1 0 0 feet of a n y est u a ry o r m arine h a bitat or wit h i n 1 0 0 f eet

o f a n y d itc h es, d ra i n a g e tiles, o r o t h er waterways t h at d ra i n d irectly i n to (wit h in 1⁄2 m ile) est u aries and mari n e h a b itats.

“ A p ply n o m o re t h an a c o m b i n ed t o tal of 6 o z

. p e r 1 0 0 0 sq u a re feet a s a b ro adcast a pplication d u r i ng a s i ngle g r o wi n g

season ” or similar statement Use

Restrictions

section

f o llowing

Directions for use

secti o n

Directions for Use

Prod u cts la b eled for turf

a n d or n a m e n t a ls

“Make no m o re than 4 appli c ations of (product) per year t o orna m ental plantings.” After G e n e ral

I n f o r m ation o n Gr een h o u se/Sa r an and s h ade

h o use / Ou t d o o r Contain e r/Field

G r o w n O rna m ental

N u rsery St o c k

Sp r ay D rift Ma nage m ent “S p ray e q uip m ent a n d weath e r affect s p ray drift. C ons i d er a ll factors w h e n m aking a p pli c ation decisi o n s

. Wh e re states
h a v e m o re str i ng e n t reg u latio n s, t h ey m u st be o b ser v e d

. Av o i d ing spray drift is t h e respo n si b ility o f t h e a pp licator o r

g r o w er. To red u ce t h e p o te n tial for d rift, t h e a pp lication e q ui p m e n t m u st b e set to ap p ly Me d i u m o r lar g er dro p lets (i.e.

A S ABE Sta n dard 57 2 ) w it h c o r r es p on d in g s p ray p r essu re. Use h i g h fl o w ra t e n o zzle s t o a pp ly t h e h i ghes t p r actical

spray v o l u m e, usi n g t h e a p pr o p riate d r o p let size to e n s u re a d e q uate c an o p y distri b u ti o n
, cov e r a ge, an d pene t rati o n

. W i t h m o st n o zzle ty p es, n arrow s p ray an g les prod u ce lar g er dro p lets. F o llow t h e n o zzle m a n u facturer’s directi on s on

pres su re, o rie n tation, s p ray v o l u m e, etc., in o r der to m ini m ize drift a n d op ti m ize cov e ra g e a n d c on t rol.” Directi o ns f o r Use

Description Labeling Language for Flutolanil End Use Peanut Products with aerial application

Spray Drift Management “Spray equipment and weather affect spray drift. Consider all factors when making application decisions. Where states have more stringent regulations, they must be observed. Avoiding spray drift is the responsibility of the applicato r or grower. To reduce the potential for drift, the application equipment must be set to apply Medium or larger droplets (i.e. ASABE Standard 572) with corresponding spray pressure. Use high flow rate nozzles to apply the highest practical spray volume, us ing the appropriate droplet size to ensure adequate canopy distribution, coverage, and penetration. With most nozzle types, narrow spray angles produce larger droplets. Follow the nozzle manufacturer’s directions on pressure, orientation, spray volume, etc ., in order to minimize drift and optimize coverage and control.” Directions for Use

19

### Appendix C: Risk Quotient Ranges

FW fish FW

invertebrates E/M Fis h 3 E/M

invertebrates FW benthic

invertebrates E/M benthic

invertebrates Birds M a mmals Terrestrial plants N o n

vas c ular aquatic plants

Use
(inclusive o f

a ll

scenar i o s)Acute RQChronic RQAcute RQChronic RQAcute RQChronicAcute RQChronic RQAcute RQChronic RQAcute RQChronic RQAcute RQChronic RQAcute RQChronic RQListed AcuteNon-listedAcuteNon-ListedAcute

Peanuts 0

. 05 0

. 2 3

- 0

. 99 2

. 6 4

- 1 1 .2 0

. 2 2

- 0

. 94 2

. 5 5

- 1 0 .8 <0.12

- 0

. 38

Potato 0

. 0 6

- 0

. 23 1

. 1 0

- 2

. 65 0

. 0 6

- 0

. 23 1

. 0 9

- 2

. 60

Cotton

So y b ean 0

. 15 1

. 74 0

. 14 1

. 65

Sugar beet

Rice 0

. 3 3

- 0

. 46 1

. 5 9

- 1

. 96 <0.12

- 0

. 17 4

. 0 8

- 8

. 70 6

. 3 8

- 8

. 69 4 6

. 2

- 5 7 .4 1

. 7 3

- 2

. 27 1 9

. 8

- 2 6 .1 >1

. 0 4

- 1

. 45

Turf 0

. 0 7

- 0

. 09 1

. 3 1

- 1

. 67 1 4

. 9

- 1 8 .9 1

. 2 1

- 1

. 57 1 3

. 9

- 1 8 .1 <0.12

- 5

. 03 1

. 0 6

- 3

. 31 <

. 0 1 0

- 0 .28 1

. 0 9

- 2

. 71 1

. 01

Nurs e ry stock 0

. 8 7

- 1

. 88 9

. 8 6

- 2 0 .59 <0.32

- 0

. 69 1

. 0 7

- 1

. 22 1 6

. 7

- 3 6 .1 1 91

- 4 08 <0.3

- 0

. 63 3

. 7 9

- 8

. 08 1 5

. 5

- 3 2 .9 1 78

- 3 79 <0.10

- 5

. 65 1

. 4 6

- 3

. 72 <0.12

- 0

. 31 <1.04

- 3

. 10 1

. 0 9

- 2

. 72 1

. 01 >2.88

- 5

. 86

Bolded val u es represe n t an LOC exceedance. Italicized values represent a “potential” LOC exceedance.

3 Ac u te and c h r on ic risk to est u ar i n e/ m ari n e fish was no t estimated as t h ere were no m o rtalities in t h e ac u te stu d y up t o s o lu b i l ity l i mit a n d no chro n ic fish stu d y is a v aila b le. An ac u te

- to

- c h r o n ic ratio (ACR) was no t u tilized to esti m a te c h ro n ic to x icity as t h ere is a h igh le v el of u n cert a i n ty in usi n g an ACR with a no n

d e fi n i t i v e ac u te to x icity e n dp o i n t. 20