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### Table of Contents

Contents

I. Introduction .................................................................................................................. ........... 3

II. Use and Usage/Background ................................................................................................. ..... 5

III. Scientific Assessments ........................................................................................................ . 5

A. Human Health Assessment .................................................................................................... 5

Hazard Characterization and Risk .......................................................................................... 5

Food Tolerances ............................................................................................................... ....... 6

Human Incidents ............................................................................................................... ...... 6

B. Environmental Assessment .................................................................................................. . 7

Ecological Risk Characterization ............................................................................................ 7

Ecological Risk Assessment Uncertainties ............................................................................. 9

Ecological Incidents .......................................................................................................... .... 10

Endangered Species Assessment .......................................................................................... 10

C. Endocrine Disruptor Screening Program ............................................................................. 11

IV. Proposed Interim Registrati on Review Decision ............................................................... 12

IV. Next Steps and Timeline .................................................................................................... 16

Appendix A: Summary of Proposed Actions Taken for Flutolanil ............................................. 17

Appendix B: Flutol anil Label Table ........................................................................................... . 18

Appendix C: Risk Quotient Ranges ............................................................................................. 193 

### I. Introduction

This document is the Environmental Prot ection Agency’s (EPA or the Agency) Proposed 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 determination whether a pesticide meets, or does not meet, the standard for registration in the Federal Insecticide, Fungicide, and R odenticide Act (FIFRA). The Agency may issue, when it determines it to be appropriate, a proposed interim registration review decision before completing a registration review. Among other thi ngs, the proposed interim registration review decision may require new risk mitigation measures, impose interim risk mitigation measures, identify data or information required to co mplete the review, and include schedules for submitting the required data, conducting the new risk assessment and completing the registration review. For further information on flutolanil, additional documents can be found in EPA’s public docket (EPA-HQ-OPP-2008-0148) at www.regulations.gov

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FIFRA, as amended by the Food Quality Pr otection Act (FQPA) of 1996, mandated the continuous review of existing pest icides. All pesticides distributed or sold in the United States generally must be registered by the EPA based on sc ientific data showing that they will not cause

unreasonable risks to human health or to the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess and reduce risk evolves and as polic ies and practices change, all regi stered pesticides continue to meet the statutory standard of no unreasonable a dverse effects. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency periodically reevaluates pes ticides to make sure that as these changes occur, products in the marketplace can continue to be used safely. Information on this program is provided as www.epa.gov/oppsrrd1/registration_review/

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In 2006, the Agency implemented the regist ration review program pursuant to FIFRA section 3(g) and will review each registered pesticide every 15 years to determine whether it

continues to meet the FIFR A standard for registration.

Flutolanil is a systemic fungicide first registered by EPA in 1993. Because it was registered after November 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 treatments on potato, co tton, sugar beet and soybean) and non-food sites (turf, greenhouse, field-grown and potted ornamentals). Flutol anil forms a protective barrier on the plant, enters the plant, and moves upw ard in the xylem. Flutolanil has both protective and curative activity.

Pursuant to 40 CFR section 155.50, EPA forma lly initiated registration review for flutolanil (case # 7010). The following highlights signi ficant events that ha ve occurred during the registration review of flutolanil:

 September 15, 2008– Publication of Flutolanil Summary Document for a 60-day public comment period. The Summary Document incl uded the Preliminary Work Plan (PWP) and was accompanied by the scoping document and problem formulation.4  February 5, 2009- Final Work Plan (FWP) for flutolanil was issued. One public comment was received during the 60-day co mment period for the flutolanil PWP but it did not change the risk assessments needed, data n eeds or the timeline in the PWP. The FWP did modify the PWP to remove the analytical standard s data requirement for metabolites and to add the UV/Visible light absorption data requirement.

 April 7, 2010 – Generic Data Call-In Notice (GDCI) for flutolanil issued.

 March 28, 2014 – The Agency published the Draft Preliminary Environmental Fate and Ecological Risk Assessment for the Registration Review Combined with the Environmental Fate and Ecological Risk A ssessment for Proposed Amendments to Certain Labels for Flutolanil and the Flutolanil – Preliminary Human Health Risk Assessment for Registration Review and Hu man Health Risk Assessment for Label Amendments for Brassica (Cole) Leafy Vegetables (Crop Group 5), Turnip Greens, Rice, and Turf in Addition to Banded Applications on Peanuts for a 60-day public comment period. No comments were recei ved during the comment period.

 September 2014 – The Agency is now publishing the Flutolanil Proposed Interim Registration Review Decision in docket number EPA-HQ-OPP-2008-0148 for a 60-day public comment period.

Additional information on flutolanil can be found in EPA’s public docket, EPA-HQ-OPP2008-0148, accessed at www.regulations.gov

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### II. Use and Usage/Background

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

, potatoes,

rice and other crops (such as leafy vege tabl es, cole crops, and seed treatment for cotton, sugar beets, and soybean), turf, greenhouses, and ornamentals. Peanuts and potatoes are the prominent use sites for flutolanil, accounting for more 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 with flutolanil for peanuts and potatoes (foliar) was 15% and 10 %, respectively

, while for potato seed treatment PCT was 5% percent.

When compared with other registered fungic ides , flutolanil is a viable alternat i ve for

contro l of white mold, (caused by Sclerotium sp.) & limb / pod rot (caused by Rhizoctonia sp.) on

peanu ts

, Rhizoctonia diseases (scurf and blight) on potatoes (seed a nd foliar treatment), and

Rhizoctonia diseases on turf and ornamentals. For turf and ornamenta l uses of flutolanil as an succinate dehydrogenase inhibitor ( SDHI) fungicide is consider ed a useful partner that may be

alternated with other fung icide chemistries (such as demethylation i nhibitors (DMI) and quinone outside inhibitor (QoI) fungicides) to provide e ffective r esis tance management as well as

effective disease control. Fl uto lanil u se on turf and ornamentals is typica lly li mited to treatment

for Rhizoctonia diseases and as s u ch is hig hl y dependent on d i sease pressure in a g i ven season as well as typica l use patterns that involve spot treatments where pockets of disease may b e observed or anticipated.



### III. Scientific Assessments

A. Human Health Assessment

A summary of the Agency’s human health ri sk assessment is presented below. The Agency used the HED scoping document, its supporting documents, and the most updated Agency science policies and risk assessment methodologies to prepare a qualitative risk assessment, including a quantitative chronic diet ary assessment, in support of the registration

review of flutolanil. The most recent human h ealth risk assessment was conducted in February 2014. For a detailed discussion, see the Flutolanil – Preliminary Hu man Health Risk Assessment for Registration Review and Human Health Risk Assessment for Label Amendments for Brassica (Cole) 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 assessment.

Hazard Characterization and Risk

There are no dietary, residen tial, occupational, or aggr egate risks of concern for

flutolanil. Flutolanil has few biol ogically significant toxicological effects, which are mainly in the liver and gastrointestinal (GI) system. The flutolanil data do not i ndicate that it is neurotoxic, or that it targets the immune system, fetal deve lopment, or reproduction. No dermal effects were observed, and the subchronic inhalation study wa s waived based on a weight-of-evidence approach; therefore no toxicologi cal endpoints were established for any dermal or inhalation6 exposure duration. No hazard was identified for inci dental oral exposure. The only endpoint that could be identified was for chronic dietary expos ure. The chronic dietar y exposure estimates 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 dermal, incidental oral, or inhalation toxicological endpoint s attributable to short- or intermediate-term exposures have been identi fied, and long term residential exposure and chronic occupational exposure are not expected. Therefore, quanti tative residential handler, postapplication, occupational, and short- and interm ediate term aggregate assessments were not required. Chronic aggregate exposure (food and dr inking water) was assessed but the resultant

risk estimates were not of concern, as stated above.

It has not been determined that flutolanil shares a common mechan ism of toxicity with other chemicals; therefore a cumulative risk a ssessment was also not required. Flutolanil is further characterized as “not likely to be carcinogenic to humans.”

Food Tolerances

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

- (3-(1-methylethoxy) phenyl)-2-(trifluoromethyl) benzamide, including its metabolites and degradates, in or on commodities. Tolerances are established [40 CFR §180. 484(a)] on rice straw and hulls but are no longer required becau se they are no longer considered significant feedstuffs for any livestock ( Table 1 Feedstuffs , June 2008) and should be removed. Based on

the OECD tolerance calculati on procedures on peanut hay, in cluding residues from both band and broadcast applications, the established toleran ce of 15.0 ppm for peanut hay should be increased to 20.0 ppm. The tolerance of 0.1 ppm on turnip greens and the Brassica (cole) leafy vegetable group 5 should be increased to 0.20 ppm; this is a reconsideration of previous recommendations, because detectab le residues of parent were f ound in one field trial on mustard

greens.

The US tolerance expression harmonizes with the Codex tolerance expression for livestock commodities but not for plants. The US tolerance expression for plant and livestock

commodities is flutolanil and its metabolites co nverted to 2-(trifluoromethyl) benzoic acid and calculated as flutolanil, whereas the Codex tole rance expression for plants is flutolanil. For animal commodities, the Codex tolerance expressi on is flutolanil and its transformation products containing the 2-(trifluorome thyl) benzoic acid moiety.

There are no Codex, Canadian, or Mexican MR 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 same for rice bran and rice straw, but are different for rice grain, i.e., 7.0 ppm in the US compared to 2.0 for husked rice grain and 1.0 for polished rice grain for Codex. For livestock commodities, most C odex tolerance levels are the same as the US tolerance levels. However, the US tolerances fo r the livestock liver and kidney are higher than

the Codex MRLs and cannot be harmonized.

Human Incidents7 The incident analyses of the Main and A ggregate Incident Data System (IDS) was updated in July 2013 to include the time peri od January 1, 2008 to May 8, 2013, where there was one incident reported that involved flutolanil that was part of a la wsuit and was not considered in this update. There were three in cidents identified in Aggregate ID S that involve flutolanil, which were classified as minor severity. The incident analysis of the National Institute of Occupational Safety and Health Sentinel Event Notifica tion System for Occupational Risks (NIOSH SENSOR) was updated in July 2013 to include th e time period from 1998 to 2009. One incident was identified in SENSOR involving flutolan il. This case occurred in New York in 2006, involved multiple active ingredients, and was moderate in severity.

The current incident analysis is consistent with the pr evious analysis. Based on the continued low frequency and sever ity of incident cases reported for flutolanil, there does not appear to be a concern at this time that woul d warrant further investigation. The Agency will

continue to monitor the incident information a nd if a concern is triggered, additional analysis

will be conducted.

B. Environmental Assessment

The risk assessment evaluates risks to speci es that are not subject to the Endangered Species Act (ESA) and provides a screening level assessment for potential risks to listed species under the ESA. A summary of the Agency’s envi ronmental risk assessment for flutolanil is presented below. For detailed discussions of all aspects of the environmental risk assessment,

see the Draft Preliminary Environmental Fate and Ecological Risk Assessment for the Registration Review Combined with the Enviro nmental Fate and Ecological Risk Assessment for Proposed Amendments to Certain Labels for Flutolanil 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 co mments on the risk assessment.

Ecological Risk Characterization

Acute and chronic risk quotients exceeded le vels of concern (LOC) for several taxa from

the use of flutolanil on a number of different use sites in accordance with current labels. In particular, acute and chronic LOCs were exceeded for freshwater fish and estuarine/marine pelagic (in the water column) a nd benthic invertebrates, as we ll as for aquatic non-vascular plants and terrestri al dicot plants.

Acute risk is below the level of concern (LOC ) for estuarine/marine fish. However, there is uncertainty as to whether exposure could ex ceed the chronic LOC for estuarine/marine fish, the acute and chronic LOCs for freshwater pelagi c and benthic invertebrates, and the acute and

chronic LOCs for birds and mammals. These un certainties arise because definitive endpoints

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

Adverse Effect Concentrati ons (NOAEC) fall somewhere above the highest treatment

concentration. Estimated Environmental Con centrations (EEC’s) may be above the nondefinitive endpoint and so there is the potential to exceed the LOC. These risks are explained in more detail below. The range of risk quotients (RQ’s) for differe nt scenarios are provided for each taxon in Appendix C.8 Risk to Aquatic Organisms

Acute LOCs were exceeded for listed and non- listed freshwater fish and aquatic phase amphibians for nursery uses and on ornamentals. The acute LOC was exceeded for only listed freshwater fish and aquatic pha se amphibians for the turf use, and for aerial application to peanuts and rice. Chronic risk LOCs were ex ceeded for freshwater fish and aquatic phase amphibians for rice and nursery and ornamentals uses, based on the chronic toxicity study which showed reductions in length, but no si gnificant physical/behavioral abnormalities.

Acute and chronic risk LOCs were exceeded for listed and non-liste d estuarine/marine pelagic and benthic invertebrates for most uses, including peanuts, rice, turf, and nurseries and

ornamentals. Flutolanil was shown to be at least one order of magnitude more toxic to

estuarine/marine invertebrates than to freshwater invertebrates on an acute a nd chronic basis. It is highly acutely toxic to mysid shrimp, with 90% a nd 100% mortality seen at the two highest test concentrations. In the chronic shrimp study, a redu ction in survival, weight, and the number of young was seen. Acute LOCs were also exceeded fo r listed estuarine/marine pelagic and benthic invertebrates for potatoes and s oybean; the listed and non-listed ch ronic LOC was also exceeded for potatoes and soybean.

The LOC for acute listed and non-listed fres hwater invertebrates is potentially exceeded for nursery and ornamentals uses, and potentially exceeded for listed freshwater invertebrates for rice. In the acute pelagic test an EC 50 was not reached at the limit of solubility for flutolanil, resulting in non-definitive endpoints. However, mortality did reach 45% at that c oncentration. In the chronic pelagic toxicity study, length, ti me to first brood, and number young were all significantly reduced; the LOC fo r listed and non-listed chronic freshwater invertebrates was

exceeded for rice and nurseries and ornamentals. No effects were seen in benthic freshwater

invertebrate acute studies and endpoints were non-definitive; however, the magnitude the EECs for nursery and ornamental uses is such that a potential LOC exceedance could be possible. The

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

No mortality was observed in the acute study fo r estuarine and marine fish, but sublethal

effects were seen at the two highest test concentrations. A chronic study is not available; however, a potential for chronic ri sk exists for estuarine/marine fish based on behavioral effects in the acute study and the estab lishment of a chronic NOAEC in th e freshwater chronic study.

Risk to Terrestrial Organisms

Flutolanil is practically non-t oxic to birds on acute oral and subacute dietary basis. The oral toxicity and dietar y studies in bobwhite and mallard s howed no mortality, no other effects, and had non-definitive endpoints. However, the ma gnitude of the screeni ng-level EECs for turf and nursery uses is great enough that these exposur es have the potential to exceed listed and nonlisted LOCs if there would be mort ality to birds at exposures greater than the highest tested in the acute toxicity studies. There are chronic RQ exceedances of the listed and non-listed LOC for turf and nursery uses. There is a defin itive NOAEC from the bobwhite reproduction study9 showing no effects other than a slight reduction in number of eggs laid, which is biologically meaningful. The mallard reproduction study showed a statistically signi ficant reduction in eggshell thickness at the highest c oncentration tested. Birds also se rve as a surrogate for reptiles and terrestrial phase amphibians, to which these results also apply.

Flutolanil is practically non-toxic to mammals on an oral acute basi s, and there were no reproductive effects. Endpoints were non-definitive, but as with bi rds, the screening-level EECs for turf and nursery and ornamentals were great enough that there is a po tential that acute and

chronic LOCs could be exceeded.

Flutolanil is practically non-toxic to insects, based on an acute contact toxicity study with adult honeybees.

Risk to Plants

For terrestrial plants, the seedling emer gence study showed significant effects on emergence, survival, and height, with dicots being slightly more sensitive than monocots. However some species tested showed promotion of emergence. The vegetative vigor study also generally showed promotion of su rvival and height, and weight in some species or no reduction in survival for dicots, and therefore no definitiv e endpoint could be determined based on lack of toxicity. For monocots there were effects at the lowest and highest treatment concentrations and so a definitive endpoint could not be determined, and risk could not be estimated. EPA’s LOC is exceeded for listed and nonlisted terrestrial plan ts from the use on turf and nursery stock.

For aquatic vascular and non-vascular plan ts, the endpoints were non-definitive for all species tested. There were signi ficant reductions in frond/cell c ounts at a single concentration exposure that was greater than the solubility limit for flutolanil, used in all studies except the freshwater diatom. However, the EECs for listed aquatic nonvascular plants exceed the acute LOC for at least rice and nursery uses, and potenti ally for other uses as well. There were no LOC exceedances for listed aquatic vascular plants, but some uncertainty due to screening-level EECs greater than the non-definitive endpoints. Ther e are no LOC exceedances for nonlisted aquatic vascular plants.

Ecological Risk Assess ment Uncertainties

Exposure

Exposure to aquatic animals and plants in aq uatic environments were modeled with the

P esticide R oot Z one M odel and Ex posure A nalysis M odeling S ystem (PRZM/EXAMS) to provide estimated environmental co ncentrations (EECs) which were compared to toxicity values

to calculate risk. A number of conservative assumptions were included in this Tier 1 risk

assessment. EECs are based on maximum labeled si ngle use rates, which ar e likely lower based on typical use information (BEAD, 8/8/2014). For example, t h e ave r age app licat ion rate for

peanuts is 0.4 pounds of active ingred i ent (lbs a .i. ) per ac re
, 0.5 l bs. a .i . for potatoes (foliar and seed) and 0.3 lbs. a.i. for rice (2008 -20 12, EPA Proprietary Data) . For aquatic modeling, the risk

assessment assumed between 0.742-2.00 lbs a.i/acre for peanuts, 0.36 (seed )-0.77 lbs a.i./acre for potatoes, and 0.490-0.980 lbs a.i./acre for rice. Also, since the chemical shows medium to high10 pest resistance (as indicated by Fungicide Re sistance Action Committee for chemicals in Group 7), it may not be applied as often to rice as modeled in PRZM/EXAMS.

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, sediments in the aquatic metabolism study, and the study only examin es short time durations, the results were extrapolated, introducing a 3X uncertainty factor into the aquatic modeling results. Finally, the standard pond used in PRZM/EXAMS does not in clude flow or turnover, among other things, which may remove part of the flutolanil received in the pond.

The bioavailability of flutolan il in aquatic media is uncertain due to low to moderate recoveries of the test material and precipitate observed in some studies; this could underestimate risk to aquatic organisms.

Nursery Use

The risks calculated from use of flutolanil on nursery stock are likely overestimated. It is likely that for the nursery scenario, there is lo wer persistence than what was modeled using the standard input parameters. Considering lower pers istence, the FL nursery (soil drench) scenarios yield acute and chronic RQs th at are approximately 2.3 fold less than those derived from standard input parameters. Acute and chronic ri sk to estuarine/marine invertebrates remains

above the listed and nonlisted LOC for both uses in cluding these modified parameters, but acute

and chronic risk to all othe r assessed taxa falls below th e nonlisted level of concern.

Turf Use

As a refinement for the turf use for risk to estuarine/marine invertebrates, the spray drift value was decreased considering the buffer zone of 100 feet towa rds freshwater bodies of water for ground applications currently on most labels, decreasing EECs. The buffer may also decrease EEC’s further due to reductions in runoff, whic h cannot be quantified. However when compared to the available acute and chronic toxicity da ta for estuarine/marine pelagic and benthic invertebrates, the refined scenario s of exposure resulted in RQs that were very similar to those

that were estimated without the use of a buffer zone.

Ecological Incidents

An October 2013 search of OPP’s Ecological Inci dent 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 System, of all years of available data up until October 2013. There were no

bird incidents in the American Bird Conser vancy and Avian Incide nt Monitoring System databases, of all years of avai lable data up until October 2013.

Endangered Species Assessment

In November 2013, the EPA, along with the U. S. Fish & Wildlife Service (USFWS), the

National Marine Fisheries Service (NMFS) (collectively, the Servi ces), and the U.S. Department11 of Agriculture (USDA) released a summary of th eir joint Interim Approaches for assessing risks to listed species from pesticides. The Inte rim Approaches were developed jointly by the agencies in response to the National Academy of Sciences’ (NAS) recommendations and reflect a common approach to risk assessment shared by the agencies as a way of addressing scientific

differences between the EPA and the Services. The NAS report 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 Endangered Species Act (ESA) and FIFRA.

The joint Interim Approaches were released prior to a stakeholder workshop held on November 15, 2013. In addition, the EPA presen ted the joint Interim Approaches at the December 2013 Pesticide Program Dialogue Co mmittee (PPDC) and State-FIFRA Issues Research and Evaluation Group ( SFIREG) meetings, and held a stakeholder workshop in April 2014, allowing additional opportunities for stakeholde rs to comment on the Interim Approaches. As part of a phased, iterative process for deve loping the Interim Approaches, the agencies will also consider public comments on the Interim Appr oaches in connection with the development of upcoming Registration Review deci sions. The details of the jo int Interim Approaches are

contained in the white paper “Interim Approaches for Natio nal-Level Pesticide Endangered Species Act Assessments Based on the Recommenda tions of the National Academy of Sciences April 2013 Report,” dated November 1, 2013.

Given that the agencies are continuing to de velop and work toward implementation of the Interim Approaches to assess the potential risk s of pesticides to listed species and their designated critical habitat, the ecological risk assessment supporting this Proposed Interim Registration Review Decision for flutolanil does not contain a complete ESA analysis that includes effects determinations for specific listed species or designated crit ical habitat. Although EPA has not yet completed effects determinations for specific species or habitats, for this preliminary assessment EPA conducted a screening- level assessment for all taxa of non-target wildlife and plants that assumes for the sake of the assessment th at listed species and designated critical habitats may 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. While the agencies continue to develop a common method for ESA analysis, the regulatory section of the Proposed Interim Registration Review Decision document will describe the level of ESA analysis completed fo r this particular registration review case. Once the agencies have fully developed and implemente d 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.

C. Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA review s numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute,

subchronic and chronic toxici ty, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or syst emic toxicity. These studies include endpoints which may be susceptible to endocrine influenc e, including effects on endocrine target organ12 histopathology, organ weights, es trus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard asse ssments, EPA evaluates

acute tests and chronic studies that assess growth, developmen tal and reproductive effects in different taxonomic groups. As part of its most recent registration decision for flutolanil, EPA

reviewed these data and select ed the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), flutolanil is subject to the endocrine screening part of th e Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredie nts) may have an effect in hu mans or wildlife similar to an effect produced by a “naturally occurring estr ogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two-tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact w ith the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal sy stems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Ti er 2 tests are necessary based on the available data. Tier 2 testing is designe d to identify any adverse endocr ine-related effects caused by the substance, and establish a dose-re sponse relationship between the dos e and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pest icide active ingredients and 9 inert ingredients. A second list of

chemicals identified for EDSP scr eening was published on June 14, 2013 1 and includes some pesticides scheduled for Regi stration Review and chemicals found in water. For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, pleas e visit our website. 2

Flutolanil is on List 1 for whic h EPA has received all the requ ired Tier 1 assay data. The Agency is currently reviewing all of the assay da ta received for the appropriate List 1 chemicals and planning to make the conclusions of those reviews available in early 2015.

In this proposed interim decision, EPA is making no human health or environmental safety findings associated with the EDSP screen ing of flutolanil. Before completing this Registration Review, the Agency will make an EDSP FFDCA section 408(p) determination.



### IV. Proposed Interim Registration Review Decision

In accordance with 40 CFR Sections 155.56 and 155.58, the Agency is issuing this proposed interim registration revi ew decision document for flutol anil. Except for the EDSP and ESA components of the flutolan il registration review case, th e Agency has made the following

1 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of

chemicals.

2 http://www.epa.gov/endo/13 proposed interim decision: (1) no additional data are required at this time; and (2) changes are required to flutolanil product labels.

Pending consideration under the Endocrine Di sruptor Screening Program, the Agency has identified no human dietary, residential, occ upational, or aggregate risks of concern for flutolanil. The qualitative risk assessment perf ormed in support of the registration review of flutolanil supports this conclu sion in compliance with the most updated Agency science policies and human health risk assessment methodologies. As a result, no revision of flutolanil labels is currently necessary to address a ny human health risk concerns.

The proposed mitigation focuses on ecological risk to estuarine and marine invertebrates,

the taxon for which there were the most acute and chronic risk exceedances, and also on risk to freshwater fish. Peanuts and potatoes are the pr ominent 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 use is the least prominent, w ith PCT with flutolanil less than 1%. One registrant, Gowan, has indicat ed that they intend to voluntarily cancel their registrations of flutolanil.

For the peanut use, the predominant use of fl utolanil, RQs are at the acute LOC from drift and runoff for listed freshwater fish (acute), and above the LOCs for listed and non-listed estuarine/marine invertebrates (acute and chroni c) in the water column and the benthos. The highest RQs correspond to aerial ap plications, and the ex ceedance for listed freshwater fish is only for aerial application. However, 95% of th e applied flutolanil to peanuts was via ground application, with only 5% applie d aerially (BEAD, 8/8/2014). Acco rding 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 estuarine/marine invertebrates in the water column and the benthos for potato and soybean uses, although these exce edances are marginal.

The acute LOC exceedances are for listed estuarin e/marine invertebrates only, while the chronic

LOC exceedances are for both listed and non-listed estuarine/marine invertebrates. Acute and chronic RQs for listed and non-listed freshwater fish, and for listed and nonlisted estuarine

marine invertebrates in the water column and be nthos, were also exceeded for turf, rice, and

nursery uses.

In order to reduce offsite exposure from spray dr ift, the registrant with all of the flutolanil turf and nursery use registrations, Bayer Envir onmental Science, has agreed to change their labels to require applicators to use a Medium droplet size spectr um or coarser for all uses of flutolanil, as defined by the American Societ 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 aerial application to pea nuts. The highest RQs are for aerial applications, which accoun ts for 5% of flutolanil applica tion to peanuts, with 95% of the applied flutolanil to pea nuts was via ground application

. The proposed label changes requiring at least a Medium dropl et size spectrum should reduce th e mass of flutolanil that might drift from applications to all use sites and should reduce the pote ntial for risk to all non-target organisms off of treated fields.14 In addition to the spray drift restrictions described above, Bayer Environmental Science has agreed that all turf labels for flutolanil will include a 100-foot buffer from turf applications to estuarine or marine habitat, and to ditches, drainage tiles, or ot her waterways that drain directly into (within 1⁄2 mile of) estuaries and marine habi tats. Such language is currently on some of the flutolanil turf use labels, but some are curre ntly missing this language . The ecological risk

assessment considered the effect a 100-foot buffer would have on spray-drift exposure to estuarine and marine invertebrates, but was not able to quantify the resulting reduction of flutolanil transport in runoff. It is clear, however , that extending this mitigation to all turf labels

should reduce to some extent the overall mass of flutolanil reaching estuaries from use on turf.

Similarly, the rice use had some of the highest pr edicted exposure for aquatic organisms of all registered uses of flutolanil. However, curr ent label language prohibits the use of flutolanil application within 3 miles of any estuarine/ marine waterway or watershed, which was not accounted for quantitatively in calculating RQs. EECs are likely overestimated and so all RQs that exceeded the LOCs for the use on rice are also likely to be overestimated. Although flutolanil does not degrade readily under most te sting conditions, field studies did not show very high persistence overall. Aquatic metabolism, dilution, and binding to sediments and particulate

in the course of a 3-mile travel to encounter an estuarine/marine body of water will contribute to the dissipation of flutolanil. In addition, ba sed on usage information over the years 2008-2012, the use on rice has decreased sign ificantly, to only <1% of PCT w ith flutolanil. Therefore, EPA is not proposing any further mitigation for the use of flutolanil on rice.

Finally, Bayer Environmental Science has agreed that all of their flutolanil labels with uses on ornamental nursery stock will only allow four applications per year. This language is currently missing from one of their ornamental nursery-use labels. The nursery uses had the largest LOC exceedances for most taxa in the risk assessment, but EECs can be refined when considering nursery practice. For example, if the maximum rate we re used for foliar application then a maximum 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 compared to use rates of 9.78 lbs (ground application) to 21.5 lbs (soil drench) used in the risk assessment. In addition, as described above, the calculated exposure from the nursery use may have been overestimated due to the persistence of flutolanil simulated in e xposure modeling. As a result, the Agency is not pursuing additional mitigation for use of flutolanil in nurseries beyond those described above.

The Agency does not propose additional changes to flutolanil labels at this time to address potential risk to bird s and mammals. The ecological risk assessment indicated that a potential for LOC exceedances remained due to high screening-level EECs for turf and nursery stock. However, the RQs that suggest this possib ility for acute and chronic risk to mammals and

acute risk to birds are derive d from studies in which no toxi c effects were observed, which makes the potential for risk highly uncertain.

Screening-level chronic RQs for birds exceeded the LOC for several turf uses and for use in nurseries, but the potential for and extent of possible risk is uncertai n. The magnitude of the RQs is less than 2 for most of these uses, whic h suggests that exposures of concern would not extend beyond the treated field, and that RQs calculated with typical instead of maximum screening EECs would be below the level of con cern for most uses. In addition, the highest of the RQs which exceed the chronic LOC are for sm all birds consuming only short grass, which15 would represent a very small portion of potentiall y exposed birds. Finall y, birds would not likely

derive all of their food from some of the use sites mode led, such as golf tees, greens and aprons, and nurseries. Nonetheless, the spray droplet-s ize restrictions that are proposed to be incorporated on flutolanil product labels should reduce off-site tran sport of flutolanil, and should reduce the potential for chronic risk to birds.

The Agency does not propose additional changes to flutolanil labels at this time to address potential risk to terrestrial plants. The screening level risk assessment resulted in risk quotients for non-listed, semi-aquatic plants at th e LOC of 1.0 for golf-cour se fairways and the highest calculated application rate for nurseries. As indicated above , this maximum rate used in the risk assessment may not reflec t actual nursery practices, sugges ting that the risk quotient at the LOC may well be an overestimate. In addition, the model used to estimate potential exposure to semi-aquatic plants only considers areas dire ctly adjacent to the trea ted area, assuming a set

amount of runoff that does not take local soil and weather conditions into account. Finally, the RQ at the non-listed plant LOC was based on th e most sensitive plan t tested, and may not represent all plants well; flutolanil actually e nhanced seedling emergence and vegetative vigor in a number of plant species tested. Nonetheless, the spray droplet-si ze 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 flutol anil, which will further reduce the potential for risk to semi-aquatic plants. These measures coul d also reduce the potential for exposure to listed plants, for which the risk assessment indicated some LOC exceedances. The extent to which any listed plants might be exposed will be determined in future consultation on flutolanil with the

Fish and Wildlife Service.

The Agency also does not propose additional change s to flutolanil labels at this time to address potential risk to aquati c plants. Most vascular and non- vascular plants tested had no toxicity endpoint established at concentrations that indicate no ri sk at the screening level. There is uncertainty associated with RQs for the mo st sensitive aquatic plant tested, a freshwater diatom. However, while these RQ s were based on a study in which some effects to the diatoms were observed, the effects were not sufficient to establish a toxicity endpoint for the risk assessment. Nonetheless, as with other aquatic ta xa, 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 s hould further reduce the potential for risk to aquatic plants.

In the interim, EPA is making no human h ealth or environmental safety findings associated with the EDSP screening of flutolan il. While the risk assessment supporting this Proposed Interim Registration Review Decision evaluates risks to sp ecies that are not subject to the ESA, it is premature to make effects dete rminations for listed species until the interim approaches developed in response to the Natio nal Academy of Science (NAS) April 2013 report are vetted; therefore, EPA has not completed eff ects determinations for listed species associated with the registered uses of flut olanil. Therefore, consultation w ith the Fish and Wildlife Service and National Marine Fisheries Service (the Servi ces) on the potential risk of flutolanil to listed species will be necessary. The Agency is issui ng a proposed interim registration review decision pending the evaluation of potential endocrine disruptor risk and c onsultation with the Services. Before completing this Registration Review, the Agency will make an EDSP FFDCA section 408(p) determination and an endangered specie s effects determination under the ESA. The16 Agency is issuing a Proposed Interim Registra tion Review Decision pend ing completion of the

ESA and EDSP assessments.



### IV. Next Steps and Timeline

A. Interim Registration Review Decision

A Federal Register Notice will announce the availability of this Proposed Interim Registration Review Decision for flutolanil and allow a 60-day comment period. If there are no significant comments or additional information submitted to the docket during the comment period that leads the Agency to change its decision, EPA may issue an interim registration review decision for flutolanil (cas e 7010). However, a final decision for flutolanil may be issued without having previously issued an interi m decision. A final decision on the flutolanil registration review case will occur after an EDSP FFDCA section 408(p) and ESA

determinations have been made.

B. Implementation of Mitigation Measures

Once the Interim Registration Review Decision is issued in final form, registrants will need to submit proposed amended labels that include the agreed-upon end risk mitigation and submit them to the Agency for approval within 60 days of issuance of the Interim Registration Review Decision. The mitigation measures and label amendments are described in Appendix A

and B.17Appendix A: Summary of ProposedActions Taken for FlutolanilRegistrationReviewCase#:7010PCCode:128975ChemicalType:FungicideChemicalFamily:phenyl‐benzamide(benzanilide)ModeofAction:succinate‐dehydrogenaserespirationinhibitor(SDHI)AffectedPopulation(s)SourceofExposureRouteofExposureDurationofExposureRisk(s)ofConcernAction(s)TakenCommentsFreshwaterfishWater(directcontact,non‐dietary)IngestionDermalabsorptionAcuteChronicAcuteToxicityChronictoxicity‐growthBufferSpecifyMediumorlargerdropletsizeRestrictnumberofapplicationsBufferonTurfusesforestuaryandmarinehabitats.Medium‐largedropletsizetoreducespraydrifttoaquatichabitats.Restrictapplicationsperyeartoornamentalplantings.AquaticInvertebratesestuarine/marineWater(directcontact,non‐dietary)IngestionDermalabsorptionAcuteChronicAcuteToxicityChronictoxicity‐reproduction18Appendix B: Flutolanil Label TableSummary of Proposed Labeling Changes for Flutolanil UsesDescriptionAmended Labeling Language for Flutolanil Use ProductsPlacement on LabelEnd Use ProductsUse Precautions –Products labeled for turfand ornamentals“For use rates over x oz. per 1000 sq ft, do not apply within 100 feet of any estuary or marine habitat or within 100 feetof any ditches, drainage tiles, or other waterways that draindirectly into (within 1⁄2 mile) estuaries and marine habitats.Apply no more than a combined total of x oz. per 1000 square feet as a broadcast application during a single growingseason.”Use Precautions andRestrictions,followingApplicationInstructions sectionGeneral Information -Products labeled for turfand ornamentals“Make no more than 4 applications of (product) per year to ornamental plantings.”After GeneralInformation onGreenhouse/Saranand shadehouse/OutdoorContainer/FieldGrown OrnamentalNursery StockSpray Drift Management “Spray equipment and weather affect spray drift. Consider all factors when making application decisions. Where stateshave more stringent regulations, they must be observed. Avoiding spray drift is the responsibility of the applicator orgrower. 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 practicalspray volume, using 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 onpressure, orientation, spray volume, etc., in order to minimize drift and optimize coverage and control.”Directions for Use19Appendix C: Risk Quotient RangesBolded values represent an LOC exceedance. Italicized values represent a “potential” LOC exceedance.3Acute and chronic risk to estuarine/marine fish was not estimatedas there were no mortalities in the acute study up to solubility limit and no chronic fish studyis available. An acute-to-chronic ratio (ACR) was not utilized toestimate chronic toxicity as there is a high level of uncertainty in using an ACR with a nondefinitiveacute toxicity endpoint.FW fish FWinvertebratesE/M Fish3E/MinvertebratesFW benthicinvertebratesE/M benthicinvertebratesBirds Mammals TerrestrialplantsNonvascularaquaticplantsUse(inclusive ofallscenarios) Acute RQ Chronic RQ Acute RQ Chronic RQ Acute RQ Chronic Acute RQ Chronic RQ Acute RQ Chronic RQ Acute RQ Chronic RQ Acute RQ Chronic RQ Acute RQ Chronic RQ Listed Acute Non-listed A cute Non-Listed AcutePeanuts0.050.23-0.992.64-11.20.22-0.942.55-10.8<0.12-0.38Potato0.06-0.231.10-2.650.06-0.231.09-2.60CottonSoybean0.151.740.141.65Sugar beetRice0.33-0.461.59-1.96<0.12-0.174.08-8.706.38-8.6946.2-57.41.73-2.2719.8-26.1>1.04-1.45Turf0.07-0.091.31-1.6714.9-18.91.21-1.5713.9-18.1<0.12-5.031.06-3.31<.010-0.281.09-2.711.01Nurserystock0.87-1.889.86-20.59<0.32-0.691.07-1.2216.7-36.1191-408<0.3-0.633.79-8.0815.5-32.9178-379<0.10-5.651.46-3.72<0.12-0.31<1.04-3.101.09-2.721.01>2.88-5.86