### Table of Contents

I. INTRODUCTION

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

A. Public Comments .............................................

.......................................... 5

II. USE AND USAGE

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

III. SCIENTIFIC ASSESSMENTS

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

A. Human Health

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

1. Risk Conc lusions

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

2. Food Tolerances..................................................................................7

B. Ecological

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

1. Environmental Fate and Exposure

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

2. Risk Conclusions & Characterization

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

Terrestrial Assessment

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

Aquatic Assessment

................................ ................................ ................................ .. 9

C. Endangered Species Assessment

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

D. Endocrine Disruptor Screening Program

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

IV. CHARACTERIZATION OF USE & USAGE

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

V. INTERIM REGISTRATION REVIEW DECISION

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

A. Risk Miti gation and Regulatory Rational.........................................................13 B. Interim Registration Review Decision.............................................................13

VI. NEXT STEPS AND TIMELINE

................................ ................................ .......................... 14

A. Registration Review Decision

................................ ................................ ............................... 1 4

2

### I. INTRODUCTION

This document is the Environmental Protection Agency’s (EPA or the Agency ) Interim Registration Review Decision for fluazinam (PC code 129098 ) 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 Rodentic ide Act (FIFRA). The Agency may issue, when it determines it to be appropriate, a n I nterim R egistration R eview D ecision before completing a registration review. Among other things, an I nterim R egistration R eview D ecision may 1) require new risk mitigatio n measures ; 2) impose interim risk mitigation measures ; 3) identify data or information required to complete the review ; and 4) include schedules for submitting the required data, conducting the new risk assessment and completing the registration review. For

further information on fluazinam , additional documents can be found in EPA’s public docket (EPA

- HQ

- OPP

- 2009

- 0039 ) at www.regulations.gov

.

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

unreasonable risks to human health or to the en vironment 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 policies and practices change, all registered pesticides continue to

meet the statut ory standard of no unreasonable adverse effects. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency periodically re

- evaluates pesticides to make sure that as these change s occur, products in the marketplace can continue to be used safely. Information on this program is provided as www.epa.gov/oppsrrd1/registration_review/

. In 2006, the Agency implemented the registration 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 FIFRA standard for registration.

Fluazinam is a contact fungicide of the pyridine (dinitroan iline) class registered for agricultural use on a variety of crops, including peanuts, potatoes, and beans. It is also registered for use on turf grass. Since fluazinam was registered after 1984, it was not subject to reregistration

Pursuant to 40 CFR s ection 155.50, EPA formally initiated registration review for

fluazinam (case 7013 ). The following highlights significant events that have occurred during the registration review of fluazinam and can be found in EPA’s public docket, EPA

- HQ

- OPP

- 2009

- 0032 , accessed at www.regulations.gov

.

• September 23, 2009

– Publication of the Fluazinam Summary Document for a 60

- day public comment period

. The Summary Document included the Preliminary W ork P lan (PWP) and was acc ompanied by the scoping document and problem formulation.

• March 9, 2010

– Final Work Plan (FWP) for fluazinam was issued . T wo public comments were received during the 60

- day comment period for the fluazinam PWP

. However , the FWP did not modify the PWP.

3• January 12, 2011

– Generic Data Call

- In (GDCI ) for fluazinam issued.

• June 26, 2013

– The Agency published the Environmental Fate and Ecological Effects Preliminary Risk Assessment for the Registration Review of Fluazinam , June 4, 2013; the
Fluazinam Human Health Risk Assessment to Support New Uses on Soybeans, the Melon Subgroup (9

- A), and the Pepper/Eggplant Subgroup (8

- 10B), and to Support Registration

Review

, September 10, 2012 ; and the Fluazinam Addendum to the Human Health Risk Assessment for New Uses and Registration Review: Incorporation of New Acute Toxicity Data and Updated Restricted Entry Interval (REI)

, February 14, 2013 for a 60

- day public comment period. One comment was received during the comment period.

• September 2014

– The Agency published the Response to Public Comments on the Preliminary Ecological Risk Assessment for the Registration Review of Fluazinam

, November 25, 2013

.

• September 2014

– The Agency published the Addendum to the Environmental Fate and Ecological Effects Prelim inary Risk Assessment for the Registration Review of
Fluazinam

, April 1, 2014

.

• September 2014

– The Agency publish ed the Fluazinam Proposed Interim Registration

Review Decision

, September 17 , 2014

, for a 60

- day public comment period. Two

comments were rec eived. One comment was received from the Center for Biological Diversity regarding the Agency’s obligations under the Endangered Species Act (ESA).

A second comment was received from a concerned citizen.

• March 201 5

– The Agency is now publishing the Fluazinam Interim Registration Review

Decision.

Additional information on fluazinam can be found in EPA’s public docket

, EPA

- HQ

- OPP

2009

- 0039, accessed at www.regulations.gov

.

4A. Public Comments

Comments Received from the Center for Biological Diversity (EPA

- HQ

- OPP

- 2009

- 0039

- 0031 )

Comment : The Center for Biological Diversity’s (CBD) comments focus on the EPA’s duty to consult with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) on the registration review of fluazinam in accordance with the Endangered Species Act ( ESA )

. The CBD comments menti on 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 (listed) and their designated critical habitat. CBD also expresses concern regarding the rigor of the Agency’s preliminary determinations regarding the effects of fluazinam on listed species and their designated critical habitat for the fluazinam registration review.

Response : The A gency has reviewed the comments from CBD on the Fluazinam Proposed

Interim Decision and plans to address many of the concerns raised by CBD as part of the implementation plan for assessing the risks to listed species based on the recommendations of the April 2013 National Acade my of Sciences (NAS) report. The agency is currently working with its federal counterparts and other stakeholders to implement an interim approach for assessing potential risk to listed species and their designated critical habitats. At this time the agen cy’s decision is only an interim one. Once the scientific methods necessary to complete risk assessments for listed species and their designated critical habitats are finalized, the A gency will complete its endangered species assessment for fluazinam and issue a final decision for registration review . See Section II I. (C.) for a description of the A gency’s plan to address risks to endangered species and critical habitat.

Comments Received from Alexander Smith (EPA

- HQ

- OPP

- 2009

- 0039

- 0030)

Comment : Mr. Smith believes that pesticides are important but should be closely

monitored. Specifically to fluazinam, Mr. Smith describes a case report where a worker was apparently exposed to fluazinam and experienced a sore throat and other respiratory tract

sympto ms.

Response : The Agency has evaluated the human health risk from fluazinam, and found that no human health risk estimates exceeded the Agency’s level of concern for existing uses of

fluazinam. In support of the registration review of fluazinam, t he Ag ency conducted a review of reported fluazinam incidents in 2009 (located in the fluazinam docket) and found only one incident, for which symptoms appeared generic and not confirmed to be related to exposure

. In response to this comment, EPA searched its main sources of incident data (i.e., Main Incident Data System (IDS), Aggregate IDS) from January 1, 2009 to February 12, 2015, and noted three

additional incidents that were classified as minor in severity. B ased on the low frequency and low severity of reported incidents , including the case report referenced by Mr. Smith

, EPA does

not believe there is a risk of concern at this time when fluazinam is used as directed by labels. The Agency will continue to mon itor the incident information and if a concern is triggered,

5additional analysis will be conducted. Incidents may be reported to the Agency through the

National Pesticide Information C enter : ht tp://npic.orst.edu/incidents.html#hum



### II

. USE AND USAGE

Fluazinam was initially registered as a fungicide for use on peanuts and potatoes in 2000.

Several new uses were added from 2008

- 2012, which include: beans, except peas ( edible , shelled succulent, dry beans ) ; brassica leafy vegetables, including turnip greens; bush

- berries; ginseng; leaf and head lettuce; bulb onion; apples; carrots; ornamental turf; melon; eggplant/pepper . In recent years, an average of 57,000 lbs fluazinam wa s applied annually on all crops. Use of fluazinam on potatoes, peanuts and other crops has declined since 2000. In the years from 2007

- 2012

, use on potatoes and peanuts constituted approximately 90% of all fluazinam use. In the years from 2004

- 2012, the average percent crop treated (PCT) for use of fluazinam was 15% on
potatoes , less than 2.5% on peanut s, and less than 2.5% for the remaining crops. Data from

2007

- 2012 indicate the average total number of applications and average maximum a pplication

rates for use on potatoes and peanuts are less than the current maximum labeled applications and application rates. Data on the use of fluazinam on other crops (including beans, apples, and carrots) are not available given how recently it was r egistered for use on these sites.



### III. SCIENTIFIC ASSESSMENTS

A. Human Health

A summary of the Agency’s human health risk assessment is presented below. For detailed discussions of all aspects of the human health risk assessment, see Fluazinam

. Human Health Risk Assessment to Support New Uses on Soybeans, the Melon Subgroup (9

- A), and the Pepper/Eggplant Subgroup (8

- 10B), dated September 10, 2012

, and Addendum to the Human Health Risk Assessment for New Uses and Registration Review: Incorporati on of New Acute Toxicity Data and Updated Restricted Entry Interval (REI), dated February 14, 2013 and in the public docket ( EPA

- HQ

- OPP

- 200 9

- 0 0 39 ) which can be accessed at http://www.regulations.gov/

.

The Agency used the most updated Agency science policies and risk assessment methodologies to prepare a quantitative risk assessment in support of the registration review of

f luazinam

. It has not been determined that fluazinam shares a common mechanism of toxicity with other chemicals; therefore a cumulative risk assessment was not required

. No risk estimates exceeded the Agency’s level of concern (LOC) for existing uses of fluazinam.

1. Risk Conclusions

The Agency conducted dietary, occupational, aggregate, and residential risk assessments to support the registration review of fluazinam. No risk estimates exceeded the Agency’s level of concern (LOC) for existing uses of fluazinam.

62. Food Tolerances

U.S. food tolerances are listed under 40 CFR 180.574(a) (1) for fluazinam. No change to the U.S. tolerance is being proposed at this time nor are changes needed to achieve tolerance harmonization between the U.S., Codex, Canada, or Mexico.

B. Ecological

A summary of the Agency’s ecological risk assessment is presented below. The A gency used the most updated A gency science policies and risk assessment methodologies to complete a quantitative risk assessment in support of the registration review of f luazinam. T his Interim Registration Review Decision focuses primarily on risk to non

- listed species. For a detailed

discussion

, see the following documents in the fluazinam registration review public docket (EPA

- HQ

- OPP

- 2009

- 0039) at http://www.regulations.gov: Environmental Fate and Ecological Effects Preliminary Ecological Risk Assessment for the Registration Review of Fluazinam

, June 4, 2013 ; Response to Public Comments on the Preliminary Ecological Risk Assessment for the Registration Review of Fluazinam , November 25, 2013 ; and Addendum to the Environmental Fate and Ecological Effects Preliminary Risk Assessment for the Registration Review of
Fluazinam

, April 1, 2014

.

The Agency also completed a s creening

- level endangered and threatened (listed) species

assessment for fluazinam and identified potential risks to several taxa ( birds; mammals;

freshwater and estuarine /marine fish, invertebrates and sediment

- dwelling invertebra tes; and aquatic non

- vascular plants ) . The Agency is currently working with its federal counterparts and other stakeholders to implement an interim approach for assessing potential risk to listed species and their designated critical habitats. Once the s cientific methods necessary to complete risk assessments for listed species and their designated critical habitats are finalized, the Agency will complete its endangered species assessment for fluazinam

. Risks to listed species will not be

characterized h erein.

1. Environmental Fate and Exposure

Fluazinam binds to sediment readily. Fluazinam degrades at moderate to low rates in soil, but is rapidly transformed into other compounds of similar structure in high pH conditions or in aerobic or anaerobic aquatic media. Eight major transformation products of fluazinam were

identified. The transformation products of fluazinam are relatively p ersistent under most

conditions. In the a bsence of chemical specific toxicity data on the eight individual degradates of fluazinam, the Agency conducted a structural

- activity relationship (SAR) analysis to estimate their toxicity. This analysis determined that three of the degradates are several orders of magnitude less toxic than fluazinam to aqua tic taxa, so these were excluded from a T otal T oxic

Residue (TTR) analysis. The remaining five degradates were estimated to have similar toxicity characteristics to parent fluazinam for one or more taxa and were included in a TTR analysis that

was conduct ed for aquatic environments to account for the uncertainty in the SAR analysis.

As a result of comments, the risk assessment was amended to incorporate the use of a

refined foliar residue half

- life of 7.33 day s for peanuts and potatoes (only)

. The use of the new

half

- life resulted in a significant reduction to the RQs for terrestrial organisms (for further details

7see below). The Agency’s findings after revising the terrestrial risk assessment are presented in

the Addendum to the Environmental Fate and Ecological Effects Preliminary Risk Assessment for the Registration Review of Fluazinam , dated April 1, 2014.

2. Risk Conclusions & Characterization

To estimate potential ecological risk, EPA integrates the results of exposure and eco

toxicity studie s using the risk quotient method. Risk quotients (RQs) are calculated by dividing acute and chronic estimated environmental concentrations (EECs) by eco

- toxicity values for various wildlife and plant species. RQs are then compared to levels of concern (L OCs), and when the RQ exceeds the level of concern for a particular category, the Agency evaluates the potential for a risk of concern to that category. Risk characterization provides further information on potential adverse effects and the possible impac t of those effects by considering the fate of the chemical and its degradates in the environment, organisms potentially at risk, and

the nature of the effects observed.

Although the risk assessment indicates RQs that exceed LOCs for certain acute and

chro nic exposure scenarios for non

- listed aquatic and terrestrial organisms, the Agency believes that the overall ecological risk from fluazinam is low and risk s of concern are considered unlikely as the ecological risk assessment is a scree ning level analysis that used the following conservative assumptions

, which may over

- estimate risk: the use of a total toxic residue analysis (for aquatic exposure scenarios) ; the use of maximum labeled rat es vs. typical use information;

the use of a default residue half

- life value of 35

- days for certa in crops in the absence of data ; and the assumption that 100% of a mammalian diet comes from one food source on a treated field

.

Terrestrial Assessment

The primary route of exposure for terrestrial organisms is the di etary route from consumption of food items such as plant leaves or insects that have fluazinam residues. Direct contact and spray drift are the major routes of exposure assumed for terrestrial and riparian plants. Fluazinam exhibits low acute toxicity to birds and mammals. For mammals and birds some uses resulted in RQs that exceed the LOCs. For terrestrial plants there are no LOC exceedances

. T he Agency found that using a shorter foliar dissipation half

- life for calculating risk from terrestrial

expos ure from the peanut and potato use was appropriate, which substantially reduced the risk

estimates for these u ses for terrestrial organisms. Although the shorter half

- life value casts uncertainty on the default half

- life value used to assess terrestrial ri sk from the other fluazinam uses, the Agency could not assume the shorter half

- life was appropriate for use in assessing terrestrial risk from the other uses since foliar dissipation data was only submitted for peanut and
potato. Current Agency policy is to use a 35

- day half

- life unless there are three values available on different representative crops. Howev er, the peanut and potato uses account for approximately

90 % of all fluazinam use, and so the Agency has confidence that overall terrestrial exposure and

risk from fluazinam use is low.

Mammals

There are no acute dose

- based risks of concern for non

- listed mammals. The chronic dietary and dosed based RQs for non

- listed mammals are ab ove the LOC of 1 for all uses. As

8part of sta ndard screening level ecological risk assessment practice, a default residue half

- life of 35 days was used to assess all uses

, with the exception of potatoes and peanuts. A cross mammal

sizes

, feeding ca tegories and uses

, chronic dose

- based RQ exceedances (for all uses except peanuts and potatoes) r an ged from 1.35

– 33.51 (ginseng ; cucurbits and fruiting vegetables

, respectively )

. C hronic dietary

- based RQ exceedances ranged from 1.04

- 8.19 (soybean; cucurbits and fruiting vegetables

, respectively ).

Usin g the refined residue half

- life of 7.33 days for peanuts and potatoes , the RQs were significantly reduced. Although they were reduced, RQs still resulted in LOC exceedances for

these two uses. The chronic

- dose based RQ exceedances ranged from 1.43

– 7. 95 ( peanuts ) and

1.10

- 5.24 ( potatoes ) . T he chronic

- dietary based RQ exceedances ranged from 1.09

– 1.94 (peanuts) and 1.28 ( potatoes ).

Birds

There are no acute dietary or dose

- based risk s of concern for non

- list ed birds ( surrogates
for reptiles and amphibians). The chronic RQs for non

- listed birds are marginally above the

LOC of 1 for all uses except edible podded legume vegetables, peanuts , and potatoes (for these three uses, RQs were below the LOC). Amon g the uses with chronic LOC exceedance s, RQs ranged from 1.07

– 4.09 (bulb vegetables; cucurbit

, respectively ).

Although RQs exceeded the target LOCs for certain terrestrial taxa and uses, it should be noted that certain conservative assumptions were used in the screening level risk assessme nt. These assumptions include the use of a default foliar residue dissipation half

- life of 35 days for all uses (expect peanuts and potatoes ) and for the av ian risk assessment it was assumed that

100% of an av ian diet comes from one food type on a treated field.

Aquatic Assessment

The primary route of exposure to aquatic organisms is through direct contact with the water column, sediment, and water with residues from spray drift and/or runoff from treated areas. Fluazinam exhibits high acute toxicity to freshwater and estuarine/marine fish, and

freshwater and estuarine/marine invertebrates. Data were not available to assess chronic risk to

estuarine/marine sediment

- dwelling invertebrates and aquatic vascular plants. The Agency’s

calculated RQs exceed th e target LOCs for the following non

- listed taxa:

Acute, Aqua tic Fish & Invertebrates

• F reshwater fish RQs = 1.06

- 1.15 (apples; cucurbit vegetables , melon)

• Estuarine/marine invertebrates RQs = 1.07

- 8.81 (ginseng; cucurbit vegetables , melon)

• Estuarine/ma rine sediment dwelling invertebrates, pore water RQs = 1.02

- 1.81 (fruiting vegetables , pe ppers, eggplant)

Chronic, Aquatic Fish & Invertebrates

• F reshwater fish RQs = 1.10

- 13.59 (brassica (cole) leafy vegetables ; apples)

• F reshwater sed iment

- dwelling invertebrates RQs = 1.27

- 4.09 (carrots; fruiting vegetables , peppers, eggplants)

9• Freshwater sediment

- dwel ling invertebrates, pore water RQs = 1.22

- 3.96 (carrots; fruiting vegetables , peppers, eggplants)

• E stuarine/marine invertebrates RQs = 1.09

- 8.85 (turf grasses on golf courses; cucurbit vegetables, melon)

Aquatic Plants

• Non

- vascular plants RQs = 1.05

- 37.64 ( bulb vegetables ; cucurbit vegetables, melon)

For acute and chronic exposure, t he Agency assumed that fish

, aquatic invertebrates , and aquatic plants were exposed to fluazinam and five of its eight degradates ; and conducted a total

toxic residue analysis (TTR). Given the lack of toxicity data on the eight individual degradates of fluazinam, the Agency conducted a structure

- activity relat ionship (SAR) analysis to estimate their toxicity. This analysis determined that three of the degradates we re several orders of magnitude less toxic than parent fluazinam to aquatic taxa, and so these were excluded from the TTR analysis. The remaining fi ve degrad ates were estimated to have similar toxicity characteristics to parent fluazinam for one or more taxa and were included in the TTR analysis given the uncertainty in the SAR analysis

. There is also some uncertainty as to how quickly parent fluazin am deg rades in aquatic environments. A erobic and anaerobic metabolism data show a range of half

- lives, ≤ 8 hours to 8.33 days. Even the greatest value indicates fluazinam degrades relatively quickly in aquatic environments, which means that the majority of chronic aquatic exposure is to the fluazinam degradates.

In addition, the two currently registered product s (EPA Registration Numbers 71512

- 1

and 71512

- 20) have use restrictions that proh ibit application near water bodies

, which likely reduce aquatic environmental exposure. These restrictions include (for both products ) that they cannot be applied within 25 ft

. of permanent water bodies (such as lakes, reservoirs, rivers,
permanent stream s, marshes or natural ponds, and estuaries) . F or the agricultural product (EPA Reg. No. 71512

- 1 ) a 150 ft

. buffer zone for aerial application near estuarine /marine

environments is required (“Do not apply within 150 ft

. of marine/estuarine areas ” )

, and a

v egetative buffer/setback of 25 ft

. from the perimeter of permanen t water bodies is required (“Do

not cultivate within 25 ft

. of permanent water bodies...so as to allow growth of vegetative filter strip”). In addition, the turf product (EPA Reg. No. 71512

- 20 ) can not be applied aerially (“Do not apply Fluazi nam Turf by aerial application ”)

. Assessment t ools are not currently availabl e to the Agency to quantitatively evalu a te the effectiveness of vegetative buffers/ setbacks on runoff and loadings to environmental systems

. However, it is believed that a well

- established, healthy vegetative buffer/ setback can be a n e ffective means of substantially reducing runoff and erosion

from agricultural fields thereby reducing potential aquatic exposures

. Al ternatively , a setback of poor vegetative quality or one that is channelized may be ineffective at reducing loadings.

Although RQs exceeded the target LOCs for certain aquatic taxa and uses , it should be noted that certain conservative assumptions were also used in the screening level risk assessment including the use of a TTR appr oach and maximum application and use rates. In addition, although they cannot quantitatively be assessed, current label restrictions (buffer zones) and other application restr ictions likely reduce aquatic environmental exposure.

10C. Endangered Species Assessment

Consistent with EPA’s responsibility under the ESA, the Agency will evaluate risks to federally listed species from registered uses of pesticides in accordance with the Joint Interim Approaches developed to implement the recommendations of the April 2013 N ational Academy of Sciences (NAS) report, Assessing Risks to Endangered and Threatened Species from

Pesticides

. The NAS report [1] 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 fluazinam in connection with the development of its final registration review

decision for fluazinam

.

In Novembe r 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 f rom pesticides. These Interim Approaches were developed jointly by the agencies in response to the NAS recommendations, and reflect a common approach to risk assessment shared by the agencies as a way of addressing scientific differences between the EPA a nd the Services. Details of the joint Interim Approaches are contained in the November 1, 2013 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]

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 a ssessment supporting this Interim Registration

Review Decision for fluazinam does not contain a complete ESA analysis, including effects determinations for specific listed species or designated critical habitat. While the agencies continue to develop a co mmon method for ESA analysis, the preliminary risk assessment for the registration review of fluazinam describes the level of ESA analysis completed for this particular registration review case. This assessment will allow EPA to focus its future evaluation s 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 a ssessments for listed species and their designated critical habitats, these methods will be applied to subsequent analyses of fluazinam as part of completing this registration review.

D. Endocrine Disruptor Screening Program

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

chronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, repro ductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates,

[1] http://www.nap.edu/catalog.php?record_id=18344

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

11reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of its most recent registration decision for fluazinam , EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p),

fluazinam is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife s imilar to an effect produced by a “naturally occurring estrogen, 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 with 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 systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine

- related effects caused by the substance, and establish a dose

- response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call

- in s for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of chemicals identified for EDSP screening was published on June 14, 2013 1 , and includes some pesticides scheduled for Registration Review and chemicals found in water. Neither of these lists should be construed as a list of known or likely endocrine disruptors. 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, please visit our website 2

.

In this interim decision, EPA is making no human health or environmental safety findings associated with the EDSP screening of fluazinam

. Before completing this Registration R eview, the Agency will make an EDSP FFDC A section 408(p) determination.



### IV. CHARACTERIZATION OF USE & USAGE

The Agency conducted additional characterization of fluazinam use and usage on its major crops and found that it is reported to play an important role in resistance management because its mode of action is different from that of the registered alternatives and it has a low risk of developing resistance in fungi. Also, the available usage data show that as much as 15% of potato acreage is treated w ith fluazinam, a relatively high proportion that suggests a large number of growers find the chemical useful. In addition, data suggest that the average number of applications and single maximum application rates for peanut s and potato es (the primary uses of fluazinam) are less than the highest number of applications and single maximum application

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/

12rates allowed on current labels

. The screening level ecological risk assessment calculated RQs using the highest labeled application rates and the maximum allow ed number of applications to be protective of potential risk. However, based on the available use and usage data, average use rates are lower than what is currently labeled. This usage data suggests that actual environmental concentration (EECs) and corr esponding RQs for these uses are likely lower and therefore, that the screening level ecological risk assessment may over

- estimate environmental exposure and

risk. For more information see the memorandum Characterization of Fluazinam Use and Usage on Maj or Crops (mainly Potatoes and Peanuts) , dated April 7, 2014.



### V. INTERIM REGISTRATION REVIEW DECISION

A. Risk Mitigation and Regulatory Rationale

For human health, no risk estimates exceeded the Agency’s level of concern (LOC) for existing uses of fluazinam . For ecological exposure, although the risk assessment indicates RQs that exceed LOCs for certain acute and chronic exposure scenarios for non

- listed aquatic and terrestrial organisms, the Agency believes that the overall ecological risk from fl uazinam is low and risks of concern are not likely for the following reasons. The ecological risk assessment is a screening level analysis for which conservative assumptions were used which may over estimate risk for certain taxa (i.e., use of currently l abeled maximum number of applications and rates; for the terrestrial RA, the use of a default residue half

- life for all uses expect potatoes and peanuts

, and assumed 100% of mammalian diet comes from one food source on a treated filed; and for the aquatic RA a TTR approach used ). In addition, RQs are relatively low for the predominate uses, peanuts and potatoes, which comprise approximately 90% of fluazinam use. Also, currently registered labels have language restricting application near water bodies whic h likely reduce aquatic environmental exposure (i.e., both products cannot be applied within 25 ft. of permanent water bodies. The agricultural use product, EPA Reg. No. 71512

- 1, cannot be applied within 150 ft. of marine/estuarine areas by aerial equipme nt and a vegetative buffer/setback of 25 ft. from the perimeter of permanent water bodies is required. The turf product, EPA Reg. No.

71512

- 20, cannot be applied by aerial equipment)

. Although the Agency cannot quantitatively

assess the effectiveness of vegetative buffers/setbacks at this time, it is believed that the current labeled use restrictions likely reduce potential runoff and exposure in aquatic environments. In addition, fluazinam plays an important role in resistance management because its mod e of action is different from the registered alternatives and it has a low risk of developing resistance when compared with other registered fungicide alternatives [ Characterization of Fluazinam Use and Usage on Major Crops (mainly Potatoes and Peanuts) , A pril 7, 2014]. Therefore, h uman health and ecological risk mitigation i s not required because the currently registered uses of fluazinam do not, on the basis of current analysis, warrant any additional mitigation at this time.

B. Interim Registration Review Decision

In accordance with 40 CFR Sections 155.56 and 155.58, the Agency is issuing this Interim Registration Review Decision for fluazinam

. Except for the EDSP and Endangered Species Act (ESA) components of this case, the Agency has made the following interim registration review decision: (1) no additional data are required at this time; and (2) no changes to the affected registrations or their labeling are needed at this time.

13In this interim registration review decision, EPA is making no human health or environmental safety findings associated with the EDSP screening of fluazinam, nor is it making a complete endangered species finding. The Agency’s final registration review decision for fluazinam will depend up on both the result of an ESA Section 7 consultation with the Services and an EDSP FFDCA section 408(p) determination.



### VI. NEXT STEPS AND TIMELINE

A. Registration Review Decision

A final decision on the fluazinam registration review case will occur after ES A and EDSP FFDCA section 408(p) determinations have been made.

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