Docke t

Numbe r EPA-HQ-OPP-2009-003 9 www.regulations.go v



## Fluazina m

Propose d Interi m Registratio n Revie w Decisio n

Cas e Numbe r 701 3

Septembe r 201 4

Approve d by : S^^icvcci 

## P Vjei^tr^. 

## Y)

Richar d P

. Keigwin

, Jr

. Directo r

Pesticid e Re-evaluatio n Divisio n

Date : 

## ^'H-^i^j-2 

### Table of Contents

I. INTRODUCTION

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

A. Public Comments

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

II. USE AND USAGE

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

III. SCIENTIFIC ASSESSMENTS

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

A. Human Health

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

1. Risk Conclusions

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

2. Food Tolerances

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

B. Ecological

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

1. Environmental Fate and Exposure

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

2. Risk Conclusions

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

Terrestrial Assessment

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

Aquatic Assessment

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

C. Endangered Species Assessment

................................ ................................ ............................. 9
D. Endocrine Disruptor Screening Program

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

I V

. CHARECTERIZATION OF USE & USAGE

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

V. PROPOSED INTERIM REGISTRATION REVIEW DECISION

................................ ....... 11
A. Risk Mitigation and Regulator Rationale

................................ ................................ .............. 11
B. Proposed Interim Registration Review Decision

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

VI. NEXT STEPS AND TIMELINE

................................ ................................ ........................... 12
A. Interim Registration Review Decision

................................ ................................ .................. 123



### I. INTRODUCTION

This document is the Environmental Protection Agency’s (EPA or the Agency) Proposed Interim Registration Review Decision for fluazinam 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 Rodenticide Act (FIFRA). The Agency may issue, when it
determines it to be a ppropriate, 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 mitigation measures ; 2) impose interim risk mitigation measures ; 3) identify
d ata 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 fou nd 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 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 policies and practices change, all registered pesticides continue to meet the statutory 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 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/

. 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 f

ungicide of the pyridine (dinitroaniline) 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

r eregistration

Pursuant to 40 CFR section 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 pu blic 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 accompanied 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 flua zinam PWP

. However , the FWP did not modify the PWP.4

 January 12, 2011

– Generic Data Call

- In (GDCI) Notice for fluazinam issued.

 June 26, 2013

– The Agency published the Environmental Fate and Ecological Effects Preliminary Risk Assessment for the Registration Review of Fluazinam , 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

, and the Fluazinam Addendum to the Human He alth Risk Assessment for New Uses and Registration Review: Incorporation of New Acute Toxicity Data and Updated Restricted Entry Interval (REI) for a 60

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

 September 2014

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

.

 September 2014

– The Agency is now publishing the Addendum to the Environmental Fate and Ecological Effects Pr eliminary Risk Assessment for the Registration Review of Fluazinam

.

 September 2014

– The Agency is now publishing the Fluazinam Proposed Interim Registration Review Decision , dated September 17 , 2014 in docket number EPA

- HQ

OPP

- 2009

- 0039 for a 60

- day public comment period.

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

, EPA

- HQ

- OPP

2009

- 0039, accessed at www.regulations.gov

.5

A. Public Comments

During the 60

- day public comment period for the draft human health and environmental
risk assessments

, one comment was submitted to the public docket by ISK Bi osciences Corporation (ISK ), the only technical registrant of fluazinam

. ISK cited seve ral studies to support the use of a shorter foliar residue half

- life value (7.33 days) tha n the default 35 day half

life value used in the initial environmental risk a ssessment. After review, the Agency found t hat the submitted data supports the use of a 7.33 day foliar half

- life for the assessment of fluazinam to terrestrial organisms for the peanut and potato uses onl y, as these were the crops that were
used in the studies to derive the shorter foliar dissipation half

- life value

. The use of the revised
half

- life (for peanuts and potatoes) resulted in a significant reduction to the acute and chronic

r isk q uotients (RQs) for terrestrial organism s. In the determination of a shorter foliar dissipation
half

- life value, t ypically, the Agency can supplement th e default half

- life of 35 days provided
that acceptable residue data on a minimum of three crops is provided to the Agency

. Because acceptable data for only two crops (potatoes, peanuts ) were available, the Agency could not apply the revised half

- life to any of the other registered cro ps. However, it should be noted that
potatoes and peanuts account for approximately 90% of all fluazinam use. The Agency’s findings after revising the terrestrial risk assessment are presented in the Addendum to the

Environ mental Fate and Ecological Effects Preliminary Risk Assessment for the Registration Review of Fluazinam , dated April 1, 2014. The Agency’s response to public comments is presented in the Response to Public C omments on the Preliminar y Envir onmental Fate and Ecological Risk Assessment for the Registration of Fluazinam , dated November 25, 2014.



### 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, a n average of 57,000 lbs fluazinam was 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 indicates the average total number of applications and average maximum application
rates for use on potatoes and peanuts is 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 h ow recently it was registered for use on these sites.6



### III. SCIENTIFIC ASSESSMENTS

A. Human Health

A summary of the Agency’s human health risk assessment is presented below. 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, aggreg ate, 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.

2. 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, and Mexico.

B. Ecologic al

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

- listed species only.

The Agency also completed a s creening

- level endangered and threatened (listed) s pecies
assessment for fluazinam and identified potential risks to several taxa ( birds; mammals;
freshwater and estuarine /marine fish, invertebrates and sediment

- dwelling invertebrates; 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 scientific 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 herein.

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 most7

conditions. T herefore, some of these transformation products are considered with parent fluazinam as part of the total toxic residues (TTR) analysis which was conducted for aqu atic
environments. In the a

bsence of 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 a re several orders magnitude less toxic than fluazinam to aquatic taxa, so these were excluded from TTR analysis. The remaining 5 degradates were estimated to be approximately 1

- 2 orders of magnitude less toxic than parent fluazinam, but were included in t he TTR and assumed to have similar toxicity characteristics to parent fluazinam to account for the uncertainty in the SAR analysis estimate.

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 see 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 ecotoxicity studies using the risk quotient method. Risk quotients (RQs) are calculated by dividing acute and chronic estimated environmental concentrations (EECs) by ecotoxicity values for various wildlife and plant species. RQs are then compared to levels of concern (LOCs), 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
informa tion on potential adverse effects and the possible impact 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 chronic exposure scenarios for non

- listed aquatic and terrestrial organisms, the Agency believes that the overall ecological risk from fluazinam is minimal and risk is not ex pected because 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 label ed rates vs. typical use information; and, the use
of a default residue half

- life value of 35

- days for certa in crops in the absence of data. In addition, fluazinam plays an important role in resistance management because its mode of action
is different fr om the registered alternatives and it has a low risk of developing resistance when compared with other reg istered fungicide alternatives [ Characterization of Fluazinam Use and Usage on Major Crops (mainly Potatoes and Peanuts) , Apri l 7, 2014]

.

Terrestria l Assessment

The primary route of exposure for terrestrial organisms is the dietary 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 uses8

resulted in RQs that exceed the LOCs. For terrestrial plants there are no LOC exceedances

. T he Agency found that a shorter foliar dissipation half

- life for calculating risk from terrestrial exposure from the pean ut and potato use was appropriate, which substantially reduced the risk estimates for these uses for terrestrial organisms. Although the shorter half

- life value casts uncertainty on the
default half

- life value used to assess terrestrial risk from the othe r 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 3 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 fluaz inam 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 part of sta ndard screening level ecological risk assess ment 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 ).

Using 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 marginal LOC
exceedances for these two uses. The chronic

- dose based RQ exceedances ranged from 1.43

– 7. 95 ( peanuts ) and 1.10

- 5.24 ( potatoe s ) . 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

- lis ted 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 m arginal chronic LOC exceedances, RQs ranged from 1.07

– 4.09 (bulb vegetables; cucurbit

, respectively ).

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. The Agency’s calculated RQs that exceed the
LOCs for acute risk to non

- listed freshwater fish and estuarine/marine invert ebrates and for chronic risk to freshwater fish, freshwater sediment

- dwelling invertebrates and estuarine/marine
invertebrates. For aquatic nonvascular plants all uses exceed the LOC. Data were not available to estimate risk to vascular plants. A number of scenarios exceed the Agency’s chronic LOC for aquatic risk.9

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

, aquatic invertebrates , and aquatic plants were exposed to fluazinam and its 5 degradates of concern ; and conducted a total
toxic residue analysis (TTR). In this type of TTR analysis, the Agency assumes that the degradates have similar toxicity characteristics to the parent. In the absence of toxicity data on
the eight individual degradates of fluazinam, the Agency conducted a structure

- activity relationship (SAR) analysis to estimate their toxicity. This analysis determined that three of the degradates are several orders magnitude less toxic than fluazinam to aquatic taxa, and so these
were excluded from th e TTR analysis. The remaining five degrad ates were estimated to be approximately 1

- 2 orders of magnitude less toxic than parent fluazinam, but were included in the TTR and assumed to have similar toxicity characteristics to parent fluazinam to account fo r the uncertainty in the SAR analysis estimate.

There is also some uncertainty in how quickly parent fluazinam 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 quickly in aquatic environments, which means that the majority of chronic aquatic exposure is to the fluazinam degradates. Given the conservative assumptions in the assessment of chronic aquatic risk, the Agency believe s that actual risk to aquatic taxa is not expected

.

C. 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 Services) , and the U.S. D epartment of Agriculture (USDA) released a summary of their joint Interim Approaches for assessing risks to listed species from pesticides. The Interim Approaches were developed jointly by the

a g encies in response to the N ational A cademy of S ciences’ (NAS ) recommendations and reflect a common approach to risk assessment shared by the a gencies as a way of addressing scientific
differences between the EPA and the Services. The NAS report outline s 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 presented the joint Interim Approaches at the
December 2013 P esticide P rogram D ialogue C ommittee (PPDC) and S tate

- FIFRA Issues
Research and E valuation Group ( SFIREG ) meetings, and held a stakeholder workshop in April 2014, allowing additional opportunities for stakeholders to comment on the Interim Approaches. As part of a phased, iterative process for developing the Interim Approaches, the ag encies will also consider public comments on the Interim Approaches in connection with the development of upcoming r egistration 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,” dated November 1, 2013.

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 t his Proposed Interim10

Registration Review Decision for fluazinam does not contain a complete ESA analysis that includes effects determinations for specific listed species or designated critical habitat

. Although EPA has not yet completed effects determinat ions 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 that listed species and designated
critical habitat s may be present in the vicinity of the application of fluazinam . 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
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, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, 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, reproductive loss, and sex ratios in offspring. For ecological hazard assessme nts, 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 sens itive 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 similar 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, an drogen, 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

- ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingred ients. A second list of11

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 Review, the Agency will make an EDSP FFDCA 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 with fluazinam, a relatively high proportion that su ggests a large number of growe rs find the chemical usef u l. In addition , data suggest that the average number of applications for peanut s and potato es (the primary uses of fluazinam) are less than the highest number of applications allowed on current labels

. The screening level ecologi cal risk assessment
calculated RQs using the highest labeled application rates to be protective of potential risk. However, based on the available use and usage data, average use rates are much lower then what is currently labeled . This usage data sugges ts that actual environmental concentration (EECs) and corresponding 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 mem orandum Characterization of Fluazinam Use and Usage on Major Crops (mainly Potatoes and Peanuts) , dated April 7, 3014.



### V

. PROPOSED 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 organ isms, the Agency believes that the overall ecological risk from fluazinam is minimal and risk is not expected because the ecological risk assessment is a screening level analysis for which conservative assumptions were used which may over estimate risk. I n addition, fluazinam plays an important role in resistance management because its mode of action is different from the registered alternatives and it has a low risk of developing resistance when compared with other registered fungicide alternatives. Ther efore, h uman health and ecological risk mitigation i s not required because the currently regi stered uses of fluazinam do not, on the basis of current analysis, warrant any mitigation.

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/12

B. Proposed Interim Registration Review Decision

In accordance with 40 CF R Sections 155.56 and 155.58, the Agency is issuing this

P roposed I nterim R egistration R eview D ecision. Except for the EDSP and ESA components of this case, the Agency has made the following Proposed Interim Registration Review Decision: (1) no additional data are required at this time; and (2) no changes to the affected registrations and their labeling are needed at this time.

In this proposed interim registration rev iew 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 expects to issue a Final Decision on the fluazinam registratio n review case after both (1) conclusion of ESA Section 7 consultatio n with the Services, and (2) an EDSP FFDCA section 408(p) determination has been made.



### V I

. NEXT STEPS AND TIMELINE

A. Interim Registration Review Decision

In accordance with 40 CFR Sectio ns 155.56 and 155.58, the Agency is issuing this Proposed Interim Registration Review Decision, and placing it in the fluazinam registrat ion review docket (EPA

- HQ

- OPP

- 2009

- 0039 ) for public comment for 60 days. A Federal Register
N otice will announce the availability of this P roposed I nterim R egistration R eview D ecision for
fluazinam and initiate 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 will issue an I nterim R egistration R eview D ecision for fluazinam (case 7013 ).