Docket Number EPA-HQ-OPP-2009-0039 

www.regulations.gov 

Fluazinam 

Proposed Interim Registration Review Decision 

Case Number 7013 

September 2014 

Approved by: S^^icvcci P Vjei^tr^. Y) 

Richard P. Keigwin, Jr. 

Director 

Pesticide Re-evaluation Division 

Date: ^'H-^i^j-
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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

IV. 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..................................................................................12
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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 appropriate, an Interim Registration Review Decision before completing a 

registration review. Among other things, an Interim Registration Review Decision may 1)

require new risk mitigation 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 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 fungicide 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 

reregistration

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 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 Work Plan

(PWP) and was accompanied by the scoping document and problem formulation.

 March 9, 2010 – Final Work Plan (FWP) for fluazinam was issued. Two public 

comments were received during the 60-day comment period for the fluazinam PWP.

However, the FWP did not modify the PWP. 
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 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 Health 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 Preliminary 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-HQOPP-2009-0039 for a 60-day public comment period.

Additional information on fluazinam can be found in EPA’s public docket, EPA-HQ-OPP2009-0039, accessed at www.regulations.gov.
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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 Biosciences 

Corporation (ISK), the only technical registrant of fluazinam. ISK cited several studies to 

support the use of a shorter foliar residue half-life value (7.33 days) than the default 35 day halflife value used in the initial environmental risk assessment. After review, the Agency found that 

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 only, 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 

risk quotients (RQs) for terrestrial organisms. In the determination of a shorter foliar dissipation 

half-life value, typically, the Agency can supplement the 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 crops. 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 

Environmental 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 Comments on the Preliminary Environmental 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, an 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 peanuts, 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 how recently it was registered for use on these sites. 
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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 fluazinam. 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.

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. Ecological

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. This Proposed 

Interim Registration Review Decision focuses primarily on risk to non-listed species only. 

The Agency also completed a screening-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 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 persistent under most 
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conditions. Therefore, some of these transformation products are considered with parent 

fluazinam as part of the total toxic residues (TTR) analysis which was conducted for aquatic 

environments. In the absence 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 are 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 the 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 days 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 

information 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 expected because the 

ecological risk assessment is a screening 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 rates vs. typical use information; and, the use 

of a default residue half-life value of 35-days for certain crops in the absence of data. In 

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 [Characterization of Fluazinam Use and 

Usage on Major Crops (mainly Potatoes and Peanuts), April 7, 2014]. 

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

Agency found that a shorter foliar dissipation half-life for calculating risk from terrestrial exposure 

from the peanut 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 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 3 values available on different representative 

crops. However, 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 above the LOC of 1 for all uses. As 

part of standard 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. Across mammal 

sizes, feeding categories and uses, chronic dose-based RQ exceedances (for all uses except 

peanuts and potatoes) ranged from 1.35 – 33.51 (ginseng; cucurbits and fruiting vegetables, 

respectively). Chronic 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 (potatoes). The 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 risks of concern for non-listed 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). Among the uses with marginal 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 invertebrates 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. 
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For acute and chronic exposure, the 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 the TTR analysis. The remaining five degradates 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 for 

the uncertainty in the SAR analysis estimate. 

There is also some uncertainty in how quickly parent fluazinam degrades in aquatic 

environments. Aerobic 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 believes 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. Department 

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 

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 presented the joint Interim Approaches at the

December 2013 Pesticide Program Dialogue Committee (PPDC) and State-FIFRA Issues 

Research and Evaluation 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 agencies will 

also consider public comments on the Interim Approaches in connection with the development of 

upcoming registration review 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 this Proposed Interim 
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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 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 that listed species and designated 

critical habitats may be present in the vicinity of the application of fluazinam. This screeninglevel 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 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 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, 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-ins for the first group of 67 

chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of 
11

chemicals identified for EDSP screening was published on June 14, 20131, 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 suggests a large 

number of growers find the chemical useful. In addition, data suggest that the average number 

of applications for peanuts and potatoes (the primary uses of fluazinam) are less than the highest 

number of applications allowed on current labels. The screening level ecological 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 suggests 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 memorandum 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 organisms, 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. In 

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. Therefore, human health and ecological 

risk mitigation is not required because the currently registered 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/
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B. Proposed Interim Registration Review Decision

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

Proposed Interim Registration Review Decision. 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 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 expects to issue a Final Decision on the 

fluazinam registration review case after both (1) conclusion of ESA Section 7 consultation with 

the Services, and (2) an EDSP FFDCA section 408(p) determination has been made. 

VI. NEXT STEPS AND TIMELINE

A. Interim Registration Review Decision

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

Proposed Interim Registration Review Decision, and placing it in the fluazinam registration 

review docket (EPA-HQ-OPP-2009-0039) for public comment for 60 days. A Federal Register 

Notice will announce the availability of this Proposed Interim Registration Review Decision 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 Interim Registration Review Decision for fluazinam

(case 7013).