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 Conclusions.......................................................................................................... 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 Mitigation and Regulatory Rational.........................................................13

 B. Interim Registration Review Decision.............................................................13

VI. NEXT STEPS AND TIMELINE.......................................................................................... 14

A. Registration Review Decision...............................................................................................14

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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 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) 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 Preliminary Risk Assessment for the Registration Review of 

Fluazinam, April 1, 2014.

• September 2014 – The Agency published the Fluazinam Proposed Interim Registration 

Review Decision, September 17, 2014, for a 60-day public comment period. Two 

comments were received. 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 2015 – 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-OPP2009-0039, accessed at www.regulations.gov.

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A. 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 mention various aspects of the risk assessment process, including use 

of the best available data to develop endangered species risk assessments, and evaluation of 

effects on endangered and threatened species (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 Agency 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 Academy 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 agency’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 Agency will 

complete its endangered species assessment for fluazinam and issue a final decision for 

registration review. See Section III. (C.) for a description of the Agency’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 

symptoms.

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, the Agency 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. Based 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 monitor the incident information and if a concern is triggered, 

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

National Pesticide Information Center: http://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 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 indicate the average total number of applications and average maximum application 

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 registered 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: Incorporation of New Acute 

Toxicity Data and Updated Restricted Entry Interval (REI), dated February 14, 2013 and in the 

public docket (EPA-HQ-OPP-2009-0039) 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 

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.

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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, or 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 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 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 

conditions. In the absence 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 aquatic taxa, so these were excluded from a Total Toxic 

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 conducted 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 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 

7
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 eco-toxicity 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 low and risks of concern are considered 

unlikely as 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;

the use of a default residue half-life value of 35-days for certain 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 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 

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

Agency found that using 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 three 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 

8
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 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 chronic LOC exceedances, 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 assessment. 

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 avian risk assessment it was assumed that 

100% of an avian 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 the target LOCs for the following non-listed taxa:

Acute, Aquatic Fish & Invertebrates

• Freshwater fish RQs = 1.06 - 1.15 (apples; cucurbit vegetables, melon)

• Estuarine/marine invertebrates RQs = 1.07 - 8.81 (ginseng; cucurbit vegetables, melon)

• Estuarine/marine sediment dwelling invertebrates, pore water RQs = 1.02 - 1.81 (fruiting 

vegetables, peppers, eggplant)

Chronic, Aquatic Fish & Invertebrates

• Freshwater fish RQs = 1.10 - 13.59 (brassica (cole) leafy vegetables; apples)

• Freshwater sediment-dwelling invertebrates RQs = 1.27 - 4.09 (carrots; fruiting 

vegetables, peppers, eggplants)

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• Freshwater sediment-dwelling invertebrates, pore water RQs = 1.22 - 3.96 (carrots; 

fruiting vegetables, peppers, eggplants)

• Estuarine/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, the 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 relationship (SAR) analysis to estimate 

their toxicity. This analysis determined that three of the degradates were several orders of 

magnitude less toxic than parent fluazinam to aquatic taxa, and so these were excluded from the 

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 the TTR analysis

given the uncertainty in the SAR analysis. There is also some uncertainty as to 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 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 products (EPA Registration Numbers 71512-1 

and 71512-20) have use restrictions that prohibit 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 streams, marshes or natural ponds, and estuaries). For 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 

vegetative buffer/setback of 25 ft. from the perimeter of permanent 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) cannot be applied aerially (“Do 

not apply Fluazinam Turf by aerial application”). Assessment tools are not currently available to 

the Agency to quantitatively evaluate 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 an effective means of substantially reducing runoff and erosion

from agricultural fields thereby reducing potential aquatic exposures. Alternatively, 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 approach and maximum application and use rates. In addition, 

although they cannot quantitatively be assessed, current label restrictions (buffer zones) and 

other application restrictions likely reduce aquatic environmental exposure. 

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C. 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 National 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 November 2013, EPA, the U.S. Fish and Wildlife Service, National Marine Fisheries 

Services (the Services), and the U.S. Department of Agriculture released a white paper 

containing a summary of their joint Interim Approaches for assessing risks to listed species from 

pesticides. These Interim Approaches were developed jointly by the agencies in response to the 

NAS recommendations, and reflect a common approach to risk assessment shared by the 

agencies as a way of addressing scientific differences between the EPA and the Services. Details 

of the joint Interim Approaches are contained in the November 1, 2013 white paper, Interim 

Approaches for 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 assessment 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 common 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 evaluations on the 

types of species where the potential for effects exists, once the scientific methods being 

developed by the agencies have been fully vetted. Once the agencies have fully developed and 

implemented the scientific methods necessary to complete risk assessments for listed species and 

their designated critical habitats, these methods will be applied to subsequent analyses of 

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, 

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

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

11

 
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 

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 website2

. 

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 and single maximum application rates for peanuts and potatoes (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/

12

 
rates allowed on current labels. The screening level ecological risk assessment calculated RQs 

using the highest labeled application rates and the maximum allowed 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 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, 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 fluazinam 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 labeled 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 which 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 equipment 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 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]. 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 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.

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In 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 upon 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 ESA and EDSP 

FFDCA section 408(p) determinations have been made.

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