Document ID: EPA-HQ-OPP-2008-0148-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-09-15T04:00Z

SEQ CHAPTER \h \r 1 

				

Problem Formulation for the Environmental Fate and Ecological Risk
Assessment in Support of the Registration Review of Flutolanil

Flutolanil (CAS 66332-96-5)

May 19, 2008

Prepared by:

Larry Liu, Chemist, ERB-5

Keith Sappington, Biologist, ERB-5	U. S. Environmental Protection Agency

Office of Pesticide Programs

Environmental Fate and Effects Division

Environmental Risk Branch IV

1200 Pennsylvania Ave., NW

Mail Code 7507P

Washington, DC 20460

Reviewed by:

Mah Shamim, Branch Chief, ERB-5

	

Table of Contents

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc198968431"  Table of
Contents	  PAGEREF _Toc198968431 \h  2  

  HYPERLINK \l "_Toc198968432"  List of Tables	  PAGEREF _Toc198968432
\h  3  

  HYPERLINK \l "_Toc198968433"  List of Figures	  PAGEREF _Toc198968433
\h  3  

  HYPERLINK \l "_Toc198968435"  I.  Purpose	  PAGEREF _Toc198968435 \h 
4  

  HYPERLINK \l "_Toc198968436"  II.  Problem Formulation	  PAGEREF
_Toc198968436 \h  4  

  HYPERLINK \l "_Toc198968437"  A.  Nature of Regulatory Action	 
PAGEREF _Toc198968437 \h  4  

  HYPERLINK \l "_Toc198968438"  B.  Conclusions from Previous Risk
Assessments	  PAGEREF _Toc198968438 \h  4  

  HYPERLINK \l "_Toc198968439"  1.  Drinking Water Assessment for Use of
Flutolanil on Rice	  PAGEREF _Toc198968439 \h  4  

  HYPERLINK \l "_Toc198968440"  2.  Drinking Water Assessment for Use of
Flutolanil on Potato Seed Piece	  PAGEREF _Toc198968440 \h  6  

  HYPERLINK \l "_Toc198968441"  3.  Section 3 New Use on Potato
Seed-Pieces (2000)	  PAGEREF _Toc198968441 \h  7  

  HYPERLINK \l "_Toc198968442"  4.  Human Health Risk Assessment:
Request for Inadvertent or Indirect Tolerances for Use on Soybean,
Wheat, Corn and Cotton (2007)	  PAGEREF _Toc198968442 \h  9  

  HYPERLINK \l "_Toc198968443"  III.  Stressor Source and Distribution	 
PAGEREF _Toc198968443 \h  10  

  HYPERLINK \l "_Toc198968444"  A.  Mechanism of Action	  PAGEREF
_Toc198968444 \h  10  

  HYPERLINK \l "_Toc198968445"  B.  Overview of Pesticide Usage	 
PAGEREF _Toc198968445 \h  10  

  HYPERLINK \l "_Toc198968446"  C.  Environmental Fate and Transport	 
PAGEREF _Toc198968446 \h  13  

  HYPERLINK \l "_Toc198968447"  IV.  Receptors	  PAGEREF _Toc198968447
\h  18  

  HYPERLINK \l "_Toc198968448"  A.  Aquatic and Terrestrial Effects	 
PAGEREF _Toc198968448 \h  18  

  HYPERLINK \l "_Toc198968449"  B.  Ecosystems Potentially at Risk	 
PAGEREF _Toc198968449 \h  21  

  HYPERLINK \l "_Toc198968450"  V.  Assessment Endpoints	  PAGEREF
_Toc198968450 \h  21  

  HYPERLINK \l "_Toc198968451"  VI. Conceptual Model	  PAGEREF
_Toc198968451 \h  21  

  HYPERLINK \l "_Toc198968452"  A.  Risk Hypothesis	  PAGEREF
_Toc198968452 \h  22  

  HYPERLINK \l "_Toc198968453"  B.  Conceptual Diagram	  PAGEREF
_Toc198968453 \h  22  

  HYPERLINK \l "_Toc198968454"  VII.  Analysis Plan	  PAGEREF
_Toc198968454 \h  25  

  HYPERLINK \l "_Toc198968455"  A.  Stressors of Concern	  PAGEREF
_Toc198968455 \h  25  

  HYPERLINK \l "_Toc198968456"  B.  Measures of Exposure	  PAGEREF
_Toc198968456 \h  25  

  HYPERLINK \l "_Toc198968457"  C.  Measures of Effect	  PAGEREF
_Toc198968457 \h  27  

  HYPERLINK \l "_Toc198968458"  D.  Integration of Exposure and Effects	
 PAGEREF _Toc198968458 \h  28  

  HYPERLINK \l "_Toc198968459"  1.  Deterministic and Probabilistic
Assessment Methods	  PAGEREF _Toc198968459 \h  28  

  HYPERLINK \l "_Toc198968460"  E.  Endangered Species Assessments	 
PAGEREF _Toc198968460 \h  28  

  HYPERLINK \l "_Toc198968461"  F.  Preliminary Identification of Data
Gaps	  PAGEREF _Toc198968461 \h  30  

  HYPERLINK \l "_Toc198968462"  1. Environmental Fate	  PAGEREF
_Toc198968462 \h  30  

  HYPERLINK \l "_Toc198968463"  2. Ecological Effects	  PAGEREF
_Toc198968463 \h  31  

  HYPERLINK \l "_Toc198968464"  3. Rationale for Data Call In	  PAGEREF
_Toc198968464 \h  34  

  HYPERLINK \l "_Toc198968465"  VIII. Bibliography	  PAGEREF
_Toc198968465 \h  37  

  HYPERLINK \l "_Toc198968466"  A. Fate References	  PAGEREF
_Toc198968466 \h  37  

  HYPERLINK \l "_Toc198968467"  B.  Ecological Effects References	 
PAGEREF _Toc198968467 \h  39  

 

List of Tables

  TOC \h \z \c "Table"    HYPERLINK \l "_Toc198968501"  Table 1. 
Drinking Water Estimated Concentrations Based on the July 2, 1998 Risk
Assessment.	  PAGEREF _Toc198968501 \h  5  

  HYPERLINK \l "_Toc198968502"  Table 2  Drinking Water Estimated
Concentrations Based on the December 13, 1999 Risk Assessment.	  PAGEREF
_Toc198968502 \h  7  

  HYPERLINK \l "_Toc198968503"  Table 3. Uses and application rates for
flutolanil.	  PAGEREF _Toc198968503 \h  11  

  HYPERLINK \l "_Toc198968504"  Table 4.  Physical and Chemical
Properties for Flutolanil and its Degradate [desisopropyl flutolanil
(DIP)].	  PAGEREF _Toc198968504 \h  14  

  HYPERLINK \l "_Toc198968505"  Table 5.  Summary of Environmental Fate
data for Flutolanil	  PAGEREF _Toc198968505 \h  15  

  HYPERLINK \l "_Toc198968506"  Table 6.  Test Species Evaluated for
Assessing Potential Acute and Chronic Ecological Effects of Flutolanil.	
 PAGEREF _Toc198968506 \h  19  

  HYPERLINK \l "_Toc198968507"  Table 7. Environmental Fate Data
Requirements for Flutolanil.	  PAGEREF _Toc198968507 \h  30  

  HYPERLINK \l "_Toc198968508"  Table 8. Ecological Effects Data
Requirements for Flutolanil.	  PAGEREF _Toc198968508 \h  32  

  HYPERLINK \l "_Toc198968509"  Table 9.   Environmental Fate and
Ecological Effects Data Needs for Flutolanil.	  PAGEREF _Toc198968509 \h
 35  

  

List of Figures

  TOC \h \z \c "Figure"    HYPERLINK \l "_Toc198968529"  Figure 1. 
Conceptual model for flutolanil effects on aquatic organisms.	  PAGEREF
_Toc198968529 \h  23  

  HYPERLINK \l "_Toc198968530"  Figure 2. Conceptual Model of Flutolanil
Effects on Terrestrial Organisms.	  PAGEREF _Toc198968530 \h  24  

 I.  Purpose 

	The purpose of this problem formulation is to provide an understanding
of what is known about the environmental fate and ecological effects of
the registered uses of flutolanil. This document will provide a plan for
analyzing data relevant to flutolanil and for characterizing the
ecological risks of its registered uses.  Additionally, this problem
formulation is intended to identify data gaps, uncertainties and
potential assumptions to address those uncertainties relative to
characterizing the ecological risk associated with the registered uses
of flutolanil.  Flutolanil is a fluorinated toluanilide fungicide with
uses on potatoes, rice, peanuts, turf and ornamentals.

II.  Problem Formulation

A.  Nature of Regulatory Action

	The Food Quality Protection Act of 1996 mandated the EPA to implement a
new program, i.e., registration review (  HYPERLINK
"http://www.epa.gov/oppsrrd1/registration_review/" 
http://www.epa.gov/oppsrrd1/registration_review/ ). All pesticides
distributed or sold in the United States generally must be registered by
EPA.  The decision to register a pesticide is based on the consideration
of scientific data and other factors showing that it will not cause
unreasonable risks to human health, workers, or the environment when
used as directed on product labeling. The registration review program is
intended to ensure that, as the ability to assess risk evolves and as
policies and practices change, all registered pesticides continue to
meet the statutory standard of no unreasonable adverse effects to human
health and the environment. Changes in science, public policy, and
pesticide use practices will occur over time. Through the new
registration review program, the Agency periodically reevaluates
pesticides to make sure that as change occurs, products in the
marketplace can be used safely. 

	As part of the implementation of the new Registration Review program
pursuant to Section 3(g) of the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA), the Agency is beginning its evaluation to
determine whether flutolanil continues to meet the FIFRA standard for
registration. This problem formulation for the environmental fate and
ecological risk assessment chapter in support of the registration review
is intended for the initial docket opening the public phase of the
review process. 

B.  Conclusions from Previous Risk Assessments 

1.  Drinking Water Assessment for Use of Flutolanil on Rice

	The Agency completed a drinking water assessment for use of flutolanil
on rice on July 2, 1998.  GENEECX-Beta Version Model and EFED Interim
Rice Model were used to estimate concentrations in surface water used as
a source of drinking water.  Ground water EECs were modeled using
SCI-GROW, a screening groundwater regression model developed using data
from prospective groundwater studies submitted to the OPP in support of
registration.  SCI-GROW provides a reasonable high-end estimate of
ground water concentrations of pesticides within a defined set of fate
and transport characteristics on soils that are known to be vulnerable
to pesticide leaching (high sand content with shallow depth to
groundwater).   The EECs from the modeling mentioned above are
summarized in Table 1.

Table   SEQ Table \* ARABIC  1 .  Drinking Water Estimated
Concentrations Based on the July 2, 1998 Risk Assessment.

Modeling

	

Groundwater	

Surface Water

	

Concentration	

Acute EECs	

Chronic EECs

Estimated Groundwater Conc.(SCI-GROW Model) 

0.5 lb ai/A/application, 2 applications/year,  and 1.0 lb ai/A/year
0.999 ppb	N/A	N/A

Estimated Surface Water Conc. (GENEECX-Beta Version) 

0.5 lb ai/A/application, 2 applications/year, and 1.0 lb ai/A/year 	

N/A	

565 ppb	

542 ppb

+

Estimated Surface Water Conc. (EFED Interim Rice Model) 

0.5 lb ai/A/application, 2 applications/year, and 1.0 lb ai/A/year 	

N/A	

11.7 ppb	

3.78 ppb

The 1998 drinking water assessment concluded that because of the high
uncertainty associated with the estimated surface water concentrations
of flutolanil generated by either GENEECX-Beta Version Model or the
Interim Rice Model, neither model was recommended over the other for
drinking water risk assessments. The Agency further noted the
difficulties with extrapolating concentrations of pesticides in “paddy
water” to concentrations that may be observed at the drinking water
intake. However, the Agency considered the estimated concentrations
using GENEECX as establishing a conservative upper-end bounding estimate
of concentrations that might have been observed at drinking water
intakes. As a result, the Agency concluded if the levels of concern for
flutolanil were not exceeded with these concentrations, real world
exposure would not likely exceed these levels. Estimates generated with
the Interim Rice Model may have well provided an upper end estimate of
concentrations at drinking water intakes as well. However, because these
estimates were substantially lower than an equally reasonable model,
GENEECX, the Agency did not select one over the other. The SCI-GROW
indicated that flutolanil would not likely be found in significant
concentrations in groundwater. Concentrations of this compound were
calculated based on a maximum annual application rate of 1.0 lb a.i/A.
Since the groundwater concentrations were developed through a screening
model and no monitoring data were used, the Agency was only moderately
confident of these estimates.

	It should be noted that the application rates used in the 1998 Drinking
Water Assessment for Use of Flutolanil on Rice were slightly different
from those in the labels for the registration review.  The single
application rate and the yearly application rate used in GENEECX,
Interim Rice, and SCI-GROW modeling in the 1998 Drinking Water
Assessment for Use of Flutolanil on rice were 0.5 lb ai/A and 1.0 lb
ai/A, respectively.   However, according to the labels in the
registration review, flutolanil can be aerially applied to the rice
plants with a single application rate ranging from 0.35-0.75 lb ai/A and
with a maximum yearly rate of 1.0 lb ai/A.  The labels that allow the
use of flutolanil on rice under the registration review include:

Reg. No. 71711-3  (Moncut 50W)

Reg. No. 71711-14(Moncut 70 DF)

Reg. No. 71711-1(Moncut 70WP)

	SLN No. AR-050007 (Moncut SC– it does not have a Reg. No. because it
is still a pending registration) 

2.  Drinking Water Assessment for Use of Flutolanil on Potato Seed Piece

The Agency completed a drinking water assessment for use of flutolanil
on potato seed piece on December 13, 1999.  PRZM/EXAMS modeling using
the Index Reservoir (IR) and the Percent Crop Area (PCA) adjustment was
used to estimate concentrations in surface water used as a source of
drinking water.  The index reservoir represents a watershed that is more
vulnerable than most used as drinking water sources.  Ground water EEC
were modeled using SCI-GROW, a screening groundwater regression model
developed using data from prospective groundwater studies submitted to
the OPP in support of registration.  SCI-GROW provides a reasonable
high-end estimate of ground water concentrations of pesticides within a
defined set of fate and transport characteristics on soils that are
known to be vulnerable to pesticide leaching (high sand content with
shallow depth to groundwater). 

	PRZM/EXAMS 1-in-10 year estimated environmental concentrations
suggested that flutolanil might have been found in surface water used as
a source of drinking water at peak concentrations up to 0.63 µg/L and
0.28 µg/L from use on potatoes in Idaho and Maine, respectively and on
a long-term basis (mean) at 0.13 µg/L and 0.05 µg/L from use on
potatoes in Idaho and Maine, respectively.  SCI-GROW estimated
environmental concentrations in ground water, independent of the use
area, were found at concentrations up to 0.34 µg/L; peak and mean
concentrations.  The Agency concluded that due to flutolanil’s low
adsorption coefficients and long metabolic half-life, the major
mechanism of dissipation in surface and ground water would likely be
dilution.  Based on flutolanil’s structure, the Agency indicated that
flutolanil would not likely be significantly affected by chemical
oxidation employed at most community water systems. EECs from the
modeling mentioned above are summarized in Table 2.

Table   SEQ Table \* ARABIC  2   Drinking Water Estimated Concentrations
Based on the December 13, 1999 Risk Assessment.

Agricultural Setting	

Surface Water Concentrations (ppb)	

Ground Water Concentrations (ppb)

Rice

	

1-in-10 year Peak	

1-in- 10 year Mean	

                          

0.34

	

11.6	

3.75

	

Potatoes in Idaho	

1 in 10 Year Peak	

1 in 10 Year Mean

0.63	

0.13

	

Potatoes in Maine	

1 in 10 Year Peak	

1 in 10 Year Mean

0.28	

0.050

	

It should be noted that the application rates used in the 1998 Drinking
Water Assessment for Use of Flutolanil on Potato Seed Piece were
slightly different from those in the labels for the registration review.
 The application rate used in PRZM/EXAM and SCI-GROW modeling in the
1999 Drinking Water Assessment for Use of Flutolanil on Potato Seed
Piece was 0.65 lb ai/A which is more than twice the rate (0.25 lb ai/A)
as stated in the current MonCoat MZ (Reg. No. 71711-8) label considered
for registration review..  However, the application rate (0.65 lb ai/A)
used in the  PRZM/EXAMS and SCI-GROW modeling in the 1999 Drinking Water
Assessment for Use of Flutolanil on Potato Seed Piece was lower than the
rate (0.75 lb ai/A) when flutolanil is sprayed around and over the seed
pieces in a 4-8 inch band prior to covering with soil (Moncut 50W. Reg.
No. 71711-3). 

3.  Section 3 New Use on Potato Seed-Pieces (2000)

	Pursuant to FIFRA Section 3, the Agency completed a screening-level
environmental fate and ecological risk assessment for a new flutolanil
use on February 15, 2000 (USEPA 2000; D260099).  This proposed new use
consisted of a single application of 1.0 lbs product (0.015 lbs. a.i.)
per 100 lbs of cut potato seed pieces for the control of Fusarium dry
rot and Rhizoctonia stem canker.  According to this new use, flutolanil
is co-formulated with Mancozeb (6 percent) in an Adler bark dust
formulation and is applied immediately after cutting followed by general
planting practices.  This new use assessment was based on
laboratory/field fate and ecotoxicological data submitted by the
registrant and from data in publicly available literature.

 

	The environmental fate assessment concluded that flutolanil is
practically resistant to all modes of abiotic and biotic degradation.
Degradation half lives were not calculated for abiotic processes
(hydrolysis, photolysis) because they extended well beyond the study
duration.  Biotic degradation half lives (metabolism in aerobic soils,
aerobic aquatic, anaerobic aquatic) were all greater than 200 days.  
SEQ CHAPTER \h \r 1 The degradate, desisopropyl flutolanil (DIP) is
considered more mobile than the parent and no other degradate data were
available.

	The ecological toxicity assessment concluded that flutolanil is
practically nontoxic to birds, mammals, and insects (honeybee) on an
acute and subacute basis.  

	Flutolanil was found to be moderately toxic to freshwater fish and
invertebrates on an acute basis and highly toxic to estuarine/marine
invertebrates on an acute basis.  On a chronic toxicity basis,
flutolanil was found to cause adverse effects on avian reproduction
(decreased egg production and egg shell thickness), growth of fish,
freshwater invertebrate reproduction rate (number of young/adult) and
survival, reproduction and growth of estuarine/marine invertebrates.  

	Based on the available information, the 2000 screening level risk
assessment concluded that flutolanil would not likely to pose a risk of
acute or chronic toxicity to non-target animals.  The risk associated
with the co-formulated product was not addressed due to the lack of
information on effects to terrestrial and aquatic organisms. Flutolanil
was considered persistent in the environment under aerobic and anaerobic
conditions and  likely to reach surface water sorbed to soils, organic
materials, and in dissolution and reach ground water despite information
from the field dissipation studies which showed that flutolanil appeared
to bind to soils. The assessment further concluded that the proposed
application method (seed-piece dust treatment) and the general
agricultural practice (planting the seed-piece at 2 or more inches below
the surface followed by mounding of approximately 2 inches of additional
soil) would likely reduce the likelihood of surface water runoff but
potentially exacerbate leaching to ground water.

	The primary environmental concerns identified in the environmental fate
and ecological risk assessment in support of the registration for
flutolanil associated with the (now historical) uses of flutolanil
(USEPA, 2000) were the behavior of the co-formulated product (flutolanil
is co-formulated with mancozeb (6%) in an Adler bark dust formulation)
in the environment.  Specifically, it was uncertain whether the two
active ingredients would behave independently or impart a synergistic or
antagonistic effect on non-target species.  

	As a result of this assessment, a number of data needs were identified.
 Regarding environmental fate, a bare ground terrestrial field
dissipation study was recommended.  In response, the registrant
submitted one aerobic soil metabolism study (MRID 45756601) and two
terrestrial field dissipation studies (MRIDs 45756602 and 45756603)
which are under review.  

	Regarding ecological effects, studies on the acute toxicity of the
co-formulated end use product Moncoat MZ fungicide (co-formulated with
Mancozeb) were requested as part of its conditional registration on
February 22, 2001 (EPA Reg. No. 71711-8). These tests include:

	Acute avian oral (71-1)

	Acute avian dietary – mallard (71-2)

	Avian reproduction (71-4)

	Acute Freshwater Fish (72-1)

	Acute freshwater invertebrate (72-2)

	Chronic life cycle / estuarine invertebrate (72-4)

	Three toxicity tests of the technical grade active ingredient (TGAI)
were also requested as part of the aforementioned conditional
registration. These tests include:

	Acute estuarine/marine fish (72-3)

	Chronic freshwater fish life cycle (72-5)

	Chronic marine fish life cycle (72-5)

	In response to this the ecotoxicity data request, the registrant
(Nichino America, Inc.) submitted a waiver request of the data
requirements to the Agency on Sept 9th, 2002.  The required data and
waiver request are being considered as part of the data needs outlined
in this problem formulation.  

	It should also be noted that the ecological risk assessment was
conducted based on a lower application rate for potato seed piece, not
on the much higher rates for rice, peanuts and turf.  According to the
labels under the registration review, the maximum yearly application
rates for other crops or non-crop (rice, peanuts, and turf) are much
higher than that for potato piece treatment.  Table 3 showed that the
yearly rate for potato piece treatment ranges from 0.25-0.75 lb ai/A
whereas those for rice, peanuts and turf are 1 lb ai/A, 2 lb ai/A and
8.5 lb ai/A, respectively.

4.  Human Health Risk Assessment: Request for Inadvertent or Indirect
Tolerances for Use on Soybean, Wheat, Corn and Cotton (2007)

	A recent human health risk assessment was conducted on flutolanil in
response registrant petitions proposing the establishment of permanent
tolerances for inadvertent or indirect residues in/on corn, cotton,
soybean, and cotton commodities (USEPA, 2007).  Although this assessment
did not address ecological risks, it does contain information that is
relevant to the current problem formulation.  For example, based on
mammalian toxicity data, flutolanil was not identified as a reproductive
or developmental toxicant nor was it identified as being neurotoxic. 
The chronic NOAEL of 50 mg/kg/day (increased incidence of clinical toxic
signs) was identified based on a 2-year dietary study in dogs (relevant
to the chronic mammalian toxicity assessment). Furthermore, the major
metabolite identified in plants and rotational crops (potentially
relevant to herbaceous birds and mammals) were M-4
(N-(3’-hydroxyphenyl)-2-(trifluoromethyl)benzamide) and M-5
(N-(3’,4’-(dihydroxyphenyl)-2-(trifluoromethyl)benzamide).  

	There are no established MCL for residues of flutolanil in drinking
water.  No health advisory levels for flutolanil in drinking water have
been established.  The residues in water are the parent compound and M4;
and the parent is the major residue.  HED concluded that only the parent
needs to be included in the drinking water exposure assessment for
flutolanil.  In the chronic dietary assessment, HED used EECs in surface
water and groundwater that were estimated by EFED based on the use of
flutolanil on rice paddy (0.5 lb ai/a x 2 applications/year.  See
Section 2 above for detail).  The chronic dietary assessment (food and
drinking water) showed that for all included commodities, the dietary
risk estimates were below the Agency’s level of concern (<100% cPAD)
for the general U.S. population (<1% of the cPAD) and all population
subroups (< 1% cPAD). 

III.  Stressor Source and Distribution

A.  Mechanism of Action 

	Flutolanil,
[N-(3-(1-methylethoxy)-phenyl)-2-(trifluoromethyl)-benzamide], is a
systemic fungicide that exhibits both curative and protective action
against fungal diseases of crops.  Its specific mode of action in fungi
(e.g., Rhizoctonia sp.) is to inhibit mitochondrial respiration through
the interference of succinate metabolism (inhibition of succinate
dehydrogenase complex) (IFAS/UF, 2006; Motoba et al., 1988).   

B.  Overview of Pesticide Usage

	Flutolanil is for control of black scurf (Rhizoctonia solani) in
potatoes, for control of sheath blight (Rhizoctonia solani) in rice, 
for control of southern stern rot (white mold) and the limb/pod rot
complex (Rhizoctonia solani) in peanuts, for control of diseases caused
by Basidiomycetes on turf, and for control of diseases caused by rusts,
species of Rhizoctonia and Sclerotium rolfsi on ornamentals. 

	Under the registration review, there are 11 Section 3 registrations and
5 Section 24C registrations for products containing flutolanil. 
Flutolanil can be applied as a product containing only flutolanil (i.e.,
Moncut 50WP, ProStar 70 WDG) or as a co-formulated product that contains
other active ingredients (see below).

Mancut CL Flowable (Reg. No. 71711-2) contains flutolanil (10.3%) and
chlorothalonil (38.6%).

MonCoat MZ (Reg. No. 71711-8) contains flutolanil (1.5%) and mancozeb
(6%).

Artisan (Reg. No. 71711-17) contains flutolanil (32%) and propiconazole
(6%).

NAI-301 4SE (also known as Artisan Trifecta; Reg. No. 71711-24) contains
flutolanil (17.2%), chlorothalonil (21.85%), and propiconazole (1.8%).

	There are a total of three Section 3 registrations/labels [Reg. No.
71711-1 (Moncut 70WP), 71711-3 (Moncut 50W), and 71711-14 (Moncut 70
DF)] that allow the use of flutolanil on rice.  However, each of these
three labels contains the following geographical restrictions on rice in
the State of Arkansas due to concern on the endangered species. 

	“The use of flutolanil on rice is restricted to protect the
endangered fat pocketbook pearly mussel (Potamilus capax) and its
habitat.  Use is prohibited in the following areas of Arkansas:  

	Mississippi County:  Within the basin that drains directly into the
Right Hand Chute of Little River, south of Big Lake National Refuge.

Poinsett County:  Between Cowley’s Ridge and the levee east of the
Right Hand Chute of Little River and the St. Francis Floodway.  Use is
also prohibited west of Rt. 140 and north of Rt. 63 at the SIPHON near
Marked Tree.  Except that the prohibited area does not include the area
bounded by Arkansas Highway 373 on the west, Highway 63 on the east and
Highway 14 on the south.

Cross, St. Francis, and Lee Counties:  Between Crowley’s Ridge and the
levee east of the Right Hand Chute of Little River and the St. Francis
Floodway as far south as the confluence of L’Anguille River (Lee
County).”

It should be noted that, according to SLN AR-050007, flutolanil can
still be used on rice in Arkansas until 2010.  This is because the
"pending" label (Moncut SC) used in the SLN does not contain any
geographical restrictions in Arkansas.  

A list of registered flutolanil uses, along with their respective
application methods, single application rates, application intervals,
and maximum seasonal/yearly application rates are presented in Table 3. 

Table   SEQ Table \* ARABIC  3 . Uses and application rates for
flutolanil.

Crop/Labels/Restrictions	Single

Application Rate

(lb a.i./A)/Methods	Number of

Applications per Season	Application Interval (days)	Maximum Application
rate per Season

(lb a.i./A/Season)

Potato 

Reg. No. 71711-3 (Moncut 50W)

Restrictions in CA

Reg. No. 71711-8  (MonCoat MZ)	

0.5-0.75 (spray around and over the seed pieces in a 4-8 inch band prior
to covering with soil)

0.25 (apply to the seed pieces immediately after cutting at 0.011-0.015
lb ai per 100 lbs of cut seed)	

1

1	

N/A

N/A	

0.75

0.25

Rice

Reg. No. 71711-3 (Moncut 50W)

Restrictions in CA, AR

Reg. No. 71711-14

(Moncut 70 DF)

Restrictions in CA, NY, AR

Reg. No. 71711-1

(Moncut 70WP)

Restrictions in CA, AR

SLN No. AR-050007 (Moncut SC – it does not have a Reg. No. because it
is still a pending registration)

	

0.35-0.50 (aerial application to rice plant)

0.35-0.70 (aerial application to rice plant)

0.35-0.50 (aerial application to rice plant)

0.35-0.70 (aerial application to rice plant)

0.35-0.50 (aerial application to rice plant)

0.35-0.75 (aerial application to rice plant)

	

2

2 or more (max application frequency was not specified)

2

2 or more (max application frequency was not specified)

2

2	

10-14

Not specified

10-14

Not specified

10-14

Not specified

	

1.0

1.0

1.0

1.0

1.0

1.0

Peanuts 

Reg. No. 71711-17 (Artisan)

Reg. No. 71711-3

(Moncut 50W)

Restrictions in CA

Reg. No. 71711-1

(Moncut 70  WP)

Restrictions in CA	

0.61-0.75 (when applying Artisan alone)

(ground, chemigation, aerial)

0.305-0.493 (when applying Artisan with  chlorothalonil)

(ground, chemigation, aerial)

0.25-2 (ground, chemigation, aerial)

1-2 (ground, chemigation, aerial)	

2-3 applications for the 0.61 lb ai/application

2 applications for the 0.75 lb ai/application

Make sequential applications as needed

1-4 

2	

21-30

21-30

10-14

10-30

30	

2.0

2.0

2.0

2.0

2.0

Turf 

Reg. No. 432-1223 (ProStar 70 WP)

Reg. No. 432-1477

(ProStar 70 WDG)	

2.86-5.71 (broadcast  application) (see Footnote 1)

2.86-8.53 (broadcast  application) (see Footnote 2)

	

2

2  	

14-30

14-30	

8.53

8.53

Ornamentals 

Reg. No. 432-1223 (ProStar 70 WP)

Restrictions in NY

Reg. No. 432-1477

(ProStar 70 WDP)

Restrictions in NY

SLN No. WA-040032 (tulips and iris)	

Not specified (broadcast  foliar, soil drench, cutting/bulb dip,
chemigation, overhead/microjet/drip irrigation)

1.14-4.57 (in-furrow application)	

No more than 4 applications

1	

14-21

N/A	

Not specified 

4.57

Footnotes:

For the use of ProStar 70 WP on turf, the single application rates were
converted from oz product/1,000 square feet to lb ai/A with the
exceptions of the control of fairy ring and gray snow mold.  Since the
label states that “do not treat more than 10,000 square feet per acre
of turf area” when the highest rates are used (4.5 oz product/1,000
square feet for fairy ring and 3-4.5 oz product/1,000 square feet for
gray snow mold), the corresponding lb ai/A was adjusted accordingly.

2.	For the use of ProStar 70 WDG on turf, the maximum single application
rate (i.e., 8.53 lb ai/A) for the curative control of Rhizoctonia zeae
was calculated directly from oz product per 1,000 square feet to lb ai/A
because the label did not state any restriction in treated area, such as
that stated on ProStar 70 WDG for the control of fairy ring and gray
snow mold (see Footnote 1 above).  Note - the use of flutolanil in
control of Rhizoctonia zeae was not mentioned in the ProStar 70 WP.

C.  Environmental Fate and Transport 

	Registrant-submitted data defining the physical and chemical properties
for flutolanil and its most significant degradate [desisopropyl
flutolanil (DIP)] are summarized in Table 4, and the fate and transport
parameters associated with flutolanil and DIP are summarized in Table 5.
 In past assessments involving flutolanil, values for vapor pressure,
water solubility, Henry’s Law Constant and Kow were obtained from EFED
One-Liner.   According to the review of Flutolanil – Human Health Risk
Assessment: Request for Inadvertent or Indirect Tolerances for Use on
Soybeans, Wheat, Corn and Cottom completed by HED on 11/27/07,  vapor
pressure, water solubility, and Log Kow recorded in EFED One-Liner were
reported in MRID 42606601.

Table   SEQ Table \* ARABIC  4 .  Physical and Chemical Properties for
Flutolanil and its Degradate [desisopropyl flutolanil (DIP)].

Molecular Formula	C17H16NO2F3

Molecular Weight (g/mole)	323.3

SMILES Code	C(F)(F)(F)c1ccccc1C(=O)Nc2cccc(OC(C)C)c2 (  SEQ CHAPTER \h
\r 1 EPI Suite, v3.12)

Water Solubility	6.53 ppm at 20C

Vapor Pressure	4.87e-8 mm Hg at 25C

Henry’s Law Constant	2.12e-9 atm m3/mole

LogKow	3.74 (initial conc. 10-2 M)

3.79 (initial conc. 10-3 M)

Major Transformation Product of Flutolanil

Common Name 	Desisopropyl flutolanil (DIP)

Chemical Names

IUPAC	NA

CAS	N-(3-Hydroxyphenyl)-2-(trifluoromethyl)benzamide

CAS Number	NA

Chemical Structure	

Molecular Formula	C14H10NO2F3

Molecular Weight (g/mole)	281.2

SMILES Code	C2C=CC=C(C(F)(F)F)C=2C(=O)NC1C=CC=C(O)C=1 (  SEQ CHAPTER \h
\r 1 EPI Suite, v3.12)

Water Solubility	N/A

Vapor Pressure	N/A

Henry’s Law Constant	N/A

LogKow	N/A

Table   SEQ Table \* ARABIC  5 .  Summary of Environmental Fate data for
Flutolanil

Guide-line #	

Data Requirement	

Study MRID	Results

161-1	Hydrolysis	40342940	Stable at pH 5, 7, and 9

161-2	Photolysis in Water 	41841208

41841209	Stable at pH 7

161-3	Photodegradation on Soil	41841210

43175810	Stable (unacceptable study).  

Additional data (43175810) submitted by the registrant to upgrade
41841210  are under review.

162-1	Aerobic Soil Metabolism	40342941

40342942

45756601	T1/2 = 190 days (volcanic ash); 320 days (loam); and 300 days
(sandy loam).  Less than 3% of the applied was detected as DIP
(desisopropyl flutolanil)

Irrelevant (a publication for benthiocarb which was accidentally listed
under flutolanil)

T1/2 = 217 days  (sandy loam) (still under review).  Preliminary review
indicated that no major degradates  were detected

162-3	Anaerobic Aquatic Metabolism	41841211	T1/2 > 13 years. Less than
1% of the applied was found as DIP

162-4	Aerobic Aquatic Metabolism	41841212	T1/2 = 1 year.  No major
degradates were detected

163-1	Leaching-Adsorption/ Desorption	42606626

42606627

40342943

41841213	Degradate DIP Koc = 288 (sand); 293 (loam); 396 clay loam); 317
(loamy sand) 

Parent Koc = 571 (sand); 592 (loam); 457 (clay loam); 628 (clay loam);
1,005 (loamy sand)

Parent Koc = 1340 (sand); 883 (clay); 528 (sediment); 653 (clay loam);
1,150 (sandy loam)

No useful information

164-1	Terrestrial Field Dissipation	41837803

41837804

43175809

45756603

45756602	Unacceptable

Turf field in CA.  T1/2 was not reported.  Parent was found in 24-30
inch soil zone.  Degradate DIP was found in 12-18 inch zone 

Peanuts field in FL.  T1/2 = 44 days (0-121 days); T1/2 = 225 days (121
days – 18 months).  Degradate DIP was not detected below 8 cm.

Turf field in CA.  T1/2 = 65 days (still under review)

Bare field in FL.  T1/2 = 182 days  (still under review)

164-2	Aquatic Dissipation	42606618

43292603	Rice paddies in CA and GA.  

Sediment T1/2 = 303 days (GA); Sediment T1/2 = 63 days (CA)

Unacceptable

164-5	Long-term Soil Dissipation	43175804	Peanuts field in FL.  T1/2 =
118 days (1st year); 126 days (2nd year); 123 days (3rd year)

165-3	Accumulation in Irrigated Crops	42606615	Rice paddies in AR and
LA.  Parent and DIP did not accumulate in irrigated crops 

165-4	Accumulation in Fish	40342944

41841214

41841215	Japanese carp. 

BCF in whole fish = 13-26 (in 0.1 ppm water) 

BCF in whole fish = 9.3-24 (in 0.01 ppm water)

Bluegill sunfish. BCF = 13 (edible); 270 (non-edible); 150 (whole fish)

165-5	Aquatic Non-target Organism	42641101	Rice paddy in LA.  Parent and
degradate DIP were not found in Grayfish

	Soil Storage Stability	42606616	Stable at least 2 years

	Flutolanil has a very low solubility, has a low propensity to
volatilize, and will remain in the aqueous phase based on the low
Henry's Law Coefficient.  In laboratory tests, Flutolanil was resistant
to hydrolysis at all pHs tested and practically resistant to photolysis
on both soils and in water. Flutolanil also appears to be relatively
resistant to aerobic and anaerobic degradation in both soils and aquatic
environments with half-lives of more than 200 days in soils and greater
than one year in water.

	In laboratory aerobic metabolism studies, no major transformation
products were identified.  Three minor degradates were identified. 
3'-hydroxy- 2-trifluoromethyl-benzanilide (DIP) was formed no more than
3% of the applied. Two other degradates were formed in minor amounts
(<1%).  These were 3'-methoxy-2-trifluoromethyl-benzanilide (MDP) and
4'-hydroxy-3-methoxy-2-trifluoromethyl-benzanilide (HMD). Flutolanil was
observed to degrade faster under anaerobic conditions during the flooded
stage of the study. Two minor degradates not identified under aerobic
conditions were observed. These were:
3'-(hydroxymethy1ethoxy)-2-trifluoromethyl-benzanilide (HIP) and
4'-hydroxy-3'-isopropoxy-2-triflouromethyl-benzanilide (HFT).

	Batch equilibrium studies for flutolanil and the transformation product
DIP (desisopropyl flutolanil) determined kd values to range from 0.997 -
15.8 and 0.5 - 1 1.3, respectively. There is a minimal propencity for
flutolanil to leach based on Koc’s ranging from 457 – 1340 ml/g
(MRID Nos. 41837803, 41837804, 43175809, 45756603, 45756602) and
solubility of 6.53 ppm.  This is supported in the field dissipation
studies where the parent or DIP were not detected below the 36-inch
sample depth. However, a prospective ground water has not been conducted
nor requested to confirm whether or not it may leach. A ground water
study was waived.  

Flutolanil and the primary degradate DIP may be transported to surface
water through erosion of soil particles containing bound flutolanil or
dissolved in runoff water. Partition coefficients were not available for
the other degradates, but, would appear, based on their structure, to be
as mobile as the parent. 

	The maximum BCF for flutolanil was 270X non-edible fish (1 3X edible
tissue, 150X whole fish) as determined by total 14C.  Depuration after
termination of exposure was rapid with more than 95 percent eliminated
in 3 days. These results would indicate minimal propensity to
bioconcentrate or bioaccumulate.

	The estimated log octanol-air partition coefficient (Log KOA) of 10.6
(EPIsuite, v.3.20) suggests that bioaccumulation of flutolanil in
terrestrial organisms is possible (Kelly et al. 2007).  However, there
is uncertainty associated with this Log KOA since the value is obtained
by model estimation.

IV.  Receptors

A.  Aquatic and Terrestrial Effects 

	Consistent with the process described in the Overview Document (USEPA,
2004), the risk assessment for flutolanil will rely on a surrogate
species approach.  T  SEQ CHAPTER \h \r 1 oxicological data generated
from surrogate test species, which are intended to be representative of
broad taxonomic groups, are used to extrapolate to potential effects on
a variety of species (receptors) included under these taxonomic
groupings.  

	Acute and chronic toxicity data from studies submitted by pesticide
registrants along with the available open literature are used to
evaluate the potential direct and indirect effects of flutolanil to the
aquatic and terrestrial receptors. This includes toxicity data on the
technical grade active ingredient, degradates, and when available,
formulated products (e.g. “Six-Pack” studies).  The open literature
studies are identified through EPA’s ECOTOX database (USEPA 2007d),
which employs a literature search engine for locating chemical toxicity
data for aquatic life, terrestrial plants, and wildlife.   The
evaluation of both sources of data can also provide insight into the
direct and indirect effects of flutolanil on biotic communities from
loss of species that are sensitive to the chemical and from changes in
structure and functional characteristics of the affected communities.  

	Table 6 provides a summary of the taxonomic groups and the surrogate
species tested to help understand potential acute and chronic ecological
effects of flutolanil.  In addition, the table provides a preliminary
overview of the potential acute toxicity of flutolanil by providing the
acute toxicity classifications. 

	Technical grade flutolanil is classified as practically non-toxic to
birds, mammals and terrestrial insects on an acute toxicity basis.
Flutolanil is considered moderately toxic to freshwater fish, estuarine/
marine fish and freshwater invertebrates. Estuarine/marine crustaceans
(mysid shrimp) appear to be the most sensitive taxa tested with
flutolanil and are classified as highly toxic.  Molluscs (eastern
oyster) appear to be less sensitive to flutolanil compared to
crustaceans on an acute toxicity basis.  

	Chronic exposure to flutolanil resulted in reduced egg production and
egg shell thickness in birds, but did not exhibit chronic toxicity in
rats up to 1000 mg/kg bw.  Chronic exposure to flutolanil was associated
with reduced growth and reduced reproduction in freshwater fish and
invertebrates, respectively.  Survival, reproduction and growth were
significantly reduced following chronic exposure to flutolanil by
estuarine/marine invertebrates (mysid shrimp).  Based on Tier 1
screening tests, flutolanil is classified as moderately toxic to aquatic
vascular and nonvascular plants based on significantly reduced growth
following exposure to 8.01 mg a.i./L. 

Table   SEQ Table \* ARABIC  6 .  Test Species Evaluated for Assessing
Potential Acute and Chronic Ecological Effects of Flutolanil. 

Taxonomic Group	Surrogate Species	Acute Toxicity

--

Chronic Toxicity	Citation

MRID	Acute Toxicity Classification

Birds1	  SEQ CHAPTER \h \r 1 Mallard (Anas platyrhynchos)	

LD50 = > 2000 mg/kg bw

LC50 = > 5243 ppm in diet

--

NOAEC = 1920 ppm 

LOAEC = 4800 ppm	

40342929

40342931

--

42932302	

Practically non-toxic 

	Northern bobwhite quail

(Colinus virginianus)	LD50 > 2000 mg/kg bw

LC50 = > 5243 ppm in diet

--

NOAEC = 1920 ppm 

LOAEC = 4800 ppm	40342930

40342932

--

42932301	Practically non-toxic

  SEQ CHAPTER \h \r 1 Mammals	  SEQ CHAPTER \h \r 1 Laboratory rat
(Rattus norvegicus)	LD50 > 10,000 mg/kg bw

--

NOAEL > 1000 mg/kg	40342906 

--

40342923	Practically non-toxic 

  SEQ CHAPTER \h \r 1 Insects	  SEQ CHAPTER \h \r 1 Honey bee (Apis
mellifera L.)	LD50 (contact) = > 650 ppm 	40342938 

	Practically non-toxic 

  SEQ CHAPTER \h \r 1 Freshwater fish2	Rainbow trout (Oncorhynchus
mykiss)

	

96-hour LC50 = 5.4 mg/L

	

40342933

--

	

Moderately  toxic

	Bluegill sunfish 

(Lepomis macrochirus)	96-hour LC50 > 5.4 mg/L

	40342934

	Moderately  toxic

	Carp

(Cyprinus carpio)	96-hour LC50 = 2.5-6.4 mg/L (3 tests, different
formulations)	40342936	Moderately toxic

	Fathead minnow 

(Pimephales promelas)	96-hour LC50 = 4.8 mg/L

--

NOAEC 0.233 mg/L

LOAEC = 0.486 mg/L	41841216

---

43552001	Moderately toxic

  SEQ CHAPTER \h \r 1 Freshwater invertebrates	Water flea

 (Daphnia magna)	48-hour EC50 > 6.8 mg/L

--

NOAEC = 0.53 mg/L

LOAEC = 1.1 mg/L	41841217 

--

4 1850807	Moderately toxic 

  SEQ CHAPTER \h \r 1 Estuarine/ marine fish	Sheepshead minnow

(Cyprinodon variegatus)	

96-hour LC50 > 6.1 mg/L

	

41841218

	Moderately toxic 

Estuarine/ marine invertebrates	Mysid shrimp (Americamysis bahia)
96-hour EC50 = 0.13 mg/L

--

NOAEC = 11.3 µg/L 

LOAEC = 21.7 µg/L   SEQ CHAPTER \h \r 1 	41841220 

--

43511601	Highly toxic

	Eastern oyster 

(Crassostrea virginica)	96-hour EC50 > 1.5 mg/L

	41841219	Moderately toxic 

  SEQ CHAPTER \h \r 1 Aquatic plants and algae	Vascular Plants:

Duckweed

(Lemna gibba)	Tier 1:   8.01 mg/L (31% reduction in frond count) 

Tier 2	42606622	Moderately toxic 

	Non-Vascular Plants:

Salt Water Diatom

(Skeletonema costatum)	Tier 1:  8.01 mg/L (13% growth inhibition 
42606623

Blue-green Algae

(A. flos-aquae)	Tier 1:  8.01 mg/L (significantly growth effects)
42606621

Fresh Water Diatom 

(Navicula pelliculosa)	Tier 1:  8.01 mg/L (58% growth inhibition

Tier 1: 8.01 mg/L (no effect)	42606624

42606625

Green Algae

(Selenastrum capricornutum)	Tier 1:  8.01 mg/L (51% growth inhibition
41841224

	  SEQ CHAPTER \h \r 1 1 Birds represent surrogates for
terrestrial-phase amphibians and reptiles.

2 Freshwater fish may be surrogates for aquatic-phase amphibians.

	Flutolanil is registered for use in a number of co-formulated products.
Other co-formulated active ingredients include: chlorothalonil,
mancozeb, thiophanate methylethoxy, and propicanazol.  The potential for
greater toxicity of the formulated product compared to the TGAI, acute
was evaluated based on 8 acute oral toxicity studies with rats (MRID
40342906 = TGAI; MRID 40342907, 42255205, 43594004, 43971414, 45103901,
45136401, 45524003 = formulated products).  Reported LD50 values of the
formulated products were > 5000 mg/kg or > 2000 mg/kg in 6 of the 7
formulated products.  In only one study was a definitive LD50 quantified
(MRID  43594004 which tested a 38.8% chlorothalonil + 10.3% flutolanil
formulation).  This study reported a LD50 of 3940 mg/kg for female rats
and 1570 mg/kg for male rats.  Compared to the toxicity of the TGAI
(LD50 > 10,000 mg/kg), the formulated products does not appear to be
substantially greater in toxicity on an acute oral basis to the rat,
since LD50 values were > 2000 mg/kg (practically nontoxic) for 6 of the
7 formulations.  In the remaining study that tested a mixture of
chlorothalanil and flutolanil (MRID 43594004), the formulation was
practically nontoxic to females and only slightly toxic to males.  

	Appropriate data for comparing the toxicity formulated product with the
TGAI were not identified for other non-target species.  Based on these
comparisons with the rat, there does not appear to be evidence of
substantially greater toxicity of the formulated products compared to
the TGAI.  Based on these findings, this problem formulation will focus
on ecological risks associated with the TGAI. 

B.  Ecosystems Potentially at Risk 

	The ecosystems potentially at risk are often extensive in scope,
therefore, it may not be possible to identify specific ecosystems during
the development of a nation-wide ecological risk assessment.  However,
in general terms, terrestrial ecosystems potentially at risk could
include the treated field and areas immediately adjacent areas that may
receive drift or runoff.  Areas adjacent to the treated field could
include cultivated fields, fencerows and hedgerows, meadows, fallow
fields or grasslands, woodlands, riparian habitats and other
uncultivated areas.  

	Aquatic ecosystems potentially at risk include water bodies adjacent
to, or down stream from, the treated field and might include impounded
bodies such as ponds, lakes and reservoirs, or flowing waterways such as
streams or rivers. For uses in coastal areas, aquatic habitat also
includes marine ecosystems, including estuaries.  

	A preliminary review of the Ecological Incident Information System
(EIIS) maintained by the Agency’s Office of Pesticide Programs (OPP)
indicates only one reported ecological incident associated with the use
of flutolanil (Incident ID I014123-001).  However, the observed effect
(yellowing and stunting of 40 acres of oats) was thought to be more
likely due to fertility issues than the pesticide containing flutolanil
and is classified as ‘unlikely.’

V.  Assessment Endpoints

	Assessment endpoints represent the actual environmental value that is
to be protected, defined by an ecological entity (species, community, or
other entity) and its attribute or characteristics (EPA, 1998).  For
flutolanil, the ecological entities include the following:  birds,
reptiles, terrestrial-phase amphibians, mammals, freshwater fish,
freshwater aquatic-phase amphibians and invertebrates, estuarine/marine
fish and invertebrates, terrestrial plants, insects, and aquatic plants
and algae. The attributes for each of these entities include growth,
reproduction, and survival.  

VI. Conceptual Model tc \l2 "D.        Conceptual Model 

	For a pesticide to pose an ecological risk, it must reach ecological
receptors in biologically significant concentrations.  An exposure
pathway is the means by which a pesticide moves in the environment from
a source to an ecological receptor.  For an ecological pathway to be
complete, it must have a source, a release mechanism, an environmental
transport medium, a point of exposure for ecological receptors, and a
feasible route of exposure.

	The conceptual model for flutolanil provides a written description and
visual representation of the predicted relationships between flutolanil,
potential routes of exposure, and the predicted effects for the
assessment endpoint. According to EPA’s ecological risk assessment
guidelines (USEPA 1998) a conceptual model consists of two major
components: a risk hypothesis and a conceptual diagram 

A.  Risk Hypothesis tc \l3 "1.         Risk Hypotheses 

	A risk hypothesis describes the predicted relationship among the
stressor, exposure, and assessment endpoint response along with the
rationale for their selection.  For flutolanil, the following ecological
risk hypothesis is being employed for this national-level ecological
risk assessment:

Flutolanil, when used in accordance with current labels, can result in
off-site movement of the compound via runoff, spray drift, and eroded
soil leading to exposure of nontarget plants and animals.  Furthermore,
the high environmental persistence of flutolanil and its high KOA
suggest a potential for bioaccumulation in terrestrial food webs,
although such evidence is indirect.  These potential exposure pathways
may result in adverse effects upon the survival, growth, and
reproduction of non-target terrestrial and aquatic organisms.  These
nontarget organisms include Federally-listed threatened and endangered
species.

 

B.  Conceptual Diagram tc \l3 "2.         Diagram 

	The environmental fate properties of flutolanil indicate that runoff,
erosion, and spray drift represent potential transport mechanisms of
flutolanil to aquatic and terrestrial organisms. In addition, its high
environmental persistence combined with a large KOA suggest that
atmospheric transport and subsequent deposition may be a potential
exposure pathway for flutolanil, although existing evidence is indirect
and inconclusive (indicated by the dashed lines in Figures 1 and 2. 
These transport mechanisms (e.g. sources) are depicted in the conceptual
models below (Figures 1 and 2) and result in the movement of flutolanil
into aquatic (water) and terrestrial (soil and foliage) habitats which
in turn serve as exposure media for a broad range of biological
receptors of concern (nontarget animals) and the potential attribute
changes, i.e., effects such as reduced survival, growth and
reproduction, in the receptors due to flutolanil exposure. 

 

Figure   SEQ Figure \* ARABIC  1 .  Conceptual model for flutolanil
effects on aquatic organisms.



 

Figure   SEQ Figure \* ARABIC  2 . Conceptual Model of Flutolanil
Effects on Terrestrial Organisms.

VII.  Analysis Plan  tc \l2 "E.        Analysis Plan 

	In order to address the risk hypothesis, the potential for adverse
effects on the environment is estimated.  The use, environmental fate,
and ecological effects of flutolanil are characterized and integrated to
assess the risks.  This is accomplished using a risk quotient (ratio of
exposure concentration to effects concentration) approach.  Although
risk is often defined as the likelihood and magnitude of adverse
ecological effects, the risk quotient-based approach does not provide a
quantitative estimate of likelihood and/or magnitude of an adverse
effect.  However, as outlined in the Overview Document (USEPA, 2004),
the likelihood of effects to individual organisms from particular uses
of flutolanil is estimated using the probit dose-response slope and
either the level of concern (discussed below) or actual calculated risk
quotient value.

	This analysis plan will be revisited and may be revised depending upon
the information submitted by the public in response to the opening of
the Registration Review docket for flutolanil.

A.  Stressors of Concern 

	The most significant degradate of flutolanil is DIP. Submitted
environmental fate studies for flutolanil do not identify DIP, as it
does not form >10% of residues, indicating that it is not expected to be
a major degradate of flutolanil in aquatic and terrestrial environments.
The Agency concluded that only the parent compound needs to be included
in the drinking water exposure assessment for flutolanil, DIP may not be
of greater toxicological concern compared to flutolanil and exposure to
this transformation product may not be included in this assessment. 

	The stressors of concern for this assessment includes only the parent
compound (flutolanil) with respect to exposures in aquatic and
terrestrial habitats.

B.  Measures of Exposure tc "1.  Measures of Exposure " \l 3 

	In order to estimate risks of flutolanil exposures in aquatic and
terrestrial environments, all exposure modeling and resulting risk
conclusions will be based on maximum application rates and methods cited
in Table 3 and will be estimated for each use of flutolanil. Measures of
exposure are based on aquatic and terrestrial models that predict
estimated environmental concentrations (EECs) of flutolanil.  The models
used to predict aquatic EECs are the Pesticide Root Zone Model coupled
with the Exposure Analysis Model System (PRZM/EXAMS).  The model used to
predict terrestrial EECs on food items is T-REX.  The model used to
derive EECs relevant to terrestrial and wetland plants is TerrPlant. 
These models are parameterized using relevant reviewed
registrant-submitted environmental fate data.

PRZM (v3.12.2, May 2005) and EXAMS (v2.98.4.6, April 2005) are screening
simulation models coupled with the input shell pe5.pl (Aug 2007) to
generate daily exposures and 1-in-10 year EECs of flutolanil that may
occur in surface water bodies adjacent to application sites receiving
flutolanil through runoff and spray drift.   PRZM simulates pesticide
application, movement, and transformation on an agricultural field and
the resultant pesticide loadings to a receiving water body via runoff,
erosion and spray drift.  The EXAMS model simulates the fate of the
pesticide and resulting concentrations in the water body.  The standard
scenario used for ecological pesticide assessments assumes application
to a 10-hectare agricultural field that drains into an adjacent
1-hectare water body that is 2 meters deep (20,000 m3 volume) with no
outlet.  PRZM/EXAMS is used to estimate screening-level exposure of
aquatic organisms to flutolanil.  The measure of exposure for aquatic
species is the 1-in-10 year return peak or rolling mean concentration. 
The 1-in-10 year peak is used for estimating acute exposures of direct
effects to aquatic organisms. The 1-in-10-year 60-day mean is used for
assessing chronic exposure to the fish and aquatic-phase amphibians. The
1-in-10-year 21-day mean is used for assessing aquatic invertebrate
chronic exposure.

	Exposure estimates for terrestrial animals assumed to be in the target
area or in an area exposed to spray drift are derived using the T-REX
model (version 1.3.1, 12/07/2006).    SEQ CHAPTER \h \r 1 This model
incorporates the Kenega nomograph, as modified by Fletcher et al.
(1994), which is based on a large set of actual field residue data. The
upper limit values from the nomograph represented the 95th percentile of
residue values from actual field measurements (Hoerger and Kenega,
1972).  The Fletcher et al. (1994) modifications to the Kenega nomograph
are based on measured field residues from 249 published research papers,
including information on 118 species of plants, 121 pesticides, and 17
chemical classes.  EECs for terrestrial plants inhabiting dry and
wetland areas are derived using TerrPlant (version 1.2.2, 12/26/2006). 
This model uses estimates of pesticides in runoff and in spray drift to
calculate EECs.  EECs are based upon solubility, application rate and
minimum incorporation depth.  

	Two spray drift models, AGDisp and AgDRIFT are used to assess exposures
of terrestrial plants to flutolanil deposited on terrestrial habitats by
spray drift.  AGDisp (version 8.13; dated 12/14/2004) (Teske and
Curbishley, 2003) is used to simulate aerial and ground applications
using the Gaussian far-field extension. AgDrift (version 2.01; dated
5/24/2001) is used to simulate spray blast applications to orchard
crops.

C.  Measures of Effect 

	Ecological effect data are used as measures of direct and indirect
effects to biological receptors. Data were obtained from
registrant-submitted studies or from literature studies identified by
ECOTOX. The ECOTOXicology database (ECOTOX) was searched on May 1, 2008
in order to provide more ecological effects data to bridge existing data
gaps.  ECOTOX is a source for locating single chemical toxicity data and
potentially chemical mixture toxicity data for aquatic life, terrestrial
plants, and wildlife.  ECOTOX was created and is maintained by the
USEPA, Office of Research and Development, and the National Health and
Environmental Effects Research Laboratory's Mid-Continent Ecology
Division (ECOTOX, 2006).

	Information on the potential effects of flutolanil on non-target
animals is also collected from the Ecological Incident Information
System (EIIS; USEPA 2007c).  The EIIS is a database containing adverse
effect (typically mortality) reports on non-target organisms   where
such effects have been associated with the use of pesticides.   

	Where available, sublethal effects observed in both
registrant-submitted and open literature studies will be evaluated
qualitatively.  Such effects have included behavioral changes (e.g.,
lethargy, changes in coloration and effects olfaction).  Quantitative
assessments of risks, though, are limited to those endpoints that can be
directly linked to the Agency’s assessment endpoints of impaired
survival, growth and reproduction.

	  SEQ CHAPTER \h \r 1 The assessment of risk for direct effects to
non-target organisms makes the assumption that toxicity of flutolanil to
birds is similar to terrestrial-phase amphibians and reptiles.  The same
assumption is made for fish and aquatic-phase amphibians. 

	The acute measures of effect used for animals in this screening-level
assessment are the LD50, LC50 and EC50.  LD stands for "Lethal Dose",
and LD50 is the amount of a material, given all at once, that is
estimated to cause the death of 50% of the test organisms.  LC stands
for “Lethal Concentration” and LC50 is the concentration of a
chemical that is estimated to kill 50% of the test organisms.  EC stands
for “Effective Concentration” and the EC50 is the concentration of a
chemical that is estimated to produce a specific effect in 50% of the
test organisms.  Endpoints for chronic measures of exposure for listed
and non-listed animals are the NOAEL/NOAEC and NOEC.  NOAEL stands for
“No Observed-Adverse-Effect-Level” and refers to the highest tested
dose of a substance that has been reported to have no harmful (adverse)
effects on test organisms.  The NOAEC (i.e.,
“No-Observed-Adverse-Effect-Concentration”) is the highest test
concentration at which none of the observed effects were statistically
different from the control.  The NOEC is the
No-Observed-Effects-Concentration.  For non-listed plants, only acute
exposures are assessed (i.e., EC25 for terrestrial plants and EC50 for
aquatic plants); for listed plants, either the NOAEC or EC05 is used.  

D.  Integration of Exposure and Effects

	Risk characterization is the integration of exposure and ecological
effects characterization to determine the potential ecological risk from
the use of flutolanil on rice, peanuts, potatoes, turf and ornamentals,
and the likelihood of direct and indirect effects to non-target
organisms in aquatic and terrestrial habitats.  The exposure and
toxicity effects data are integrated in order to evaluate the risks of
adverse ecological effects on non-target species.  For the assessment of
flutolanil risks, the risk quotient (RQ) method is used to compare
exposure and measured toxicity values.  EECs are divided by acute and
chronic toxicity values.  The resulting RQs are then compared to the
Agency’s levels of concern (LOCs) (USEPA, 2004).  These criteria are
used to indicate when the use of flutolanil, as directed on the label,
has the potential to cause adverse direct or indirect effects to
nontarget organisms.

                  

1.  Deterministic and Probabilistic Assessment Methods

	The quantitative assessment of risk will primarily depend on the
deterministic point-estimate based approach described in the risk
assessment.  Should further refinement of the risk assessment be deemed
necessary, an effort will be made to further qualitatively describe risk
using probabilistic tools that the Agency has developed.  These tools
have been reviewed by FIFRA Scientific Advisory Panels and have been
deemed as appropriate means of refining assessments where deterministic
approaches have identified risks.

E.  Endangered Species Assessments

	Consistent with the Agency’s responsibility under the Endangered
Species Act (ESA), EPA will evaluate risks to Federally-listed
threatened and/or endangered (listed) species from registered uses of
flutolanil.  This assessment will be conducted in accordance with the
Overview Document (USEPA, 2004), provisions of the ESA, and the
Services’ Endangered Species Consultation Handbook (USFWS/NMFS 1998). 

	The assessment of effects associated with registrations of flutolanil
is based on an action area.  The action area is considered to be the
area directly or indirectly affected by the federal action, as indicated
by the exceedance of Agency Levels of Concern (LOCs) used to evaluate
direct or indirect effects.  The Agency’s approach to defining the
action area under the provisions of the Overview Document (USEPA, 2004)
considers the results of the risk assessment process to establish
boundaries for that action area with the understanding that exposures
below the Agency’s defined LOCs constitute a no-effect threshold.  For
the purposes of this assessment, attention will be focused on the
footprint of the action (i.e., the area where flutolanil application
occurs), plus all areas where offsite transport (i.e., spray drift,
runoff, long-range atmospheric transport, etc.) may result in potential
exposure that exceeds the Agency’s LOCs.  Specific measures of
ecological effect that define the action area for listed species include
any direct and indirect effects and/or potential modification of its
critical habitat, including reduction in survival, growth, and
reproduction as well as the full suite of sublethal effects available in
the effects literature.  Therefore, the action area extends to a point
where environmental exposures are below any measured lethal or sublethal
effect threshold for any biological entity at the whole organism, organ,
tissue, and cellular level of organization.  In situations where it is
not possible to determine the threshold for an observed effect, the
action area is not spatially limited and is assumed to be the entire
United States.   

	As part of the “effects determination,” one of the following three
conclusions will be reached regarding the potential for registration of
flutolanil at the use sites described in this document to affect listed
species and/or result in modification of designated listed species’
critical habitat: 

“No effect”; 

“May affect, but not likely to adversely affect”; or

“May affect and likely to adversely affect”. 

	Critical habitat identifies specific areas that have physical and
biological features, known as primary constituent elements (PCEs), which
are essential to the conservation of the listed species. 

	If the results of initial screening-level assessment methods show no
direct or indirect effects (no LOC exceedances) upon individual listed
species of any taxonomic group or upon the PCEs of the species’
designated critical habitat, a “no effect” determination is made for
the FIFRA regulatory action regarding flutolanil as it relates to this
species and its designated critical habitat.  If, however, direct or
indirect effects to individual listed species are anticipated and/or
effects may impact the PCEs of the listed species’ designated critical
habitat, a preliminary “may affect” determination is made for the
FIFRA regulatory action regarding flutolanil.

	If a determination is made that use of flutolanil within the action
area(s) associated with the listed species “may affect” this species
and/or its designated critical habitat, additional information is
considered to refine the potential for exposure and for effects to the
species and other taxonomic groups upon which these species depend. 
Additional information, including spatial analysis (to determine the
geographical proximity of species habitat and flutolanil use sites) may
also be used to determine whether modification to designated critical
habitat may occur.  Based on the refined information, the Agency uses
the best available information to distinguish those actions that “may
affect, but are not likely to adversely affect” from those actions
that “may affect and are likely to adversely affect” the listed
species and/or result in modification of its designated critical
habitat.  

F.  Preliminary Identification of Data Gaps  tc \l3 "1.        
Preliminary Identification of Data Gaps and Methods 

1. Environmental Fate 

	Several studies have been submitted to fulfill the conditional
registration requesting soil photolysis, aerobic soil metabolism, soil
storage stability, and terrestrial field dissipation data for
flutolanil. These studies are under review. The resulting data will be
incorporated into future flutolanil assessments as appropriate.

	In order to quantify the risk potential for flutolanil, additional
studies are required (anaerobic soil metabolism, environmental chemical
methods (ECM)/Independent Laboratory Validation (ILV) and measurement of
octanol-air partition coefficient (KOA)). The lack of data mentioned
above for flutolanil represents an uncertainty of the fate of flutolanil
in the environment.  Table 7 includes the current environmental fate
data requirements.

Table   SEQ Table \* ARABIC  7 . Environmental Fate Data Requirements
for Flutolanil.

Guide-line #	

Data Requirement	

Study ID	Study Classification	Are Additional Data Needed for Risk
Assessment?

161-1	Hydrolysis	40342940	Acceptable 	No 

161-2	Photolysis in Water 	41841208

41841209	Acceptable 	No

161-3	Photodegradation on Soil	41841210

43175810	Unacceptable

Under review	No

161-4	Photodegradation in Air	No data submitted	N/A	No

162-1	Aerobic Soil Metabolism	40342941

40342942

45756601	Acceptable 

Irrelevant (publication for benthiocarb)

Under review	No

162-2	Anaerobic Soil Metabolism	No data submitted	N/A	Yes

162-3	Anaerobic Aquatic Metabolism	41841211	Acceptable	No

162-4	Aerobic Aquatic Metabolism	41841212	Acceptable  	No

163-1	Leaching-Adsorption/ Desorption	42606626

42606627

40342943

41841213	Acceptable 

Acceptable 

Acceptable 

Acceptable 	No 

163-2	Laboratory Volatility	No data submitted	N/A	No

163-3	Field Volatility	No data submitted	N/A	No

164-1	Terrestrial Field Dissipation	41837803

43175804

43175809

45756603

45756602	Unacceptable

Acceptable Supplemental 

Under review

Under review	No

164-2	Aquatic Dissipation	42606618

43292603	Acceptable

Unacceptable	No

164-3	Forestry	No data submitted	N/A	No

164-4	Combination and Tank Mixes	No data submitted	N/A	No

164-5	Long-term Soil Dissipation	43175804	Supplemental	No

165-3	Accumulation in Irrigated Crops	42606615	Acceptable	No

165-4	Accumulation in Fish	40342944

41841214

41841215	Acceptable Acceptable Acceptable	No

165-5	Aquatic Non-target Organism	42641101	Acceptable	No

166-1	Ground Water Monitoring	No data submitted	N/A	Waived on 2/22/95

	Storage Stability	42606616	Under review	No

	Environmental Chemical Methods (ECM)/Independent Laboratory Validation
(ILV)	No data submitted	N/A	Yes

Non Guideline Study	Measurement of Octanol-Air Partition Coefficient
(KOA)	No data submitted	N/A	Yes 

N/A=Not Applicable

2. Ecological Effects 

	The ecological effects data requirements and preliminary classification
of the submitted data for flutolanil are summarized in Table 8.  The
ecological effects data requirements were determined according to CFR
Part 158 data requirements for conventional pesticides (Federal
Register, Vol. 72: 60934-60988. October, 26, 2007).  In cases where the
data requirement was not met with an acceptable study, but the results
of a new study would appear to not likely change the forthcoming risk
assessment, the study was kept in ‘reserve.’  For example, while the
new CFR Part 158 require an avian oral LD50 study with a passerine
species, this study is being held in reserve because the submitted data
indicate that flutolanil is practically non-toxic on an acute basis to
mallard and bobwhite quail.  Thus, passerine birds would have to be
several orders of magnitude more sensitive to flutolanil in order to
impact the ecological risk assessment, which appears unlikely given the
typical variability in toxicity among avian species.  Similarly, while
the estuarine acute LC50 study on oysters is now considered supplemental
(reclassification as part of this registration review), the likelihood
that oysters would be more sensitive than the most sensitive
invertebrate (mysid shrimp) appears low and thus, a repeated test is not
recommended at this time.  In the case of the Tier II plant seedling
emergence and vegetative vigor studies, requirement of these studies
depends on the outcome of the yet to be submitted Tier 1 studies; hence,
they are being held in reserve.

Table   SEQ Table \* ARABIC  8 . Ecological Effects Data Requirements
for Flutolanil.

Guideline	

Data Requirement	

Test Species	

MRID	

Preliminary Study Classification	More Data Needed For Risk Assessment? 

71-1

(850.2100)	

Avian Oral LD50	Mallard

Bobwhite Quail

Passerine Species	40342929

40342930

No data	Acceptable

Acceptable

No data	No

No

Reserved(5)

71-2

(850.2100)	

Avian Dietary LC50	Mallard

Bobwhite Quail	40342931

40342932	Acceptable  

Acceptable	No

71-4

(850.2300)	

Avian Reproduction	Mallard

Bobwhite Quail	42932302

42932301	Acceptable  

Acceptable	No

72-1

(850.1075)	

Freshwater Fish LC50	Rainbow Trout

Bluegill Sunfish

Carp

Fathead Minnow	40342933

40342934

40342936

41841216	Acceptable  

Acceptable

Supplemental

Acceptable	No

72-2

(850.1010)	

Freshwater Invertebrate Acute LC50	Water flea	41841217	Acceptable 	No

72-3(a)

(850.1075)	

Estuarine/Marine Fish LC50	Sheepshead Minnow	

41841218

	Acceptable(3) 	No

72-3(b)

(850.1025 or 1055)	

Estuarine/Marine Mollusk EC50	Eastern Oyster	41841219	Supplemental(4)
Reserved(6) 

72-3(c) (850.1035 or 1045)	

Estuarine/Marine Shrimp EC50	Mysid Shrimp	

41841220 

	Acceptable	No

72-4(a)

(850.1400)	

Freshwater Fish Early Life-Stage	Fathead Minnow	43552001	Acceptable	No

72-4(b) (850.1300)	

Aquatic Invertebrate Life-Cycle (freshwater)	Water flea	4 1850807
Acceptable	No

72-4 (850.1400)	

Estuarine/Marine Fish  Early Life Stage (1) 	Sheepshead Minnow	No Data
No data	Reserved(7) 

No Guideline Available(1)	

Whole Sediment  Chronic Invertebrate	Marine	No Data	No data	Yes

123-2

(850.4150)	

Vegetative Vigor (Tier I)	Multiple species	No Data 	No Data 	Yes

123-2

(850.4100)	Seedling Emergence

(Tier I)	Multiple species	No Data 	No Data 	Yes

123-2

(850.4150)	

Vegetative Vigor (Tier II) (1)	Multiple species	No Data	No Data 
Reserved(2)

123-2

(850.4100)	Seedling Emergence

(Tier II) (1)	Multiple species	No Data	No Data 	Reserved(2)

(850.4400)	 Aquatic Vascular Plant (Tier I)	Duckweed	42606622	Acceptable
No

(850.5400)	

Aquatic Nonvascular 

 (Tier I)

	Freshwater Diatom	42606624

42606625	Acceptable

Acceptable	No

Blue-green Algae	42606621	Acceptable	No

Salt Water Diatom

	42606623	Acceptable	No

Green algae	41841224	Acceptable	No

(850.5400)	

Aquatic Nonvascular 

 (Tier II) (1)

	Freshwater Diatom

Green Algae	No Data	No Data	Reserved(8)

(850.3020)	Honey Bee Acute Contact	Honey bee	40342938	Acceptable	No

Conditionally required per Pesticide Data Requirements for Conventional
Chemicals. CFR Part 158. Federal Register. Vol. 72 (No. 207):
60934-60988. October, 26, 2007.

Conditionally required pending results of Tier 1 plant testing.

Study likely to be reclassified from “supplemental” to
“acceptable”

Study likely to be reclassified from “acceptable/core” to
“supplemental.”

Reserved pending results from review of other information (e.g.,
literature review, data from compounds with the same modes of action)
that suggests Passerine species may be substantially more sensitive than
upland game or waterfowl avian species such that the risk assessment
conclusions would be affected by additional data for Passerines.

Reserved pending other information (e.g., literature review, data from
compounds with the same modes of action) that suggests mollusks may be
sensitive to flutolanil such that the risk assessments conclusions would
be affected by additional data for mollusks.

Reserved pending other information (e.g., literature review, data from
compounds with the same modes of action) that suggests estuarine/marine
fish may be sensitive to flutolanil such that the risk assessments
conclusions would be affected by additional data for estuarine/marine
fish.

Reserved pending other information (e.g., literature review, data from
compounds with the same modes of action) that suggests aquatic plants
are substantially more sensitive compared to existing Tier 1 tests such
that the risk assessment conclusions would be affected by additional
data for aquatic plants.

3. Rationale for Data Call In

	As part of the conditional registration of Moncoat MZ (PCC511) use on
potato seed pieces on February 22, 2001(EPA Reg. No. 71711-8), EPA
requested the registrant to conduct and submit nine ecotoxicity studies
related to flutolanil typical end use product (TEP) and TGAI:    

	(TEP)

	Acute avian oral (71-1)

	Acute avian dietary – mallard (71-2)

	Avian reproduction (71-4)

	Acute Freshwater Fish (72-1)

	Acute freshwater invertebrate (72-2)

	Chronic life cycle / estuarine invertebrate (72-4)

	(TGAI)

	Acute estuarine/marine fish (72-3)

	Chronic freshwater fish life cycle (72-5)

	Chronic marine fish life cycle (72-5)

	The TEP studies were requested to address uncertainty in the combined
toxicity of the co-formulated product (containing both mancozeb and
flutolanil). The TGAI acute LC50 study with an estuarine/marine fish was
requested because the submitted study with sheepshead minnow as
classified as supplemental (MRID 41841218).  The TGAI chronic life cycle
studies were requested on the basis of EECs triggering full life cycle
studies when compared to the ELS study with fathead minnow. 

	In response to this ecotoxicity data request, the registrant (Nichino
America, Inc.) submitted a waiver request of the data requirements to
the Agency on Sept 9th, 2002.  Part of the rationale for requesting a
waiver from the TEP studies was that there was no evidence to support
the synergistic action of the two active ingredients in the
co-formulated product.  The Agency has evaluated this waiver request and
conducted its own comparison of TGAI vs. TEP toxicity (see Section IV.A
above) and agrees that additional studies of the TEP are not required
for the ecological risk assessment supporting the registration review of
flutolanil.  The Agency has also re-evaluated the need to conduct the
full life cycle studies with the TGAI and does not believe that absence
of these data will hinder the ecological risk assessment.  Finally, with
respect to the acute toxicity test with sheepshead minnow (MRID
41841218), the Agency has re-reviewed this study and has upgraded this
study to acceptable due to lack of toxicity at the solubility limit of
flutolanil.

	The Agency has identified other environmental fate and ecological
effects data that are needed to reduce major sources of uncertainty in
the ecological risk assessment of flutolanil.  These data needs and
associated rationale are provided in Table 9.

Table   SEQ Table \* ARABIC  9 .   Environmental Fate and Ecological
Effects Data Needs for Flutolanil.

Environmental Fate Data Gaps

OPPTS Guideline	Study Title	Cost 

(if special study)	Rationale

835-4200	Guideline 162-2 Anaerobic Soil Metabolism	N/A	CFR158 requires
this study.  Currently no acceptable studies have been submitted. 

Flutolanil can be used on potatoes, rice, peanuts, turf, and
ornamentals.  Since no information is available to determine the fate
properties EFED must assume that it will runoff/drift in the environment
and persist.  

In order to calculate EEC’s in PRZM and assess the ecological risk and
the drinking water risk, anaerobic soil data are needed.

	Environmental chemical Methods (ECM)/Independent Laboratory Validation
(ILV)	N/A	CFR158 indicates that ECM used to generate data associated
with terrestrial field dissipation study (835.6100), aquatic dissipation
study (835.6200), forestry dissipation (835.6300), ground water
monitoring (835.7100), and aquatic non-target organism field dissipation
(850.1950) studies must include results of a successful confirmation
method trial by and independent laboratory (ILV).  Currently no
acceptable studies have been submitted. 

In order to use the data with confidence  in the terrestrial
dissipation, aquatic dissipation, and aquatic non-target organism field
accumulation studies as well as assess the ecological risk, ECM and ILV
data are needed.

Non Guideline Study	Measurement of Octanol-Air Partition Coefficient
(KOA)	N/A	Recent peer-reviewed studies in the scientific literature
indicate that KOA is an important factor in assessing the potential of
organic chemicals to bioaccumulate and biomagnify  in terrestrial food
chains (e.g., Armitage and Gobas, 2007; Kelly et al., 2007; Czub and
McLachlan, 2004; Kelly and Gobas, 2003; Sharp and Mackay, 2000;
McLachlan, 1996).  No measured data on the KOA of flutolanil were found.
 However, model-predicted log KOA for flutolanil is high (10.6) based on
EFED’s EPIsuite program, ver. 3.20.  Measured data on KOA are being
requested in order to confirm model-predicted values of KOA, which may
be uncertain. This measurement is very important in evaluating the
potential for flutolanil to bioaccumulate in terrestrial food chains. 

Ecotoxicity Data Gaps

OPPTS Guideline	Study Title	Cost

(if special study)	Rationale

No Guideline Available(1)	

Chronic, Whole Sediment  Invertebrate Toxicity	N/A	According to 40CFR
Part 158, the use patterns, physical-chemical properties and available
toxicity data of flutolanil qualify it for a conditionally-required
chronic sediment toxicity test.  Specifically, the anaerobic metabolism
half life of flutolanil is > 13 years (far exceeding the 10 days
criterion for a chronic sediment test).  Further, both the log KOW (3.7)
and KOC (up to 1300) exceed thresholds for chronic sediment testing (3.0
and 1000, respectively).  Finally, there is concern over
estuarine/marine benthic invertebrates due to their demonstrated high
sensitivity to flutolanil in water column tests (most sensitive aquatic
species tested; EC50 and NOAECs of 130 and 11.3 ppb, respectively). 
Therefore, results of the recommended chronic sediment toxicity testing
could reasonably be expected to have a significant impact on the
ecological risk assessment of  flutolanil.  Currently, there are no
sediment toxicity data submitted for flutolanil.

123-2

(850.4150)	

Vegetative Vigor (Tier I)	N/A	Currently, no data are available on the
toxicity of flutolanil to terrestrial plants.  Screening (Tier I)
studies are being recommended to address uncertainty regarding the
potential impacts of flutolanil  to non-target terrestrial plants.  Such
studies are required as outlined in 40CFR Part 158 and are required in
order to assess risks associated with flutolanil uses on terrestrial
plants.  These results are also needed for endangered species assessment
for flutolanil.

123-2

(850.4100)	Seedling Emergence

(Tier I)	N/A

	

(1) Other non-OPPT test guidelines are available for conducting
assessing sediment chronic toxicity.  Registrant should submit study
protocol to EPA for review prior to initiation of testing.

VIII. Bibliography

A. Fate References

MRID  40342940.  Daly, D.; Ediger, K. (1987) W14 Hydrolysis of [Carbon
14]-Fluto- lanil as a Function of pH at 25 [degrees]C: ABC Final Report
#35399.  Unpublished study prepared by Analytical Bio-Chemistry
Laboratories, Inc.  28 p. 

MRID  41841208.  Carpenter, M.; Fennessey, M. (1991) Determination of
Photodegradat- ion of [Carbon 14-Flutolanil] in Aqueous Solution: Lab
Project Number: 35176R: E642-01-87.  Unpublished study prepared by
Analytical Bio-Chemistry Laboratories, Inc.  41 p. 

MRID  41841209.  Bashir, M. (1991) Identification of Degradation
Products of Flutol- anil in an Aqueous Photosensitized Solution: Lab
Project Number: 38426: E642.01.87.  Unpublished study prepared by
Analytical Bio-Chemistry Laboratories, Inc.  34 p. 

MRID  41841210.  Carpenter, M. (1991) "Determination of the Photolysis
Rate of Flut- olanil on the Surface of Soil": Lab Project Number: 38480:
500AU Unpublished study prepared by Analytical Bio-Chemistry Laborato-
ries, Inc.  33 p. 

MRID  43175810.  Hallberg, C. (1994) Determination of the Photolysis
Rate of Flutolanil on the Surface of Soil: Amendment 1: Lab Project
Number: 38480: 500AU.  Unpublished study prepared by ABC Laboratories,
Inc. 24 p. 

MRID  40342941.  Aizawa, H. (1982) W20-Flutolanil:  Decomposition Test
of Flutolanil in Soil: Laboratory Project ID No. 56-076-(3). 
Unpublished study prepared by Mitsubishi-Kasei Institute of
Toxicological and Environmental Sciences.  38 p. 

MRID  40342942.  Nakamura, Y.; Ishikawa, K.; Kuwatsuka, S. (1977)
Degradation of benthiocarb in soils as affected by soil conditions.
Journal of Pesticide Science 2:7-16. 

MRID  45756601.  Swanson, M. (1996) Aerobic Soil Metabolism of (Carbon
14)-Flutolanil: Final Report: Lab Project Number: A55786/W70: SC920104:
520 AU.  Unpublished study prepared by Battelle Columbus Operations. 
137 p. 

MRID.  41841211.  Daly, D.; Williams, M. (1991) Anaerobic Aquatic
Metabolism of [Carbon 14]-Flutolanil: Lab Project Number: 36762:
E642.02.88.  Unpublished study prepared by Analytical Bio-Chemistry
Laboratories, Inc.  71 p. 

MRID  41841212.  Daly, D. (1989) "Aerobic Aquatic Metabolism of [Carbon
14]-Flutola- nil: Lab Project Number: 36763.  Unpublished study prepared
by Analytical Bio-Chemistry Laboratories, Inc.  42 p. 

MRID  40342943.  Daly, D. (1987) W13-Soil/Sediment Adsorption-Desorption
with [Car- bon 14]-Flutolanil: ABC Final Report #35398.  Unpublished
study prepared by Analytical Bio-Chemistry Laboratories, Inc.  52 p. 

MRID  41841213.  Daly, D. (1991) "Soil/Sediment Adsorption-Desorption of
Soil Incor- porated [Carbon 14]-Flutolanil Following Aerobic Aging": Lab
Project Number: 37793: E642.03.89.  Unpublished study prepared by
Analytical Bio-Chemistry Laboratories, Inc.  35 p. 

MRID  42606626.  Williams, M.; Heim, L. (1992) Soil/Sediment
Adsorption-Desorption of (Carbon 14)-Desisopropyflutolanil: Lab Project
Number: 40410.  Unpublished study prepared by ABC Labs, Inc.  58 p. 

MRID  42606627.  Williams, M.; Berghaus, L. (1992) Soil/Sediment
Adsorption-Desorption of (Carbon 14)-Flutolanil: Lab Project Number:
40130.  Unpublished study prepared by ABC Labs, Inc. 58 p. 

MRID  41837803.  Castro, L. (1991) Dissipation of Flutolanil on Bare
Soil Following Application of Flutolanil 50 WP, USA, 1989: Lab Project
Number: R642.07.89.   Unpublished study prepared by NOR-AM Chemical Co.
63 p. 

MRID  41837804.  Castro, L. (1991) Dissipation of Flutolanil in Soil
following Application of Flutolanil 50WP to Turf, USA, 1989: Lab Project
Number: R642.10.89: 38122.  Unpublished study prepared by Nor-Am
Chemical Co. in assoc. with ABC Laboratories, Inc.  65 p. 

MRID  43175809.  Castro, L. (1993) Dissipation of Flutolanil in Soil
Following Application of SN 84364 50WP To Peanuts, USA, 1988: Lab
Project Number: R642.04.88.  Unpublished study prepared by NOR-AM
Chemical Co. (Analytical Services Dept. and Residue Chemistry Dept.).  
84 p. 

MRID  45756602.  Castro, L. (1994) Dissipation of Flutolanil on Bare
Soil Following Application of Flutolanil 50 WP: Lab Project Number:
FLUTOLANIL/W43: R642.07.89: B002392.  Unpublished study prepared by
Nor-Am Chemical Company.  97 p. 

MRID  45756603.  Castro, L. (1995) Dissipation of Flutolanil in Soil
Following Application of Flutolanil 50 WP to Turf, USA, 1998: Lab
Project Number: 38122: B002400: R642.10.89.  Unpublished study prepared
by ABC Laboratories, Inc. and AgrEvo Research Center.  117 p. 

MRID  42606618.  Castro, L. (1992) Aquatic Field Dissipation of
Flutolanil following Use at Highest Recommended Label Rates in Rice: Lab
Project Number: R642.06.89.  Unpublished study prepared by NOR-AM
Chemical Co. and ABC Labs.  138 p. 

MRID  43292603.  Castro, L. (1993) Flutolanil/W62: Aquatic Field
Dissipation of Flutolanil Following Application of MONCUT 50WP to Rice
at Highest Recommended Label Rates, USA, 1991: Lab Project Number:
AU/91R/03.  Unpublished study prepared by NOR-AM Chemical Co., Residue
Chemistry Dept.  94 p. 

MRID  43175804.  Castro, L. (1993) Long-Term Field Dissipation of
Flutolanil under Conditions of Peanut Cultivation Initiated 1989, USA:
Lab Project Number: R642.08.89.  Unpublished study prepared by NOR-AM
Chemical Co.; ABC Laboratories.  114 p. 

MRID  42606615.  Castro, L. (1992) Residues of Flutolanil in Crops and
Soil Irrigated with Water Drained from Rice Fields Treated with
Flutolanil 50WP: Lab Project Number: R642.03.90.  Unpublished study
prepared by NOR-AM Chemical Co.  89 p. 

MRID  40342944.  Sudo, Y. (1984) W4-Flutolanil: Test on the Degree of
Bioaccumula- tion of a, a, a-Trifluoro-3'-isopropoxy-o-toouanilide (Test
Sub- stance No. S-837) in Carp: Report No. 35524E.  Unpublished study
prepared by Chemicals Inspection & Testing Institute.  62 p. 

MRID  41841214.  Forbis, A. (1991) Uptake, Depuration and
Bioconcentration of [Carb- on 14]-Flutolanil by Bluegill (Lepomis
macrochirus): Lab Project Number: 37902: E642.04.89.  Unpublished study
prepared by Analy- tical Bio-Chemistry Laboratories, Inc.  39 p. 

MRID  41841215.  Heitkamp, J. (1991) Characterization of [Carbon
14]-Flutolanil Residues in Bluegill (Lepomis macrochirus) Water and
Tissues: Lab Project Number: 38946: E642.04.89.  Unpublished study
prepa- red by Analytical Bio-Chemistry Laboratories, Inc.  58 p. 

MRID  42641101.  Brady, S. (1992) Flutolanil-Derived Residues in or on
Crayfish Grown in Rice Paddies Treated with Flutolanil 50 WP: Lab
Project Number: R642.02.90.  Unpublished study prepared by Nor-Am
Chemical Co.  132 p. 

MRID  42606616.  Castro, L. (1991) Stability of Flutolanil and
Desisopropyl Flutolanil in Soil under Freezer Conditions for a Period of
Two Years: Lab Project Number: E642.05.88.  Unpublished study prepared
by NOR-AM Chemical Co.  42 p. 

B.  Ecological Effects References

Studies from the Open Literature

Armitage, J.M. and F.A.P.C. Gobas. 2007.  A Terrestrial Food-Chain
Bioaccumulation Model for POPs. Environ. Sci. Technol., 41(11):4019
-4025. 

Czub, G. and M.S. McLachlan. 2004. Bioaccumulation Potential of
Persistent Organic Chemicals in Humans. Environ. Sci. Technol.
38:2406-2412.

Fletcher, J.S., J.E. Nellessen, and T.G. Pfleeger.  1994.  Literature
review and evaluation of the EPA food-chain (Kenaga) nomogram, an
instrument for estimating pesticide residues on plants.  Environ. Tox.
Chem. 13:1383-1391.

Hoerger, F. and E. E. Kenaga, 1972. Pesticide Residues on Plants:
Correlation of Representative Data as a Basis for Estimation of their
Magnitude in the Environment. In: F. Coulston and F. Korte, eds.,
Environmental Quality and Safety: Chemistry, Toxicology, and Technology,
Georg Thieme Publ., Stuttgart, West Germany, pp. 9-28.

IFAS/UF. 2006. Fungicide Resistance Action Committee's (FRAC)
Classification Scheme of Fungicides According to Mode of Action.  PI-94,
Pesticide Information Office, Florida Cooperative Extension Service,
Institute of Food and Agricultural Sciences, University of Florida.  
HYPERLINK "http://edis.ifas.ufl.edu/PI131" 
http://edis.ifas.ufl.edu/PI131 . 

Kelly, B.C. and F.A.P.C. Gobas. 2003. An Arctic Terrestrial Food-Chain
Bioaccumulation Model for Persistent Organic Pollutants. Environ. Sci.
Technol. 37:2966-2974.

Kelly, B.C., Ikonomou, M.G., Blair, J.D., Morin, A.E., and F.A.P.C.
Gobas. 2007. Food Web-Specific Biomagnification of Persistent Organic
Pollutants. Science. 317:236-239.

Motoba, K., Uchida, M., and Tada, E. 1988. Mode of antifungal action and
selectivity of flutolanil. Agric. Biol. Chem. 52(6):1445-1449.

McLachlan, M.S. 1996. Bioaccumulation of Hydrophobic Chemicals in
Agricultural Food Chains. Environ. Sci. Technol. 30:252-259.

Sharpe, S. and D. Mackay. 2000. A Framework for Evaluating
Bioaccumulation in Food Webs. Environ. Sci. Technol. 34:2373-2379.

Teske, Milton E., and Thomas B. Curbishley. 2003. AgDisp ver 8.07 Users
Manual. USDA Forest Service,  Morgantown, WV.

U.S. Environmental Protection Agency.  1998.  Guidelines for Ecological
Risk Assessment.  Risk Assessment Forum, Office of Research and
Development,  Washington, D.C.  EPA/630/R-95/002F.  April 1998.  
HYPERLINK "http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=30759" 
http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=30759 

U.S. Environmental Protection Agency. 2000. Flutolanil Section 3 New Use
on Potato Seed-Pieces: Environmental Fate and Ecological Risk
Assessment. Office of Pesticide Programs, Environmental Fate and Effects
Division. Washington, DC  20460 (DP 260099) 

U.S. Environmental Protection Agency.  2004.  Overview of the Ecological
Risk Assessment Process in the Office of Pesticide Programs, U.S.
Environmental Protection Agency.  Endangered and Threatened Species
Effects Determinations.  Office of Prevention, Pesticides and Toxic
Substances, Office of Pesticide Programs, Washington, D.C.  January 23,
2004.   HYPERLINK
"http://www.epa.gov/espp/consultation/ecorisk-overview.pdf" 
http://www.epa.gov/espp/consultation/ecorisk-overview.pdf  

U.S. Environmental Protection Agency. 2007a. Flutolanil:  Human Health
Risk Assessment: Request for Inadvertent or Indirect Tolerances for Use
on Soybean, Wheat, Corn and Cotton. Office of Pesticide Programs, Health
Effects Division. Washington, DC  20460 (DP 335050, 334156).

U. S.  Environmental Protection Agency 2007b.  ECOTOXicology Database. 
Office of Research and Development National Health and Environmental
Effects Research Laboratory’s (NHEERL’s) Mid-Continent Ecology
Division (MED).   HYPERLINK "http://cfpub.epa.gov/ecotox/" 
http://cfpub.epa.gov/ecotox/  

U. S. Environmental Protection Agency.  2007c. Ecological Incident
Information System.    HYPERLINK
"http://www.epa.gov/espp/consultation/ecorisk-overview.pdf" 
http://www.epa.gov/espp/consultation/ecorisk-overview.pdf 

Registrant Submitted Studies:

Guideline:  71-1      Avian Single Dose Oral Toxicity

MRID:  40342929

Roberts, N.; Fairley, C. (1986) W8-The Acute Oral Toxicity (LD50) of
Flutolanil to the Mallard Duck: Laboratory Project ID No. NNU
21BT/861566.  Unpublished study prepared by Huntingdon Research Centre. 
31 p. 

MRID:  40342930

Roberts, N.; Fairley, C. (1987) W9-The Acute Oral Toxicity (LD50) of
Flutolanil to the Bobwhite Quail: Laboratory Project ID No. NNU
20BT/861565.  Unpublished study prepared by Huntingdon Re- search
Centre.  31 p. 

Guideline:  71-2      Avian Dietary Toxicity

MRID:  40342931

Roberts, N.; Fairley, C. (1986) W10-The Subacute Dietary Toxicity (LC50)
of Flutolanil to the Mallard Duck: Laboratory Project ID No. NNu
23BT/861568.  Unpublished study prepared by Huntingdon Research Centre. 
28 p. 

MRID:  40342932

Roberts, N.; Fairley, C. (1986) W7-The Subacute Dietary (LC50) of
Flutolanil to the Bobwhite Quail: Laboratory Project ID No. NNU
22BT/861567.  Unpublished study prepared by Huntingdon Research Centre. 
29 p. 

Guideline:  71-4      Avian Reproduction

MRID:  42932301

Beavers, J.; Hoxter, K.; Jaber, M. (1993) W64 Flutolanil: Flutolanil
Technical: A One-Generation Reproduction Study with the Bobwhite
(Colinus virginianus): Lab Project Number: 244-108. Unpublished study
prepared by Wildlife International Ltd.  167 p. 

MRID:  42932302

Beavers, J.; Hoxter, K.; Jaber, M. (1993) W64 Flutolanil: Flutolanil
Technical: A One-Generation Reproduction Study with the Mallard (Anas
platyrhynchos): Lab Project Number: 244-109. Unpublished study prepared
by Wildlife International Ltd. 173 p. 

Guideline:  72-1      Acute Toxicity to Freshwater Fish

MRID:  40342933

Bowman, J. (1987) W16 Acute Toxicity of Flutolanil Technical to Rainbow
Trout (Salmo gairdneri): ABC Final Report #35378.  Un- published study
prepared by Analytical Bio-Chemistry Laboratories, Inc.  143 p. 

MRID:  40342934

Bowman, J. (1987) W17 Acute Toxicity of Flutolanil Technical to Bluegill
Sunfish (Lepomis macrochirus): ABC Final Report #35377. Unpublished
study prepared by Analytical Bio-Chemistry Laboratories, Inc.  149 p. 

MRID:  40342936

Tsuchiya, K.; Sugimoto, T. (1982) W6-Report on Flutolanil Toxicity Tests
on Aquatic Organisms: Laboratory Project ID No. W-3001. Unpublished
study prepared by Institute of Life Science Re- search.  35 p. 

MRID:  41841216

Bowman, J. (1990) Acute Toxicity of Flutolanil Technical to Fathead
Minnow (Pimephales promelas): Lab Project Number: 38101: E642.05 .89. 
Unpublished study prepared by Analytical Bio-Chemistry Laboratories,
Inc.  39 p. 

Guideline:  72-2      Acute Toxicity to Freshwater Invertebrates

MRID:  41841217

Hicks, S.; Young, B.; Forbis, A. (1990) Acute Toxicity of Flutolan- il
to Daphnia magna: Lab Project Number: 38718: E642.08.89.  Un- published
study prepared by Analytical Bio-Chemistry Laboratori- es, Inc.  40 p. 

Guideline:  72-3      Acute Toxicity to Estuarine/Marine Organisms

MRID:  41841218

Bowman, J.; Gormley, M. (1991) Acute Toxicity of Flutolanil Technical to
Sheepshead Minnow (Cyprinodon variegatus): Lab Project Number: 38719:
502 AU.  Unpublished study prepared by Analytical Biochemistry
Laboratories, Inc.  30 p. 

MRID:  41841220

Forbis, A. (1991) Acute Toxicity of Flutolanil to Mysidopsis bahia: Lab
Project Number: 38720: E642.07.89.  Unpublished study prepa red by
Analytical Biochemistry Laboratories, Inc.  44 p.

MRID:  41841219

Ward, T.; Boeri, R. (1991) Acute Flow-through Mollusc Shell Deposition
Test with Flutolanil: Lab Project Number: 9062-AB: E642.09 .89. 
Unpublished study prepared by Resource Analysts, Inc.  55 p. 

Guideline:  72-4      Fish Early Life Stage/Aquatic Invertebrate Life
Cycle Study

MRID:  43552001

Rhodes, J.; Muckerman, M. (1995) W69 Flutolanil: Early Life-Stage
Toxicity of Flutolanil to the Fathead Minnow (Pimephales promelas) Under
Flow-Through Conditions: Final Report: Lab Project Number: 41685. 
Unpublished study prepared by ABC Labs, Inc.  176 p. 

MRID:  41850807

Blakemore, G.; Burgess, D. (1991) 21-Day Chronic Static Renewal Toxicity
of Flutolanil to Daphnia magna: Flutolanil/W 48: Final Report #38721;
503 AU.  Unpublished study prepared by Analytical Bio-Chemistry
Laboratories, Inc.  51 p. 

MRID:  43511601

Boeri, R.; Kowalski, P.; Ward, T. (1995) Life-Cycle Toxicity of
Flutolanil to the Mysid, Mysidopsis bahia: Lab Project Number: 522AU:
481-NI: W66.  Unpublished study prepared by T.R. Wilbury Labs, Inc.  51
p. 

Guideline:  81-1      Acute oral toxicity in rats

MRID:  40342906

Kosaka, T.; Saito, T. (1982) T6-NNF-136: Acute Toxicity Study in Rats. 
Unpublished study prepared by The Institute of Environ- mental
Toxicology.  17 p. 

MRID:  40342907

Cummins, H. (1986) T9-Flutolanil:  Moncut Wettable Powder: Acute Oral
Toxicity in the Rat: Laboratory Project ID No. 86/NNH004/ 227. 
Unpublished study prepared by Life Science Research Ltd. 22 p. 

MRID:  42255205

Rees, S.; Routh, M. (1992) T44 Flutolanil 70 WDG (CR 19769-1): Rat Acute
Oral Toxicity Study: Lab Project Number: TOX/91/237-1.  Unpublished
study prepared by Schering Ag., Ltd.  24 p. 

MRID:  43594004

Shults, S.; Brock, A.; Laveglia, J. (1994) ASC 66783: Acute Oral
Toxicity (LD50) Study in Rats With Chlorothalonil Plus Flutolanil (ASC
66783-0201-0202): Lab Project Number: 5933-93-0350-TX-001.  Unpublished
study prepared by Ricerca, Inc.  42 p. 

MRID:  43971414

McFarlane, M. (1994) T49 Flutolanil: PC 511 Formulation
(CR21305/01/940101): Rat Acute Oral Toxicity Study: Lab Project Number:
TOX 94168: TOX/94/237-13.  Unpublished study prepared by AgrEvo UK Ltd. 
22 p. 

MRID:  45103901

Graver, K. (2000) Acute Oral Toxicity/LD50 in Rats: Systar WDG: Lab
Project Number: MB 99-7541.01: 1000.  Unpublished study prepared by MB
Research Labs.  13 p.  {OPPTS 870.1100} 

MRID:  45136401

Cerven, D. (1998) Single Dose Oral Toxicity in Rats/LD 50 in Rats:
Systar Fungicide: Lab Project Number: MB 97-6294.01: 67-04.  Unpublished
study prepared by MB Research Laboratories, Inc.  12 p. 

MRID:  45524003

Merkel, D. (2001) Acute Oral Toxicity Study in Rats: NAI-007: Lab
Project Number: 10929.  Unpublished study prepared by Product Safety
Labs.  21 p. {OPPTS 870.1100} 

Guideline:  83-4      2-generation repro.-rat

MRID:  40342923

Tsujimura, S. (1982) T2-Flutolanil:  Three Generation Reproduction and
Teratogenicity Study on Flutolanil in the Rat: Study No. 124. 
Unpublished study prepared by Imamichi Institute for Animal
Reproduction.  264 p. 

Guideline:  122-2      Aquatic plant growth

MRID:  41841223

Bogers, M. (1990) Scenedesmus Subpicatus, Fresh Water Algal Growth
Inhibition Test with Flutolanil Technical: Lab Project Number: 024467. 
Unpublished study prepared by R C C Notox B.V.  25 p. 

MRID:  41841224

Hughes, J. (1990) The Toxicity of Flutolanil Technical to Selenastrum
capricornutum: Lab Project Number: B643-01-4: 507 AU.  Unpublished study
prepared by Malcolm Pirnie, Inc.  25 p. 

MRID:  42606621

Hughes, J. (1990) The Toxicity of Flutolanil Technical to Anabaena
flos-aquae: Lab Project Number: B643-01-5. Unpublished study prepared by
Malcolm Pirnie, Inc.  23 p. 

MRID:  42606622

Hughes, J. (1990) The Toxicity of Flutolanil Technical to Lemna gibba
G3: Lab Project Number: B643-01-8.  Unpublished study prepared by
Malcolm Pirnie, Inc.  22 p. 

MRID:  42606623

Hughes, J. (1991) The Toxicity of Flutolanil Technical to Skeletonema
costatum: Lab Project Number: B643-01-7. Unpublished study prepared by
Malcolm Pirnie, Inc.  23 p. 

MRID:  42606624

Hughes, J. (1991) The Toxicity of Flutolanil Technical to Navicula
pelliculosa: Lab Project Number: B643-01-6. Unpublished study prepared
by Malcolm Pirnie, Inc.  23 p. 

MRID:  42606625

Hughes, J. (1991) The Toxicity of Flutolanil Technical to Navicula
pelliculosa at the Concentration Equivalent to the Maximum Treatment
Rate for Rice: Lab Project Number: B643-02-1. Unpublished study prepared
by Malcolm Pirnie, Inc.  23 p. 

Guideline:  141-1      Honey bee acute contact

MRID:  40342938

Matsuura, M. (1987?) W3-Flutolanil:  Effects of Moncut Dry Flow- able on
Honey Bee: Laboratory Project ID No. N3001.  Unpublished study prepared
by Mie University.  8 p. 

 PAGE   

Page   PAGE  45  of   NUMPAGES  45 

Ingestion

Terrestrial food web Amphibians

Root uptake

Dermal uptake/Ingestion

Ingestion

Ingestion

Ingestion

Ingestion

Soil

Exposure

Media

Mammals

Runoff

Terrestrial/riparian plants

grasses/forbs, fruit, seeds (trees, shrubs)

Habitat integrity

Reduction in primary productivity

Reduced cover

Community change

Food chain

Reduction in prey

Individual organisms

Reduced survival

Reduced growth

Reduced reproduction

Terrestrial 

insects

Birds / Terrestrial-phase amphibians / reptiles / mammals

Juvenile

Adult

Spray drift

Direct

application

Flutolanil applied to use site

Attribute

Change

Receptors

Source

Stressor

Riparian plant terrestrial exposure pathways see Figure 2

Uptake/cell, 

roots, leaves

Aquatic Plants

Non-vascular

Vascular

Uptake/gills 

or integument

Ground water

Soil

Ingestion

Ingestion

Uptake/gills 

or integument

Exposure

Media

Aquatic Animals

Invertebrates

Vertebrates

Runoff

Surface water/

Sediment

Habitat integrity

Reduction in primary productivity

Reduced cover

Community change

Food chain

Reduction in algae

Reduction in prey

Individual organisms

Reduced survival

Reduced growth

Reduced reproduction

Fish/aquatic-phase amphibians

Eggs     

Larvae 

Juveniles / Adults

Spray drift

Flutolanil applied to use site

Attribute

Change

Receptors

Source

Stressor