Document ID: EPA-HQ-OPP-2009-0039-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-09-23T04:00Z

Problem Formulation,

 for Ecological Risk Assessment,

 for Fluazinam

June15, 2009

Environmental Fate and Effects Division

Office of Pesticide Programs

U.S. Environmental Protection Agency

Table of Contents

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc208220340"  1.	Purpose	 
PAGEREF _Toc208220340 \h  3  

  HYPERLINK \l "_Toc208220341"  2.	Problem Formulation	  PAGEREF
_Toc208220341 \h  3  

  HYPERLINK \l "_Toc208220342"  2.1  Nature of Regulatory Action	 
PAGEREF _Toc208220342 \h  3  

  HYPERLINK \l "_Toc208220343"  2.2. Previous Risk Assessments	  PAGEREF
_Toc208220343 \h  3  

  HYPERLINK \l "_Toc208220344"  3.	Stressor Source and Distribution	 
PAGEREF _Toc208220344 \h  3  

  HYPERLINK \l "_Toc208220345"  3.1.  Mechanism of Action	  PAGEREF
_Toc208220345 \h  3  

  HYPERLINK \l "_Toc208220346"  3.2.  Overview of Pesticide Usage	 
PAGEREF _Toc208220346 \h  5  

  HYPERLINK \l "_Toc208220347"  3.3.  Environmental Fate and Transport	 
PAGEREF _Toc208220347 \h  8  

  HYPERLINK \l "_Toc208220348"  4.	Receptors	  PAGEREF _Toc208220348 \h 
13  

  HYPERLINK \l "_Toc208220349"  4.1.  Aquatic and Terrestrial Effects	 
PAGEREF _Toc208220349 \h  13  

  HYPERLINK \l "_Toc208220350"  4.2.  Incident Database Review	  PAGEREF
_Toc208220350 \h  Error! Bookmark not defined.  

  HYPERLINK \l "_Toc208220351"  4.3.  Ecosystems Potentially at Risk	 
PAGEREF _Toc208220351 \h  18  

  HYPERLINK \l "_Toc208220352"  6.        Conceptual Model	  PAGEREF
_Toc208220352 \h  19  

  HYPERLINK \l "_Toc208220353"  6.1.   Risk Hypothesis	  PAGEREF
_Toc208220353 \h  19  

  HYPERLINK \l "_Toc208220354"  6.2.   Conceptual Diagram	  PAGEREF
_Toc208220354 \h  20  

  HYPERLINK \l "_Toc208220355"  7.        Analysis Plan	  PAGEREF
_Toc208220355 \h  21  

  HYPERLINK \l "_Toc208220356"  7.1.  Stressors of Concern	  PAGEREF
_Toc208220356 \h  22  

  HYPERLINK \l "_Toc208220357"  7.2.  Measures of Exposure	  PAGEREF
_Toc208220357 \h  22  

  HYPERLINK \l "_Toc208220358"  7.3.  Measures of Effect	  PAGEREF
_Toc208220358 \h  23  

  HYPERLINK \l "_Toc208220359"  7.4.  Integration of Exposure and
Effects	  PAGEREF _Toc208220359 \h  24  

  HYPERLINK \l "_Toc208220360"  7.5.  Deterministic and Probabilistic
Assessment Methods	  PAGEREF _Toc208220360 \h  24  

  HYPERLINK \l "_Toc208220361"  7.6.  Endangered Species Assessments	 
PAGEREF _Toc208220361 \h  25  

  HYPERLINK \l "_Toc208220362"  7.7.  Drinking Water Assessment	 
PAGEREF _Toc208220362 \h  25  

  HYPERLINK \l "_Toc208220363"  7.8.  Preliminary Identification of Data
Gaps	  PAGEREF _Toc208220363 \h  25  

  HYPERLINK \l "_Toc208220364"  7.8.1.  Fate	  PAGEREF _Toc208220364 \h 
25  

  HYPERLINK \l "_Toc208220365"  7.8.2  Effects	  PAGEREF _Toc208220365
\h  27  

  HYPERLINK \l "_Toc208220367"  8.  References	  PAGEREF _Toc208220367
\h  31  

  HYPERLINK \l "_Toc208220368"  Appendix A.   SRRD data request
justification tables	  PAGEREF _Toc208220368 \h  32  

 

1.	Purpose

The purpose of this problem formulation is to provide the foundation for
the ecological risk assessment being conducted for fluazinam.  As such,
it articulates the purpose and objectives of the risk assessment,
evaluates the nature of the problem, and provides a plan for analyzing
the data and characterizing the risk (EPA, 1998).  

2.	Problem Formulation

	2.1. Nature of Regulatory Action

This report summarizes the Environmental Fate and Effects Division’s
(EFED) Problem Formulation for the Registration Review of fluazinam. 
Previous risk assessments were completed for the uses of the chemical,
through 2007, which serve as the basis for this assessment.  

2.2. Previous Risk Assessments

In 2007, two risk assessments were issued for fluazinam.  One was an
IR-4 petition (dated 5/16/2007; DP Barcodes 338293 and 338294) for uses
on legume vegetable Crop Subgroup 6A, bushberry Crop Subgroup 13B,
brassica leafy vegetable Crop Group 5, ginseng, dry bean, lima bean and
succulent bean Crop Subgroup 6B.  Chronic LOCs were exceeded for avian
(RQs ranged from 3.40 to 0.06) and mammalian (RQs ranged from 6.80 to
0.12) endangered and non-endangered species.  In addition, there was
acute and chronic risk indicated for aquatic organisms.    SEQ CHAPTER
\h \r 1 Since fluazinam is practically nontoxic to honey bees, no
labeling precautions were required.  Risks to plants were below LOCs.

In addition, a risk assessment was issued for the proposed aerial use of
fluazinam on potatoes (dated 11/21/07; DP Barcode 342007) (previously,
only ground applications were allowed).  In the risk assessment, it was
found that chronic LOCs were exceeded for avian (RQs ranged from 1.0 to
1.5) and mammalian (RQs ranged from 0.2 to 3.0) endangered and
non-endangered species.  Chronic risk was indicated for endangered and
non-endangered freshwater fish, estuarine/ marine invertebrates and
estuarine/ marine benthic organisms.  Acute LOCs were exceeded for
endangered and non-endangered estuarine/ marine benthic organisms.  When
comparing ground applications, and aerial applications with and without
using a buffer, generally, ground applications produced the lowest risk
while aerial applications using buffer zones had RQs that were slightly
less than aerial applications without buffers. As in the previous case, 
 SEQ CHAPTER \h \r 1 no labeling precautions were required to honey
bees.  Risks to plants were below LOCs.

3.	Stressor Source and Distribution tc \l2 "B.	Stressor Source and
Distribution 

3.1. Mechanism of Action

Fluazinam, CAS Name:
3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-
(trifluo-romethyl)-2-pyridinamine, and IUPAC Name:
3-chloro-N-(3-chloro-5-trifluoromethyl-2-
pyridyl)-α,α,α-trifluoro-2,6-dinitro-p-toluidine, has a CAS Number of
79622-59-61 and a PC Code of 129098.  It is a pyridine (dinitroaniline)
fungicide.  The structure consists of one phenyl ring with two nitro
groups, and a pyridine ring.  Both rings have a trifluoromethyl group. 
The rings are attached by an amine group.  The product name is Omega
500F Agricultural Fungicide (EPA Reg. No. 71512-1).  It contains 40.0%
fluazinam.  Fluazinam is a protectant and contact fungicide.  According
to the Fungicide Resistance Action Committee (FRAC) classification
scheme of fungicides, fluazinam belongs to the chemical group of
2,6-dinitroanilines and is classified as FRAC numerical code 29,
according to the mode of action, which is inhibition of respiration. 
Fluazinam is an uncoupler of oxidative phosphorilation in the
respiration chain involving protonation/ deprotonation (it inhibits
fungal respiration, and the production of energy within the fungus).  
SEQ CHAPTER \h \r 1  Fluazinam belongs to a chemical group classified as
a multi-site fungicide (chemicals which act as general toxophores with
several sites of action).  Table 1 shows the chemical structures of
fluazinam and various of its transformation products (CAPA, DAPA, AMPA,
DCPA, HYPA, G-504 and MAPA).  It is noted that all these chemicals
(except for G-504, which is a tricyclic compound) are structurally
similar (they have the same backbone structure).  They are also
considered stressors.

Table 1.  Fluazinam and Various Transformation Products

Common Name	Chemical Name	Structure

Fluazinam	CAS Name: 3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)
phenyl]-5- (trifluo-romethyl)-2-pyridinamine;

IUPAC Name: 3-chloro-N-(3-chloro-5-trifluoromethyl-2-
pyridyl)-α,α,α-trifluoro-2,6-dinitro-p-toluidine	

CAPA	3-chloro-6-(3-chloro-2,6-dinitro-4-trifluoromethyl
anilino)nicotinic acid;

5-chloro-6-(3-chloro-α,α,α-trifluoro-2,6-dinitro-p-toluidino)nicotini
c acid	

DAPA
3-chloro-N4-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluorotol
uene-3,5,5-triamine;
3-chloro-2(2,6-diamino-3-chloro-α,α,α-trifluoro-p-toluidino)-5-(trifl
uoromethyl) pyridine	

AMPA
2-(6-amino-3-chloro-α,α,α-trifluoro-2-nitro-p-toluidino)-3-chloro-5-(
trifluoromethyl)pyridine	

DCPA	6-(4-carboxy-3-chloro-2,6-dinitroanilino)-5-chloronicotinic acid	

MAPA
3-chloro-N4-(3-chloro-5-trifluoromethyl-2-pyridyl)-5-nitro-α,α,α-trif
luoro-toluene-3,4-diamine	

HYPA,

Compound XII
5-[[3-chloro-5-(trifluoromethyl-2-pyridyl]amino]-α,α,α-trifluoro-4,6-
dinitro-o-cresol	

G-504
4,9-dichloro-6-nitro-8-(trifluoromethyl)pyrido-[1,2-α]-benzimidazole-2-
carboxylic acid	

		

3.2. Overview of Pesticide Usage

A summary table of all use patterns for fluazinam follows (Table 2).

  SEQ CHAPTER \h \r 1 Table 2.  Summary use information for fluazinam
(based on Omega 500F label, EPA Reg. No. 71512-1).

USE	SINGLE  APP. RATE (lb. a.i./A)	NUMBER OF APPS.	SEASONAL APP. RATE
(lb. a.i./A)	INTERVAL BETWEEN APPS. (days)	APP. METHOD	PHI (days)

Peanut 	0.52-1.04	2	2.09	21	Ground, Sprinkler irrigation	Do not apply
w/in 30 d of threshing for harvest

Potato	0.18-0.26	7	1.82	7	Aerial, Ground, Sprinkler irrigation	14

Crop Subgroup 6A, Edible-Podded Legume Vegetables except peas, such as,
but not limited to: Phaseolus spp. Such as: runner bean, snap bean, wax
bean; Vigna spp. Such as: asparagus bean, Chinese longbean, moth bean,
yardlong bean; jackbean, and sword bean	0.26-0.44	2	0.91	7	Ground,
Sprinkler irrigation	14

Succulent Bean Crop Subgroup 6B (such as, but not limited to lima bean
and broad bean)	0.26-0.44	2	0.91	7	Ground, Sprinkler irrigation	14

Dry Bean Crop Subgroup 6C, except Peas and Soybeans (such as, but not
limited to dried cultivars of bean: Lupinus spp.; Phaseolus spp, such as
kidney beans, dry lima bean, navy bean, pinto bean; Vigna spp., such as
adzuki bean; and broad bean, such as lablab bean)	0.26-0.44	2	0.91	7
Ground, Sprinkler irrigation	30

Crop Subgroup 13-07B, Bushberry, such as, but not limited to: Aronia
berry, blueberry (highbush and lowbush), Chilean guava, currant
(Buffalo, black, red, and Native), elderberry, European barberry,
gooseberry, highbush cranberry, honeysuckle, huckleberry, jostaberry,
juneberry, lingonberry, salal, and sea buckthorn	0.65	6	3.90	7	Ground	30

Crop Group 5, Brassica (Cole) Leafy Vegetables, such as, but not limited
to: broccoli; broccoli raab (rapini); Chinese cabbage (napa);
cauliflower; collards, kale; mizuna; mustard spinach; turnip greens;
Chinese broccoli; Brussels sprouts; Chinese cabbage (bok choy); Chinese
mustard cabbage; cavalo broccoli; kohlrabi; mustard greens; rape greens
[Transplant 6.45 fl oz/100 gal or presumably 0.64 lb a.i./A]

Soil incorpo-ration 1.36 at a soil depth of 6-8 in	1	2.00	N/A	Soil
drench after transplantingor soil incorporation (transplant the
seedlings into the treated band	20;

50 for heading vegetables such as cabbage and broccoli

Ginseng	0.52-0.78	4	3.13	7	Ground	30

Fluazinam may be applied through sprinkler irrigation (through center
pivot, motorized lateral move, traveling gun, solid set or portable
irrigation systems); however, it can also be soil incorporated before
transplant, for Crop Group 5, brassica (cole) leafy vegetables, in soils
with low infiltration rates.

The label requires a buffer zone of 25 ft within permanent bodies of
water (lakes, reservoirs, rivers, permanent streams, marshes or natural
ponds, and estuaries) so as to allow growth of a vegetative filter
strip.  The product should not be applied by aerial equipment within 150
ft of estuarine/ marine areas (aerial applications are currently allowed
only for potatoes).  The product does not require a similar buffer zone
for aerial applications on freshwater bodies of water (for freshwater
bodies of water, a 25-ft buffer applies).

The SLUA summary for fluazinam is as follows (Table 3):

Table 3.  Screening-Level Estimates of Agricultural Uses of Fluazinam
(SLUA, 10/03/08)

Crop	lb a.i.	Percent (%) Crop Treated

Average	Maximum

Peanuts	10,000	<2.5	5

Potatoes	60,000	10	20

The sources of the SLUA include the USDA-NASS (2001-2006), Private
Pesticide Market Research (2001-2007), the National Use Database (NPUD
2002) of the CropLife America Foundation and California Department of
Pesticide Regulation (CDPR) data.  The information is amalgamated and
put in a public releasable format.

The U.S. Geological Survey (USGS) pesticide use map (Fig. 1) shows
regional scale patterns in use intensity within the United States. The
USGS pesticide maps are based on State level estimates of pesticide use
rates for individual crops, which have been compiled by the National
Center for Food and Agricultural Policy (NCFAP) for 1999 through 2004,
and on the 2002 Census of Agriculture for county crop acreage crop.  It
is noted that based on the uses at the time there were already potential
estuarine/ marine areas of concern in the East coast.

The only uses for fluazinam available through the time covered by the
map were peanuts and potatoes.  Based on the map information, potatoes
used roughly two thirds of the fluazinam applied (>63,000 lb), while
peanuts covered roughly one third (>31,000 lb).

 

Fig. 1. Use of Fluazinam in 2002.

Note of Caution:  The pesticide use maps available from the web ( 
HYPERLINK
"http://water.usgs.gov/nawqa/pnsp/usage/maps/compound_listing.php?year=0
2" 
http://water.usgs.gov/nawqa/pnsp/usage/maps/compound_listing.php?year=02
 ) show the average annual pesticide use intensity expressed as average
weight (in pounds) of a pesticide applied to each square mile of
agricultural land in a county. The area of each map is based on
state-level estimates of pesticide use rates for individual crops that
were compiled by the CropLife Foundation, Crop Protection Research
Institute during based on information collected during 1999 through 2004
and on 2002 Census of Agriculture county crop acreage. The maps do not
represent a specific year, but rather show typical use patterns over the
five year period 1999 through 2004. Use intensity rates are expressed as
the pounds applied per square mile of mapped agricultural land in a
county. The area of mapped agricultural land for each county was
obtained from an enhanced version of the 1992 USGS National Land Cover
Data (NLCD). The key limitations of the data used to produce these maps
include the following: (1) state use coefficients represent an average
for the entire state and consequently do not reflect the local
variability of pesticide management practices found within states and
counties, (2) pesticide use estimates are not for a specific year, but
represent typical use patterns for the five year period, (3) state
pesticide use coefficients may not have been available for all states
where a pesticide may have been applied to agricultural land, and
therefore, are not displayed on the maps, (4) the county crop acreage is
based on the 2002 Census of Agriculture and may not represent all crop
acreage because of Census nondisclosure rules, and (5) agricultural land
area used to calculate the pesticide use intensity and display the data
was derived from 30-meter satellite remote sensing data that may over
estimate or underestimate the actual agricultural land area. The maps
are not intended for making local-scale estimates of pesticide use, such
as estimates at the county level. Please refer to   HYPERLINK
"http://water.usgs.gov/nawqa/pnsp/pubs/ofr00250/"  Method for Estimating
Pesticide Use  for a detailed discussion of how the pesticide use data
were developed.

3.3.  Environmental Fate and Transport

A summary of physicochemical and environmental fate/transport properties
of fluazinam is included in Table 4.

 tc "		1.  Environmental Fate and Transport Characterization " \l 3 

-2-pyridyl)-α,α,α-trifluoro-2,6-dinitro-p- toluidine

Henry’s Law Constant	6.73 x 10-7 atm-m3/mol at pH 7	PMRA Reg. Note
REG2003-12

Octanol/Water Partition, Log KOW	3620,   3.56   @20°C	MRID 42248403

Persistence:  

                                                                
Fluazinam                  Fluaz.+Degradates           

Hydrolysis t1/2	   pH 5

pH 7

pH 9	stable

42 days

6   days	stable

stable

stable	MRID  42208412 (a)

Photolysis  t1/2 in water	2.5 days, dark control ≈stable	one degradate
(G-504)	MRID  44807312, 43521009, 45584204 (a)

on soil	35.0 days, value corrected for dark control	degradates at ≤10%
of the applied	MRID  44807313, 45584204 (a)

Soil metabolism Aerobic t1/2	114-132 days for samples treated at 1 kg/ha
(5.56 ppm)	degradates at ≤10% of the app.; HYPA was 11.4% at 30 days
(for soil treated at 5 kg/ha)	MRID  42208413, 42208414 (a)

Soil metabolism Anaerobic t1/2	SL flooded at time 0, 4 days; SL flooded
at 30 days, 32 days	HYPA was 11.0% at 60 days for the spl. flooded at 30
days.  MAPA was up to 29.8% for the sample flooded at time 0.	MRID 
42208413, 42208414 (s)

Aquatic metabolism  Aerobic DT50	4.0-7.4 hours	51-71 days	MRID  44807314
(a)

Aquatic metabolism  Anaerobic t1/2	≈ ⅓ day (or approximately 8
hours)	stable	MRID  43521010 (a)

Mobility/Adsorption-Desorption

Batch Equilibrium - Unaged

Batch Equilibrium HYPA

Batch Equilibrium CAPA

Aged Soil Column Leaching	4 soils    KF=11-44    KFOC=1700-2300

       KF, des=34-507  KFOC, des=7000-19900

6 soils    Kd=6.6-51  KOC=640-3200

             KF=4.3-26  KFOC=450-1700

 Increasing adsorption w. increasing pH

4 soils     KF=4.9-67  KFOC=1289-3784

Studies on HYPA and CAPA were conducted w. sterile soils.

0.66% in leachate	MRID  42248628, 42974913 (a)

MRID  43528201 (a)

MRID  44807315 (s)

MRID  42208415 (a)

Field Dissipation

Terrestrial Dissipation

t1/2 in soil surface layer	Range from 9 to 49 days:  Ephrata, WA: DT50~9
days loamy sand, pinto beans; Kempton, ND: half-life=49 days, sandy
loam, beans; Porterville, CA: half-life=20 days, loamy sand, beans;
Montezuma, GA The degradation was biphasic.	MRID  44807318, 44807320,
44807316 (s)

Bioaccumulation

Accumulation in Fish, max. BCF	273-348 X for fillet portion

960-1220 X for whole fish

1410-1850 X for non-edible

(≤7.4 hr) or anaerobic aquatic (~8 hr) media.  The transformation
products of fluazinam appear to be relatively persistent under most
conditions.  Fluazinam may be photolysed relatively rapidly in water
(2.5 days) to form a tricyclic compound (G-504).  The total fluazinam
residues (fluazinam and its transformation products) are persistent in
most environments (stable to hydrolysis at all pHs, aerobic aquatic
metabolism 51-71 days, relatively stable in anaerobic aquatic
environment) and are likely to reach aquatic media as a totality through
runoff.  Since fluazinam does not alter substantially its backbone
structure in the environment, but instead, goes through slight
transformations of functional groups, EFED considered parent and
transformation products together when making assessments. While the
parent and two transformation products, HYPA and CAPA, have relatively
low mobility, indicating low potential for ground water contamination,
there is uncertainty about the other transformation products and further
information on them was required in a new Terrestrial Field Dissipation
studies.  Two such studies (MRID#’s 45584207 and 45584208) are
currently in review.  Based on the properties of the chemical,
applications of fluazinam are likely to reach the target (the crop), but
drift is also possible.  The total residues of fluazinam may reach
adjacent bodies of water via runoff events and may be persistent.  The
chemical has a low vapor pressure (8.25x10-6 mm Hg), and a relatively
low Henry’s Law constant (6.73 x 10-7 atm-m3/mol).  Due to the fact
that it appears to show short half lives in aquatic media, and it binds
to soils, EFED believes that the chemical would not volatilize
substantially.

Hydrolysis  tc "i. Hydrolysis " \l 3 

The hydrolysis of fluazinam is pH dependent.  It was relatively stable
at pH 5, and hydrolyzed with half-lives of 42 and 6 days at pH’s of 7
and 9, respectively.  The major degradate was CAPA.

Photolysis  tc "ii. Photolysis " \l 3 

Fluazinam photolyses in aqueous solutions, mainly to G-504, a tricyclic
compound, and possibly one or more other unidentified products.  The
half-life obtained in the study was 2.5 days.  The soil photolysis, on
the other hand, the half-life was 22 days (compared to 69 days for the
dark control).  The dark control corrected half-life is 35 days.

Metabolism  tc "iii. Metabolism " \l 3 

The metabolism of fluazinam appears to be moderate in a sandy loam soil
treated at 1 kg/ha (5.56 ppm) (DT50 ≤ 30 days). The calculated
half-life (linear regression, assuming first order kinetics) was about
114-132 days, which is in agreement with the fact that after 361 days,
6.8 and 9.5% of the applied fluazinam remained intact for the
14C-Pyridyl and 14C-Phenyl labels, respectively; no major metabolites
were observed.  The sandy loam treated at 5 kg/ha yielded a half-life of
227 days; in this case, Compound XII (HYPA) was observed at up to 11.4%
at 30 days posttreatment.  A loamy sand treated at 1 kg/ha yielded a
half-life of 165 days with no major metabolites.  No major degradation
products were observed in the samples treated at 1 kg/ha, but a major
fraction (~41%) was bound material at the end of the study (day 361).

Sediment/Water Systems  tc "iv. Sediment/Water Systems " \l 3 

 very short half-lives (≤8 hours in both studies).  In addition, in
such studies, various metabolites were formed.  All the major
transformation products observed have structures that resemble the
structure of the parent.  The sum of the amount of the parent
concentration plus the concentrations of the transformation products
(total fluazinam residues) decreases very slowly under both aerobic
(half-lives 51-71 days) and anaerobic (relatively stable) aquatic
conditions.  The major transformation products observed in these studies
include DAPA, SDS-67200, AMPA, DCPA, and CAPA.

Mobility  tc "v. Mobility " \l 3 

In batch equilibrium studies, fluazinam is slightly mobile in four soils
tested.  KFOC values ranged from 1705-2316.  Similarly, an available
soil column leaching study of aged fluazinam indicated low mobility of
the residues of fluazinam.  Less than 1% of the applied radiocarbon was
found in the leachates and >>80% remained at the top of the soil
columns.  There is mobility information for two of the transformation
products of fluazinam: HYPA and CAPA.  Of them, HYPA appeared to be
moderately to slightly mobile (KFOC=450-1700, 6 soils), and CAPA
appeared to be slightly mobile, but generally less mobile than the
parent (KFOC=1289-3784, 4 soils).  The latter two batch/equilibrium
studies were conducted on sterile soils.

Field Dissipation tc "vi. Field Dissipation " \l 3 

Four terrestrial field dissipation studies were submitted by the
registrant.  Such studies were found to provide only limited
supplemental information.  In particular, the data about the degradates
is very questionable due to poor recoveries in a storage stability
study.  In general, it appeared that parent fluazinam degraded
moderately rapidly in studies conducted in Ephrata, Washington, Kempton,
North Dakota, Porterville, California, and Monctezuma, Georgia.  The
dissipation half-lives ranged from 9 to 49 days.  These half-lives are
in agreement with the aerobic soil metabolism half-lives.  At this time,
the EFED has two newly submitted terrestrial field dissipation studies,
which are in review.

Bioaccumulation  tc "vii. Bioaccumulation " \l 3 

Fluazinam demonstrated some potential to bioaccumulate in fish.  The
maximum BCF’s were 348X for fillet, 1220 for whole fish, and 1850 for
viscera, all of which were obtained with the phenyl label material. 
Fish residues identified included the parent compound, AMPA, MAPA and
DAPA.  Depuration was moderately slow.  More than 67% of the residues
were eliminated from the fillet during the 21-day depuration phase.

The fate and transport characterization also includes the various
degradation and transformation products formed by each process in the
studies reviewed.  Table 5 provides a summary of these transformation
products.

Table 5.  Summary of degradate formation from degradation of fluazinam.

STUDY TYPE	DEGRADATE and MAXIMUM CONCENTRATION	SOURCE

	CAPA, G-504, HYPA AMPA, MAPA, DAPA, DCPA (% applied)

	Hydrolysis	CAPA 34% at 28 days pH 7; 84-85% at 20 days at pH 9	–	–	
 MRID: 42208412.

Aqueous Photolysis	G-504 was 14.0-17.1% by 7-10 days	_	–	  MRID:
444807312, 43521009, 45584204.

Soil Photolysis	HYPA, detected > dark control	AMPA detected > dark
control	–	  MRID: 44807313, 45584204.

Aerobic Soil Metabolism	HYPA, MAPA and DAPA detected (in the SL studies
conducted at 1 kg/ha)	  MRID: 42208413, 42208414.

Anaerobic Soil Metabolism	HYPA was 11.0% at 60 days for the SL flooded
at 30 days	MAPA was 29.8% at 14 days for the SL flooded at zero time	–
  MRID: 42208413, 42208414.

Aerobic Aquatic Metabolism	CAPA 12.6% at 72 hr	DAPA: 19.0% by 240 hr
DCPA: 11.3% at 24 hr	MRID: 44807314.

Anaerobic Aquatic Metabolism

	AMPA 24.2% at 0.2 day	DAPA: 32.7% at day 30	SDS-67200 39.6% by day 14
MRID: 43521010.

Terrestrial Field Dissipation	MAPA, CAPA, and HYPA were monitored;
however, there were problems with the storage stability data for the
degradates.	MRID: 44807318, 44807320, 44807316, 44807319, 44807317.

            

4.	Receptors

4.1.  Aquatic and Terrestrial Effects

The receptor is the biological entity that is exposed to the stressor
(EPA, 1998).  Due to the outdoor uses of fluazinam, the types of
receptors that may be exposed include both aquatic and terrestrial
receptors, such as birds, reptiles, mammals and freshwater and
estuarine/ marine fish, non-target invertebrates and terrestrial and
aquatic plants.  This list may not be comprehensive.  Spray drift and
runoff exposures are expected for both ground and aerial (potato only)
applications of fluazinam.  Consistent with the process described in the
Overview Document (EPA, 2004), this risk assessment uses a surrogate
species approach in its evaluation of fluazinam.  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.   

Table 6 provides a summary of the taxonomic groups and the surrogate
species tested to help understand potential ecological effects of
pesticides to these non-target taxonomic groups.  In addition, the table
provides a preliminary overview of the potential acute toxicity of
fluazinam by providing the acute toxicity classifications.

Terrestrial Species

  SEQ CHAPTER \h \r 1 The available toxicity data suggests that
fluazinam ranges from slightly toxic to practically nontoxic for birds. 
An LD50=1782 mg/kg per body weight for quail (MRID 422486-23) is the
most sensitive endpoint and will be used in the risk assessment. A quail
LC50 >10500 mg/kg (MRID 422486-24) as well as a mallard LD50 > 4191
mg/kg (MRID 422486-22) and an LC50 >10,600 mg/l (MRID 422486-25)
indicate that fluazinam is practically nontoxic to birds. A twenty-two
week quail reproductive study resulted in a NOEL=200 mg/kg for 14-day
survivor weight. A twenty-one week avian reproduction toxicity study
(MRID 448319-07) shows that fluazinam exposure can result in growth
reduction in young (14-day old survivors weight) with a NOAEL = 200
mg/kg and LOAEL = 500 mg/kg.

Mammalian toxicity data (MRID 422486-03) suggest that this compound is
practically nontoxic to small mammals on an acute basis (rat LD50 =
4,300 mg/kg). Reproductive effects that were based on a decreased number
of implantation sites and decreased litter size were noted at an LOAEC =
500 ppm (NOAEC = 100 mg/kg).

Terrestrial invertebrates are represented by the honey bee.  Acute
toxicity on honeybees show that fluazinam is practically nontoxic to
bees based on an LD50 > 200 µg a.i./bee (MRID 422084-11). A toxicity
test for the formulated product was also provided.  A 48-h LD50>4.0
µg/bee  indicates this fluazinam product (49.7%) is practically
non-toxic to bees.

Aquatic Species

The effect of fluazinam to freshwater fish is estimated for both cold
and warm water fish. Fluazinam is considered to be very highly toxic to
the freshwater rainbow trout (Oncorhynchus mykiss) on an acute basis,
with an LC50 = 36 µg/l (33-56 µg/l) (MRID 429749-04). This rainbow
trout estimate is the most sensitive value and will be used in the risk
assessment. Another rainbow trout study (MRID 422084-09) resulted in an
LC50=110 µg/l (100-130 µg/l). Another fish study for the bluegill
resulted in an LC50 = 52.7 µg/l (47.1-59 µg/l), indicating fluazinam
is very highly toxic to fish (MRID 429749-05). An invalid non-guideline
toxicity study for the carp (Cyprinus carpio) was also submitted (MRID
422084-08).  

In addition to the acute fish studies, two chronic studies, an early
life and a life-cycle study, were submitted. A chronic freshwater life
cycle fish study resulted in a 278 day NOAEC=0.69 µg/l for a fathead
minnow (MRID 448073-29) based on hatching success. A chronic study
resulted in a NOAEC=5.3 µg/l and a LOEC-10 µg/l for a 30 day early
life test (MRID 448073-27) with larval survival as the endpoint
effected. 

Daphnia are used as a surrogate for freshwater invertebrates for both
acute and chronic effects. Acute toxicity values for aquatic
invertebrates suggest that fluazinam is highly toxic to freshwater
invertebrates (Daphnia EC50 = 180 µg/l (MRID 422084-10) to 222 µg/l
(MRID 429749-06). Chronic toxicity to invertebrates is only represented
through the Daphnia magna life cycle (MRID 448073-28) where the NOAEC
was calculated at 68 µg/l and the LOAEC at 0.140 µg/l.  The endpoints
affected for this study were reproductive and weight effects.

Estuarine/marine fish are represented by the sheepshead minnow
(Cyprinodon variegatues) with a toxicity study indicating fluazinam is
highly toxic to estuarine/marine fish. An acute toxicity study (MRID
448073-25) resulted in LC50 = 120 µg/l (80-240 µg/l). The chronic fish
early life-stage study was classified as supplemental and resulted in a
NOEL>26 µg/l (MRID458221-02). This study does not satisfy the guideline
requirement for a chronic estuarine/marine fish study. 

Estuarine/marine aquatic invertebrates are represented by the oyster and
mysid with toxicity studies indicating fluazinam is very highly toxic to
both. An acute toxicity study (MRID 448073-24) resulted in an oyster
(Crassostrea virginica) EC50 = 4.7 µg/l (3.6-6.0 µg/l).  The acute
study (MRID 448073-26) for the mysid shrimp (Americamysis bahia)
resulted in an EC50 = 39 µg/l (34-45 µg/l).  The results from the
oyster study will be used in this assessment because it resulted in the
most sensitive acute endpoint. A chronic mysid reproductive study (MRID
458221-01 was classified as supplemental based on missing raw data.  The
missing information has been requested from the conditional registration
data call-in.  

Plants

An acceptable seedling emergence Tier I study (MRID 461728-01) using the
dicots cabbage, carrot, cucumber, lettuce radish, soybean and tomato and
the monocots corn, oat, onion and ryegrass was received. The toxicity
test resulted in an EC25>0.78lbs a.i./A based on no observed effects at
the highest tested concentration. . 

Terrestrial

The effect of fluazinam on terrestrial plants is represented through the
seedling emergence and vegetative vigor studies. An acceptable seedling
emergence study (MRID 461728-01) resulted in no effect at the highest
tested concentration of 0.78 lb/A.  A Tier I terrestrial seedling
emergence study (MRID 448073-32 and 448073-33) resulted in a 14 day
EC25<1.5 lb/A for tomato. No acceptable vegetative vigor studies have
been submitted.

Aquatic Plants

The effect of fluazinam on aquatic plants is represented by vascular and
nonvascular species. No acceptable vascular aquatic plant studies have
been submitted, but a Lemna study was requested in the conditional
registration. One acceptable nonvascular plant study was submitted. An
acceptable blue-green algae (Anabaena flos-aquae) study (MRID 458221-06)
resulted in an EC50=9200 µg/l.  A supplemental study with the green
algae Pseudokirchneriella subcapitata), a surrogate for nonvascular
aquatic plants, was submitted and resulted in a 96 hour EC50=180 µg/l
(160-200 µg/l) (MRID 448073-34). This study does not satisfy the
nonvascular plant requirement. Several invalid nonvascular studies were
submitted (MRIDs 445221-04, 458221-05 and 458221-07). 

Table 6.  Test Species Evaluated for Assessing Potential Ecological
Effects of Fluazinam and the Associated Acute Toxicity Classification

Taxonomic Group	Example(s) of Surrogate Species	Acute Toxicity
Classification

Birds1	Bobwhite (Colinus virginianus)

	Quail 14d LD50=1782 mg/kg (MRID 42248623)

Slightly toxic

Quail 8d LC50 > 10500 mg/kg body weight (MRID 422486-24) 

Practically non-toxic

Avian Reproduction

Bobwhite Quail 22 week NOEL=200 mg/kg

(MRID 448073-23)

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

	Mallard 14d LD50>4191mg/kg (MRID 422486-22)

Practically nontoxic

Mallard LC50 > 10600 mg/kg 

Mallard NOEC = 651 mg/kg (MRID 422486-25)

Practically Non-toxic

Avian Reproduction

Mallard Duck 21 week LOEL=500 mg/L

(MRID 44831907)

  SEQ CHAPTER \h \r 1 Mammals	  SEQ CHAPTER \h \r 1 Laboratory rat
(Rattus norvegicus)	LD50 = 4300 mg/kg (MRID 422486-03) Practically Non-
Toxic

  SEQ CHAPTER \h \r 1 Insects	  SEQ CHAPTER \h \r 1 Honey bee (Apis
mellifera L.)	48 h LD50 >200 µg/bee for (MRID 422084-11)

Practically nontoxic

48 h LD50>4.0 µg/bee for 49.7%a.i. (MRID 422084-11)

Freshwater Fish2	BlueGill (Lepomis macrochirus)	Bluegill LC50=52.7 µg/L
(47.1-59 µg/L) 

(MRID 429749-05)

Very highly toxic 

	Rainbow trout (Oncorhynchus mykiss)

	Rainbow trout LC50=110 µg/L (100-130 µg/L)  

(MRID 422084-09)

Highly toxic

Rainbow trout LC50=36 µg/L (33-56µg/L)

(MRID 429749-04)

Very highly toxic

	Carp (Cyprinus carpio)	Carp 96h LC50=145 µg/L (120-222 µg/L)

(MRID 422084-08)

Highly toxic

	Fathead minnow (Pimephales promelas)	Early life 30d NOEC=5.3 µg/L

LOEC=10 µg/l

(MRID 448073-27)

Life cycle 278d

NOEC = 0.69 µg/L

 LOEC=1.4 µg/l

(MRID448073-29)

Acceptable

Aquatic Invertebrates	Daphnia magna	Acute Daphnia EC50=180 µg/L
(140-222 µg/L)

 (MRID 422084-10) 

Highly toxic

Acute Daphnia EC50=222 µg/l

(MRID 429749-06)

Highly toxic

Lifecycle Daphnia 

NOEC=68 µg/L

21d LOEC=140 µg/L

(MRID448073-28)

  SEQ CHAPTER \h \r 1 Estuarine/marine fish	  SEQ CHAPTER \h \r 1
Sheepshead minnow (Cyprinodon variegatues)	96h LC50=120µg/l (80-240
µg/l)(MRID 448073-25

Highly toxic 

Chronic:  NOEC >26 µg/l all endpoints

(MRID 458221-02)

Supplemental (Not Repairable)

Estuarine/marine invertebrates	Mysid shrimp (Americamysis bahia)

	Acute Mysid 96h LC50=39µg/l (34-45 µg/l)(MRID 448073-26

Very highly toxic 

Chronic NOEC= 2.0 µg/l reproductive success

(MRID 458221-01)

Supplemental (May be Upgraded)

	Eastern oyster (Crassostrea virginica)	Acute oyster 96h LC50=4.7 µg/l

(3.6-6.0 µg/l)

(MRID 448073-24)

Very highly toxic

  SEQ CHAPTER \h \r 1 Terrestrial plants3	  SEQ CHAPTER \h \r 1 Monocots
– corn (Zea mays)

Dicots – Tomato (Lycopersicon esculentum)	VVE: Tomato  14D
EC25<1.5lb/A

(MRID 448073-32 and MRID 448073-33)

Tier I SE: EC25> 0.78 lb/A

(MRID 461728-01)

Acceptable

	  SEQ CHAPTER \h \r 1 Monocots – corn (Zea mays)

Dicots – Tomato (Lycopersicon esculentum)	Tier I Vegetative Vigor

(MRID 461728-02)

Invalid

  SEQ CHAPTER \h \r 1 Aquatic plants and algae	  SEQ CHAPTER \h \r 1
Duckweed (Lemna gibba) 

	

Lemna –Required

(MRID 458221-03)

invalid

	Green algae (Pseudokirchneriella subcapitata)	Algae 96h EC50=180µg/l

 (160-200 µg/l)

(MRID 448073-34)

Supplemental

(MRID 445221-04)

Invalid

	Blue green Algae (Anabaena flos-aquae)	96 h EC50=9200µg/l

(MRID 458221-06

Acceptable

	Freshwater Diatom  (Navicula pelliculosa)	(MRID 458-221-05)

Invalid

	Marine Diatom (Skeletonema costatum)	(MRID 458221-07)

Invalid 

  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.

3 Four species of two families of monocots, of which one is corn; six
species of at least four dicot families, of which one is soybeans.

Incident Database Review

Incident Reports:  There are no aquatic or terrestrial ecological
incident reports for fluazinam in the Agency’s Ecological Incident
Information System (EIIS).  No incidents of contamination of surface,
ground and drinking water have been reported to the Agency.  A lack of
reported incidents does not necessarily mean that such incidents have
not occurred.  In addition, incident reports for non-target plants and
animals typically provide information on mortality events only.  Reports
for other adverse effects, such as reduced growth or impaired
reproduction, are rarely received.

4.3.  Ecosystems Potentially at Risk 

Fluazinam may be applied on a variety of food crops, including beans
leafy vegetables, bushberries, ginseng, peanuts and potatoes.  Thus, the
ecosystems at risk may be extensive in scope, and as a result it may not
be possible to identify specific ecosystems during the development of a
baseline risk assessment.  In general terms, terrestrial ecosystems
potentially at risk due to the use of fluazinam, could include the
treated field and areas immediately adjacent to the treated field 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.  Due to the persistence of the total residues of
fluazinam (that is, total residues of parent and its transformation
products), they are expected to drift and/ or runoff due to application
to food crops, resulting in possible exposure to aquatic ecosystems.
Aquatic ecosystems potentially at risk due to the use of fluazinam
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. 

5.	Assessment Endpoints tc \l2 "C.	Assessment and Measurement Endpoints 

Assessment endpoints are defined as “explicit expressions of the
actual environmental value that is to be protected.”  Defining an
assessment endpoint involves two steps: 1) identifying the valued
attributes of the environment that are considered to be at risk; and 2)
operationally defining the assessment endpoint in terms of an ecological
entity (i.e., a community of fish and aquatic invertebrates) and its
attributes (i.e., survival and reproduction).  Therefore, selection of
the assessment endpoints is based on valued entities (i.e., ecological
receptors), the ecosystems potentially at risk, the migration pathways
of pesticides, and the routes by which ecological receptors are exposed
to pesticide-related contamination.  The selection of clearly defined
assessment endpoints is important because they provide direction and
boundaries in the risk assessment for addressing risk management issues
of concern.  Changes to assessment endpoints are typically estimated
from the available toxicity studies, which are used as the measures of
effects to characterize potential ecological risks associated with
exposure to pesticides, such as fluazinam.

To estimate exposure concentrations, the ecological risk assessment
considers a single application at the maximum application rate to fields
that have vulnerable soils.  The most sensitive toxicity endpoints are
used from surrogate test species to estimate treatment-related direct
effects on acute mortality and chronic reproductive, growth and survival
assessment endpoints.  Toxicity tests are intended to determine effects
of pesticide exposure on birds, mammals, fish, terrestrial and aquatic
invertebrates, and plants.  These tests include short-term acute,
sub-acute, and reproduction studies and are typically arranged in a
hierarchical or tiered system that progresses from basic laboratory
tests to applied field studies.  The toxicity studies are used to
evaluate the potential of a pesticide to cause adverse effects, to
determine whether further testing is required, and to determine the need
for precautionary label statements to minimize the potential adverse
effects to non-target animals and plants.

6.        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.

A conceptual model provides a written description and visual
representation of the predicted relationships between fluazinam,
potential routes of exposure, and the predicted effects for the
assessment endpoint. A conceptual model consists of two major
components: risk hypothesis and a conceptual diagram (EPA, 1998).

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

Risk hypotheses are specific assumptions about potential adverse effects
(i.e., changes in assessment endpoints) and may be based on theory and
logic, empirical data, mathematical models, or probability models (EPA
1998).  For this assessment, the risk is stressor-initiated, where the
stressor is the release of fluazinam into the environment.  The
following risk hypothesis is presumed for this screening-level
assessment:

The use of fluazinam will likely involve situations where terrestrial
and aquatic animals and plants will be exposed to the chemical and/or
its transformation products. Based on information on environmental fate,
mode of action, direct toxicity and potential indirect effects, EFED
assumes potential, for fluazinam and its transformation products, to
cause reduced survival, growth, and reproduction to terrestrial and/or
aquatic animals and plants as a result of the proposed use of the
pesticide.

 

The conceptual model is a generic graphic depiction of the risk
hypothesis.  It includes the potential pesticide or stressor, fluazinam
(and its transformation products), the source of the pesticide and/or
transport pathways, exposure media, exposure point, biological receptor
types, and attribute changes.

6.2.   Conceptual Diagram tc \l3 "2.         Diagram 

The conceptual site model is a generic graphic depiction of the risk
hypothesis, and assumes that the fungicide fluazinam (and its
transformation products), having outdoor uses, is capable of affecting
aquatic and terrestrial animals provided that environmental
concentrations are sufficiently elevated as a result of proposed label
uses.  Based on an examination of the physicochemical properties of
fluazinam, the fate and disposition in the environment, and mode of
application, a conceptual model was developed that represents the
possible relationships between the stressors, ecological receptors, and
the assessment endpoints.  Through a preliminary iterative process of
examining available data, the conceptual model (i.e., the representation
of the risk hypothesis) may be refined to reflect the likely exposure
pathways and the organisms that are most relevant and applicable to this
assessment (see Figure 2, below). It includes the potential pesticide or
stressor (fluazinam and its transformation products), the sources and/
or transport pathways, exposure media, exposure points, biological
receptor types and attribute changes.

In order for a chemical 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
exposure 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. In addition, the
potential mechanisms of degradation/ transformation (i.e., which
degradation/ transformation products may form in the environment, in
which media, and how much) must be understood, especially for a chemical
whose metabolites/ transformation products are of greater toxicological
concern than the parent compound.  The assessment of ecological exposure
pathways, therefore, includes an examination of the source and potential
migration pathways for constituents, and the determination of potential
exposure routes.

Under the possible uses of fluazinam, the sources and mechanisms of
release of the compound are from ground or aerial (only for potatoes)
spray applications.  Surface runoff from the areas of application is
assumed to depend on factors such as topography, irrigation, and
rainfall events.  Direct deposition may result in contamination of food
items that may be consumed by terrestrial organisms.  Spray drift
results in contaminated adjacent areas, such as bodies of water.

For aquatic receptors, the major point of exposure is through direct
contact with the water column, sediment, and pore water (gill/
integument) contaminated with spray drift (from spray application) and/
or runoff from treated areas.  Indirect effects to aquatic organisms
(especially fish) can also occur through impact to various food chains. 
The representative aquatic receptors are certain freshwater and
estuarine/ marine fish, invertebrates, and, in certain cases, aquatic
plants.  The major point of exposure for terrestrial animals is
consumption of food contaminated with residues such as grass, foliage,
and small insects.  For plants, the point of exposure is root uptake. 
The representative terrestrial receptors are mammals, birds, and, in
certain cases, terrestrial plants.  The attribute changes used to assess
risk terrestrial receptors depend on the type of test (e.g., reduced
survival, growth, or reproduction for animals and seedling emergence and
vegetative vigor for plants).  It should be noted, that these species do
not cover all the possible species in the animal and plant kingdoms;
certain taxa are considered as surrogates for other taxa.  For example,
fish are considered surrogates for aquatic phase amphibians.

      

7.        Analysis Plan 

In order to address the risk hypothesis, the potential for adverse
effects on the environment is estimated.  Usage, environmental fate and
transport, and ecological effects of fluazinam 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 a chemical is estimated using the probit
dose-response slope and either the level of concern (discussed below) or
the actual calculated risk quotient value.  

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

7.1. Stressors of Concern

The focus of this assessment is on the fluazinam, parent material. 
However, the Agency will review open literature to identify degradate(s)
of potential toxicological concern.  Various degradates of fluazinam,
such as HYPA, are structurally related to the parent compound, and
persist more than fluazinam.

Toxicity data for environmental mixtures of fluazinam with other
pesticides (those mixtures occurring in the environment following
application), if available, may be presented as part of the ecological
risk assessment.  It is expected that the toxic effect of fluazinam, in
combination with other pesticides used in the environment, is likely to
be a function of many factors including but not necessarily limited to:
(1) the exposed species, (2) the co-contaminants in the mixture, (3) the
ratio of fluazinam and co-contaminant concentrations, (4) differences in
the pattern and duration of exposure among contaminants, and (5) the
differential effects of other physical/ chemical characteristics of the
receiving waters (e.g. organic matter present in sediment and suspended
water).  Quantitatively predicting the combined effects of all these
variables on mixture toxicity to any given taxa with confidence is
beyond the capabilities of the available data and methodologies. 
However, a qualitative discussion of implications of the available
pesticide mixture effects data on the confidence of risk assessment
conclusions will be addressed as part of the uncertainty analysis.

7.2.  Measures of Exposure

In order to estimate risks of fluazinam exposures in aquatic and
terrestrial environments, all exposure modeling and resulting risk
conclusions will be made based on maximum application rates for the
current use patterns.  Measures of exposure are based on aquatic and
terrestrial models that predict estimated environmental concentrations
of fluazinam (plus its transformation products) using maximum labeled
application rates and methods, as well as any mitigation measures
specifically indicated on the label.  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 exposure 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 and transport 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 (August, 2007) to
generate daily exposures and 1-in-10 year EECs of fluazinam plus its
transformation products, that may occur from spray drift and runoff to
surface water bodies adjacent to application sites.   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 fluazinam plus its transformation products.  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 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 are derived using the T-REX model (version 1.3.1, 12/07/2006).  For
granular pesticides (not applicable for fluazinam), this includes the
amount of pesticide per square foot, used in LD50 per square foot risk
assessment calculations.    SEQ CHAPTER \h \r 1 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 (assumed to be 0% for granulars) to calculate
EECs.  EECs are based upon solubility, application rate and minimum
incorporation depth.

  

7.3.  Measures of Effect

Ecological effects data are used as measures of direct and indirect
effects to biological receptors.  Data are typically obtained from
registrant-submitted studies or from literature studies identified by
ECOTOX.  The ECOTOX database provides more ecological effects data in an
attempt to bridge existing data gaps.  ECOTOX is a source for locating
single chemical toxicity data and potential 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.

Where available, sub-lethal effects observed in both
registrant-submitted and open literature studies will be evaluated
qualitatively.  Such effects may include behavioral changes (e.g.,
lethargy and changes in coloration).  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 the toxicity of fluazinam
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 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.

  

7.4.  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 pesticides 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 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 will
be used to indicate when fluazinam’s uses, as directed on the label,
have the potential to cause adverse direct or indirect effects to
non-target organisms.  In addition, incident data from the EIIS will be
considered as part of the risk characterization.

  

7.5.  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.  An effort may also 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 ( 
HYPERLINK "http://www.epa.gov/scipoly/sap/index.htm" 
http://www.epa.gov/scipoly/sap/index.htm ) and have been deemed as
appropriate means of refining assessments where deterministic approaches
have identified risks.

7.6.  Endangered Species Assessments

Consistent with the Agency’s responsibility under the Endangered
Species Act (ESA), the Agency will evaluate risks to Federally-listed
threatened and/or endangered (listed) species from registered uses of
fluazinam.  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 the registration of fluazinam
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 fluazinam application
occurs), plus all areas where offsite transport 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 sub-lethal effects available
in the effects literature.  Therefore, the action area extends to a
point where environmental exposures are below any measured lethal or
sub-lethal effect threshold for any biological entity at the whole
organism, organ, tissue, and/ or 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.

7.7.  Drinking Water Assessment

A drinking water assessment will be conducted to support future human
health risk assessments of fluazinam. The drinking water assessment will
incorporate model estimates of fluazinam (fluazinam total residues of
concern) in surface and ground waters.  Concentrations in surface waters
will be estimated using FQPA Index Reservoir Screening Tool (FIRST,
v.1.1.1, 12/18/07) (or subsequently using PRZM/ EXAMS - see description
above, if refinements are required). Ground water estimates of
concentrations will be made using the Screening Concentration in Ground
Water (SCI-GROW) model (v.2.3, July 2003).  The drinking water
assessment will also include a summary of available surface and ground
water monitoring data. 

Preliminary Identification of Data Gaps

7.8.1. Fate

The environmental fate database is substantially complete.

835.6100: Terrestrial Field Dissipation.  EFED believes that the
available Terrestrial Field Dissipation studies provide useful
supplemental information about the parent fluazinam.  However, poor
recoveries for two of the transformation products upon storage stability
cast doubts over the results obtained for them in the field.  The
registrant submitted two new terrestrial field dissipation studies
(MRID#s 45584207 and 45584208).  These studies are currently in review.

835.6100, 835.6200:  Environmental Chemistry Methods (ECMs) and
Independent Laboratory Validations (ILVs) for Soil, Water and Sediment. 
ECMs associated with the Terrestrial Field Dissipation study (Field
dissipation §158.1300; OPPTS guidelines 835.6100, 835.6200, and
835.6300), along with successful confirmatory method trials (validation)
by an independent laboratory (i.e. ILVs), are required.  If there is
risk concern for a given taxon, ECMs should be available for the
environmental media in which organisms of the taxon reside.  These ECMs
should have limits of quantitation for the residues of concern that are
lower than the relevant toxicological levels of concern.  The latter
risk assessments conducted on fluazinam indicated risk concerns for
organisms living in freshwater and estuarine/ marine bodies of water. 
In addition, there were risk concerns for estuarine/ marine organisms
living in the benthos.  Therefore, ECMs for water and sediment are
required in addition to the ECM for soil.  The ECMs should include
parent and those residues found in the laboratory studies that exceeded
10% of the applied.  The following appear to be the residues of concern
for each media:

Soil – parent and HYPA

Water – parent, DCPA, HYPA, CAPA, DAPA and AMPA

Sediment – parent, DAPA and AMPA

The registrant is encouraged to submit state-of-the-art environmental
chemistry methods; further, multi-residue methods (MRMs) for soil, water
and sediment are preferred.

Table 7 lists the status of the environmental fate data requirements.

Table 7. Summary of Environmental Fate Data Requirements for Fluazinam 
SEQ CHAPTER \h \r 1 

Study Identification	Use Pattern1	Does EPA Have Data To Satisfy This
Requirement?	Bibliographic Citation	Must Additional Data Be Submitted
Under FIFRA 3(c)(2)(B)?

§158.1300 ENVIRONMENTAL FATE

Degradation Studies-Lab:

 835.2120   Hydrolysis	1,2	Yes	             42208412	No

 835.2240   Photodegradation In Water	1,2	Yes	44807312, 43521009,  
45584204	No

 835.2410   Photodegradation On Soil	1,2	Yes	42208413, 44807313,
45584204	No

Metabolism Studies-Lab:

 835.4100   Aerobic Soil	1,2	Yes	42208413, 42208414	No

 835.4200   Anaerobic Soil	1,2	No	42208413, 42208414	No

 835.4400   Anaerobic Aquatic	1,2	Yes	43521010	No

 835.4300   Aerobic Aquatic	1,2	Yes	44807314	No

Mobility Studies:

 835.1230 & 835.1240   Leaching - Adsorption/ Desorption	1,2	Yes	       
      44807314	No

 835.1410   Volatility (Lab)	1,2	No	                  NA	No

Dissipation Studies-Field:

 835.6100   Soil	1,2	Yes	44807318, 44807320, 44807316, 44807319,
44807317, 45584207, 45584208	In reserve                  

835.6100 Environmental Chemistry Methods (ECM) and Independent
Laboratory Validation (ILV) – Soil, Water and Sediment	1,2	No	N/A	Yes

Ground Water Monitoring Studies:

 835.7100   Ground Water Monitoring	1,2	No	NA	Reserved

§158.630  AQUATIC ORGANISMS TESTING

 850.1730  Bioaccumulation in Fish	1,2	Yes	43521012	No

§158.1100  SPRAY DRIFT

 201-1  Droplet Size Spectrum	1,2	No	NA	No2

 202-1  Drift Field Evaluation	1,2	No	NA	No2

1.  Use Patterns:1=Terrestrial/Food; 2=Terrestrial/Feed.              
2.  Data requirement covered by submission of the Spray Drift Task
Force.

7.8.2  Effects

Table 8 lists required ecological studies for fluazinam.  Based on new
data requirements, a passerine acute oral toxicity test is required. 
Chronic estuarine/marine fish and aquatic invertebrate studies are
requested based on potential exposure to estuarine/marine water bodies
and potential risk estimated in previous assessments.  Studies will
provide information to reduce uncertainty for nontarget and endangered
species assessments. A whole sediment chronic toxicity invertebrate
study (850-1790) is requested to reduce the uncertainty of risk for
chronic benthic organisms. 

Some of the submitted plant studies were deemed invalid and should be
repeated. The following plant studies are needed:

123-1: Tier II - Terrestrial Plant Growth - Vegetative vigor. 

123-2: Tier II - Aquatic Plant Growth - duckweed (Lemna gibba), green
algae (Pseudokirchneriella subcapitata), a freshwater diatom (Navicula)
and a marine diatom (Skeletonema costatum). 

Table 8. Ecological Effects Data Requirements for Fluazinam

Data Requirement	

Use

Pattern1	Does EPA Have

Data To Satisfy

This Requirement?

(Yes, No, or Partially)	

Bibliographic

Citation	Must Additional

Data Be Submitted

Under FIFRA 3(c)(2)(B)?

§158.490 WILDLIFE AND AQUATIC ORGANISMS

71-1(a)   Acute Avian Oral, Quail or Duck 	1,2	Yes	42248623, 42248622	No

71-1(a)   Acute Avian Oral, Passerine 	1,2	No

Yes

71-2(a)   Acute Avian Diet, Quail              	1,2	Yes	42248624	No

71-2(b)   Acute Avian Diet, Duck              	1,2	Yes	42248625	No

71-3       Wild Mammal Toxicity               	1,2	NA

71-4(a)   Avian Reproduction Quail	1,2	Yes	448073-23	No

71-4(b)   Avian Reproduction Duck          	1,2	Yes	44831907	No

71-5(a)   Simulated Terrestrial Field Study    	1,2	NA

71-5(b)   Actual Terrestrial Field Study                    	1,2	NA

72-1(a)   Acute Fish Toxicity Bluegill         	1,2	Yes	42974905	No

72-1(b)   Acute Fish Toxicity (TEP)	1,2	NA

72-1(c)   Acute Fish Toxicity Rainbow  Trout          	1,2	Yes	42974904,
42208409	No

72-1(d)   Acute Fish Toxicity Rainbow  Trout (TEP)	1,2	NA

72-2(a)   Acute Aquatic Invertebrate           	1,2	Yes	42974906,
42208410	No

72-2(b)   Acute Aquatic Invertebrate   (TEP)         	1,2	NA

72-3(a)   Acute Est/Mar Toxicity Fish         	1,2	Yes

Yes	44807325

45822102	No

No

72-3(b)   Acute Est/Mar Toxicity Mollusk    	1,2	Yes	44807324	No

72-3(c)   Acute Est/Mar Toxicity Shrimp    	1,2	Yes	44807326	No

72-3(d)   Acute Est/Mar Toxicity Fish (TEP)	 	1,2	NA

72-3(e)   Acute Est/Mar Toxicity Mollusk  (TEP)  	1,2	NA

72-3(f)   Acute Est/Mar Toxicity Shrimp  (TEP)  	1,2	NA

72-4(a)   Early Life Stage Fish                  	1,2	Yes (FW)	44807327
No

No (Estuarine/marine)	458221-02	Yes2

72-4(b)   Life Cycle Aquatic Invertebrate  	1,2	Yes (FW)	448073-28	No

No (Estuarine/marine)	458221-01	Yes2

72-5       Life Cycle Fish         	1,2	Yes	448073-29	No

72-6       Aquatic Organism Accumulation	1,2	NA

72-7(1)   Simulated Aquatic Field Study	1,2	NA

72-7(b)   Actual Aquatic Field Study	1,2	   NA

850-1790 Whole Sediment Chronic Toxicity Invertebrates	1,2	No

Yes

§158.540 PLANT PROTECTION

122-1(a) Seed Germ, Seedling Emergence	1,2	Yes

	461728-01	No

122-2     Aquatic Plant Growth	1,2	No

Yes

122-1(b)  Vegetative Vigor	1,2	No

	461728-02

448073-32

448073-33

	Yes2

123-2     Aquatic Plant Growth	1,2	No

No

No

No

Yes

No	448073-34

458221-03

458221-04

458221-05

458221-06

458221-07	Yes3

Yes3

Yes3

Yes3

No

Yes3

124-1     Terrestrial Field Study	1,2	NA

124-2     Aquatic Field Study	1,2	NA

§158.490 NONTARGET INSECT TESTING

141-1     Honey Bee Acute Contact           	1,2	Yes	422084-11	No

141-2     Honey Bee Residue on Foliage   	1,2	NA

141-5     Field Test for Pollinators	1,2	       NA

1. Use Patterns:1=Terrestrial/Food; 2=Terrestrial/Feed

2.  Guideline study is recommended based on review of unacceptable study
submission.

3. Guideline study recommended based on review of invalid nonvascular
study submission. 

8.  References

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. 

U.S. Environmental Protection Agency.  2000.  Risk Characterization
Handbook.  Science Policy Council, U.S. Environmental Protection Agency,
Washington, D.C.  20460.  EPA 100-B-00-002.  December 2000.

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.

U.S. Environmental Protection Agency.  2005.  Generic Format and
Guidance for the Level I Screening Ecological Risk Assessments Conducted
in the Environmental Fate and Effects Division.  Office of Pesticide
Programs, Washington, D.C.  January 24, 2005.

U.S. Fish and Wildlife Service (USFWS) and National Marine Fisheries
Service (NMFS).  1998. Endangered Species Consultation Handbook: 
Procedures for Conducting Consultation and Conference Activities Under
Section 7 of the Endangered Species Act.  Final Draft.  March 1998.

Appendix A.   SRRD data request justification tables 

The following proposed Data Call-in tables include rationales for
requiring the data requested in this problem formulation, explanations
of the utility of the data, and explanations for how the data might
impact risk assessment, following the format provided by SRRD.

Guideline Number: 835.6100

Study Title:   Environmental Chemistry Methods (ECM) and Independent
Laboratory Validation (ILV) for Soil, Water and Sediment

Rationale for Requiring the Data

According to the data requirements in 40 CFR Part 158, ECMs are
currently required along with successful confirmatory method trials
(validation) by an independent laboratory (i.e. ILVs).  In addition to
the method for soil, at this time, methods are required for water and
sediment.  Acceptable ECMs for the residues of concern (parent and its
transformation products) should have levels of quantitation that are
adequate to address risk concerns or that are at levels below the
toxicological endpoints for the relevant aquatic organisms.  The results
of previous assessments indicate that there is risk for freshwater fish,
and estuarine/ marine invertebrates and benthic organisms.  Therefore,
ECMs for water and sediment are required in addition to the ECM for
soil.  The ECMs should include parent and those residues found in the
laboratory studies that exceeded 10% of the applied. The registrant is
encouraged to submit state-of-the-art environmental chemistry methods;
further, multi-residue methods (MRMs) for soil, water and sediment are
preferred.

Practical Utility of the Data

How did the Agency make its registration decision without these data?

Instead of monitoring data, models were utilized to calculate the
exposure (i.e. Estimated Environmental Concentrations, EECs), using
available environmental fate data.  Four terrestrial field dissipation
studies were conducted with methods for parent and several of the
transformation products for which there is no ECM or ILV.

How will the data be used? 

The data will be used to verify the suitability of the methods. 
Subsequently the methods could be used by states or other enforcement
agencies, departments or entities, to monitor concentrations of the
residues of concern.  Validated analytical methods in environmental
media (a.k.a., ECMs) are useful for conducting and evaluating submitted
environmental fate and toxicity field and monitoring studies and for
addressing potential risks to the environment posed by the use and/or
accidental release of pesticides.

How could the data impact the Agency’s future decision-making? 

If monitoring of the chemical is required or performed, the Agency could
be able to determine if the chemical is present in the environment at
concentrations that are threatening to wildlife (or to humans, in the
case of drinking waters), according to the levels of concern (LOCs).  If
that is the case, measures to prevent these concentrations to occur
could be taken.  The data could also be used by enforcement entities
like the states or government agencies or departments.  Without these
data, the potential for the determination of residues of fluazinam in
soil, water and sediment is restricted.  The lack of these data will
limit the flexibility the Agency and registrants have in coming into
compliance with the Endangered Species Act, and could result in use
restrictions for fluazinam which may otherwise be avoided, or which are
unnecessarily severe.

Guideline Number: 850-2100

Study Title:  Passerine Acute Avian Oral  

Rationale for Requiring the Data

Although an acute avian oral study was received the Agency updated its
data requirements in 40 CFR Part 158 (October 26, 2007) to include an
acute oral toxicity study for both a passerine species and either a
waterfowl or an upland game species.  Prior to starting toxicity
testing, a protocol will need to be provided for review. 

Many passerine species utilize agricultural fields, forests, residential
areas and surrounding areas, and, therefore, have the potential to be
exposed to pesticides used in agricultural, forest, and residential
settings

It is likely that, for most pesticide use patterns, passerines are more
likely to be exposed to pesticides than upland game species and
waterfowl 

Passerines are smaller and have faster metabolisms than the waterfowl
and upland game bird species traditionally used in avian toxicity tests
which could impact their sensitivity to chemicals

Practical Utility of the Data

How did the Agency make its registration decision without these data?

Since this is a new requirement, EPA was using the results from the
toxicity tests for the waterfowl and the upland game bird.

How will the data be used? 

Data from passerine toxicity studies will be used to estimate potential
risks to birds associated with uses of fluazinam.  The data will reduce
uncertainties associated with the current risk assessment for passerine
species and will improve our understanding of the potential effects of
fluazinam.

How could the data impact the Agency’s future decision-making? 

Because birds significantly contribute to overall environmental quality,
a solid understanding of the potential risks to birds, including
passerine species,is essential for sound environmental management. 
Without acceptable data for fluazinam, the Agency cannot determine the
levels of fluazinam that result in effects to passerine species.  If the
data indicates that registered fluazinam usage may pose a risk of
adverse effects to non-target birds above the Agency Level of Concern,
the Agency may explore decision options to mitigate this risk.  The lack
of these data will limit the flexibility the Agency and registrants have
in coming into compliance with the Endangered Species Act, and could
result in use restrictions for fluazinam which may otherwise be avoided,
or which are unnecessarily severe.



Guideline Number:  850.1450

Study Title: Fish Early Life-Stage (saltwater) Study

Rationale for Requiring the Data

A chronic study submitted for estuarine/marine fish in response to the
RED was classified as supplemental based on number of replicates and no
observable response at the highest concentration tested. A new study is
required based on the absence of acceptable data to satisfy the
guideline for an early life stage estuarine/marine fish study.  

Chronic studies on estuarine/marine organisms are required to support
uses by which significant concentrations of a chemical are expected to
enter into estuarine/marine environments.  Persistence in water (e.g.,
half-life in water >4 days) can also trigger this data requirement.  

Practical Utility of the Data

How did the Agency make its re-registration decision without these data?

The previous assessment provided for a conditional registration while
waiting for acceptable data to be reviewed.   

How will the data be used?

The data would allow the Agency to determine chronic effects, including
effects on reproductive success and growth, to estuarine/marine fish
from water column exposure to fluazinam.  The effects data would be used
to determine the likelihood that the chronic risks can potentially
impact aquatic communities, either by direct effects on fish or by
indirect effects on other organisms by reducing their food sources.  

How could the data change the Agency’s decision, or impact the
Agency’s future decision-making?  

By conducting a chronic aquatic risk assessment, the Agency would be
able to determine the potential risk to nontarget organisms.  For
endangered species risk assessments performed without these data, the
Agency would have to assume that fluazinam "may affect" endangered fish
directly (and endangered species from other taxa indirectly), and use of
fluazinam might need to be restricted in areas where endangered species
could be exposed.  The lack of these data will limit the flexibility the
Agency and registrants have in coming into compliance with the
Endangered Species Act and could result in use restrictions for
fluazinam, which are unnecessarily severe.



Guideline Number:  850.1350

Study Title: Aquatic Invertebrate Life-cycle (saltwater)

Rationale for Requiring the Data

A chronic study submitted for estuarine/marine aquatic invertebrates in
response to the RED DCI was classified as supplemental.  The chronic
mysid study may be upgraded from supplemental if additional raw data is
provided. 

Chronic studies on estuarine/marine organisms are required to support
uses by which significant concentrations of a chemical are expected to
enter into estuarine/marine environments.  Persistence in water (e.g.,
half-life in water >4 days) can also trigger this data requirement.  

Practical Utility of the Data

How did the Agency make its re-registration decision without these data?

The previous assessment provided for a conditional registration while
waiting for acceptable data to be reviewed.   

How will the data be used?

The data would allow the Agency to determine chronic effects, including
effects on reproductive success and growth, to estuarine/marine
invertebrates from water column exposure to fluazinam.  The effects data
would be used to determine the likelihood that the chronic risks can
potentially impact aquatic communities, either by direct effects on
invertebrates or by indirect effects on other organisms by reducing
their food sources.  

How could the data change the Agency’s decision, or impact the
Agency’s future decision-making?  

By conducting a chronic aquatic risk assessment, the Agency would be
able to determine the potential risk to nontarget organisms.  For
endangered species risk assessments performed without these data, the
Agency would have to assume that fluazinam "may affect" endangered
invertebrates directly (and endangered species from other taxa
indirectly), and use of fluazinam might need to be restricted in areas
where endangered species could be exposed.  The lack of these data will
limit the flexibility the Agency and registrants have in coming into
compliance with the Endangered Species Act and could result in use
restrictions for fluazinam, which are unnecessarily severe.



Guideline Number: 850-1790

Study Title:  Chironomid Sediment Toxicity Test  

Rationale for Requiring the Data

No Chironomid sediment toxicity test has been submitted to satisfy the
Agency’s updated data requirements for outdoor uses in 40 CFR Part 158
(October 26, 2007).  The lack of chronic estuarine/marine invertebrate
toxicity data creates an additional layer of uncertainty for the
potential effect of fluazinam on benthic organisms. Additional data has
been requested to upgrade the supplemental classification for the
chronic estuarine/marine invertebrate toxicity test to reduce the
uncertainty associated with the use of fluazinam.

Benthic organisms inhabit sediment environments that may be exposed to
run-off or spray drift from fluazinam applications used in agricultural,
forest, and residential settings

The previous assessment identified a potential adverse effect for
estuarine/marine aquatic organisms based on water column toxicity
values.  Therefore, there is uncertainty associated with that estimate
that can be reduced using data from a toxicity test with benthic
organisms.  

Due to the potential for persistent exposure from fluazinam in sediment
identified in the previous assessment, benthic organisms are exposed to
fluazinam, which involves different routes of exposure for chronic
exposure.

Practical Utility of the Data

How did the Agency make its registration decision without these data?

The agency estimated pore water EECs from PRZM/EXAMS using the
equilibrium partitioning theory. An acceptable acute estuarine/marine
aquatic invertebrate study was used to estimate RQs for the effect of
fluazinam on benthic aquatic organisms in the previous assessment.  A
chronic estuarine/marine invertebrate study was also used to estimate
RQs, but there is additional uncertainty due to the supplemental
classification of the study.  

How will the data be used? 

Data from sediment toxicity studies will be used to estimate potential
risks to benthic organisms associated with uses of fluazinam.  The data
will reduce uncertainties associated with the current risk assessment
for benthic species and will improve our understanding of the potential
effects of fluazinam.

How could the data impact the Agency’s future decision-making? 

Although there was uncertainty in estimating the effect of fluazinam on
benthic organisms in the previous assessment, there was a potential risk
associated with adverse effects identified for estuarine/marine acute
and chronic organisms.  Acceptable data for benthic organisms will
reduce the uncertainty from the previous assessment   If the data
indicates that registered fluazinam usage may pose a risk of adverse
effects to non-target benthic organisms above the Agency Level of
Concern, the Agency may explore decision options to mitigate this risk. 
The lack of these data will limit the flexibility the Agency and
registrants have in coming into compliance with the Endangered Species
Act, and could result in use restrictions for fluazinam which may
otherwise be avoided, or which are unnecessarily severe.



Guideline Number: 850.4150

Study Title: Vegetative vigor, Tier I/ Tier II

Rationale for Requiring the Data

No acceptable toxicity data are currently available to assess the risk
of fluazinam to terrestrial plants.  

Since fluazinam has residential outdoor uses, vegetative vigor studies
are required.  These phytotoxicity data are needed to evaluate the level
of pesticide exposure to non-target terrestrial and aquatic plants and
to assess the impact of pesticides on endangered and threatened plants. 

Practical Utility of the Data

How did the Agency make its re-registration decision without these data?

Since EPA was unable to evaluate the potential risks to terrestrial
plants associated with the proposed uses of fluazinam, risks were
presumed for vegetative vigor endpoints for terrestrial plants.

How will the data be used?  

Data from terrestrial plant toxicity studies will be used to estimate
potential risks to plants associated with uses of fluazinam.  The data
will reduce uncertainties associated with the current risk assessment
for terrestrial plants and will improve our understanding of the
potential effects of fluazinam on plants 

How could the data impact the Agency’s future decision-making?

Because plants form the basis of most habitats and significantly
contribute to overall environmental quality, a solid understanding of
the potential risks to terrestrial plants is essential for sound
environmental management.  Without acceptable plant growth data for
fluazinam, the Agency cannot determine the levels of fluazinam that
result in effects to terrestrial plants.  If the data indicates that
registered fluazinam usage may pose a risk of adverse effects to
non-target terrestrial plants plants above the Agency Level of Concern,
the Agency may explore decision options to mitigate this risk.  The lack
of these data will limit the flexibility the Agency and registrants have
in coming into compliance with the Endangered Species Act, and could
result in use restrictions for fluazinam which may otherwise be avoided,
or which are unnecessarily severe.



Guideline Number: 850.4400*

Study Title: Aquatic Plant Growth-Lemna

Rationale for Requiring the Data

No acceptable studies have been submitted for vascular aquatic plants. 
Since the last risk assessment was signed, the Agency has finalized its
update to the data requirements in 40 CFR Part 158.  In these updated
data requirements, which were promulgated on October 26, 2007, vascular
plant testing is required for pesticides such as fluazinam with outdoor
uses.

Fluazinam is a fungicide and therefore EPA assumes it will affect
aquatic plant species.  

Practical Utility of the Data

How did the Agency make its re-registration decision without these data?

Since EPA was unable to evaluate the potential risks to aquatic plants
associated with the use of fluazinam, risks were presumed for vascular
aquatic plants.  

How will the data be used?

Data from aquatic plant toxicity studies will be used to estimate
potential risks to plants associated with uses of fluazinam.  The data
will reduce uncertainties associated with the current risk assessment
for aquatic plants and will improve our understanding of the potential
effects of fluazinam on vascular aquatic plants 

How could the data change the Agency’s decision, or impact the
Agency’s future decision-making?  

Because plants form the basis of most habitats and significantly
contribute to overall environmental quality, a solid understanding of
the potential risks to aquatic plants is essential for sound
environmental management.  Without plant growth data for fluazinam, the
Agency cannot determine the levels of fluazinam that result in effects
to vascular aquatic plants.  If the data indicates that registered
fluazinam usage may pose a risk of adverse effects to non-target aquatic
vascular plants above the Agency Level of Concern, the Agency may
explore decision options to mitigate this risk.  

If future endangered species risk assessments are performed without
these data, the Agency would have to assume that fluazinam "may affect"
endangered plants and use of fluazinam might need to be restricted in
areas where endangered species could be exposed.  The lack of these data
will limit the flexibility the Agency and registrants have in coming
into compliance with the Endangered Species Act and could result in use
restrictions for fluazinam that may be unnecessarily severe.  T



Guideline Number:  850.5400

Study Title:  Aquatic plant toxicity test using  Pseudokirchneriella
subcapitata, Navicula pelliculosa and Skeletonema costatum, Tier I  

Rationale for Requiring the Data

Although there is one acceptable study for aquatic nonvascular plants,
Anabaena flos-aquae, no toxicity data are currently available to assess
the risk of fluazinam to other aquatic nonvascular plants requested
under the DCI.   Since fluazinam has residential outdoor uses, Tier I
aquatic nonvascular plant studies are required.  These phytotoxicity
data are needed to evaluate the level of pesticide exposure to
non-target aquatic plants and to assess the impact of pesticides on
endangered and threatened plants.  

Practical Utility of the Data

How did the Agency make its re-registration decision without these data?

Since EPA was unable to evaluate the potential risks to semi-aquatic
plants associated with the proposed uses of fluazinam, risks were
presumed for aquatic plants.

In making its decision, the Agency assumed that the required mitigation
measures would reduce any potential risk of fluazinam to aquatic
nonvascular plants.

How will the data be used?  

Data from Tier I nonvascular aquatic plant toxicity studies will be used
to estimate potential risks to plants associated with uses of fluazinam.
 The data will reduce uncertainties associated with the current risk
assessment for nonvascular aquatic plants and will improve our
understanding of the potential effects of fluazinam. 

How could the data impact the Agency’s future decision-making?

Because plants form the basis of most habitats and significantly
contribute to overall environmental quality, a solid understanding of
the potential risks to nonvascular aquatic plants is essential for sound
environmental management.  Without plant growth data for fluazinam, the
Agency cannot determine the levels of fluazinam that result in effects
to aquatic plants.  If the data indicates that registered fluazinam
usage may pose a risk of adverse effects to non-target aquatic
nonvascular plants above the Agency Level of Concern, the Agency may
explore decision options to mitigate this risk.  The lack of these data
will limit the flexibility the Agency and registrants have in coming
into compliance with the Endangered Species Act, and could result in use
restrictions for fluazinam which may otherwise be avoided, or which are
unnecessarily severe.



Appendix B.  Ecological Toxicity Test Summaries

Birds

MRID 422486-22:  Roberts, N.L., A. Anderson and I.S. Dawe (1991): An
acceptable  acute oral mallard duck (Ana platyrhynchos) toxicity study
resulted in an LD50>4190 mg/kg/body weight. This indicates that
fluazinam is practically nontoxic to birds. 

MRID 422486-23:  An acute avian oral toxicity study resulted in an
LD50=1782 mg/kg (1321-3595 mg/kg) for the Bobwhite quail (Colinus
virginianus).  Nominal concentrations of 500, 100 and 200 mg/kg were
used to estimate the endpoint. This indicates fluazinam is slightly
toxic to birds. Although only three treatment concentrations were used
rather than five, this study was classified as core/acceptable.

MRID  422486-24:  An acute avian dietary toxicity study resulted in an
LC50>10,500 mg/kg for the Bobwhite quail (Colinus virginianus).  Nominal
concentrations of 313, 625, 1250, 2500, 5000 and 10,000 mg/kg were used
to estimate the endpoint. This indicates fluazinam is practically
nontoxic to birds. This study was classified as core/acceptable.

MRID 422486-25:  Roberts, N.L., A. Anderson and I.S. Dawe (1991): An
acceptable  acute dietary mallard duck (Ana platyrhynchos) toxicity
study randomly assigned ten birds to six treatment and three control
groups. An LC50>10,600 mg/kg was estimated from mean measured
concentrations of 333, 651, 1260, 2590, 5230 and 10600 mg/kg.  This
indicates that fluazinam is practically nontoxic to birds. 

MRID  448073-23:  An reproductive avian toxicity study resulted in a
NOEC=200 mg/kg for the Bobwhite quail (Colinus virginianus).  Nominal
concentrations of 750, 1500 and 500 mg/kg for phase I and 50, 200, 350,
and 500 mg/kg were used to estimate14 day old survivor weight, the most
sensitive endpoint. This study was classified as core/acceptable.

MRID  448319-07: Beavers, J.B.; D. Haberlein, L.R. Mitchell and M. Jaber
(1996).: An reproductive avian toxicity study resulted in a NOEC=200
mg/kg for the Bobwhite quail (Colinus virginianus).  Nominal
concentrations of 750, 1500 and 500 mg/kg for phase I and 50, 200, 350,
and 500 mg/kg were used to estimate14 day old survivor weight, the most
sensitive endpoint. This study was classified as core/acceptable.

Terrestrial Invertebrates

MRID  422084-11:  A 48 hour contact honey bee study resulted in an
LD50>200 µg ai/bee. This indicates fluazinam is practically nontoxic to
honey bees. There was no negative control used in this study. The study
was conducted with a solvent control and mean treatment concentrations
of 20, 50, 100 and 200 µg ai/bee.  This study was classified as
core/acceptable.

Fish

MRID 429749-04: Gelin, M.D. and J. Laveglia (1992):  A 96 hour acute
rainbow trout (Oncorhynchus mykiss) study resulted in an LC50=36 µg/l
based on mean measured concentrations. This study was classified as
core/acceptable. This toxicity test indicates that fluazinam is very
highly toxic to trout.

MRID 429749-05:  A 96 hour acute bluegill study was conducted with a
negative control, a solvent control and mean treatment concentrations of
21, 34, 44, 66 and 93 µg/l.  The analysis resulted in an LC50=52.7
µg/l (47.1-59.9 µg/l). This study was classified as core/acceptable.

MRID 422084-09: A 96 hour acute rainbow trout (Salmo gairdneri) study
was conducted with a negative control, a solvent control and mean
treatment concentrations of 0.057, 0.064, 0.091, 0.16, 0.27 and 0.46
mg/L).  The analysis resulted in an LC50-0.13 mg/l (0.10-0.18 mg/L). 
This study was classified as core/acceptable.

MRID 448073-27: An early life cycle fathead minnow (Pimephales promelas)
study was conducted with a negative control, a solvent control and mean
treatment concentrations of 1.6, 2.7, 5.3, 10 and 23 µg/L).  The
analysis resulted in a NOEC=5.3 µg/L).  This study was classified as
core/acceptable.

MRID 448073-29: A 278 day fathead minnow (Pimephales promelas) was
conducted with a negative control, a solvent control and mean treatment
concentrations of 0.69, 1.4, 2.9, 6.4, and 14 µg/L.  The analysis
resulted in a NOEC=0.69 µg/L.  This study was classified as
core/acceptable.

MRID 448073-25:  Machado, M.W. (199 3).A 96 hour acute marine fish
(sheepshead) was conducted with a negative control, a solvent control
and mean treatment concentrations of 0.13, 0.22, 0.36, .0.60 and 1.0
mg/l.  No mortality was observed in the negative or solvent control. The
analysis resulted in an LC50=0.12 mg/l (0.08-0.24 mg/l).  This study was
classified as core/acceptable.  

MRID 458221-02:  Sousa, J.V. (2001). The chronic toxicity of IKF-1216
Technical (fluazinam) to the early life-stage of Sheepshead Minnow
(Cyprinodon variegatus) was studied under flow-through conditions for 35
days (7-day hatching period and 28-day post-hatch period).  Fertilized
embryos (160/treatment), 21- to 27-hours old, were exposed to IKF-1216
Technical at nominal concentrations of 0 (negative and solvent
controls), 2.2, 4.4, 8.7, 17, and 35 ppb.  Mean-measured treatment
concentrations were <0.18 (<LOQ, controls), 1.6, 2.8, 5.9, 12, and 26
ppb a.i., respectively. No treatment-related effects on embryo or larval
survival, or on length and weight were observed.  The NOEC for all
endpoints was 26 ppb a.i., the highest concentration tested.  A LOEC was
not established.

Aquatic Invertebrates

MRID 429749-06:  A 48 hour acute aquatic invertebrate (Daphnia magna)
was conducted with a negative control, a solvent control and mean
treatment concentration s of 34,54 94, 150 and 260 µg/l.  The analysis
resulted in an EC50=220 µg/l (190-300 µg/l).  This study was
classified as core/acceptable.

MRID 422084-10:  A 48 hour acute aquatic invertebrate (Daphnia magna)
was conducted without a negative control, but with a solvent control and
mean treatment concentration s of 0.06, 0.13, 0.22, 0.38, 0.92 and 1.64
µg/l.  The analysis resulted in an EC50=180 µg/l (140-220 µg/l). 
This study was classified as core/acceptable.

MRID 448073-28: A 21 day chronic freshwater invertebrate (Daphnia magna)
was conducted.  The flow through study used a negative control, a
solvent control and mean treatment concentrations of 8.9, 16, 33, 68 and
140 µg/l.  The analysis resulted in an NOAEC=68 µg/l for the most
sensitive endpoints of dry weight and reproduction as total number of
young per female.  This study was classified as core/acceptable.

MRID 448073-26: A 96 hour acute estuarine/marine invertebrate
(Mysidopsis bahia) was conducted.  The flow through
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ᜀMRID 448073-24:  A 96 hour acute marine oyster (Crassotrea virginica)
toxicity test was conducted. The flow through study used a negative
control, a solvent control and mean treatment concentration s of 0.84,
1.4, 2.6, 4.4 and 9.7 µg/l.  The analysis resulted in an EC50=4.7 µg/l
(3.6-6.0 µg/l).  This study was classified as core/acceptable.

MRID 458221-01: Lima. W. (2002). In a 28-day life cycle test,
Americamysis bahia neonates were exposed under flow-through conditions
to IKF-1216 Technical (fluazinam) at nominal concentrations of 0
(negative and solvent controls), 0.25, 0.50, 1.0, 2.0, and 4.0 ppb. 
Mean-measured concentrations were <0.054 (<LOQ, controls), 0.25, 0.52,
1.0, 2.0, and 3.9 ppb a.i., respectively.  Prior to sexual maturity and
pairing, there were 60 mysids/level.  At Day 13, 20 pair/level were
isolated for individual matings; the remainder of first-generation
mysids were group retained.  First-generation mysids were observed for
mortality and signs of abnormal behavior once daily throughout the
study.  Once daily during the reproduction period, second-generation
mysids were counted and discarded.  Data endpoints included terminal
percent survival of first-generation mysids (Day 28; combined sexes),
number of young produced per female per reproductive day, and dry weight
and length of surviving first-generation mysids (Day 28;
gender-specific).

Plants

Terrestrial

MRID 461728-01. Stewart, P. (2003):  An acceptable seedling emergence
Tier I study (MRID 461728-01) using the dicots cabbage, carrot,
cucumber, lettuce radish, soybean and tomato and the monocots corn, oat,
onion and ryegrass was received . The toxicity test  resulted in an
EC25>0.78lbs a.i./A based on no observed effects at the highest tested
concentration. . 

Aquatic

MRID448073-34:  A 96 hour freshwater algae (Selenastrum capricornutum)
toxicity test analysis resulted in an EC50=180 µg/l (160-200 µg/l). 
This study was classified as supplemental due to a 96 hour versus 120
hour recommended duration.  In addition, the light intensity exceeded
the recommendation. 

MRID 458221-06: Hoberg, J. (2002). In a 96-hour acute toxicity study,
cultures of Anabaena flos-aquae were exposed to Fluazinam under static
conditions at nominal concentrations 0 (negative and solvent controls),
13, 25, 50, 100, and 200 ppb a.i.  The initial measured concentrations
were <0.88 (negative and solvent controls), 12, 26, 36, 72, and 140 ppb
a.i. The initial measured concentrations were used instead of the 96
hour measured or means of the 0 and 96 hour measured concentrations
because the test material declined to <70% of nominal for both.  The
96-hour cell density percent inhibitions based on the control were 19,
27, 10, 23, and 30% in the 12, 26, 36, 72, and 140 ppb a.i. treatment
groups, respectively.  Mean cell density was significantly reduced
compared to the control for 140 ppb a.i.  The cell density NOEC was 72
ppb a.i. based on the Williams Test. The cell density EC50 was 9,200 ppb
a.i. based on a Nuthatch analysis. This study was classified as
acceptable.

 

 Wheel move, side roll, end tow, or hand move portable irrigation
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