UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

MEMORANDUM							May 29, 2009

Subject:	Registration Review –Preliminary Problem Formulation for
Ecological Risk and Environmental Fate, Endangered Species, and Drinking
Water Assessments for Propyzamide (PC Code 101701; DP 363909)

To:		Wilhelmena Livingston, Chemical Review Manager

		Eric Olson, Team Leader

		Special Review Branch

		Special Review and Reregistration Division (SRRD)

		Office of Pesticide Programs

From:		Greg Orrick, Environmental Scientist

		Thomas Steeger, Ph.D., Senior Biologist

		Environmental Risk Branch 4

		Environmental Fate and Effects Division (EFED)

		Office of Pesticide Programs

Through:	Elizabeth Behl, Chief

		Environmental Risk Branch 4

		Environmental Fate and Effects Division (EFED)

		Office of Pesticide Programs

The Environmental Fate and Effects Division (EFED) has completed the
preliminary problem formulation (attached) for the ecological risk,
environmental fate, endangered species, and drinking water assessments
to be conducted as part of the Registration Review of the organochlorine
herbicide, propyzamide (DP 363909) (a.k.a. pronamide).  The problem
formulation draws on information from both open literature and studies
submitted by the technical registrants in response to data requirements.
 This document is intended to provide an overview of what is currently
known regarding the environmental fate and ecological effects associated
with propyzamide and all of its degradates containing the 3,
5-dichlorobenzoyl moiety and outlines uncertainties regarding attributes
of the parent compound and its transformation products.  It describes
the preliminary ecological risk hypothesis and the processes that will
be used during the completion of drinking water and ecological risk
assessments in support of registration review.  This document also
recommends studies that should be included in a data call-in (DCI) to
address uncertainties surrounding the environmental fate and potential
ecological effects of propyzamide.

  SEQ CHAPTER \h \r 1

Problem Formulation for the

Environmental Fate and Ecological Risk, Endangered Species,

and Drinking Water Assessments

in Support of the Registration Review of Propyzamide

Propyzamide (CAS 23950-58-5)

Prepared by:

Greg Orrick, Environmental Scientist

Thomas Steeger, Ph.D., Senior Biologist	U. S. Environmental Protection
Agency

Office of Pesticide Programs

Environmental Fate and Effects Division

Environmental Risk Branch IV

1200 Pennsylvania Ave., NW

Mail Code 7507P

Washington, DC 20460

Reviewed by:

Marietta Echeverria, Risk Assessment Process Leader

Anita Pease, Senior Biologist

Elizabeth Behl, Branch Chief

Table of Contents

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc231367609"  List of Figures
  PAGEREF _Toc231367609 \h  4

  HYPERLINK \l "_Toc231367610"  I.  Purpose	  PAGEREF _Toc231367610 \h
5

  HYPERLINK \l "_Toc231367611"  I.  Purpose	  PAGEREF _Toc231367611 \h
5

  HYPERLINK \l "_Toc231367612"  II.  Problem Formulation	  PAGEREF
_Toc231367612 \h  5

  HYPERLINK \l "_Toc231367613"  A.  Nature of Regulatory Action
PAGEREF _Toc231367613 \h  5

  HYPERLINK \l "_Toc231367614"  B.  Conclusions from Previous Risk
Assessments	  PAGEREF _Toc231367614 \h  6

  HYPERLINK \l "_Toc231367615"  1.	Propyzamide Ecological Risk
Assessments	  PAGEREF _Toc231367615 \h  6

  HYPERLINK \l "_Toc231367616"  2.   Drinking Water Exposure Assessments
  PAGEREF _Toc231367616 \h  7

  HYPERLINK \l "_Toc231367617"  III. Stressor Source and Distribution
PAGEREF _Toc231367617 \h  8

  HYPERLINK \l "_Toc231367618"  A.  Mechanism of Action	  PAGEREF
_Toc231367618 \h  8

  HYPERLINK \l "_Toc231367619"  B.  Overview of Pesticide Usage
PAGEREF _Toc231367619 \h  8

  HYPERLINK \l "_Toc231367620"  C.  Environmental Fate and Transport
PAGEREF _Toc231367620 \h  9

  HYPERLINK \l "_Toc231367621"  IV.  Receptors	  PAGEREF _Toc231367621
\h  12

  HYPERLINK \l "_Toc231367622"  A.  Effects to Aquatic Organisms
PAGEREF _Toc231367622 \h  14

  HYPERLINK \l "_Toc231367623"  B.  Effects to Terrestrial Organisms
PAGEREF _Toc231367623 \h  15

  HYPERLINK \l "_Toc231367624"  C.  Degradate toxicity	  PAGEREF
_Toc231367624 \h  16

  HYPERLINK \l "_Toc231367625"  D.  Ecological Incidents	  PAGEREF
_Toc231367625 \h  16

  HYPERLINK \l "_Toc231367626"  E.	Ecosystems Potentially at Risk
PAGEREF _Toc231367626 \h  17

  HYPERLINK \l "_Toc231367627"  V.  Assessment Endpoints	  PAGEREF
_Toc231367627 \h  17

  HYPERLINK \l "_Toc231367628"  VI. Conceptual Model	  PAGEREF
_Toc231367628 \h  17

  HYPERLINK \l "_Toc231367629"  A.  Risk Hypothesis	  PAGEREF
_Toc231367629 \h  18

  HYPERLINK \l "_Toc231367630"  B.  Conceptual Diagram	  PAGEREF
_Toc231367630 \h  18

  HYPERLINK \l "_Toc231367631"  VII.  Analysis Plan	  PAGEREF
_Toc231367631 \h  20

  HYPERLINK \l "_Toc231367632"  A.  Stressors of Concern	  PAGEREF
_Toc231367632 \h  21

  HYPERLINK \l "_Toc231367633"  B.  Measures of Exposure	  PAGEREF
_Toc231367633 \h  21

  HYPERLINK \l "_Toc231367634"  C.  Measures of Effect	  PAGEREF
_Toc231367634 \h  23

  HYPERLINK \l "_Toc231367635"  D.  Integration of Exposure and Effects
 PAGEREF _Toc231367635 \h  24

  HYPERLINK \l "_Toc231367636"  1.  Deterministic and Probabilistic
Assessment Methods	  PAGEREF _Toc231367636 \h  24

  HYPERLINK \l "_Toc231367637"  E.  Endangered Species Assessments
PAGEREF _Toc231367637 \h  24

  HYPERLINK \l "_Toc231367638"  F.  Drinking Water Assessment	  PAGEREF
_Toc231367638 \h  25

  HYPERLINK \l "_Toc231367639"  G.  Preliminary Identification of Data
Gaps	  PAGEREF _Toc231367639 \h  26

  HYPERLINK \l "_Toc231367640"  1.  Fate	  PAGEREF _Toc231367640 \h  26

  HYPERLINK \l "_Toc231367641"  2.  Effects	  PAGEREF _Toc231367641 \h
27

  HYPERLINK \l "_Toc231367642"  VIII.  References	  PAGEREF
_Toc231367642 \h  31

  HYPERLINK \l "_Toc231367643"  Appendix 1.  Currently Registered Uses
of Propyzamide.	  PAGEREF _Toc231367643 \h  36

  HYPERLINK \l "_Toc231367644"  Appendix 2.  Chemical Names, Structures,
and Maximum Reported Amounts of Propyzamide and its Degradates.
PAGEREF _Toc231367644 \h  46

  HYPERLINK \l "_Toc231367645"  Appendix 3.  Data Call-in Justification.
  PAGEREF _Toc231367645 \h  50

List of Tables

  TOC \h \z \c "Table"    HYPERLINK \l "_Toc231367646"  Table 1.
General physico-chemical and environmental fate properties of
propyzamide.	  PAGEREF _Toc231367646 \h  10

  HYPERLINK \l "_Toc231367647"  Table 2.  Test Species Evaluated for
Assessing Potential Ecological Effects of Propyzamide and the Associated
Acute Toxicity Classification.	  PAGEREF _Toc231367647 \h  13

  HYPERLINK \l "_Toc231367648"  Table 3.  Available environmental fate
data for propyzamide and remaining data gaps.	  PAGEREF _Toc231367648 \h
 26

  HYPERLINK \l "_Toc231367649"  Table 4.  Available ecological effects
data for terrestrial animals exposed to technical propyzamide and
remaining data gaps (NA=not available).	  PAGEREF _Toc231367649 \h  28

  HYPERLINK \l "_Toc231367650"  Table 5.  Available ecological effects
data for aquatic animals exposed to technical propyzamide and remaining
data gaps (NA=not available).	  PAGEREF _Toc231367650 \h  28

  HYPERLINK \l "_Toc231367651"  Table 6.  Available ecological effects
data for plants exposed to propyzamide and remaining data gaps (NA=not
available).	  PAGEREF _Toc231367651 \h  29

List of Figures  TOC \h \z \c "Figure"

  HYPERLINK \l "_Toc231367652"  Figure 1.  National propyzamide use (in
pounds per square mile) by major use category as of 2001.  Source:  U.S.
Geological Survey
(http://water.usgs.gov/nawqa/pnsp/usage/maps/show_map.php?year=02&map=m1
888)	  PAGEREF _Toc231367652 \h  9

  HYPERLINK \l "_Toc231367653"  Figure 2. Conceptual model for
propyzamide effects on aquatic organisms.  Dotted lines indicate
exposure pathways that have a low likelihood of contributing to
ecological risk.	  PAGEREF _Toc231367653 \h  19

  HYPERLINK \l "_Toc231367654"  Figure 3.  Conceptual model for
propyzamide effects on terrestrial organisms.	  PAGEREF _Toc231367654 \h
 20

 I.  Purpose

The purpose of this problem formulation is to provide an understanding
of the environmental fate and ecological effects of the registered uses
of propyzamide, also known as pronamide.  Propyzamide is a selective,
systemic, restricted–use, organochlorine herbicide that is formulated
as a wettable powder in water soluble pouches and can be applied
pre-plant, pre-emergence, or post-emergence by ground or aerial spray
equipment, depending on the use.  Propyzamide is currently registered
for use on a variety of outdoor crops, orchards, and other agricultural
and nonagricultural areas.  This document will provide a plan for
analyzing data relevant to propyzamide and for conducting environmental
fate and ecological risk, endangered species and drinking water
assessments for its registered uses.  Additionally, this problem
formulation is intended to identify data gaps, uncertainties, and
potential assumptions used to address those uncertainties, relative to
characterizing the ecological risk associated with the registered uses
of propyzamide.

II.  Problem Formulation

	A.  Nature of Regulatory Action

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

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

B.  Conclusions from Previous Risk Assessments

Propyzamide was first registered under the name pronamide in 1972 for
use on broadleaf weeds and grasses.  The Agency conducted multiple
subsequent assessments through the preparation of the 1994
Reregistration Eligibility Decision (RED), including an emergency
exemption assessment in 1988 (DP barcode unspecified) for use on
marigolds in California.  That assessment concluded that impacts to
non-target organisms were not expected, but the potential of leaching
could not be assessed due to the lack of data.  Ecological risk and
drinking water exposure assessments on propyzamide conducted in support
of the RED and those in the interim are briefly discussed below.  These
assessments serve as a basis for this problem formulation.

Propyzamide Ecological Risk Assessments

Ecological risk assessments completed for propyzamide include two
emergency exemption (FIFRA Section 18) assessments conducted in 1994 for
use on grass grown for seed in Oregon (DP Barcode unspecified) and in
1998 for use on cranberries in Massachusetts (DP Barcode 242640).  The
FIFRA Section 18 assessment for use on grass grown for seed identified
potential risk to terrestrial and wetland plants, including the listed
plant Bradshaw's Lomatium (Lomatium bradshawii), and identified
significant data gaps for aquatic plants and other taxa.  The FIFRA
Section 18 assessment for use on cranberries in Massachusetts found no
potential risk to listed or non-listed organisms.

A Reregistration Eligibility Decision (RED) document was prepared for
propyzamide in 1994 (USEPA 1994).  The RED assessed use on food crops
(artichoke, blackberry, blueberry, boysenberry, cherry, endive,
escarole, lettuce, nectarine, peach, pear, plum, prune, raspberry,
rhubarb), food and feed crops (fallow land, apple, grapes, peas, sugar
beet), feed crops (alfalfa clover, sainfoin, trefoil, vetch) and
non-food crops (Christmas tree farms, golf course and recreational turf,
ornamentals), concluding that all products were eligible for
reregistration, except for broadcast application on residential turf and
late season uses on artichokes (USEPA 1994).  The RED identified no
potential risk to terrestrial animals, aquatic animals, or aquatic
plants.  Studies of toxicity to aquatic invertebrates (chronic), aquatic
plants, and terrestrial dicots were requested to eliminate data gaps.
Potential risk to terrestrial monocots was identified from all
registered uses.

An ecological risk assessment of proposed uses on chicory, Belgian
endive, dandelion, and berries was completed in 2007 (DP Barcode 329358;
Jun. 14, 2007).  This assessment identified potential chronic risk to
mammals and potential risk to terrestrial and semi-aquatic plants.
Potential risk of direct effects was identified to listed mammals,
birds, estuarine invertebrates, and terrestrial and semi-aquatic plants.
 Potential risk of indirect effects was identified for most taxa due to
potential risk to plants.  An addendum to the ecological risk assessment
(DP Barcode 329358; Oct. 22, 2007) indicated no potential risk to listed
estuarine invertebrates.

An endangered species assessment was conducted of risks of propyzamide
use to the federally threatened California red-legged frog (CRLF; Rana
aurora draytonii) (USEPA 2008).  The Agency made a Likely to Adversely
Affect determination for the CRLF from the use of propyzamide and
determined that there is the potential for modification of CRLF
designated critical habitat as well.  The use of propyzamide was found
likely to adversely affect terrestrial-phase CRLF through chronic
effects.  Additionally, propyzamide was found likely to adversely affect
the terrestrial-phase CRLF through reductions in terrestrial plants that
serve as cover.  The decrease in terrestrial plants along riparian zones
was also found likely to adversely affect the aquatic-phase CRLF through
indirect effects on water quality.  The use of propyzamide was also
found likely to modify the principle constituent elements (PCEs) of
designated critical habitat for both aquatic- and terrestrial-phase
CRLF.

2.   Drinking Water Exposure Assessments

A drinking water exposure assessment was conducted in 1998 in support of
human health risk assessment (DP Barcode 242640).  Screening
concentrations were 14.5 ppb and 8.3 ppb for respective acute and
chronic exposures in surface water and 0.28 ppb for exposure in ground
water.  Two drinking water exposure assessments were conducted in
support of the 2002 Tolerance Reassessment Eligibility Decision (TRED).
A Tier I assessment conducted in 2001 estimated screening concentrations
of 390 ppb and 122 ppb for respective acute and chronic exposures in
surface water and 3.0 ppb for exposure in ground water (DP Barcode
274842).  A follow-up Tier II assessment in 2002 included refined
exposure estimates of 10.3 ppb, 4.45 ppb, and 4.30 ppb for respective
acute, chronic, and cancer exposures in surface water and 1.1 ppb for
exposure in ground water, reflecting a maximum use pattern for pears of
one application per year at 4.0 lbs a.i./A (DP Barcode 281443+).  The
residues of concern for dietary assessment were defined in the TRED as
propyzamide and its metabolites containing the 3,5-dichlorobenzoyl
moiety (USEPA 2002); however, the drinking water assessment estimated
exposure to propyzamide parent alone.  Based on this assessment, the
TRED identified a cancer risk due to propyzamide exposure in drinking
water.  However, proposed mitigations did not address this risk.

The Agency evaluated human exposure to propyzamide through consumption
of contaminated drinking water as part of a 2007 Interregional Research
Project No. 4 (IR-4) minor crops registration assessment (DP Barcode
344249).  Tier II exposure estimates, that included the residues of
concern defined in the 2002 TRED, were 243 ppb, 148 ppb, and 105 ppb for
respective acute, chronic, and cancer exposures in surface water and 1.4
ppb for exposure in ground water.  Surface water estimates reflected a
maximum use pattern on lettuce of two applications per year at 2.0 lbs
a.i./A.  Available monitoring data were limited to propyzamide parent
alone and were consistent with the peak and chronic exposure estimates
for propyzamide alone that supported the 2002 TRED for propyzamide (DP
Barcode 281443+).

III. Stressor Source and Distribution

A.  Mechanism of Action

Propyzamide is a selective, systemic, restricted–use herbicide.  The
compound is absorbed by plants via the root system and distributed
throughout the plant.  The mode of action of propyzamide is largely
unknown although it has been shown to inhibit cell division by
preventing the formation of spindle fibers during mitosis via binding to
proteins associated with microtubule assembly (Griffen 2003).  The
details regarding the active site of the chemical are not known.

B.  Overview of Pesticide Usage

Current labels allow use of propyzamide on blueberries, alfalfa, clover,
birdsfoot trefoil, crown vetch, sainfoin, lettuce, endive, escarole,
radicchio, apples, apricots, cherries, nectarines, peaches, pears,
plums, prunes, grapes, sod, turf, fallow land, Christmas trees, and
ornamentals without restriction to the region of application (EPA Reg.
No. 62719-397, 62719-578).  Current labels also allow the following uses
of propyzamide within the specified States: globe artichokes in
California, leaf lettuce in California and Arizona, cane berries and
rhubarb in Oregon and Washington, and winter peas and conservation
reserves in Idaho, Oregon, and Washington.  There are no indoor or
residential uses of propyzamide.  Currently registered uses of
propyzamide are listed in   REF _Ref227737252 \h  \* MERGEFORMAT
Appendix 1 .  The maximum labeled single application rate is 4 lbs
a.i./A for the orchard, grape, and artichoke uses.  The maximum seasonal
and annual application rate is 4 lbs a.i./A as well, for use on
artichokes (seasonal limit) and on grapes and orchards (annual limit),
respectively.

Figure 1 presents the national usage pattern of propyzamide in 2002.
Usage was concentrated in California, the Pacific Northwest, and a few
states in the eastern U.S.  Note that lettuce was estimated to represent
61% of propyzamide agricultural usage at that time.  Alfalfa and other
field crops accounted for an additional 29% of propyzamide usage (USGS
2007).

The screening-level use assessment (SLUA) estimates of agricultural uses
of propyzamide indicate that use on lettuce, seed crops, grapes,
artichokes and apples account for roughly 97% of the total use (USEPA
2009).  Use of propyzamide on lettuce alone accounts for roughly 80% of
the agricultural use.

Figure   SEQ Figure \* ARABIC  1 .  National propyzamide use (in pounds
per square mile) by major use category as of 2001.  Source:  U.S.
Geological Survey ( HYPERLINK
"http://water.usgs.gov/nawqa/pnsp/usage/maps/show_map.php?year=02&map=m1
888"
http://water.usgs.gov/nawqa/pnsp/usage/maps/show_map.php?year=02&map=m18
88 )

C.  Environmental Fate and Transport

Propyzamide [3,5-dichloro-N-(1,1-dimethylprop-2-ynyl)benzamide] is a
moderately to slightly mobile chemical that is expected to dissipate in
terrestrial and aquatic environments over weeks or months.
Registrant-submitted data defining the physical, chemical, fate and
transport characteristics associated with propyzamide and combined
residues of concern are summarized in   REF _Ref227384058 \h  \*
MERGEFORMAT  Table 1 .  The residues of concern for human dietary
assessment were defined in the 2002 TRED as propyzamide and its
metabolites containing the 3,5-dichlorobenzoyl moiety (USEPA 2002).

Table   SEQ Table \* ARABIC  1 .  General physico-chemical and
environmental fate properties of propyzamide.

Parameter	Value(s)	Source (MRID)

Physico-chemical Parameters

Molecular weight	256.13 g/mol	USEPA 1994

Vapor pressure (at 25(C)	8.5 x 10-5 torr	USEPA 1994

Water solubility (at 25(C)	15 mg/L	USEPA 1994

Henry’s law constant (at 25(C)	1.9 x 10-6 atm-m3/mol	(calculated)

Octanol-air partition coefficient (KOA) (at 25(C)	1.3 x 107	EpiSuite
v4.00

Octanol-to-water partition coefficient (KOW)	1000 - 1900	Acc. No. 143745

Persistence

Hydrolysis half-lives (20-40(C)	Stable pH 5

Stable pH 7

Stable pH 9	00107980

Aqueous photolysis half-life	t1/2 = 41.7 d (parent)

217 d (TRCA)	40420301

40320601

Soil photolysis half-life	t1/2 = 249 d (parent)

Stable (TRCA)	41913504

Aerobic soil metabolism half-life	t1/2 = 20.1, 21.5, 44.6, 392 d
(parent)

64.9, 96.6, 166, 2340 d (TRCA)	41568901

46413407

Aerobic aquatic metabolism half-life	t1/2 = 69.0, 119 d (parent)

899, 782 d (TRCA)	46427901

Anaerobic aquatic metabolism half-life	t1/2 = 127 d (parent)

402 d (TRCA)	46413408

Soil Mobility

Freundlich adsorption coefficient (KF-ads); Organic carbon-normalized
Freundlich adsorption coefficient (KFOC-ads)	3.15 (1/n=1.22); 1340L/kgOC

3.47 (1/n=1.14); 1180 L/kgOC

4.85 (1/n=1.10);  688 L/kgOC

5.16 (1/n=1.07); 548 L/kgOC

8.05 (1/n=1.01); 578 L/kgOC

10.1 (1/n=1.00); 714 L/kgOC	40211103

Dissipation

Terrestrial field dissipation half-life

(soil texture)	18-24 d (sandy loam)

34-53 d (loam)	44078601

Fish bioconcentration factors (BCF)	21 (edible)

77 (non-edible)

50 (whole fish)	43196701

A “TRC” means total residues of concern, which includes propyzamide
and its degradates of risk concern.

Propyzamide is soluble in water up to 15 mg/L at 25(C (USEPA 1994).  The
potential for volatilization from soil and water is expected to be low
to moderate.  Propyzamide’s moderately low vapor pressure (8.5 x 10-5
torr at 25ºC; USEPA 1994) and Henry’s law constant (calculated to be
1.9 x 10-6 atm-m3/mol at 25°C) indicate that the compound may be
semi-volatile.  The California Department of Pesticide Regulation has
proposed air monitoring for propyzamide and, potentially, its degradate
3,5-dichlorobenzamide (RH-24298) in order to investigate the
compounds’ presence in ambient air and at an application site
(Department of Pesticide Regulation 2009).

Due to low fish bioconcentration factors (range of 21-77), propyzamide
is not expected to bioconcentrate in aquatic environments (MRID
43196701).  However, the octanol-water partition coefficient (KOW) of
propyzamide (1000-1900; log KOW of 3.00-3.28) indicates that the
compound is oliophilic (Acc. No. 143745).  EpiSuite (v4.00; Jan., 2009)
estimates for propyzamide an octanol-air partition coefficient (KOA) of
1.3 x 107 (log KOA of 7.11) using a log KOW value of 3.00 and the
Henry’s law constant (HLC) value at 25°C of 1.9 x 10-6 atm-m3/mol
(log HLC of -5.72).  Kelly and Gobas (2003) and Armitage and Gobas
(2007) concluded that chemicals with a log KOW >2 and a log KOA >5 have
the potential to biomagnify in terrestrial habitats.  Therefore,
propyzamide has the potential to biomagnify in terrestrial habitats.

Propyzamide is moderately mobile in low organic carbon soils and
slightly mobile in other soils, with organic carbon-normalized
Freundlich adsorption coefficients that range from 548 to 1340 L/kgOC
for six soils (MRID 40211103).  Propyzamide may also have greater
mobility in sandy, clay-poor soils, as the compound’s mobility in soil
correlates with cation exchange capacity (R2 = 0.92).

Propyzamide undergoes both biotic (aerobic metabolism) and abiotic
(aqueous photolysis) degradation on the order of weeks to months (MRID
40420301, 40320601, 41568901, 46413407, 46427901).  Half-lives for total
residues of concern, however, are estimated to be on the order of months
to years, because all identified degradates except carbon dioxide are
presumed to be of toxicological concern.  Propyzamide does not hydrolyze
(MRID 00107980) and is not readily metabolized in anaerobic environments
(MRID 46413408).

The end use product Kerb® dissipated (0-12 inch depth) in a bare ground
plot of sandy loam soil in California and a bare ground plot of loam
soil in Wisconsin with half-lives of 18-24 days and 34-53 days,
respectively, at the 95% confidence interval (MRID 44078601).  These
dissipation rates are consistent with degradation rates in the submitted
fate and transport studies.  Analytes included propyzamide parent and
degradates RH-24644 and RH-24580 (the limit of detection for all
analytes was 3 ppb).  Propyzamide was detected at the deepest depth
sampled (6-12 inches) on the day of application at both sites and at
study termination (day 540) at the California site.  Propyzamide was
also detected at a maximum depth of 18-24 inches at the California site
12 days after application and at a maximum depth of 12-18 inches at the
Arkansas site 1, 2, 178, and 274 days after application, all of which
were intervals when propyzamide was not detected at the deepest sampled
depth.  RH-24644, and RH-24580 were also detected at the deepest depth
sampled (6-12 inches) on the day of application in Wisconsin.  RH-24580
was also detected at maximum depths of 24-30 inches in California (one
day after application) and 6-12 inches in Wisconsin (on multiple
intervals).  RH-24644 was detected at maximum depths of 12-18 inches in
California (seven days after application) and 18-24 inches (the deepest
depth sampled on this interval) in Wisconsin (58 days after
application).

Major degradates of propyzamide include RH-24644, RH-24580, RH- 24655,
RH-26059, UK1, and carbon dioxide (chemical names, structures, and
maximum reported amounts of propyzamide’s degradates are provided in
REF _Ref228878202 \h  \* MERGEFORMAT  Appendix 2 ).  Eleven minor
degradates have been identified.  All identified degradates other than
carbon dioxide contain the 3,5-dichlorobenzoyl moiety of propyzamide.
RH-24644 has similar to lower mobility compared to propyzamide (KFOC
range = 993-3910 L/kgOC), whereas RH-24580 is more mobile than
propyzamide (KFOC range = 96.3-210 L/kgOC; MRID 40211104).

The 2002 TRED states that for dietary risk assessment, propyzamide and
its metabolites containing the 3,5-dichlorobenzoyl moiety are the
residues of concern (USEPA 2002).  Because all identified organic
degradates of propyzamide contain the 3,5-dichlorobenzoyl moiety and
toxicity data for these degradates were unavailable, the Health Effects
Division (HED) assumed that all degradates have the same toxicity as
propyzamide parent and are all residues of risk concern (USEPA 2007d).
Therefore, a total residues of concern approach has been used since the
2002 TRED in order to evaluate the potential exposure to the residues of
risk concern, i.e., propyzamide and all identified degradates other than
carbon dioxide, with respect to both drinking water exposure and
ecological risk assessment.

IV.  Receptors

Consistent with the process described in the Overview Document (USEPA
2004), the risk assessment for propyzamide will rely on a surrogate
species approach.  T  SEQ CHAPTER \h \r 1 oxicological data generated
from surrogate test species, which are intended to be representative of
broad taxonomic groups, are used to extrapolate to potential effects on
a variety of species (receptors) included under these taxonomic
groupings.  Because of the structural similarity of several of the
propyzamide degradates to the parent and the absence of toxicity data on
those degradates, the initial presumption is that the degradates are as
toxic as the parent and total residues are evaluated in the aquatic
exposure assessment. Due to limitations in the terrestrial exposure
model, only the parent compound and not total residues will be
evaluated.

Acute and chronic toxicity data from studies submitted by pesticide
registrants along with the available open literature are used to
evaluate the potential direct and indirect effects of propyzamide on
aquatic and terrestrial receptors.  This includes toxicity data on the
technical grade active ingredient, degradates, and when available,
formulated products (e.g. “Six-Pack” studies).  The open literature
studies are identified using EPA’s ECOTOX database (USEPA 2007), which
employs a literature search engine for locating chemical toxicity data
for aquatic life, terrestrial plants, and wildlife.  The evaluation of
both sources of data can also provide insight into the direct and
indirect effects of propyzamide on biotic communities from loss of
species that are sensitive to the chemical and from changes in structure
and functional characteristics of the affected communities. The ECOTOX
database was searched in April 2009 and did not yield any additional
data that could be used to address uncertainties identified in this
problem formulation.

  REF _Ref227384113 \h  \* MERGEFORMAT  Table 2  provides a summary of
the taxonomic groups and the surrogate species tested to characterize
the potential acute and chronic ecological effects of propyzamide.  In
addition, the table provides a preliminary overview of the potential
acute toxicity of propyzamide by providing the acute toxicity
classifications.

Table   SEQ Table \* ARABIC  2 .  Test Species Evaluated for Assessing
Potential Ecological Effects of Propyzamide and the Associated Acute
Toxicity Classification.

Taxonomic Group	Surrogate Species	Acute Toxicity

--

Chronic Toxicity	Citation

MRID	Acute Toxicity Classification

Birds1	  SEQ CHAPTER \h \r 1 Japanese quail (Coturnex japonica)

Bobwhite quail

(Colinus virginianus)

--

estimated	1-day LD50 =8870 mg/kg bw4

8-day LC50>10,000 mg/kg diet4

--

NOAEC=19 mg/kg day

(200 mg/kg diet)	00107997

00108003

--

Estimated with ACR	Practically Non-toxic

  SEQ CHAPTER \h \r 1 Mammals	  SEQ CHAPTER \h \r 1 Laboratory rat
(Rattus norvegicus)	96-hr LD50

8350 (males) mg/kg bw

5620 (females) mg/kg bw

--

NOAEC/LOAEC

200 ppm / 1500 ppm

15 mg/kg/day  / 114 mg/kg/day)	000855-05

--

415403-01	Practically Non-toxic

  SEQ CHAPTER \h \r 1 Insects	  SEQ CHAPTER \h \r 1 Honey bee

(Apis mellifera L.)	48-hr LD50>181 μg/bee	00028772	Practically
Non-toxic

  SEQ CHAPTER \h \r 1 Freshwater fish2	Rainbow trout

(Oncorhyncus mykiss)

--

Rainbow trout	96-hr LC50=72 mg/L4

--

NOAEC=7.7  mg/L4

	001079-96

--

Estimated with ACR	Slightly Toxic

  SEQ CHAPTER \h \r 1 Freshwater invertebrates	  SEQ CHAPTER \h \r 1
Water flea

(Daphnia magna)

__

Water flea	48-hr EC50 >5.6 mg/L

--

NOAEC/LOAEC = 0.6/1.2 mg/L	98313

--

436799-01	Moderately Toxic

  SEQ CHAPTER \h \r 1 Estuarine/marine fish	NA5	NA	__	__

Estuarine/marine invertebrates	Mysid

(Americamysis bahia)

--

Eastern oyster

(Crassostrea virginica)	96-hr LC50>3.9 mg/L

--

96-hr EC50=3.5 mg/L	436084-02

--

436084-01	Moderately Toxic

--

Moderately Toxic

  SEQ CHAPTER \h \r 1 Terrestrial plants3	Seedling Emergence   SEQ
CHAPTER \h \r 1 Monocots (ryegrass)

Dicots (cucumber)

Vegetative Vigor   SEQ CHAPTER \h \r 1 Monocots (oat)

Dicots (tomato)	EC25/NOAEC

0.019/<0.015

0.015/0.004

--

0.0088/<0.2

0.0104/<0.041	421768-01

440290-01

421768-01

421768-01

	  SEQ CHAPTER \h \r 1 Aquatic plants and algae	Blue-green algae

(Anabaena flos-aquae)

Duckweed

(Lemna gibba)	5-day EC50>4.0 mg/L

NOAEC=0.39 mg/L

--

14-day EC50=1.18 mg/L

NOAEC= 0.56 mg/L	437383-04

437383-01

	  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 (one is corn); six species of
at least four dicot families (one is soybeans).

4 Formulated product tested.

5 NA Data not available

A.  Effects to Aquatic Organisms

Propyzamide is classified as slightly toxic to freshwater fish,
aquatic-phase amphibians and moderately toxic to freshwater and
estuarine/marine invertebrates on an acute exposure basis.  For the fish
studies, nominal concentrations were reported despite the solubility of
propyzamide (15 mg/L; USEPA 1994) and formulated product was used
instead of technical grade active ingredient.  No data are available for
freshwater fish to determine the toxicity of technical grade active
ingredient relative to formulated product.  Given the use of nominal
concentrations instead of measured and the reported low solubility of
propyzamide, it is likely that actual exposure concentrations were lower
than the reported nominal concentrations; however, it is not possible to
gauge the extent to which propyzamide was in solution without measured
concentrations.  Additionally, no data are available to evaluate the
toxicity of propyzamide to estuarine/marine fish.

The acute toxicity study with mysid shrimp (Americamysis bahia) study
only tested up to 3.9 mg/L due to solubility limits of propyzamide in
salt water and failed to establish definitive LC50.  The study failed to
filter and/or centrifuge samples prior to analysis, therefore actual
exposure concentrations are uncertain.

No studies on the chronic toxicity of propyzamide to freshwater fish
were conducted due to the apparent low acute toxicity.  To estimate the
chronic toxicity endpoint for fish, an acute-to-chronic ratio of 9.3 was
historically used to derive the endpoint for freshwater invertebrates.
However, the ACR relied on an indeterminate measure of acute toxicity,
i.e., LC50>5.6 mg/L, and cannot be relied on to accurately estimate the
ACR values.

There were effects of propyzamide on daphnid egg production (20%
reduction at 2.4 mg/L) and larval survival (28% reduction at 1.2 ppm).
The NOAEC for the daphnid life-cycle test is 0.6 mg/L.  This chronic
toxicity endpoint for freshwater invertebrates was used to develop an
acute-to-chronic ratio for aquatic animals.  The ratio of the acute
NOAEC to the chronic NOAEC is 5.6/0.6 or 9.3.

Given that under certain environmental conditions, propyzamide may
partition to benthic sediments, there is uncertainty regarding the
potential effect of this compound and its degradates on benthic
invertebrates.

Several studies on the toxicity of propyzamide to freshwater and marine
aquatic plants were submitted for review.  A 14-day EC50 was estimated
only for the aquatic vascular plant, duckweed (Lemna gibba) and is 1.18
mg/L based on decreased frond density; the associated NOAEC is 0.56
mg/L.  For the other three non-vascular aquatic plant species, an EC50
could not be estimated because effects did not exceed the 50% level; in
all three cases, the EC50 is greater than the highest tested
concentration (4 mg/L).  There was, however, an estimated NOAEC (0.39
mg/L) associated with the freshwater blue-green algae, Anabaena
flos-aquae, based on diminished growth (cell density).

B.  Effects to Terrestrial Organisms

Avian acute toxicity tests show that a formulated product of propyzamide
(RH-315, 75% ai) is practically nontoxic to birds on an acute oral
exposure basis.  The LD50 is 8770 mg ai/kg bw for Japanese quail
(Coturnix japonica) and >14,000 mg ai/kg bw for mallard ducks (Anas
platyrhynchos).  Although these supplemental studies provide some
insight into the acute toxicity of propyzamide to avian species, the
studies deviated from guidelines because formulated product was used
instead of technical product.  As such, there is uncertainty regarding
the acute oral toxicity of the technical grade active ingredient.

Three bobwhite (Colinus virginianus) and one mallard study showed that
propyzamide (technical grade ai) is practically nontoxic to avian
species on a subacute dietary exposures basis with LC50 values ranging
from >30 to >10000 mg/kg diet.

There are no chronic avian toxicity data available on propyzamide from
either registrant-submitted studies or ECOTOX.  Since there are no
chronic toxicity data for birds, the acute-to-chronic ratio (ACR=466)
for mammals (discussed below) was used to estimate a chronic toxicity
value for birds.

Propyzamide is classified as practically nontoxic to mammals on an acute
oral exposure basis.  In a 2-generation reproduction study in laboratory
rats (Ratus norvegicus), propyzamide caused effects on adult and
offspring body size at the highest exposure level of 1500 ppm (114 mg/kg
bw males, 127.3 mg/kg bw females), which is the LOAEC.  There was a
7-13% reduction in male body weights and a 12-18% reduction in female
body weights for rats exposed to 1500 ppm.  An acute-to-chronic ratio
(ACR) was determined for mammals using the mean (average of male and
female) acute oral LD50 (6985 mg/kg bw) and the mean (average of male
and female) chronic NOAEC (15 mg/kg bw/day or 200 mg/kg diet) yielding
an ACR of 466.

81 μg/bee); mortality in the highest dose (181 μg/bee) was 4.9%.

The effects of propyzamide on terrestrial monocotyledonous and
dicotyledonous plants were tested in Tier II seedling emergence and
vegetative vigor tests.  Results of the Tier II seedling emergence study
identify cucumber as the most sensitive dicot with an EC25 and NOAEC of
0.015 and 0.004 lb ai/A, respectively, based on a decrease in shoot
length compared to the control (MRID 440290-01).  The most sensitive
monocot, based on seedling emergence, is ryegrass with an EC25 of 0.03
lb ai/A and a NOAEC of 0.015 lb ai/A, based on a decrease in percent
emergence.

Results of the Tier II vegetative vigor studies identify oat as the most
sensitive monocot and tomato as the most sensitive dicot, with decreased
shoot weight and root weight, respectively, as the most sensitive
endpoints.  The EC05 and EC25 values of 0.0001 lbs a.i./A and 0.088 lbs
a.i./A, respectively, for oat, and the EC05 and EC25 values 0.0079 lbs
a.i./A and 0.0104 lbs a.i./A, respectively, for tomato, are used to
assess the effects of exposure to propyzamide on vegetative vigor in
non-listed and listed terrestrial plants.

C.  Degradate toxicity

No data are available to assess the potential toxicity of propyzamide
degradates containing the 3, 5-dichlorobenzoyl moiety.  In the absence
of data, the degradates are presumed to be as toxic as the parent
compound, as was done for human health risk assessment.

D.  Ecological Incidents

A preliminary review in April 2009 of the Ecological Incident
Information System (EIIS) maintained by the Agency’s Office of
Pesticide Programs (OPP) indicates no incidents have been reported
involving terrestrial or aquatic animals from the use of propyzamide.
However, the lack of reported incidents cannot be construed as the lack
of incidents.

A total of three incidents involving terrestrial plants are reported in
the EIIS database over the period of 2001 through 2004.  Two incidents
(I014702-047 and I012525-008) of unspecified plant damage to lettuce
(Lactuca sativa) occurred from the registered use of propyzamide on
lettuce in California and Arizona.  The third incident (I016962-004)
involved mortality of broccoli (Brassica oleracea) due to growth
retardance resulting from the registered use of propyzamide on broccoli
in Japan.

Ecosystems Potentially at Risk

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

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

V.  Assessment Endpoints

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

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

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

The conceptual model for propyzamide provides a written description and
visual representation of the predicted relationships between
propyzamide, 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 (USEPA 1998).

As discussed previously, several ecological risk assessments have been
conducted by EFED for propyzamide, including a national level risk
assessment supporting the reregistration eligibility decision, local
Section 18 emergency exemption assessments and an endangered species
assessment for the California red-legged frog (USEPA 2007b).

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

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

Propyzamide, when used in accordance with current labels, can result in
off-site movement of the compound via runoff, erosion of sediment-bound
residues and spray drift leading to exposure of nontarget plants and
animals.  Applications to foliar surfaces may serve as a major source of
propyzamide exposure to wildlife.  This potential exposure pathway may
result in adverse effects upon the survival, growth, and reproduction of
non-target terrestrial and aquatic organisms.  These nontarget organisms
include Federally-listed threatened and endangered species.

B.  Conceptual Diagram tc \l3 "2.         Diagram

The environmental fate properties of propyzamide indicate that runoff,
erosion of sediment-bound residues, and spray drift represent potential
transport mechanisms of propyzamide to aquatic and terrestrial
organisms.  These transport mechanisms (e.g. sources) are depicted in
the conceptual models below (Figures 1 and 2) and result in the movement
of propyzamide into aquatic (water and sediment) and terrestrial (soil
and foliage) habitats.  The movement away from the site of application
in turn represents exposure pathways for a broad range of biological
receptors of concern (nontarget animals) and the potential attribute
changes, i.e., effects such as reduced survival, growth and
reproduction, in the receptors due to propyzamide exposure.

Figure   SEQ Figure \* ARABIC  2 . Conceptual model for propyzamide
effects on aquatic organisms.  Dotted lines indicate exposure pathways
that have a low likelihood of contributing to ecological risk.

Figure   SEQ Figure \* ARABIC  3 .  Conceptual model for propyzamide
effects on terrestrial organisms.

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

In order to address the risk hypothesis, the potential for adverse
effects on the environment is estimated.  The use, environmental fate,
and ecological effects of propyzamide 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
propyzamide is estimated using the probit dose-response slope and either
the level of concern (discussed below) or actual calculated risk
quotient values.

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

A.  Stressors of Concern

The stressor of concern in the assessment includes the parent
(propyzamide) plus the degradates containing the 3,5-dichlorobenzoyl
moiety.  These include all sixteen identified organic degradates of
propyzamide.  Depending on the environmental fate studies evaluated,
several of the degradates had differing mobility and persistence
profiles.  Exposures in terrestrial habitats will consider propyzamide
alone given current limitations in modeling terrestrial exposure.

Evaluation of environmental pesticide mixtures is beyond the scope of
this assessment because of the myriad factors that cannot be quantified
based on the available data.  Those factors include identification of
other possible co-contaminants and their concentrations, differences in
the pattern and duration of exposure among contaminants, and the
differential effects of other physical/chemical characteristics of the
receiving waters (e.g. organic matter present in sediment and suspended
water).  Evaluation of factors that could influence additivity/synergism
is beyond the scope of this assessment and the capabilities of the
available data to allow for an evaluation.  However, it is acknowledged
that not considering mixtures could over- or under-estimate risks
depending on the type of interaction and factors discussed above.  The
assessment will, however, analyze the toxicity of formulated products
(including formulations involving more than one active ingredient) and
will determine whether formulated products are more toxic than the
technical grade active ingredient.

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

In order to estimate risks of propyzamide exposures in aquatic and
terrestrial environments, all exposure modeling and resulting risk
conclusions will be based on maximum application rates and methods cited
in Table 1 (of   REF _Ref227737252 \h  \* MERGEFORMAT  Appendix 1 ) and
will be estimated for each use of propyzamide.  Measures of exposure are
based on aquatic and terrestrial models that predict estimated
environmental concentrations (EECs) of propyzamide.  The models used to
predict aquatic EECs are the Pesticide Root Zone Model coupled with the
Exposure Analysis Modeling System (PRZM/EXAMS).  The model used to
predict terrestrial EECs on food items is T-REX.  The model used to
derive EECs relevant to terrestrial and wetland plants is TerrPlant.
These models are parameterized using relevant reviewed environmental
fate data from registrant submissions and the literature; model input
values will be consistent with the most recent version of the input
parameter guidance (Version 2; EFED 2002).

PRZM  and EXAMS are simulation models coupled with the linkage program
shell, PE5, which incorporates the standard scenarios developed by EFED.
 The models generate daily exposures and calculated 1-in-10 year EECs of
propyzamide (plus the 3, 5-dichlorobenzoyl moiety degradates of concern)
that may occur in surface water bodies adjacent to application sites.
PRZM simulates pesticide fate and transport as a result of leaching,
direct spray drift, runoff and erosion from an agricultural field, and
EXAMS estimates environmental fate and transport of pesticides in a
surface water body for a 30-year period.  The standard scenarios used
for ecological pesticide assessments assume 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.  The combined
models (i.e., PRZM/EXAMS) are designed to estimate pesticide
concentrations found in the water body (standard pond) at the edge of
the treated field.  As such, they provide high-end values of the
pesticide concentrations that might be found in ecologically sensitive
environments following pesticide application.  The location of the field
is specific to the crop being simulated using site-specific information
on the soils, weather, cropping, and management factors associated with
the scenario.  The crop/location scenario is intended to represent a
high-end exposure site on which the crop is normally grown.  Based on
historical rainfall patterns, the receiving water body receives multiple
runoff events during the years simulated.  Weather and agricultural
practices are simulated for 30 years so that the 10-year exceedance
probability at the site can be estimated.  The simulation is generated
using 30 years of meteorological data, encompassing the years from 1961
to 1990.  Additional information on these models can be found at:
HYPERLINK "http://www.epa.gov/oppefed1/models/water/index.htm"
http://www.epa.gov/oppefed1/models/water/index.htm .

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 chronic exposure to aquatic invertebrates.

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

Available monitoring data will be used to qualitatively characterize
exposure and compare with modeling results.  The Agency is aware of
monitoring conducted by storm water management agencies and this route
of exposure will be considered in the assessment to the extent that data
on propyzamide are available.

Two spray drift models, AGDisp and AgDRIFT are used to assess exposures
of terrestrial plants to propyzamide deposited in terrestrial habitats
by spray drift.  AGDisp (Teske and Curbishley 2003) is used to simulate
aerial and ground applications using the Gaussian far-field extension.
AgDrift is used to simulate spray blast applications to orchard crops.

C.  Measures of Effect

Ecological effect data are used as measures of direct and indirect
effects to biological receptors.  Data were obtained from
registrant-submitted studies or from literature studies identified by
ECOTOX.  The ECOTOXicology database (ECOTOX) was searched in order to
provide more ecological effects data 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 (USEPA 2007).

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

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

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

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

In the absence of data for either acute or chronic effects, the
conservative assumption will be to presume that propyzamide is toxic.

D.  Integration of Exposure and Effects

Risk characterization is the integration of exposure and ecological
effects characterization to determine the potential ecological risk from
the use of propyzamide on blueberries, alfalfa, clover, birdsfoot
trefoil, crown vetch, sainfoin, lettuce, endive, escarole, radicchio,
apples, apricots, cherries, nectarines, peaches, pears, plums, prunes,
grapes, sod, turf, fallow land, Christmas trees, and ornamentals and the
likelihood of direct and indirect effects to non-target organisms in
aquatic and terrestrial habitats.  The exposure and toxicity effects
data are integrated in order to evaluate the risks of adverse ecological
effects on non-target species.  For the assessment of propyzamide risks,
the risk quotient (RQ) method is used to compare exposure and measured
toxicity values.  EECs are divided by acute and chronic toxicity values.
 The resulting RQs are then compared to the Agency’s levels of concern
(LOCs) (USEPA 2004).  These criteria are used to indicate when
propyzamide’s uses, as directed on the label, have the potential to
cause adverse direct or indirect effects to non-target organisms.  As
noted previously, where data are lacking on the toxicity of propyzamide,
risk will be presumed.

1.  Deterministic and Probabilistic Assessment Methods

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

E.  Endangered Species Assessments

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

The assessment of effects associated with registrations of propyzamide
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 propyzamide application
occurs), plus all areas where offsite transport (i.e., spray drift,
runoff, etc.) may result in potential exposure that exceeds the
Agency’s LOCs.  Specific measures of ecological effect that define the
action area for listed species include any direct and indirect effects
and/or potential modification of its critical habitat, including
reduction in survival, growth, and reproduction as well as the full
suite of sublethal effects available in the effects literature.
Therefore, the action area extends to a point where environmental
exposures are below any measured lethal or sublethal effect threshold
for any biological entity at the whole organism, organ, tissue, and
cellular level of organization.  In situations where it is not possible
to determine the threshold for an observed effect, the action area is
not spatially limited and is assumed to be the entire United States.

F.  Drinking Water Assessment

A drinking water assessment will be conducted to support future human
health dietary risk assessments of propyzamide.  The drinking water
assessment will incorporate model estimates of propyzamide plus the 3,
5-dichlorobenzoyl moiety degradates of concern in surface water and
ground water.  Concentrations of propyzamide residues in surface waters
will be estimated using PRZM/EXAMS (see description above).

An Estimated Drinking Water Concentration (EDWC) of propyzamide residues
in ground water will be estimated using EFED’s Tier I aquatic model
SCI-GROW (Screening Concentration in Ground Water).  SCI-GROW is a
regression model used as a screening tool to estimate pesticide
concentrations found in ground water used as drinking water.  The output
of SCI-GROW represents the concentrations that might be expected in
shallow unconfined aquifers under sandy soils, which is representative
of the ground water most vulnerable to pesticide contamination likely to
serve as a drinking water source.

The drinking water assessment will also include available surface and
ground water monitoring data with consideration of changes in use
patterns that may have occurred.  States are encouraged to submit
monitoring data for review.  Monitoring data were summarized in drinking
water assessments conducted in 2002 and 2007 (DP Barcodes 281443+ and
344249).  The data indicate that propyzamide has been detected at up to
1.12 µg/L in surface water (in Shelby County, Tennessee in January,
2003) and up to 0.82 µg/L in ground water (in Benton County, Arkansas
in April, 1994).  Monitoring data on the degradates of propyzamide are
not available.  The monitored concentrations for propyzamide parent are
consistent with the peak (3.7-10.3 µg/L) and annual mean (0.53-4.45
µg/L) exposure estimates of propyzamide parent in the 2002 drinking
water exposure assessment (DP Barcodes 281443+).

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

1.  Fate

The environmental fate database for propyzamide is nearly complete (
REF _Ref227384151 \h  \* MERGEFORMAT  Table 3 ).  An environmental
chemistry method in soil was never submitted in support of the submitted
terrestrial field dissipation study.  An environmental chemistry method
in soil and an independent laboratory validation (ILV) of the method are
requested in order to evaluate the field study and to provide the public
a method with which residues in soil may be analyzed.  The submitted
method should include propyzamide and its major degradates as analytes.
Levels of quantitation should be below concentrations that result in
potential risks.  If the analytical method used in the terrestrial field
dissipation study does not meet these criteria and/or a newer,
state-of-the-art method is available that meets these criteria, a
current environmental chemistry method and ILV are requested in lieu of
the method used in support of the terrestrial field dissipation study.

The U.S. Geological Survey (USGS) National Water-Quality Assessment
(NAWQA) program lists a multi-residue analytical method for pesticides
in water that includes propyzamide (pronamide) as an analyte (USGS
1995).  However, an analytical method for the major degradates of
propyzamide, RH-24644, RH-24580, RH-24655, UK1, and RH-26059, is not
available.  These major degradates are residues of concern for which
government agencies and the public may wish to analyze. Therefore, an
environmental chemistry method in water that includes as analytes
RH-24644, RH-24580, RH-24655, UK1, and RH-26059 at levels of
quantitation below 5 µg/L is requested as well as an ILV of the method.
 Alternatively, a multi-residue method may be identified if independent
validation indicates that it includes with acceptable recovery the
analytes RH-24644, RH-24580, RH-24655, UK1, and RH-26059 at levels of
quantitation below 5 µg/L.

Submission of an octanol-air partition coefficient (KOA) study is also
requested in order to describe the fate of propyzamide in the atmosphere
in support of terrestrial bioaccumulation modeling.  Further rationale
for these data is contained in   REF _Ref231367296 \h  \* MERGEFORMAT
Appendix 3 .

Table   SEQ Table \* ARABIC  3 .  Available environmental fate data for
propyzamide and remaining data gaps.

158

Guideline

(OPPTS)	Description	Reference (MRID)	Classification	Data Gap?	Comments

161-1

(835.2120)	Hydrolysis	107980	Acceptable	No

	161-2

(835.2240)	Photodegradation in water	107956

107990

40320601, 40420301	Unacceptable

Unacceptable

Acceptable	No

	161-3

(835.2410)	Photodegradation on soil	107990

143746

41913504	Unacceptable

Unacceptable

Supplemental	No

	162-1

(835.4100)	Aerobic soil metabolism	Hance, 1979

Walker and Thompson, 1977

Walker, 1976

Walker, 1978

Yih, 19??

107968

107984

107953

41568901

41913502

46413407	Unacceptable

Unacceptable

Unacceptable

Unacceptable

Unacceptable

Unacceptable

Unacceptable

Unacceptable Upgradeable

Acceptable

(in review)	No

	162-2

(835.4200)	Anaerobic soil metabolism	Acc No. 263649

161097

40244401

41913505	Unacceptable

Unacceptable

Unacceptable Acceptable	No

	162-4

(835.4300)	Aerobic Aquatic Metabolism	107989

46427901	Unacceptable

 (in review)	No

	162-3

(835.4400)	Anaerobic Aquatic Metabolism	46413408	(in review)	No

	163-1

(835.1230)

(835.1240)	 Leaching and adsorption/

desorption	Walker and Thompson, 1978

107983

107971, 107982

107970

40211103

40211104

41913501	Unacceptable

Unacceptable

Unacceptable

Unacceptable

Acceptable

Acceptable

Acceptable	No

	164-1

(835.6100)	Terrestrial Field Dissipation	Walker, 1976

Walker, 1978

Yih, 19??

Zandvoort et al., 1979

Rohm and Hass Co., 19??

Hance et al., 1978

Hance et al., 1978 (2)

40925401

107953

44078601	Unacceptable

Unacceptable

Unacceptable

Unacceptable

Unacceptable

Unacceptable

Unacceptable

Unacceptable

Unacceptable

Upgradeable	Yes	Submission of an acceptable, independently validated
environmental chemistry method in soil will upgrade the study
classification of MRID 44078601.

165-4

(850.1730)	Bioaccumulation in Fish	43196701	Acceptable	No

2.  Effects

Although many submissions have been made to provide data on the effects
of propyzamide to aquatic and terrestrial organisms, data gaps still
exist (  REF _Ref227384184 \h  \* MERGEFORMAT  Table 4  to   REF
_Ref227384200 \h  \* MERGEFORMAT  Table 6 ).  These include: avian acute
oral, avian reproduction, freshwater fish acute toxicity with technical
grade active ingredient, freshwater fish lifecycle, and estuarine/marine
fish toxicity tests.  These data gaps are discussed below.  Some of
these data gaps were identified in the 1994 RED.  Additionally, no data
have been provided on the toxicity of propyzamide degradates; as
discussed previously, in the absence of data to the contrary, the major
degradates will be presumed to be as toxic as the parent. Also, given
that under certain environmental conditions, propyzamide may partition
to sediments, there is uncertainty regarding the potential effects of
this compound and its degradates on benthic freshwater invertebrates.
More thorough rationale for the data is contained in   REF _Ref231367296
\h  \* MERGEFORMAT  Appendix 3 .

Table   SEQ Table \* ARABIC  4 .  Available ecological effects data for
terrestrial animals exposed to technical propyzamide and remaining data
gaps (NA=not available).

158

Guideline

(OPPTS)	Description	MRID/

Accession	Classification	Data Gap?	Comments

71-1

(850.2100)	Avian oral toxicity	001079-97	Supplemental	Yes

No data available on acute oral toxicity of propyzamide to passerine
species; nor are there data on the technical grade active ingredient for
any of the required test species.

No data are available on the chronic toxicity of propyzamide to birds.

71-2

(850.2200)	Avian dietary toxicity 	001079-93

001080-03

001079-94

001080-02	Supplemental	No

	71-4

(850.2300)	Avian reproduction	NA	NA	Yes

	141-1

(850.3020)	Honeybee acute contact toxicity	00028772	Acceptable	No

Table   SEQ Table \* ARABIC  5 .  Available ecological effects data for
aquatic animals exposed to technical propyzamide and remaining data gaps
(NA=not available).

Guideline	Description	MRID/ Accession	Classification	Data Gap?	Comments

72-1

(850.1075)	Freshwater fish –

Acute toxicity 	001071-96	Supplemental	Yes	Freshwater fish studies
conducted with formulated product; data required on technical grade
active ingredient

Estuarine/marine fish acute toxicity study required

Mysid shrimp study only tested up to 3.9 mg/L and failed to establish
definitive LC50 also, study failed to filter and/or centrifuge samples
prior to analysis therefore actual exposure concentrations are
uncertain.

Reproductive physiology of aquatic imvertebrates is impairded by
propyzamide and fish may be similarly affected.  Since no data available
on fish, a fish full life-cycle study required

72-3

(850.1075)	Saltwater fish –

Acute toxicity 	NA	NA	Yes

	72-2

(850.1010)	Freshwater invertebrates –

Acute toxicity	98313	Acceptable	No

	72-3

(850.1025)

(850.1035)	Saltwater invertebrates –

Acute toxicity

Mysid shrimp

Eastern yster

436084-02

436084-01

Supplemental

Acceptable

Yes

No

	72-4

(850.1300)	Freshwater  invertebrate –

 life cycle test	436799-01	Acceptable	No

	72-4

(850.1350)	Saltwater invertebrates –

life cycle test	NA	NA	Reserve

	72-4

(850.1400)	Freshwater fish –

early life stage test	NA	NA	Reserve

	72-4

(850.1400)	Saltwater fish –

early life stage test	NA	NA	Reserve

	72-5

(850.1500)	Fish –

life cycle test	NA	NA	Yes

Table   SEQ Table \* ARABIC  6 .  Available ecological effects data for
plants exposed to propyzamide and remaining data gaps (NA=not
available).

Guideline	Description	MRID	Classification	Data Gap?	Comments

122-1

(850.4100)	Terrestrial Plant toxicity: Tier I seedling emergence	NA	NA
No	Tier 2 studies are available

Tier 2 studies are available

123-1

(850.4225)	Terrestrial Plant toxicity: Tier 2 seedling emergence
421768-01

440290-01	Supplemental

Acceptable	No

	122-1

(850.4150)	Terrestrial Plant toxicity: Tier I vegetative vigor	NA	NA	No

	123-1

(850.4150)	Terrestrial Plant toxicity: Tier 2 vegetative vigor	421768-01
Supplemental	No

	123-2

(850.4400)	Aquatic Plant Growth: algae	437383-04

437383-02

437383-03	Acceptable

Acceptable

Acceptable	No

	123-2

(850.4400)	Aquatic Plant Growth: vascular plants	437383-01	Acceptable	No

Acute Effects to Birds

No acute oral toxicity data are available to assess the potential risks
of propyzamide to passerines.  Also, the acute oral toxicity of the
technical grade active ingredient is uncertain with respect to upland
game birds and water fowl.  Consistent with 158 test guideline
requirements, an acute oral toxicity test with a passerine species
(Guideline 850.2100) should be submitted as well as with the Bobwhite
quail and/or mallard duck using technical grade active ingredient.  In
the absence of these data, the risk assessment will presume that
propyzamide is acutely toxic to passerines.

Chronic Effects to Birds

No chronic toxicity data are available for birds.  Consistent with 158
Guideline requirements, avian reproduction studies using mallard ducks
and bobwhite quail (Guideline 850.2300) should also be submitted.  In
the absence of these data, the risk assessment will presume that
propyzamide affects reproductive endpoints.

Acute freshwater fish acute toxicity studies

No acute toxicity data are available for fish using technical grade
active ingredient.  Consistent with 158 guidelines, acute toxicity
testing of freshwater fish should be conducted with technical grade
active ingredient and not formulated product.  Therefore, acute toxicity
testing of bluegill sunfish and rainbow trout (Guideline 850.1075)
should be submitted using technical grade active ingredient.

Chronic studies with freshwater fish

No chronic toxicity data are available for freshwater fish; however,
reproductive physiology of aquatic invertebrates was impaired by
propyzamide.  Because of the uncertainty regarding the reproductive
effects in freshwater fish, a fish full lifecycle study (Guideline
850.1500) should be submitted.  Without a definitive chronic toxicity
endpoint for freshwater fish, chronic risk will be presumed for
freshwater fish and aquatic-phase amphibians.

Acute toxicity with estuarine/marine invertebrate crustacean

The estuarine/marine acute toxicity study of mysid shrimp only tested to
3.9 mg/L and failed to establish an LC50 value.  The study also noted
that a precipitate was observed in the three highest test
concentrations; however, there is no indication that samples were
filtered and/or centrifuged prior to analysis.  As such, the study has
not adequately demonstrated exposure.  A study should be submitted that
tests up to the solubility limit of the compound.  Because the current
study does not establish an LC50 and there are uncertainties concerning
actual exposure concentrations, an estuarine/marine invertebrate study
with mysid shrimp (Guideline 850.1035) should be submitted.

Degradate Toxicity studies

Although not described in the preceding toxicity data tables nor in
REF _Ref231367296 \h  \* MERGEFORMAT  Appendix 3 , there are no toxicity
data available on the major environmental degradates, RH-24644,
RH-24580, RH-24655, UK1, and RH-26059.  Acute and chronic aquatic
toxicity studies involving fish and invertebrates are recommended to
address this uncertainty.  As discussed previously, in the absence of
data to the contrary, all degradates will be presumed to be as toxic as
the parent.

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Appendix   SEQ Appendix \* ARABIC  1 .  Currently Registered Uses of
Propyzamide.

Table 1.  Methods and rates of application of currently registered uses
of propyzamide.

  SEQ CHAPTER \h \r 1 Use Site	Max. Rate

per App	Max. Rate

 Unit/Area

*UG	Form	Max.#

Apps

cc & yr	Max. App

Rate/

cc & yr	Min. App

 Interval

 (days)	Application Equipment

 //Type

(Reg # Code)

NON-FOOD/NON-FEED USES

agricultural fallow/idle land

 	.5000	lb A	WP	1/1 yr	.5 lb/yr	NS	Aircraft/ Low pressure ground sprayer

//Broadcast (a)

	.5156	lb A	L	1/1 yr	1.25 lb (L)/yr	NS	Aircraft/ Low pressure ground
sprayer

//Broadcast (b)

agricultural uncultivated areas

 	.2000	lb A	WP	1/1 yr	.2 lb/yr	NS	Aircraft/ Low pressure ground sprayer

//Broadcast (a)

	.5000	lb A	WP	1/1 yr	.5 lb/yr	NS	Aircraft/ Low pressure ground sprayer

//Spray (b)

	.5156	lb A	L	1/1 yr	.5156 lb/yr	NS	Aircraft/ Low pressure ground
sprayer

//Spray (c)

	.2063	lb A	L	1/1 yr	0.4 lb (L)/yr	NS	Aircraft/ Low pressure ground
sprayer

//Broadcast (d)

alfalfa

 	2	lb A	WP	NS	2 lb/cc	NS	Irrigation/ Low pressure  ground sprayer

//Broadcast/ Soil in-furrow

treatment (a)

	2.0625	lb A	L	NS	2.0625 lb/yr	NS	Low pressure ground sprayer

//Broadcast (b)

	2.0625	lb A	L	NS	NS	NS	Irrigation

//Soil in-furrow treatment (c)

Christmas tree plantations

 	2	lb A	WP	1/1 yr	2 lb/yr	NS	Low pressure ground sprayer

//Directed spray (a)

	2.0625	lb A	L	1/1 yr	2.0625 lb/yr	NS	Low pressure ground sprayer

//Band treatment/ Directed

spray (b)

	2~	lb A	WP	NS	3 lb/yr	NS	Aircraft

//Broadcast (c)

	2~	lb A	WP	NS	NS	NS	Aircraft

//Broadcast (d)

clover

 	2	lb A	WP	NS	2 lb/cc	NS	Low pressure ground sprayer

//Broadcast (a)

	2.0625	lb A	L	NS	2.0625 lb/yr	NS	Low pressure ground sprayer

//Broadcast (b)

commercial/industrial lawns 	1.444	lb A	L	1/cc	1.444 lb/cc	NS	Aircraft/
Ground/ Sprayer

//Band treatment/ Broadcast (a)

crown vetch

 	2	lb A	WP	NS	2 lb/cc	NS	Low pressure ground sprayer

//Broadcast (a)

	2.0625	lb A	L	NS	2.0625 lb/yr	NS	Low pressure ground sprayer

//Broadcast (b)

golf course turf

 	1.444	lb A	L	1/cc	1.444 lb/cc	NS	Aircraft/ Ground/ Sprayer

//Band treatment/ Broadcast (a)

	1.5	lb A	WP	1/cc	1.5 lb/cc	NS	Aircraft/ Band sprayer/ Ground

//Band treatment/ Broadcast (b)

ornamental and/or shade trees

 	2	lb A	WP	1/1 yr	2 lb/yr	NS	Low pressure ground sprayer

//Directed spray (a)

	2.0625	lb A	L	1/1 yr	2.0625 lb/yr	NS	Low pressure ground sprayer

//Band treatment/ Directed spray (b)

ornamental grasses 	1.5	lb A	WP	1/cc	1.5 lb/cc	NS	Aircraft/ Band
sprayer/ Ground

//Band treatment/ Broadcast (a)

ornamental herbaceous plants

 	2~	lb A	WP	4/cc	8 lb/yr	NS	Low pressure ground sprayer

//Ground spray (a)

	2	lb A	WP	1/1 yr	2 lb/yr	NS	Low pressure ground sprayer

//Directed spray (b)

	2.0625	lb A	L	1/1 yr	2.0625 lb/yr	NS	Low pressure ground sprayer

//Band treatment/ Directed spray (c)

ornamental lawns and turf

 	1.444	lb A	L	1/cc	1.444 lb/cc	NS	Aircraft/ Ground/ Sprayer

//Band treatment/ Broadcast (a)

	1.5	lb A	WP	1/cc	1.5 lb/cc	NS	Aircraft/ Band sprayer/ Ground

//Band treatment/ Broadcast (b)

ornamental nonflowering plants

 	2	lb A	WP	1/1 yr	2 lb/yr	NS	Low pressure ground sprayer

//Directed spray (a)

	2.0625	lb A	L	1/1 yr	2.0625 lb/yr	NS	Low pressure ground sprayer

//Band treatment/ Directed spray (b)

ornamental sod farm (turf)

 	1.444	lb A	L	1/cc	1.444 lb/cc	NS	Aircraft/ Ground/ Sprayer

//Band treatment/ Broadcast (a)

	1.5	lb A	WP	1/cc	1.5 lb/cc	NS	Aircraft/ Band sprayer/ Ground

//Band treatment/ Broadcast (b)

ornamental woody shrubs and vines

 	2	lb A	WP	1/1 yr	2 lb/yr	NS	Low pressure ground sprayer

//Directed spray (a)

	2.0625	lb A	L	1/1 yr	2.0625 lb/yr	NS	Low pressure ground sprayer

//Band treatment/ Directed spray (b)

recreation area lawns 	1.444	lb A	L	1/cc	1.444 lb/cc	NS	Aircraft/
Ground/ Sprayer

//Band treatment/ Broadcast (a)

sainfoin

 	2	lb A	WP	NS	2 lb/cc	NS	Low pressure ground sprayer

//Broadcast (a)

	2.0625	lb A	L	NS	2.0625 lb/yr	NS	Low pressure ground sprayer
//Broadcast (b)

sugar beet 	1~	lb A	WP	NS	NS	NS	Ground

//High volume spray (dilute) (a)

trefoil

 	2	lb A	WP	NS	2 lb/cc	NS	Low pressure ground sprayer

//Broadcast (a)

	2.0625	lb A	L	NS	2.0625 lb/yr	NS	Low pressure ground sprayer

//Broadcast (b)

FOOD/FEED USES

alfalfa

 	2	lb A	WP	NS	2 lb/cc	NS	Irrigation/ Low pressure ground sprayer

//Broadcast/ Soil in-furrow treatment (a)

	2.0625	lb A	L	NS	2.0625 lb/yr	NS	Low pressure ground sprayer

//Broadcast (b)

	2.0625	lb A	L	NS	NS	NS	Irrigation

//Soil in-furrow treatment (c)

apple

 	4	lb A	WP	1/cc	4 lb/cc	NS	Low pressure ground sprayer

//Directed spray/ Soil band treatment (a)

	3.919	lb A	L	1/1 yr	3.919 lb/yr	NS	Low pressure ground sprayer

//Band treatment/ Directed spray (b)

apricot

 	4	lb A	WP	1/cc	4 lb/cc	NS	Low pressure ground sprayer

//Directed spray/ Soil band treatment (a)

	3.919	lb A	L	1/1 yr	3.919 lb/yr	NS	Low pressure ground sprayer

//Band treatment/ Directed spray (b)

artichoke

 	2~	lb A	WP	1/cc	NS	NS	Aircraft/ Ground

//Broadcast (a)

	2	lb A	WP	2/cc	2 lb/cc	NS	Aircraft/ Low pressure ground sprayer
              //Soil band treatment/ Soil broadcast treatment (b)

	4	lb A	WP	2/cc	4 lb/cc	NS	Aircraft/ Low pressure ground sprayer

//Soil band treatment/ Soil broadcast treatment (c)

	2.0625	lb A	L	NS	2.0625 lb/cc	NS	Aircraft/ Low pressure ground sprayer

//Band treatment/ Broadcast (d)

	3.919	lb A	L	NS	3.919 lb/cc	NS	Aircraft/ Low pressure ground sprayer

//Band treatment/ Broadcast (e)

blackberry 	2.8875	lb A	L	1/cc	2.8875 lb/cc	NS	Low pressure ground
sprayer

//Band treatment/ Broadcast (a)

 	3~	lb A	WP	1/1 yr	3 lb/yr	NS	Low pressure ground sprayer

//Band treatment/ Broadcast (b)

blueberry

 	2	lb A	WP	1/1 yr	2 lb/yr	NS	Low pressure ground sprayer

//Band treatment/ Broadcast (a)

	2.0625	lb A	L	1/1 yr	2.0625 lb/yr	NS	Low pressure ground sprayer

//Band treatment/ Broadcast (b)

boysenberry

 	2.8875	lb A	L	1/cc	2.8875 lb/cc	NS	Low pressure ground sprayer

//Band treatment/ Broadcast (a)

	3	lb A	WP	1/1 yr	3 lb/yr	NS	Low pressure ground sprayer

//Band treatment/ Broadcast (b)

cherry

 	4	lb A	WP	1/cc	4 lb/cc	NS	Low pressure ground sprayer

//Directed spray/ Soil band treatment (a)

	3.919	lb A	L	1/1 yr	3.919 lb/yr	NS	Low pressure ground sprayer

//Band treatment/ Directed spray (b)

clover

 	2	lb A	WP	NS	2 lb/cc	NS	Low pressure ground sprayer

//Broadcast (a)

	2.0625	lb A	L	NS	2.0625 lb/yr	NS	Low pressure ground sprayer

//Broadcast (b)

crown vetch

 	2	lb A	WP	NS	2 lb/cc	NS	Low pressure ground sprayer

//Broadcast (a)

	2.0625	lb A	L	NS	2.0625 lb/yr	NS	Low pressure ground sprayer

//Broadcast (b)

endive (escarole)

 	1~	lb A	WP	1/cc	1 lb/cc	NS	Sprinkler irrigation

//Chemigation (a)

	1.5	lb A	WP	1/cc	1.5 lb/cc	NS	Low pressure ground sprayer

//Band treatment/ Broadcast (b)

	2~	lb A	WP	1/cc	2 lb/cc	NS	Aircraft

//Broadcast (c)

	2.0625	lb A	L	1/cc	2.0625 lb/cc	NS	Low pressure ground sprayer

//Band treatment/ Broadcast (d)

grapes

 	4	lb A	WP	1/cc	4 lb/cc	NS	Low pressure ground sprayer

//Directed spray/ Soil band treatment (a)

	3.919	lb A	L	1/1 yr	3.919 lb/yr	NS	Low pressure ground sprayer

//Band treatment/ Directed spray (b)

grasses grown for seed

 	.3750~	lb A	WP	1/cc	.375 lb/cc	NS	Ground

//Broadcast (a)

	.2550~	lb A	WP	NS	NS	NS	Ground

//Broadcast (b)

leafy greens

 	1~	lb A	WP	1/cc	1 lb/cc	NS	Sprinkler irrigation

//Chemigation (a)

	1.5	lb A	WP	1/cc	1.5 lb/cc	NS	Low pressure ground sprayer

//Band treatment/ Broadcast (b)

	2.0625	lb A	L	1/cc	2.0625 lb/cc	NS	Low pressure ground sprayer

//Band treatment/ Broadcast (c)

lettuce

 	1~	lb A	WP	1/cc	1 lb/cc	NS	Sprinkler irrigation

//Chemigation (a)

	2~	lb A	WP	1/cc	2 lb/cc	NS	Aircraft/ Low pressure ground sprayer

//Band treatment/ Broadcast (b)

	2.0625	lb A	L	1/cc	2.0625 lb/cc	NS	Low pressure ground sprayer

//Band treatment/ Broadcast (c)

	1.5~	lb A	WP	1/cc	NS	NS	Low pressure ground sprayer

//Band treatment/ Broadcast (d)

lettuce, leaf (black seeded simpson, salad bowl, etc.)

 	1~	lb A	WP	1/cc	1 lb/cc	NS	Sprinkler irrigation

//Chemigation (a)

	1.5~	lb A	WP	1/cc	1.5 lb/cc	NS	Low pressure ground sprayer

//Band treatment/ Broadcast/ Soil band treatment/ Soil treatment
(surface) (b)

	2.0625	lb A	L	1/cc	2.0625 lb/cc	NS	Low pressure ground sprayer

//Band treatment/ Broadcast (c)

	1.5~	lb A	WP	1/cc	NS	NS	Low pressure ground sprayer

//Band treatment/ Broadcast (d)

nectarine

 	4	lb A	WP	1/cc	4 lb/cc	NS	Low pressure ground sprayer

//Directed spray/ Soil band treatment (a)

	3.919	lb A	L	1/1 yr	3.919 lb/yr	NS	Low pressure ground sprayer

//Band treatment/ Directed spray (b)

peach 	4	lb A	WP	1/cc	4 lb/cc	NS	Low pressure ground sprayer

//Directed spray/ Soil band treatment (a)

 	3.919	lb A	L	1/1 yr	3.919 lb/yr	NS	Low pressure ground sprayer

//Band treatment/ Directed spray (b)

pear 	4	lb A	WP	1/cc	4 lb/cc	NS	Low pressure ground sprayer

//Directed spray/ Soil band treatment (a)

 	3.919	lb A	L	1/1 yr	3.919 lb/yr	NS	Low pressure ground sprayer

//Band treatment/ Directed spray (b)

peas (unspecified)

 	1.444	lb A	L	1/1 yr	1.444 lb/yr	NS	Low pressure ground sprayer

//Broadcast (a)

	1.5	lb A	WP	1/1 yr	1.5 lb/yr	NS	Low pressure ground sprayer

//Broadcast (b)

plum

 	4	lb A	WP	1/cc	4 lb/cc	NS	Low pressure ground sprayer

//Directed spray/ Soil band

treatment (a)

	3.919	lb A	L	1/1 yr	3.919 lb/yr	NS	Low pressure ground sprayer

//Band treatment/ Directed spray (b)

prune

 	4	lb A	WP	1/cc	4 lb/cc	NS	Low pressure ground sprayer

//Directed spray/ Soil band treatment (a)

	3.919	lb A	L	1/1 yr	3.919 lb/yr	NS	Low pressure ground sprayer

//Band treatment/ Directed spray (b)

raspberry (black, red)

 	2.8875

	lb A

	L

	1/cc

	2.8875 lb/cc

	NS

	Low pressure ground sprayer

//Band treatment/ Broadcast (a)

	3~	lb A	WP	1/1 yr	3 lb/yr	NS	Low pressure ground sprayer

//Band treatment/ Broadcast (b)

rhubarb

 	2	lb A	WP	1/1 yr	2 lb/yr	NS	Low pressure ground sprayer

//Band treatment/ Broadcast (a)

	2.0625	lb A	L	1/1 yr	4 lb (L)/yr	NS	Low pressure ground sprayer

//Band treatment/ Broadcast (b)

sainfoin

 	2	lb A	WP	NS	2 lb/cc	NS	Low pressure ground sprayer

//Broadcast (a)

	2.0625	lb A	L	NS	2.0625 lb/yr	NS	Low pressure ground sprayer

//Broadcast (b)

trefoil 	2	lb A	WP	NS	2 lb/cc	NS	Low pressure ground sprayer

//Broadcast (a)

 	2.0625	lb A	L	NS	2.0625 lb/yr	NS	Low pressure ground sprayer

//Broadcast (b)

LEGEND

HEADER ABBREVIATIONS

Use Site                : The use site refers to the entity (crop,
building, surface or article) where a

                          pesticide is applied and/or which is being
protected.

Max.Rate per App        : Maximum dose for a single application to a
single site. System calculated.

Max.Rate Unit/Area      : Units and Area associated with the maximum
dose.

*UG                     : Use Group codes.

Form                    : The physical form of the end use product found
in the container.

Max. # Apps cc & yr     : The maximum number of applications.

Max. App Rate/cc & yr   : The maximum amount of pesticide product that
can be applied to a site in one

                          growing season (/cc) or during the span of one
year (/yr).

Min. App Interval (days): The minimum retreatment interval between
applications in days (aggregated).

Application Equipment   : The equipment used to apply pesticide
(aggregated).

Application Type        : The type of pesticide application
(aggregated).

Current as of -         : The label data for the listed products in this
report is current as of this date.

ABBREVIATIONS

AN  - As Needed.

NA  - Not Applicable.

NS  - Not Specified (on label).

(L) - The dosage information provided is from the label in terms of
product (e.g., ounces, gallons, or

      pounds of the product) because there was insufficient information
(e.g., missing density, area, or

      active ingredient percentages) to provide converted dosage
information.

~   - The tilde in "Max. Rate per App" indicates a dosage that includes
information from a SLN label.

UC  - Unconverted due to lack of data (on label).

APPLICATION RATE

W                       : PPM calculated by weight

V                       : PPM calculated by volume

U                       : Unknown whether PPM is given by weight or by
volume

cwt                     : Hundred Weight.

nnE-xx                  : nn times (10 power -xx), for instance,
"1.234E-4" is equivalent to ".0001234".

--                      : No description available in LUIS unit
conversion vocabulary.

~                       : The dosage information includes a contribution
from one or more (TQ, CL, BR, I)

                          active ingredients.

FORMULATION CODES

L       : Liquid

WP      : Wettable Powder

Appendix   SEQ Appendix \* ARABIC  2 .  Chemical Names, Structures, and
Maximum Reported Amounts of Propyzamide and its Degradates.

Table A.    SEQ CHAPTER \h \r 1 Maximum Reported Amounts of Propyzamide
Degradation Products.

  SEQ CHAPTER \h \r 1 Degradate	  SEQ CHAPTER \h \r 1 Maximum % of
Applied	Study Type	MRID

RH-24644 (M1)	3.75 (14 d, pH 7)

3.22 (1 d)

2.02 (28 d)

31.9 (21 d)

26.6 (12 mo)

12.8 (60 d)

4.54 (63 d)

17.7 (123 d)

6.9 (105 d)

0.168 ppm (60 d)	Hydrolysis

Aqueous photolysis

Soil photolysis

Aerobic soil metabolism

Aerobic soil metabolism

Anaerobic soil metabolism

Anaerobic soil metabolism

Anaerobic aquatic metabolism

Aerobic aquatic metabolism

Terrestrial field dissipation1	MRID 00107980

MRID 40420301

MRID 41913504

MRID 46413407

MRID 41568901

MRID 41913505

Acc. No. 263649

MRID 46413408

MRID 46427901

MRID 44078601

RH-24655 (M2, UK 2)	2.3 (123 d)

27.3 (105 d)	Anaerobic aquatic metabolism

Aerobic aquatic metabolism	MRID 46413408

MRID 46427901

RH-20839 (M3)	1.7 (30 d)

3.9 (76 d)

6.3 (123 d)	Aqueous photolysis

Aerobic soil metabolism

Anaerobic aquatic metabolism	MRID 40420301

MRID 46413407

MRID 46413408

RH-24580 (M4)	3.10 (28 d, pH 5)

1.40 (14 d)

12.6 (28 d)

24.0 (45 d)

14.0 (12 mo)

32.2 (30 d)

2.9 (123 d)

2.3 (105 d)

0.178 ppm (29 d)	Hydrolysis

Aqueous photolysis

Soil photolysis

Aerobic soil metabolism

Aerobic soil metabolism

Anaerobic soil metabolism

Anaerobic aquatic metabolism

Aerobic aquatic metabolism

Terrestrial field dissipation1	MRID 00107980

MRID 40420301

MRID 41913504

MRID 46413407

MRID 41568901

Acc. No. 263649

MRID 46413408

MRID 46427901

MRID 44078601

M5	0.1 (14-56 d)	Anaerobic aquatic metabolism	MRID 46413408

M6	0.2 (123 d)	Anaerobic aquatic metabolism	MRID 46413408

M8	2.9 (123 d)	Anaerobic aquatic metabolism	MRID 46413408

RH-26521 (M9)	4.2 (9 mo)

0.1 (56 d)

1.9 (105 d)	Aerobic soil metabolism

Anaerobic aquatic metabolism

Aerobic aquatic metabolism	MRID 41568901

MRID 46413408

MRID 46427901

M10	0.3 (123 d)	Anaerobic aquatic metabolism	MRID 46413408

M11	3.5 (123 d)	Anaerobic aquatic metabolism	MRID 46413408

UK 1	9.9 (105 d)	Aerobic aquatic metabolism	MRID 46427901

UK 3	7.1 (105 d)	Aerobic aquatic metabolism	MRID 46427901

RH-26059	15.0 (30 d)	Aqueous photolysis	MRID 40420301

RH-25891	1.34 (28 d, pH 5)

1.88 (30 d)

9.44 (63 d)	Hydrolysis

Aqueous photolysis

Anaerobic soil metabolism	MRID 00107980

MRID 40420301

Acc. No. 263649

RH-26702	5.16 (14 d)

8.18 (28 d)	Aqueous photolysis

Soil photolysis	MRID 40420301

MRID 41913504

RH-24298	3.6 (30 d)	Aqueous photolysis	MRID 40420301

Carbon dioxide 	50.4 (104 d)

0.1 (56-123 d)	Aerobic soil metabolism

Anaerobic aquatic metabolism	MRID 46413407

MRID 46413408

1 The terrestrial field dissipation study initial application was 4 lbs
a.i./A.  Only two degradates were analyzed for.

Table B.  Chemical Names and Structures of Propyzamide and its
Degradates.

Chemical Name	Structure

Propyzamide (Pronamide,

RH-23315)

IUPAC name:  3,5-dichloro-N-(1,1-dimethylprop-2-ynyl)benzamide

CAS name:  3,5-dichloro-N-(1,1-dimethyl-2-propynyl)benzamide

RH-24644 (M1)

IUPAC name:  3,5-dichloro-N-(1,1,2-trimethylprop-2-enyl)benzamide

CAS name:  2-(3,5-dichlorophenyl)-4,4-dimethyl-5-methylene-2-oxazoline

RH-24655 (M2, UK 2)

IUPAC name:  3,5-dichloro-N-(1,1-dimethylpropenyl)benzamide

CAS name:  3,5-dichloro-N-(1,1-dimethyl-2-propenyl)benzamide

RH-20839 (M3)

IUPAC, CAS name:  3,5-dichlorobenzoic acid

RH-24580 (M4)

IUPAC name:  3,5-dichloro-N-(1,1-dimethyl-2-oxopropyl)benzamide

CAS name: N-(1,1-dimethylacetonyl)-3,5-dichlorobenzamide

RH-26521 (M9)

IUPAC name:  3,5-dichloro-N-(2-hydroxy-1,1-dimethylpropyl) benzamide

CAS name:  N-(1,1-dimethyl-2,3-dihydroxypropyl)-3,5-dichlorobenzamide

RH-26059

β-(3,5-dichlorobenzamino-β-methyl-butyric acid

RH-25891

IUPAC name:  3,5-dichloro-N-(1,1,2-trimethylpropyl)benzamide

CAS name:  2-(3,5-dichlorophenyl)-4,4-dimethyl-S-hydroxymethyloxazoline

RH-26702

IUPAC name:  3,5-dichloro-N-(1,1-dimethyl-2-oxopropyl)benzamide

CAS name:  N-(1,1-dimethyl-3-hydroxacetonyl)-3,5-dichlorobenzamide

RH-24298

IUPAC, CAS name:  3,5-dichlorobenzamide

MDCB

CAS name:  methyl 3,5-dichlorobenzoate

UK 1

IUPAC name:  3-chloro-N-(1,1-dimethylpropynyl)benzamide

UK 3

IUPAC name:  3-chloro-N-(1,1-dimethylpropenyl)benzamide

Carbon dioxide

Appendix   SEQ Appendix \* ARABIC  3 .  Data Call-in Justification.

Guideline Number:  (Non-guideline)

Study Title: Partition Coefficient (n-Octanol/Air)

Rationale for Requiring the Data

The Agency has a limited understanding of how propyzamide behaves in the
environment once applied.  Depending on how the compound partitions
between environmental organic surfaces and air, propyzamide may or may
not pose potential exposure concern in terrestrial environments.
Because propyzamide partitioning between organic surfaces and air is not
well understood, the Agency is requiring data.

Practical Utility of the Data

How will the data be used?

n-Octanol-air partitioning data will facilitate a better understanding
of the bioaccumulation potential of propyzamide residues in terrestrial
environments.  If data indicate that propyzamide is highly oliophilic
relative to air, then the Agency could potentially determine that
propyzamide readily bioaccumulates in terrestrial organisms.  If data
indicate that propyzamide is not highly oliophilic relative to air, then
the Agency could conclude that propyzamide does not readily
bioaccumulate in terrestrial organisms.

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

In the absence of the requested data, the n-octanol-air partitioning of
propyzamide will be estimated with the KOAWIN model, the results of
which are characterized by high uncertainty.  If the required data
indicate that propyzamide does not readily bioaccumulate in terrestrial
organisms, then risk assessment conclusions and associated labeled use
precautions and/or restrictions could be made less restrictive.

Guideline Number: 835.6100

Study Title: Analytical Method (and Associated Independent Laboratory
Validation) for Residues in Soil

Rationale for Requiring the Data

Independently validated analytical methods for residues in soil, water,
sediment, and plant material (environmental chemistry methods) submitted
by the registrant are used to evaluate analyses described in submitted
environmental fate and ecological effects studies.  Submitted analytical
methods are also used by various Federal, State, Tribal, and local
agencies to detect and monitor residues that are or are suspected to be
in environmental compartments due to outdoor uses and accidental
releases.  Independent laboratory validations for submitted analytical
methods are necessary to confirm that the methods are functional and to
confirm the levels of detection and quantitation reported in
registrant-prepared validations.

An environmental chemistry method in soil was not submitted in support
of submitted terrestrial field dissipation studies.  An independently
validated environmental chemistry method in soil is necessary to
evaluate the results of the most recently submitted terrestrial field
dissipation study, MRID 44078601.  Also, use of propyzamide may impact
soil quality due to runoff and/or leaching of residues.  Therefore,
outside agencies may request analytical methods with which to monitor
for propyzamide residues in soil.

Practical Utility of the Data

How will the data be used?

In the absence of an independently validated environmental chemistry
method in soil, the submitted terrestrial field dissipation study is not
reviewable and entities outside the Agency may lack a chemical-specific
method for analyses in soil.  An independently validated environmental
chemistry method will be used to evaluate the submitted terrestrial
field dissipation study and will be made available for enforcement and
monitoring purposes at the federal, state, and local levels.

The submitted environmental chemistry method in soil should include as
analytes propyzamide and its major degradates.  Levels of quantitation
should be below concentrations that result in potential risks.  If the
analytical method used in the most recently submitted terrestrial field
dissipation study (MRID 44078601) does not meet these criteria or a
newer, state-of-the-art method is available that meets these criteria, a
current environmental chemistry method and independent laboratory
validation are requested in lieu of the method used in support of the
terrestrial field dissipation study.

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

Risk assessment conclusions could be altered if they are not supported
by either study data or environmental monitoring detections that are
based on independently validated environmental chemistry methods.
Furthermore, while not directly related to Agency decision-making,
independently validated environmental chemistry methods are necessary to
ensure the safety of those in proximity to releases of propyzamide
residues in the environment.

Guideline Number: 835.6200

Study Title: Analytical Method (and Associated Independent Laboratory
Validation) for Residues in Water

Rationale for Requiring the Data

Independently validated analytical methods for residues in soil, water,
sediment, and plant material (environmental chemistry methods) submitted
by the registrant are used to evaluate analyses described in submitted
environmental fate and ecological effects studies.  Submitted analytical
methods are also used by various Federal, State, Tribal, and local
agencies to detect and monitor residues that are or are suspected to be
in environmental compartments due to outdoor uses and accidental
releases.  Independent laboratory validations for submitted analytical
methods are necessary to confirm that the methods are functional and to
confirm the levels of detection and quantitation reported in
registrant-prepared validations.

Use of propyzamide may impact surface water quality due to runoff of
rain water and drift of residues.  This is especially true for poorly
draining soils and soils with shallow ground water.  Propyzamide
residues have a high potential for reaching surface water via runoff for
several months after application.  Therefore, outside agencies may
request analytical methods with which to monitor for propyzamide
residues in water.

An environmental chemistry method in water was not submitted to the
Agency; however, the U.S. Geological Survey (USGS) National
Water-Quality Assessment (NAWQA) program has made available a
multi-residue analytical method for pesticides in water that includes
propyzamide (pronamide) as an analyte (USGS 1995).  Regardless, an
analytical method for the major degradates of propyzamide, RH-24644,
RH-24580, RH-24655, UK1, and RH-26059, is not available.  These major
degradates are residues of concern for which government agencies and the
public may wish to analyze. Therefore, an environmental chemistry method
in water that includes as analytes propyzamide, RH-24644, RH-24580,
RH-24655, UK1, and RH-26059 at an aggregate level of quantitation below
5 µg/L is requested as well as an ILV of the method.  Alternatively, a
multi-residue method may be identified if independent validation
indicates that it includes with acceptable recovery the analytes
propyzamide, RH-24644, RH-24580, RH-24655, UK1, and RH-26059 at an
aggregate level of quantitation below 5 µg/L.

Practical Utility of the Data

How will the data be used?

In the absence of independently validated environmental chemistry
methods, submitted environmental fate and ecological effects data may
not be reviewable and entities outside the Agency may lack
chemical-specific methods for analyses in environmental compartments.
Independently validated environmental chemistry methods will be used to
evaluate any newly submitted environmental fate and ecological effects
data and will be made available for enforcement and monitoring purposes
at the federal, state, and local levels.

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

Risk assessment conclusions could be altered if they are not supported
by either study data or environmental monitoring detections that are
based on independently validated environmental chemistry methods.
Furthermore, while not directly related to Agency decision-making,
independently validated environmental chemistry methods are necessary to
ensure the safety of those in proximity to releases of propyzamide
residues in the environment.

Guideline Number:  850.2300

Study Title:   Acute Oral Avian Toxicity (Passerines) and Mallard Duck
and/or Bobwhite Quail

Rationale for Requiring the Data

Acceptable avian acute oral toxicity testing is now required under 40
CFR Part 158 (CFR 40 2007) data requirements for conventional pesticides
(72 FR 60934; USEPA 2007c).  Avian acute oral toxicity data (OPPTS
Guideline 850.2100;   HYPERLINK
"http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/850_Ecologica
l_Effects_Test_Guidelines/Drafts/850-2100.pdf"
http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/850_Ecological
_Effects_Test_Guidelines/Drafts/850-2100.pdf ) must be submitted for
propyzamide to satisify the guideline requirement.  Although avian acute
oral toxicity data are available for upland game birds (Bobwhite quail),
the 158 Guidelines require testing of a passerine species as well.
Although toxicity data are available for Bobwhite quail on a formulated
product of propyzamide, no data are available on the technical grade
active ingredient; therefore,acute oral toxicity data on the Bobwhite
quail and/or mallard duck must be submitted on the technical grade
active ingredient as well.

Practical Utility of the Data

How will the data be used?

These data are necessary to characterize the potential risks to birds,
terrestrial-phase amphibians and reptiles associated with the use of
propyzamide.

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

If future endangered species risk assessments are performed without
these data, the Agency would have to assume that propyzamide
consistently affects passerine species and upland game birds on an acute
oral exposure basis.  Without data to the contrary, the Agency will
assume that acute risks to birds, terrestrial-phase amphibians and
reptiles are likely and “may affect” Federally-listed
threatened/endangered species.  The lack of these data will limit the
flexibility that the Agency and registrants have in coming into
compliance with the Endangered Species Act and could result in use
restrictions for propyzamide which are unnecessarily severe.  In
addition, the lack of these data may result in assumed risk and
potential mitigation of propyzamide under FIFRA.

Guideline Number:  850.2300

Study Title:   Avian Reproduction (Mallard Duck and Bobwhite Quail)

Rationale for Requiring the Data

Acceptable avian reproduction data for mallard ducks and bobwhite quail
are required under 40 CFR Part 158 (CFR 40 2007) data requirements for
conventional pesticides (72 FR 60934; USEPA 2007c).  Avian reproduction
toxicity data (OPPTS Guideline 850.2300;   HYPERLINK
"http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/850_Ecologica
l_Effects_Test_Guidelines/Drafts/850-2300.pdf"
http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/850_Ecological
_Effects_Test_Guidelines/Drafts/850-2300.pdf  ) must be submitted for
propyzamide to satisfy the guideline requirement.

Practical Utility of the Data

How will the data be used?

These data are necessary to characterize the potential risks to birds,
terrestrial-phase amphibians and reptiles associated with the use of
propyzamide.    These data will be used in the national-level risk
assessment to estimate the scope of sublethal effects and potential
chronic risks associated with the used of propyzamide.    In the absence
of the avian reproduction data, the Agency would rely on the acute to
chronic ratio for mammals to derive an estimated chronic toxicity
endpoint for birds.

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

If future endangered species risk assessments are performed without
these data, the Agency would have to assume that propyzamide
consistently affects bird reproduction.  Without data to the contrary,
the Agency will assume that chronic risks to birds, terrestrial-phase
amphibians and reptiles are likely and “may affect” Federally-listed
threatened/endangered species.  The lack of these data will limit the
flexibility that the Agency and registrants have in coming into
compliance with the Endangered Species Act and could result in use
restrictions for propyzamide which are unnecessarily severe.  In
addition, the lack of these data may result in assumed risk and
potential mitigation of propyzamide under FIFRA.

Guideline Number:  850.1075

Study Title:   Fish Acute Toxicity

Rationale for Requiring the Data

Freshwater fish acute toxicity testing is required under under 40 CFR
Part 158 (CFR 40 2007) data requirements for conventional pesticides (72
FR 60934; USEPA 2007c).  Freshwater fish acute toxicity data (OPPTS
Guideline 850.1075;   HYPERLINK
"http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/850_Ecologica
l_Effects_Test_Guidelines/Drafts/850-1075.pdf"
http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/850_Ecological
_Effects_Test_Guidelines/Drafts/850-1075.pdf ) using technical grade
active ingredient must be submitted for propyzamide to satisfy the
guideline requirement.

Practical Utility of the Data

How will the data be used?

These data are necessary to characterize the potential risks to
freshwater fish and aquatic-phase amphibians for which the fish serve as
surrogates.  These data will be used in the national-level risk
assessment to estimate the scope of sublethal effects and potential
acute risks to freshwater vertebrates associated with the used of
technical grade propyzamide.    In the absence of the acute freshwater
fish data, the Agency will have to presume risk.

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

Without data to the contrary, the Agency will assume that acute risks to
fish and aquatic-phase amphibians are likely and “may affect”
Federally-listed threatened/endangered species.  The lack of these data
will limit the flexibility that the Agency and registrants have in
coming into compliance with the Endangered Species Act and could result
in use restrictions for propyzamide which are unnecessarily severe.  In
addition, the lack of these data may result in assumed risk and
potential mitigation of propyzamide under FIFRA.

Guideline Number:  850.1500

Study Title:   Fish Full Lifecycle

Rationale for Requiring the Data

A fish full lifecycle study is conditionally required under under 40 CFR
Part 158 (CFR 40 2007) data requirements for conventional pesticides (72
FR 60934; USEPA 2007c) if the compound is expected to be transported to
water from the intended use site and when studies in other organisms
indicate that the reproductive physiology of fish may be affected.  Fish
full lifecycle toxicity data (OPPTS Guideline 850.1500;   HYPERLINK
"http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/850_Ecologica
l_Effects_Test_Guidelines/Drafts/850-1500.pdf"
http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/850_Ecological
_Effects_Test_Guidelines/Drafts/850-1500.pdf  ) must be submitted for
propyzamide to satisfy the guideline requirement.

Practical Utility of the Data

How will the data be used?

These data are necessary to characterize the potential risks to
freshwater fish and aquatic-phase amphibians for which the fish serve as
surrogates.  Given the persistence of this compound and its capacity to
move to aquatic environments, it is likely that freshwater fish will be
exposed to the compound.  These data will be used in the national-level
risk assessment to estimate the scope of sublethal effects and potential
chronic risks to freshwater vertebrates associated with the used of
propyzamide.    In the absence of the freshwater fish lifecycle data,
the Agency will presume chronic risk to freshwater fish.

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

Without data to the contrary, the Agency will assume that chronic risks
to fish and aquatic-phase amphibians are likely and “may affect”
Federally-listed threatened/endangered species.  The lack of these data
will limit the flexibility that the Agency and registrants have in
coming into compliance with the Endangered Species Act and could result
in use restrictions for propyzamide which are unnecessarily severe.  In
addition, the lack of these data may result in assumed risk and
potential mitigation of propyzamide under FIFRA.

Guideline Number:  850.1035

Study Title:   Estuarine/marine Invertebrate Acute Toxicity Test

Rationale for Requiring the Data

An acceptable acute estuarine/marine invertebrate toxicity test with
mysid shrimp is required under 40 CFR Part 158 (CFR 40 2007) data
requirements for conventional pesticides (72 FR 60934; USEPA 2007c).
The acute toxicity test with mysid shrimp (Americamysis bahia) (OPPTS
Guideline 850.1035;   HYPERLINK
"http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/850_Ecologica
l_Effects_Test_Guidelines/Drafts/850-1035.pdf"
http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/850_Ecological
_Effects_Test_Guidelines/Drafts/850-1035.pdf  ) must be submitted for
propyzamide to satisfy the guideline requirement.  These data are
important toward determining whether propyzamide can potentially affect
estuarine/marine invertebrates (crustaceans).  While a study of mysids
was submitted previously, the study failed to establish a definitive
LC50 and exposure was not properly documented in the study.

Practical Utility of the Data

How will the data be used?

These data are necessary to characterize the potential direct effects of
propyzamide to estuarine/marine invertebrates. The data from the study
will be used to address the uncertainty regarding potential effects to
estuarine/marine crustaceans and will in turn be used to estimate
potential risks to the estuarine/marine invertebrate community. If a
definitive toxicity endpoint is not available, the LC50 will be assumed
to be the maximum concentration tested.

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

The absence of these toxicity data will represent a major uncertainty
regarding the potential effect of propyzamide on estuarine/marine
crustaceans.  In the absence of data, the Agency will presume risk to
this taxon.  The lack of these data will limit the flexibility that the
Agency and registrants have in coming into compliance with the
Endangered Species Act and could result in use restrictions for
propyzamide which are unnecessarily severe.  In addition, the lack of
these data may result in assumed risk and potential mitigation of
propyzamide under FIFRA.

Guideline Number:  850.1735

Study Title:   Whole Sediment Acute Toxicity Invertebrates, Freshwater

Rationale for Requiring the Data

An acceptable acute estuarine/marine invertebrate toxicity test with
mysid shrimp is required under 40 CFR Part 158 (CFR 40 2007) data
requirements for conventional pesticides (72 FR 60934; USEPA 2007c).
The whole sediment acute toxicity test with freshwater invertebrate
(OPPTS Guideline 850.1735;
http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/850_Ecological
_Effects_Test_Guidelines/Drafts/850-1735.pdf) must be submitted for
propyzamide to satisfy the guideline requirement.  These data are
important toward determining whether propyzamide can potentially affect
benthic invertebrates.

Practical Utility of the Data

How will the data be used?

These data are necessary to characterize the potential direct effects of
propyzamide to benthic invertebrates given the propensity of propyzamide
to partition to sediments under certain environmental conditions. The
data from the study will be used to address the uncertainty regarding
potential effects to freshwater invertebrates and will in turn be used
to estimate potential risks to the freshwater invertebrate community.

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

The absence of these toxicity data will represent an uncertainty
regarding the potential effect of propyzamide on freshwater
invertebrates.  In the absence of data, the Agency will presume risk to
benthic invertebrates.  The lack of these data will limit the
flexibility that the Agency and registrants have in coming into
compliance with the Endangered Species Act and could result in use
restrictions for propyzamide which are unnecessarily severe.  In
addition, the lack of these data may result in assumed risk and
potential mitigation of propyzamide under FIFRA.

Page   PAGE  19  of   NUMPAGES  58

Page   PAGE  24  of   NUMPAGES  58

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