Document ID: EPA-HQ-OPP-2007-0461-0009
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-01-16T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

Chemical Code: 036602

DP Barcode: 328531, 337542, 338102

MEMORANDUM	July 30, 2007

SUBJECT:	EFED risk assessment for the registration of the new chemical
Mandipropamid

TO:		Tony Kish, Risk Manager

Registration Division (7505P)

FROM:	Fred Jenkins, MS, Biologist

Ibrahim Abdel-Saheb, Ph.D., Environmental Scientist

Ron Dean, MS, Biologist

Environmental Risk Branch II

Environmental Fate and Effects Division

THROUGH:	Dana Spatz, Branch Chief (acting)

Environmental Risk Branch II

Environmental Fate and Effects Division (7507P)

EFED has completed the screening level ecological risk assessment for
the registration of the new chemical, mandipropamid.  The risk
assessment has been conducted in accordance with the Agency’s
Guidelines for Ecological Risk Assessment, and is in compliance with the
paper titled “Overview of the Ecological Risk Assessment Process in
the Office of Pesticide Programs, U.S. Environmental Protection
Agency” (“Overview Document”) (January 2004).

Risks Conclusions

Based on the available data, EFED has determined that mandipropamid’s
proposed uses are not expected to pose significant:

acute or chronic risk to birds

acute or chronic risk to mammals

acute risk to aquatic invertebrates

chronic risk to fish

acute risk to terrestrial or aquatic plants

EFED is unable to access the acute risk of mandipropamid to fish and
mammals, and the chronic risks to aquatic invertebrates because all the
fish acute toxicity data are deemed invalid, the mammal acute toxicity
data were not submitted, and the chronic aquatic invertebrate toxicity
data are deemed invalid.

Recommended Label Statements

Based on the use pattern of mandipropamide EFED recommends that the
following statement be applied to the mandipropamide end-use product
label.

Recommended Label Statements:

“This product may contaminate water through drift of spray in wind. 
This product has “a potential for runoff” for “several months or
more after application.” Poorly draining soils and soils with shallow
water tables are more prone to produce runoff that contains this
product.  A level, well maintained vegetative buffer strip between areas
to which this product is applied and surface water features such as
ponds, streams, and springs will reduce the potential for contamination
of water from rainfall-runoff.  Runoff of this product will be reduced
by avoiding applications when rainfall is forecasted to occur within 48
hours.”

“Do not apply directly to water, or to areas where surface water is
present or to intertidal areas below the mean high water mark.  Do not
contaminate water when disposing of equipment washwater or rinsate."

Uncertainties and Data Gaps

The following provides a summary of the data gaps in this assessment.

Assessment Data Gaps:

Fish acute toxicity:  All data submitted are invalid.  The studies were
invalidated because the dissolved mandipropamid concentration was not
determined (test solutions contained undissolved particulate test
material and the measured concentrations were significantly unstable
throughout the testing). Therefore, it is not possible to obtain
accurate toxicity endpoint values that could be used for risk assessment
purposes.

	Invertebrate chronic toxicity:   The submitted study is invalid because
reproduction of the daphnids in the solvent control was significantly
lower than in the negative control.

Risk Mitigation Options

Since this screening level risk assessment has demonstrated that the
proposed use of mandipropamid is not expected to pose any significant
risks above the Agency’s Level of Concern (LOC), EFED does not
currently believe that any additional risk mitigation measures are
needed.

Table of Contents  TOC \h \z \t "EFED Hdg 2,2,EFED Hdg 1,1,EFED Hdg
3,3,EFED Hdg 4,4,EFED Hdg 5,5"  	

  HYPERLINK \l "_Toc159897315"  I.	EXECUTIVE SUMMARY	  PAGEREF
_Toc159897315 \h  7  

  HYPERLINK \l "_Toc159897316"  A.	Nature of Chemical Stressor	  PAGEREF
_Toc159897316 \h  7  

  HYPERLINK \l "_Toc159897317"  B.	Potential Risks to Non-Target
Organisms	  PAGEREF _Toc159897317 \h  7  

  HYPERLINK \l "_Toc159897318"  C.	Conclusions – Exposure
Characterization	  PAGEREF _Toc159897318 \h  8  

  HYPERLINK \l "_Toc159897319"  D.	Conclusions – Effects
Characterization	  PAGEREF _Toc159897319 \h  8  

  HYPERLINK \l "_Toc159897323"  E.	Uncertainties and Data Gaps	  PAGEREF
_Toc159897323 \h  9  

  HYPERLINK \l "_Toc159897324"  II.	PROBLEM FORMULATION	  PAGEREF
_Toc159897324 \h  11  

  HYPERLINK \l "_Toc159897325"  A.	Stressor Source and Distribution	 
PAGEREF _Toc159897325 \h  11  

  HYPERLINK \l "_Toc159897326"  1.	Source and Intensity…….	  PAGEREF
_Toc159897326 \h  11  

  HYPERLINK \l "_Toc159897327"  2.	Physical/Chemical/Fate and Transport
Properties	  PAGEREF _Toc159897327 \h  11  

  HYPERLINK \l "_Toc159897328"  3.	Pesticide Type, Class, and Mode of
Action	  PAGEREF _Toc159897328 \h  14  

  HYPERLINK \l "_Toc159897329"  4.	Overview of Pesticide Usage	  PAGEREF
_Toc159897329 \h  14  

  HYPERLINK \l "_Toc159897330"  B.	Receptors	  PAGEREF _Toc159897330 \h 
14  

  HYPERLINK \l "_Toc159897331"  1.	Aquatic Effects………….	 
PAGEREF _Toc159897331 \h  15  

  HYPERLINK \l "_Toc159897332"  2.	Terrestrial Effects……….	 
PAGEREF _Toc159897332 \h  16  

  HYPERLINK \l "_Toc159897333"  3.	Ecosystems at Risk………	  PAGEREF
_Toc159897333 \h  16  

  HYPERLINK \l "_Toc159897334"  C.	Assessment Endpoints	  PAGEREF
_Toc159897334 \h  19  

  HYPERLINK \l "_Toc159897335"  D.	Conceptual Model	  PAGEREF
_Toc159897335 \h  19  

  HYPERLINK \l "_Toc159897336"  1.	Risk Hypotheses…………	  PAGEREF
_Toc159897336 \h  20  

  HYPERLINK \l "_Toc159897337"  2.	Diagram………………….	 
PAGEREF _Toc159897337 \h  20  

  HYPERLINK \l "_Toc159897338"  E.	Analysis Plan	  PAGEREF _Toc159897338
\h  21  

  HYPERLINK \l "_Toc159897339"  1.	Preliminary Identification of Data
Gaps and Methods	  PAGEREF _Toc159897339 \h  21  

  HYPERLINK \l "_Toc159897340"  2.	Measures to Evaluate Risk Hypotheses
and Conceptual Model	  PAGEREF _Toc159897340 \h  21  

  HYPERLINK \l "_Toc159897341"  a.	Measures of Exposure	  PAGEREF
_Toc159897341 \h  21  

  HYPERLINK \l "_Toc159897342"  b.	Measures of Effect	  PAGEREF
_Toc159897342 \h  22  

  HYPERLINK \l "_Toc159897343"  c.	Measures of Ecosystem and Receptor
Characteristics	  PAGEREF _Toc159897343 \h  22  

  HYPERLINK \l "_Toc159897344"  III.	ANALYSIS	  PAGEREF _Toc159897344 \h
 24  

  HYPERLINK \l "_Toc159897345"  A.	Use Characterization	  PAGEREF
_Toc159897345 \h  24  

  HYPERLINK \l "_Toc159897346"  B.	Exposure Characterization	  PAGEREF
_Toc159897346 \h  25  

  HYPERLINK \l "_Toc159897347"  1.	Environmental Fate and Transport
Characterization	  PAGEREF _Toc159897347 \h  25  

  HYPERLINK \l "_Toc159897348"  a.	Summary of Empirical Data	  PAGEREF
_Toc159897348 \h  25  

  HYPERLINK \l "_Toc159897349"  b.	Degradation and Metabolism	  PAGEREF
_Toc159897349 \h  26  

  HYPERLINK \l "_Toc159897350"  c. 	Transport and Mobility	  PAGEREF
_Toc159897350 \h  26  

  HYPERLINK \l "_Toc159897351"  d.	Field Studies	  PAGEREF _Toc159897351
\h  27  

  HYPERLINK \l "_Toc159897352"  2.	Measures of Exposure……	  PAGEREF
_Toc159897352 \h  27  

  HYPERLINK \l "_Toc159897353"  a.	Aquatic Exposure Modeling	  PAGEREF
_Toc159897353 \h  27  

  HYPERLINK \l "_Toc159897354"  b.	Aquatic Exposure Monitoring and Field
Data	  PAGEREF _Toc159897354 \h  28  

  HYPERLINK \l "_Toc159897355"  3.	Measures of Terrestrial Exposures	 
PAGEREF _Toc159897355 \h  28  

  HYPERLINK \l "_Toc159897356"  a.	Terrestrial Exposure Modeling	 
PAGEREF _Toc159897356 \h  28  

  HYPERLINK \l "_Toc159897357"  b.	Terrestrial Residue Studies	  PAGEREF
_Toc159897357 \h  32  

  HYPERLINK \l "_Toc159897358"  C.	Ecological Effects Characterization	 
PAGEREF _Toc159897358 \h  32  

  HYPERLINK \l "_Toc159897359"  1.	Aquatic Effects Characterization	 
PAGEREF _Toc159897359 \h  32  

  HYPERLINK \l "_Toc159897360"  a.	Aquatic Animals	  PAGEREF
_Toc159897360 \h  36  

  HYPERLINK \l "_Toc159897361"  (1).	Acute Effects	  PAGEREF
_Toc159897361 \h  36  

  HYPERLINK \l "_Toc159897362"  (2).	Chronic Effects	  PAGEREF
_Toc159897362 \h  37  

  HYPERLINK \l "_Toc159897363"  (3).	Sublethal Effects	  PAGEREF
_Toc159897363 \h  39  

  HYPERLINK \l "_Toc159897364"  (4).	Field Studies	  PAGEREF
_Toc159897364 \h  39  

  HYPERLINK \l "_Toc159897365"  b.	Plants Inhabiting Aquatic Areas	 
PAGEREF _Toc159897365 \h  39  

  HYPERLINK \l "_Toc159897366"  2.	Terrestrial Effects Characterization	
 PAGEREF _Toc159897366 \h  40  

  HYPERLINK \l "_Toc159897367"  a.	Terrestrial Animals	  PAGEREF
_Toc159897367 \h  43  

  HYPERLINK \l "_Toc159897368"  (1).	Acute Effects	  PAGEREF
_Toc159897368 \h  43  

  HYPERLINK \l "_Toc159897369"  (2).	Chronic Effects	  PAGEREF
_Toc159897369 \h  44  

  HYPERLINK \l "_Toc159897370"  (3).	Sublethal Effects	  PAGEREF
_Toc159897370 \h  45  

  HYPERLINK \l "_Toc159897371"  (4).	Field Studies	  PAGEREF
_Toc159897371 \h  46  

  HYPERLINK \l "_Toc159897372"  b.	Terrestrial Plants	  PAGEREF
_Toc159897372 \h  46  

  HYPERLINK \l "_Toc159897374"  IV.	RISK CHARACTERIZATION	  PAGEREF
_Toc159897374 \h  48  

  HYPERLINK \l "_Toc159897375"  A.	Risk Estimation – Integration of
Exposure and Effects Data	  PAGEREF _Toc159897375 \h  48  

  HYPERLINK \l "_Toc159897376"  1.	 Non-Target Aquatic Animals and
Plants	  PAGEREF _Toc159897376 \h  48  

  HYPERLINK \l "_Toc159897377"  a.	Acute Risk to Aquatic Animals	 
PAGEREF _Toc159897377 \h  48  

  HYPERLINK \l "_Toc159897378"  b.	Chronic Risk to Aquatic Animals	 
PAGEREF _Toc159897378 \h  49  

  HYPERLINK \l "_Toc159897379"  c.	Risks to Aquatic Plants	  PAGEREF
_Toc159897379 \h  50  

  HYPERLINK \l "_Toc159897380"  2.	 Non-Target Terrestrial Animals	 
PAGEREF _Toc159897380 \h  50  

  HYPERLINK \l "_Toc159897381"  a.	Acute Risk to Mammals and Birds	 
PAGEREF _Toc159897381 \h  50  

  HYPERLINK \l "_Toc159897382"  b.	Chronic Risk to Birds and Mammals	 
PAGEREF _Toc159897382 \h  50  

  HYPERLINK \l "_Toc159897383"  c.	Risk to Terrestrial Invertebrates	 
PAGEREF _Toc159897383 \h  51  

  HYPERLINK \l "_Toc159897384"  3.	Non-target Plants Inhabiting
Terrestrial and Semi-Aquatic Areas	  PAGEREF _Toc159897384 \h  51  

  HYPERLINK \l "_Toc159897385"  B.	Risk Description	  PAGEREF
_Toc159897385 \h  52  

  HYPERLINK \l "_Toc159897386"  1.	Risks to Aquatic Organisms	  PAGEREF
_Toc159897386 \h  52  

  HYPERLINK \l "_Toc159897390"  2.	Risks to Terrestrial Organisms	 
PAGEREF _Toc159897390 \h  52  

  HYPERLINK \l "_Toc159897391"  a.	Terrestrial Animals (Mammals and
Birds)	  PAGEREF _Toc159897391 \h  52  

  HYPERLINK \l "_Toc159897392"  b.	Insects	  PAGEREF _Toc159897392 \h 
53  

  HYPERLINK \l "_Toc159897393"  c.	Plants	  PAGEREF _Toc159897393 \h  53
 

  HYPERLINK \l "_Toc159897394"  3.	Review of Incident Data…	  PAGEREF
_Toc159897394 \h  53  

  HYPERLINK \l "_Toc159897395"  4.	Endocrine Effects……….	  PAGEREF
_Toc159897395 \h  53  

  HYPERLINK \l "_Toc159897396"  C. 	Federally Threatened and Endangered
(Listed) Species Concerns	  PAGEREF _Toc159897396 \h  54  

  HYPERLINK \l "_Toc159897397"  1. 	Action Area………………	 
PAGEREF _Toc159897397 \h  54  

  HYPERLINK \l "_Toc159897398"  2. 	Taxonomic Groups Potentially at Risk
  PAGEREF _Toc159897398 \h  54  

  HYPERLINK \l "_Toc159897404"  3.	 Probit Dose Response Relationship	 
PAGEREF _Toc159897404 \h  55  

  HYPERLINK \l "_Toc159897405"  4.	 Indirect Effects Analysis.	  PAGEREF
_Toc159897405 \h  55  

  HYPERLINK \l "_Toc159897406"  5. 	Critical Habitat…………..	 
PAGEREF _Toc159897406 \h  55  

  HYPERLINK \l "_Toc159897407"  D.	Description of Assumptions,
Limitations, Uncertainties, Strengths and Data Gaps	  PAGEREF
_Toc159897407 \h  56  

  HYPERLINK \l "_Toc159897408"  1. 	Assumptions, Limitations,
Uncertainties, Strengths and Data Gaps Related to Exposure for All
Taxa…………………..	  PAGEREF _Toc159897408 \h  56  

  HYPERLINK \l "_Toc159897409"  2. 	Assumptions, Limitations,
Uncertainties, Strengths and Data Gaps Related to Exposure for Aquatic
Species……………	  PAGEREF _Toc159897409 \h  56  

  HYPERLINK \l "_Toc159897410"  a.	GENEEC Standard Runoff Model	 
PAGEREF _Toc159897410 \h  56  

  HYPERLINK \l "_Toc159897411"  3. 	Assumptions, Limitations,
Uncertainties, Strengths and Data Gaps Related to Exposure for
Terrestrial Species…………	  PAGEREF _Toc159897411 \h  57  

  HYPERLINK \l "_Toc159897412"  a.	Residue Concentration	  PAGEREF
_Toc159897412 \h  57  

  HYPERLINK \l "_Toc159897413"  b.	Variation in Habitat and Dietary
Requirements	  PAGEREF _Toc159897413 \h  57  

  HYPERLINK \l "_Toc159897414"  c.	Variation in Diet Composition	 
PAGEREF _Toc159897414 \h  57  

  HYPERLINK \l "_Toc159897415"  d.	Exposure Routes Other than Dietary	 
PAGEREF _Toc159897415 \h  58  

  HYPERLINK \l "_Toc159897416"  e.	Incidental Soil Ingestion Exposure	 
PAGEREF _Toc159897416 \h  58  

  HYPERLINK \l "_Toc159897417"  f.	Inhalation Exposure	  PAGEREF
_Toc159897417 \h  58  

  HYPERLINK \l "_Toc159897418"  g.	Dermal Exposure	  PAGEREF
_Toc159897418 \h  58  

  HYPERLINK \l "_Toc159897419"  h.	Drinking Water Exposure	6 7

  HYPERLINK \l "_Toc159897420"  i.	Dietary Intake – Differences
Between Laboratory and Field Conditions	  PAGEREF _Toc159897420 \h  59  

  HYPERLINK \l "_Toc159897421"  4. 	Assumptions, Limitations,
Uncertainties, Strengths and Data Gaps Related to Effects
Assessment…………………….	  PAGEREF _Toc159897421 \h  60  

  HYPERLINK \l "_Toc159897422"  a.	Age Class and Sensitivity of Effects
Thresholds	  PAGEREF _Toc159897422 \h  60  

  HYPERLINK \l "_Toc159897423"  b.	Use of the Most Sensitive Species
Tested	  PAGEREF _Toc159897423 \h  61  

  HYPERLINK \l "_Toc159897424"  V.	REFERENCES	  PAGEREF _Toc159897424 \h
 62  

 

I.	EXECUTIVE SUMMARY

A.	Nature of Chemical Stressor

Mandipropamid is a new fungicide intended for the control of foliar
oomycete pathogens in a range of crops.  Mandipropamid’s mode of
action is as a preventive foliar fungicide that is effective at
inhibiting spore germination, mycelial growth and sporulation. 
Mandipropamid is absorbed to the plant wax layer, providing resistance
to rainwater wash-off.  Once mandipropamid is taken up by the plant
tissue, translaminar mobility provides protection of the opposition leaf
surface.

In accordance with the registrant submitted label, the proposed maximum
use rate for all crops is four applications of 0.13 lbs a.i./acre with
7-10 days between each application. Mandipropamid is formulated as a
suspension concentrate that requires the use of an external adjuvant
(such as a non-ionic surfactant, crop oil concentrate, silicone based,
or blend methylated or ethylated seed oil) to enhance fungicidal
activity.

Potential Risks to Non-Target Organisms

Based on the available data, EFED has determined that mandipropamid’s
proposed uses are not expected to pose significant:

acute or chronic risk to birds

acute or chronic risk to mammals

acute risk to aquatic invertebrates

chronic risk to fish

acute risk to terrestrial or aquatic plants

EFED is unable to access the acute risk of mandipropamid to fish and the
chronic risks to aquatic invertebrates because all the fish acute
toxicity data are deemed invalid and the chronic aquatic invertebrate
toxicity data are deemed invalid as well.

Table 1 summarizes the conclusions of this assessment in regards to
endangered species.

Table 1.  Summary of Screening Level Risk Assessment Findings in Regards
to Direct and Indirect Effects of Mandipropamid to Federally Listed
Species.  TC "Table IB-1.  Listed species risks associated with direct
or indirect effects due to applications of propazine on sorghum" \f C \l
"1"  

Listed Taxon	Direct Effects	Indirect Effects

Terrestrial and semi-aquatic plants - monocots	No	No

Terrestrial and semi-aquatic plants - dicots	No	No

Terrestrial invertebrates	No	No

Birds	No	No

Terrestrial-phase amphibians	No	No

Reptiles	No	No

Mammals	No

	Aquatic non-vascular plants	No	No

Aquatic vascular plants	No	No

Freshwater fish	No data	No

Aquatic-phase amphibians	No	No

Freshwater crustaceans	No	No

Mollusks	No	No

Marine/estuarine fish	No	No

Marine/estuarine crustaceans	No	No

C.	Conclusions – Exposure Characterization

Aquatic and terrestrial species may be exposed to mandipropamid through
its proposed agricultural uses. tc "C.  Conclusions - Exposure
Characterization  " \l 2   Mandipropamid is considered to be persistent
in the environment.  Mandipropamid appears to be stable to hydrolysis at
environmental pH (pH range 5–9) but susceptible to photolysis in soil
and water.  Based on its vapor pressure and Henry’s Law constant,
volatilization from water and soil are not expected to be important
environmental fate processes. Mandipropamid is moderately mobile in soil
and has the potential to leach into ground water. The stressors of
concern are the parent chemical, mandipropamid, and its’ degradates
SYN500003 and SYN504851 both of which were identified by the Human
Health Effects Division (HED) as toxic degradates of concern.

Conclusions – Effects Characterization

Fish Acute Toxicity

No acceptable fish acute toxicity data are available.  The studies
submitted are invalid (See Appendix E for further details).

Fish Chronic Toxicity

The registrant submitted a freshwater fish chronic toxicity study that
demonstrates chronic exposure to technical mandipropamid causes
significant decreases to fish growth at a NOAEC and LOAEC concentration
of 0.21 ppm and 0.45 ppm respectively (See Appendix E for further
details).

Aquatic Invertebrate Toxicity

The registrant submitted aquatic invertebrate acute toxicity studies
demonstrate that technical mandipropamid is moderately toxic to
freshwater invertebrates and very highly to moderately toxic
marine/estuarine invertebrates (See Appendix E for further details).

Aquatic Invertebrate Chronic Toxicity

The registrant submitted aquatic invertebrate chronic toxicity data are
invalid (See Appendix E for further details).

Plant Toxicity

i. Terrestrial Plants tc \l3 "Terrestrial Plants 

The registrant submitted a vegetative vigor terrestrial plant toxicity
study and a seedling emergence terrestrial plant toxicity study.  Both
studies demonstrate that the measured endpoints did not reach the EC25
toxicity level in any of species tested with the exception of the carrot
species, which rendered unreliable results in the seedling emergence
study (See Appendix E for further details).  The monocot and dicot NOAEC
values for the seedling emergence studies are 0.660 lbs a.i./A and 0.165
lbs a.i./A respectively.  The monocot and dicot NOAEC values for the
vegetative vigor studies are 0.198 lbs a.i./A and 0.792 lbs a.i./A
respectively.

ii. Aquatic Plant Toxicity

The registrant has submitted a nonvascular aquatic plant toxicity study
testing the effect of mandipropamid on the green alga,
Pseudokirchneriella subcapitata (MRID 468001-21) and a vascular aquatic
plant toxicity study testing the effect of mandipropamid on Lemna gibba
(MRID 468001-19).  The green algal study demonstrates an EC50 > 2.5 ppm
a.i. for all endpoints measured and a NOAEC of 1.3 ppm based on biomass.
 The Lemna gibba study demonstrates an EC50 > 7.9 ppm a.i. for all
endpoints measured and a NOAEC of 1.3 based on growth rate. (See
Appendix E for further details).

Uncertainties and Data Gaps

The following provides a summary of the data gaps in this assessment.

Assessment Data Gaps:

Fish acute toxicity:  All data submitted are invalid.  The studies were
invalidated because the dissolved mandipropamid concentration was not
determined (test solutions contained undissolved particulate test
material and the measured concentrations were significantly unstable
throughout the testing). Therefore, it is not possible to obtain
accurate toxicity endpoint values that could be used for risk assessment
purposes.

Invertebrate chronic toxicity:   The submitted study is invalid because
reproduction of the solvent control daphnids was significantly lower
than that of negative control daphnids.II.	PROBLEM FORMULATION

A.	Stressor Source and Distribution

1.	Source and Intensity

Mandipropamid, a fungicide (proposed name RevusTM), is specifically
intended to control foliar oomycete pathogens in a range of crops. 
Mandipropamid is not currently registered for agricultural use in the
U.S.  This chemical is applied to crops via ground and aerial methods.
This assessment focuses on the proposed uses of mandipropamid on
brassica vegetables, bulb vegetables, cucurbits, fruiting vegetables,
grapes, leafy vegetables, potatoes, tomatoes, tuberous and corm
vegetables.

2.	Physical/Chemical/Fate and Transport Properties

  SEQ CHAPTER \h \r 1  Mandipropamid is considered to be persistent in
the environment.  The major route of dissipation is degradation under
aerobic aquatic conditions.  Mandipropamid degrades to several
intermediatery degradation products. The transformation products are
ultimately degraded to non-extractable residues and carbon dioxide. 
Mandipropamid is moderately mobile and some of its metabolites are
mobile to highly mobile in soils, and therefore have the potential to
leach into ground water.   Mandipropamid can reach surface waters via
spray drift and rainfall events that cause runoff.  The important
physical and chemical properties for mandipropamid are summarized in
Table 2 followed by its chemical structure (Figure 1).

  SEQ CHAPTER \h \r 1 Table 2. Chemical and Physical Properties for
Mandipropamid

CAS number	374726-62-2	MRID 46800009

SMILES notation	Clc1ccc(cc1)C(OCC#C)C(=O)NCCc1ccc(c(c1)OC)OCC#C

(ISIS v2.3/Universal SMILES).

C1=C(Cl)C=CC(C(OCC#C)C(=O)NCCC2=CC=C(OCC#C)C(OC)=C2)=C1 (  SEQ CHAPTER
\h \r 1 EPI Suite, v3.12 SMILES).

C1c(ccc(c1)C(C(NCCc1ccc(c(c1)OC)OCC#C)=O)OCC#C)C1	MRID 46800009

Molecular weight	411.9	MRID 46800009

Molecular formula	C23H22ClNO4	MRID 46800009

Vapor pressure	3.52 X 10-8 Torr	MRID 46800007&8

Solubility in water (pH 7, 20 oC)	2.3 ppm	MRID 46800009

Henry’s Law constant	8.293E-09 (atm.m3/mole)	Calculated from Vp,
Solubility, and M.wt

Log Kow	3.13	MRID 46800007&8

pKa	Not reported

	Hydrolysis half-life (days) for pH 5, 7, and 9	Stable at pH 5, 7, and 9
MRID 46800007&8

Aquatic photolysis half-life	0.63 -1.1 days	MRID# 46800009,10,13,14

Soil photolysis half-life	16.4 – 24 days	MRID 46800015,16,17

Aerobic soil metabolism half-life	72.2 days (sandy loam)

26.1days  (silt loam)

78 - 103 days (silt loam)

32.4 days (loan, silt loam)

51.3  days (sandy clay loam, )

90 days (loam)

83.5 (loamy sand)	MRID 46800020,21

MRID 46800022

MRID 46800024,25

MRID 46800027

MRID 46800028

Anaerobic soil metabolism half-life	151	MRID 46800022

Koc (adsorption)	782 (Loam/silt loam )

1294 (Loamy sand )

1067 (Silty clay loam )

1064 (Silt loam )

694 (sandy loam)

405 (loamy sand)

624 (loamy sand)	MRID 46800038,39

MRID 46800040,41

Aerobic aquatic metabolism half-life	17.7 days	MRID 46800030,31

Anaerobic aquatic metabolism half-life	No data available	Unacceptable
study (MRID 466800033,34)

Mandipropamid

SYN500003

SYN504851

Figure 1. Chemical Structures of Mandipropamid and its major degradates.

3.	Pesticide Type, Class, and Mode of Action

Mandipropamid belongs to the new mandelamide chemical class of
fungicides.  Mandipropamid’s mode of action is as a preventive foliar
fungicide that is effective at inhibiting spore germination, mycelial
growth and sporulation.  Mandipropamid is absorbed to the plant wax
layer, providing resistance to rainwater wash-off.  Once mandipropamid
is taken up by the plant tissue, translaminar mobility provides
protection of the opposition leaf surface.

4.	Overview of Pesticide Usage

The proposed label specifies that mandipropamid is a ground and aerially
applied fungicide formulated as a suspension concentrate that requires
the use of an external adjuvant.

The proposed label specifies that the maximum amount of mandipropamid
that may be used per growing season is 0.52 lbs a.i./acre which may be
divided into 4 applications of 0.13 lbs a.i./acre with a 7-day minimum
interval between each application.

Actual pesticide usage data are not available since this chemical is
currently not registered for use in the US.  Because this chemical is
proposed for use on field brassica vegetables, bulb vegetables,
cucurbits, fruiting vegetables, grapes, leafy vegetables, potatoes,
tomatoes, tuberous and corm vegetables, the current geographic
distribution of these crops is expected to be generally representative
of potential mandipropamid application areas.

B.	Receptors

Each assessment endpoint requires one or more measures of ecological
effect, which are defined as changes in the attributes of an assessment
endpoint itself or changes in a surrogate entity or attribute in
response to exposure to a pesticide.  Ecological measures of effect for
the screening level risk assessment are based on a suite of
registrant-submitted toxicity studies performed on a limited number of
organisms in broad groupings listed in Table 3.

Table 3. Taxonomic Groups and Test Species Evaluated for Ecological
Effects in Screening-Level Risk Assessments

Taxonomic Group	Example(s) of Representative Species

Birds a	Mallard duck (Anas platyrhynchos)

Bobwhite quail (Colinus virginianus)

Mammals	Laboratory rat (Rattus norvegicus)

Freshwater fish b	Bluegill sunfish (Lepomis macrochirus)

Rainbow trout (Oncorhynchus mykiss)

Freshwater invertebrates	Water flea (Daphnia magna)

Estuarine/marine fish	Sheepshead minnow (Cyprinodon variegatus)

Estuarine/marine invertebrates	Eastern oyster (Crassostrea virginica)

Mysid shrimp (Americamysis bahia)

Terrestrial plants	Monocot and dicot

Insects	Honeybee

Aquatic plants	Bluegreen alga

Green alga

Saltwater diatom

Duckweed (Lemna gibba)

a Birds are considered surrogates for amphibians (terrestrial phase) and
reptiles when no data are available.

b Freshwater fish may be surrogates for amphibians (aquatic phase) when
no data are available.

Within each of these very broad taxonomic groups, an acute and/or
chronic endpoint is selected from the available test data.  A complete
discussion of all toxicity data available for this risk assessment and
the resulting measures of effect selected for each taxonomic group are
included in Appendix E.

1.	Aquatic Effects

Direct application of mandipropamid to streams, lakes, and ponds is
prohibited by the product label.  Immediately following application, the
highest mandipropamid residue levels are expected to be located in
surface waters adjacent to treated agricultural fields due to spray
drift at the time of application and/or from runoff after a rain event. 
Mandipropamid may be transported off the field in runoff for several
months after application.  Exposure estimates for this screening level
risk assessment focuses on the total residues for aquatic concentrations
of the parent, mandipropamid, and its degradates of toxic concern
SYN500003 and SYN504851.  These degradates, which were identified in the
suite of environmental fate studies, are according to the Health Effects
Division, toxic degradates also found in residue studies. Fish,
amphibians, and aquatic invertebrates that live in aquatic environments
are potentially exposed to mandipropamid residues in surface water by
direct contact of their integument (covering of the body or a part such
as skin, gill membranes, cuticle, etc.) and via uptake through their
gills or integument.  Assessment endpoints were selected to assess
reduced survival, growth, and reproduction in these taxonomic groups
from combined direct contact with integument and uptake across the gill
or integument.  Because toxicity data for amphibians are rarely
available, fish were used as a surrogate to assess risks to
aquatic-stage amphibians (USEPA 2004).  Aquatic plants are also
potentially exposed by contact of their outer surface area with
mandipropamid residues in surface water or through sorption and uptake
through roots or across cell walls.

Aquatic animals may also be exposed to mandipropamid residues in
sediment or in their diet (i.e., detritus, aquatic plants, and/or prey).
Sediment residues of mandipropamid and its degradates may potentially
occur because of eroded soil in runoff depositing out to sediment and
from the chemicals partitioning to sediment from water.  Food chain
transfer has the potential to occur where higher trophic level organisms
feed on organisms that have taken up mandipropamid from surface water
through their gills or integument or on organisms or detrital matter
that have sorbed mandipropamid.  No studies have been submitted
regarding the potential for bioconcentration in aquatic organisms. 
Although the Koc values indicate that mandipropamid residues will
partition to sediment to some degree, the log Kow of 3.13 indicates that
bioconcentration should not be of particular concern.

Leaching (infiltration/percolation) may result in transport of
mandipropamid through the soil column into ground water which may, in
some circumstances, flow into a surface water body. The mobility of
mandipropamid in soil is considered moderate based on batch adsorption
experiments conducted in seven soils.

2.	Terrestrial Effects

The highest mandipropamid residue levels are expected to be located in
the surface soil and on foliage (e.g., short and tall grasses, broadleaf
weeds), seeds, and insects on the treated agriculture field immediately
following ground spraying. While spray drift may result in transport of
mandipropamid to off-target field surface soil, foliage, and insects,
the highest concentrations for these media are still expected to be
those in the treated field.  Birds, mammals, reptiles, and amphibians
that ingest foliage, insects, and/or soil invertebrates from either the
treated area or from spray drift impacted areas are potentially exposed
to mandipropamid residues in their diet. Endpoints will be included that
assess reduced survival, growth, and reproduction in these taxonomic
groups from dietary exposure.  Because toxicity data for reptiles and
terrestrial-phase amphibians are rarely available, risk assessment
results for birds will be used as surrogates to assess risks to reptiles
and terrestrial-phase amphibians (USEPA 2004).

Mandipropamid may reach off-field terrestrial or riparian/wetland
vegetation environments in spray drift at the time of application. 
Following a rain event, mandipropamid may also reach off-field
terrestrial or riparian/wetland vegetation environments in sheet and
channel flow runoff.

3.	Ecosystems at Risk

Ecosystems potentially at risk are expressed in terms of the selected
assessment endpoints (Table 4). The typical assessment endpoints for
screening-level pesticide ecological risks are reduced survival, and
reproductive and growth impairment for both aquatic and terrestrial
animal species. Aquatic animal species of potential concern include
freshwater fish and invertebrates, estuarine/marine fish and
invertebrates, and amphibians. Terrestrial animal species of potential
concern include birds, mammals, and beneficial insects. For both aquatic
and terrestrial animal species, direct acute and direct chronic
exposures are considered. In order to protect threatened and endangered
species, all assessment endpoints are measured at the individual level. 
Although endpoints are measured at the individual level, they provide
insight about risks at higher levels of biological organization (e.g.,
populations and communities). For example, pesticide effects on
individual survivorship have important implications for both population
rates of increase and habitat carrying capacity.

For terrestrial and semi-aquatic plants, the screening assessment
endpoint is the perpetuation of populations of non-target species (crops
and non-crop plant species).  Existing testing requirements have the
capacity to evaluate emergence of seedlings and vegetative vigor.
Although it is recognized that the endpoints of seedling emergence and
vegetative vigor may not address all terrestrial and semi-aquatic plant
life cycle components, it is assumed that impacts at emergence and in
active growth have the potential to impact individual competitive
ability and reproductive success.  For aquatic plants, the assessment
endpoint is the maintenance and growth of standing crop or biomass.
Measurements for this assessment endpoint focus on cell density, growth
rates, and biomass in non-vascular plants (i.e., freshwater algae) and
frond number, growth rate, and biomass in aquatic vascular plants
(duckweed).

The ecological relevance of selecting the above-mentioned assessment
endpoints is as follows: (1) complete exposure pathways exist for these
receptors; (2) the receptors may be potentially sensitive to pesticides
in affected media and in residues on plants, seeds, and insects; and (3)
the receptors could potentially inhabit areas where pesticides are
applied, or areas where runoff and/or spray drift may impact the sites
because suitable habitat is available.

Table 4. Summary of Assessment Endpoints and Measures of Effect in
Screening Level Risk Assessment

Assessment Endpoint	Measures of Effect

1. Abundance (i.e., survival, reproduction, and growth) of individuals
and populations of birds in close proximity to sites	1a. Mallard duck
(at least) acute oral LD50

1b. Mallard duck and bobwhite quail subacute 5-day dietary LC50

1c. Mallard duck (at least) reproduction NOAEL (e.g., number of eggs
laid, set, cracked, etc.)

2. Abundance (i.e., survival, reproduction, and growth) of individuals
and populations of mammals in close proximity to sites	2a. Laboratory
rat (at least) acute oral (single dose) LD50

2b. Laboratory rat (at least) chronic (reproductive) NOAEC or NOAEL

3. Survival and reproduction of individuals and communities of
freshwater fish and invertebrates in close proximity to sites	3a.
Rainbow trout and bluegill sunfish (at least) acute 96-hr LC50

3b. Rainbow trout or bluegill sunfish (preferred species tested that of
the more acutely sensitive species tested) chronic early life-stage or
life-cycle NOAEC (e.g., number hatched, time to hatch, mortality, growth
of young)

3c. Daphnia magna (at least) acute 48-hr EC50 (or 96-hr LC50 for other
invertebrates) where effect measured is surrogate for death

3d. Daphnia magna (at least) chronic reproductive NOAEC (e.g., number of
young produced, time to first brood release, parental survival, parental
growth)

4. Survival and reproduction of individuals and communities of
estuarine/marine fish and invertebrates in close proximity to sites	4a.
Atlantic silverside or sheepshead minnow (at least) acute 96-hr LC50

4b. Eastern oyster (at least) acute 96-hr EC50 where the effect measured
is shell deposition or embryo/larval fertilization, survival, and normal
shell development

4c. Pink shrimp or mysid shrimp (at least) acute 96-hr LC50 or EC50
where the effect measured is a surrogate for mortality

4d. Fish (prefer species that matches the most acutely sensitive fish
tested) early life stage or life cycle NOAEC (e.g., number hatched, time
to hatch, growth of young, overall survival)

4e. Mysid shrimp (at least) chronic NOAEC

5. Survival of beneficial insect populations in close proximity to sites
1. Honey bee acute contact LD50

6. Survival and growth of terrestrial plants in close proximity to sites
6a. Monocot and dicot seedling emergence EC25

6b. Monocot and dicot seedling emergence EC05 or NOAEC

6c. Monocot and dicot vegetative vigor EC25

6d. Monocot and dicot vegetative vigor EC05 or NOAEC

7. Standing crop or biomass and growth of aquatic plants in close
proximity to sites	7a. Green and blue-green alga (at least) EC50

7b. Freshwater and saltwater diatom and duckweed (at least duckweed)
acute EC50

7c. Green and blue-green algae, a freshwater and saltwater diatom and
duckweed (at least) EC05 or NOAEC

LD50 = Lethal dose to 50% of the test population.

LC50 = Lethal concentration to 50% of the test population.

EC50/EC25/EC05= Effect concentration to 50/25/5% of the test population.

IC25/IC05 = 25/5% Inhibitory concentration.

NOAEC = No observed adverse effect level.

LOAEC = Lowest observed adverse effect level.

C.	Assessment Endpoints

Assessment endpoints are defined as “explicit expressions of the
actual environmental value that is to be protected”. Defining an
assessment endpoint involves two steps: (1) identifying the valued
attributes of the environment that are considered to be at risk; and (2)
operationally defining the assessment endpoint in terms of an ecological
entity (i.e., a community of fish and aquatic invertebrates) and its
attributes (i.e., survival and reproduction). Therefore, selection of
the assessment endpoints is based on valued entities (i.e., ecological
receptors), the ecosystems potentially at risk, the migration pathways
of pesticides, and the routes by which ecological receptors are exposed
to pesticides. The selection of clearly defined assessment endpoints is
important because they provide direction and boundaries in the risk
assessment for addressing risk management issues of concern.

This ecological risk assessment considers maximum application rates of
mandipropamid to fields that have vulnerable soils, maximum number of
applications, and minimum intervals for uses on representative crops
grown on runoff prone soils to estimate exposure concentrations.  In
addition, this assessment is not intended to represent a site- or
time-specific analysis.  Instead, this assessment is intended to
represent high-end exposures at a national level. Likewise, the most
sensitive toxicity measures of effect are used from surrogate test
species to estimate treatment-related direct effects on acute mortality
and chronic reproductive, growth, and survival assessment endpoints.
Toxicity tests are intended to determine effects of mandipropamid
exposure on birds, mammals, fish, terrestrial and aquatic invertebrates,
and plants. These tests include short-term acute, subacute, and
reproductive studies and are typically arranged in a hierarchical or
tiered system that progresses from basic laboratory tests to applied
field studies. The toxicity studies are used to evaluate the potential
of mandipropamid to cause adverse effects, to determine whether further
testing is required, and to determine the need for precautionary label
statements to minimize the potential adverse effects to non-target
animals and plants (CFR 40 §158.202, 2002a). A summary of measures of
effects selected to characterize potential ecological risks associated
with exposure to mandipropamid is provided in Table 4.

D.	Conceptual Model

In order for a chemical to pose an ecological risk, it must reach
ecological receptors in biologically significant concentrations.  An
exposure pathway is the means by which a contaminant moves in the
environment from a source to an ecological receptor. For an ecological
exposure pathway to be complete, it must have a source, a release
mechanism, an environmental transport medium, a point of exposure for
ecological receptors, and a feasible route of exposure. In addition, the
potential mechanisms of transformation (i.e., which degradates may form
in the environment, in which media, and how much) must be known,
especially for a chemical whose metabolites/degradates are of greater
toxicological concern. In this assessment the parent, mandipropamid, and
its degradates of toxic concern, SYN500003 and SYN504851 (as identified
by HED) are quantitatively assessed together as total residues of
mandipropamid.  The assessment of ecological exposure pathways includes
an examination of the source and potential migration pathways for
constituents, and the determination of potential exposure routes (e.g.,
ingestion, inhalation, and dermal absorption).

1.	Risk Hypotheses

  SEQ CHAPTER \h \r 1 Risk hypotheses are specific assumptions about
potential adverse effects (i.e., changes in assessment endpoints) and
may be based on theory and logic, empirical data, mathematical models,
or probability models (USEPA 2004). For this assessment, the risk is
stressor-initiated, where the stressor is the release of mandipropamid
to the environment. The following risk hypothesis is presumed for this
screening level assessment:

The use of mandipropamid as an fungicide in agricultural settings on
field brassica vegetables, bulb vegetables, cucurbits, fruiting
vegetables, grapes, leafy vegetables, potatoes, tomatoes, tuberous and
corm vegetables involves situations where terrestrial and/or aquatic
animals and plants may be exposed to the chemical. Based on information
on persistence, mode of action, direct toxicity and potential indirect
effects to trophic food webs, EFED assumes that mandipropamid together
with its degradates of concern, SYN500003 and SYN504851 have the
potential to cause reduced survival and reproductive impairment to
terrestrial and aquatic animals and plants.

2.	Diagram

The source and mechanisms of release of mandipropamid are ground and
aerial application to agricultural crops.  The conceptual model and
subsequent analysis of exposure and effects are all based on
mandipropamid and its degradates of concern, SYN500003 and SYN504851. 
Surface water runoff from the areas of application is assumed to follow
topography.  Additional release mechanisms include spray drift and wind
erosion, which may potentially transport contaminants into the air. 
Potential emission of volatile compounds is not considered as a viable
release mechanism for mandipropamid, because vapor pressure information
suggests that volatilization is not expected to be a significant route
of dissipation. The conceptual model shown in Figure 2 depicts the
potential source, release mechanisms, abiotic receiving media, and
biological receptor types.

Figure 2. Conceptual Model Depicting Ecological Risk Based on the
Proposed Mandipropamid Application

 

E.	Analysis Plan

1.	Preliminary Identification of Data Gaps and Methods

Based on EFED’s review of the currently available data, the identified
data gaps are as follows:

acceptable fish acute toxicity data (current studies are invalid)

acceptable invertebrate chronic toxicity data (current studies are
invalid)

2.	Measures to Evaluate Risk Hypotheses and Conceptual Model

a.	Measures of Exposure

The proposed uses for mandipropamid are for brassica vegetables, bulb
vegetables, cucurbits, fruiting vegetables, grapes, leafy vegetables,
potatoes, tomatoes, tuberous and corm vegetables.  Since mandipropamid
is currently not registered for use on these crops, no statistics exist
regarding the amount of mandipropamid that has been applied to these
crops in the past.  However, the present geographic distribution for
these proposed site uses are expected to generally represent potential
mandipropamid application areas.

For agricultural uses, exposure concentrations for aquatic ecosystem
assessments will be estimated based on EFED’s aquatic Tier I model
GENEEC.  Among the major degradates identified in various fate studies
(CGA380778, NOA458422, CGA380775, SYN500003, SYN536638, and SYN504851),
only SYN500003 and SYN504851 were identified by the Office of Pesticides
Programs Human Health Effects Division (HED) to be of toxic concern.
There are no available ecotoxicity data for these two degradates.  This
assessment will assume that these degradates have similar toxicity as
the parent. Total residue data were used in EFED’s aquatic Tier I
model GENEEC.

Residues in potential dietary sources (e.g., vegetation and insects) for
mammals and birds will be estimated using the Tier I model T-REX Version
1.3.1 (USEPA 2006a). This model provides estimates of concentrations
(maximum, or upper bound, and average) of chemical residues on the
surfaces of different types of foliage that may be sources of dietary
exposure to avian, mammalian, reptilian, or terrestrial-phase amphibian
receptors. The surface residue concentration (ppm) is estimated by
multiplying the application rate (pounds active ingredient per acre) by
a value specific to each food item.    SEQ CHAPTER \h \r 1 For both
mammals and birds, three animal body weight classes are considered. The
T-REX model will be run using the maximum application rate for all
proposes uses (which is 4 applications of 0.13 lbs a.i./acre with a
minimum of 7 days between each application).

Exposure to terrestrial and semi-aquatic (wetland) plants will be
estimated using the TerrPlant model Version 1.2.2 (USEPA 2006b). The
TerrPlant model estimates risk quotients for non-target monocot and
dicot plants that may be exposed to pesticides applications via runoff
and/or spray drift to terrestrial plants inhabiting dry and semi-aquatic
(wetland) areas. RQs are calculated using the EC25 value for
non-threatened/endangered plants and the EC05 or NOAEC value for
threatened/endangered plants.

b.	Measures of Effect

  SEQ CHAPTER \h \r 1 Measures of ecological effects are obtained from a
suite of registrant-submitted guideline studies conducted with a limited
number of surrogate species.  Registrant-submitted data suitable for
quantitative risk assessment are available for acute exposure of birds,
terrestrial invertebrates, freshwater and marine/estuarine invertebrate,
and terrestrial plants, and for chronic exposure to birds, mammals, and
freshwater fish.  A generic summary of the measures of effect based on
pesticide toxicity studies for different ecological receptors and effect
endpoints (acute/chronic) is given in Table 4.

c.	Measures of Ecosystem and Receptor Characteristics

For the assessments using the Tier I aquatic model GENEEC and the Tier I
terrestrial models T-REX and TerrPlant, the ecosystems that are modeled
are intended to be generally representative of any aquatic or
terrestrial ecosystem associated with areas where mandipropamid could be
used.  For aquatic assessments, fish and aquatic invertebrates in both
freshwater and estuarine/marine environments are represented, as well as
aquatic plants.  For terrestrial assessments, three different size
classes of small birds and mammals are represented, along with four
potential foraging categories, as well as two terrestrial plant groups
(upland plants and plants growing in semi-aquatic areas).

  SEQ CHAPTER \h \r 1 III.	ANALYSIS

A.	Use Characterization  tc "A.	Use Characterization " \l 2 

The purpose of the ecological risk assessment is to assist the Agency in
evaluating the actions needed, if any, to address ecological risks
associated with uses of the new fungicide, RevusTM (proposed name
mandipropamid), for use on brassica vegetables, bulb vegetables,
cucurbits, fruiting vegetables, grapes, leafy vegetables, potatoes,
tomatoes, tuberous and corm vegetables.  This chemical is to be applied
on commercial or farm plantings via ground or aerial applications.  It
requires the use of an external adjuvant (such as a non-ionic
surfactant, crop oil concentrate, silicone based, or blend) to enhance
fungicidal activity.

Mandipropamid is a new chemical, currently unregistered for use.
Therefore, there is no current chemical usage information available in
the National Center for Food and Agricultural Policy (NCFAP) pesticide
use database or the U.S. Department of Agriculture National Agriculture
Statistics Service (NASS) chemical use database.

The proposed label specifies that mandipropamid is intended for the
control of foliar oomycete pathogens in a range of crops including
Plasmopara viticola in grapes, Phytophthora infestans in potatoes and
tomatoes and Pseudoperonospora cubensis in cucurbits

The proposed label specifies that the maximum amount of the active
ingredient that may be applied in a single growing season is 0.52 lbs
a.i./acre.  According to the proposed label, this application amount may
be divided into 4 applications of 0.13 lbs a.i./acre with 7 day
intervals between each application.

Product information:

Product Name: Mandipropamid Fungicide (proposed name RevusTM)

Active Ingredients:

Mandipropamid	23.3%

Inert ingredients	76.7%

Total	100%

(CAS Number 374726-62-2)

Table 5. Application Rates of Mandipropamid

Crops	Disease Control	Application Rate

(lbs a.i./acre)	Maximum No. Applications per Season	Interval
Restrictions

Brassica vegetables,

bulb vegetables, cucurbits, fruiting vegetables, grapes,

leafy vegetables, potatoes, tomatoes, tuberous and corm vegetables
foliar oomycete pathogens in a range of crops including Plasmopara
viticola

in

grapes, Phytophthora infestans	0.13	4	7-day minimum interval between
applications	Do not apply:

1. More than 32 fl oz of product /A/Season

2. Within 1 day of harvest for brassica, leafy vegetables, fruiting
vegetables, tomatoes.

3. Within 7 days of harvest for bulb vegetables.

4. Within 14 days of harvest for potatoes, grapes

B.	Exposure Characterization

1.	Environmental Fate and Transport Characterization

Data were submitted regarding the hydrolysis, photolysis,
biodegradation, soil adsorption properties, and field dissipation of
mandipropamid.  These data are sufficient to characterize the transport,
partitioning, mobility, and degradation of mandipropamid and several of
its major metabolites in the environment.  The physical and chemical
properties used to characterize the environmental fate of mandipropamid
were summarized in Table 2. Chemical names and structures of the
metabolites discussed below are provided in Appendix A.

a.	Summary of Empirical Data

Registrant submitted studies indicate that mandipropamid is persistent
in the environment, under aerobic aquatic conditions.  Mandipropamid
appears to be stable to hydrolysis at environmental pH (pH range 5–9)
but susceptible to photolysis in soil and water.  Due to its vapor
pressure and Henry’s Law constant, volatilization from water and soil
is not expected to be an important environmental fate process.
Mandipropamid and several of its metabolites can be mobile in soil and
have the potential to leach into ground water.

b.	Degradation and Metabolism

Mandipropamid did not undergo abiotic hydrolysis in pH 5, 7, and 9
aqueous buffered solutions maintained at 25 °C over the course of a 30
day incubation period (MRID 46800007&8). The environmental photolysis
half-lives of mandipropamid in pH 7, 25°C aqueous solution were
estimated as 0.63-1.1 days (MRID# 46800009,10,13,14). The soil
photolysis half-lives of mandipropamid were estimated as 16.4–23.9
days (MRID 46800015,16,17).

The linear biodegradation half-life of mandipropamid in six European and
one U.S. soils ranged from approximately 26 to 103 days under aerobic
conditions (MRIDs 46800020,21,22,24-28).

Based on results form a supplemental study, under anaerobic conditions
the rate of biodegradation appears to be much slower. Mandipropamid
degraded with linear half-lives of 151 days in a silt loam soil from
Switzerland maintained under anaerobic conditions (MRID 48600022).

The aerobic aquatic degradation half-lives of mandipropamid were
17.8-18.5 days in two river water/silt loam sediment systems from
England Germany (MRID 46800030-31).

The degradation of one mandipropamid metabolites was studied in three
soils under aerobic conditions, and this metabolite appears to be
non-persistent. Based on linear regression analysis, the half-lives of 
CGA380778 in silt loam soil from Switzerland, a sandy clay loam soil
from England, and sandy loam soil from US,  were 6.4, 6.9, and 58 days,
respectively (MRID# 46800023).

c. 	Transport and Mobility

Volatilization of mandipropamid from treated fields and water surfaces
is not expected to be an important environmental fate process based on a
Henry’s Law constant of 8.29x10-9 atm-m3/mol, and vapor pressure of
3.52x10-8 mm Hg (MRID# 46800007, 8).

Mandipropamid is expected to possess moderate mobility in soils based
upon Koc values ranging from 405 - 1294, measured in seven soils from
the U.S. and Europe (MRID 46800038-41). Given the range of Koc values in
the six soils tested, mandipropamid possesses the potential to leach
into ground water.

The mobility of mandipropamid metabolites SYN52119, SYN500003,
CGA380778, and SYN504851 were also studied.  All of these metabolites
are expected to possess high mobility in soils based upon the submitted
data and have the potential to leach into ground water. Koc values of <1
to 31 L/kg were observed in 12 soils (MRID# 46800035, 36, 42-44).

d.	Field Studies

Terrestrial field dissipation studies (MRID 46800045-47) for
mandipropamid were studied in four bare plots cropped with field
potatoes: in California (sandy loam soil), New York (loamy sand soil),
and Georgia (sandy loam soil).

The field dissipation half-lives of mandipropamid were: 75.3 days
(California site); 100.5 days (New York); 81.5 days (Georgia).

At the California, residues of mandipropamid and CGA380778 were only
detected in the top 15 cm of the soil.

At the New York site, residues of mandipropamid and CGA380778 were only
detected in the top 15 cm of the soil.

At the Georgia site, residues of mandipropamid and CGA380778 were only
detected in the top 15 cm of the soil with one exception; mandipropamid
was detected once in the 15-30 cm depth at 14 days post-treatment.

2.	Measures of Exposure

a.	Aquatic Exposure Modeling

Exposure concentrations of mandipropamid together with its degradates of
concern (SYN500003 and SYN504851) were estimated based on the EFED
aquatic Tier I model GENEEC 2.0 (see Appendix B for explanation of
model).  

The aquatic exposure modeling inputs and outputs for mandipropamid
including its degradates, SYN500003 and SYN504851, are shown in Tables 6
and 7.

Table 6. GENEEC Chemical Specific Input Parameters for mandipropamid
and its degradate, SYN500003 and SYN504851.

Parameter	Input Value and Unit	Source

Maximum application rate	0.13 lb a.i./A	Product Label EPA Reg. No.
100-RELU.

Maximum number of applications	4	Product Label EPA Reg. No. 100-RELU.

Method of	Aerial	Product Label EPA Reg. No. 100-RELU.

Minimum interval between applications	7 days	Product Label EPA Reg. No.
100-RELU.

Partition coefficient Koc	2.89 mL/g	For SYN500003; Lowest non-sand  SEQ
CHAPTER \h \r 1  Koc; MRID 46800042,43

Aerobic soil metabolism	72.04  days	Total toxic of parent and
degradates; MRID 46800021. Input Parameters Guidance, 2002

Aerobic aquatic metabolism (t1/2)	102  days	Total toxic of parent and
degradates; MRID 46800030-31. Input Parameters Guidance, 2002

Aquatic photolysis t1/2 (days)	1.1	For parent; MRID 46800014; input
Parameters Guidance, 2002

Table 7. GENEEC2 Model Estimated Environmental Concentrations (EEC) of
mandipropamid and its degradates identified as of toxicological
concerns, in standard farm pond.

Compound	Peak (ppb)	4-day (ppb)	21-day (ppb)	60-day (ppb)	90-day (ppb)

Total

Residue including mandipropamid and

its degradates, SYN500003 and SYN504851	20.9	20.7	19.4	16.9	15.3

b.	Aquatic Exposure Monitoring and Field Data

Since mandipropamid is a new use chemical that has not been registered,
no monitoring data exist at this time.

3.	Measures of Terrestrial Exposures

a.	Terrestrial Exposure Modeling

  SEQ CHAPTER \h \r 1 The EFED terrestrial exposure model T-REX (T-REX,
version 1.3.1) is used to estimate exposures and risks to avian and
mammalian species.  The model provides estimates of exposure
concentrations and risk quotients (RQs). Specifically, the model
provides estimates of concentrations (maximum, or upper bound, and
average, or mean) of chemical residues on the surface of different types
of foliage and insects that may be dietary sources of exposure to
terrestrial wildlife receptors.

T-REX was run for the proposed new uses of mandipropamid using the input
values provided in Table 8.  Potential risk from mandipropamid and its
degradates were addressed by using the default half-life of 35 days
which operationally results in mandipropamid being relatively stable and
is comparable to a total residue approach where the degradates are
assumed to be as toxic as the parent.  The maximum label rate selected
for modeling is the same maximum label rate for all proposed uses.

  SEQ CHAPTER \h \r 1 Table 8. Input Parameters Used in T-REX Version
1.3.1 to Determine Terrestrial EECs for Mandipropamid Application on all
proposed uses.

Input Variable	Parameter Value	Source

Maximum application rate	0.13	Product label

Maximum number of applications per year	4	Product label

Minimum application interval	7	Product label

Foliar half-life	35	Default value

Mineau et al. scaling factor	1.15	Default value

Application type	Ground Spray

or Aerial Spray	Product label

Toxicity values	Avian

acute

oral toxicity	No input

value

because mandipropamid is

practically nontoxic

to birds on an acute oral basis (No mortalities in acute oral test)
468001-10

	Avian

acute

dietary

toxicity	No

input

value

because mandipropamid

practically nontoxic

to birds on an acute

dietary basis

(No mortalities

in acute dietary test )	468001-12

	Avian reproductive toxicity:	NOAEC = 1060	467152-14

	Mammalian Acute

Oral LD50 1	No

input

value

because mandipropamid

practically nontoxic

to mammals on an acute

dietary basis

(No mortalities

in acute dietary test )	46800202

	Mammalian Reproductive Toxicity	NOAEC =

250 ppm	46800230

  SEQ CHAPTER \h \r 1 A summary of the terrestrial animal estimated
exposure concentrations (EECs) in forage generated by T-REX is presented
in Table 9.  Mandipropamid residues (ppm) ranged from 6 ppm
(fruits/pods/large insects) to 103 ppm (short grass) for maximum
residues and 3 ppm (fruits/pods/large insects) to 36 ppm (short grass)
for mean residues.

Table 9. Peak Terrestrial EECs Estimated Using Kenaga Values for
Mandipropamid Applied to all the proposed uses

Forage Type	Maximum Residue (ppm)	Mean Residue (ppm)

S  SEQ CHAPTER \h \r 1 hort grass	103	36

Tall grass	47	15

Broadleaf plants and small insects	58	19

Fruits/pods/large insects	6	3

  SEQ CHAPTER \h \r 1 TerrPlant (TerrPlant, version 1.2.2, dated
December 26, 2006) was used to estimate exposures and risks to
terrestrial plant species. Input parameters for the model included: (1)
toxicity values for monocots and dicots; (2) application rate; (3)
runoff, based on chemical solubility; and (4) soil incorporation depth.
The model provides estimates of exposure concentrations and risk
quotients (RQs) for non-listed and listed terrestrial and semi-aquatic
plants. Input and output values used for estimating terrestrial and
semi-aquatic plant exposure risks to mandipropamid are summarized in
Tables 10 and 11, respectively.  Only one application is considered in
this assessment due to model limitations.  More detailed information on
TerrPlant Version 1.2.2 is presented in Appendix D.

  SEQ CHAPTER \h \r 1 Table 10. Input Parameters Used in TerrPlant 1.2.2
to Determine Terrestrial EECs for Plants for Mandipropamid Application
on all proposed Crops based on the maximum proposed application rate.

Input Variable	Parameter Value	Source

Maximum application rate	0.13 lbs a.i./acre	Product label

Runoff value (0.01, 0.02, or 0.05 if chemical solubility <10, 10–100,
or >100 ppm, respectively)	0.02 *	MRID 46800009

Minimum incorporation depth (inches)	0	Product label

Toxicity Values	Most Sensitive Vegetative Vigor Endpoint Values

EC25 >0.792

NOAEC =  0.198 lbs a.i./acre

Most Sensitive Seedling Emergence Endpoint Values

EC25 >

NOAEC = 0.165 lbs a.i./acre	

MRID 46695512

a Based on the water solubility of 2.3 ppm.

  SEQ CHAPTER \h \r 1 Table 11. Summary Output EECS from TerrPlant for
Mandipropamid

Application Method	EECs for Plants Inhabiting Areas Adjacent to

Treatment Site (lbs a.i./acre),

Run off & Drift Load	EECs for Semi-Aquatic Plants Inhabiting Areas
Adjacent to Treatment Site (lbs a.i./acre),

Run off & Drift Load	Drift EEC (lbs a.i./acre)

Ground spray (unincorporated)	0.0039	0.0273	0.0013

Aerial	0.0091	0.0325	0.0065

b.	Terrestrial Residue Studies

No residues studies were submitted for any of the proposed new uses.

  SEQ CHAPTER \h \r 1 C.	Ecological Effects Characterization

In screening-level ecological risk assessments, the effects
characterization describes the types of effects a pesticide can have on
aquatic or terrestrial organisms.  This characterization is based on
registrant-submitted studies that describe information regarding acute
and chronic toxicity effects of mandipropamid (Technical Grade Active
Ingredient (TGAI)) for various aquatic and terrestrial animals.  Also
included in this characterization is a limited set of aquatic organism
studies testing the toxicity of the mandipropamid degradate, CGA380778. 
Appendix E summarizes the results of all registrant-submitted toxicity
studies used to characterize effects for this risk assessment.

1.	Aquatic Effects Characterization

The most sensitive freshwater and estuarine/marine acute and chronic
toxicity values for mandipropamid and its degradate, CGA380778, are
summarized in Tables 12 and 13.  Toxicity values typically used by EFED
to assess a pesticide’s acute risk to fish were not available.  This
is because all fish acute toxicity studies were deemed invalid. 
Although aquatic organism results were limited, a Daphnia magna, water
flea, acute toxicity test was available for both the parent (48-h 7.1
ppm a.i.) and degradate (48-h 54.2 ppm).  As the degradate was less
toxic than the parent, the measures of toxicity used to evaluate risks
to aquatic organisms were based solely on the parent toxicity data
(Table 15).

Table 12.  Mandipropamid Values Used to Calculate Screening Level Risks
to Aquatic Organisms and Aquatic Plants

Assessment Endpoint(a)	Measures of Effect(a)	Selected Test and
Measurement Endpoint

Species	Toxicity Value	Study Conditions	Basis for selection	Reference

(Classification)

Survival and reproduction of individuals and communities of freshwater
fish and invertebrates in close proximity to sites	3a.  freshwater fish
acute 96-hr LC50	No acceptable studies b	--	--	--	--

	3c. Freshwater invertebrate acute 96-h LC50 (for copepods 48-h LC50 or
EC50 where the effect measured is surrogate)	Water flea (Dapnia magna)

<24 hours old	48-h EC50 = 7.1 ppm a.i.

(effects: immobility and mortality)	TGAI 96.5% a.i.,

pH range of 7.93-8.07,

Temperature range of

20O + 1OC

Hardness range of

226 mg as CaCO3/L

	Most sensitive (only a single TGAI test)	MRID 468000-50

(Acceptable)

	3d. Freshwater invertebrate reproductive NOAEC	No acceptable studies	--
--	--	--

Survival and reproduction of individuals and communities of
estuarine/marine fish and invertebrates in close proximity to sites	4a.
Estuarine or marine fish acute 96-hr LC50	No acceptable study	--	--	--
--

	4b. Mollusc acute 96-hr EC50 shell deposition	Eastern oyster

(Crassostrea virginica)

	96-h EC50 = 0.91 ppm a.i.	TGAI 96.1 % a.i., pH range of

8.1- 8.3, Temperature range of 19.1-19.7OC,	Most sensitive (only a
single test result)	MRID 468001-01

(Acceptable)

	4c. Shrimp acute 96-hr LC50	Mysid shrimp

(Americamysis bahia)	96-h LC50 = 1.7 ppm a.i.	TGAI 96.1% a.i.,

pH range of 8.1-8.4, pH 7.5 + 1, Temperature range 23OC-26O	Most
sensitive (only a single test result)	MRID 468001-02

(Acceptable)

	4d. Fish early life stage or full life cycle NOAEC	Fathead minnow

(Pimephales promelas)	NOAEC = 0.22 ppm

LOAEC =

0.47 ppm	TGAI 96.5% a.i.,

Hardness range of 38.3-58.0 mg/L as CaCO3

pH: 7.1-7.9

Temperature range of

24.0-25.5°C	Most sensitive

endpoint produced in the only fish chronic toxicity test available	MRID
468001-08 (Acceptable)

	4e. Invertebrate life cycle NOAEC	No data submitted	--	--	--	--

Standing crop or biomass and growth of aquatic plants in close proximity
to sites	7a. Freshwater green algae, cyanobacteria or diatom 96-h EC50
for biomass	Green algae

(Pseudokirchneriella subcapitata)	96-h EC50

>2.5 ppm

	TGAI

96.5%, static, temperature range of 24 -25OC

	Most sensitive endpoint

(Only nonvascular aquatic plant endpoint available)	MRID 468001-21

(Acceptable)

	7b. Saltwater green algae or diatom 96-h EC50 for biomass	No submitted
studies	--	--	--	--

	7c. Vascular plant (at least duckweed) 7- to 14-d EC50 for biomass	Duck
weed

(Lemna Gibba G3)	96-h EC50

> 7.9 ppm

	TGAI

96.1%, static renewal, pH  of 7.5 temperature range of 24.5-24.9oC,

	Most sensitive

(Only vascular aquatic plant endpoint available)	MRID 468001-19

(Acceptable)

	7d. Freshwater green algae, cyanobacteria or diatom 96-h NOAEC (or
EC05) for biomass	Green algae

(Pseudokirchneriella subcapitata)	96-h EC50

NOAEC

= 1.3 ppm	TGAI

96.5%, static, temperature range of 24 -25OC

	Most sensitive endpoint

(Only nonvascular aquatic plant endpoint available)	MRID 468001-21

(Acceptable)

	7e.Vascular plant (at least duckweed) 7- to 14-d NOAEC (or EC05) for
biomass	Duck weed

(Lemna Gibba G3)	96-h IC05

= 1.3 ppm	TGAI

96.1%, static renewal, pH  of 7.5 temperature range of 24.5-24.9oC,

	Most sensitive

(Only vascular aquatic plant endpoint available)	MRID 468001-19

(Acceptable)

(a) Assessment endpoints and measures of effect identified to be
assessed in the problem formulation (Table 4).

(b) Fish acute toxicity is currently unavailable because the submitted
fish acute toxicity studies were deemed invalid

Table 13. Mandipropamid degradate, CGA380778, Aquatic Organism and
Aquatic Plant Toxicity Values

Assessment Endpoint	Measures of Effect	Test and Measurement Endpoints

Species	Toxicity Value	Study Conditions	Basis for selection	Reference

(Classification)

Survival and reproduction of individuals and communities of freshwater
fish and invertebrates in close proximity to sites	3a. Freshwater fish
acute 96-hr LC50	No acceptable study	--	--	--	--

	3c. Freshwater invertebrate acute 96-h LC50 (for copepods 48-h LC50 or
EC50 where the effect measured is surrogate)	Water flea (Dapnia magna)

<24 hours old	48-h EC50 = 54.2 ppm a.i.

(effects: immobility and mortality)	98% purity, static, pH range of
7.9-8.0,Temperature

range of 20+1OC, Hardness of 219 mg as CaCO3/L,	--	MRID 468000-51

(Acceptable)

Standing crop or biomass and growth of aquatic plants in close proximity
to sites	7a. Freshwater green algae, cyanobacteria or diatom 96-h EC50
for biomass	Pseudokirchneriella subcapitata

(Freshwater green algae)	96-h

EC50 = 16 ppm a.i.

	98% purity,

static, pH range 7.4 – 10, Temperature range of 23.8-24.3oC

	--	--

	7d. Freshwater green algae, cyanobacteria or diatom 96-h NOAEC (or
EC05) for biomass	Pseudokirchneriella subcapitata

(Freshwater green algae)	96-h NOAEC = 2.4 ppm	--	--	--

a.	Aquatic Animals

(1).	Acute Effects

Freshwater Fish

At a minimum two freshwater fish acute toxicity studies using the TGAI
are required to establish the toxicity of mandipropamid to fish.  The
preferred test species are rainbow trout (a coldwater fish) and bluegill
sunfish (a warmwater fish).  The registrant submitted three freshwater
fish toxicity studies including two studies testing mandipropamid (TGAI;
MRID’s 468001-05, and MRID 468001-06) and one study testing the
degradate CGA380778 (MRID 468001-04).  All of the studies were deemed
invalid because of significant deviations from the guidelines.  The
studies were invalidated because the dissolved mandipropamid
concentration was not determined (test solutions contained undissolved
particulate test material and the measured concentrations were
significantly unstable throughout the testing). Therefore, it is not
possible to obtain accurate toxicity endpoint values that could be used
for risk assessment purposes.

Freshwater Invertebrates

A freshwater aquatic invertebrate toxicity test using the TGAI is
required to establish the toxicity of mandipropamid to aquatic
invertebrates.  The preferred test species is Daphnia magna. Two
freshwater invertebrate toxicity studies, one testing mandipropamid
(TGAI), and the other testing the mandipropamid degradate, CGA38077,
(MRID’s 468001-50 and 468001-51, respectively) were submitted by the
registrant.  Both studies were classified as scientifically sound and
acceptable for assessing risks to freshwater invertebrates; Guideline
§72-2 (draft OPPTS 850.1010) is fulfilled.  Since the 48-h EC50 (7.1
ppm a.i.) for mandipropamid falls in the range of 1 - 10 ppm,
mandipropamid is classified as moderately toxic to aquatic invertebrates
on an acute basis.  Since the 48-h EC50 (54.2 ppm) for the major
degradate of mandipropamid, CGA380778 falls in the range of 10 – 100
ppm, CGA380778 is classified as practically nontoxic to freshwater
invertebrates. The more sensitive value of the parent was selected for
use in assessing risk to freshwater invertebrates (Table 12).

Estuarine/Marine Fish

Mandipropamid usage may occur in some areas associated with
marine/estuarine habitats.  Thus, marine/estuarine fish toxicity data is
required (40CFR Part 158) to assess acute risks from mandipropamid use. 
Two marine/estuarine fish studies testing mandipropamid were submitted
by the registrant (MRID 468001-03 and –05).  However both studies were
reviewed and identified as scientifically unsound because of significant
deviations from the 850 guidelines.  The studies were invalidated
because test solutions contained undissolved particulate test material,
and the mean measured concentrations were significantly unstable
throughout the test.  Hence, no scientifically sound dissolved endpoint
value can be determined for these studies.  The 40CFR Part 158 acute
marine/estuarine fish test requirement (Guideline §72-1, draft OPPTS
850.1075) is not fulfilled.

Estuarine/Marine Invertebrates

Mandipropamid usage may occur in some areas associated with
marine/estuarine habitats.  Thus, marine/estuarine invertebrate toxicity
data for a mollusk (shell deposition or embryo-larval test), and shrimp
is required (40CFR Part 158) to assess acute risks from mandipropamid
use.  The registrant submitted two marine/estuarine invertebrate
toxicity studies testing mandipropamid (MRID’s 468001-02 and
468001-01).  One study tested the acute toxic effect of manipropamid on
mysid shrimp mortality and the other study tested mandipropamid’s
acute toxic effects on shell deposition of the eastern oyster.  Both
tests were reviewed and found to be scientifically sound and acceptable
for assessing risk to marine/estuarine invertebrates.  The studies
demonstrated that mandipropamid was moderately toxic to mysid shrimp
(96-h LC50: 1.7 ppm a.i.) and very highly toxic to eastern oyster shell
deposition (96-h EC50: 0.91 ppm a.i.).  The endpoints produced in these
studies will be used to assess the risk of mandipropamid to
marine/estuarine invertebrates specifically mollusk and arthropod
species (Table 12).

(2).	Chronic Effects

Freshwater Fish

Mandipropamid is mobile and is likely to readily and frequently (due to
multiple applications during a growing season) reach surface water
bodies.  Thus, a fish early life stage toxicity study testing
mandipropamid is required (40CFR Part 158) to evaluate the potential for
reproductive effects.  The registrant submitted an early life-stage
study testing the technical grade mandipropamid on fathead minnow (MRID
468001-08).  The study was classified as scientifically sound and
acceptable for use in assessing risk.  The most sensitive endpoint in
this study was on fish growth.  The NOAEC for this endpoint was 0.22 ppm
a.i..  This endpoint will be used to assess the chronic risk of
mandipropamid use to freshwater fish.

Freshwater Invertebrates

Mandipropamid is mobile and is likely to readily and frequently (due to
multiple applications during a growing season) reach surface water
bodies.  Thus, invertebrate chronic toxicity testing mandipropamid is
required (40CFR Part 158) to evaluate chronic effects to use of
mandipropamid.  The freshwater invertebrate reproductive toxicity study
submitted by the registrant (MRID 468001-07) was deemed scientifically
unsound for use in a risk assessment because of significant deviations
from the guidelines for an invertebrate reproductive toxicity test.  The
reviewer’s analysis showed that reproduction of solvent control
daphnids was significantly lower than that of negative control daphnids,
which according to the EPA memo titled, “Interim Policy Guidance for
the Use of Dilution-Water (Negative) and Solvent Controls in Statistical
Data Analysis for Guideline Aquatic Toxicology Studies”, dated March
30, 2006, would result in the invalid classification of this study.

Estuarine/Marine Fish

Currently, no estuarine and marine fish chronic toxicity studies have
been submitted to the Agency.

Estuarine/Marine Invertebrates

Currently, no estuarine and marine invertebrate chronic toxicity studies
have been submitted to the Agency.

(3).	Sublethal Effects

Freshwater Fish

All of the acute freshwater fish toxicity studies were reviewed and
identified as scientifically unsound (MRID’s 468001-05, 468001-06, and
468001-04).  Thus, although sublethal effects (loss of equilibrium,
lethargy, surfacing, lying on the bottom of the aquarium) were observed
in these studies, the dissolved concentrations at which these occur can
not be determined.

The most significant sublethal effects demonstrated by the freshwater
fish chronic toxicity study were adverse effects on fish growth at a
NOAEC of 0.210 ppm (MRID 468001-08).  Sublethal effects noted in acute
studies (loss of equilibrium, lethargy, surfacing, lying on the bottom
of the aquarium) were not observed in juveniles in the fish early life
stage test.

Freshwater Invertebrates

The only sublethal effects reported for the freshwater invertebrate
toxicity studies were in the study testing the mandipropamid degradate,
CGA380778.  The study reported the test organism (daphnia magna) having
slow and/or lethargic movement during the test termination at 4.6 – 65
ppm (MRID’s 468001-51).

Estuarine/Marine Fish

All of the acute marine/estuarine fish toxicity studies were reviewed
and identified as scientifically unsound (MRID 468001-03 and –05). 
Thus, although sublethal effects (erratic swimming, loss of equilibrium,
lying on the bottom of test vessel, lethargy) were observed in these
studies, the dissolved concentrations at which these occur cannot be
determined.

Estuarine/Marine Invertebrates

Except for the effect on shell deposition no other sublethal effects
were reported in the shell deposition or mysid shrimp studies (MRID’s
468001-02, and 468001-01).

(4).	Field Studies

No aquatic field studies for mandipropamid were submitted.

Plants Inhabiting Aquatic Areas

The registrant has submitted a nonvascular aquatic plant toxicity study
testing the effect of mandipropamid on the green alga,
Pseudokirchneriella subcapitata (MRID 468001-21) and a vascular aquatic
plant toxicity study testing the effect of mandipropamid on Lemna gibba
(MRID 468001-19).  Both studies of these studies are acceptable for
aquatic plant toxicity requirements.  The green algal study demonstrated
an EC50 > 2.5 ppm a.i. for all endpoints measured and a NOAEC of 1.3 ppm
based on biomass.  The Lemna gibba study demonstrated an EC50 > 7.9 ppm
a.i. for all endpoints measured and a NOAEC of 1.3 based on growth rate.
  These endpoints will be used to assess the risk of mandipropamid to
aquatic nonvascular and vascular plants respectively.

The registrant has also submitted a nonvascular aquatic plant toxicity
study testing the effect of CGA380778, a mandipropamid degradate, on
Pseudokirchneriella subcapitata (MRID 468001-20).  This study was
reviewed and identified as a scientifically sound and an acceptable
study for estimating risks to aquatic plants.  The EC50 and NOAEC values
produced in the study were 16 ppm and 2.4 ppm respectively.  Since the
aquatic plant toxicity studies testing the parent, mandipropamid,
demonstrated a more sensitive NOAEC values than the study testing
CGA380778 (a NOAEC of 1.3 ppm for the parent vs. a NOAEC of 2.4 for
CGA380778), the risk to aquatic plants will be assessed solely based on
the parent toxicity data.

2.	Terrestrial Effects Characterization

The most sensitive acute and chronic toxicity values associated with
mandipropamid exposure to mammals, birds, and terrestrial plants are
summarized in Table 14.  These values are used to assess risk to
terrestrial animals. All toxicity endpoint values utilized to assess the
potential terrestrial risks of mandipropamid exposure were obtained from
studies testing the technical grade mandipropamid.  Except for an
earthworm acute toxicity study testing, CGA380778, no other terrestrial
organism toxicity tests were available testing any of the mandipropamid
formulated products or mandipropamid degradates or metabolites.  A more
detailed summary of all available terrestrial toxicity data used to
characterize effects associated with mandipropamid is given in Appendix
E.

Table 14. Mandipropamid Selected Toxicity Values for Screening Risk to
Terrestrial Organisms

Assessment Endpoint	Measures of Effect	Selected Test and Measurement
Endpoints

Species	Toxicity Value	Study Conditions	Basis for Selection	Reference

(Classification)

Abundance (i.e., survival, reproduction, and growth) of individuals and
populations of birds in close proximity to sites	1a. Avian (single dose)
acute oral LD50	Mallard duck	LD50 >1000 mg a.i./kg-bw(a)

(no mortality observed)	TGAI, 96.5% a.i., Single dose, 18weeks of age
Lowest value of the two species tested	MRID 468001-10

(Acceptable)

	1b. Avian subacute 5-day dietary LC50	Mallard duck and Bobwhite quail
5-d LC50 > 6080 mg a.i./kg diet(a)

(no mortality observed)	TGAI, 96.5% a.i., 8-d test, 5-d exposure in
food, 10 days old	Both available studies were of equal sensitivity	MRID
468001-12

(Acceptable)

MRID 468001-13

(Acceptable)

	1c. Avian reproduction NOAEL	Mallard duck and Bobwhite quail	NOAEC >
1060 mg a.i./kg diet(c)	TGAI, 20-week avian reproduction study, exposed
via food	Both available studies were of equal sensitivity	MRID

468001-14

(Acceptable)

MRID

468001-15

(Acceptable)

Abundance (i.e., survival, reproduction, and growth) of individuals and
populations of mammals in close proximity to sites	2a. Mammalian acute
oral (single dose) LD50	No data	--	--	--	--

	2b. Mammalian reproductive NOAEC or NOAEL	Laboratory Rat

(Rattus norvegicus)	NOAEC = 250 ppm a.i.(a)

(based on most sensitive endpoints: decreased body weights, weight
gains, food consumption, and food utilization)	TGAI, Two-generation,
exposure via food	Most sensitive study (only study available)	MRID
46800230

(Acceptable)

Survival of beneficial insect populations in close proximity to sites
Honey bee acute contact LD50	Honey bee

(Apis mellifera L.)	72-h LC50 >200 ug a.i./bee	TGAI, applied to	Most
sensitive (only study available)	468001-16

(Acceptable)

Survival and growth of terrestrial plants in close proximity to sites
6a. Monocot seedling emergence EC25	All monocot species tested including
corn, oat, onion, ryegrass	>0.660 lbs a.i./A	Mandipropamid Formulation
A12496B	All four monocots tested were equally sensitive	468001-17

(Acceptable)

	Dicot seedling emergence EC25	All dicot species tested except for
carrot which produced unreliable results.  The other tested dicot
species  included cucumber, radish, soybean, sugar beet, and tomato
>0.660 lbs a.i./A	Manipropamid formulation A12496B	Most sensitive of the
validated endpoint of the  dicots tested	468001-17

(Supplemental)

	6b. Monocot seedling emergence NOAEC	corn, oat, onion, and ryegrass
0.660 lbs a.i./A	Mandipropamid formulation A12496B	All four monocots
tested were equally sensitive	468001-17

(Acceptable)

	Dicot seedling emergence NOAEC	cucumber, and soybean	0.165 lbs a.i./A
Mandipropamid formulation A12496B	Most sensitive validated endpoint of
the dicots tested.	468001-17

(Supplemental)

	6c. Monocot vegetative vigor EC25	corn, oat, onion, ryegrass	>0.792 lbs
a.i./A	Mandipropamid formulation A12496B	All four monocots tested were
equally sensitive	468001-18

(Acceptable)

	Dicot vegetative vigor EC25	carrot, cucumber, radish, soybean, sugar
beet, tomato	>0.792 lbs a.i./A	Mandipropamid formulation A12496B	All six
dicots tested were equally sensitive	468001-18

(Acceptable)

	6d. Monocot vegetative vigor NOAEC	oat	0.198 lb a.i./A	Mandipropamid
formulation A12946B	Most sensitive of the four monocots tested	468001-18

(Acceptable)

	Dicot vegetative vigor NOAEC	Carrot, cucumber, radish, soybean, sugar
beet, tomato	0.792 lb a.i./A	Mandipropamid formulation A12946B	All six
species tested were equally sensitive	468001-18

(Acceptable)

(a) Note: Since, acute toxicity studies in birds demonstrated acute
toxicity (LC50 or LD50) values higher than the highest concentrations
tested and resulted in no mortalities, acute risk quotients will not be
derived for birds.

a.	Terrestrial Animals

(1).	Acute Effects

Birds

An acute oral toxicity study and two subacute dietary studies using the
technical grade of the active ingredient (TGAI) are required (40CFR Part
158) to establish the acute toxicity of mandipropamid to birds.  The
preferred test species are a waterfowl (Mallard duck) and an upland
gamebird (Northern bobwhite quail).  Two studies were submitted by the
registrant evaluating the acute oral toxicity and acute dietary toxicity
of the technical grade of mandipropamid on Bobwhite quail and the
Mallard duck (MRID’s 468001-10, 468001-11, 468001-12, and 468001-13,
respectively).  All four studies were reviewed and identified to be
scientifically sound and classified as acceptable for use in assessing
risks to birds. No mortalities were observed in acute oral exposures to
mandipropamid at up to 1000 mg a.i./kg-bw (highest concentration tested)
for the Mallard duck and at up to 2250 mg a.i./kg-bw for the Northern
bobwhite quail or in acute dietary exposure to mandipropamid at up to
6080 ppm a.i. for both species.  Thus, mandipropamid is classified as
practically nontoxic to avian species on an acute basis.

Mammals

Wild mammal testing is required on a case-by-case basis, depending on
the results of lower tier laboratory mammalian studies, intended use
pattern and pertinent environmental fate characteristics.  In most
cases, rat or mouse toxicity values obtained from the Agency's Health
Effects Division (HED) substitute for wild mammal testing.  The
registrant has submitted one acute oral mammalian toxicity study testing
mandipropamid toxicity on rats (MRID 46800202).  The study demonstrated
mandipropamid is practically nontoxic to mammals (LD50 > 5000 mg/kg).

Terrestrial Invertebrates

A honey bee acute contact study using the TGAI is required for
mandipropamid because its proposed uses may result in honey bee
exposure.  An acceptable 72-hour contact toxicity study of technical
grade mandipropamid in honey bees yielded a LD50 >200 µg a.i./bee (MRID
468001-16), indicating that technical grade mandipropamid is practically
non-toxic to honey bees.  This value was used to screen for risks to
terrestrial beneficial insects.

A scientifically sound earthworm acute toxicity study testing the
technical grade mandipropamid (MRID 468001-22) and an earthworm acute
toxicity study testing the mandipropamid degradate, CGA380778, (MRID
468001-23) were submitted to the Agency.  No earthworm mortality was
observed in either study the highest concentration tested was 1000 mg
a.i./kg of soil.

(2).	Chronic Effects

Birds

There were two registrant submitted avian reproductive toxicity studies
testing technical grade mandipropamid.  The test organisms in these
studies were Bobwhite quail and Mallard duck.  Both studies demonstrated
that mandipropamid did not cause any significant effects on reproduction
or growth and survival of chicks at 1060 ppm a.i. which was the highest
concentration tested.  This value was used to screen for chronic
reproductive risks.

Mammals

There is one registrant submitted rat multigenerational reproductive
toxicity study (MRID 468002-30).  The results of the study demonstrated
a parental systemic NOAEL and offspring NOAEL of 250 ppm a.i. based on
decreased parental body weights, decreased parental weight gains,
decreased parental food consumption, decreased parental food
utilization, decreased pup body weights in both sexes and delayed sexual
maturation in offspring.  The NOAEL of 250 ppm a.i. produced in this
study will be used to assess the chronic risk of mandipropamid to
mammals.

Terrestrial Invertebrates

No chronic toxicity study was submitted for technical grade
mandipropamid, its formulations, or degradates for terrestrial
invertebrates.

(3).	Sublethal Effects

Birds

In the acute oral toxicity study testing the acute oral effect of
technical grade mandipropamid on bobwhite quail study, the only
sublethal effects were the appearance of ruffled feathers on one bird in
the control group and in five birds from the 2250 mg a.i./kg bw group. 
All birds appeared normal in appearance after 4 hours of dosing. 
Although the ruffled appearance may have been due to stress caused by
handling during dosing, a treatment-related effect could not be
precluded (MRID 468001-10).  No similar sublethal effects were observed
in the dietary study with bobwhite quail (MRID 468001-13) or in the
acute oral toxicity and dietary studies with Mallard ducks (MRID
468001-11 and –12, respectively).

In the acute oral toxicity study testing mandipropamid on the Mallard
duck the only sublethal effects were four females in the 1000 mg
a.i./kg-bw group observed drinking frequently during the first 2 hours
following dosing.  No birds, however, from this level were observed to
regurgitate.  In the 1500 mg a.i./kg-bw group, one female and two males
were observed drinking frequently, almost immediately following dosing. 
Both females that were observed drinking frequently were observed
regurgitating approximately 30 minutes following dosing.  One male was
also observed regurgitating approximately 1 hour and 20 minutes
following dosing.  All birds were normal in appearance and behavior by
3.5 hours following dosing.  Based on regurgitation, the NOAEL for
clinical signs of toxicity was 1000 mg a.i./kg-bw (MRID 468001-11).

Both acute dietary studies demonstrated visually determined treatment
related decrease in body at the highest concentration tested which was
6080 ppm a.i. (MRID’s 468001-12 and 468001-13).

Mammals

Based on the available mammalian toxicity data, the only sublethal
effects of mandipropamid to mammals was demonstrated in the rat
multigenerational study (MRID 46800230).  The sublethal effects
demonstrated in this study were decreased parental body weights,
decreased parental weight gains, decreased parental food consumption,
decreased parental food utilization, decreased pup body weights in both
sexes and delayed sexual maturation in offspring.  The NOAEL of these
effects were 250 ppm a.i..

Terrestrial Invertebrates

The only terrestrial invertebrate studies which demonstrated any
sublethal effects were the mandipropamid and CGA380778 earthworm
toxicity studies (MRID’s 468001-22 and 468001-23).  The sublethal
effects in the studies included significant reductions in percent weight
loss which were demonstrated at a NOAEC of 320 mg/kg of soil and a LOAEC
of 1000 mg/kg of soil for the study testing mandipropamid and at a NOAEC
of 100 mg/kg of soil and a LOAEC 1000 mg/kg of soil for the study
testing CGA380778.

(4).	Field Studies

No field studies were submitted for mandipropamid or any of its
degradates.

Terrestrial Plants

The registrant submitted a seedling emergence and vegetative vigor study
testing the A12946B, the formulation containing the active ingredient
Mandipropamid.  The following summarizes the results of both studies.

The effect of A12946B on the seedling emergence of monocot (corn, Zea
mays; oat, Avena sativa; onion, Allium cepa; and ryegrass, Lolium
perenne) and dicot (carrot, Daucus carota; cucumber, Cucumis sativa;
radish, Raphanus sativus; soybean, Glycine max; sugar beet, Beta
vulgaris; and tomato, Lycopersicon esculentum) crops was studied at
nominal application rates of 0 (negative and surfactant controls),
0.0413, 0.0825, 0.165, 0.330 and 0.660 lbs a.i./A.  The growth medium
used in the seedling emergence test was natural soil, classified as a
loam soil, with an organic matter content of 1.7% (1.0% organic carbon)
and an adjusted pH of 7.4.  On day 21 the surviving plants per pot were
recorded and cut at soil level for measuring the plant height and dry
weight.

Dry weight was significantly affected in cucumber, soybean and tomato,
but reductions did not exceed 25%.  The percent inhibition in seedling
emergence in the treated species as compared to the control ranged from
-4 to 8%.  No monocot species were sensitive to treatment, but an EC05
value could be calculated for corn dry weight.  Carrot was the only
dicot species to exhibit a reduction of ≥25% (based on dry weight)
relative to the negative control; however, the response was not
dose-dependent, with the three lowest treatment groups experiencing
increases in dry weight of 2-21%.  The reviewer was unable to determine
reliable ECx values for carrot dry weight.   Additionally, one replicate
in the highest treatment group failed to emerge and overall emergence of
the controls and treatment groups was fairly low (60-73%). This implies
that factors other than treatment contributed to the poor performance of
carrot in this study.  The study was deemed supplemental because of this
study deficiency.

The effect of A12946B on the vegetative vigor of monocot (corn, Zea
mays; oat, Avena sativa; onion, Allium cepa; and ryegrass, Lolium
perenne) and dicot (carrot, Daucus carota; cucumber, Cucumis sativa;
radish, Raphanus sativus; soybean, Glycine max; sugar beet, Beta
vulgaris; and tomato, Lycopersicon esculentum) crops was studied at
nominal application rates of 0 (negative and surfactant controls),
0.0495, 0.0994, 0.198, 0.396 and 0.792 lbs a.i./A.  The growth medium
used in the test was an artificial soil that represented a loam soil and
was composed of a mixture of kaolinite clay, industrial quartz sand and
peat; the organic matter content was 1.7% (1.0% organic carbon) and the
pH was 7.4.  On day 21 the surviving plants per pot were recorded and
cut at soil level for measuring the plant height and dry weight.

In the vegetative vigor test, plant height was affected by A12946B
treatment in oat only.  Dry weight, plant height and survival were not
affected in any other species.  The most sensitive monocot species,
based on plant height, in the vegetative vigor test was oat with an EC25
of >0.792 lbs a.i./A and a NOAEC of 0.198 lbs a.i./A.  No dicot was
sensitive to treatment, so the EC25 value was >0.792 lbs a.i./A and the
NOAEC values was 0.792 lbs a.i./A (the highest concentration tested).

The study was deemed acceptable for a Tier II vegetative vigor
terrestrial plant toxicity study.

IV.	RISK CHARACTERIZATION

Risk characterization is the integration of exposure and effects
characterization to determine the ecological risk from the use of
mandipropamid and the likelihood of effects on aquatic life and wildlife
based on all the proposed uses at the maximum proposed use rate. The
risk characterization provides estimation and description of the risk;
articulates risk assessment assumptions, limitations, and uncertainties;
synthesizes an overall conclusion; and provides the risk managers with
information to make regulatory decisions.

A.	Risk Estimation – Integration of Exposure and Effects Data

Results of the exposure and toxicity effects data are used to evaluate
the likelihood of adverse ecological effects on non-target species. For
the assessment of mandipropamid risks, the risk quotient (RQ) method is
used to compare exposure and measured toxicity values. Estimated
environmental concentrations (EECs) for acute and chronic exposure are
divided by acute and chronic toxicity values, respectively. The
resulting RQs are then compared to the Agency’s levels of concern
(LOCs). The LOCs, as summarized in the Risk Characterization Section,
are the Agency’s interpretive policy used to analyze potential risk to
non-target organisms and the need to consider regulatory action.

1.	 Non-Target Aquatic Animals and Plants

  SEQ CHAPTER \h \r 1 To assess risks of mandipropamid on all proposed
uses to non-target aquatic organisms (i.e., fish, invertebrates,
plants), surface water EECs for total residues of mandipropamid
including its degradates of toxic concern, SYN500003 and SYN504851 (as
identified by HED), were obtained using GENEEC based on the maximum
proposed label rate of 4  applications, 7 days apart at 0.13 lbs a.i./A.
 The instaneous peak concentration is used to derive RQs for acute
exposure and the 21-day and 60-day peak exposure concentrations were
used to derive RQ values for chronic exposure to invertebrates and fish,
respectively. The most sensitive toxicity values for the TGAI
mandipropamid were used to calculate risk quotients for aquatic
organisms exposed to mandipropamid.

a.	Acute Risk to Animals (Fish and Invertebrates)

Only acute RQ values for freshwater and marine/estuarine invertebrates
were calculated.  According to the acute RQ values for aquatic
invertebrates, mandipropamid does not pose a risk to freshwater or
marine/estuarine invertebrates above the Agency’s Level of Concern
(see Table 15).  Acute RQ values could not be calculated for freshwater
and marine/estuarine fish because all the acute fish toxicity data were
deemed invalid.

Table 15. Acute RQs for Aquatic Organisms Exposed to Mandipropamid
including its degradate of toxic concern, SYN500003 and SYN504851.

Measure of Effect(Test Species)	Toxicity

Value

(ppm)	EEC Peak (ppm)	Acute RQ

(EEC/Toxicity Value)

Freshwater Invertebrates (Test Species: Water flea)	48-h EC50 7.l	0.021
0.003 *

Marine/Estuarine Invertebrates

(Test Species: Mysid Shrimp)	96-h LC50 1.7	0.021	0.01 *

Marine/Estuarine Invertebrates

(Test Species: Eastern Oyster)	96-h EC50 0.91	0.021	0.02 *

* Does not exceed acute endangered species LOC of 0.05 or acute LOC of
0.1

b.	Chronic Risk to Aquatic Animals (Fish and Invertebrates)

Only a chronic RQ for freshwater fish from exposure to mandipropamid was
calculated. Chronic RQ values for estuarine and marine fish and
invertebrates and freshwater invertebrates from exposure to
mandipropamid could not be calculated because either the submitted data
were invalid or no study was submitted.  Based on the freshwater fish
chronic RQ value, mandipropamid does not pose a chronic risk to fish
(Table 16).

Table 16. Chronic RQs for Aquatic Organisms Exposed to Mandipropamid

Chemical	Measure of Effect (Test Species)	NOAEC

(ppm)	60 day EEC value (ppm)	Chronic RQ (EEC/NOAEC)

Mandipropamid	Freshwater fish (Test Species: Fathead minnow)	0.210
0.0095	0.05 *

* Does not exceed chronic LOC of 1.

Risks to Aquatic Plants

Based on the RQ calculations for aquatic plants, mandipropamid usage is
not expected to exceed the Agency’s Level of Concern for risk to
aquatic plants (Table 17).

Table 17. Risk Quotients for Aquatic Plants Algae Exposed to the
Mandipropamid

Type of aquatic plant	Organism	4-d EC50 (ppm)	4-d NOAEC

(ppm)	EEC Peak

(ppm)	RQ

Non-Listed

(EEC/EC50)	RQ

Listed

(EEC/NOAEC)

Aquatic vascular plant	Duck weed

(Lemna gibba)	> 7.9	1.3	0.021	< 1	0.02*

Aquatic nonvascular plant

>2.5 ppm

	1.3	0.021	< 1	0.02*

* Does not exceeds endangered  or non-endangered species LOC (1)

2.	 Non-Target Terrestrial Animals  tc "2.     Non-Target Terrestrial
Animals " \l 3 

To assess risks of mandipropamid to non-target terrestrial animals, EECs
and acute and chronic RQs for residues on various forage categories
(short grass, tall grass, broadleaf plants/small insects,
fruits/pods/large insects, and seeds) were obtained from the Tier I
model T-REX for maximum proposed application rates.  An explanation of
the model is presented in Appendix C. 

  SEQ CHAPTER \h \r 1 a.	Acute Risk to Mammals and Birds

Acute RQ values for avian or mammalian species were not calculated
because the highest concentration or dosages tested in the acute dietary
test (6080 ppm) and acute oral test (>1000 mg/kg-bw) for both a Mallard
duck and Northern bobwhite and the acute oral test for mammals (> 5000
mg/kg) did not result in any mortality (MRID 468001-10, 468001-11,
468001-12, and 468001-13).  Therefore at the highest dietary residue
level (103 ppm) no mortality from mandipropamid is likely given that no
mortality was observed at concentrations 60 times above this residue
level in laboratory birds and mammals.

  SEQ CHAPTER \h \r 1 b.	Chronic Risk to Birds and Mammals tc "b.       
Chronic Risk to Mammals and Birds " \l 4 

  SEQ CHAPTER \h \r 1 Dietary-based chronic RQs for birds and mammals
are summarized in Table 18.  Chronic RQs for birds and mammals are below
the chronic LOC (1) for all dietary residue categories.



Table 18. Dietary-Based Chronic RQs for Birds and Mammals Based on Upper
Bound Residues as Calculated by T-REX

Crop Use	Avian Chronic Risk Quotients

Based on Chronic NOAEC of 1060 ppm.

	Short Grass	Tall Grass	Broadleaf Plants/Small Insects	Fruits/Pods/

Large Insects

All proposed crops (See Usage Overview Section 4.)	0.10*	0.04*	0.05*
0.01*

* Note: Does not exceed the chronic LOC (1) for terrestrial animals.

Crop Use	Mammalian Chronic Risk Quotients

Based on a Chronic NOAEC of 250 ppm.

	Short Grass	Tall Grass	Broadleaf Plants/Small Insects	Fruits/Pods/

Large Insects

All proposed crops (See Usage Overview Section 4.)	0.41*	0.19*	0.23*
0.03*

* Note: Does not exceed the chronic LOC (1) for terrestrial animals

  SEQ CHAPTER \h \r 1 c.	Risk to Terrestrial Invertebrates

Although EFED does not quantitatively assess risks to non-target
terrestrial invertebrates, acute toxicity studies show that
mandipropamid TGAI is practically non-toxic to honey bees and nontoxic
to earthworms at the highest dose tested.  Additionally, acute toxicity
studies on the mandipropamid degradate, CGA380778, demonstrated that
CGA380778 is nontoxic to earthworms at the highest dose tested.

  SEQ CHAPTER \h \r 1 3.	Non-target Plants Inhabiting Terrestrial and
Semi-Aquatic Areas

RQs were not calculated to determine mandipropamid’s risk to nontarget
nonlisted terrestrial plant species because for all the plant species
tested in the vegetative vigor study and seedling emergence study the
validated EC25 values were above the highest levels tested. These test
levels were above the highest proposed use rates.  Thus, EFED does not
expect mandipropamid to pose a significant risk to nonlisted terrestrial
plants.  Table 19 demonstrates the listed terrestrial plant RQs for
mandipropamid based on the NOAEC values demonstrated in the terrestrial
plant studies.  The RQs indicate that mandipropamid does not pose a risk
to listed terrestrial plants that exceeds the Agency’s Level of
Concern.

  SEQ CHAPTER \h \r 1 Table 19. Risk Quotients for Non-Listed Species
and Listed Species Terrestrial and Semi-Aquatic Plant Emergence in Areas
Adjacent to Treatment Sites (due to drift) for Mandipropamid

Application Rate (lbs a.i./acre)	

Crop Use	Risk Quotients b

Terrestrial Plant Emergence

(Adjacent Area)	Semi-Aquatic Plant Emergence

(Adjacent Area)	Terrestrial Plant Vegetative Vigor (Drift)

Monocot	Dicot	Monocot	Dicot	Monocot	Dicot

Listed Terrestrial and Semi-Aquatic Plant

0.14	All proposed uses at the maximum application rate	0.006 c	0.02 c
0.04 c	0.17 c	0.0001 c	0.0001 c

a RQs are calculated using TerrPlant. See Appendix D for explanation
TerrPlant model.

b Based on the NOAEC values = 0.165 lb a.i./acre and 0.660 lb a.i./acre
for seedling emergence study in dicots and monocots respectively and
NOAEC = 0.792 for vegetative vigor in monocots and dicots.

c Does not Exceed Listed Species LOC for Terrestrial and Semi-Aquatic
Plants (≥1)

Risk Description

Risks to Aquatic Organisms

Based on risk estimates, the proposed mandipropamid uses are not
expected to pose a significant

acute risk to freshwater or marine and estuarine invertebrates

acute risk to aquatic plants

chronic risk to freshwater fish.

These conclusions are based on the premise that the RQ values for acute
risk to aquatic invertebrate, acute risk to plants, and chronic risk to
fish are several orders of magnitude below the Agency LOC.  Currently,
EFED is unable to definitively determine whether mandipropamid poses an
acute risk to fish because of the lack of acceptable fish acute toxicity
data.

  SEQ CHAPTER \h \r 1 2.	Risks to Terrestrial Organisms

a.	Terrestrial Animals (Mammals and Birds)

Based on available registrant submitted data, mandipropamid is not
expected to pose a significant chronic or acute risk to birds or
mammals.  

EFED avian and mammal acute and chronic risk conclusions are based on
the fact that the acute toxicity studies in birds and mammals failed to
establish acute lethality values, with no mortalities at the highest
doses/concentrations tested and the RQs for chronic risk to birds were
several orders of magnitude lower than the Agency Level of Concern for
avian chronic risk.

EFED’s conclusion regarding the chronic mammalian risk is based on the
premise that the chronic RQ values (derived from the rat
multigenerational NOAEC of 250 ppm based on decreases in body weight,
weight gains, food consumption, and food utilization) were more than 2
times less than the LOC for chronic dietary risk.  Thus, EFED does not
expect mammalian chronic exposure to mandipropamid to be a significant
risk.

b.	Insects

Although EFED does not derive RQ values for non-target insects, risks
can be assessed qualitatively. Results of toxicity studies on technical
grade mandipropamid show that the compound is practically non-toxic to
honey bees on both a contact and an oral basis and non toxic to
earthworms at the highest concentrations tested (1000 mg/kg in soil).
Therefore, acute risks of technical grade mandipropamid exposure to
pollinators and other beneficial insects are not anticipated.

c.	Plants

Formulated Product

EFED does not expect mandipropamid to pose a significant risk to
terrestrial plants.  This determination is based on the premise that the
RQ values for plants are several orders of magnitude lower than the
Agency LOC.

There is some uncertainty regarding the plant emergence RQ values
because they are based on a supplemental seedling emergence study.  The
study was deemed supplemental because the carrot species tested did not
yield any reliable endpoint values.  EFED assessed the plant emergence
risk of mandipropamid based on the other 9 species tested (all of which
demonstrated no significant risk from mandipropamid that exceeded the
Agency LOC).  Thus, there is some uncertainty whether plant species
closely related to carrots may be adversely affected by mandipropamid,
since EFED had no reliable test data on carrots.

3.	Review of Incident Data

Incident reports submitted to EPA since approximately 1994 have been
tracked by assignment of EIIS (Environmental Incident Information
System) in an Incident Data System (IDS). Since mandipropamid is a new
chemical and has not been previously approved for use in the U.S., there
are no incident reports.

4.	Endocrine Effects

None of the available data indicate that mandipropamid may have
detrimental effects on the endocrine system.

C. 	Federally Threatened and Endangered (Listed) Species Concerns

1. 	Action Area

For listed species assessment purposes, the action area is considered to
be the area affected directly or indirectly by the Federal action and
not merely the immediate area involved in the action. At the initial
screening level, the risk assessment considers broadly described
taxonomic groups and so conservatively assumes that listed species
within those broad groups are collocated with the pesticide treatment
area. This means that terrestrial plants and wildlife are assumed to be
located on or adjacent to the treated site and aquatic organisms are
assumed to be located in a surface water body adjacent to the treated
site. The assessment also assumes that the listed species are located
within an assumed area which has the relatively highest potential
exposure to the pesticide, and that exposures are likely to decrease
with distance from the treatment area. This risk assessment presents the
use of mandipropamid on all proposed uses including brassica, leafy
greens, bulb vegetables, cucurbits, grapes, leafy vegetables, peppers,
and other fruiting vegetables and establishes initial collocation of
species with treatment areas.

If the assumptions associated with the screening level assessment result
in RQs that are below the listed species LOCs, a "no effect"
determination conclusion is made with respect to listed species in that
taxa, and no further refinement of the action area is necessary.
Furthermore, RQs below the listed species LOCs for a given taxonomic
group indicate no concern for indirect effects upon listed species that
depend upon the taxonomic group covered by the RQ as a resource.
However, in situations where the screening assumptions lead to RQs in
excess of the listed species LOCs for a given taxonomic group, a
potential for a "may affect" conclusion exists and may be associated
with direct effects on listed species belonging to that taxonomic group
or may extend to indirect effects upon listed species that depend upon
that taxonomic group as a resource. In such cases, additional
information on the biology of listed species, the locations of these
species, and the locations of use sites could be considered to determine
the extent to which screening assumptions regarding an action area apply
to a particular listed organism. These subsequent refinement steps could
consider how this information would impact the action area for a
particular listed organism and may potentially include areas of exposure
that are downwind and downstream of the pesticide use site.

2. 	Taxonomic Groups Potentially at Risk

This screening level risk assessment indicates that uses of
mandipropamid will have: 1) no direct or indirect acute risk to listed
aquatic invertebrates, 2) no direct or indirect chronic risk to fish, 3)
no direct or indirect acute or chronic risk to birds, 3) no direct or
indirect acute or chronic risk to mammals, and no direct risk to aquatic
plants.  Currently, EFED cannot definitively determine the acute risk to
fish, or chronic risk to aquatic invertebrate because of the lack of
acceptable toxicity data for these organisms.

The Agency has developed the Endangered Species Protection Program to
identify pesticides whose use may cause adverse impacts on endangered
and threatened species, and to implement mitigation measures that
address these impacts. The Endangered Species Act (ESA) requires federal
agencies to ensure that their actions are not likely to jeopardize
listed species or adversely modify designated critical habitat. To
analyze the potential of registered pesticide uses that may affect any
particular species, EPA uses basic toxicity and exposure data and
considers it in relation to individual species and their locations by
evaluating important ecological parameters, pesticide use information,
geographic relationship between specific pesticide uses and species
locations, and biological requirements and behavioral aspects of the
particular species, as part of a refined use and species-specific
analysis. When conducted, this species-specific analysis will take into
consideration any regulatory changes that have been implemented at that
time.

3.	 Probit Dose Response Relationship

Because there were no LOC exceedances for any organisms based on any of
the available data a Probit Analysis was not warranted.

Indirect Effects Analysis

Because there were no LOC exceedances for any organisms based on any of
the available data an indirect effects analysis was not warranted.

5. 	Critical Habitat

In the evaluation of pesticide effects on designated critical habitat,
consideration is given to the physical and biological features
(constituent elements) of a critical habitat identified by the U.S Fish
and Wildlife and National Marine Fisheries Services as essential to the
conservation of a listed species and which may require special
management considerations or protection. The evaluation of impacts for a
screening level pesticide risk assessment focuses on the biological
features that are constituent elements and is accomplished using the
screening level taxonomic analysis (RQs) and listed species’ levels of
concern (LOCs) that are used to evaluate direct and indirect effects to
listed organisms.

Because there were no LOC exceedances for any organisms based on any of
the available data an identification of any endangered species critical
habitat was not warranted.

D.	Description of Assumptions, Limitations, Uncertainties, Strengths and
Data Gaps

1. 	Assumptions, Limitations, Uncertainties, Strengths and Data Gaps
Related to Exposure for All Taxa

There are a number of areas of uncertainty in the aquatic and
terrestrial risk assessments. The toxicity assessment for terrestrial
and aquatic animals is limited by the number of species tested in the
available toxicity studies. Use of toxicity data on representative
species does not provide information on the potential variability in
susceptibility to acute and chronic exposures.

This screening level risk assessment relies on labeled statements of the
maximum rate of mandipropamid application, the maximum number of
applications, and the shortest interval between applications. Together,
these assumptions constitute a maximum use scenario. The frequency at
which actual uses approach these maximums is dependant on resistance to
the fungicide, timing of applications, and market forces.

2. 	Assumptions, Limitations, Uncertainties, Strengths and Data Gaps
Related to Exposure for Aquatic Species

a.	GENEEC 2.0 Model

GENEEC is a single event model. It assumes one single large
rainfall/runoff event occurs that removes a large quantity of pesticide
from the field to the water all at one time. Longer-term, multiple-day
average concentration values are calculated based on the peak day value
and subsequent values considering degradation processes.  This
computer-based model utilizes basic chemical parameters (solubility,
photolysis, hydrolysis, Koc, and soil degradation) combined with
application rate and method of soil incorporation to determine the EEC.
The model considers the reduction in dissolved pesticide residues due to
adsorption to soil or sediment, incorporation depth, degradation in soil
before washoff to a water body, and degradation of the residues within
the water body. The model assumes that the runoff from a 10 hectare
(24.7 acre) field is entering a 1 hectare (2.47 acre) by 2 meter (6.56
feet) deep pond. GENEEC is a more extensive mathematical model designed
from output generated by the PRZM and EXAM models. However GENEEC is a
generic, in that it does not consider differences in climate, soil,
topography, or crop in estimating pesticide exposure.  GENEEC is used as
a tool to specifically estimate a pesticide concentration in a standard
water body due to off-target movement of pesticide. This model has been
used by OPP primarily in the first-tier risk assessment of pesticide
exposure to aquatic life.

OPP uses computer modeling (GENEEC) to estimate pesticide concentrations
in an edge-of-the-field pond for use in screening ecological exposure
and risk assessments. Such modeling has also been used as a screen for
drinking water assessments
(http://www.epa.gov/oscpmont/sap/meetings/1997/december/finaldec.pdf).



3. 	Assumptions, Limitations, Uncertainties, Strengths and Data Gaps
Related to Exposure for Terrestrial Species

a.	Residue Concentration

The data available to support the exposure assessment for mandipropamid
is substantially complete, with the exception of a foliar dissipation
study, which is an input variable for Tier I modeling of risks to birds
and mammals (i.e., T-REX Model). The terrestrial modeling was conducted
with a default foliar half-life of 35 days, which may not be realistic,
however, is likely a conservative foliar half-life for this compound.

b.	Variation in Habitat and Dietary Requirements

For screening terrestrial risk assessments, a generic bird or mammal is
assumed to occupy either the treated field or adjacent areas receiving
pesticide at a rate commensurate with the treatment rate on the field.
The habitat and feeding requirements of the modeled species and the
wildlife species may be different. It is assumed that species occupy,
exclusively and permanently, the treated area being modeled. This
assumption leads to a maximum level of exposure in the risk assessment.

  SEQ CHAPTER \h \r 1 The acute studies have a fixed exposure period,
not allowing for the differences in response of individuals to different
durations of exposure. Further, for the acute oral study, mandipropamid
is administered in a single dose which does not mimic wild birds’
exposure through multiple feedings. Also, it does not account for the
effect of different environmental matrices on the absorption rate of the
chemical into the animal. Because exposure occurs over several days,
both the accumulated dose and elimination of the chemical from the body
for the duration of the exposure determine the exact exposure to
wildlife, however, they are not taken into account in the screening
assessment. There was also no assumption of an effect of repeated doses
that change the tolerance of an individual to successive doses.

c.	  SEQ CHAPTER \h \r 1 Variation in Diet Composition

The risk assessment and calculated RQs assume 100% of the diet is
relegated to single food types foraged only from treated fields. The
assumption of 100% diet from a single food type may be realistic for
acute exposures, but diets are likely to be more variable over longer
periods of time. This assumption is likely to be conservative and will
tend to overestimate potential risks for chronic exposure, especially
for larger organisms that have larger home ranges. These large animals
(e.g., deer and geese) will tend to forage from a variety of areas and
move on and off of treated fields. Small animals (e.g., mice, voles, and
small birds) may have home ranges smaller than the size of a treated
field and will have little or no opportunity to obtain foodstuffs that
have not been treated with mandipropamid. Even if their home range does
cover area outside the treated field, mandipropamid may have drifted or
runoff to areas adjacent to the treated field.

d.	Exposure Routes Other than Dietary

Screening level risk assessments for spray applications of pesticides
consider dietary exposure to terrestrial organisms. Other exposure
routes are possible for animals residing in or moving through treated
areas. These routes include ingestion of contaminated drinking water,
ingestion of contaminated soils, preening/grooming, and dermal contact.
Preening exposures, involving the oral ingestion of material from the
feathers remains an unquantified, but potentially important, exposure
route. If toxicity is expected through any of these other routes of
exposure, then the risks of a toxic response to mandipropamid is
underestimated in this risk assessment. Other routes of exposure, not
considered in this assessment, are discussed below.

e.	Incidental Soil Ingestion Exposure

This risk assessment does not consider incidental soil ingestion.
Available data suggests that up to 15% of the diet can consist of
incidentally ingested soil depending on the species and feeding strategy
(Beyer et al. 1994). Although mandipropamid it is not expected to be
persistent in soils, incidental ingestion of soil within days of
mandipropamid application may be an important exposure pathway.

f.	Inhalation Exposure

The screening risk assessment does not consider inhalation exposure, due
to the low volatility of mandipropamid; it is not expected to be an
important exposure pathway.

g.	Dermal Exposure

The screening assessment does not consider dermal exposure. Dermal
exposure may occur through three potential sources: (1) direct
application of spray to terrestrial wildlife in the treated area or
within the drift footprint; (2) incidental contact with contaminated
vegetation; or (3) contact with contaminated water or soil.

The available measured data related to wildlife dermal contact with
pesticides are extremely limited. The Agency is actively pursuing
modeling techniques to account for dermal exposure via direct
application of spray and by incidental contact with vegetation.

h.	Drinking Water Exposure

Drinking water exposure to a pesticide active ingredient may be the
result of consumption of surface water or consumption of the pesticide
in dew or other water on the surfaces of treated vegetation. Given that
mandipropamid has a high solubility in water, there is the potential for
mandipropamid to dissolve in runoff and puddles on the treated field.
Consumption of drinking water would appear to be inconsequential if
water concentrations were equivalent to the concentrations from
PRZM/EXAMS; however, concentrations in puddled water sources on treated
fields may be higher than concentrations estimated in the 1 ha pond used
in EXAMS.  Given that this exposure route is not included in the
assessment, overall risk may be underestimated. Although the potential
impact of discharging groundwater is not explicitly delineated, it
should be noted that groundwater could provide a source of pesticide to
surface water bodies – especially low-order streams, headwaters, and
groundwater-fed pools.  This is particularly likely if the chemical is
persistent and mobile.  Soluble chemicals that are only subject to
photolytic degradation will be very likely to persist in groundwater,
and can be transportable over long distances.  Much of this groundwater
will eventually be discharged to the surface – often supporting stream
flow in the absence of rainfall. Continuously flowing low-order streams
in particular are sustained by groundwater discharge, which constitutes
100% of stream flow during baseflow (no runoff) conditions. Thus, it is
important to keep in mind that pesticides in groundwater can have a
major (detrimental) impact on surface water quality.

i.	Dietary Intake – Differences Between Laboratory and Field
Conditions

  SEQ CHAPTER \h \r 1 Several aspects of the dietary test introduce
uncertainty into calculation of the LC50 value (Mineau et al. 1994;
ECOFRAM 1999). The endpoint of this test is reported as the
concentration mixed with food that produces a response rather than as
the dose ingested. Although food consumption sometimes allows for the
estimate of a dose, calculations of the mg/kg/day dose are confounded by
undocumented spillage of feed and how consumption is measured over the
duration of the test. Usually, if measured at all, food consumption is
estimated once at the end of the five-day exposure period. Furthemore,
for studies in avian, group housing of birds undergoing testing only
allows for a measure of the average consumption per day for a group;
consumption estimates can be further confounded if birds die within a
treatment group. The exponential growth of young birds also complicates
the estimate of the dose; controls often nearly double in size over the
duration of the test. Since weights are only taken at the initiation of
the exposure period and at the end, the dose per body weight (mg/kg) is
difficult to estimate with any precision. The interpretation of this
test is also confounded because the response of birds is not only a
function of the intrinsic toxicity of the pesticide, but also the
willingness of the birds to consume treated food.

Further, the acute and chronic characterization of risk rely on
comparisons of wildlife dietary residues with LC50 or NOAEC values
expressed in concentrations of pesticides in laboratory feed. These
comparisons assume that ingestion of food items in the field occurs at
rates commensurate with those in the laboratory. Although the screening
assessment process adjusts dry-weight estimates of food intake to
reflect the increased mass in fresh-weight wildlife food intake
estimates, it does not allow for gross energy and assimilative
efficiency differences between wildlife food items and laboratory feed.
On gross energy content alone, direct comparison of a laboratory dietary
concentration based effects threshold to a fresh-weight pesticide
residue estimate would result in an underestimation of field exposure by
food consumption by a factor of 1.25–2.5 for most food items. Only for
seeds would the direct comparison of dietary threshold to residue
estimate lead to an overestimate of exposure.

Differences in assimilative efficiency between laboratory and wild diets
suggest that current screening assessment methods do not account for a
potentially important aspect of food requirements. Depending upon
species and dietary matrix, bird assimilation of wild diet energy ranges
from 23–80%, and mammal's assimilation ranges from 41–85% (USEPA
1993). If it is assumed that laboratory chow is formulated to maximize
assimilative efficiency (e.g., a value of 85%), a potential for
underestimation of exposure may exist by assuming that consumption of
food in the wild is comparable with consumption during laboratory
testing. In the screening process, exposure may be underestimated
because metabolic rates are not related to food consumption.

Finally, the screening procedure does not account for situations where
the feeding rate may be above or below requirements to meet free living
metabolic requirements. Gorging behavior is a possibility under some
specific wildlife scenarios (e.g., bird migration) where the food intake
rate may be greatly increased. Kirkwood (1983) has suggested that an
upper-bound limit to this behavior might be the typical intake rate
multiplied by a factor of 5. In contrast is the potential for avoidance,
operationally defined as animals responding to the presence of noxious
chemicals in their food by reducing consumption of treated dietary
elements. This response is seen in nature where herbivores avoid plant
secondary compounds.

In the absence of additional information, the acute oral LD50 test
provides the best estimate of acute effects for chemicals where exposure
can be considered to occur over relative short feeding periods, such as
the diurnal feeding peaks common to avian species (ECOFRAM 1999).

4. 	Assumptions, Limitations, Uncertainties, Strengths and Data Gaps
Related to Effects Assessment

a.	Age Class and Sensitivity of Effects Thresholds

It is generally recognized that test organism age may have a significant
impact on the observed sensitivity to a toxicant. The screening risk
assessment acute toxicity data for fish are collected on juvenile fish
between 0.1 and 5 grams. Aquatic invertebrate acute testing is
performed on recommended immature age classes (e.g., first instar for
daphnids, second instar for amphipods, stoneflies, and mayflies, and
third instar for midges). Similarly, acute dietary testing with birds is
also performed on juveniles, with mallard ducks being 5–10 days old
and bobwhite quail 10–14 days old.

Testing of juveniles may overestimate toxicity of older age classes for
pesticidal active ingredients, such as mandipropamid, that act directly
(without metabolic transformation) because younger age classes may not
have the enzymatic systems associated with detoxifying xenobiotics. The
screening risk assessment has no current provisions for a generally
applied method that accounts for this uncertainty. In so far as the
available toxicity data may provide ranges of sensitivity information
with respect to age class, the risk assessment uses the most sensitive
life-stage information as the conservative screening endpoint.

b.	Use of the Most Sensitive Species Tested

Although the screening risk assessment relies on a selected toxicity
endpoint from the most sensitive species tested, it does not necessarily
mean that the selected toxicity endpoint reflects sensitivity of the
most sensitive species existing in a given environment. The relative
position of the most sensitive species tested in the distribution of all
possible species is a function of the overall variability in sensitivity
among species to a particular chemical. In the case of listed species,
there is uncertainty regarding the relationship of the listed species'
sensitivity and the most sensitive species tested.

The Agency is not limited to a base set of surrogate toxicity
information in establishing risk assessment conclusions. When available,
the Agency also considers toxicity data on non-standard test species.

V.	REFERENCES

  SEQ CHAPTER \h \r 1 Open Literature, Government Reports, and Product
Labels

Beyer, W.N. 1994. Estimates of soil ingestion by wildlife. J Wildl
Manage 58(2):375–382.

Davis, G.E., P.L. Haaker, and D.V. Richards. 1996. Status and trends of
white abalone at the California Channel Islands. Transactions of the
American Fisheries Society 125:42–48.

Fletcher, J.S., J.E. Nellesson, and T. G. Pfleeger. 1994. Literature
review and evaluation of the EPA food-chain (Kenaga) nomogram, an
instrument for estimating pesticide residues on plants. Environ Toxicol
Chem 13(9):1383–1391.

Kirkwood JK. 1983. Minireview. A limit to metabolisable energy intake in
mammals and birds. Comp Biochem Physiol A 75(1):1-3.

Martin, C. M., H. S. Zim, and A. C. Nelson. 1951. American Wildlife and
Plants - A Guide to Wildlife Food Habits, Dover Publishers Inc., New
York.

Mineau, P., B.T. Collins, and A. Baril. 1996. On the use of scaling
factors to improve interspecies extrapolation to acute toxicity in
birds.  Reg Toxicol Pharmacol  24:24–29.

Urban, D.J. and Cook, N. 1986. Hazard Evaluation Division, Standard
Evaluation Procedure: Ecological Risk Assessment 104.pp. Document Number
No. PB 86 247 657. EPA-540/9-86-167.

USDA. 2002. 2002 Census of Agriculture.  Available on-line at  
HYPERLINK "http://www.nass.usda.gov/Census_of_Agriculture/index.asp" 
http://www.nass.usda.gov/Census_of_Agriculture/index.asp 

U.S. EPA. 1993. Wildlife Exposure Factors Handbook. Volume I of II.
EPA/600/R-93/187a. U.S. Environmental Protection Agency, Office of
Research and Development, Washington, DC. 20460.

U.S. EPA. 1999. ECOFRAM. U.S. Environmental Protection Agency,
Washington, DC. Available on-line at   HYPERLINK
"http://www.epa.gov/oppefed1/ecorisk/index.htm" 
http://www.epa.gov/oppefed1/ecorisk/index.htm .

  SEQ CHAPTER \h \r 1 U.S. EPA. 2001. Ecological Risk Assessor
Orientation Package. U.S. Environmental Protection Agency, Ecological
Fate and Effects Division. Draft Version, August 2001.

  SEQ CHAPTER \h \r 1 U.S. EPA. 2002a. Data Requirements for
Registration. U.S. Environmental Protection Agency, Washington, DC. 
Code of Federal Regulations 40 CFR §158.202.

U.S. EPA. 2002b. Guidance for Selecting Input Parameters in Modeling the
Environmental Fate and Transport of Pesticides, Version II. U.S.
Environmental Protection Agency, Washington, DC.  February 28, 2002.

U.S. EPA. 2004. Overview of Ecological Risk Assessment Process in the
Office of Pesticide Programs, U.S. Environmental Protection Agency.
Endangered and Threatened Species Effects Determinations. Office of
Prevention, Pesticides, and Toxic Substances, Office of Pesticides
Programs. Washington, DC. January 23, 2004.

U.S. EPA. 2006a. User’s Guide for T-REX (Terrestrial Residue Exposure
model) Version 1.3.1 U.S. Environmental Protection Agency. Release
December 7, 2006.

U.S. EPA. 2006b. TerrPlant Terrestrial Plant Exposure Model. Version
1.2.2. U.S. Environmental Protection Agency. Released December 26, 2006.



APPENDIX A.	Environmental Fate Data

161-1. Hydrolysis

MRID 46800007,8  (Acceptable)

[ethyl-1-14C]-labeled
2-(4-chlorophenyl)-N-[2-(3-methoxy-4-prop-2-ynyloxy-phenyl)-ethyl]-2-pro
p-2-ynyloxy-acetamide (mandipropamid; NOA446510; radiochemical purity
98.9%)

was stable in pH 5, 7, and 9 sterile aqueous buffered solutions at 25
ºC over the course of a 32-day incubation period. Overall recoveries of
[14C]residues averaged 100.0 ( 3.4% of the applied (range 94.4-104.9%)
from the pH 5 buffer solution, 98.1 ( 0.8% of the applied (range
97.2-99.4%) from the pH 7 buffer solution, and 100.1 ( 1.1% (range
99.1-101.6%) from the pH 9 buffer solution.  There was no pattern of
loss of material over time from any of the buffer solutions.
[14C]Mandipropamid averaged 97.8-102.5% of the applied in the pH 5
solutions, 97.5-99.0% in the pH 7 solutions, and 99.3-101.6% in the pH 9
solutions.  No major or minor transformation products were detected;
mandipropamid was the only compound detected and comprised 100% of the
recovered at all sampling intervals.  Volatiles were not measured. This
study is classified as Acceptable.

161-2. Aqueous Photolysis

MRID 46800009(Acceptable)

[chlorophenyl-U-14C]-labeled
2-(4-chlorophenyl)-N-[2-(3-methoxy-4-prop-2-ynyloxy-phenyl)-ethyl]-2-pro
p-2-ynyloxy-acetamide (mandipropamid; NOA446510; radiochemical purity
(98%), at a nominal concentration of 1 (g a.i./mL, at 25(C in sterilized
pond  water from the UK (pH 7.02), degraded with a reviewer-calculated
first-order linear half-life of 15.2 hours based on the continuous
irradiation of  44.79 W/m2 (300-400 nm); 1 hour of artificial light was
equivalent to 0.65 hours of summer sunlight (68.98 W/m2; 300-400 nm) at
40(N latitude.  Mandipropamid was stable in the dark controls during the
7 days of incubation. In the irradiated buffer solutions, no major
transformation products were identified.  Polar compounds totaled a
maximum average of 36.7% of the applied at 168 hours posttreatment
(individual samples 24.7% and 48.7%).  Two minor nonpolar transformation
products were identified.  CGA380778 and NOA458422 averaged maximums of
3.7% and 3.9% of the applied, respectively.  The study is Acceptable.

MRID 46800010(Acceptable)

[methoxyphenyl-U-14C]-labeled
2-(4-chlorophenyl)-N-[2-(3-methoxy-4-prop-2-ynyloxy-phenyl)-ethyl]-2-pro
p-2-ynyloxy-acetamide (mandipropamid; NOA446510; radiochemical purity
(95.7%), at a nominal concentration of 1 (g a.i./mL, at 25(C in
sterilized pond water from the UK (pH 7.02). degraded with a
reviewer-calculated first-order linear half-life of 15.2 hours based on
the continuous irradiation of  22.4 hours, continuously irradiated using
a filtered xenon lamp (300- 800 nm) for 166.4 hours (ca. 7 days). 
Mandipropamid was stable in the dark control during the 3 days of
incubation. No major transformation products were isolated and no minor
transformation products were identified in either the irradiated samples
or dark controls.  In the irradiated solutions only, unidentified polar
compounds totaled a maximum of 25.0% of the applied at 72.2 hours
posttreatment.  This fraction consisted of at least 14 separate
components with no single component (8.4% of the applied.  At 72 hours
posttreatment, 14CO2 averaged 6.0% of the applied in the irradiated
samples and were not detected in the dark controls. Based on the study
results, mandipropamid photodegrades to numerous minor polar compounds
and CO2. The study is Acceptable.

MRID 46800011,12(supplemental)

[chlorophenyl-U-14C]-labeled
2-(4-chloro-phenyl)-N-[2-(3-methoxy-4-prop-2-ynyloxy-phenyl)-ethyl]-2-pr
op-2-ynyloxy-acetamide (mandipropamid; NOA446510) radiochemical purity
98.1%), at a nominal concentration of 1.0 mg a.i./L at 25(C sterile pH 7
buffer (0.01M phosphate), continuously irradiated using a filtered xenon
lamp (290- 750 nm) for 15 days, dissipated with a half-life of 6.6 days
(158.4 hours), based on the continuous irradiation of 30.74 W/m2
(300-400 nm); 1 hour of artificial light was equivalent to 0.45 hours of
summer sunlight (68.98 W/m2; 300-400 nm) at 40(N latitude. 
[14C]Mandipropamid was stable in the dark controls. No major
transformation products were isolated from either the irradiated samples
or dark controls.  Based on the study results, mandipropamid
photodegrades to numerous minor transformation products and CO2. This
study is supplemental and upgradeable upon submission of the detailed
results (concentration of parent) or the square vessel experiment.

MRID 46800013,14(Acceptable)

[methoxyphenyl-U-14C]-labeled
2-(4-chloro-phenyl)-N-[2-(3-methoxy-4-prop-2-ynyloxy-phenyl)-ethyl]-2-pr
op-2-ynyloxy-acetamide (mandipropamid; NOA446510; radiochemical purity
(99%), at a nominal concentration of 1.0 mg a.i./L, at 25(C sterile pH 7
buffer (0.01M phosphate) continuously irradiated using a filtered xenon
lamp (300- 800 nm) for 336 hours, dissipated with a half-life of 26.4
hours, based on the continuous irradiation of 29.93 W/m2 (300-400 nm); 1
hour of artificial light was equivalent to 93 W/m2 (300-400 nm); 1 hour
of artificial light was equivalent to 0.43 hours of summer sunlight
(68.98 W/m2; 300-400 nm) at 40(N latitude.  No major transformation
products were isolated from either the irradiated samples or dark
controls.  No minor transformation products were identified in the
irradiated samples and none were isolated from the dark controls.  In
the irradiated buffer solution, 16 minor nonpolar transformation
products, none averaging (5% of the applied, and at least 10 minor polar
transformation products were isolated.

161-3. Soil Photolysis

MRID 46800015 (Acceptable)

[14C-chlorophenyl]-labeled
2-(4-chlorophenyl)-N-[2-(3-methoxy-4-prop-2-ynyloxy-phenyl)-ethyl]-2-pro
p-2-ynyloxy-acetamide (mandipropamid; NOA446510; radiochemical purity
(98.0%) on loam soil (pH 7.1, organic matter 3.5%) from Switzerland
under continuous irradiation for 15 days at 20 ( 2(C, degraded with a
half-life of 16.39 days and 20.33 days in the irradiated samples for the
dry soil and moist soil experiments, respectively. The intensity of the
Xenon arc lamp was 53.14-53.98 W/m2/nm, which was reported to be similar
to natural summer sunlight at latitude 30-50(N.  Mandipropamid degrades
to CGA380778, NOA458442 and SYN521195.  CGA380778 degrades to NOA459119
and CGA380775.  NOA458442 degrades to CGA380775 and SYN505503. 
SYN521195 degrades to SYN505503.  CGA380775 degrades to NOA459119.  The
transformation products are ultimately degraded to non-extractable
residues and carbon dioxide. This study is acceptable.

162-1. Aerobic Soil Metabolism

MRID 46800020,21 (Acceptable)

[14C-chlorophenyl]-labeled
2-(4-chlorophenyl)-N-[2-(3-methoxy-4-prop-2-ynyloxy-phenyl)-ethyl]-2-pro
p-2-ynyloxy-acetamide (mandipropamid; NOA446510; radiochemical purity
99.28%) was applied at the rate of 0.23 mg a.i./kg soil, equivalent to
150 g a.i./ha (nominal)

to a sandy loam soil (pH 6.6, organic carbon 0.5%) from Visalia,
California for 371 days under aerobic conditions in darkness at 25 ( 1(C
and 75% field moisture capacity at 1/3 bar. The linear and nonlinear
half-lives of [14C]mandipropamid in aerobic soil were 72.2 and 34.3
days, respectively.  No major transformation products were identified. 
Four minor transformation products identified: CGA380778
(benzeneacetamide,
4-chloro-alpha-hydroxy-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl])
was a maximum of 4.25% at 30 days, CGA380775 (benzeneacetamide,
4-chloro-alpha-hydroxy-N-[2-(4-hydroxy-3-methoxyphenyl)ethyl]) was a
maximum of 0.51% at 30 days, SYN500003 was a maximum of 0.27% at 7 days,
and NOA458422 was a maximum 0.18% at study termination.

A supplementary study at a high dose was conducted in order to identify
mandipropamid and transformation products.  Mandipropamid was applied to
soil at 1.35 mg a.i./ kg soil.  The concentration of mandipropamid
decreased from 97.25% of the applied at day 0 to 48.74% at 59 days and
was 6.69% at study termination.  The first-order linear and nonlinear
half-life values were 100.5 and 59.2 days, respectively, in the sandy
loam soil.  The major transformation product was volatilized 14CO2
totaling 43.1% of the applied.  Four minor transformation products were
identified as CGA380778, CGA380775, SYN500003 and NOA458422.

A second supplementary study was performed to determine the microbial
viability of the soil by monitoring for carbon dioxide efflux with a
Micro-Oxymax Biomass Analyzer for ca. 18 hours.  The biomass of the soil
samples after incubation for 0, 182 and 371 days was 124.07, 62.32 and
44.43 mg C/kg soil, respectively. This study is acceptable.

MRID 46800022 (Supplemental)

[methoxyphenyl-U-14C]-labeled
2-(4-chlorophenyl)-N-[2-(3-methoxy-4-prop-2-ynyloxy-phenyl)-ethyl]-2-pro
p-2-ynyloxy-acetamide (mandipropamid, NOA 446510; radiochemical purity
98.9%} was studied in a silt loam soil (pH 7.2, organic carbon 2.14%)
from Switzerland for 120 days under aerobic conditions in dark at 20.3 (
0.3(C and 40% of water holding capacity at pF 1.  [14C]Mandipropamid was
applied at the rate of 0.40 mg a.i./kg soil, which is  equivalent to
0.30 kg a.i./ha.  Based on nonlinear analysis and using individual
sample data, the half-life was determined to be 19.6 days.  The
first-order linear half-life was 26.1 days.

No major transformation products were isolated.  The only minor
transformation product that was identified was CGA380778 which averaged
a maximum of 2.9% of the applied.  Unidentified “Minor metabolites”
(up to 13 compounds) totaled a maximum of 2.4%, and “remainder”
(unresolved radioactivity in HPLC and Soxhlet extracts) was observed at
a maximum of 8.7%.  Extractable [14C] residues decreased from 96.79% of
the applied at time 0 to 9.07% at 120 days, while nonextractable
[14C]residues increased to 45.45% at 120 days. At 120 days
posttreatment, 14CO2 and organic volatiles accounted for 37.06% and
0.01% of the applied, respectively. This study is classified as
supplemental and upgradeable upon submission of additional information
related to classification of soils used in this study, in accordance to
FAO Soil Classification (i.e. Soil Units) or equivalent U.S. Soil
Taxonomy.

MRID 46800023 (Supplemental)

The biotransformation of [14C-methoxyphenyl]-labeled
2-(4-chloro-phenyl)-2-hydroxy-N-[2-(3-methoxy-4-prop-2-ynyloxy-phenyl)-e
thyl]-acetamide (CGA380778; radiochemical purity 97.9%) was studied in a
silt loam soil (pH 7.35, organic carbon 2.2%) from Switzerland and a
sandy clay loam soil (pH 5.88, organic carbon 2.7%) from the United
Kingdom for 28 days and a sandy loam soil (pH 6.0, organic carbon 0.5%)
from the United States for 120 days under aerobic conditions in darkness
at 19.3 ( 0.5(C and soil moisture of pF2.   [14C]CGA380778 was applied
at a rate of 0.09 mg a.i./kg, equivalent to 9 g a.i./ha (nominal). 
CGA380778 dissipated more slowly in the sandy loam soil compared to the
silt loam and sandy clay loam soils.  The linear and nonlinear
half-lives of CGA380778 were 6.4 and 3.5 days in the silt loam soil, 6.9
and 3.1 days in the sandy clay loam soil and 57.8 and 41.5 days in the
sandy loam soil, respectively. One major transformation product was
volatilized 14CO2 (identification confirmed) totaling means of 51.0%,
50.6% and 31.5% of the applied for the silt loam, sandy clay loam and
sandy loam soils, respectively, at study termination; volatile
[14C]organic compounds were not detected ((0.2%) for all three soils at
any sampling interval.  No minor transformation products were
identified.

This study is classified as supplemental and upgradeable upon submission
additional information related to classification of soils used in this
study, in accordance to FAO Soil Classification (i.e. Soil Units) or
equivalent U.S. Soil Taxonomy.

MRID 46800024,25 (Supplemental)

The biotransformation of [14C-methoxyphenyl]-labeled
2-(4-chlorophenyl)-N-[2-(3-methoxy-4-prop-2-ynyloxy-phenyl)-ethyl]-2-pro
p-2-ynyloxy-acetamide (mandipropamid; NOA446510; radiochemical purity
(97%) was studied in a sandy loam soil (pH 7.3, organic carbon 2.3%)
from Switzerland for 119 days under aerobic conditions in darkness at 20
( 2(C and 75% of pF2 moisture.  Mandipropamid was applied at the rate of
0.2 mg a.i./kg soil and 1.0 mg a.i./kg soil (nominal).  At the 0.2 mg
a.i./kg application rate, the linear and nonlinear half-lives of
mandipropamid were 77.9 and 77.0 days, respectively.  Two minor
transformation products, CGA380778 and SYN536638 (unknown 1) formed at
maximums of 1.4% (28 and 119 days) and 2.4% (91 days) of the applied,
respectively.  One transformation product, NOA458422, was detected by
LC/MS/MS, but was below the limit of detection for HPLC.  At study
termination volatilized 14CO2 totaled 21.8% of the applied.

At the 1.0 mg a.i./kg application rate, the linear and nonlinear
half-lives of mandipropamid were 103.5 days.  Two minor transformation
products, CGA380778 and SYN536638 (unknown 1) formed at maximums of 1.7%
(7 days) and 3.1% (119 days) of the applied, respectively.  Total
extractable [14C]residues decreased from an average of 94.4% of the
applied at day 0 to 49.2% at study termination, while nonextractable
[14C]residues increased from 1.3% of the applied at day 0 to 27.1% at
study termination.  At study termination, volatilized 14CO2 totaled
19.7% of the applied.

Mandipropamid is ultimately degraded into carbon dioxide and
unextractable residues.

Two supplementary studies were performed with soil samples treated with
0.2 mg a.i./kg mandipropamid maintained at low moisture (30% of pF2
moisture) and at low temperature (10(C) for 119 days.  Mandipropamid
degraded more slowly in the supplementary experiments.  In the low
moisture study, the concentration of mandipropamid decreased from an
average of 92.6% of the applied at day 0 to 53.7% at study termination. 
The calculated DT50 and DT90 were 149.5 and 497.2 days, respectively,
based on both simple first-order regression, and first-order
multi-compartment regression. The same transformation products,
CGA380778 and SYN536638 (unknown 1), were detected in each study at
(1.7% of the applied.

This study is classified as supplemental and upgradeable upon the
submission of additional information related to classification of soils
used in this study, in accordance to FAO Soil Classification (i.e. Soil
Units) or equivalent U.S. Soil Taxonomy.

MRID 46800027 (Supplemental)

The biotransformation of [chlorophenyl-U-14C]-labeled
2-(4-Chlorophenyl)-N-[2-(3-methoxy-4-prop-2-ynyloxy-phenyl)-ethyl]-2-pro
p-2-ynyloxy-acetamide (mandipropamid, NOA446510, radiochemical purity
100%} was studied in a loam/silt loam soil (pH (KCl) 7.3, organic carbon
1.7%) from Switzerland for 120 days under aerobic conditions in dark at
19.0 ( 0.6(C and soil moisture content of 100% of pF 2. 
[14C]Mandipropamid was applied at the rate of 0.40 mg a.i./kg soil,
which is  equivalent to 0.30 kg a.i./ha.  The nonlinear analysis
(SigmaPlot v 9) and using individual sample data, the half-life was
determined to be 26.1 days.  The first-order linear half-life was 32.4
days.  No major transformation products were isolated.  The only minor
transformation product that was identified was CGA380778, which averaged
a maximum of 3.2% of the applied.  Nine minor transformation products
totaled a maximum of 2.4% of the applied and “remainder” (unresolved
radioactivity) was observed at a maximum of 11.4%.  At 120 days
posttreatment, [14C]CO2 and organic volatiles accounted for 36.0% and
0.0% of the applied, respectively.

Based on the study results, mandipropamid degrades into multiple minor
metabolites, including CGA380778, CO2, and tightly bound residues.

This study is classified as as supplemental and upgradeable upon the
submission of additional information related to classification of soils
used in this study, in accordance to FAO Soil Classification (i.e. Soil
Units) or equivalent U.S. Soil Taxonomy.

MRID 46800028 (Supplemental)

The biotransformation of [14-C-chlorophenyl]-labeled
2-(4-chlorophenyl)-N-[2-(3-methoxy-4-prop-2-ynyloxy-phenyl)-ethyl]-2-pro
p-2-ynyloxy-acetamide (mandipropamid; NOA446510; radiochemical purity
(98.7%) was studied in a sandy clay loam soil (pH 6.2, organic carbon
3.5%) from the United Kingdom, a loamy sand soil (pH 6.5, organic carbon
0.8%) from Germany and a loam soil (pH 8.5, organic carbon 1.3%) from
France for 120 days under aerobic conditions in darkness at 20 ( 2(C and
pF2 moisture.  Mandipropamid was applied at the rate of 0.2 mg a.i./kg
soil (nominal).

In sandy clay loam soil, based on first-order linear and nonlinear
regression analysis, mandipropamid degraded with half-life values of
51.3 and 43.9 days, respectively.

In loamy sand soil, based on first-order linear and nonlinear regression
analysis, mandipropamid degraded with half-life values of 83.5 and 80.6
days, respectively.

In loam soil, based on first-order linear and In sandy clay loam soil,
based on first-order linear (Excel 2003) and nonlinear (SigmaPlot v 9)
regression analysis, mandipropamid degraded with half-life values of
51.3 and 43.9 days, respectively (DER Attachment 2).  Observed DT50
value was 21-28 days (Table 9, p. 51).  Using Model Manager v. 1.1, the
study author determined the half-life for mandipropamid using simple
first order and first order multicompartment kinetics as 43.9 and 33.7
days, respectively (p. 26, Table 8, p. 50, Appendix 7, p. 40 and Figure
29-30, pp. 116-117).

In loamy sand soil, based on first-order linear and nonlinear regression
analysis, mandipropamid degraded with half-life values of 83.5 and 80.6
days, respectively.

In loam soil, based on first-order linear and nonlinear regression
analysis, mandipropamid degraded with half-life values of 90.0 and 85.6
days, respectively. In each of the soils, one minor transformation
product was identified as CGA380778.  LC/MS/MS analysis identified low
levels of transformation products not identified by HPLC and 2D-TLC
including: CGA380775, NOA458422 and SYN505503. Mandipropamid is
ultimately degraded into carbon dioxide and bound residues. This study
is classified as as supplemental and upgradeable upon the submission of
additional information related to classification of soils used in this
study, in accordance to FAO Soil Classification (i.e. Soil Units) or
equivalent U.S. Soil Taxonomy.

162-2 Anaerobic Soil Metabolism

MRID 46800027 (Supplemental)

The biotransformation of [chlorophenyl-U-14C]-labeled
2-(4-chlorophenyl)-N-[2-(3-methoxy-4-prop-2-ynyloxy-phenyl)-ethyl]-2-pro
p-2-ynyloxy-acetamide (mandipropamid, NOA446510, radiochemical purity
100%} was studied in flooded loam/silt loam soil (pH (KCl) 7.3, organic
carbon 1.7%) from Switzerland for 120 days under anaerobic conditions in
dark at 19.0 ( 0.6(C.  [14C]Mandipropamid was applied at the rate of
0.40 mg a.i./kg soil, which is  equivalent to 0.30 kg a.i./ha. 
Anaerobicity, temperature and other experimental conditions were
reportedly maintained throughout the study.  In the water layer, the
dissolved oxygen and pH levels were 0.01-0.96 mg/L and 6.50-8.77,
respectively.  Redox potentials in the water layer ranged from (148 to
(68 mV; redox potentials in the soil ranged (232 to (72 mV.  The
viability of the soil microflora in soil treated with mandipropamid was
not determined.

Based on first-order linear regression analysis, mandipropamid
dissipated with a half-life of 198.0 days.  Based on nonlinear analysis,
the half-life was 183 days.

No major transformation products were isolated.  The only minor
transformation product that was identified was CGA380778, which averaged
a maximum of 3.9% of the applied.  Nine minor transformation products
totaled a maximum of 4.1% of the applied and “remainder” (unresolved
radioactivity) was observed at a maximum of 9.6%.  At 120 days
postflooding, the nonextractable residues were partitioned into 3.1-6.5%
of the applied as fulvic acids, 1.3-5.6% humic acids and 16.7-25.2%
humin.  At 120 days postflooding, 14CO2 and organic volatiles accounted
for 17.4% and 0.2%, respectively.  Based on the study results,
mandipropamid degrades into multiple minor metabolites, including
CGA380778, CO2, and tightly bound residues. This study is classified as
supplemental and upgradeable upon the submission of additional
information related to classification of soils used in this study, in
accordance to FAO Soil Classification (i.e. Soil Units) or equivalent
U.S. Soil Taxonomy.

162-3 Anaerobic Aquatic Metabolism

MRID 46800033,34 (Unacceptable)

The biotransformation of [methoxyphenyl-U-14C]-labeled
2-(4-chloro-phenyl)-N-[2-(3-methoxy-4-prop-2-ynyloxy-phenyl)-ethyl]-2-pr
op-2-ynyloxy-acetamide (mandipropamid, NOA446510; radiochemical purity
(98.0%) was studied in lake water-silt loam sediment (water pH 8.1-8.25,
dissolved organic carbon 12.1 mg/L; sediment pH 7.2-7.6, organic carbon
5.5%) and lake water-loamy sand sediment (water pH 5.8-5.83, dissolved
organic carbon 1.5 mg/L; sediment pH 4.6-5.3, organic carbon 0.9%)
systems from the United Kingdom for 120 days under anaerobic conditions
in darkness at 20 ( 2(C.  Based on the water volume, [14C]mandipropamid
was applied at a rate of 0.26 mg a.i./L.  For both systems, the
sediment:water ratio used was 1:4 (40 g dry wt. sediment:160 g water).

The test conditions presented in the study appear to have been
maintained throughout the 120-day incubations.  In untreated lake
water-silt loam systems incubated alongside the treated systems,
conditions were moderately reducing to moderately oxidizing in the water
layers and moderately reducing in the sediment with average redox
potentials of (253 ( 79 mV and (124 ( 15 mV, respectively, and water pH
levels of 8.24 ( 0.15.  In untreated lake water-loamy sand systems,
conditions in the water layers and sediment went from moderately
reducing during the initial month posttreatment to moderately oxidizing
from 2 months to study termination with average redox potentials in the
water layer and sediment increasing from (78 ( 14 mV at 6 days
posttreatment to (231 ( 10 mV at 59 days and were (229 ( 7 mV at 119
days; water pH levels averaged 7.51 ( 0.33 over the 120-day incubation.

For both systems, the following four transformation products were
detected:

2-(4-chloro-phenyl)-N-[2-(3-hydroxy-4-prop-2-ynyloxy-phenyl)-ethyl]-2-pr
op-2-ynyloxy-acetamide (SYN521195),

N-[2-(4-allyloxy-3-hydroxy-phenyl)-ethyl]-2-(4-chloro-phenyl)-2-prop-2-y
nyloxy-acetamide (SYN539678),

2-allyloxy-N-[2-(4-allyloxy-3-hydroxy-phenyl)-ethyl]-2-(4-chloro-phenyl)
-acetamide (SYN539679) and

N-[2-(4-allyloxy-3-methoxy-phenyl)-ethyl]-2-(4-chloro-phenyl)-2-prop-2-y
nyloxy-acetamide (SYN536638).

SYN521195 and SYN539678 were major transformation products in the lake
water-silt loam systems, but minor products in the lake water-loamy sand
systems.  SYN539679 and SYN536638 were minor products in both systems. 
Dissipation of mandipropamid and formation of products in the total
system occurred at a faster rate in the silt loam systems as compared to
the loamy sand systems.  The faster dissipation rate in the silt loam
systems may have been due to greater microbial activity, with microbial
biomass (as (C/g soil) ca. 5- to 10-fold higher in the silt loam systems
as compared to the loamy sand systems.  14CO2 was a major volatile
product with maximum totals of 40.3% and 36.0% of the applied at study
termination for the lake water-silt loam and lake water-loamy sand
systems, respectively, while no [14C]residues were extracted from the 7-
to 3-day organic volatiles carbon traps. Mandipropamid in the total
system decreased from 96.3% of the applied at day 0 to 58.2% at 21days,
41.3% at 30 days, 9.5% at 62 days, 2.3-2.4% at 83-100 days and was 0.1%
at study termination; 120-day sediment extracts were not analyzed.  In
the water layer, mandipropamid decreased from 93.6% at day 0 to 51.8% at
21 days, 38.7% at 30 days, 9.5% at 62 days, 1.4% at 100 days and was
0.1% at 120 days.  In the sediment, [14C]mandipropamid increased from
2.7% at day 0 to 7.3% at 14 days, then decreased to 2.6% at 30 days and
was (1.1% at 42-100 days.  Observed DT50 values were 21-30 days in the
water layer, sediment and total system.  Calculated linear half-lives
(r2 = 0.4053-0.9473) were 14 days in the water layer and total system
and 13 days in the sediment, while nonlinear half-lives (r2 =
0.9406-0.9861) were 22 days in the water and total system and 12 days in
the sediment.  Maximum levels of the transformation products in the
water, sediment and total system were as follows:  2.8%, 5.6% and 8.5%,
respectively, for SYN521195, 2.1%, 6.4% and 6.4%, respectively, for
SYN539678, and 3.3%, 2.3% and 4.0%, respectively, for
SYN539679/SYN536638.  Unretained [14C]residues were detected at maximums
of 10.4%, 5.5% and 15.5% in the water, sediment and total system,
respectively.  In a supplementary experiment, volatilized 14CO2 (2M KOH)
and volatile [14C]organic compounds (combustion furnace/2M KOH) totaled
23.29% and 8.55% of the applied, respectively, after 40 days of
anaerobic incubation of [methoxyphenyl-U-14C]mandipropamid treated lake
water-silt loam systems.  Based on these results, the study author
proposed that the incomplete material balances in this study were due to
untrapped low molecular weight organic volatiles, such as methane. This
study is classified as unacceptable for the following reasons:

For both systems, material balances were incomplete with up to 46.4% and
40.0% of the applied unaccounted for in the lake water-silt loam and
lake water-loamy sand systems, respectively.

For both systems, all transformation products detected at (10% of the
applied may not have been identified.

162-4 Aerobic Aquatic Metabolism

MRID 46800030,31 (Supplemental)

The biotransformation of [chlorophenyl-U-14C]-labeled
2-(4-chloro-phenyl)-N-[2-(3-methoxy-4-prop-2-ynyloxy-phenyl)-ethyl]-2-pr
op-2-ynyloxy-acetamide (mandipropamid, NOA446510; radiochemical purity
(98.6%) was studied in lake water-silt loam sediment (water pH
7.63-7.84, dissolved organic carbon (2.0 mg/L; sediment pH 7.0-7.2,
organic carbon 5.8%) and lake water-sand sediment (water pH 6.48-6.68,
dissolved organic carbon 9.3 mg/L; sediment pH 4.9-5.3, organic carbon
0.5%) systems from the United Kingdom for 100 days under aerobic
conditions in darkness at 20 ( 2(C.  For both systems, the
sediment:water ratio used was 1:4 (45 g dry wt. sediment:180 g water). 
Sediment and water were pre-incubated for 13-15 days, then following
treatment, duplicate vessels per system type were collected after 0, 1,
2, 3, 10, 30, 45, 70 and 100 days of incubation; however, only one of
the two replicates per system type was processed and analyzed at the 2-
and 3-day intervals.  Water layers were separated from the sediment via
aspiration and analyzed directly.  Sediment samples were extracted
either once (0-day sediments) or twice (all remaining sediment samples)
with acetonitrile; resulting extracts were concentrated
(method/conditions not reported.

The test conditions presented in the study appear to have been
maintained throughout the incubations.  In untreated lake water-silt
loam systems incubated alongside the treated systems, conditions were
moderately oxidizing in the water layers and moderately reducing in the
sediment with average redox potentials of (280 ( 25 mV and (112 ( 11 mV,
respectively, and dissolved oxygen and pH levels of 3.3 ( 0.2 mg/L and
7.23 ( 0.74, respectively, in the water.  In untreated lake water-sand
systems, conditions were strongly oxidizing in the water layers and
moderately to strongly oxidizing in the sediment with average redox
potentials of (485 ( 30 mV and (392 ( 22 mV, respectively, and dissolved
oxygen and pH levels of 4.0 ( 0.0 mg/L and 4.92 ( 0.16, respectively, in
the water.

For both systems, the following six transformation products were
detected:

SYN500003 (chemical name not provided),

SYN504851 (chemical name not provided),

SYN539678
(N-[2-(4-allyloxy-3-hydroxy-phenyl)-ethyl]-2-(4-chloro-phenyl)-2-prop-2-
ynyloxy-acetamide),

SYN539679
(2-allyloxy-N-[2-(4-allyloxy-3-hydroxy-phenyl)-ethyl]-2-(4-chloro-phenyl
)-acetamide),

SYN536638
(N-[2-(4-allyloxy-3-methoxy-phenyl)-ethyl]-2-(4-chloro-phenyl)-2-prop-2-
ynyloxy-acetamide) and

SYN521195
(2-(4-chloro-phenyl)-N-[2-(3-hydroxy-4-prop-2-ynyloxy-phenyl)-ethyl]-2-p
rop-2-ynyloxy-acetamide).

SYN504851 was a major transformation product, while SYN500003,
SYN539678, SYN539679, SYN536638 and SYN521195 were minor products. 
Dissipation of mandipropamid and formation of products in the total
system occurred at a faster rate in the silt loam systems as compared to
the sand systems.  The faster dissipation rate in the silt loam systems
may have been due to greater microbial activity, with microbial biomass
(as (C/g soil) 10-fold higher in the silt loam systems as compared to
the sand systems.  Additionally, after application of [14C]mandipropamid
to the water layers, [14C]residues readily partitioned from the water
layer to the silt loam sediment, with movement from the water layer to
the sand sediment occurring at a slower rate.

MRID 46800032 (Unacceptable)

The biotransformation of [chlorophenyl-U-14C]- and
[methoxyphenyl-U-14C]-labeled
2-(4-chloro-phenyl)-N-[2-(3-methoxy-4-prop-2-ynyloxy-phenyl)-ethyl]-2-pr
op-2-ynyloxy-acetamide (mandipropamid; NOA446510; radiochemical purities
99.1%) was studied in a simulated pond water-sandy clay loam sediment
(water pH 7.91, total organic carbon 5.6 mg/L; sediment pH 7.2-7.7,
organic carbon 1.9%) system from the United Kingdom for 120 days under
natural, outdoor conditions.  Based on the water volume,
[14C]mandipropamid was applied at a rate of 0.06-0.07 mg a.i./L.  The
sediment:water ratio used was ca. 1:3 (ca. 10-cm sediment layer:30-cm
water layer); the water volume was ca 648 L, but sediment weight/volume
was not reported.

For both systems, conditions were moderately reducing in the water
layers and reducing to strongly reducing in the sediments during the
initial month posttreatment, after which redox potentials were not
measured.  Redox potentials in the water layers decreased from (177.7 to
(199.2 mV at 3 days to (5.6 to 11.9 mV at 17-31 days, while in the
sediment were (160.1 to (324.4 mV at 3-17 days and (84.2 to (80.6 mV at
31 days.

Observed DT50 values for mandipropamid (both labels) were 2-7 days in
the water layer and total system and 7-15 days in the sediment.  In the
water, sediment and total system, calculated linear half-lives (r2 =
0.6742-0.9818) were 4, 39 and 21 days, respectively, with nonlinear
half-lives (r2 = 0.7428-0.8769) of 4, 11 and 7 days, respectively.

SYN504851 was a major transformation product, with SYN521195 a major
product in the chlorophenyl-label treated system and neared 10% of
applied in the methoxyphenyl-label treated system.  SYN539678,
SYN539679, SYN536638 and SYN500003 were minor products.  In the
chlorophenyl-label treated system, SYN521195 was detected at a maximum
mean 10.8% of applied in the sediment and total system at 15 days,
decreasing to 2.5% at study termination, and was only detected at one
interval in the water at 1.1%; while in the methoxyphenyl-label treated
system, SYN521195 was detected only in the sediment at a maximum mean
8.8% (range 7.9-9.6%).  SYN504851 was detected at maximum means of 7.2%
(120 days), 4.5% (71 days) and 11.1% (120 days) in the water, sediment
and total system, respectively.  SYN500003 was detected at maximum means
of 5.4%, 1.7% and 6.4% in the water, sediment and total system,
respectively.  SYN539678, SYN539679 and SYN536638 were detected only in
the sediment (both labels) at maximum means of 5.6-6.9%, 0.6-0.9% and
1.1-1.9%, respectively.  Unidentified [14C]residues
(unassigned/unaccounted for organo-and aqueous-soluble residues) were
detected at maximums of 7.2-7.7%, 2.0-3.3% and 8.7-9.0% of the applied
in the water, sediment and total system, respectively.  Extractable
[14C]residues (both labels) increased from means of 5.6-7.7% of the
applied at 1 hour to maximum means of 24.7-31.8% at 15 days, then
decreased to 6.8-14.9% at 120 days.  Nonextractable chlorophenyl-label
[14C]residues increased from a mean 0.6% at day 0 (1 and 6 hours) to
27.1% at 120 days, while methoxyphenyl-label residues increased from
0.3-0.7% at day 0 to 29.2% at 71 days and were 20.2% at study
termination.  [14C]Residues (both labels) in the plant material
comprised only 1.3-5.0% of the applied. In a supplemental experiment
investigating the distribution depth of residues in the sediment,
[14C]residues were found primarily in the upper 0- to 5-cm sediment
layer; quantitative results were not reported. This study is classified
as unacceptable for the following reasons:

Material balances were incomplete with up to 58.6% and 71.8% of the
applied unaccounted for in the chlorophenyl- and methoxyphenyl-label
treated systems, respectively.

The systems were not maintained at a constant temperature between 18 and
30(C.

The systems were not maintained in continuous darkness.

163-1 Adsorption/Desorption

MRID 46800035 (Supplemental)

The adsorption/desorption characteristics of
[chlorophenyl-U-14C]-labeled
2-(4-chloro-phenyl)-N-[2-(3-hydroxy-4-prop-2-ynyloxy-phenyl)-ethyl]-2-pr
op-2-ynyloxy-acetamide (SYN521195) were studied in a silt loam soil [pH
7.6, organic carbon 2.0%] from Switzerland, a silt loam soil [pH 7.9,
organic carbon 0.8%] from France, and a sandy loam soil [pH 6.0, organic
carbon 0.5%] from the United States, in a batch equilibrium experiment. 
The experimental temperature employed during the study was reported to
be maintained at 19.3 ( 0.04(C.  The pH of the test solutions after
adsorption ranged from 6.89-7.33

After 48 hours of equilibration, 23.1-61.1%, 27.9-46.6%, and 17.7-36.4%
of the applied [14C]SYN521195 was adsorbed to the Gartenacker silt loam,
Marsillargues silt loam, and Visalia sandy loam soils, respectively
(reviewer-calculated).  The Freundlich adsorption K values were 31.0,
9.2, and 2.83 for the Gartenacker silt loam, Marsillargues silt loam,
and Visalia sandy loam soils, respectively; corresponding Freundlich Koc
values were 1537, 1145, and 567.  The Freundlich desorption K values
were 161.2, 49.95, and 3.34 for the Gartenacker silt loam, Marsillargues
silt loam, and Visalia sandy loam soils, respectively; corresponding
Freundlich desorption Koc values were 7979, 6244, and 668.  This study
is classified as supplemental and upgradeable upon the submission of
additional information related to classification of soils used in this
study, in accordance to FAO Soil Classification (i.e. Soil Units) or
equivalent U.S. Soil Taxonomy. The study was conducted using three
soils, and only two soil types were represented. Additional study with a
fourth soil is needed fourth soil as required by the Subdivision N,
Chemistry: Environmental Fate, Section 163-1

MRID 46800036 (Supplemental)

The adsorption/desorption characteristics of
[chlorophenyl-U-14C]-labeled SYN539678 were studied in a loam soil [pH
7.1, organic carbon 2.0%] from Switzerland, a loam soil [pH 7.8, organic
carbon 0.58%] from France, and a sandy loam soil [pH 6.0, organic carbon
0.47%] from California, in a batch equilibrium experiment.  The
equilibrating solution used was 0.01M CaCl2 solution with a soil
solution ratio of 1:39 (w:v) for all soils. All samples were prepared in
duplicate.  A desorption phase was not conducted.

After 3 or 24 hours of equilibration, 7.6-8.9%, 15.0-23.2%, and
2.6-15.3% of the applied [14C]SYN539678 was adsorbed to the Gartenacker
loam, Marsillargues loam, and Visalia sandy loam soils, respectively. 
The adsorption K values were 10.57, 12.68, and 6.17 for the Gartenacker
loam, Marsillargues loam, and Visalia sandy loam soils, respectively;
corresponding Koc values were 520, 2200, and 1300.  The Freundlich
adsorption K values were 8.77, 11.96, and 9.19 for the Gartenacker loam,
Marsillargues loam, and Visalia sandy loam soils, respectively;
corresponding Freundlich Koc values were 430, 2100, and 2000. This study
is classified as unacceptable because a desorption phase was not
conducted for the degradates.

MRID 46800037 (Supplemental)

The adsorption/desorption characteristics of [phenyl-U-14C]-labeled
(4-chloro-phenyl)-prop-2-ynyloxy-acetic acid (SYN500003) were studied in
a silt loam soil [Gartenacker, pH 7.6, organic carbon 2.0%] from
Switzerland, a silt loam soil [Marsillargues, pH 7.9, organic carbon
0.8%] from France, and a sandy loam soil [Visalia, pH 6.0, organic
carbon 0.5%] from the United States, in a batch equilibrium experiment.
The adsorption phase of the study was carried out by equilibrating
air-dried soil with [14C]SYN500003 at nominal test concentrations of
0.01, 0.05, 0.10, 0.50, and 1.00 mg a.i./kg soil, in the dark at 19.4 (
0.1(C for 48 hours.  The equilibrating solution used was 0.01M CaCl2
solution with a soil solution ratio of 1:1 (w:v) for all soils. The
desorption phase of the study was carried out by replacing the
adsorption solution with an equivalent volume of 0.01M CaCl2 solution
and equilibrating in the dark at 19.4 ( 0.1(C for 24 hours.  A single
desorption step was conducted for all soils. The experimental
temperature employed during the study was reported to be maintained at
19.4 ( 0.1(C.  The pH of the test solutions after adsorption ranged from
7.10-7.75. After desorption, the pH ranged from 6.74-6.85.

After 48 hours of equilibration, 0.0-6.1%, 18.2-27.0%, and 1.4-30.0% of
the applied [14C]SYN500003 was adsorbed to the Gartenacker silt loam,
Marsillargues silt loam, and Visalia sandy loam soils, respectively. 
The Freundlich adsorption K values were 0.06, 0.23, and 0.01 for the
Gartenacker silt loam, Marsillargues silt loam, and Visalia sandy loam
soils, respectively; corresponding Freundlich Koc values were 2.92,
19.79, and 2.89.  The adsorption K and Koc values were not reported. 
The Freundlich desorption K values were 0.08, 0.38, and 0.04 for the
Gartenacker silt loam, Marsillargues silt loam, and Visalia sandy loam
soils, respectively; corresponding Freundlich desorption Koc values were
3.88, 32.52, and 8.66.  The desorption K and Koc values were not
reported. This study is classified as supplemental and upgradeable upon
the submission of additional information related to classification of
soils used in this study, in accordance to FAO Soil Classification (i.e.
Soil Units) or equivalent U.S. Soil Taxonomy. Additional study with a
fourth soil is needed as required by Subdivision N, Chemistry:
Environmental Fate, Section 163-1.

MRID 46800038, 39 (Supplemental)

The adsorption/desorption characteristics of
[methoxyphenyl-U-14C]-labeled
2-(4-chlorophenyl)-N-[2-(3-methoxy-4-prop-2-ynyloxy-phenyl)-ethyl]-2-pro
p-2-ynyloxy-acetamide (mandipropamid; NOA446510) were studied in a
loam/silt loam soil [pH 7.1, organic carbon 2.6%] and a silt loam soil
[pH 7.2, organic carbon 5.0%], each from Switzerland, a loamy sand soil
[pH 5.1, organic carbon 1.0%] from Germany, and a silty clay loam soil
[pH 7.3, organic carbon 1.2%] from France, in a batch equilibrium
experiment.  The adsorption phase of the study was carried out by
equilibrating air-dried soil with [14C]mandipropamid at nominal test
concentrations of 0.16, 0.81, 1.61, 3.23, and 8.06 mg a.i./kg soil
(loam/silt loam); 0.06, 0.30, 0.60, 1.20, and 3.0 mg a.i./kg soil (loamy
sand); 0.08, 0.40, 0.79, 1.59, and 3.97 mg a.i./kg soil (silty clay
loam); and 0.25, 1.25, 2.5, 5.0, and 12.5 mg a.i./kg soil (silt loam),
in the dark at 20.3 ( 0.3(C for 24 hours.  The equilibrating solution
used was 0.01M CaCl2 solution with a soil solution ratio of 3.1:50 (w:v;
loam/silt loam); 8.3:50 (w:v; loamy sand); 6.3:50 (w:v; silty clay
loam); and 2.0:50 (w:v; silt loam).  The desorption phase of the study
was carried out by replacing the adsorption solution with an equivalent
volume of 0.01M CaCl2 solution and equilibrating in the dark at 20.3 (
0.3(C for 24 hours.  Two desorption steps were performed for each test
soil. The experimental temperature employed during the study was
reported to be maintained at 20.3 ( 0.3(C. The pH of the test solutions
during the study was not reported.  After 24 hours of equilibration,
65.0-93.8%, 77.1-100.8%, 60.8-81.9%, and 69.5-80.6% of the applied
[14C]mandipropamid was adsorbed to the Gartenacker loam/silt loam,
Borstel loamy sand, Marsillargues silty clay loam, and Vetroz silt loam
soils.  The Freundlich adsorption K values were 20.3, 12.9, 12.6, and
53.2 for the Gartenacker loam/silt loam, Borstel loamy sand,
Marsillargues silty clay loam, and Vetroz silt loam soils, respectively;
corresponding Freundlich Koc values were 782, 1294, 1067, and 1064.  The
adsorption K and Koc values were not reported.  Following the second
desorption step, the percent of [14C]mandipropamid desorbed from the
test soils, as percent of the radioactivity adsorbed, was 30.8-46.9% for
the Gartenacker loam/silt loam, 25.4-36.0% for the Borstel loamy sand,
19.5-36.3% for the Marsillargues silty clay loam, and 30.9-38.9% for the
Vetroz silt loam soil.  The Freundlich desorption K values were 32.9,
20.8, 21.7, and 86.8 for the Gartenacker loam/silt loam, Borstel loamy
sand, Marsillargues silty clay loam, and Vetroz silt loam soils,
respectively; corresponding Freundlich desorption Koc values were 1271,
2076, 1836, and 1736.  The desorption K and Koc values were not
reported. This study is classified as supplemental and upgradeable upon
the submission of additional information related to classification of
soils used in this study, in accordance to FAO Soil Classification (i.e.
Soil Units) or equivalent U.S. Soil Taxonomy. Additional study with a
fourth soil is needed as required by Subdivision N, Chemistry:
Environmental Fate, Section 163-1.

MRID 46800040, 41 (Supplemental)The adsorption/desorption
characteristics of [methoxyphenyl-U-14C]-labeled
2-(4-chlorophenyl)-N-[3-methoxy-4-(prop-2-ynyloxy)phenylethyl]-2-(prop-2
-ynyloxy)acetamide (mandipropamid; NOA446510) were studied in a sandy
loam soil [pH 6.6, organic carbon 0.52%] from California, a loamy sand
soil [pH 4.9, organic carbon 0.70%] from Georgia, and a loamy sand soil
[pH 6.7, organic carbon 1.16%] from New York, in a batch equilibrium
experiment.  The adsorption phase of the study was carried out by
equilibrating air-dried soil with [14C]mandipropamid at nominal test
concentrations of 0.05, 0.25, 0.50, 1.00, and 3.00 mg a.i./kg soil
(Sanger sandy loam); 0.05, 0.23, 0.45, 0.90, and 2.70 mg a.i./kg soil
(Chula loamy sand); and 0.07, 0.37, 0.74, 1.47, and 4.41 mg a.i./kg soil
(North Rose loamy sand), in the dark at 19.4 ( 0.2(C for 24 hours.  The
equilibrating solution used was 0.01M CaCl2 solution with a soil
solution ratio of 10.0:50 (w:v; Sanger sandy loam); 11.1:50 (w:v; Chula
loamy sand); and 6.8:50 (w:v; North Rose loamy sand).  The experimental
temperature employed during the study was reported to be maintained at
19.4 ( 0.2(C; supporting data were not provided.  The pH of the test
solutions after adsorption ranged from 5.01 to 7.08.  The pH of the test
solutions ranged from 6.16 to 7.03 at the first desorption step (one
desorption step for all test concentrations except high-dose), 6.14 to
7.03 during the second desorption step (high dose only), and from 6.01
to 7.08 during the third desorption step (high dose only).  After 24
hours of equilibration, 47.2-71.0%, 46.3-72.0%, and 55.7-91.4% of the
applied [14C]mandipropamid was adsorbed to the Sanger sandy loam, Chula
loamy sand, and North Rose loamy sand soils, respectively.  The
Freundlich adsorption K values were 3.68, 2.88, and 7.37 for the Sanger
sandy loam, Chula loamy sand, and North Rose loamy sand soils,
respectively; corresponding Freundlich Koc values were 693.9, 405.1, and
624.3.  The adsorption K and Koc values were not reported.  Following
the first desorption step, the percent of [14C]mandipropamid desorbed
from the test soils, as percent of the radioactivity adsorbed, was
21.4-40.1% for the Sanger sandy loam, 19.2-40.9% for the Chula loamy
sand, and 21.9-34.9% for the North Rose loamy sand.  Following the third
desorption step, the percent of [14C]mandipropamid desorbed from the
high-dose soils was 69.3%, 68.0%, and 63.2% for the Sanger sandy loam,
Chula loamy sand, and the North Rose loamy sand soils, respectively
(reviewer-calculated).  The Freundlich desorption K values were 4.98,
4.33, and 11.86 for the Sanger sandy loam, Chula loamy sand, and North
Rose loamy sand soils, respectively; corresponding Freundlich desorption
Koc values were 939.6, 609.9, and 1004.8.  For the high-dose soils
following the third desorption step, Freundlich desorption K values were
2.39, 1.63, and 4.13 for the Sanger sandy loam, Chula loamy sand, and
North Rose loamy sand soils, respectively; corresponding Freundlich
desorption Koc values were 423, 229, and 229.  The desorption K and Koc
values were not reported for any of the test soils. This study is
classified as supplemental and upgradeable upon the submission of
additional information related to classification of soils used in this
study, in accordance to FAO Soil Classification (i.e. Soil Units) or
equivalent U.S. Soil Taxonomy. The study was conducted using three
soils, and only two soil types were represented. Additional study with a
fourth soil is needed as required by the Subdivision N, Chemistry:
Environmental Fate, Section 163-1

MRID 46800042, 43 (Supplemental)

The adsorption/desorption characteristics of
[methoxyphenyl-U-14C]-labeled
2-(4-chloro-phenyl)-2-hydroxy-N-[2-(3-methoxy-4-prop-2-ynyloxy-phenyl)-e
thyl]acetamide (CGA380778) were studied in a sandy clay loam soil [pH
5.6, organic carbon 3.25%] from the United Kingdom, a loam soil [pH 7.2,
organic carbon 2.06%] from Switzerland, and a sandy loam soil [pH 6.3,
organic carbon 0.46%] from the United States, in a batch equilibrium
experiment.  The adsorption phase of the study was carried out by
equilibrating air-dried soil with [14C]-CGA380778 at actual
concentrations of 0.23, 0.61, 1.18, 6.19, and 11.85 mg a.i./kg soil (18
Acres sandy clay loam and Gartenacker loam); and 0.11, 0.31, 0.59, 3.09,
and 5.93 mg a.i./kg soil (Visalia sandy loam), in the dark at 25 ( 0.1(C
for 48 hours.  The equilibrating solution used was 0.01M CaCl2 solution
with a soil solution ratio of 1.0:12.5 (w:v; 18 Acres sandy clay loam
and Gartenacker loam); and 1.0:6.25 (w:v; Visalia sandy loam).  The
desorption phase of the study was carried out by replacing the
adsorption solution with an equivalent volume of 0.01M CaCl2 solution
and equilibrating in the dark at 25 ( 0.1(C for 48 hours.  A single
desorption step was conducted for all soils. The experimental
temperature employed during the study was reported to be maintained at
25 ( 0.1(C. The pH of the test solutions during the study ranged from
6.2-6.5.  After 48 hours of equilibration, 58.0-68.3%, 46.3-59.5%, and
21.0-39.0% of the applied [14C]CGA380778 was adsorbed to the 18 Acres
sandy clay loam, Gartenacker loam, and Visalia sandy loam soils,
respectively.  The Freundlich adsorption K values were 15.7, 10.3, and
1.7 for the 18 Acres sandy clay loam, Gartenacker loam, and Visalia
sandy loam soils, respectively; corresponding Freundlich Koc values were
482, 501, and 361. The adsorption K and Koc values were not determined. 
At the end of the desorption phase, the percent of [14C]CGA380778
desorbed from the test soils, as percent of the radioactivity adsorbed,
was 93.0-174.2% for the 18 Acres sandy clay loam, 49.3-100.8% for the
Gartenacker loam, and 10.2-40.9% for the Visalia loam soils.  The
Freundlich desorption K values were 20.0, 13.5, and 3.8 for the 18 Acres
sandy clay loam, Gartenacker loam, and Visalia sandy loam soils,
respectively; corresponding Freundlich desorption Koc values were 615,
654, and 818.

This study is classified as supplemental and upgradeable upon the
submission of additional information related to classification of soils
used in this study, in accordance to FAO Soil Classification (i.e. Soil
Units) or equivalent U.S. Soil Taxonomy. The study was conducted using
three soils. Additional study with a fourth soil is needed as required
by the Subdivision N, Chemistry: Environmental Fate, Section 163-1

164-1 Terrestrial Field Dissipation

MRID 46800045 (Acceptable)

Soil dissipation/accumulation of mandipropamid
(4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-α-(2-propynylo
xy)benzeneacetamide) under U.S. field conditions was conducted in bare
plots of sandy loam soil at one site in California. Mandipropamid was
broadcast four times (7-day intervals) at a target rate of 0.165 kg
a.i./ha (0.147 lb a.i./A) to a 21 x 43 m test plot divided into three
replicate areas. The total target rate applied was 660 g a.i./ha or 110%
of the proposed maximum annual rate for leafy vegetables. The
application was made to approximate the timing of typical fungicide
applications in the fall for control of foliar oomycete pathogens on
leafy vegetables in the San Joaquin Valley of California. Total water
input during the study period was 70.32 inches or over 300% of the
30-year historical average precipitation. A control plot was located
approximately 59 m from the treated plot.

Soil samples were collected at 0, 1, and 6 days following the first
three applications and at 0, 1, 3, 7, 14, 21, 30, 58, 90, 125, 182, 272,
359, 454, and 540 days following the fourth application to a depth of
0-120 cm (except application 1, day-0 samples which were collected to a
depth of 15 cm).

The measured zero-time recovery of mandipropamid in the 0-15 cm soil
layer was 56 ppb or 70% of the theoretical. Mandipropamid was detected
in the 0-15 cm soil layer at 97 ppb following the second application,
146 ppb following the third application, and at a maximum of 165 ppb
following the fourth application. Following the fourth application,
mandipropamid decreased to 83 ppb by 58 days, 31 ppb by 182 days, 4.1
ppb by 272 days, and ranged from 2.1-2.6 ppb from 359 to 540 days
posttreatment. Mandipropamid was not detected below the 0-15 cm soil
depth. No transformation products were detected in the soil at greater
than 10% of the applied mandipropamid. Under field conditions at the
test site, mandipropamid had a half-life value of 75.3 days in soil (r2
= 0.9158), calculated using linear regression and the equation t½ = ln
2 / k, where k is the rate constant, and based on all available data
following the fourth application. The major route of dissipation of
mandipropamid under terrestrial field conditions could not be determined
because transformation products were detected at <2% of the applied
mandipropamid, leaching and carryover of residues were not observed, and
volatilization and runoff were not studied. However, the study author
stated that no major degradation product was identified in the
laboratory environmental fate studies.

MRID 46800046 (Acceptable)

-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-α-(2-propynyloxy)benzenea
cetamide) under U.S. field conditions was conducted in a bare plot and a
cropped plot (potatoes) of loamy sand soil at one site in New York.
Mandipropamid was broadcast four times (6- to 7-day intervals) at a
target rate of 0.165 kg a.i./ha (0.147 lb a.i./A) to two 29 x 35 m test
plots each divided into three replicate areas. The total target rate
applied was 660 g a.i./ha or 110% of the proposed maximum annual rate
for potatoes. The potato crop was at the late bloom stage (20-inch
height) at the first application and at the post bloom stage (24-inch
height) at subsequent applications; coverage was 70% at the first
application and 85-90% by the fourth application. The crop was harvested
57 days after the fourth application. The application was made to
approximate the timing of typical fungicide applications for control of
oomycete pathogens (late blight) on potatoes in the Northeastern region
of the U.S. Total water input during the study period was 80.60 inches
or 142% of the 30-year historical average precipitation. A control plot
was located approximately 70 m from the nearest treated plot. Soil
samples were collected at 0, 1, and 5 days following the first
application, at 0, 1, and 6 days following the second and third
applications, and at 0, 1, 3, 7, 14, 21, 30, 65, 91, 124, 194, 275, 356,
448, and 505 days following the fourth application to a depth of 0-120
cm (except application 1, day-0 samples which were collected to a depth
of 15 cm).

In the bare plot, the measured zero-time recovery of mandipropamid in
the 0-15 cm soil layer was 68 ppb or 79% of the theoretical.
Mandipropamid was detected in the 0-15 cm soil layer at 100 ppb
following the second application, 136 ppb following the third
application, and 120 ppb following the fourth application. Following the
fourth application, mandipropamid decreased to 63-65 ppb by 7-21 days,
43-54 ppb by 30-194 days, 12 ppb by 275 days, and ranged from 2.7-4.4
ppb from 356 to 505 days posttreatment. Mandipropamid was not detected
below the 0-15 cm soil depth. No transformation products were detected
in the soil at greater than 10% of the applied mandipropamid. In the
cropped plot, the measured zero-time recovery of mandipropamid in the
0-15 cm soil layer was 52 ppb or 60% of the theoretical. Mandipropamid
was detected in the 0-15 cm soil layer at 53 ppb following the second
application, 90 ppb following the third application, and 101 ppb
following the fourth application. Following the fourth application,
mandipropamid increased to a maximum of 167 ppb by 65 days, coinciding
with the sampling interval following the harvest of the potato crop at
57 days posttreatment, when residues bound to the potato leaves were
incorporated into the soil. Following 65 days, mandipropamid decreased
to 68 ppb by 194 days, 20-21 ppb by 356-448 days, and was 16 ppb at 505
days posttreatment. Mandipropamid was not detected below the 0-15 cm
soil depth. No transformation products were detected in the soil at
greater than 10% of the applied mandipropamid. Under field conditions in
the bare plot, mandipropamid had a half-life value of 100.5 days in soil
(r2 = 0.8628), calculated using linear regression and the equation t½ =
ln 2 / k, where k is the rate constant, and based on all available data
following the fourth application. However, dissipation was bi-phasic,
with a more rapid decline phase during the first month of the study; the
half-life based on 0-30 day data was 27.8 days (r2 = 0.5521).

Under field conditions in the cropped plot, mandipropamid had a
half-life value of 126 days in soil (r2 = 0.9384), calculated using
linear regression and the equation t½ = ln 2 / k, where k is the rate
constant, and based on all available data following the maximum
detection of mandipropamid at 65 days following the fourth application.
The major route of dissipation of mandipropamid under terrestrial field
conditions could not be determined because transformation products were
detected at <2% of the applied mandipropamid, leaching and carryover of
residues were not observed (carryover was <5%), and volatilization and
runoff were not studied. However, the study author stated that there was
no major degradation product identified in the laboratory environmental
fate studies.

MRID 46800047 (Acceptable)

Soil dissipation/accumulation of mandipropamid
(4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-α-(2-propynylo
xy)benzeneacetamide) under US field conditions was conducted in bare
plots of loamy sand soil at one site in Georgia. Mandipropamid was
broadcast four times (7-day intervals) at a target rate of 0.165 kg
a.i./ha (0.147 lb a.i./A) to a 35 x 35 m test plot divided into three
replicate areas. The total target rate applied was 660 g a.i./ha or 110%
of the proposed maximum annual rate for squash. The applications were
made to approximate the timing of typical fungicide applications in the
spring for control of oomycete pathogens on squash in the Southeastern
region of the U.S. Total water input during the study period was 138.54
inches or 189% of the 30-year historical average precipitation. A
control plot was located approximately 46 m from the treated plot. Soil
samples were collected at 0, 1, and 6 days following the first three
applications and at 0, 1, 3, 7, 14, 21, 30, 62, 93, 120, 183, 268, 364,
457, and 540 days following the fourth application to a depth of 0-120
cm (except application 1, day-0 samples which were collected to a depth
of 15 cm). The measured zero-time recovery of mandipropamid in the 0-15
cm soil layer was 58 ppb or 76% of the theoretical. Mandipropamid was
detected in the 0-15 cm soil layer at 86 ppb following the second
application, a maximum of 136 ppb following the third application, and
124 ppb following the fourth application. Following the fourth
application, mandipropamid decreased to 60 ppb by 21 days, 19 ppb by 62
days, 4.0-5.9 ppb by 268-364 days, and was 0.74 ppb at 540 days
posttreatment. Mandipropamid was only detected in the 15-30 cm soil
depth once, at 0.53 ppb at 14 days posttreatment, and was not detected
below that depth. No transformation products were detected in the soil
at greater than 10% of the applied mandipropamid. Under field conditions
at the test site, mandipropamid had a half-life value of 81.5 days in
soil (r2 = 0.8934), calculated using linear regression and the equation
t½ = ln 2 / k, where k is the rate constant, and based on all available
data following the fourth application. However, dissipation was
bi-phasic, with a more rapid decline phase during the first two months
of the study; the half-life based on 0-62 day data was 24.5 days (r2 =
0.9090). The major route of dissipation of mandipropamid under
terrestrial field conditions could not be determined because
transformation products were detected at <2% of the applied
mandipropamid, leaching and carryover of residues were not observed, and
volatilization and runoff were not studied. However, the study author
stated that there was no major degradation product identified in the
laboratory environmental fate studies.

The important metabolites formed by the degradation of mandipropamid are
provided in Table A-7 and the chemical structures of these metabolites
are illustrated in Table A-8.



Table A-7. Maximum Amounts of Mandipropamid Metabolites in Degradation
Studies Characterized by Study Type

Study Type	Metabolite (% Maximum)	MRID

161-1 Hydrolysis	No degradation products observed	46800007,8

161-2 Aqueous photolysis	Polar compounds totaled average of 36.7%.

Unidentified polar compounds totaled a maximum of 25.0%.

Unidentified minor residues maximum of (6.2% of the applied

minor nonpolar transformation products, none averaging (5% of the
applied	46800009

46800010

46800011,12

46800013,14

161-3 Soil photolysis	CO2 (6.3%)

CGA380775 (4.1%)

SYN505503 (3.0%)

CGA380778 (2.5%)

NOA495119 (0.2%)

NOA458422 (0.7%)

SYN521195 (not quantified)

CO2 (17.1%)

CGA380778 (3.9%)

CO2 (`14.98%)

CGA380778 (3.80%)	46800015

46800016,17

46800018,19

162-1 Aerobic soil metabolism	CO2 (maximum 56.3%

CGA380778 (4.25%)

CGA380775 (0.51%)

SYN500003 (0.27%)

NOA458422 (0.18%)

CGA380778 (2.9%)

CO2 (maximum 51.0%)

CO2 (21.8%)

CGA380778 (1.4%)

SYN536638 (2.4%)

NOA458422 (below limit of detection

CGA380778 (3.2%)

CO2 (12.3%)

CGA380778 (4.8%)	46800020,21

46800022

46800023

46800024,25

46800027

46800028

162-2 Anaerobic soil metabolism	CO2 was the only significant degradation
product.

CGA380778(4.6%)	46800022

162-3 Anaerobic aquatic metabolism	SYN500003 (25.9%)

SYN504851 (73.5%)

SYN521195 (10.3%)

CO2 (15.8%)

SYN539678 (4.6%)

SYN539679 (6.1%)

SYN536638 (0.9%)	46800030,31

162-4 Aerobic aquatic metabolism	SYN521195 (10.8%)

SYN504851 (11.1%)

SYN500003 (6.4%)

SYN539678 (6.9%)

SYN539679 (0.9%)

SYN536638 (1.9)

	46800032

Table A-8. The Chemical Structure of  NOA446510 (Mandipropamid) and its
Metabolites

NOA446510

SYN505503

CGA380778

CGA380775

SYN536638

SYN521195

SYN539678

SYN504851

SYN539679



Appendix B. GENEEC Aquatic Exposure Model

The GENEEC (GENeric Estimated Environmental Concentration) model, the
tier one computer program, uses the soil/water partition coefficient and
degradation kinetic data to estimate runoff from a ten hectare field
into a one hectare by two meter deep "standard" pond. This first tier is
designed as a coarse screen and estimates conservative pesticide
concentrations in surface water from a few basic chemical parameters and
pesticide label use and application information. Tier 1 is used to
screen chemicals to determine which ones potentially pose sufficient
risk to warrant higher level modeling. Chemicals failing to pass this
program, move on to the tier two modeling. As a matter of policy, OPP
does not take significant adverse regulatory action based upon the
results of tier 1 screening models.

GENEEC is a program to calculate acute as well as longer-term estimated
environmental concentration (EEC) values. It considers reduction in
dissolved pesticide concentration due to adsorption of pesticide to soil
or sediment, incorporation, degradation in soil before washoff to a
water body, direct deposition of spray drift into the water body, and
degradation of the pesticide within the water body ((  HYPERLINK
"http://www.epa.gov/oppefed1/models/water/geneec2_users_manual.htm#intro
duction" 
http://www.epa.gov/oppefed1/models/water/geneec2_users_manual.htm#introd
uction )).

GENEEC Output

RUN No.   1 FOR Total Residue    ON   all           * INPUT VALUES *

--------------------------------------------------------------------

RATE (#/AC)   No.APPS &   SOIL  SOLUBIL   APPL TYPE  NO-SPRAY INCORP

ONE(MULT)    INTERVAL     Koc   (PPM )    (%DRIFT)   ZONE(FT)  (IN)

--------------------------------------------------------------------

.130(   .477)   4   7       2.9*******   AERL_B( 13.0)    .0    .0

FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

--------------------------------------------------------------------

METABOLIC  DAYS UNTIL  HYDROLYSIS   PHOTOLYSIS   METABOLIC  COMBINED

(FIELD)   RAIN/RUNOFF   (POND)     (POND-EFF)    (POND)     (POND)

--------------------------------------------------------------------

72.04        2          N/A      1.10-  136.40   102.00     58.36

GENERIC EECs (IN MICROGRAMS/LITER (PPB))     Version 2.0 Aug 1, 2001

--------------------------------------------------------------------

PEAK      MAX 4 DAY     MAX 21 DAY    MAX 60 DAY    MAX 90 DAY

GEEC      AVG GEEC       AVG GEEC      AVG GEEC      AVG GEEC

--------------------------------------------------------------------

20.88       20.67         19.42         16.92         15.29

APPENDIX C.	Explanation of T-REX Model

1.	Introduction

This spreadsheet based model calculates the decay of a chemical applied
to foliar surfaces for single or multiple applications. It uses the same
principle as the batch code models FATE and TERREEC for calculating
terrestrial estimates exposure (TEEC) concentrations on plant surfaces
following application. A first-order decay assumption is used to
determine the concentration at each day after initial application based
on the concentration resulting from the initial and additional
applications. The decay is calculated by from the first-order rate
equation:

CT = Cie-kT

or in log form:

ln (CT/Ci) = kT

where:

CT =	concentration at time T = day zero.

Ci =	concentration, in parts per million (ppm) present initially (on day
zero) on the surfaces. Ci is calculated based on Kenaga and Fletcher by
multiplying the Ci based on the Kenaga nomogram (Hoerger and Kenaga
[1972] as modified by Fletcher [1994]). For maximum concentration the
application rate, in pounds active ingredient per acre, is multiplied by
240 for short grass, 110 for tall grass, and 135 for broad leafed
plants/small insects and 15 for fruits/pods/large insects. Additional
applications are converted from pounds active ingredient per acre to ppm
on the plant surface and the additional mass added to the mass of the
chemical still present on the surfaces on the day of application.

k = 	If the foliar dissipation data submitted to EFED are found
scientifically valid and statistically robust for a specific pesticide,
the 90% upper-confidence limit of the mean half-lives should be used.
When scientifically valid, statistically robust data are not available
TETT recommends the use of a default half-life value of 35 days. The
use of the 35 day half-life is based on the highest reported value
(36.9 days) reported by Willis and McDowell (1987).

T =	time, in days, since the start of the simulation. The initial
application is on day 0. The simulation is designed to run for
365 days.

The program calculates concentration on each type of surface on a daily
interval for one year. The maximum concentrations during the year are
calculated for both maximum and mean residues. The inputs required are:

Application rate:	The maximum label application rate (in pounds
a.i./acre)

Half-life:	The degradation half-life for the dominate process (in days)

Frequency of application:	The interval between repeated applications,
from the label (in days)

Maximum number of application per year:	From the label

The calculated concentrations are used to calculate Avian and Mammalian
RQ values. The maximum calculated concentration is divided by user input
values for acute and chronic endpoints to give RQs for each type of
plant surface.

2.	Avian Species

For calculating dose-based RQs in birds, the maximum and mean Kenaga
residue values are adjusted for avian class and food consumption based
on the following scaling factor (USEPA 1993):

FI (g/d) = 0.648 (g bw)^0.651

For the three avian weight classes considered (20, 100, and 1000 g),
this results in percent of body weight consumption of:

Weight (g)	FI	Wet FI	% Body Weight Consumed

20	4.555599463	22.77799731	114

100	12.98897874	64.94489369	65

1000	58.15338588	290.7669294	29

A.	Dose-Based Acute RQs

Dose-based acute RQs are then calculated using the formula:

RQ = adjusted EEC/LD50 or NOAEL

where the adjusted EEC is considered to be the daily dose weighted for
percent of body weight consumed of a given food source.

B.	Dietary-Based RQs

For dietary-based RQs, two values are given for each food group. First,
the consumption-weighted RQ for each weight class (20, 100, and 1000 g
birds) is displayed and calculated using the equation:

RQ = EEC/((LC50 or NOAEC)/(%bw consumed))

In the second method, no adjustment is made for consumption differences
among the weight classes. This RQ is calculated:

RQ = EEC/LC50 or NOAEC

3.	Mammalian Species

A.	Dose-Based RQs

For calculating dose-based RQs in mammals, the maximum and mean Kenaga
values are adjusted for mammalian class and food consumption (0.95,
0.66, and 0.15 body weight for herbivores and insectivores and 0.21,
0.15, and 0.03 body weight for granivores). Dose-based acute and chronic
RQs are then calculated by dividing the adjusted EECs (daily dose) by
the LD50 or NOAEL.

B.	Dietary-Based RQs

Dietary-based RQs are calculated using the equation:

RQ = EEC/((LC50 or NOAEC)/(% bw consumed))

4.	Graph

A graph of concentration on each plant surface vs. time is plotted and a
concentration of concern line can be added at a user specified level.
The concentration of concern (e.g., avian LC50, mammalian NOAEL) label
should be entered in the cell underneath the value. The graph
automatically plots a line at this concentration and the label is
extracted from that cell. The graph is plotted for the first 100 days
post-application. Graphs displaying acute and chronic LOCs for both
birds and mammals are displayed in the "Graph" worksheet. These graphs
may be useful as a visual aid to communicate risk in your assessment and
can be copy/pasted into your document. To help with scaling issues on
the y axis, you may want to delete one of the endpoints.

5.	New Version Notes

A new look is used in this update in an effort to decrease confusion and
increase transparency in the risk assessment process. This version of
T-REX (v1.3.1) incorporates the ability to calculate EECs and RQs for
maximum and mean residues. Mean residues are calculated exactly as the
maximum residues are, except the corresponding Kenaga values are:
85 for short grass, 36 for tall grass, and 45 for broad leafed
plants/small insects and 7 for fruits/pods/large insects.

Appendix D. Explanation of TerrPlant Model

Introduction

Exposure to Terrestrial Plants including Wetlands (December 26, 2005;
version 1.2.1)

The change to this model version is the removal of the 60% efficiency
factor for aerial applications.

Terrestrial plants inhabiting dry and semi-aquatic (wetland) areas may
be exposed to pesticides from runoff and/or spray drift. Semi-aquatic
areas are low-lying wet areas that may dry up at times throughout the
year.

EFED's runoff scenario is:

(1)	based on a pesticide's water solubility and the amount of pesticide
present on the soil surface and its top one centimeter;

(2)	characterized as "sheet runoff" (one treated acre to an adjacent
acre) for dry areas;

(3)	characterized as "channel runoff" (10 acres to a distant low-lying
acre) for semi-aquatic or wetland areas; and

(4)	based on percent runoff values of 0.01, 0.02, and 0.05 for water
solubilities of <10, 10–100, and <100 ppm, respectively.

EFED's Spray Drift scenario is assumed as: (1) 1% for ground
application; and (2)	5% for aerial, airblast, forced air, and spray
chemigation applications.

The spray drift ratio used here is in agreement with the policy
procedures at the time the worksheet was designed.

Currently, (1) this worksheet is designed to derive the plant exposure
concentrations from a single, maximum application rate only; and (2) for
pesticide applications with incorporation of depth of less than 1 inch,
the total loading EECs derived for the incorporation method will be same
as the unincorporated method.

To calculate RQ values for Non-Endangered Terrestrial Plants:

Terrestrial Plants Inhabiting Areas Adjacent to Treatment Site:

Emergence RQ = Total Loading to Adjacent Area or EEC/Seedling Emergence
EC25

Drift RQ = Drift EEC/Vegetative Vigor EC25

Terrestrial Plants Inhabiting Semi-aquatic Areas Adjacent to Treatment
Site:

Emergence RQ = Total Loading to Semi-aquatic Area or EEC/Seedling
Emergence EC25

Drift RQ = Drift EEC/Vegetative Vigor EC25

To calculate RQ values for Endangered Terrestrial Plants:

Endangered Terrestrial Plants Inhabiting Areas Adjacent to Treatment
Site:

Emergence RQ = Total Loading to Adjacent Area or EEC/Seedling Emergence
EC05 or NOAEC

Drift RQ = Drift EEC/Vegetative Vigor EC05 or NOAEC

Endangered Terrestrial Plants Inhabiting Semi-aquatic Areas Near
Treatment Site:

Emergence RQ = Total Loading to Semi-aquatic Area or EEC/Seedling
Emergence EC05 or NOAEC

Drift RQ = Drift EEC/Vegetative Vigor EC05 or NOAEC

Background for EEC Calculation

Formulas used to calculate EEC values (November 9, 2005; version 1.2.1)

To calculate EECs for terrestrial plants inhabiting in areas adjacent to
treatment sites:

Un-incorporated Ground Application (Non-granular):

Sheet Runoff = Application Rate (lbs a.i./acre) x Runoff Value

Drift = Application Rate (lbs a.i./acre) x 0.01

Total Loading = EEC = Sheet Runoff + Drift

Incorporated Ground Application with Drift (Non-granular):

Sheet Runoff = [Application Rate (lbs a.i./acre)/Incorporation Depth
(cm)] x Runoff Value

Drift = Application Rate (lbs a.i./acre) x 0.01

Total Loading = EEC = Sheet Runoff + Drift

Un-incorporated Ground Application (Granular):

Sheet Runoff = EEC = Application Rate (lbs a.i./acre) x Runoff Value

Incorporated Ground Application without Drift (Granular):

Sheet Runoff = EEC = [Application Rate (lbs a.i./acre)/Incorporation
Depth (cm)] x Runoff Value

Aerial/Airblast/Spray Chemigation Applications1:

Sheet Runoff = Application Rate (lbs a.i./acre) x Runoff Value

Drift = Application Rate (lbs a.i./acre) x 0.05

Total Loading = EEC = Sheet Runoff + Drift

Runoff Value = 0.01, 0.02, or 0.05 when the solubility of the chemical
is <10 ppm, 10-100 ppm, or >100 ppm, respectively. Incorporation Depth:
Use the minimum incorporation depth reported on the label.

Formulas used to calculate EEC values:

To calculate EECs for terrestrial plants inhabiting semi-aquatic
low-lying areas near treatment sites:

Un-incorporated Ground Application (Non-granular):

Channelized Runoff = Application Rate (lbs a.i./acre) x Runoff Value x
Factor 10

Drift = Application Rate (lbs a.i./acre) x 0.01

Total Loading = EEC = Channelized Runoff + Drift

Incorporated Ground Application with Drift (Non-granular):

Channelized Runoff = [Application Rate (lbs a.i./acre)/Incorporation
Depth (inch)] x Runoff Value x Factor 10

Drift = Application Rate (lbs a.i./acre) x 0.01

Total Loading = EEC = Channelized Runoff + Drift

Un-incorporated Ground Application (Granular):

Channelized Runoff = EEC = Application Rate (lbs a.i./acre) x Runoff
Value x Factor 10

Incorporated Ground Application without Drift (Granular):

Channelized Runoff = EEC = [Application Rate (lbs
a.i./acre)/Incorporation Depth (inch)] x Runoff Value x Factor 10

Aerial/Airblast/Spray Chemigation Applications:

Channelized Runoff = Application Rate (lbs a.i./acre) x Runoff Value x
Factor 10

Drift = Application Rate (lbs a.i./acre) x 0.05

Total Loading = EEC = Channelized Runoff + Drift

Runoff Value = 0.01, 0.02, or 0.05 when the solubility of the chemical
is <10 ppm, 10-100 ppm, or >100 ppm, respectively. Factor 10 represents
10 treated acres per acre of low-lying area. Incorporation Depth: Use
the minimum incorporation depth reported on the label.

Appendix E. Description of Ecological Effects Studies

Toxicity to Terrestrial Animals

Birds, Acute and Subacute

An acute oral toxicity study using the technical grade of the active
ingredient (TGAI) is required to establish the toxicity of mandipropamid
to birds.  The preferred test species is either mallard duck (a
waterfowl) or bobwhite quail (an upland gamebird).  Results of this test
are tabulated below.

Avian Acute Oral Toxicity

Species	

% a.i.	

LD50 (mg/kg a.i.)	

Toxicity Category	MRID No.

	Study

Classification1

Mallard Duck

(Anas platyrhychos)	96.5	> 1000	Practically nontoxic	468001-11
Acceptable

Northern Bobwhite Quail

(Colinus virginianus)	96.5	

> 2250	

Practically nontoxic	

468001-10	

Acceptable

The results of these studies demonstrate that mandipropamid is
practically nontoxic to avian species on an acute oral basis.

Two subacute dietary studies using the TGAI are required to establish
the toxicity of mandipropamid to birds.  The preferred test species are
mallard duck and bobwhite quail.  Results of these tests are tabulated
below.

Avian Subacute Dietary Toxicity

Species	

% a.i.	5-Day LC50

(ppm a.i.)	

Toxicity Category	MRID No.

	

Study Classification1

Mallard Duck

(Anas platyrhychos)	96.5	

> 6080	

Practically Nontoxic	

468001-12	

Acceptable

Northern Bobwhite Quail

(Colinus virginianus)	

96.5

	

> 6080	

Practically Nontoxic	

468001-13	

Acceptable

The results of the avian acute dietary studies indicate mandipropamid is
practically nontoxic to avian species on a subacute dietary basis.

ii. Birds, Reproductive Toxicity

Two avian reproduction studies testing mandipropamid were submitted to
the Agency. The details of these studies are illustrated in the
following table.  The results of these studies demonstrated no
significant effects to either avian reproduction or growth.

Avian Reproductive Toxicity

Species/

Exposure Duration	

% a.i.	Test

Type	Toxicity

Value (ppm)	Affected

Endpoints	MRID No.	Study Classification

Mallard Duck

(Anas platyrhychos)	96.5	Avian Reproduction	NOAEC: 1060

LOAEC: > 1060	None	467152-14	Acceptable

Northern Bobwhite

(Colinus virginianus)	96.5	Avian Reproduction	NOAEC: 1060

LOAEC: > 1060	None	468001-15	Acceptable

Mammals, Acute and Chronic

Wild mammal testing is required on a case-by-case basis, depending on
the results of lower tier laboratory mammalian studies, intended use
pattern and pertinent environmental fate characteristics.  In most
cases, rat or mouse toxicity values obtained from the Agency's Health
Effects Division (HED) substitute for wild mammal testing.   A rat
multigenerational study and a rat acute oral toxicity study have been
submitted to the Agency. The toxicity values for this study are
tabulated below.

Mammalian Toxicity

Species	

% a.i.	Test

Type	Toxicity

Value	Affected

Endpoints	MRID No.	Study Classification

Laboratory Rat

(Rattus norvegicus)	Technical	Rat Multi-generational Reproduction
toxicity	250 ppm	Decreased body weights, weight gains, food consumption,
and food utilization	468002-30	Acceptable

Laboratory Rat

(Rattus norvegicus)	Technical	Rat Acute Oral Toxicity	> 5000 mg/kg	No
mortality	MRID 468002-30

	Acceptable

Terrestrial Invertebrates

A honey bee acute contact study using the TGAI is required for
mandipropamid because its proposed uses may result in honey bee
exposure.  Results of this test are tabulated below.

Non-target Insect Acute Contact Toxicity

Species	

% a.i.	LD50

(ug/bee)	

Toxicity Category	MRID No.

	Study Classification

Honey Bee

(Apis mellifera L.)	99 %	> 200 ug ai/bee	Practically non-toxic	

468001-16

	Acceptable

The registrant has also submitted two earthworm acute toxicity studies.
One of the studies tested the TGAI and the other study tested the
mandipropamid degradate, CGA380778.  The results of these studies are
illustrated in the table below.

Earthworm Acute Toxicity Test Toxicity

Species	Chemical	

% purity	

LC50	

Toxicity Category	MRID No.

	Study Classification

Earthworms (Eisenia fetida)	Mandipropamid	99	>1000 mg ai/kg dw of soil.
Nontoxic at the highest concentrations tested	

468001-23	Acceptable

Earthworms (Eisenia fetida)	CGA380778

(Mandipropamid

Degradate)	99	>1000 mg ai/kg dw of soil.	Nontoxic at the highest
concentrations tested	

468001-22	Acceptable

The above analysis of the results show that mandipropamid is practically
non-toxic to honey bees and that mandipropamid and its’ degradate,
CGA380778, is nontoxic to earthworms at the highest concentrations
tested.  Therefore, it is presumed that the use of mandipropamid will
not pose a significant risk to non-target terrestrial invertebrates.

b. Toxicity to Freshwater Aquatic Animals

I.  Freshwater Fish, Acute

Two freshwater fish acute toxicity studies using the TGAI are required
to establish the toxicity of mandipropamid to fish.  The preferred test
species are rainbow trout (a coldwater fish) and bluegill sunfish (a
warmwater fish). The registrant has submitted 3 freshwater fish acute
toxicity studies. Two of the studies tested the TGAI and one tested,
CGA380778. Currently, all of the registrant submitted freshwater fish
toxicity studies testing mandipropamid and the mandipropamid degradate,
CGA380778, are deemed invalid.  The studies were invalidated because of
the failure of the study authors to take appropriate measures to ensure
the test chemical was adequately dissolved in the test water.  This was
indicated by the failure of the measured concentrations to remain at
least 80% of the nominal concentrations, as required by the fish acute
toxicity Guideline, 850.1075.  Additionally, the test solutions
contained undissolved particulate test material. This was an additional
indication of the failure to successfully dissolve the test solution. 
Solubility is defined by the Agency’s Pesticide Registration Rejection
Rate Analysis Document as the amount of chemical retained in the
supernatant of a conventionally centrifuged sample of test media. 
Because the test material was not adequately dissolved, it was not
possible to obtain accurate toxicity endpoint values that could be used
for risk assessment purposes.  Further details regarding these studies
are listed in the table below.

Freshwater Fish Acute Toxicity

Species	

Chemical

% purity	96-hour

LC50 (a.i. ppm)

	

NOAEC (ppm a.i.)	

Toxicity Category	

MRID No.

Author/Year	

Study Classification

Fathead Minnow (Pimephales promelas)	Mandipropamid

96.1% a.i.	> 5.8	4.4 Note 1	Undeterminable Note 4	468001-05	Invalid Note
5

Rainbow trout (Oncorhynchus mykiss)	Mandipropamid 96.1% a.i.	4.4	1.7
Note  2	Undeterminable Note 4

	468001-06	Invalid Note 5

Rainbow trout (Oncorhynchus mykiss)	CGA380778	> 43	9.3  Note  3
Undeterminable Note 4

	468001-04	Invalid Note 5

Note 1: The NOAEC value, based on sub-lethal effects, was 4.4 mg a.i./L.
 Sub-lethal effects (loss of equilibrium and lethargy) were observed in
the group exposed to 5.8 mg a.i./L of NOA446510 (Mandipropamid).  As no
sub-lethal quantitative measurements were taken, the reviewer was unable
to determine an EC50 value.

Note 2: This NOAEC value based on mortality and sub-lethal effects, was
1.7 mg a.i./L.  Sub-lethal effects (surfacing, lying on the bottom of
the aquarium, loss of equilibrium, lethargy, erratic swimming and
morphological deformity) were observed in the groups exposed to
mean-measured concentrations 3.1-6.5 mg a.i./L of NOA446510.  As no
sub-lethal quantitative measurements were taken, the reviewer was unable
to determine an EC50 value.

Note 3:  This NOAEC is value, based on mortality and sub-lethal effects,
was 9.3 mg/L.  Sub-lethal effects (quiescence, sounding, dark
discoloration, loss of balance, ceased swimming, labored respiration and
swollen abdomen) were observed in the groups exposed to 17-43 mg/L of
CGA380778.  As no sub-lethal quantitative measurements were taken, the
reviewer was unable to determine an EC50 value.

Note 4: Because of the failure of the mean measured concentrations to
remain at least 80% of the nominal concentrations, the concentrations in
which these effects were observed cannot be validated.

Note 5: The studies were invalidated because of the failure of the study
authors to take appropriate measures to ensure the test chemical was
adequately dissolved in the test water.  This was indicated by the
failure of the measured concentrations to remain at least 80% of the
nominal concentrations, as required by the fish acute toxicity
Guideline, 850.1075.

ii. Fish, Chronic toxicity.

Mandipropamid is mobile and is likely to readily and frequently (due to
multiple applications during a growing season) reach surface water
bodies.  Thus, a fish chronic toxicity study testing mandipropamid is
required.  The registrant has submitted a fish early life-stage chronic
toxicity study testing the TGAI.  The results of the study demonstrated
a NOAEC of 0.210 ppm based on growth.  The details of this study are
listed in the table below.

Freshwater Fish Chronic Toxicity

Species	

% ai	Chronic Toxicity NOAEC and LOAEC

(a.i. ppm)

	Most sensitive Endpoint Affected	

MRID No.

Author/Year	

Study Classification

Fathead minnow	96.5	NOAEC: 0.22

LOAEC:

0.47

	Length, wet and dry weight	468001-08	Acceptable

iii. Freshwater Invertebrates, Acute

A freshwater aquatic invertebrate toxicity test using the TGAI is
required to establish the toxicity of mandipropamid to aquatic
invertebrates.  The preferred test species is Daphnia magna.  Results of
this test are tabulated below.  The registrant has submitted a study
testing the TGAI and a study testing the mandipropamid degradate,
CGA380778.

Freshwater Invertebrate Acute Toxicity for Mandipropamid and a
Mandipropamid degradate, CGA380778

Species	

Chemical (% purity).	48-hour EC50 (ppm a.i.)

	NOAEC (ppm a.i.; based on mortality)	

Toxicity Category	

MRID No.

	

Study Classification

Waterflea

(Daphnia magna)	

Mandipropamid

(96.5 %)	

7.1	

4.7	

Moderately

toxic

	

468001-50	Acceptable

Waterflea

(Daphnia magna)	

CGA380778 (98%)	

54.2	

37

	

Slightly

Toxic	

468001-51	

Acceptable

Since the EC50 for the TGAI, mandipropamid, falls in the range of 1 - 10
ppm, mandipropamid  is moderately toxic to aquatic invertebrates on an
acute basis.  Since the EC50 for the major degradate of mandipropamid,
CGA380778 falls in the range of 10 ppm – 100 ppm, CGA380778 is
classified as practically nontoxic to freshwater invertebrates.



Freshwater Invertebrate, Chronic

Mandipropamid is highly mobile and is likely to readily and frequently
(due to multiple applications during a growing season) reach surface
water bodies.  Thus, invertebrate chronic toxicity testing mandipropamid
is required.  The registrant has submitted one freshwater invertebrate
chronic toxicity study however the study was deemed invalid.  The study
was invalid because reproduction of solvent control daphnids was
significantly lower than that of negative control daphnids. According to
the EPA memo titled, “Interim Policy Guidance for the Use of
Dilution-Water (Negative) and Solvent Controls in Statistical Data
Analysis for Guideline Aquatic Toxicology Studies”, dated March 30,
2006, the study exhibiting such results would be invalidated.  The
details of the study are demonstrated below.

Freshwater Invertebrate Chronic Toxicity

Species	

% ai	Chronic Toxicity NOAEC and LOAEC

(a.i. ppm)

	

Most sensitive Endpoint Affected	

MRID No.

Author/Year	

Study Classification

Daphnia magna	99	* NOAEC:

< 0.023

LOAEC:

0.023	Reproduction	468001-07	Invalid Note 1

* Note: The reviewer’s analysis showed that reproduction of solvent
control daphnids was significantly lower than that of negative control
daphnids, which according to the EPA memo titled, “Interim Policy
Guidance for the Use of Dilution-Water (Negative) and Solvent Controls
in Statistical Data Analysis for Guideline Aquatic Toxicology
Studies”, dated March 30, 2006, would result in the INVALID
classification of this study.

c. Toxicity to Estuarine/Marine Animals

I.  Estuarine/Marine Fish, Acute

Mandipropamid usage may occur in some areas associated with
marine/estuarine habitats.  Thus, marine/estuarine fish toxicity data is
required. There are two registrant submitted acute toxicity studies
testing marine/estuarine fish.  However both studies were deemed
invalid.  The studies were invalidated because of the failure of the
study authors to take appropriate measures to ensure the test chemical
was adequately dissolved in the test water.  This was indicated by the
failure of the measured concentrations to remain at least 80% of the
nominal concentrations, as required by the fish acute toxicity
Guideline, 850.1075.  Additionally, the test solutions contained
undissolved particulate test material. This was an additional indication
of the failure to successfully dissolve the test solution.  Solubility
is defined by the Agency’s Pesticide Registration Rejection Rate
Analysis Document as the amount of chemical retained in the supernatant
of a conventionally centrifuged sample of test media.  Because the test
material was not adequately dissolved, it was not possible to obtain
accurate toxicity endpoint values that could be used for risk assessment
purposes. The details of the studies are demonstrated in the table
below.

Marine/Estuarine Fish Toxicity for Mandipropamid

Species	

(% purity)	96-hour LC50 (ppm a.i.)

	

NOAEC (ppm a.i.)	

Toxicity Category	

MRID No.

	

Study Classification

Sheepshead minnow

(Cyprinodon variegates)	

96.1	4.5	2.8 Note 1	Undeterminable

***	468001-03	Invalid Note 4

Sheepshead minnow

(Cyprinodon variegatus)

	

96.1	

>5.8 mg a..i./L	

4.4 Note 2	

Undeterminable Note 3	468001-05	

Invalid Note 4

Note 1: The NOAEC value, based on mortality and sub-lethal effects, was
2.8 mg a.i/L.  Sub-lethal effects (erratic swimming, lying on the bottom
of the test vessel, and surfacing for unusually long periods of time)
were observed in the groups exposed to 4.3 and 6.1 mg a.i./L of
NOA446510.   As no sub-lethal quantitative measurements were reported,
the reviewer was unable to determine an EC50 value.

Note 2: The NOAEC value, based on sub-lethal effects, was 4.4 mg a.i./L.
 Sub-lethal effects (loss of equilibrium and lethargy) were observed in
the group exposed to 5.8 mg a.i./L of NOA446510 (Mandipropamid).  As no
sub-lethal quantitative measurements were taken, the reviewer was unable
to determine an EC50 value.

Note 3:  Because of the failure of the mean measured concentrations to
remain at least 80% of the nominal concentrations, the concentrations in
which these effects were observed cannot be validated.

Note 4:  The studies were invalidated because of the failure of the
study authors to take appropriate measures to ensure the test chemical
was adequately dissolved in the test water.  This was indicated by the
failure of the measured concentrations to remain at least 80% of the
nominal concentrations, as required by the fish acute toxicity
Guideline, 850.1075.

Estuarine and Marine Fish, Chronic

Currently, no estuarine and marine fish chronic toxicity studies have
been submitted to the Agency.

iii. Estuarine and Marine Invertebrates, Acute

Mandipropamid usage may occur in some areas associated with
marine/estuarine habitats.  Thus, marine/estuarine fish toxicity data is
required.  There are two registrant submitted acute toxicity studies
testing marine/estuarine invertebrate.  The details of the studies are
demonstrated in the table below.

Freshwater Invertebrate Toxicity for Mandipropamid

Species	

Chemical (% purity).	96-hour EC50 (ppm a.i.)

	

NOAEC

(ppm a.i.;)	

Toxicity Category	

MRID No.

	

Study Classification

Mysid shrimp (Americamysis bahia)	96.1%	1.7(based on mortality)	0.58
Moderately toxic	468001-02	Acceptable

Oyster

Crassostrea virginica	

96.1	

0.91 (based on sublethal effect of shell deposition)	

0.46	

Very

Highly toxic	468001-01

	

Acceptable

iv.  Estuarine and Marine Invertebrate, Chronic

Currently, no estuarine and marine invertebrate chronic toxicity studies
have been submitted to the Agency.

d.   Toxicity to Plants

 tc \l2 "Toxicity to Plants 

i.  Terrestrial Plants tc \l3 "Terrestrial Plants 

The registrant submitted a seedling emergence and vegetative vigor study
testing the A12946B, the formulation containing the active ingredient
Mandipropamid.  The following summarizes the results of both studies.

The effect of A12946B on the seedling emergence of monocot (corn, Zea
mays; oat, Avena sativa; onion, Allium cepa; and ryegrass, Lolium
perenne) and dicot (carrot, Daucus carota; cucumber, Cucumis sativa;
radish, Raphanus sativus; soybean, Glycine max; sugar beet, Beta
vulgaris; and tomato, Lycopersicon esculentum) crops was studied at
nominal application rates of 0 (negative and surfactant controls),
0.0413, 0.0825, 0.165, 0.330 and 0.660 lbs ai/A.  The growth medium used
in the seedling emergence test was natural soil, classified as a loam
soil, with an organic matter content of 1.7% (1.0% organic carbon) and
an adjusted pH of 7.4.  On day 21 the surviving plants per pot were
recorded and cut at soil level for measuring the plant height and dry
weight.

Dry weight was significantly affected in cucumber, soybean and tomato,
but reductions did not exceed 25%.  The % inhibition in seedling
emergence in the treated species as compared to the control ranged from
-4 to 8%.  No monocot species was sensitive to treatment, but an EC05
value could be calculated for corn dry weight.  Carrot was the only
dicot species to exhibit a reduction of ≥25% (based on dry weight)
relative to the negative control; however, the response was not
dose-dependent, with the three lowest treatment groups experiencing
increases in dry weight of 2-21%.  The reviewer was unable to determine
reliable ECx values for carrot dry weight.   Additionally, one replicate
in the highest treatment group failed to emerge and overall emergence of
the controls and treatment groups was fairly low (60-73%). This implies
that factors other than treatment contributed to the poor performance of
carrot in this study.  The study was deemed supplemental because of this
study deficiency.

Seedling Emergence Study (468001-17) Summary of Most Sensitive
Parameters by Species (lbs ai/A).

Species	Endpoint	NOAEC	EC05	EC25	EC50

Corn	None	0.660	<0.0413	>0.660	>0.660

Oat	None	0.660	>0.660	>0.660	>0.660

Onion	None	0.660	ND	>0.660	>0.660

Ryegrass	None	0.660	ND	>0.660	>0.660

Carrot	Not Determinable	Not Determinable	Not Determinable	Not
Determinable	Not Determinable

Cucumber	None	0.165	<0.0413	>0.660	>0.660

Radish	None	0.660	0.36	>0.660	>0.660

Soybean	None	0.165	<0.0413	>0.660	>0.660

Sugar beet	None	0.660	ND	>0.660	>0.660

Tomato	None	0.660	ND	>0.660	>0.660

The effect of A12946B on the vegetative vigor of monocot (corn, Zea
mays; oat, Avena sativa; onion, Allium cepa; and ryegrass, Lolium
perenne) and dicot (carrot, Daucus carota; cucumber, Cucumis sativa;
radish, Raphanus sativus; soybean, Glycine max; sugar beet, Beta
vulgaris; and tomato, Lycopersicon esculentum) crops was studied at
nominal application rates of 0 (negative and surfactant controls),
0.0495, 0.0994, 0.198, 0.396 and 0.792 lbs ai/A.  The growth medium used
in the test was an artificial soil that represented a loam soil and was
composed of a mixture of kaolinite clay, industrial quartz sand and
peat; the organic matter content was 1.7% (1.0% organic carbon) and the
pH was 7.4.  On day 21 the surviving plants per pot were recorded and
cut at soil level for measuring the plant height and dry weight.

In the vegetative vigor test, plant height was affected by A12946B
treatment in oat only.  Dry weight, plant height and survival were not
affected in any other species.  The most sensitive monocot species,
based on plant height, in the vegetative vigor test was oat with an EC25
of >0.792 lbs ai/A and a NOAEC of 0.198 lbs ai/A.  No dicot was
sensitive to treatment, so the EC25 value was >0.792 lbs ai/A and the
NOAEC values was 0.792 lbs ai/A.

The study was deemed acceptable for a tier II vegetative vigor
terrestrial plant toxicity study.



Vegetative Vigor STUDY (468001-18) Summary of most sensitive parameters
by species (lbs ai/A).

Species	Endpoint	NOAEC	EC05	EC25	EC50

Corn	None	0.792	>0.792	>0.792	>0.792

Oat	Plant Height	0.198	>0.792	>0.792	>0.792

Onion	None	0.792	>0.792	>0.792	>0.792

Ryegrass	None	0.792	>0.792	>0.792	>0.792

Carrot	None	0.792	>0.792	>0.792	>0.792

Cucumber	None	0.792	>0.792	>0.792	>0.792

Radish	None	0.792	>0.792	>0.792	>0.792

Soybean	None	0.792	>0.792	>0.792	>0.792

Sugar beet	None	0.792	>0.792	>0.792	>0.792

Tomato	None	0.792	>0.792	>0.792	>0.792



Aquatic Plants

The registrant has submitted a nonvascular aquatic plant toxicity study
testing the effect of mandipropamid on Pseudokirchneriella subcapitata,
and a vascular aquatic plant toxicity study testing the effect of
mandipropamid on lemna gibba.  The registrant has also submitted a
nonvascular aquatic plant toxicity study testing the effect of
CGA380778, a mandipropamid degradate, on Pseudokirchneriella
subcapitata.  Results of the studies are tabulated below.

Tier II Mandipropamid Aquatic Plant Toxicity Test

	Test Species	Test Chemical and % purity	EC50 (ppm)	NOEAL or EC05 (ppm)
Endpoint Effected	Study Category	MRID

Lemna gibba	Mandipropamid

96.1	> 7.9	1.3 (EC05)	Biomass	Acceptable	468001-19

Pseudokirchneriella subcapitata	Mandipropamid

96.5	> 2.5	2.5 (NOEAL)	Biomass	Acceptable	468001-21

Pseudokirchneriella subcapitata	CGA380778 98.2%	16	2.4	Biomass
Acceptable	468001-20

APPENDIX F.	The Risk Quotient Method and Levels of Concern

The risks to terrestrial and aquatic organisms are determined based on a
method by which risk quotients (RQs) are compared with levels of concern
(LOCs). This method provides an indication of a chemical’s potential
to cause an effect in the field from effects observed in laboratory
studies, when used as directed. Risk quotients are expressed as the
ratio of the estimated environmental concentration (EEC) to the
species-specific toxicity reference value (TRV):

 

Units for EEC and TRV should be the same (e.g., µg/L or ppb). The RQ
is compared to the LOC as part of a risk characterization. Acute and
chronic LOCs for terrestrial and aquatic organisms are given in recent
Agency guidance (USEPA 2004) and summarized in Table F-1 below.

Table F-1. Level of concern (LOC) by risk presumption category (USEPA
2004)

Risk Presumption	RQ	LOC

Mammals and Birds

Acute Risk a	EEC b/LC50 or LD50/sqft c or LD50/day d	0.5

Acute Restricted Use e	EEC/LC50 or LD50/sqft or LD50/day (or LD50
<50 mg/kg)	0.2

Acute Endangered Species f	EEC/LC50 or LD50/sqft or LD50/day	0.1

Chronic Risk	EEC/NOEC	1

Aquatic Animals

Acute Risk	EEC g/LC50 or EC50	0.5

Acute Restricted Use	EEC/LC50 or EC50	0.1

Acute Endangered Species	EEC/LC50 or EC50	0.05

Chronic Risk	EEC/NOEC	1

Terrestrial and Semi-aquatic Plants

Acute Risk	EEC/EC25	1

Acute Endangered Species	EEC/EC05 or NOEC	1

Aquatic Plants

Acute Risk	EEC h/EC50	1

Acute Endangered Species	EEC g/EC05 or NOEC	1

a Potential for acute toxicity for receptor species if RQ > LOC (USEPA
2004).

b Estimated environmental concentration (ppm) on avian/mammalian food
items

c mg/ft2

d mg of toxicant consumed per day

e Potential for acute toxicity for receptor species, even considering
restricted use classification, if RQ > LOC (USEPA 2004).

f Potential for acute toxicity for endangered species of receptor
species if RQ > LOC (USEPA 2004).

g EEC = ppb or ppm in water

h EEC = lbs a.i./acre

For acute exposure to terrestrial and aquatic plants, an LOC of 1 is
used. Currently the Agency does not perform assessments for chronic risk
to plants or acute/chronic risks to non-target insects.

  SEQ CHAPTER \h \r 1 For the Tier II aquatic assessment of
mandipropamid acute exposure is represented by the maximum 24-hour EEC
value calculated using PRZM/EXAMS. EECs used to assess acute and chronic
risk to avian and mammalian species to mandipropamid were calculated
using the Tier I model T-REX.

The Agency has developed an Endangered Species Protection Program to
identify pesticides whose use may cause adverse impacts on endangered
and threatened species, and to implement mitigation measures that will
eliminate the adverse impacts. At present, the program is being
implemented on an interim basis as described in a Federal Register
notice (54 FR 27984–28008, July 3, 1989), and is providing information
to pesticide users to help them protect these species on a voluntary
basis. As currently planned, the final program will call for label
modifications referring to required limitations on pesticide uses,
typically as depicted in county-specific bulletins or by other
site-specific mechanisms as specified by state partners. A final
program, which may be altered from the interim program, will be
described in a future Federal Register notice. The Agency is not
imposing label modifications at this time. Rather, any requirements for
product use modifications will occur in the future under the Endangered
Species Protection Program.



APPENDIX G. Data Requirments

  SEQ CHAPTER \h \r 1 Table G-1. Environmental Fate Data Requirements
for Mandipropamid

Guideline No.	Data Requirement	MRID No.	Study Classification

161-1	Hydrolysis	46800007,8	Acceptable

161-2	Photodegradation in Water (pH 7)	46800009,10,11,12,13, 14
Acceptable

161-3	Photodegradation on Soil	4680000	Acceptable

161-4	Photodegradation in Air	No Data

	162-1	Aerobic Soil Metabolism	4680020,21,22,23,24,25,26,27,28
Acceptable

Supplemental

Supplemental

Supplemental

Supplemental

Supplemental

Supplemental

Supplemental

Supplemental

162-2	Anaerobic Soil Metabolism	468000027	Supplemental

162-3	Anaerobic Aquatic Metabolism	46800033,34	Unacceptable

162-4	Aerobic Aquatic Metabolism	46800032	Unacceptable

163-1	Adsorption/Desorption	46800035, 36, 37,38, 39,40,41,42, 43
Supplemental

163-2	Laboratory Volatility	No Data

	163-3	Field Volatility	No Data

	164-1	Terrestrial Field Dissipation	46800045	Acceptable

164-2	Aquatic Field Dissipation	No Data

	164-3	Forestry Dissipation	No Data

	165-4	Accumulation in Fish	No Data

	166-1	Ground Water – small prospective	No Data

	166-2	Ground Water – small retrospective	No Data

	201-1	Droplet Size Spectrum	No Data

	202-1	Drift Field Evaluation	No Data

	

Table G-2.   SEQ CHAPTER \h \r 1 Ecological Effects Data Requirements
for Mandipropamid

Guideline No.	Data Requirement	Species	Formulation	Are data adequate for
ecological risk assessment?	MRID Number

(Study Classification)

71-1

850.2100	Avian Acute Oral Toxicity	Anas Platyrhynchos (mallard duck)
Technical	Yes	46800110

(Acceptable)

Colinus virginianu (bobwhite quail)	Technical	Yes	46800111

(Acceptable)

71-2

850.2200	Avian Subacute Dietary Toxicity	Colinus virginianu

 (bobwhite quail)	Technical	Yes	46800112

(Acceptable)

Anas Platyrhynchos 

(mallard duck)	Technical	Yes	46800113

(Acceptable)

71-4

850.2300	Avian Reproduction Toxicity	Colinus virginianu 

(bobwhite quail)	Technical

	Yes

	46800114

(Acceptable)

Anas Platyrhynchos (mallard duck)	Technical	Yes

	46800115

(Acceptable)

72-1

850.1075	Freshwater Fish LC50	Pimephales promelas

(fathead minnow)	Technical	No	46800104

(Unacceptable)

Oncorhynchus mykiss

 (rainbow trout)	Technical	No	46800105

(Unacceptable)

72-2

850.1010	Freshwater Invertebrate Acute LC50	Daphnia magna 

(water flea)	Technical	Yes	46800150 (Acceptable)

72-3(a)

850.1075	Estuarine/Marine Fish LC50	Cyprinodon variegatus 

(sheepshead minnow)	Technical	No	46800101 (Unacceptable)

72-3(b)

850.1025	Estuarine/Marine Invertebrate (Mollusk)	Crassostrea virginica 

(eastern oyster)	Technical	Yes	46800101 (Acceptable)

72-3(c)

850.1035

850.1045	Estuarine/Marine Invertebrate (Mysid)	Americamysis bahia

 (mysid shrimp)	Technical	Yes	46800102 (Acceptable)

72-4 (a)

850.1400	Fish Early Life-Stage

(Freshwater)

(Marine)	Pimephales promelas

 (fathead minnow)	Technical	Yes

	46800108 (Acceptable)

72-4 (b)

850.1300

850.1350	Aquatic Invertebrate Life-Cycle

(Freshwater)

(Marine)	Americamysis bahia

 (mysid shrimp)	Technical	No data submitted

	72-5

850.1500	Fish Full Life-Cycle

(Freshwater)

(Marine)	No data submitted	No data submitted	No	–

122-1(a)

850.4100	Seed Germination/ Seedling Emergence (Tier I)	No data
submitted	No data submitted	No

	–

122-1(b)

850.4150	Vegetative Vigor

(Tier I)	No data submitted	No data submitted	No	–

122-2

850.4400	Aquatic Plant Growth (Tier I)	Lemna gibba (duckweed)	Technical
Yes

Technical	Yes

	123-1(a)

850.4225	Seed Germination/ Seedling Emergence (Tier II)	Monocots and
Dicots	Formulation c	Partially	46800117 (Supplemental)

123-1(b)

850.4250	Vegetative Vigor (Tier II)	Monocots and Dicots	Formulation c
Yes	46800118 (Acceptable)

123-2

850.4400	Aquatic Plant Growth (Tier II)	Lemna gibba (duckweed)	Technical
Yes	466800119 (Acceptable)

123-2

850.5400	Algal Plant Toxicity

(Tier I and Tier II)	Anabaena flos-aquae (freshwater alga)	Technical	No

	Skeletonema costatum (marine alga)	Technical	No

	Pseudokirchneriella subcapitata	Technical	Yes	46800121 (Acceptable)

Navicula pelliculosa (freshwater alga)	Technical	No

	141-1

850.3020	Honeybee Acute Contact Toxicity Test	Apis mellifera (honey bee)
Technical	Yes	46800116 (Supplemental)

141-2

850.3030	Residues on Foliage Honeybee Toxicity Test	No data submitted	No
data submitted	No

	Non-Guideline   SEQ CHAPTER \h \r 1 	  SEQ CHAPTER \h \r 1 Honeybee
Feeding Toxicity Test	No Data Submitted	No data submitted	No

	Non-Guideline	Benthic Organisms	Chironomus riparius 

(midge)	No data submitted	No

	Non-Guideline	Earthworm Subacute	No	No data submitted	No

	

APPENDIX H. Use Characterization Maps

There are no madnipropamid use characterization maps available.

APPENDIX I. Environmental Fate Bibliography

MRID   SEQ CHAPTER \h \r 1 Environmental Fate Studies Submitted to EPA

MRID 46800007 - Buckel, T. 2002. Hydrolysis of [ethyl-1-14C]-labelled
NOA446510 under laboratory conditions.  Unpublished study performed and
sponsored by Syngenta Crop Protection AG, Basel, Switzerland, and
submitted by Syngenta Crop Protection, Inc.  Greensboro, NC. Basel No.:
02TB01; Syngenta No.: T004591-02.  Experiment started April 2, 2002, and
completed May 13, 2002.  Final report issued November 8, 2002.

MRID 46800008 - Murphy, T.  2006.  Hydrolysis of [ethyl-1-14C]-labelled
NOA446510 under laboratory conditions, study profile.  Unpublished study
summary prepared, sponsored and submitted by Syngenta Crop Protection,
Inc., Greensboro, North Carolina.  Syngenta Study No.: T004591-02. 
Experimental start and termination dates not applicable.  Final report
issued February 24, 2006.

MRID 46800009- Kuet, S.F.  2004.  NOA446510: photolysis of
14C-chlorophenyl ring labelled NOA446510 in sterile natural water under
laboratory conditions.  Unpublished study performed by Jealott’s Hill
International Research Centre, Berkshire, UK, and submitted and
sponsored by Syngenta Crop Protection, Inc. Greensboro, NC.  Jealott’s
Hill No.: RJ3510B; Syngenta No.: T004575-02.  Experiment started October
2, 2003, and completed January 20, 2004. Final report issued November
25, 2004.

MRID 46800010- Harrison, C.L.  2004.  NOA446510: 14C-methoxyphenyl
labelled sterile natural water photolysis under laboratory conditions. 
Unpublished study performed by Jealott’s Hill International Research
Centre, Berkshire, UK, and submitted and sponsored by Syngenta Crop
Protection, Inc. Greensboro, NC.  Jealott’s Hill No.: RJ3481B;
Syngenta No.: T004607-02.  Experiment started November 27, 2003, and
completed March 22, 2004.  Final report issued December 22, 2004.

MRID 46800011 - Nicollier, G. 2003.  Aqueous photolysis of
[chlorophenyl-U-14C]-labelled NOA446510 under laboratory conditions. 
Unpublished study performed and sponsored by Syngenta Crop Protection
AG, Basel, Switzerland, and submitted by Syngenta Crop Protection, Inc.
Greensboro, NC.  Basel No.: 02GN07; Syngenta No.: T004618-02. 
Experiment started May 14, 2002, and completed July 01, 2003. Final
report issued October 31, 2003.

MRID 46800012 - Murphy, T.  2006.  Aqueous photolysis of
[chlorophenyl-U-14C]-labelled NOA446510 under laboratory conditions,
study profile.  Unpublished study summary prepared, sponsored and
submitted by Syngenta Crop Protection, Inc., Greensboro, North Carolina.
 Syngenta Study No.: T004618-02.  Experimental start and termination
dates not applicable.  Final report issued February 23, 2006.

MRID 46800013 - Hand, L.H. and J. Towers. 2003.  Aqueous photolysis of
14C-methoxyphenyl-NOA446510 under laboratory conditions.  Unpublished
study performed and sponsored by Syngenta Jealott’s Hill International
Research Centre, Berkshire, UK and submitted by Syngenta Crop
Protection, Inc., Greensboro, NC.  Study No.: 02JH091; Syngenta No.:
T004630-02.  Experiment started November 20, 2002, and completed May 28,
2003.  Final report issued August 18, 2003.

MRID 46800014 - Murphy, T.  2006.  Aqueous photolysis of
14C–methoxypehnyl-NOA446510 under laboratory conditions, study
profile.  Unpublished study summary prepared, sponsored and submitted by
Syngenta Crop Protection, Inc., Greensboro, North Carolina.  Syngenta
Study No.: T004630-02.  Experimental start and termination dates not
applicable.  Final report issued February 13, 2006.

MRID 46800015 - Bramley, Y.M.  NOA446510: Soil photolysis of
14C-chlorophenyl ring

labelled NOA446510 under laboratory conditions.  Unpublished study
performed by Jealott’s

Hill International Research Centre, Berkshire, UK and sponsored and
submitted by Syngenta

Crop Protection, Inc., Greensboro, NC.  Report No.: RJ3535B.  Syngenta
No.: T008105-03.

Experiment initiated January 14, 2004 and completed January 7, 2005. 
Final report issued

February 7, 2005.

MRID 46800016: Murphy, T.  2006.  NOA446510: Soil photolysis of
14C-methoxyphenyl ring labelled NOA446510 under laboratory conditions. 
Unpublished study sponsored and submitted by Syngenta Crop Protection,
Inc., Greensboro, NC.  Syngenta No.: T004595-02.  Experiment start and
completion date not applicable.  Final report issued February 13, 2006.

MRID 46800017: Kuet, S.F.  2003.  NOA446510: Soil photolysis of
14C-methoxyphenyl ring labelled NOA446510 under laboratory conditions. 
Unpublished study performed by Jealott’s Hill International Research
Centre, Berkshire, UK and sponsored and submitted by Syngenta Crop
Protection, Inc., Greensboro, NC.  Jealott’s Hill No.: RJ3400B. 
Syngenta No.: T004595-02.  Study started January 8, 2003 and completed
August 20, 2003.  Final report issued December 10, 2003.

MRID 46800016: Murphy, T.  2006.  NOA446510: Soil photolysis of
14C-methoxyphenyl ring labelled NOA446510 under laboratory conditions. 
Unpublished study sponsored and submitted by Syngenta Crop Protection,
Inc., Greensboro, NC.  Syngenta No.: T004595-02.  Experiment start and
completion date not applicable.  Final report issued February 13, 2006.

MRID 46800018: McKillican, C. B.  2005.  Photodegradation of
14C-NOA-446510 on soil under artificial light.  Unpublished study
performed, sponsored and submitted by Syngenta Crop Protection, Inc.,
Greensboro, NC.  Syngenta No.:  737-02.  Study started June 15, 2004 and
completion date not reported . Final report issued July 29, 2005.

MRID 46800019: Murphy, T.  2006.  Photodegradation of 14C-NOA-446510 on
soil under artificial light.  Unpublished study sponsored and submitted
by Syngenta Crop Protection, Inc., Greensboro, NC.  Syngenta No.: 
000737-02.  Experiment start and completion date not applicable.  Final
report issued February 13, 2006.

MRID 46800020: Clark, A.  2004.  Metabolism of
[14C-chlorophenyl]-NOA-446510 in viable soil under aerobic conditions. 
Unpublished study performed, submitted and sponsored by Syngenta Crop
Protection, Inc, Greensboro, NC.  Study No.: T000680-02.  Syngenta No.:
680-02.  Experiment started March 7, 2003.  Experimental completion date
not reported.  Final report issued September 1, 2004.

MRID 46800021: Murphy, T.  2006.  Metabolism of
[14C-chlorophenyl]-NOA-446510 in viable soil under aerobic conditions. 
Unpublished study submitted and sponsored by Syngenta Crop Protection,
Inc, Greensboro, NC.  Syngenta No.: T000680-02.  Experiment start and
completion date not applicable.  Final report issued February 13, 2006.

MRID 46800022: Nicollier, G.  2003.  Metabolism of [methoxyphenyl-U-14C]
labelled

NOA446510 under aerobic, aerobic/anaerobic and sterile aerobic
laboratory conditions in one

soil at 20(C.  Unpublished study performed by Syngenta Crop Protection
AG, Basel,

Switzerland, and submitted and sponsored by Syngenta Crop Protection,
Inc., Greensboro, NC.

Basel Number: 02RF02.  Syngenta Number: T004633-02.  Experiment
initiated on June 6, 2002

and completed on November 28, 2003.  Final report issued on December 18,
2003.

MRID 46800023: Berdat, T. 2005.  Rate of degradation of [14C] CGA380778
(metabolite of NOA446510) in various soils under aerobic laboratory
conditions at 20(C.  Unpublished study performed and sponsored by
Syngenta Crop Protection AG, Basel, Switzerland and submitted by
Syngenta Crop Protection, Inc., Greensboro, NC.  Sygenta No.:
T004943-04.  Experiment started August 4, 2004 and completed January 20,
2005.  Final report issued March 13, 2005.

MRID 46800024: Hand, L.H.  2004.  NOA446510: Rate of degradation in one
soil under various laboratory conditions.  Unpublished study performed
by Jealott’s Hill International Research Centre, Berkshire, UK and
submitted and sponsored by Syngenta Crop Protection, Inc, Greensboro,
NC.  Report No.: RJ3487B.  Syngenta No.: T008097-03.  Experiment started
July 7, 2003 and completed February 27, 2004.  Final report issued July
14, 2004.

MRID 46800025:  Murphy, T.  2006.  NOA446510: Rate of degradation in one
soil under various laboratory conditions.  Unpublished study submitted
and sponsored by Syngenta Crop Protection, Inc., Greensboro, NC. 
Syngenta No.:  T008097-03.  Experiment start and completion date not
applicable.  Final report issued February 13, 2006.

MRID 46800026:  Dorn, R., A. Clark, J. Perine, W. Chen, and T. Murphy. 
2006.  Evaluation of degradation times after adjustment for temperature
and moisture effects of NOA446510 and its metabolite in various soils
under laboratory conditions.  Unpublished summary report prepared,
sponsored and submitted by Syngenta Crop Protection, Inc., Greensboro,
North Carolina.  Syngenta Study No.: T014422-05.  Experimental start
date and termination date not applicable.  Final report issued March 1,
2006.

MRID 46800027:  Nicollier, G.  2003.  Metabolism of [chlorophenyl-U-14C]
labelled NOA446510 under aerobic and aerobic/anaerobic laboratory
conditions in one soil at 20(C.  Unpublished study performed by Syngenta
Crop Protection AG, Basel, Switzerland, submitted and sponsored by
Syngenta Crop Protection, Inc., Greensboro, NC.  Basel Number: 02TB03;
Syngenta Number: T004572-02.  Experiment initiated on July 16, 2002 and
completed on January 7, 2003 (p. 9).  Final report issued on November 6,
2003.

MRID 46800028:  Kuet, S.F.  NOA446510: Metabolism and rate of
degradation of 14C-chlorophenyl ring labelled NOA446510 under aerobic
laboratory conditions, in three soils, at 20(C.  Unpublished study
performed by Jealott’s Hill International Research Centre, Berkshire,
UK and submitted and sponsored by Syngenta Crop Protection, Inc,
Greensboro, NC.  Report No.: RJ3469B.  Syngenta No.: T008109-03. 
Experiment started March 27, 2003 and completed December 3, 2003 (p.
28).  Final report issued July 16, 2004.

MRID 46800029:  Dorn, R. 2005.  Evaluation of half-lives of selected
metabolites of

NOA446510 in aquatic systems.  Unpublished summary report prepared,
sponsored and

submitted by Syngenta Crop Protection, Inc., Greensboro, North Carolina.
 Syngenta Study No.:

T001209-06 and Report No.: Ass05RD04 (pp. 1, 4).  Experimental start
date and termination

date not applicable.  Final report issued August 16, 2005.

MRID 46800030: Murphy, T.  2006.  NOA446510: degradation in two aquatic
sediment systems, study profile.  Unpublished study summary prepared,
sponsored and submitted by Syngenta Crop Protection, Inc., Greensboro,
North Carolina.  Syngenta Study No.: T008095-03.  Experimental start and
termination dates not applicable.  Final report issued March 9, 2006.

MRID 46800031: Hurt, A.D.  2005.  NOA446510: degradation on two aquatic
sediment systems, final report.  Unpublished study performed by
Jealott's Hill International Research Centre, Berkshire, United,
Kingdom, sponsored and submitted by Syngenta Crop Protection, Inc.,
Greensboro, North Carolina.  JH Study No.: 03JH023 and Report No.:
RJ3669B (pp. 1, 15 in MRID 46800031).  Syngenta Study No.: T008095-03. 
Experimental start date July 16, 2003, and termination date February 24,
2005 (p. 50 in MRID 4600031).  Final report issued July 27, 2005.

MRID 46800032:  Oliver, R.G., et al.  2005.  NOA446510: degradation in
an outdoor aquatic sediment system.  Unpublished study performed by
Jealott's Hill International Research Centre, Berkshire, United Kingdom,
sponsored and submitted by Syngenta Crop Protection, Inc., Greensboro,
North Carolina.  JH Study No.: 04JH007 and Report No.: RJ3569B (pp. 1,
12).  Syngenta Study No.: T009117-04.  Experimental start date June 2,
2004, and termination date May 10, 2005 (p. 35).  Final report issued
July 27, 2005.

MRID 46800033: Hurt, A.D.  2005.  NOA446510: degradation in two aquatic
sediment systems (methoxyphenyl ring), final report.  Unpublished study
performed by Jealott's Hill International Research Centre, Berkshire,
United Kingdom, sponsored and submitted by Syngenta Crop Protection,
Inc., Greensboro, North Carolina.  JH Study No.: 03JH035 and Report No.:
RJ3580B (pp. 1, 6 in MRID 46800033).  Syngenta Study No.: T008104-03. 
Experimental start date May 6, 2004, and termination date April 13, 2005
(p. 43 in MRID 4600033).  Final report issued July 14, 2005.

MRID 46800034: Clark, A.  2006.  NOA446510: degradation on two aquatic
sediment systems (methoxyphenyl ring), study profile.  Unpublished study
summary prepared, sponsored and submitted by Syngenta Crop Protection,
Inc., Greensboro, North Carolina.  Syngenta Study No.: T008104-03. 
Experimental start and termination dates not applicable.  Final report
issued March 3, 2006.

MRID 46800035:  Indergand, P.  2005.  Adsorption/desorption of a
[chlorophenyl-U-14C]-labeled SYN521195 in various soils.  Unpublished
study performed and sponsored by Syngenta Crop Protection AG, Bracknell,
Basel, Switzerland; submitted by Syngenta Crop Protection Inc.,
Greensboro, North Carolina.  Syngenta Number T013384-04.  Experimental
start date January 27, 2005, and experimental completion date June 21,
2005 (p. 9).  Study completion date August 19, 2005.

MRID 46800036:  Hand, L.H. and E.A. Fleming.  2005. 
Adsorption/desorption properties of a metabolite (SYN539678) in three
soils.  Unpublished study performed by Jealott’s Hill International
Research Centre, Bracknell, Berkshire, United Kingdom; submitted and
sponsored by Syngenta Crop Protection Inc., Greensboro, North Carolina. 
Syngenta Number T013385-04.  Jealott’s Hill Number RJ3674B. 
Experimental start date January 11, 2005, and experimental completion
date May 11, 2005 (p. 22). Study completion date July 6, 2005.

MRID 46800037:  Indergand, P. and G. Nicollier.  2005. 
Adsorption/desorption of [phenyl-U-14C]-labeled SYN500003 in various
soils (including final report amendment 1).  Unpublished study performed
and sponsored by Syngenta Crop Protection AG, Basel, Switzerland;
submitted by Syngenta Crop Protection Inc., Greensboro, North Carolina. 
Syngenta Number T0006595-04.  Experimental start date January 11, 2005,
and experimental completion date May 2, 2005 (p. 9).  Study completion
date June 9, 2005.

MRID 46800038:  Nicollier, G. 2003.  Adsorption/desorption of
[methoxyphenyl-U-14C]-labelled NOA446510 in various soils (including
final report amendment 1).  Unpublished study performed and sponsored by
Syngenta Crop Protection AG, Basel, Switzerland; and submitted by
Syngenta Crop Protection Inc., Greensboro, NC.    Syngenta AG Study
Number T004577-02.  Basel Number 02TB04.  Experimental start date August
9, 2002, and completion date February 18, 2002 (p. 9).  Final report
issued October 24, 2003.

MRID 46800039: Murphy, T.  2006.  Adsorption/desorption of
[methoxyphenyl-U-14C]-labelled

NOA446510 in various soils.  Unpublished study submitted and sponsored
by Syngenta Crop

Protection Inc., Greensboro, NC.  Syngenta Study Number T004577-02. 
Study completion date

February 27, 2006.

MRID 46800040:  Berdat, T. and G. Nicollier.  2004.  NOA446510: 
Adsorption/desorption of [methoxyphenyl-U-14C]-labelled NOA446510 in
various US field soils (includes final report amendment 1).  Unpublished
study performed by Syngenta Crop Protection AG, Basel, Switzerland;
sponsored and submitted by Syngenta Crop Protection Inc., Greensboro,
North Carolina.  Study Number 04TB01.  Syngenta Number T000738-02. 
Experimental start date January 16, 2004, and experimental completion
date March 17, 2004 (p. 9).  Study completion date December 23, 2004.

MRID 46800041:  Murphy, T.  2006.  NOA446510: Adsorption/desorption of
[methoxyphenyl-U-14C]-labelled NOA446510 in various US field soils. 
Sponsored and submitted by Syngenta Crop Protection Inc., Greensboro,
North Carolina.  Syngenta Number T000738-02.  Completion date March 8,
2006.

MRID 46800042:  Adam, D.  2004.  Adsorption/desorption of
[14C]-CGA380778 on various soils.  Unpublished study performed by RCC
Ltd, Itingen, Switzerland; sponsored and submitted by Syngenta Crop
Protection Inc., Greensboro, North Carolina.  RCC Study Number 855381. 
Syngenta Number T004956-04.  Experimental start date August 11, 2004,
and completion date September 22, 2004 (p. 12).  Study completion date
December 6, 2004.

MRID 46800043:  Murphy, T.  2006.  Adsorption/desorption of
[14C]-CGA380778 on various soils.  Sponsored and submitted by Syngenta
Crop Protection Inc., Greensboro, North Carolina.  Syngenta Number
T004956-04.  Study completion date March 8, 2006.

MRID 46800044:  Harrison, C.L.  2005.  NOA446510:  Adsorption/desorption
properties of a water sediment metabolite SYN504851 in three soils. 
Unpublished study performed by Jealott’s Hill International Research
Centre, Bracknell, Berkshire, United Kingdom; submitted and sponsored by
Syngenta Crop Protection Inc., Greensboro, North Carolina.  Syngenta
Number T013383-04.  Jealott’s Hill Number RJ3633B.  Experimental start
date January 5, 2005, and experimental completion date April 1, 2005 (p.
20). Study completion date May 19, 2005.

MRID 46800045:  Peters, J. 2005. Dissipation of NOA446510 250SC in bare
soil plot under simulated leafy vegetable production conditions in the
San Joaquin Valley of California. Unpublished study performed by
Syngenta Crop Protection, Inc., Greensboro, NC; Excel Research Services,
Inc., Fresno, CA (field research facility); and North Coast
Laboratories, Ltd., Arcata, CA (analytical laboratory); and sponsored
and submitted by Syngenta Crop Protection, Inc., Greensboro, NC.
Syngenta No. T000052-03. Excel Study No. ERS23039. NCL No. 110.025.
Experiment initiation October 1, 2003 (first application date; Appendix
1, p. 84) and completion April 29, 2005 (analytical phase termination
date; Appendix 2, p. 133). Final report issued October 3, 2005.

MRID 46800046:  Peters, J. 2005. Dissipation of NOA446510 250SC under
field conditions on crop (potatoes) and bare soil in New York.
Unpublished study performed by Syngenta Crop Protection, Inc.,
Greensboro, NC; Waterborne Environmental, Inc., Leesburg, VA (field
phase management); A.C.D.S. Research , Inc., North Rose, NY (field
research facility); and Enviro-Test Laboratories, Edmonton, Alberta,
Canada (analytical laboratory); and sponsored and submitted by Syngenta
Crop Protection, Inc., Greensboro, NC. Syngenta No. T000053-03. ETL
Report No. 05SYN150.REP. WEI Study No. 242.68. Experiment initiation
August 7, 2003 (first application date; Appendix 1, p. 93) and
completion February 24, 2005 (analytical phase termination date;
Appendix 2, p. 199). Final report issued October 3, 2005.

MRID 46800047:  Peters, J. 2005. Dissipation of NOA446510 250SC in a
bare soil plot under simulated squash production conditions in Georgia.
Unpublished study performed by Syngenta Crop Protection, Inc.,
Greensboro, NC (analytical laboratory); Waterborne Environmental, Inc.,
Leesburg, VA (field management); Ag. Research Associates, LLC, Chula, GA
(field research facility); and sponsored and submitted by Syngenta Crop
Protection, Inc., Greensboro, NC. Syngenta No. T000054-03. WEI Study No.
242.69. Experiment initiation May 21, 2003 (first application date;
Appendix 1, p. 78) and completion July 13, 2005 (analytical phase;
Appendix 2, p. 165). Final report issued October 3, 2005.

MRID 46800109: Roberts, G.C. and F. Peurou.  2003.  NOA446510:
Determination of the accumulation and elimination of [14C]NOA446510 in
fathead minnow (Pimephales promelas).  Unpublished study performed by
Brixham Environmental Laboratory, United Kingdom; sponsored and
submitted by Syngenta Crop Protection, Inc., Greensboro, NC.  Brixham
Number BL7579/B.  Syngenta Number T011831-05.  Experiment initiated
March 12, 2003, and completed May 30, 2003 (p. 10).  Final report issued
December 18, 2003.

MRID 46800048 (NG study):  Peters, J. and B. Schwartz. 2005. Stability
of NOA-446510 and CGA-380778 in soil under freezer storage conditions.
Unpublished study performed and sponsored and submitted by Syngenta Crop
Protection, Inc., Greensboro, NC. Syngenta No. T001672-03. Experiment
initiation November 24, 2003 and completion September 9, 2005 (p. 8 and
Appendix 1, p. 68). Final report issued November 7, 2005.

MRID 46800049 (NG study):  Chen, W. 2006. Degradation of NOA446510
influenced by soil temperature under cropped and bare soil conditions: A
conceptual model approach to bridge data from laboratory to field.
Unpublished summary report prepared, sponsored, and submitted by
Syngenta Crop Protection, Inc., Greensboro, North Carolina. Syngenta
Study No.: T021955-04. Experimental start date and termination date not
applicable. Final report issued March 22, 2006.

MRID 46800124 (NG study):  Kendall, T. and W. Nixon.  2005.  Analytical
method verification for the determination of NOA446510 in saltwater. 
Unpublished study performed by Wildlife International, Ltd., Easton,
Maryland, sponsored and submitted by Syngenta Crop Protection, Inc.,
Greensboro, North Carolina.  Wildlife International Project No.:
528C-123 (p. 8).  Syngenta Study No.: T003405-03.  Experimental start
and termination date November 15, 2004 (p. 8).  Final report issued May
13, 2005.

MRID 46800125 (NG study):  Bruns, G. and S. Nelson.  2004.  Independent
laboratory validation: Syngenta: “Analytical method REM 202.02 for the
determination of NOA-446510 and its metabolite CGA-380778, in soil,
using liquid chromatography-electrospray ionization tandem mass
spectrometry (including validation data).”  Unpublished study
performed by Enviro-Test Laboratories, Edmonton, Alberta, Canada,
sponsored and submitted by Syngenta Crop Protection, Inc., Greensboro,
North Carolina.  ETL Study No.: 04ILV05SYN and Report No.: 04SYN142.REP.
 Syngenta Study No.: T006443-04.  Experimental start and termination
dates not reported; study initiation date September 17, 2004 (p. 8). 
Final report issued November 23, 2004.

MRID 46800126 (NG study):  Williams, R.  2003.  Analytical method REM
202.02 for the determination of NOA-446510 and its metabolite
CGA-380778, in soil, using liquid chromatography-electrospray ionization
tandem mass spectrometry (including validation data).  Unpublished study
performed, sponsored and submitted by Syngenta Crop Protection, Inc.,
Greensboro, North Carolina.  Syngenta Study No.: T000056-03. 
Experimental start date not reported; study initiation date August 11,
2003 (p. 8).  Experimental termination date September 9, 2003 (p. 8). 
Final report issued October 9, 2003.

APPENDIX J. Ecological Toxicity Bibliography

MRID Ecotoxicity Studies Submitted to EPA

MRID 468001-01 Palmer, S.J., et al., NOA446510: A 96-Hour Flow-Through
Shell Deposition Test with the Eastern Oyster (Crassostrea virginica)
Study Completion Date: May 9, 2005 Wildlife International, Ltd., Easton,
MD Syngenta Crop Protection, Greensboro, NC

MRID  468001-02 Palmer, Susan J., et al. NOA446510: A 96-Hour
Flow-Through Acute Toxicity Test with the Saltwater Mysid (Americamysis
bahia) May 10, 2005 Wildlife International, Ltd., Easton, MD Sponsor:
Syngenta Crop Protection, Inc., Greensboro, NC Laboratory Report ID:
528A-137 MRID No.:468001-02

MRID 468001-03 Palmer, Susan J., et al.  2005.  NOA446510: A 96-Hour
Flow-Through Acute Toxicity Test with the Sheepshead Minnow (Cyprinodon
variegatus).  Unpublished study performed by Wildlife International,
Inc., Easton, MD.  Laboratory report number 528A-138.  Study sponsored
by Syngenta Crop Protection, Inc., Greensboro, NC.  Study completed May
9, 2005.

MRID  468001-04 Maynard, S.J. and R.H. Swarbrick.  2005.  NOA446510
Metabolite (CGA380778): Acute Toxicity to Rainbow Trout (Oncorhynchus
mykiss).  Unpublished study performed by Brixham Environmental
Laboratory, Brixham, Devon TQ5 8BA, UK.  Laboratory number BL7958/B. 
Study sponsored by Syngenta Crop Protection, Inc.  Study completed
January 4, 2005.

MRID  468001-05 Palmer, S.J., et al.  2006.  NOA446510: A 96-Hour
Flow-Through Acute Toxicity Test with the Fathead Minnow (Pimephales
promelas).  Unpublished study performed by Wildlife International, Ltd.,
Easton, MD.  Laboratory report number 528A-146.  Stud sponsored by
Syngenta Crop Protection, Inc., Greensboro, NC.  Study completed March
7, 2006.

MRID  468001-06 Palmer, S.J., et al.  2006.  NOA446510: A 96-Hour
Flow-Through Acute Toxicity Test with the Rainbow Trout (Oncorhynchus
mykiss).  Unpublished study performed by Wildlife International, Inc.,
Easton, MD.  Laboratory report number 528A-147.  Study sponsored by
Syngenta Crop Protection, Inc., Greensboro, NC.  Study completed March
7, 2006.

MRID  468001-07  Grade, R.  2003.  Daphnia magna Reproduction Test: 
Effects of NOA 446510 on the Reproduction of the Cladoceran Daphnia
magna STRAUS in a Semi-Static Laboratory Test.  Unpublished study
performed by Ecological Sciences, Basel, Switzerland.  Laboratory Study
No. 2013604.  Study sponsored by Syngenta Crop Protection, Inc.,
Greensboro, NC.  Study initiated July 31, 2001 and submitted March 24,
2003.

MRID  468001-08  Maynard, S.J.  2003.  NOA 446510 tech: Early-Life Stage
Toxicity Test to the Fathead Minnow (Pimephales promelas).  Unpublished
study performed by Brixham Environmental Laboratory, Devon, UK. 
Laboratory Project No. BL7577/B.  Study submitted by Syngenta Crop
Protection, Inc., Greensboro, NC.  Study initiated May 12, 2003 and
submitted December 22, 2003.

MRID  468001-09   Gallagher, S.P., L.R. Mitchell, and J.B. Beavers. 
2002.  NOA446510 (AMS):  An Acute Oral Toxicity Study with the Northern
Bobwhite.  Unpublished study performed by Wildlife International Ltd.,
Easton, MD.  Laboratory Project No. 528-141.  Study submitted by
Syngenta Crop Protection, Inc., Greensboro, NC.  Study initiated May 15,
2002 and submitted December 11, 2002.

MRID  468001-10 Gallagher, S.P., and J.B. Beavers.  2005.  NOA446510
(AMS):  An Acute Oral Toxicity Study with the Mallard.  Unpublished
study performed by Wildlife International Ltd., Easton, MD.  Laboratory
Project No. 528-142.  Study submitted by Syngenta Crop Protection, Inc.,
Greensboro, NC.  Study initiated May 15, 2002 and submitted July 18,
2005.

MRID  468001-11  Gallagher, S.P., et al.  2002.  NOA446510 (AMS):  A
Dietary LC50 Study with the Mallard.  Unpublished study performed by
Wildlife International, Ltd., Easton, MD.  Laboratory Project No.
528-140.  Study submitted by Syngenta Crop Protection, Inc., Greensboro,
NC.  Study initiated May 15, 2002 and submitted December 12, 2002.

MRID  468001-12  Gallagher, S.P., et al.  2002.  NOA446510 (AMS):  A
Dietary LC50 Study with the Northern Bobwhite.

MRID  468001-13 Gallagher, S.P., et al.  2002.  NOA446510 (AMS):  A
Dietary LC50 Study with the Northern Bobwhite.  Unpublished study
performed by Wildlife International, Ltd., Easton, MD.  Laboratory
Project No. 528-139.  Study submitted by Syngenta Crop Protection, Inc.,
Greensboro, NC.    SEQ CHAPTER \h \r 1 Study initiated May 15, 2002 and
submitted December 11, 2002.

MRID 468001-14 Frey, L.T., et al.  2003.  NOA446510 (AMS):  A
Reproduction Study with the Mallard.  Unpublished study performed by
Wildlife International Ltd., Easton, MD.  Laboratory Project No.
528-150.  Study submitted by Syngenta Crop Protection, Inc., Greensboro,
NC.  Study initiated August 12, 2002 and submitted June 13, 2003.

MRID 468001-15 Frey, L.T., et al.  2003.  NOA446510 (AMS):  A
Reproduction Study with the Northern Bobwhite.  Unpublished study
performed by Wildlife International Ltd., Easton, MD.  Laboratory
Project No. 528-149.  Study submitted by Syngenta Crop Protection, Inc.,
Greensboro, NC.  Study initiated August 12, 2002 and submitted June 13,
2003.

MRID 468001-16 Dr. C. Grimm, Acute Contact and Oral Toxicity of
NOA446510 to Honey Bees (Apis mellifera L.) June 03, 2002 Laboratory:
Syngenta Crop Protection AG, Ecological Sciences, CH-4002 Basel,
Switzerland Syngenta Crop Protection, Greensboro, NC Laboratory Report
ID:2013603 (Basel); T011807-05 (Syngenta)

MRID 468001-17 Porch, John R., et al.  2005.  NOA446510: A Glasshouse
Toxicity Study to Determine the Effects of a 250 g ai/Litre SC
Formulation (A12946B) on the Seedling Emergence of Ten Species of
Plants.  Unpublished study performed by Wildlife International, Ltd.,
Easton, MD.  Laboratory report number 528-192.  Study sponsored by
Syngenta Crop Protection, Inc., Greensboro, NC.  Study completed October
21, 2005.

MRID 468001-18 Porch, John R., W. Krip and H.O. Krueger.  2005. 
NOA446510: A Glasshouse Toxicity Study to Determine the Effects of a 250
g ai/Litre SC Formulation (A12946B) on the Vegetative Vigor on Ten
Species of Plants.  Unpublished study performed by Wildlife
International, Ltd., Easton, MD.  Laboratory report number 528-193. 
Study sponsored by Syngenta Crop Protection, Inc., Greensboro, NC. 
Study completed August 12, 2005.

!

,

0

b

e

&

1

]

Ø	@

H	#

@

H	#

@

j

＀ࡵ␁

j±

j¥

摧䠄xပ਀&䘋

h>m

h>m

ပ਀&䘋

 hB

hB

h©

h©

h©

h©

h©

h©

h©

h©

h©

h©

h©

h©

h©

h©

h©

h©

h©

h©

h©

h©

h©

h©

h©

h©

h©

h©

h©

h©

 h

 h

H* h

H*

$

Üˆ

$

Üˆ

ˆ

«

$

Ø	@

Ø	@

Ø	@

h"

 h"

h"

 h"

h"

h"

Ø	@

 h"

 h"

Ø	@

°

$

%

(

+

,

-

‚

¢

»

Ð

Ó

Ö

Ù

Ú

Ø	@

%Ú

Û

î

摧䠄xကZ

w

~

›

¥

«

Á

Ê

Û

Ý

Þ

h"

h"

h"

h"

h"

Ñ

 h®

h®

! h®

h®

h®

H*

”ÿS

¿

”ÿS

”# 	¿

”ÿS

¿

”ÿS

¿

”ÿS

¿

”ÿS

¿

$

Æ

$

$

$

$

N	®

摧䠄x଀

[

d

*d

f

~

Å

É

Ê

Ø

Ý

Þ

ê

ì

î

ñ

þ

-

|

ƒ

Ž

¬

®

H*

”ÿ”

 h@

-

 

!

"

#

-

.

/

9

K

S

Y

Z

š

¥

¼

*#

$

%

&

'

(

)

*

+

,

-

.

/

Z

g

¼

–

ð

’	\

ô

@

ô

ô

ô

␅؁Ĥ萏Ũꐔ 葞Ũ摧䠄xက

ƒìtjtj^tjWjtjtjtj

@

@

Ø	@

Ø	@

Ø	@

Ø	@

Ø	@

Ø	@

Ø	@

Ø	@

Ø	@

Ø	@

Ø	@

Ø	@

Ø	@

Ø	@

Ø	@

Ø	@

Ø	@

Ø	@

Ø	@

Ø	@

Ø	@

Ø	@

	

	

	

	

摧䠄xᬀ

kdA

kdç

t with Duckweed (Lemna gibba G3).  Unpublished study performed by
Wildlife International, Ltd., Easton, MD.  Laboratory report number
528A-148.  Study sponsored by Syngenta Crop Protection, Inc.,
Greensboro, NC.  Study completed March 7, 2006.

MRID 468001-20 Maynard, S.J. and R.H. Swarbrick.  2005.  NOA446510
Metabolite (CGA380778): Toxicity to the Green Alga Pseudokirchneriella
subcapitata (Formerly Selenastrum capricornutum).  Unpublished study
performed by Brixham Environmental Laboratory, UK.  Laboratory report
number BL7960/B.  Study sponsored by Syngenta Crop Protection, Inc.,
Greensboro, NC.  Study completed on January 4, 2005.

MRID 468001-21 Volz, Ernst.  2005.  Mandipropamid (NOA446510): Toxicity
to Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum)
in a 96-hour Algal Growth Inhibition Test.  Unpublished study performed
by Environmental Chemistry and Pharmanalytics, RCC Ltd., Switzerland. 
Laboratory study number A33175.  Study sponsored by Syngenta Crop
Protection, Inc., Greensboro, NC.  Study completed December 15, 2005.

MRID 468001-22 Friedrich, Sabine.  2004.  CGA380778 (Metabolite of
NOA446510): Acute Toxicity to the Earthworm Eisenia fetida.  Unpublished
study performed by BioChem agrar, Laboratory for Biological and Chemical
Analysis, Ltd., Germany.  Laboratory report number 04 10 48 068.  Study
sponsored by Syngenta Crop Protection, Inc., Greensboro, NC (Syngenta
Number T006608-04).  Study completed November 16, 2004.

MRID 468001-23 Friedrich, Sabine.  2001.  Acute Toxicity of NOA446510 to
the Earthworm Eisenia fetida.  Unpublished study performed by BioChem
agrar, Laboratory for Biological and Chemical Analysis, Ltd., Germany. 
Laboratory report number 01 10 48 060.  Study sponsored by Syngenta Crop
Protection, Inc., Greensboro, NC.  Study completed October 29, 2001.

 PAGE   

 PAGE   23 

  PAGE  17