**UNITED STATES ENVIRONMENTAL PROTECTION AGENCY**

WASHINGTON, D.C. 20460

![](media/image1.wmf){width="0.85in" height="0.925in"}

> OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

Date: 02/21/2008

**[MEMORANDUM]{.underline}**

SUBJECT: Pyraclostrobin: Human Health Risk Assessment for Proposed Uses
on Oats, Oilseed Group (Canola & Flax), Plus Seed Treatment on Oats,
Canola, and Flax; Tropical Fruits (Avocado, Black Sapote, Canistel,
Mamey Sapote, Mango; Papaya, Sapodilla, & Star Apple); Increased
Tolerance on Barley; Adding Aerial Application to Turf & Ornamentals;
and Adding In-Furrow Applications to Corn, Soybean, and Sugar Beets. PC
Code: 099100, Petition Nos.: 6F7105, 6E7165 and 7E7245. DP Barcodes
334535, 336189, 342971, 342585, 340585.

Regulatory Action: Registration Action New Section 3 Uses

Risk Assessment Type: Single Chemical Aggregate

FROM: Barry O'Keefe, Risk Assessor/Senior Biologist

Kelly O'Rourke, Biologist

Registration Action Branch 3

Health Effects Division (7509P)

AND

Jerry Stokes, Chemist

Re-Registration Branch 4

Health Effects Division (7509P)

AND

Shelia Piper, Chemist

Alternative Risk Integration Assessment (ARIA) Team

Risk Integration Minor Use & Emergency Response Branch (RIMUERB)

Registration Division (7505)

THROUGH: Paula Deschamp, Branch Chief

Registration Action Branch 3

Health Effects Division (7509P)

TO: Barbara Madden, Team Leader

Minor Use, Inerts and Emergency Response Branch (MUIERB)

Registration Division (RD) (7505P)

AND

John Bazuin/Tony Kish, PM Team 22

Fungicide Branch

Registration Division (RD) (7505P)

The Registration Division (RD) of the Office of Pesticide Programs (OPP)
has requested that HED evaluate toxicology and residue chemistry data
and conduct dietary, aggregate, and occupational exposure and risk
assessments, as needed, to estimate the risk to human health that will
result from existing and proposed uses of pyraclostrobin.

BASF Corporation submitted a petition (6F7105) requesting the
establishment of pyraclostrobin tolerances and the addition of new
foliar uses on oats, canola, and flax. In addition, the petitioner
proposed seed treatment on oats, canola, and flax.

BASF Corporation also submitted a label amendment to add aerial
application to a variety of turf and ornamentals onto the Insignia label
(EPA Reg. No. 7969-184).

BASF Corporation also submitted a supplemental label to add an in-furrow
spray application at planting for corn, soybean and sugar beet onto the
Headline^®^ label (EPA Reg. No. 7969-186).

IR-4 submitted a petition (6E7165) requesting the establishment of
pyraclostrobin tolerances and new uses on avocado, black sapote,
canistel, mamey sapote, mango, papaya, sapodilla, star apple, and fresh
herbs on the Pristine^®^ Fungicide label (EPA Reg. No. 7969-199).

IR-4 submitted another petition (7E7245) requesting to increase the
tolerance levels for barley commodities, and to revise the barley
pre-harvest interval (PHI) on the Headline^®^ label (EPA Reg. No.
7969-186).

The Health Effects Division (HED) has conducted a human health risk
assessment for these proposed and changed uses. HED has high confidence
in the quality of the toxicology, chemistry and exposure databases used
to assess risk from pyraclostrobin.

A summary of the findings and an assessment of human risk resulting from
the registered and proposed tolerances for pyraclostrobin are provided
in this document. The risk assessment was provided by Barry O'Keefe
(RAB3), the residue chemistry data review by Jerry Stokes (RRB4), the
dietary risk assessment by Sheila Piper (ARIA/RIMUERB), and the
occupational/residential exposure assessment by Kelly O'Rourke (RAB3).

**Table of Contents**

**1.0** **Executive Summary** [4](#__RefHeading___Toc191365813)

**2.0** **Ingredient Profile** [12](#__RefHeading___Toc191365814)

2.1 Summary of Registered/Proposed Uses
[12](#__RefHeading___Toc191365815)

2.2 Physical and Chemical Properties [14](#__RefHeading___Toc191365816)

**3.0** **Hazard Characterization/Assessment**
[15](#__RefHeading___Toc191365817)

3.1 Hazard and Dose-Response Characterization
[15](#__RefHeading___Toc191365818)

3.1.1 Database Summary [15](#__RefHeading___Toc191365819)

3.1.2 Toxicological Effects [16](#__RefHeading___Toc191365820)

3.1.3 Dose-response [19](#__RefHeading___Toc191365821)

3.2 Safety Factor for Infants and Children
[20](#__RefHeading___Toc191365822)

3.3 Summary of Toxicological Doses and Endpoints for Use in Human Health
Risk Assessments [21](#__RefHeading___Toc191365823)

3.4 Recommendation for Aggregate Exposure Risk Assessments
[24](#__RefHeading___Toc191365824)

3.5 Endocrine disruption [24](#__RefHeading___Toc191365825)

**4.0** **Public Health and Epidemiology Data**
[25](#__RefHeading___Toc191365826)

**5.0** **Dietary Exposure/Risk Characterization**
[25](#__RefHeading___Toc191365827)

5.1 Pesticide Metabolism and Environmental Degradation
[25](#__RefHeading___Toc191365828)

5.1.1 Metabolism in Primary Crops [25](#__RefHeading___Toc191365829)

5.1.2 Metabolism in Livestock [26](#__RefHeading___Toc191365830)

5.1.3 Analytical Methodology [26](#__RefHeading___Toc191365831)

5.1.4 Storage Stability Data [27](#__RefHeading___Toc191365832)

5.1.5 Magnitude of the Residue in Plants
[27](#__RefHeading___Toc191365833)

5.1.6 Magnitude of the Residue in Processed Food/Feed
[34](#__RefHeading___Toc191365834)

5.1.7 Magnitude of the Residue in Meat, Milk, Poultry, and Eggs
[35](#__RefHeading___Toc191365835)

5.1.8 Confined and Field Accumulation in Rotational Crops
[38](#__RefHeading___Toc191365836)

5.1.9 Drinking Water Residue Profile [39](#__RefHeading___Toc191365837)

5.1.10 Proposed Tolerances [40](#__RefHeading___Toc191365838)

5.2 Dietary Exposure and Risk [43](#__RefHeading___Toc191365839)

5.3 Anticipated Residue and Percent Crop Treated (%CT) Information
[47](#__RefHeading___Toc191365840)

**6.0** **Residential (Non-Occupational) Exposure/Risk
Characterization** [47](#__RefHeading___Toc191365841)

**7.0** **Aggregate Risk Assessments and Risk Characterization**
[48](#__RefHeading___Toc191365842)

**8.0** **Cumulative Risk Characterization/Assessment**
[49](#__RefHeading___Toc191365843)

**9.0** **Occupational Exposure/Risk Pathway**
[49](#__RefHeading___Toc191365844)

9.1 Short-/Intermediate-Term Handler Risk
[49](#__RefHeading___Toc191365845)

9.2 Short-/Intermediate-Term Postapplication Risk
[55](#__RefHeading___Toc191365846)

**10.0** **Data Needs and Label Recommendations**
[58](#__RefHeading___Toc191365847)

10.1 Residue Chemistry Data Needs and Label Recommendations
[58](#__RefHeading___Toc191365848)

10.2 Occupational Label Recommendations
[60](#__RefHeading___Toc191365849)

**11.0** **International Residue Limit Status**
[60](#__RefHeading___Toc191365850)

**12.0** **Appendix: Toxicity Profile**
[63](#__RefHeading___Toc191365851)

12.1 Appendix 1.: Pyraclostrobin Toxicology Requirements and Available
Studies for Food Uses [63](#__RefHeading___Toc191365852)

12.2 Appendix 2.: Acute Toxicity Data on Pyraclostrobin Technical
[64](#__RefHeading___Toc191365853)

12.3 Appendix 3.: Subchronic, Chronic and Other Toxicity Profile
[65](#__RefHeading___Toc191365854)

**1.0 Executive Summary**[]{#__RefHeading___Toc191365813 .anchor}

Pyraclostrobin \[carbamic acid,
\[2-\[\[\[1-(4-chlorophenyl)-1*H*-pyrazol-3-yl\]oxy\]methyl\]
phenyl\]methoxy-, methyl ester\] (CAS nomenclature) belongs to the
strobilurin class of fungicides (β-methoxyacrylate class of compounds).
Strobilurins are synthetic analogs of a natural antifungal substance
which inhibit spore germination, mycelial growth, and sporulation of the
fungus on the leaf surface.

Pyraclostrobin is currently registered on barley, berries, *Brassica*
vegetables, bulb vegetables, citrus, corn (field, pop and sweet),
cotton, cucurbit vegetables, fruiting vegetables, grapes, grass grown
for seed, hops, leafy vegetables, legumes (dried peas and beans,
succulent shelled peas and beans), mint, peanuts, pistachios, pome
fruit, potatoes, root vegetables, rye, soybean, strawberries, stone
fruits, sugar beets, sunflower, tuberous and corm vegetables, tree nuts,
and wheat, as well as residential and golf course turf. The formulated
end use products evaluated in this assessment are labeled under the
trade names Headline^®^ (EPA Reg. No. 7969-186), Pristine^®^ Fungicide
(EPA Reg. No. 7969-199), Insignia^®^ (EPA Reg. No. 7969-184), and BAS
500 ST (EPA File Symbol 7969-EUN). Pristine^®^ Fungicide (EPA Reg. No.
7969-199) is a dual active ingredient product containing pyraclostrobin
and boscalid. Proposed uses/tolerances for boscalid are evaluated in a
separate assessment.

BASF Corporation submitted a petition (6F7105) requesting the
establishment of tolerances for the combined residues of the fungicide
pyraclostrobin and its desmethoxy metabolite, expressed as parent
compound, in/on the following commodities: oats grain at 1.0 ppm; oats,
hay at 17 ppm; oats, straw at 17 ppm; and oilseed, group 20 at 0.4 ppm.

Concurrently, BASF Corp. wishes to amend the product label for Headline®
Fungicide (EPA Reg. No. 7969-186), an EC formulation containing 23.6% ai
(2.09 lb/gal) pyraclostrobin, to add new foliar uses on oats, canola,
and flax. Headline^®^ Fungicide is proposed for foliar applications at
maximum seasonal rates of 0.39 lb ai/A for canola and flax and 0.29 lb
ai/A for oats. Proposed applications may be made using ground or aerial
equipment. The proposed pre-harvest intervals (PHI) range from 21 days
(oilseed crops) to the beginning of flowering stage (oats). In addition,
the petitioner wishes to register a supplemental label, BAS 500 ST (EPA
File Symbol 7969-EUN), a 20% WDG formulation, for seed treatment on
oats, canola, and flax. BAS 500 ST is proposed for seed treatment at
rates of 0.005-0.04 lb ai/100 lb seed.

BASF Corporation submitted a label amendment to add aerial application
to a variety of turf and ornamentals onto the Insignia label (EPA Reg.
No. 7969-184) at a proposed maximum application of 0.5 lb ai/acre and a
maximum seasonal of 3.0 lb ai/acre at 10 to 28-day intervals.

BASF Corporation submitted a supplemental label to add an in-furrow
spray application at planting for corn, soybean and sugar beet onto the
Headline^®^ label (EPA Reg. No. 7969-186) at 0.2 lb ai/acre.

IR-4 submitted a petition (6E7165) requesting the establishment of
pyraclostrobin tolerances, expressed as parent *per se*, in/on the
following commodities: herb subgroup 19A, fresh herb at 30.0 ppm; and
tropical fruits each at 0.7 ppm (avocado; black sapote; canistel; mamey
sapote; mango; papaya; sapodilla; and star apple). Concurrent with the
tolerances proposed above, IR-4 wishes to amend the product label for
Pristine® Fungicide (EPA Reg. No. 7969-199) to incorporate new uses on
avocado, black sapote, canistel, mamey sapote, mango, papaya, sapodilla,
star apple, and fresh herbs. Pristine® Fungicide is a WDG formulation
containing multiple active ingredients of pyraclostrobin (12.8%) and
boscalid (25.2%). The product is proposed for two foliar applications at
a 7 or greater day interval on the above crops at rates up to 0.15 lb
ai/A with a 0-day PHI.

IR-4 submitted another petition (7E7245) requesting the establishment of
tolerances for the combined residues of the fungicide pyraclostrobin and
its desmethoxy metabolite, expressed as parent compound, in/on barley,
grain at 1.3 ppm and barley, straw at 9.0 ppm. Concurrently, IR-4 wishes
to amend the product label for Headline® Fungicide (EPA Reg. No.
7969-186) to revise the barley PHI from "apply no later than 50% head
emergence (Feekes 10.3, Zadok's 55)" to 14 days. The maximum seasonal
rate of 0.29 lb ai/A remains the same.

The Health Effects Division (HED) has conducted a human health risk
assessment for these proposed and changed uses. HED has high confidence
in the quality of the toxicology, chemistry and exposure databases used
to assess risk from the use of pyraclostrobin.

***Hazard Assessment and Dose Response***

The quality of the toxicology database for pyraclostrobin is good and
the confidence in the hazard and dose-response assessments is high. The
toxicity database for pyraclostrobin is considered complete, and deemed
adequate for endpoint selection for exposure risk assessment scenarios
and for FQPA evaluation. Please refer to Appendix A for the toxicity
profile tables. Please also refer to the previous pyraclostrobin risk
assessment document for further extensive details (B. O'Keefe, DP
Barcode 343700, 9/7/07). The last risk assessment document included an
updated toxicology and hazard evaluation, including results of recently
submitted toxicity studies, a new carcinogenicity evaluation, and
selection of new study/endpoints for exposure by the inhalation route.
As there are no new toxicity data associated with these current actions,
the hazard characterization and endpoint selection from the previous
risk assessment are applied directly to this action.

Pyraclostrobin has a low to moderate acute toxicity. The main target
organs for pyraclostrobin are the upper gastrointestinal tract (mainly
the duodenum and stomach), the spleen/hematopoiesis, the immune system,
and the liver. In reproductive and developmental studies, there was
evidence of increased qualitative susceptibility following
[in]{.underline} [utero]{.underline} exposure in the rabbit, but not in
rats. In the two-generation reproduction study, the highest dose tested
did not cause maternal systemic toxicity, nor did it elicit reproductive
or offspring toxicity. Nonetheless, HED determined that, when evaluated
with the findings of the dose-range finding one-generation reproduction
study, there is no need to repeat the two-generation reproduction study.
In both the acute and subchronic neurotoxicity studies, there were no
indications of treatment-related neurotoxicity.

Number range CHAPTERThe CARC classified pyraclostrobin into the category
**"**Not Likely to be Carcinogenic to Humans**"** based on no
treatment-related increase in tumors in both sexes of rats and mice,
which were tested at doses that were adequate to assess carcinogenicity,
and the lack of evidence of mutagenicity.

A variety of oral toxicity studies were used for the different risk
assessment scenarios including the rabbit developmental toxicity study,
the acute neurotoxicity study in rats, the rat carcinogenicity study,
and the 13-week study in dogs. In addition, the 28-day inhalation study
in rats was used for short- and intermediate-term occupational and
residential inhalation risk assessments. The endpoints in these studies
are well characterized and are the most sensitive among available
comparable toxicity studies in other species. All dietary points of
departure (i.e., acute and chronic RfDs) are calculated from the
respective study's NOAEL after applying a 100-fold safety factor (10 X
to account for interspecies extrapolation and 10X for intraspecies
variation). For all other scenarios, including dermal, inhalation, and
incidental oral, an MOE approach will be used with a Level of Concern
(LOC) at 100.

The toxicity data base for pyraclostrobin is adequate for evaluation of
the FQPA safety factor. The following acceptable studies are
available: 1) developmental toxicity studies in rats and rabbits; and 2)
a two-generation reproduction study in rats. This assessment reaffirms
previous conclusions that the 10X FQPA safety factor for the protection
of infants and children should be removed for all potential exposure
scenarios to pyraclostrobin because the database is complete and
adequate and there are no residual uncertainties for pre- and/or
postnatal toxicity. The doses chosen as quantitative risk estimates are
adequately protective for infants and children. Exposure data are
complete or are estimated based on data that reasonably account for
potential exposures. Based on these data and conclusions, the FQPA
Safety Factor can be reduced to 1X.

***Drinking Water Exposure Estimates***

The Environmental Fate and Effects Division (EFED) reviewed the proposed
use rates associated with the Section 3 amended registration requests
for the use of pyraclostrobin on oats and oilseed crops (canola and
flax), fresh herbs (crop group 19), and tropical fruits (avocado, black
sapote, canistel, mamey sapote, mango, papaya, sapodilla, and star
apple). Additionally, EFED reviewed the proposal to add aerial
applications to existing turf and ornamentals use sites and the proposal
to add in-furrow use to the existing corn, soybean, and sugar beets use
sites.

This drinking water exposure assessment was based on the application of
the highest seasonal use rate (proposed or registered) of
pyraclostrobin, i.e., the aerial application on turf and ornamentals at
0.5 lbs a.i./acre with 6 maximum seasonal applications at 14 day
intervals. For surface water, a Tier II drinking water assessment was
performed using the PRZM/EXAMS models with index reservoir (IR)
scenarios and percent cropped area (PCA) adjustment factors.
Concentrations of pyraclostrobin in surface water are not likely to
exceed 35.6 µg/L for the peak concentration, 2.3 µg/L for the annual
average concentration, and 1.5 µg/L for the 30 year average
concentration.

Ground water concentrations were estimated using a Tier I SCI-GROW,
which predicts the acute and chronic concentrations of pyraclostrobin in
shallow ground water to be 0.02 ppb. Ground water sources were not
included in the dietary assessment, as the estimated drinking water
concentrations (EDWCs) for this water source are minimal in comparison
to surface water.

***Dietary Exposure Assessment***

Acute and chronic dietary exposure assessments were conducted for the
proposed and existing food uses and drinking water inputs. These acute
and chronic dietary risk assessments are considered only minimally
refined.

The acute analysis was conducted using either tolerance level residues
or highest residues derived from field trial data conducted at the
maximum application rate and minimum PHI permitted on the proposed or
existing labels. For all commodities 100% crop treated was assumed. A
limited number of experimentally derived processing factors were used to
refine the acute analysis. Of note is that relative contribution from
drinking water is minimal. HED concludes that the acute exposure
estimates are unlikely to underestimate actual acute exposure.

The chronic dietary assessment was conducted using tolerance level
residues for all crops except for apple, grape, head lettuce, leaf
lettuce, celery, spinach, orange, pepper and tomato where average
residues from crop field trials were used. These field trials represent
maximum application rates and minimum PHIs. For all commodities 100%
crop treated was assumed. A limited number of experimentally derived
processing factors from pyraclostrobin processing studies were used to
refine the analysis. Again, the relative contribution from drinking
water is minimal. HED concludes that the chronic exposure estimates in
this analysis are unlikely to underestimate actual exposure.

Acute and chronic exposures and risks do not exceed HED's level of
concern for the U.S. population and for all relevant population
subgroups. At the 95^th^ percentile, the acute dietary exposure utilized
1.4% of the aPAD for the general U.S. population and 80% of the aPAD for
females 13-49 years old, the most highly exposed population subgroup.
The chronic dietary exposure utilized 19% of the cPAD for the general
U.S. population and 48% of the cPAD for children 1-2 years old, the most
highly exposed population subgroup.

***Aggregate Exposure Assessment***

There are existing residential uses on turf which contribute to
aggregate exposures. Residential and recreational turf applications are
applied by professional pest control operators (PCOs) only, and
therefore, residential handler exposures do not occur. There is,
however, a potential for exposure to homeowners in residential settings
from entering previously treated lawns where children might play and
adults might work or play. As a result, risk assessments have been
completed for postapplication scenarios. Postapplication short- and
intermediate-term dermal and incidental oral exposures are expected to
occur from the turf use pattern. Common effects (i.e., decreased body
weight gain, food intake, and food efficiency) were seen in the studies
selected to evaluate dietary, dermal and incidental oral ingestion
exposures; and therefore, route-specific exposures can be aggregated.

Aggregate assessments were conducted for acute and chronic dietary
(food + drinking water) exposures. Additionally, short- and
intermediate-term aggregate risk assessments were conducted. Both short-
and intermediate-term exposures may occur during postapplication
activities for adults and children. However, because the toxicity
endpoints and points of departure are identical for short- and
intermediate-term exposures, separate risk estimates for short- and
intermediate-term exposures were not calculated. These
short-/intermediate-term aggregate risk assessments take into account
average exposure estimates from dietary consumption of pyraclostrobin
(food and drinking water) and non-occupational/residential uses (turf);
i.e. for toddlers incidental oral, dermal, and average food plus
drinking water exposures are aggregated, and for adults, dermal and
average food plus drinking water exposures are aggregated.

The total combined MOE from dietary (food + water) and
non-occupational/residential exposure is 100 for children 1-2 years old,
which is not of concern to HED. For adults the total combined MOE is
200, which also is not of concern to HED. These aggregate exposure risk
assessments are considered conservative estimates, that should not
underestimate risks, because of the following inputs: 1) dietary inputs
primarily used tolerance level residues; 2) crop specific (turf)
screening level drinking water modeling data were used (i.e., Tier II
surface water model); 3) maximum application rates and minimum
application intervals were used; and 4) conservative SOPs and upper
level estimates of exposure were employed.

***Occupational Handler Exposure Assessment***

No chemical-specific handler exposure data were submitted in support of
these registrations. For the assessment of the foliar and in-furrow
uses, data from the Pesticide Handlers Exposure Database (PHED) Version
1.1 as presented in PHED Surrogate Exposure Guide (8/98) were used. For
assessing seed treatment activities, exposure data were taken from HED
Science Advisory Council for Exposure Policy 14: Standard Operating
Procedures for Seed Treatment and HED Science Advisory Council for
Exposure Standard Operating Procedure 15: Amount of Seed Treated or
Planted per Day.

Results from the assessment of all occupational handler scenarios
indicate that risks are not of concern with baseline clothing, or in
some cases, when gloves and respirator are used to mitigate exposure.
For foliar treatments, gloves were added for scenarios involving
mixing/loading liquids, and a dust/mist respirator was necessary
specifically for the oats use scenario in order to reach an MOE of 100
or greater. For seed treatment activities, gloves were needed for
several scenarios, with the addition of a dust/mist respirator for the
scenario designated "multiple activity".

The proposed Headline® Fungicide label requires chemical resistant
gloves, however, a respirator is not indicated. The proposed BAS 500 ST
label is a supplemental label only, and does not provide information
regarding personal protective equipment (PPE).

***Occupational Postapplication Exposure Assessment***

Previously submitted chemical-specific dislodgeable foliar residue (DFR)
data and the interim transfer coefficient policy developed by HED's
Science Advisory Council for Exposure, which includes proprietary data
from the Agricultural Re-entry Task Force (ARTF) database (policy \#
3.1), was used in estimating postapplication exposures.

The results of the postapplication exposure and risk assessment indicate
that MOEs of 100 are achieved on Day 0 for all scenarios. The
pyraclostrobin technical material has been classified in Toxicity
Category III for acute dermal, primary eye irritation, and primary skin
irritation. Per the Worker Protection Standard (WPS), a 12-hr restricted
entry interval (REI) is required for chemicals classified under Toxicity
Category III or IV. The proposed labels indicate an REI of 12 hrs, which
is in compliance with the WPS.

***Recommendations for Tolerances***

HED has completed a human health risk assessment for the proposed new
uses of the active ingredient pyraclostrobin.

**For Petition #6F7105 -** Provided that a revised label is submitted
that specifies the appropriate 14-day plantback interval restriction for
all annual crops that are not registered and a revised Section F is
submitted reflecting the recommended tolerances and commodity
definitions presented in Table 14, the residue chemistry, toxicological,
and occupational databases support the acceptance of a *conditional
registration* on oats, canola, and flax, and establishment of permanent
tolerances for pyraclostrobin residues of concern in/on the following
raw agricultural commodities:

> Oat, grain 1.2 ppm
>
> Oat, hay 18 ppm
>
> Oat, straw 15 ppm
>
> Borage, Crambe, Cuphea, Echium, Flax seed, Gold of pleasure, Hare's
> ear mustard, Lesquerella, Lunaria, Meadowfoam, Milkweed, Mustard seed,
> Oil radish, Poppy seed, Rapeseed, Sesame, Sweet rocket (rapeseed
> subgroup) 0.45 ppm
>
> Castor oil plant, Chinese tallowtree, Euphorbia, Evening primrose,
> Jojoba, Niger seed, Rose hip, Safflower, Stokes aster, Sunflower,
> Tallowwood, Tea oil plant, Vernonia (sunflower subgroup) 0.45 ppm
>
> Cotton (cotton subgroup) 0.45 ppm

The petitioner should submit a revised Section F to propose individual
tolerances of 0.45 ppm for all oilseeds in subgroups rapeseed,
sunflower, and cotton, as follows: 1) [rapeseed]{.underline} (i.e.,
borage, crambe, cuphea, echium, flax seed, gold of pleasure, hare's ear
mustard, lesquerella, lunaria, meadowfoam, milkweed, mustard seed, oil
radish, poppy seed, rapeseed, sesame, and sweet rocket); 2)
[sunflower]{.underline} (i.e., Castor oil plant, Chinese tallowtree,
Euphorbia, Evening primrose, Jojoba, Niger seed, Rose hip, Safflower,
Stokes aster, Sunflower, Tallowwood, Tea oil plant, Vernonia ); and 3)
[cotton]{.underline} (only entry presently in this subgroup).

Note: The existing tolerances on sunflower at 0.3 ppm and cotton,
undelinted seed at 0.3 ppm should be removed from 40 CFR §180.582.

**For Petition #7E7245 -** Provided that a revised label is submitted
that specifies the appropriate 14-day plantback interval restriction for
all annual crops that are not registered and a revised Section F is
submitted reflecting the recommended tolerances and commodity
definitions presented in Table 14, the residue chemistry, toxicological,
and occupational databases support the proposed amended use pattern for
barley and permanent tolerances for pyraclostrobin residues of concern
in/on the following raw agricultural commodities:

> Barley, grain 1.4 ppm
>
> Barley, straw 6.0 ppm

**For Petition #6E7165 --** Provided that a revised label is submitted
that specifies the appropriate 14-day plantback interval restriction for
all annual crops that are not registered and a revised Section F is
submitted, the residue chemistry, toxicological, and occupational
databases support the establishment of a *conditional registration* on
avocados, black sapote, canistel, mamey sapote, mango, papaya,
sapodilla, and star apple, and permanent tolerances for pyraclostrobin
residues of concern in/on the following raw agricultural commodities:

> Avocado 0.6 ppm
>
> Sapote, black 0.6 ppm
>
> Canistel 0.6 ppm
>
> Sapote, mamey 0.6 ppm
>
> Mango 0.6 ppm
>
> Papaya 0.6 ppm
>
> Sapodilla 0.6 ppm
>
> Star Apple 0.6 ppm
>
> Note: HED is in the process of revising the Commodity Definitions
> listed under 40 CFR §180.1(h) to make the tropical/subtropical fruit
> avocado a general commodity; see same 6/14/06 memo by B. Schneider.
> The specific commodities included in the general definition for
> avocado include black sapote, canistel, mamey sapote, mango, papaya,
> sapodilla, and star apple. Until the regulations have been finalized
> in the Federal Register, separate tolerances are needed for each
> specific commodity, at the same level as the respective general
> commodity tolerance.

A withdrawal letter for withdrawal of the fresh herbs section of
petition #6E7165 was recently received by OPP from IR-4 (2/6/08).
Therefore, at this time HED is not recommending for tolerances on any
herbs in the Herbs subgroup 19A.

The petitioner should submit a revised Section F to correct the
tolerance residue definition (parent + metabolite) and to make it
consistent with the definition listed in 40 CFR §180.582 (a)(1). The
revised Section F should also incorporate the recommended tolerances and
commodity definitions presented in Table 14.

***Recommendations for Field Residue Data***

[860.1500 Crop Field Trials]{.underline}

The submitted residue data for avocado are inadequate to fulfill data
requirements because the field trials were conducted at exaggerated
rates (ca 2.6x). Since the submitted data represent an overestimate of
the residues expected from the proposed use, HED considers that the
tolerance for avocado may need to be reduced. Also, since the proposed
use is for late season foliar application, includes a 0-day preharvest
interval, and these data are being translated to support a wide number
of tropical/subtropical fruits, HED requests that the petitioner provide
additional, bridging field trial data (i.e., two to three field trials
at the proposed label rate of 2 applications, total 0.3 lb ai/season) as
a condition of registration.

***Recommendations for Labels***

The proposed Headline® Fungicide label requires chemical resistant
gloves; however, a respirator is not indicated and is needed for the
handler scenario of mixing/loading liquids for aerial application or
chemigation.

The proposed BAS 500 ST label is a supplemental label only, and does not
provide information regarding personal protective equipment (PPE). Such
PPE information should be added to the label. Gloves are needed for
several seed treatment scenarios, and a respirator is needed for the
multiple activity scenario.

**Environmental Justice Considerations**

Potential areas of environmental justice concerns, to the extent
possible, were considered in this human health risk assessment, in
accordance with U.S. Executive Order 12898, \"Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations,\"
<http://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf>).

As a part of every pesticide risk assessment, OPP considers a large
variety of consumer subgroups according to well-established procedures.
In line with OPP policy, HED estimates risks to population subgroups
from pesticide exposures that are based on patterns of that subgroup's
food and water consumption, and activities in and around the home that
involve pesticide use in a residential setting. Extensive data on food
consumption patterns are compiled by the USDA under the Continuing
Survey of Food Intake by Individuals (CSFII) and are used in pesticide
risk assessments for all registered food uses of a pesticide. These data
are analyzed and categorized by subgroups based on age, season of the
year, ethnic group, and region of the country. Additionally, OPP is able
to assess dietary exposure to smaller, specialized subgroups and
exposure assessments are performed when conditions or circumstances
warrant. Whenever appropriate, non-dietary exposures based on home use
of pesticide products and associated risks for adult applicators and for
toddlers, youths, and adults entering or playing on treated areas
postapplication are evaluated. Further considerations are currently in
development as OPP has committed resources and expertise to the
development of specialized software and models that consider exposure to
bystanders and farm workers as well as lifestyle and traditional dietary
patterns among specific subgroups.

**Review of Human Research**

This risk assessment relies in part on data from Pesticide Handlers
Exposure Database (PHED) studies in which adult human subjects were
intentionally exposed to a pesticide or other chemical. These studies
have been determined to require a review of their ethical conduct, have
received that review, and have been determined to be ethical.

**2.0 Ingredient Profile**[]{#__RefHeading___Toc191365814 .anchor}

**2.1 Summary of Registered/Proposed
Uses**[]{#__RefHeading___Toc191365815 .anchor}

Pyraclostrobin is currently registered on barley, berries, *Brassica*
vegetables, bulb vegetables, citrus, corn (field, pop and sweet),
cotton, cucurbit vegetables, fruiting vegetables, grapes, grass grown
for seed, hops, leafy vegetables, legumes (dried peas and beans,
succulent shelled peas and beans), mint, peanuts, pistachios, pome
fruit, potatoes, root vegetables, rye, soybean, strawberries, stone
fruits, sugar beets, sunflower, tuberous and corm vegetables, tree nuts,
and wheat, as well as residential and golf course turf.

A summary of the pyraclostrobin end-use products and proposed crop use
patterns discussed in this document is listed in Table 1. No rotational
crop restrictions are listed on the product labels.

+---------+---------+--------+-------+--------+-----+----------------+
| **T     |         |        |       |        |     |                |
| able 1. |         |        |       |        |     |                |
| Summary |         |        |       |        |     |                |
| of      |         |        |       |        |     |                |
| P       |         |        |       |        |     |                |
| roposed |         |        |       |        |     |                |
| Dir     |         |        |       |        |     |                |
| ections |         |        |       |        |     |                |
| for Use |         |        |       |        |     |                |
| of      |         |        |       |        |     |                |
| Pyr     |         |        |       |        |     |                |
| aclostr |         |        |       |        |     |                |
| obin.** |         |        |       |        |     |                |
+=========+=========+========+=======+========+=====+================+
| Applic. | Form    | A      | Max.  | Max.   | PHI | Use Directions |
| Timing, | ulation | pplic. | No.   | Se     |     | and            |
| Type,   |         | Rate   | Ap    | asonal | (da | Limitations    |
| and     | \[EPA   |        | plic. | A      | ys) |                |
| Equip.  | Reg.    | (lb    | per   | pplic. |     |                |
|         | No.\]   | ai/A)  | S     | Rate   |     |                |
|         |         |        | eason |        |     |                |
|         |         |        |       | (lb    |     |                |
|         |         |        |       | ai/A)  |     |                |
+---------+---------+--------+-------+--------+-----+----------------+
| **Fresh |         |        |       |        |     |                |
| Herbs   |         |        |       |        |     |                |
| (in     |         |        |       |        |     |                |
| cluding |         |        |       |        |     |                |
| An      |         |        |       |        |     |                |
| gelica, |         |        |       |        |     |                |
| Balm,   |         |        |       |        |     |                |
| Basil,  |         |        |       |        |     |                |
| Borage, |         |        |       |        |     |                |
| Burnet, |         |        |       |        |     |                |
| Cha     |         |        |       |        |     |                |
| momile, |         |        |       |        |     |                |
| Catnip, |         |        |       |        |     |                |
| C       |         |        |       |        |     |                |
| hervil, |         |        |       |        |     |                |
| Chive,  |         |        |       |        |     |                |
| Chinese |         |        |       |        |     |                |
| Chive,  |         |        |       |        |     |                |
| Clary,  |         |        |       |        |     |                |
| Co      |         |        |       |        |     |                |
| riander |         |        |       |        |     |                |
| (leaf), |         |        |       |        |     |                |
| Co      |         |        |       |        |     |                |
| stmary, |         |        |       |        |     |                |
| C       |         |        |       |        |     |                |
| ilantro |         |        |       |        |     |                |
| (leaf), |         |        |       |        |     |                |
| Curry   |         |        |       |        |     |                |
| (leaf), |         |        |       |        |     |                |
| D       |         |        |       |        |     |                |
| illweed |         |        |       |        |     |                |
| (fresh  |         |        |       |        |     |                |
| and for |         |        |       |        |     |                |
| pro     |         |        |       |        |     |                |
| cessing |         |        |       |        |     |                |
| into    |         |        |       |        |     |                |
| oil),   |         |        |       |        |     |                |
| Hor     |         |        |       |        |     |                |
| ehound, |         |        |       |        |     |                |
| Hyssop, |         |        |       |        |     |                |
| La      |         |        |       |        |     |                |
| vender, |         |        |       |        |     |                |
| Lemo    |         |        |       |        |     |                |
| ngrass, |         |        |       |        |     |                |
| Lovage  |         |        |       |        |     |                |
| (leaf), |         |        |       |        |     |                |
| Ma      |         |        |       |        |     |                |
| rigold, |         |        |       |        |     |                |
| M       |         |        |       |        |     |                |
| arjoram |         |        |       |        |     |                |
| (*Or    |         |        |       |        |     |                |
| iganum* |         |        |       |        |     |                |
| spp.),  |         |        |       |        |     |                |
| Nast    |         |        |       |        |     |                |
| urtium, |         |        |       |        |     |                |
| P       |         |        |       |        |     |                |
| arsley, |         |        |       |        |     |                |
| Penn    |         |        |       |        |     |                |
| yroyal, |         |        |       |        |     |                |
| Ro      |         |        |       |        |     |                |
| semary, |         |        |       |        |     |                |
| Rue,    |         |        |       |        |     |                |
| Sage,   |         |        |       |        |     |                |
| Summer  |         |        |       |        |     |                |
| Savory, |         |        |       |        |     |                |
| Winter  |         |        |       |        |     |                |
| Savory, |         |        |       |        |     |                |
| Sweet   |         |        |       |        |     |                |
| Bay,    |         |        |       |        |     |                |
| Tansy,  |         |        |       |        |     |                |
| Ta      |         |        |       |        |     |                |
| rragon, |         |        |       |        |     |                |
| Thyme,  |         |        |       |        |     |                |
| Winte   |         |        |       |        |     |                |
| rgreen, |         |        |       |        |     |                |
| Wo      |         |        |       |        |     |                |
| odruff, |         |        |       |        |     |                |
| and     |         |        |       |        |     |                |
| Worm    |         |        |       |        |     |                |
| wood)** |         |        |       |        |     |                |
+---------+---------+--------+-------+--------+-----+----------------+
| Foliar  | Pr      | 0.08 - | 2     | 0.30   | 0   | Begin          |
|         | istine® | 0.15   |       |        |     | applications   |
| Ground, | Fu      |        |       |        |     | prior to the   |
| aerial  | ngicide |        |       |        |     | onset of       |
| or      |         |        |       |        |     | disease        |
| through | 12.8%   |        |       |        |     | development    |
| sp      | WDG     |        |       |        |     | and repeat     |
| rinkler |         |        |       |        |     | applications 7 |
| irr     | \[796   |        |       |        |     | days later as  |
| igation | 9-199\] |        |       |        |     | needed, or     |
|         |         |        |       |        |     | alternate with |
|         |         |        |       |        |     | another        |
|         |         |        |       |        |     | registered     |
|         |         |        |       |        |     | fungicide      |
|         |         |        |       |        |     | having a       |
|         |         |        |       |        |     | different mode |
|         |         |        |       |        |     | of action.     |
+---------+---------+--------+-------+--------+-----+----------------+
| # Avo   |         |        |       |        |     |                |
| cado, B |         |        |       |        |     |                |
| lack Sa |         |        |       |        |     |                |
| pote, C |         |        |       |        |     |                |
| anistel |         |        |       |        |     |                |
| , Mamey |         |        |       |        |     |                |
|  Sapote |         |        |       |        |     |                |
| , Mango |         |        |       |        |     |                |
| , Papay |         |        |       |        |     |                |
| a, Sapo |         |        |       |        |     |                |
| dilla,  |         |        |       |        |     |                |
| and Sta |         |        |       |        |     |                |
| r Apple |         |        |       |        |     |                |
+---------+---------+--------+-------+--------+-----+----------------+
| Foliar  | Pr      | 0.15   | 2     | 0.30   | 0   | Begin          |
|         | istine® |        |       |        |     | application    |
| Ground, | Fu      |        |       |        |     | prior to the   |
| aerial  | ngicide |        |       |        |     | onset of       |
| or      |         |        |       |        |     | disease        |
| through | 12.8%   |        |       |        |     | development    |
| sp      | WDG     |        |       |        |     | and repeat     |
| rinkler |         |        |       |        |     | applications 7 |
| irr     | \[796   |        |       |        |     | days later as  |
| igation | 9-199\] |        |       |        |     | needed, or     |
|         |         |        |       |        |     | alternate with |
|         |         |        |       |        |     | another        |
|         |         |        |       |        |     | registered     |
|         |         |        |       |        |     | fungicide      |
|         |         |        |       |        |     | having a       |
|         |         |        |       |        |     | different mode |
|         |         |        |       |        |     | of action.     |
+---------+---------+--------+-------+--------+-----+----------------+
| # C     |         |        |       |        |     |                |
| anola a |         |        |       |        |     |                |
| nd Flax |         |        |       |        |     |                |
+---------+---------+--------+-------+--------+-----+----------------+
| Foliar  | He      | 0.10   | Not   | 0.39   | 21  | Begin          |
|         | adline® |        | spec  |        |     | applications   |
| Ground, | Fu      |        | ified |        |     | prior to       |
| aerial  | ngicide |        |       |        |     | disease        |
| or      |         |        |       |        |     | development,   |
| through | 23.6%   |        |       |        |     | and continue   |
| sp      | EC      |        |       |        |     | on a 7- to     |
| rinkler |         |        |       |        |     | 14-day         |
| irr     | (2.09   |        |       |        |     | interval if    |
| igation | lb/gal) |        |       |        |     | conditions are |
|         |         |        |       |        |     | conducive for  |
|         | \[796   |        |       |        |     | disease        |
|         | 9-186\] |        |       |        |     | development.   |
|         |         |        |       |        |     | To limit the   |
|         |         |        |       |        |     | potential for  |
|         |         |        |       |        |     | development of |
|         |         |        |       |        |     | resistance, do |
|         |         |        |       |        |     | not make more  |
|         |         |        |       |        |     | than one       |
|         |         |        |       |        |     | application    |
|         |         |        |       |        |     | before         |
|         |         |        |       |        |     | alternating to |
|         |         |        |       |        |     | a fungicide    |
|         |         |        |       |        |     | with a         |
|         |         |        |       |        |     | different mode |
|         |         |        |       |        |     | of action. May |
|         |         |        |       |        |     | be used with   |
|         |         |        |       |        |     | adjuvants.     |
+---------+---------+--------+-------+--------+-----+----------------+
| Seed    | BAS 500 | 0.0    | 1     | 0.04   | N/A | For control of |
| tr      | ST      | 2-0.04 |       | lb     |     | seed and       |
| eatment |         | lb     |       | ai/100 |     | seedling       |
|         | 20% WDG | ai/100 |       | lb of  |     | disease caused |
|         |         | lb of  |       | seed   |     | by *Pythium*   |
|         | \[796   | seed   |       |        |     | spp. on black  |
|         | 9-EUN\] |        |       |        |     | mustard,       |
|         |         |        |       |        |     | crambe, field  |
|         |         |        |       |        |     | mustard, flax, |
|         |         |        |       |        |     | Indian         |
|         |         |        |       |        |     | mustard,       |
|         |         |        |       |        |     | Indian         |
|         |         |        |       |        |     | rapeseed,      |
|         |         |        |       |        |     | rapeseed       |
|         |         |        |       |        |     | (canola),      |
|         |         |        |       |        |     | safflower, and |
|         |         |        |       |        |     | sunflower,     |
|         |         |        |       |        |     | apply only in  |
|         |         |        |       |        |     | conjunction    |
|         |         |        |       |        |     | with           |
|         |         |        |       |        |     | registered     |
|         |         |        |       |        |     | rates of       |
|         |         |        |       |        |     | mefenoxam- or  |
|         |         |        |       |        |     | metala         |
|         |         |        |       |        |     | xyl-containing |
|         |         |        |       |        |     | seed treatment |
|         |         |        |       |        |     | products.      |
+---------+---------+--------+-------+--------+-----+----------------+
| # Oats  |         |        |       |        |     |                |
+---------+---------+--------+-------+--------+-----+----------------+
| Foliar  | He      | 0.15   | 2     | 0.29   | 14  | Begin          |
|         | adline® |        |       |        | (   | applications   |
| Ground, | Fu      |        |       |        | hay | prior to       |
| aerial  | ngicide |        |       |        | or  | disease        |
| or      |         |        |       |        | f   | development,   |
| through | 23.6%   |        |       |        | eed | immediately    |
| sp      | EC      |        |       |        | g   | after flag     |
| rinkler |         |        |       |        | ree | leaf           |
| irr     | (2.09   |        |       |        | n-c | emergence.     |
| igation | lb/gal) |        |       |        | hop | Apply no later |
|         |         |        |       |        | ped | than the       |
|         | \[796   |        |       |        | oa  | beginning of   |
|         | 9-186\] |        |       |        | ts) | flowering      |
|         |         |        |       |        |     | (Feeke's       |
|         |         |        |       |        |     | 10.5.to        |
|         |         |        |       |        |     | Zadok's 59)    |
|         |         |        |       |        |     | stage. May be  |
|         |         |        |       |        |     | used with      |
|         |         |        |       |        |     | adjuvants.     |
+---------+---------+--------+-------+--------+-----+----------------+
| Seed    | 20% WDG | 0.00   | 1     | 0.01   | N/A |                |
| tr      |         | 5-0.01 |       | lb     |     |                |
| eatment | \[796   | lb     |       | ai/100 |     |                |
|         | 9-EUN\] | ai/100 |       | lb of  |     |                |
|         |         | lb of  |       | seed   |     |                |
|         |         | seed   |       |        |     |                |
+---------+---------+--------+-------+--------+-----+----------------+
| **B     |         |        |       |        |     |                |
| arley** |         |        |       |        |     |                |
+---------+---------+--------+-------+--------+-----+----------------+
| Foliar  | He      | 0.15   | 2     | 0.29   | 14  | Use limited to |
|         | adline® |        |       |        | (   | the following  |
| Ground, | Fu      |        |       |        | hay | states: AZ,    |
| aerial  | ngicide |        |       |        | or  | CO, ID, MT,    |
| or      |         |        |       |        | f   | NV, NM, OR,    |
| through | 23.6%   |        |       |        | eed | TX, UT, WA,    |
| sp      | EC      |        |       |        | g   | and WY. Begin  |
| rinkler |         |        |       |        | ree | applications   |
| irr     | (2.09   |        |       |        | n-c | prior to       |
| igation | lb/gal) |        |       |        | hop | disease        |
|         |         |        |       |        | ped | development,   |
|         | \[796   |        |       |        | b   | immediately    |
|         | 9-186\] |        |       |        | arl | after flag     |
|         |         |        |       |        | ey) | leaf           |
|         |         |        |       |        |     | emergence.     |
|         |         |        |       |        |     | Apply no later |
|         |         |        |       |        |     | than 50% head  |
|         |         |        |       |        |     | emergence      |
|         |         |        |       |        |     | (Feeke's       |
|         |         |        |       |        |     | 10.3.to        |
|         |         |        |       |        |     | Zadok's 55)    |
|         |         |        |       |        |     | stage. May be  |
|         |         |        |       |        |     | used with      |
|         |         |        |       |        |     | adjuvants.     |
+---------+---------+--------+-------+--------+-----+----------------+
| **Corn, |         |        |       |        |     |                |
| Soybean |         |        |       |        |     |                |
| and     |         |        |       |        |     |                |
| Sugar   |         |        |       |        |     |                |
| beet**  |         |        |       |        |     |                |
+---------+---------+--------+-------+--------+-----+----------------+
| In      | He      | 0.20   | 1     | 0.20   | N/A | Apply at       |
| -Furrow | adline® |        |       |        |     | planting as an |
|         | Fu      |        |       |        |     | in-furrow      |
|         | ngicide |        |       |        |     | application by |
|         | 23.6%   |        |       |        |     | directing the  |
|         | EC      |        |       |        |     | spray into the |
|         |         |        |       |        |     | furrow before  |
|         | (2.09   |        |       |        |     | seed is        |
|         | lb/gal) |        |       |        |     | covered. Use a |
|         |         |        |       |        |     | minimum volume |
|         | \[796   |        |       |        |     | of 2.5 gal     |
|         | 9-186\] |        |       |        |     | water per      |
|         |         |        |       |        |     | acre.          |
+---------+---------+--------+-------+--------+-----+----------------+
| **Turf  |         |        |       |        |     |                |
| and     |         |        |       |        |     |                |
| Orname  |         |        |       |        |     |                |
| ntals** |         |        |       |        |     |                |
+---------+---------+--------+-------+--------+-----+----------------+
| Foliar  | In      | 0.28 - |       | 3.0    | N/A | For aerial     |
|         | signia® | 0.5    |       |        |     | application,   |
| Aerial  | Fu      |        |       |        |     | apply in no    |
| appl    | ngicide |        |       |        |     | less than 10   |
| ication |         |        |       |        |     | gallons of     |
|         | 20% WDG |        |       |        |     | spray solution |
|         |         |        |       |        |     | per acre.      |
|         | \[796   |        |       |        |     | Repeat at 10-  |
|         | 9-184\] |        |       |        |     | to 28-day      |
|         |         |        |       |        |     | intervals,     |
|         |         |        |       |        |     | depending on   |
|         |         |        |       |        |     | disease. Do    |
|         |         |        |       |        |     | not apply more |
|         |         |        |       |        |     | than 2         |
|         |         |        |       |        |     | sequential     |
|         |         |        |       |        |     | applications.  |
|         |         |        |       |        |     | No aerial      |
|         |         |        |       |        |     | application in |
|         |         |        |       |        |     | New York state |
|         |         |        |       |        |     | except as      |
|         |         |        |       |        |     | permitted      |
|         |         |        |       |        |     | under FIFRA    |
|         |         |        |       |        |     | Section 24(c). |
+---------+---------+--------+-------+--------+-----+----------------+

[]{.mark}

*Conclusions*. The field trial data for herbs subgroup 19A and tropical
fruits do not reflect the proposed use patterns since they were
conducted at exaggerated rates. Additional bridging field trial residue
data are required to reflect the proposed label rates. In addition,
label revision is required to specify appropriate rotational crop
restrictions. Details of label revisions are incorporated in the
respective crop section.

**2.2 Physical and Chemical Properties**[]{#__RefHeading___Toc191365816
.anchor}

Common Name: Pyraclostrobin

IUPAC

Nomenclature: methyl
*N*-{2-\[1-(4-chlorophenyl)-1*H*-pyrazol-3-yloxymethyl\]phenyl}(*N*-methoxy)carbamate

CAS

Nomenclature: methyl
\[2-\[\[\[1-(4-chlorophenyl)-1*H*-pyrazol-3-yl\]oxy\]methyl\]phenyl\]methoxycarbamate

CAS Number: 175013-18-0

Chemical Class/Type: β-methoxyacrylate (compound class) / Strobilurin
(fungicide class)

Mode of Action: Acts at the cellular level by inhibiting electron
transport in the mitochondrial respiratory chain at the cytochrome-bc1
complex; this disrupts the energy producing systems and can lead to the
breakdown of the mitochondrial and cytoplasmic membranes.

Impurities

of Concern: The technical grade pyraclostrobin does not contain any
impurities or microcontaminants of concern.

Molecular Formula: C~19~H~18~ClN~3~O~4~

Molecular Weight: 387.82

Appearance: White to light beige solid

Melting Point: 63.7 - 65.2°C

Boiling Point: N/A

Density: 1.285 g/cm^3^ at 20°C

Water Solubility: 2.41 mg/L in deionized water at 20°C

1.9 mg/L in buffer system pH 7 at 20°C

2.3 mg/L in buffer system pH 4 at 20°C

1.9 mg/L in buffer system pH 9 at 20°C

Solvent Solubility: at 20°C in: acetone (≥160 mg/L); methanol (11 mg/L);
2-propanol (3.1 mg/L); ethyl acetate (≥160 mg/L); acetonitrile (≥76
mg/L); dichloromethane (≥110 mg/L); toluene (≥100 mg/L); n-heptane (0.36
mg/L); 1-octanol (2.4 mg/L); olive oil (2.9 mg/L); DMF (≥62 mg/L).

Vapor Pressure: 2.6 x 10^-10^ hPa (at 20°C); 6.4 x 10^-10^ hPa (at 25°C)

pK~a~: Does not dissociate in water. There are no dissociable moieties.

K~ow~: n-Octanol/water partition coefficient (K~ow~) at room temperature
(=K~ow~ of 3.80, pH 6.2; = K~ow~ 4.18, pH 6.5).

**3.0 Hazard
Characterization/Assessment**[]{#__RefHeading___Toc191365817 .anchor}

**3.1 Hazard and Dose-Response
Characterization**[]{#__RefHeading___Toc191365818 .anchor}

**3.1.1 Database Summary**[]{#__RefHeading___Toc191365819 .anchor}

The quality of the toxicology database for pyraclostrobin is good and
the confidence in the hazard and dose-response assessments is high. The
toxicity database for pyraclostrobin is considered complete, and deemed
adequate for endpoint selection for exposure risk assessment scenarios
and for FQPA evaluation.

The most recent risk assessment included an updated toxicology and
hazard evaluation, including results of recently submitted toxicity
studies, a new carcinogenicity evaluation, and selection of new
study/endpoints for exposure by the inhalation route. Please refer to
this previous pyraclostrobin risk assessment document for further
extensive details (B. O'Keefe, DP Barcode 343700, 9/7/07). Also, please
refer to Appendices 2 and 3 of this current risk assessment document for
the toxicity profile tables. As there are no new toxicity data
associated with these current actions, the hazard characterization and
endpoint selection, from the previous risk assessment are applied
directly to this action.

Pyraclostrobin has a low to moderate acute toxicity. The main target
organs for pyraclostrobin are the upper gastrointestinal tract (mainly
the duodenum and stomach), the spleen/hematopoiesis, the immune system,
and the liver. In reproductive and developmental studies, there was
evidence of increased qualitative susceptibility following
[in]{.underline} [utero]{.underline} exposure in the rabbit, but not in
rats. In the two-generation reproduction study, the highest dose tested
did not cause maternal systemic toxicity, nor did it elicit reproductive
or offspring toxicity. Nonetheless, HED determined that, when evaluated
with the findings of the dose-range finding one-generation reproduction
study (MRID# 45596210), there is no need to repeat the two-generation
reproduction study. In both the acute and subchronic neurotoxicity
studies, there were no indications of treatment-related neurotoxicity.

**3.1.2 Toxicological Effects**[]{#__RefHeading___Toc191365820 .anchor}

The toxicity profile of pyraclostrobin, including acute toxicities, may
be found in Appendices 2 and 3.

Number range CHAPTER**[Acute Toxicity:]{.underline}** Pyraclostrobin has
a low to moderate acute toxicity based on its classification in Toxicity
Category IV via the oral route, Toxicity Category III by the dermal
route, and Toxicity Category II by the inhalation route of exposure.
Pyraclostrobin produces moderate eye irritation (Toxicity Category III),
is a moderate dermal irritant (Toxicity Category III), and is not a
dermal sensitizer (Appendix 2).

**[Toxicity from Repeated Oral Exposure:]{.underline}** Based on
findings in repeated dosing oral studies in more than one species, the
main target organs for pyraclostrobin are the upper gastrointestinal
tract (mainly the duodenum and stomach), the spleen/hematopoietic
system, the liver, and the immune system (listed in the order from most
to least sensitive). In addition, reduced body weight/gain and feed
intake/efficiency are also common findings. In the 90-day dietary rat,
mouse, and dog feeding studies, one or more of the following
gastrointestinal (GI) changes were noted: thickening of the duodenal
wall, duodenum mucosal hypertrophy or hyperplasia, as well as gross and
microscopic ulceration/erosion in the glandular stomach. Mucosal
hyperplasia in the duodenum was also observed in rats of both sexes
after 28-day administration of 500 (42.3/46.6 (M/F) mg/kg/day) and 1500
(120.2/126.3 (M/F) mg/kg/day) ppm pyraclostrobin. The upper GI-tract
effects might, at least partly, explain some of the adverse effects on
food consumption/utilization, and body weight; all these effects had a
similar threshold which was lower than that needed to elicit the other
toxic responses.

The liver was a target organ in the 28-day rat and the 90-day rat and
mouse dietary feeding studies based on slight to moderate increased
relative liver weight in both species and hepatocellular hypertrophy in
the rat studies. Liver necrosis was also increased in the two-year rat
carcinogenicity study.

Other findings in the rat and mouse 90-day studies included
hematopoietic toxicity. In rats, the hematopoietic effects included mild
hemolytic anemia accompanied by increased reticulocytes, increased
spleen weight, spleen microscopic changes, and increased total
leukocytes, neutrophils, and lymphocytes. In mice, there was mild
hemolytic anemia accompanied by a large decline (≥50%) in leukocytes
(leukopenia), neutrophils, and lymphocytes. The large decline in white
blood cell (WBC) populations was accompanied by dose-dependent thymus
atrophy and increased lymph node apoptosis. The incidences of thymus
atrophy ranged from 3/10 to 8/10 in each of the top four dose groups of
both sexes compared to 0/10 in the control and lowest dose groups; the
severity also increased dose-dependently.

**[Reproductive & Developmental Toxicity:]{.underline}** The pre- and
post-natal toxicology database for pyraclostrobin includes the rat and
rabbit developmental toxicity studies and the two-generation
reproduction toxicity study in rats. There was no evidence of increased
quantitative or qualitative susceptibility following [in
utero]{.underline} exposure to rats. The developmental findings of
increased incidences of dilated renal pelvis and cervical ribs with no
cartilage were seen at a higher dose than that which caused maternal
toxicity and these findings were within historical control background
incidences; therefore, they are considered developmental variations
rather than malformations. In the rabbit developmental toxicity study,
there was evidence of qualitative susceptibility; increases in
resorptions/litter and post-implantation losses were seen in the
presence of maternal toxicity (decreases in body weight gain and food
consumption). However, the concern is low for the qualitative
susceptibility in the rabbit developmental study because: The
developmental effects were seen in the presence of maternal toxicity;
there are clear NOAELs for maternal and developmental toxicities; and
this endpoint is used for the acute dietary (RfD) for Females+ 13 as
well as for short- and intermediate-term dermal risk assessments.

In the two-generation study, there were no adverse maternal systemic
toxicity other than a marginal (non-adverse) decrease (\<= 5%) in F0 and
F1 parental body weights at the high dose of 300 ppm. The F1 and F2 pups
of the 300 ppm dose group had slight decreases in body weights during
lactation which were explained to be "likely due to the fact that pups
start eating food at this time (day 7) along with potentially receiving
test compound or its metabolites in mother milk." The findings were not
considered adverse in part because of almost total body weight recovery
in F1 parental animals during premating, gestation, and lactation. The
NOAEL/LOAEL were 300/\>300 ppm for parental, reproductive, and offspring
toxicities. In the one generation study, the NOAEL/LOAEL were \<200/\<=
200 ppm based on dose-dependent decrease in F1 pup body weights.

The HIARC decided that, when evaluated with the findings of the
dose-range one-generation reproduction study, there is no need to repeat
the two-generation reproduction study (document dated 2/10/03, TXR no.
0051553). The HIARC noted that the greater body weight/body weight gain
sensitivity in the offspring of the one-generation reproduction study is
possibly due to decreased feed intake by treated pups as they start
eating solid feed around day 14; this effect was not reproduced in the
two-generation toxicity study.

It should be noted that there was some overlap in the magnitude of the
body weight decrease in F1 pups at 300 ppm (4-10%), 200 ppm (7-14%), and
400 ppm (11-20%) to the extent possible from two completely different
and independent studies. For any end-point, some degree of variation is
to be expected between control animals from different studies for
different reasons including animal husbandry (e.g., diurnal, seasonal)
as well as differences in instruments and people who collect the
measurements. This inter-study variation may explain the F1 pup body
weight variance and lack of a perfect dose-response among the similar
dose levels (300 ppm vs. 200 and 400 ppm) in both studies.

Number range CHAPTERIn conclusion, athough no toxicity was seen at 300
ppm (29.0 mg/kg/day) in the two-generation reproduction study, a new
study is not required since such a study would be conducted using a much
higher dose and would not provide any additional data for risk
assessment purposes. The concern with that study is not that it did not
test at a low enough dose but the opposite. Further, it should be noted
that acute and chronic reference doses for dietary risks as well as
doses for non-dietary risks are based on other studies with NOAELs below
the high dose in the two generation study.

**[Neurotoxicity:]{.underline}** In both the acute and subchronic
neurotoxicity studies, there were no indications of treatment-related
neurotoxicity including clinical signs, qualitative or quantitative
neurobehavioral effects, brain weight, or gross/microscopic pathology.
None of the other guideline studies reported treatment-related effects
on any of these parameters. However, there was a large decrease (about
50%) in serum cholinesterase (but not in erythrocyte or brain
cholinesterases) among the females in the rat 28- and 90-day dietary
studies at relatively large doses (1000/1500 ppm or about 80 - 126
mg/kg/day). This response might require exposure to a relatively high
dose since serum cholinesterase (ChE) was not affected at the end of the
two-year chronic toxicity feeding study in rats including the top dose
of 200 ppm (9.2/12.6 mg/kg/day in males/females). Also, pyraclostrobin
does not seem to persist in rat tissues (see following section) which
might explain why serum ChE is not affected by a lifetime exposure to a
relatively low dose but is depressed following a short-term exposure at
a high dose.

**[Carcinogenicity]{.underline}:** The Cancer Assessment Review
Committee (CARC) classified pyraclostrobin into the category **"Not
Likely to be Carcinogenic to Humans"** based on no treatment-related
increase in tumors in both sexes of rats and mice, which were tested at
doses that were adequate to assess carcinogenicity, and the lack of
evidence of mutagenicity. The CARC concluded that quantification of
carcinogenic potential is not required (TXR document no. 0054516, dated
2/15/07).

**3.1.3 Dose-response**[]{#__RefHeading___Toc191365821 .anchor}

A variety of oral toxicity studies were used for the different risk
assessment scenarios including the rabbit developmental toxicity study,
the acute neurotoxicity study in rats, the rat carcinogenicity study,
and the 13-week study in dogs. In addition, the 28-day inhalation study
in rats was used for short- and intermediate-term occupational and
residential inhalation risk assessments. The endpoints in these studies
are well characterized and are the most sensitive among available
comparable toxicity studies in other species. All dietary points of
departure (i.e., acute and chronic RfDs), are calculated from the
respective study's NOAEL after applying a 100-fold safety factor (10 X
to account for interspecies extrapolation and 10X for intraspecies
variation). For all other scenarios, including dermal, inhalation, and
incidental oral, an MOE approach will be used with a Level of Concern
(LOC) at 100.

The selected point of departure from the acute neurotoxicity study of
300 mg/kg/day for the acute dietary (general population) risk assessment
is appropriate because the decreased body weight gain in males occurred
during the first week after a single oral high dose of 1000 mg/kg.

The rabbit developmental toxicity study findings are used for endpoint
selections for acute dietary (Females 13+) as well as for short- and
intermediate-term dermal exposures. For the acute dietary endpoint
(Females 13+), the rabbit developmental findings of increased
resorptions/post-implantation loss at the LOAEL of 10 mg/kg/day are
assumed to occur following a single *in utero* exposure. These effects
were dose-dependently increased at the next (high) dose of 20 mg/kg/day.
The same study and developmental endpoint are used for short- and
intermediate-term dermal exposures after applying a dermal absorption
factor of 14%. Additionally, the maternal endpoints of decreased body
weight gain and decreased food intake and food efficiency were found at
the LOAEL of 10 mg/kg/day. This selection mitigates any concern from the
observed developmental toxicity findings in rabbits which are not
assessed in the rat dermal toxicity study.

The rat carcinogenicity study findings are used for endpoint selections
for chronic dietary and dermal exposures based on findings of decreased
body weight/gain and kidney tubular casts/atrophy in both sexes in
addition to liver necrosis and stomach lesions in males at the high dose
(LOAEL) of 9.2 mg/kg/day. This study has the lowest NOAEL (3.4
mg/kg/day) in the most sensitive species following chronic exposure. The
dermal absorption factor of 14% will be applied to the dermal long-term
risk scenario.

The short-, intermediate-, and long-term inhalation endpoints are from
the 28-day inhalation toxicity study in rats which had dose-dependent
adverse findings in the respiratory system and duodenum. The study's
oral equivalents NOAEL/LOAEL are 0.23/6.92 mg/kg/day (corresponding to
study's air concentration of 0.001/0.03 mg/L air). The findings are well
characterized in that the severity, frequency, and location (e.g., along
the respiratory tract) are dose-dependent ranging from no effects at the
NOAEL of 0.001 mg/L air to severe respiratory effects and death at the
highest dose of 0.3 mg/L air.

The short- and intermediate-term incidental oral endpoints are from the
13-week feeding study in dogs. The NOAEL of 5.8 mg/kg/day is based on
increased incidence of diarrhea, clinical chemistry changes, duodenum
mucosal hypertrophy, and effects on body weight and food
intake/efficiency at 13 mg/kg/day (LOAEL). The NOAEL/LOAEL in this study
are comparable to the maternal NOAEL/LOAEL (5/10 mg/kg/day) established
in the rabbit developmental toxicity study, and the end-point is
appropriate for the population of concern (toddlers).

**3.2 FQPA Safety Factor for Infants and
Children**[]{#__RefHeading___Toc191365822 .anchor}

The toxicity data base for pyraclostrobin is adequate for evaluation of
the FQPA safety factor. The following acceptable studies are
available: 1) developmental toxicity studies in rats and rabbits; and 2)
a two-generation reproduction study in rats. This assessment reaffirms
previous conclusions that the 10X FQPA safety factor for the protection
of infants and children should be removed for all potential exposure
scenarios to pyraclostrobin because the database is complete and
adequate and there are no residual uncertainties for pre- and/or
postnatal toxicity. The doses chosen as quantitative risk estimates are
adequately protective for infants and children. Exposure data are
complete or are estimated based on data that reasonably account for
potential exposures.

The acute dietary analysis was based on tolerance level or highest
residues and 100% crop treated assumptions for all commodities.
Experimentally derived processing factors were used for fruit juices and
tomato and wheat commodities. The contribution from drinking water is
minimal. HED concludes that the acute exposure estimates in this
analysis are unlikely to underestimate actual exposure.

The chronic dietary analysis included tolerance level or average
residues from field trial data and 100% crop treated assumptions for all
commodities. A limited number of experimentally derived processing
factors were used for fruit juices and tomato and wheat commodities. The
field trials represent maximum application rates and minimum PHIs. The
contribution from drinking water is minimal. HED concludes that the
chronic exposure estimates in this analysis are unlikely to
underestimate actual exposure.

The dietary drinking water assessment utilizes water concentration
values generated by model and associated modeling parameters which are
designed to provide conservative, health protective, high-end estimates
of water concentrations which will not likely be exceeded.

While there is potential for postapplication residential exposure, the
best data and approaches currently available were used in the
pyraclostrobin residential assessment. The Agency used the current
conservative approaches for residential assessment, many of which
include recent upgrades to the SOPs. The Agency believes that the
calculated risks represent conservative estimates of exposure because
maximum application rates are used to define residue levels upon which
the calculations are based. Exposures are unlikely to be under estimated
because the assessment was a screening level assessment.

Based on these data and conclusions, the FQPA Safety Factor can be
reduced to 1X.

**3.3 Summary of Toxicological Doses and Endpoints for Use in Human
Health Risk Assessments**[]{#__RefHeading___Toc191365823 .anchor}

HED recently completed a Section 3 human health risk assessment for the
use of pyraclostrobin on cotton and Belgian endive (Memo B. O'Keefe, et.
al., 9/7/07, DP# 343700). As there are no new toxicity data associated
with this current action, the hazard characterization and endpoint
selection, from the previous risk assessment are applied directly to
this action. All previous exposure risk assessments remain unchanged.
Below are the up-to-date tables.

+-----------+-----------+--------+---------+-------------------------+
| **Table   |           |        |         |                         |
| 2.        |           |        |         |                         |
| Summary   |           |        |         |                         |
| of        |           |        |         |                         |
| Toxi      |           |        |         |                         |
| cological |           |        |         |                         |
| Doses and |           |        |         |                         |
| Endpoints |           |        |         |                         |
| for       |           |        |         |                         |
| Pyrac     |           |        |         |                         |
| lostrobin |           |        |         |                         |
| for Use   |           |        |         |                         |
| in        |           |        |         |                         |
| Dietary   |           |        |         |                         |
| and       |           |        |         |                         |
| Non-Occ   |           |        |         |                         |
| upational |           |        |         |                         |
| Human     |           |        |         |                         |
| Health    |           |        |         |                         |
| Risk      |           |        |         |                         |
| Asse      |           |        |         |                         |
| ssments** |           |        |         |                         |
+===========+===========+========+=========+=========================+
| Exposure/ | Point of  | Unce   | RfD,    | Study and Toxicological |
|           | Departure | rtaint | PAD,    | Effects                 |
| Scenario  |           | y/FQPA | Level   |                         |
|           |           | Safety | of      |                         |
|           |           | F      | Concern |                         |
|           |           | actors | for     |                         |
|           |           |        | Risk    |                         |
|           |           |        | Ass     |                         |
|           |           |        | essment |                         |
+-----------+-----------+--------+---------+-------------------------+
| Acute     | NOAEL=    | UF~A~= | Acute   | Rat Acute Oral          |
| Dietary   | 300       | 10x    | RfD =   | Neurotoxicity           |
| (General  | mg/kg/day |        | 3.0     |                         |
| Po        |           | UF~H~= | mg      | LOAEL = 1000 mg/kg/day  |
| pulation, |           | 10x    | /kg/day | based on decreased body |
| including |           |        |         | weight gain in males.   |
| Infants   |           | FQPA   | aPAD =  |                         |
| and       |           | SF= 1x | 3.0     |                         |
| Children) |           |        | mg      |                         |
|           |           |        | /kg/day |                         |
+-----------+-----------+--------+---------+-------------------------+
| Acute     | NOAEL =   | UF~A~= | Acute   | Rabbit Prenatal         |
| Dietary   | 5.0       | 10x    | RfD =   | Developmental Toxicity  |
|           | mg/kg/day |        | 0.05    |                         |
| (Females  |           | UF~H~= | mg      | LOAEL = 10.0 mg/kg/day  |
| 13-49     |           | 10x    | /kg/day | based on developmental  |
| years of  |           |        |         | toxicity findings of    |
| age)      |           | FQPA   | aPAD =  | increased               |
|           |           | SF= 1x | 0.05    | resorptions.Number      |
|           |           |        | mg      | range CHAPTER           |
|           |           |        | /kg/day |                         |
+-----------+-----------+--------+---------+-------------------------+
| Chronic   | NOAEL=    | UF~A~= | Chronic | Number range CHAPTERRat |
| Dietary   | 3.4       | 10x    | RfD =   | Oral Carcinogenicity    |
| (All      | mg/kg/day |        | 0.034   |                         |
| Pop       |           | UF~H~= | mg      | LOAEL = 9.2 mg/kg/day   |
| ulations) |           | 10x    | /kg/day | based on decreased body |
|           |           |        |         | weight/body weight      |
|           |           | FQPA   | cPAD =  | gain, kidney tubular    |
|           |           | SF= 1x | 0.034   | casts and atrophy in    |
|           |           |        | mg      | both sexes; increased   |
|           |           |        | /kg/day | incidence of liver      |
|           |           |        |         | necrosis and            |
|           |           |        |         | erosion/ulceration of   |
|           |           |        |         | the glandular- stomach  |
|           |           |        |         | and fore-stomach in     |
|           |           |        |         | males.                  |
+-----------+-----------+--------+---------+-------------------------+
| I         | NOAEL=    | UF~A~= | Resi    | Number range            |
| ncidental | 5.8       | 10x    | dential | CHAPTER13-Week Feeding  |
| Oral      | mg/kg/day |        | LOC for | Dog Study               |
| S         |           | UF~H~= | MOE =   |                         |
| hort-Term |           | 10x    | 100     | LOAEL = 12.9 mg/kg/day  |
| (1-30     |           |        |         | based on increased      |
| days)     |           | FQPA   |         | incidence of diarrhea,  |
|           |           | SF= 1x |         | clinical chemistry      |
|           |           |        |         | changes, duodenum       |
|           |           |        |         | mucosal hypertrophy,    |
|           |           |        |         | and decreased body      |
|           |           |        |         | weight and food         |
|           |           |        |         | intake/efficiency.      |
+-----------+-----------+--------+---------+-------------------------+
| I         | NOAEL=    | UF~A~= | Resi    | Number range            |
| ncidental | 5.8       | 10x    | dential | CHAPTER13-Week Feeding  |
| Oral      | mg/kg/day |        | LOC for | Dog Study               |
| Intermed  |           | UF~H~= | MOE =   |                         |
| iate-Term |           | 10x    | 100     | LOAEL = 12.9 mg/kg/day  |
| (1-6      |           |        |         | based on increased      |
| months)   |           | FQPA   |         | incidence of diarrhea,  |
|           |           | SF= 1x |         | clinical chemistry      |
|           |           |        |         | changes, duodenum       |
|           |           |        |         | mucosal hypertrophy,    |
|           |           |        |         | and decreased body      |
|           |           |        |         | weight and food         |
|           |           |        |         | intake/efficiency.      |
+-----------+-----------+--------+---------+-------------------------+
| Dermal    | Oral      | UF~A~= | Resi    | Rabbit Prenatal         |
| S         | study     | 10x    | dential | Developmental Toxicity  |
| hort-Term | NOAEL =   |        | LOC for |                         |
| (1-30     | 5.0       | UF~H~= | MOE =   | LOAEL = 10.0 mg/kg/day  |
| days)     | mg/kg/day | 10x    | 100     | based on developmental  |
|           |           |        |         | toxicity findings of    |
|           | Number    | FQPA   |         | increased resorptions   |
|           | range     | SF= 1x |         | and maternal toxicity   |
|           | CHAPT     |        |         | based on decreased body |
|           | ER(dermal |        |         | weight gain and         |
|           | a         |        |         | decreased food          |
|           | bsorption |        |         | intake/efficiency.      |
|           | rate = 14 |        |         |                         |
|           | %)        |        |         |                         |
+-----------+-----------+--------+---------+-------------------------+
| Dermal    | Oral      | UF~A~= | Resi    | Rabbit Prenatal         |
| Intermed  | study     | 10x    | dential | Developmental Toxicity  |
| iate-Term | NOAEL =   |        | LOC for |                         |
| (1-6      | 5.0       | UF~H~= | MOE =   | LOAEL = 10.0 mg/kg/day  |
| months)   | mg/kg/day | 10x    | 100     | based on developmental  |
|           |           |        |         | toxicity findings of    |
|           | Number    | FQPA   |         | increased resorptions   |
|           | range     | SF= 1x |         | and maternal toxicity   |
|           | CHAPT     |        |         | based on decreased body |
|           | ER(dermal |        |         | weight gain and         |
|           | a         |        |         | decreased food          |
|           | bsorption |        |         | intake/efficiency.      |
|           | rate = 14 |        |         |                         |
|           | %)        |        |         |                         |
+-----------+-----------+--------+---------+-------------------------+
| Number    | Number    | UF~A~= | Resi    | Number range CHAPTERRat |
| range     | range     | 10x    | dential | Oral Carcinogenicity    |
| CHAPTER   | CH        |        | LOC for |                         |
| Long-Term | APTEROral | UF~H~= | MOE =   | LOAEL = 9.2 mg/kg/day   |
| Dermal    | study     | 10x    | 100     | based on decreased body |
| (\>6      | NOAEL =   |        |         | weight/body weight      |
| months)   | 3.4       | FQPA   |         | gain, kidney tubular    |
|           | mg/kg/day | SF= 1x |         | casts and atrophy in    |
|           |           |        |         | both sexes; increased   |
|           | (dermal   |        |         | incidence of liver      |
|           | a         |        |         | necrosis and            |
|           | bsorption |        |         | erosion/ulceration of   |
|           | rate = 14 |        |         | the glandular- stomach  |
|           | %)        |        |         | and fore-stomach in     |
|           |           |        |         | males.                  |
+-----------+-----------+--------+---------+-------------------------+
| I         | NOAEL=    | UF~A~= | Resi    | Rat 28-day Inhalation   |
| nhalation | 0.23      | 10x    | dential |                         |
| Short-    | mg/kg/day |        | LOC for | LOAEL = 6.9 mg/kg/day   |
| Term      | (air      | UF~H~= | MOE =   | (air concentration =    |
| (1-30     | conc      | 10x    | 100     | 0.03 mg/L) based on     |
| days)     | entration |        |         | duodenum mucosal        |
|           | = 0.001   | FQPA   |         | hyperplasia and         |
|           | mg/L)     | SF= 1x |         | respiratory system      |
|           |           |        |         | findings including      |
|           |           |        |         | alveolar histiocytosis  |
|           |           |        |         | and olfactory           |
|           |           |        |         | atrophy/necrosis in     |
|           |           |        |         | nasal tissue.           |
+-----------+-----------+--------+---------+-------------------------+
| I         | NOAEL=    | UF~A~= | Resi    | Rat 28-day Inhalation   |
| nhalation | 0.23      | 10x    | dential |                         |
| Intermed  | mg/kg/day |        | LOC for | LOAEL = 6.9 mg/kg/day   |
| iate-Term | (air      | UF~H~= | MOE =   | (air concentration =    |
| (1-6      | conc      | 10x    | 100     | 0.03 mg/L) based on     |
| months)   | entration |        |         | duodenum mucosal        |
|           | = 0.001   | FQPA   |         | hyperplasia and         |
|           | mg/L)     | SF= 1x |         | respiratory system      |
|           |           |        |         | findings including      |
|           |           |        |         | alveolar histiocytosis  |
|           |           |        |         | and olfactory           |
|           |           |        |         | atrophy/necrosis in     |
|           |           |        |         | nasal tissue.           |
+-----------+-----------+--------+---------+-------------------------+
| I         | NOAEL=    | UF~A~= | Resi    | Rat 28-day Inhalation   |
| nhalation | 0.23      | 10x    | dential |                         |
| Long-Term | mg/kg/day |        | LOC for | LOAEL = 6.9 mg/kg/day   |
| (\>6      | (air      | UF~H~= | MOE =   | (air concentration =    |
| months)   | conc      | 10x    | 100     | 0.03 mg/L) based on     |
|           | entration |        |         | duodenum mucosal        |
|           | = 0.001   | FQPA   |         | hyperplasia and         |
|           | mg/L)     | SF= 1x |         | respiratory system      |
|           |           |        |         | findings including      |
|           |           |        |         | alveolar histiocytosis  |
|           |           |        |         | and olfactory           |
|           |           |        |         | atrophy/necrosis in     |
|           |           |        |         | nasal tissue.           |
+-----------+-----------+--------+---------+-------------------------+
| Cancer    | Classi    |        |         |                         |
| (oral,    | fication: |        |         |                         |
| dermal,   | "Not      |        |         |                         |
| in        | likely to |        |         |                         |
| halation) | be        |        |         |                         |
|           | Car       |        |         |                         |
|           | cinogenic |        |         |                         |
|           | to        |        |         |                         |
|           | Humans"   |        |         |                         |
|           | based on  |        |         |                         |
|           | the       |        |         |                         |
|           | absence   |        |         |                         |
|           | of        |        |         |                         |
|           | si        |        |         |                         |
|           | gnificant |        |         |                         |
|           | tumor     |        |         |                         |
|           | increases |        |         |                         |
|           | in two    |        |         |                         |
|           | adequate  |        |         |                         |
|           | rodent    |        |         |                         |
|           | carcin    |        |         |                         |
|           | ogenicity |        |         |                         |
|           | studies.  |        |         |                         |
+-----------+-----------+--------+---------+-------------------------+

Point of Departure (POD) = A data point or an estimated point that is
derived from observed dose-response data and used to mark the beginning
of extrapolation to determine risk associated with lower environmentally
relevant human exposures. NOAEL = no observed adverse effect level.
LOAEL = lowest observed adverse effect level. UF = uncertainty factor.
UF~A~ = extrapolation from animal to human (interspecies). UF~H~ =
potential variation in sensitivity among members of the human population
(intraspecies). UF~L~ = use of a LOAEL to extrapolate a NOAEL. UF~S\ =~
use of a short-term study for long-term risk assessment. UF~DB~ = to
account for the absence of key date (i.e., lack of a critical study).
FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute,
c = chronic). RfD = reference dose. MOE = margin of exposure. LOC =
level of concern. N/A = not applicable.

+----------+-----------+--------+-----------+-------------------------+
| **Table  |           |        |           |                         |
| 3.       |           |        |           |                         |
| Summary  |           |        |           |                         |
| of       |           |        |           |                         |
| Toxic    |           |        |           |                         |
| ological |           |        |           |                         |
| Doses    |           |        |           |                         |
| and      |           |        |           |                         |
| E        |           |        |           |                         |
| ndpoints |           |        |           |                         |
| for      |           |        |           |                         |
| Pyracl   |           |        |           |                         |
| ostrobin |           |        |           |                         |
| for Use  |           |        |           |                         |
| in       |           |        |           |                         |
| Occu     |           |        |           |                         |
| pational |           |        |           |                         |
| Human    |           |        |           |                         |
| Health   |           |        |           |                         |
| Risk     |           |        |           |                         |
| Asses    |           |        |           |                         |
| sments** |           |        |           |                         |
+==========+===========+========+===========+=========================+
| E        | Point of  | Uncer  | Level of  | Study and Toxicological |
| xposure/ | Departure | tainty | Concern   | Effects                 |
|          |           | F      | for Risk  |                         |
| Scenario |           | actors | A         |                         |
|          |           |        | ssessment |                         |
+----------+-----------+--------+-----------+-------------------------+
| Dermal   | NOAEL=    | UF~    | Occ       | Rabbit Prenatal         |
| Sh       | 5.0       | A~=10x | upational | Developmental Toxicity  |
| ort-Term | mg/kg/day |        | LOC for   |                         |
| (1-30    |           | UF~    | MOE = 100 | LOAEL = 10.0 mg/kg/day  |
| days)    | Number    | H~=10x |           | based on developmental  |
|          | range     |        |           | toxicity findings of    |
|          | CHAPT     |        |           | increased resorptions.  |
|          | ER(dermal |        |           |                         |
|          | a         |        |           |                         |
|          | bsorption |        |           |                         |
|          | rate = 14 |        |           |                         |
|          | %)        |        |           |                         |
+----------+-----------+--------+-----------+-------------------------+
| Dermal   | Oral      | UF~A~= | Occ       | Rabbit Prenatal         |
| I        | study     | 10x    | upational | Developmental Toxicity  |
| ntermedi | NOAEL =   |        | LOC for   |                         |
| ate-Term | 5.0       | UF~H~= | MOE = 100 | LOAEL = 10.0 mg/kg/day  |
| (1-6     | mg/kg/day | 10x    |           | based on developmental  |
| months)  |           |        |           | toxicity findings of    |
|          | Number    |        |           | increased resorptions.  |
|          | range     |        |           |                         |
|          | CHAPT     |        |           |                         |
|          | ER(dermal |        |           |                         |
|          | a         |        |           |                         |
|          | bsorption |        |           |                         |
|          | rate = 14 |        |           |                         |
|          | %)        |        |           |                         |
+----------+-----------+--------+-----------+-------------------------+
| Number   | Number    | UF~A~= | Occ       | Number range CHAPTERRat |
| range    | range     | 10x    | upational | Oral Carcinogenicity    |
| CHAPTERL | CH        |        | LOC for   |                         |
| ong-Term | APTEROral | UF~H~= | MOE = 100 | LOAEL = 9.2 mg/kg/day   |
| Dermal   | study     | 10x    |           | based on decreased body |
| (\>6     | NOAEL =   |        |           | weight/body weight      |
| months)  | 3.4       |        |           | gain, kidney tubular    |
|          | mg/kg/day |        |           | casts and atrophy in    |
|          |           |        |           | both sexes; increased   |
|          | (dermal   |        |           | incidence of liver      |
|          | a         |        |           | necrosis and            |
|          | bsorption |        |           | erosion/ulceration of   |
|          | rate = 14 |        |           | the glandular- stomach  |
|          | %)        |        |           | and fore-stomach in     |
|          |           |        |           | males.                  |
+----------+-----------+--------+-----------+-------------------------+
| In       | NOAEL=    | UF~A~= | Occ       | Rat 28-day Inhalation   |
| halation | 0.23      | 10x    | upational |                         |
| Short-   | mg/kg/day |        | LOC for   | LOAEL = 6.9 mg/kg/day   |
| Term     | (air      | UF~H~= | MOE = 100 | (air concentration =    |
| (1-30    | conc      | 10x    |           | 0.03 mg/L) based on     |
| days)    | entration |        |           | duodenum mucosal        |
|          | = 0.001   |        |           | hyperplasia and         |
|          | mg/L)     |        |           | respiratory system      |
|          |           |        |           | findings including      |
|          |           |        |           | alveolar histiocytosis  |
|          |           |        |           | and olfactory           |
|          |           |        |           | atrophy/necrosis in     |
|          |           |        |           | nasal tissue.           |
+----------+-----------+--------+-----------+-------------------------+
| In       | NOAEL=    | UF~A~= | Occ       | Rat 28-day Inhalation   |
| halation | 0.23      | 10x    | upational |                         |
| I        | mg/kg/day |        | LOC for   | LOAEL = 6.9 mg/kg/day   |
| ntermedi | (air      | UF~H~= | MOE = 100 | (air concentration =    |
| ate-Term | conc      | 10x    |           | 0.03 mg/L) based on     |
| (1-6     | entration |        |           | duodenum mucosal        |
| months)  | = 0.001   |        |           | hyperplasia and         |
|          | mg/L)     |        |           | respiratory system      |
|          |           |        |           | findings including      |
|          |           |        |           | alveolar histiocytosis  |
|          |           |        |           | and olfactory           |
|          |           |        |           | atrophy/necrosis in     |
|          |           |        |           | nasal tissue.           |
+----------+-----------+--------+-----------+-------------------------+
| In       | NOAEL=    | UF~A~= | Occ       | Rat 28-day Inhalation   |
| halation | 0.23      | 10x    | upational |                         |
| L        | mg/kg/day |        | LOC for   | LOAEL = 6.9 mg/kg/day   |
| ong-Term | (air      | UF~H~= | MOE = 100 | (air concentration =    |
| (\>6     | conc      | 10x    |           | 0.03 mg/L) based on     |
| months)  | entration |        |           | duodenum mucosal        |
|          | = 0.001   |        |           | hyperplasia and         |
|          | mg/L)     |        |           | respiratory system      |
|          |           |        |           | findings including      |
|          |           |        |           | alveolar histiocytosis  |
|          |           |        |           | and olfactory           |
|          |           |        |           | atrophy/necrosis in     |
|          |           |        |           | nasal tissue.           |
+----------+-----------+--------+-----------+-------------------------+
| Cancer   | Classi    |        |           |                         |
| (oral)   | fication: |        |           |                         |
|          | "Not      |        |           |                         |
|          | likely to |        |           |                         |
|          | be        |        |           |                         |
|          | Car       |        |           |                         |
|          | cinogenic |        |           |                         |
|          | to        |        |           |                         |
|          | Humans"   |        |           |                         |
|          | based on  |        |           |                         |
|          | the       |        |           |                         |
|          | absence   |        |           |                         |
|          | of        |        |           |                         |
|          | si        |        |           |                         |
|          | gnificant |        |           |                         |
|          | tumor     |        |           |                         |
|          | increases |        |           |                         |
|          | in two    |        |           |                         |
|          | adequate  |        |           |                         |
|          | rodent    |        |           |                         |
|          | carcin    |        |           |                         |
|          | ogenicity |        |           |                         |
|          | studies.  |        |           |                         |
+----------+-----------+--------+-----------+-------------------------+

Point of Departure (POD) = A data point or an estimated point that is
derived from observed dose-response data and used to mark the beginning
of extrapolation to determine risk associated with lower environmentally
relevant human exposures. NOAEL = no observed adverse effect level.
LOAEL = lowest observed adverse effect level. UF = uncertainty factor.
UF~A~ = extrapolation from animal to human (interspecies). UF~H~ =
potential variation in sensitivity among members of the human population
(intraspecies). UF~L~ = use of a LOAEL to extrapolate a NOAEL. UF~S\ =~
use of a short-term study for long-term risk assessment. UF~DB~ = to
account for the absence of key date (i.e., lack of a critical study).
MOE = margin of exposure. LOC = level of concern. N/A = not applicable.

**3.4 Recommendation for Aggregate Exposure Risk
Assessments**[]{#__RefHeading___Toc191365824 .anchor}

As per the FQPA, when there are potential residential exposures to the
pesticide, aggregate risk assessment must consider exposures from three
major sources: oral, dermal and inhalation exposures. When common
toxicity endpoints are selected for these routes of exposure they may be
aggregated. Aggregate assessments are required for acute and chronic
dietary (food + water) exposures, and short-term residential exposures
(i.e., chronic dietary plus incidental oral and dermal exposures).

Residential short-/intermediate-term dermal exposure for adults and
toddlers were assessed using the NOAEL (5 mg/kg/day) from the rabbit
developmental study. While the developmental effect of increased
resorptions is not applicable to toddlers, it should be noted that the
maternal NOAEL from this study is also 5 mg/kg/day, and is based on
reduced body weight gain, food consumption, and food efficiency at the
LOAEL of 10 mg/kg/day; this more relevant endpoint was used to assess
toddler dermal exposure. For incidental oral ingestion, exposure was
assessed using the endpoint from a 13-week feeding study in the dog. The
NOAEL from this study is 5.8 mg/kg/day, based on increased incidence of
diarrhea, clinical chemistry changes, duodenum mucosal hypertrophy, and
decreased body weight and food intake/efficiency at the LOAEL of 12.9
mg/kg/day. A common effect (i.e., decreased body weight gain, food
intake, and food efficiency) was seen in the studies selected to
evaluate toddler dermal and incidental oral ingestion exposure;
therefore, route-specific MOEs were aggregated for toddlers.

**3.5 Endocrine disruption**[]{#__RefHeading___Toc191365825 .anchor}

EPA is required under the FFDCA, as amended by FQPA, to develop a
screening program to determine whether certain substances (including all
pesticide active and other ingredients) "may have an effect in humans
that is similar to an effect produced by a naturally occurring estrogen,
or other such endocrine effects as the Administrator may designate."
Following recommendations of its Endocrine Disruptor Screening and
Testing Advisory Committee (EDSTAC), EPA determined that there was a
scientific basis for including, as part of the program, the androgen and
thyroid hormone systems, in addition to the estrogen hormone system. EPA
also adopted EDSTAC's recommendation that the Program include
evaluations of potential effects in wildlife. For pesticide chemicals,
EPA will use FIFRA and, to the extent that effects in wildlife may help
determine whether a substance may have an effect in humans, FFDCA
authority to require the wildlife evaluations. As the science develops
and resources allow, screening of additional hormone systems may be
added to the Endocrine Disruptor Screening Program (EDSP).

When additional appropriate screening and/or testing protocols being
considered under the Agency's EDSP have been developed, pyraclostrobin
may be subjected to further screening and/or testing to better
characterize effects related to endocrine disruption.

**4.0 Public Health and Pesticide Epidemiology Data**
[]{#__RefHeading___Toc191365826 .anchor}

The Centers for Disease Control (CDC) and Prevention recently reported
and described five incident events to the Iowa Department of Public
Health (IDPH) of exposures that occurred during aerial applications of
pyraclostrobin (MMWR Weekly, 2/4/08, 56(51) pp.1343-1345). IDPH
investigated the reports. In one event migrant workers were
inadvertently exposed to pyraclostrobin due to pilot error and
off-target drift of pyraclostrobin to an adjacent field. The migrant
workers experienced symptoms including upper respiratory tract pain or
irritation, chest pain, nausea, skin redness, eye pain, weakness,
headache, and dizziness. In another event, a crop-dusting pilot suffered
first degree burns after being exposed to pyraclostrobin which had
spilled after his airplane crashed during takeoff. Another three events
also involved acute pesticide poisoning associated with off-target drift
of pyraclostrobin from nearby aerial applications. In all five of these
cases, symptoms subsided after the exposed persons moved indoors or away
from the pyraclostrobin treated fields.

Pyraclostrobin labels that permit aerial applications contain specific
label language stating not to apply under circumstances where possible
drift may occur and how to reduce drift potential.

**5.0 Dietary Exposure/Risk
Characterization**[]{#__RefHeading___Toc191365827 .anchor}

Reference: *Pyraclostrobin. Petitions for the Establishment of Permanent
Tolerances on: (i) Oat Grain, Hay, and Straw, and Oilseed (Crop Group
20) - PP#6F7105; (ii) Fresh Herbs (Herbs Subgroup 19A), Avocado, Black
Sapote, Canistel, Mamey Sapote, Mango, Papaya, Sapodilla, and Star
Apple - PP#6E7165; and (iii) Barley Grain and Straw- PP#7E7245. Summary
of Analytical Chemistry and Residue Data. DP Numbesr 345965, 348700 &
343754; J. Stokes; 02/12/08.*

**5.1 Pesticide Metabolism and Environmental
Degradation**[]{#__RefHeading___Toc191365828 .anchor}

**5.1.1 Metabolism in Primary Crops**[]{#__RefHeading___Toc191365829
.anchor}

Adequate metabolism studies with pyraclostrobin on grapes, potatoes, and
wheat have previously been reviewed (D269668, L. Cheng, 11/28/01) in
conjunction with PP#0F06139. The results of these studies indicate that
the metabolism of pyraclostrobin is similar in the three crops
investigated. The HED Metabolism Assessment Review Committee (MARC)
concluded that the nature of the residue in plants is understood (HED
Metabolism Committee Decision Memo; D278044, L. Cheng, 10/9/01). For
purposes of tolerance setting and risk assessment, the terminal residues
of concern in plants consist of pyraclostrobin and its desmethoxy
metabolite (BF 500-3).

**5.1.2 Metabolism in Livestock**[]{#__RefHeading___Toc191365830
.anchor}

Adequate metabolism studies with pyraclostrobin on ruminants and laying
hens were previously reviewed (D269668, L. Cheng, 11/28/01) in
conjunction with PP#0F06139. The HED MARC has determined that for
purposes of tolerance setting and risk assessment, the residues of
concern in livestock commodities consist of pyraclostrobin and its
metabolites convertible to 1-(4-chlorophenyl)-1*H*-pyrazol-3-ol and
1-(4-chloro-2-hydroxyphenyl)-1*H*-pyrazol-3-ol (HED Metabolism Committee
Decision Memo; D278044, L. Cheng, 10/9/01).

**5.1.3 Analytical Methodology**[]{#__RefHeading___Toc191365831 .anchor}

***Enforcement Method for Plants***

Two adequate methods were proposed for enforcing tolerance for residues
of pyraclostrobin and BF 500-3 in/on plant commodities: a LC/MS/MS
method (BASF Method D9808), and an HPLC/UV method (BASF Method D9904).
The validated method LOQ for both pyraclostrobin and BF 500-3 is 0.02
ppm in all tested plant matrices, for a combined LOQ of 0.04 ppm.
Adequate independent method validation and radiovalidation data were
submitted for both methods (D269668, 11/28/01, L. Cheng), and both
methods were forwarded to ACB/BEAD for a petition method validation
(D269850, 11/8/00, L. Cheng).

Samples of raw agricultural and processed commodities from the current
crop field trials were analyzed for residues of pyraclostrobin and BF
500-3 using the LC/MS/MS method (BASF Method D9908, MRID 46710001
(currently under BEAD review)). Briefly, residues were extracted by
shaking with methanol:water:2 N HCl (70:25:5; v:v:v) and centrifuged.
Residues were then partitioned with cyclohexane, concentrated to
dryness, and re-dissolved in buffered methanol:water (80:20, v:v). The
final chromatographic analysis of residues was determined by LC/MS/MS.
Total residues of pyraclostrobin and BF 500-3 are expressed as
pyraclostrobin equivalents. For each analyte, the validated method LOQ
is 0.02 ppm, and the estimated LODs are 0.003-0.03 ppm. The method is
adequate for data collection based on acceptable concurrent method
recovery data.

***Analytical Methods - Livestock***

Two methods have also been proposed for enforcing tolerances for
livestock commodities: HPLC/UV method 439/0 and Method 446 (consisting
of GC/MS method 446/0 and LC/MS/MS method 446/1). The HPLC/UV method
determines residues of pyraclostrobin *per se*. Method 446 has a
hydrolysis step, and determines residues of pyraclostrobin and its
metabolites as BF 500-5 and BF 500-8. The validated method LOQs for BF
500-5 type residues, in parent equivalents, are 0.01 ppm for milk and
0.05 ppm for tissues, and the validated LOQs for BF 500-8 type residues,
in parent equivalents, are 0.01 ppm for milk and 0.05 ppm for tissues.
Independent method validation data for the HPLC/UV and LC/MS/MS methods
are acceptable (D269668, 11/28/01, L. Cheng). Radiovalidation data
submitted for the GC/MS and LC/MS/MS methods are adequate for liver and
milk, and marginal for muscle. Method 446 has been forwarded to ACB/BEAD
for petition method validation. As poultry tolerances are not currently
necessary, an enforcement method for poultry commodities is not required
at the present time.

***Multiresidue Methodology (860.1360)***

Data pertaining to the multiresidue methods testing of pyraclostrobin
and its desmethoxy metabolite were reviewed (PP#0F6139, D269668,
11/28/01, L. Cheng). Pyraclostrobin was successfully evaluated through
several of the FDA protocols, while recovery of BF 500-3 was
unsuccessful in all protocols. Pyraclostrobin was completely recovered
through Protocol D (in grape) and E (in grape), and partially recovered
through Protocol F (in peanut). Metabolite BF 500-3 had poor peak shape
and inadequate sensitivity with Protocol C columns, and therefore, was
not further analyzed under Protocol D, E, and F. The results of the
multiresidue testing for pyraclostrobin were forwarded to FDA on 1/4/02
for the purpose of updating PAM, Volume I.

**5.1.4 Storage Stability Data**[]{#__RefHeading___Toc191365832 .anchor}

Adequate storage stability studies are available indicating that
pyraclostrobin and metabolite BF 500-3 are relatively stable at ≤-10ºC
in fortified samples of grape juice (juices), sugar beet tops (leafy
vegetables), sugar beet roots (root crop), tomato (fruit/fruiting
vegetable), wheat grain (non-oily grain) and wheat straw (dry feed) for
up to 25 months, and in fortified samples of peanut nutmeats (oilseed)
and peanut oil for up to 19 months (D269668, L. Cheng, 11/28/01).

*Conclusions*. There are adequate storage stability data from PP#0F6139
which may be translated in the current petitions to validate sample
storage conditions and durations. There are no corrections which need to
be applied as pyraclostrobin residues of concern were found to be
relatively stable over a wide range of commodities under frozen storage
conditions for 19-25 months.

**5.1.5 Magnitude of the Residue in
Plants**[]{#__RefHeading___Toc191365833 .anchor}

The field trials conducted on fresh herbs (basil, chives, and dill) and
avocados included a tank mixture of the pyraclostrobin test formulation
(BAS 500 02F) with another active ingredient, boscalid (formulated as
BAS 510 UCF). The field trials conducted on oats also reflect a tank
mixture with metconazole (formulated as BAS 555 01F). Only the residue
data from treatments with pyraclostrobin are reported in this risk
assessment.

[]{.mark}

**Field Trial Data Submitted Under PP#6F7105**

[Canola]{.underline} -DER Reference: 46925301.der.doc

[]{.mark}

BASF Corporation has submitted field trial data for pyraclostrobin on
canola. A summary of residue data from the canola field trials is
presented in Table 4. The residue decline data indicate that residues of
pyraclostrobin decrease at longer preharvest intervals.

<table>
<colgroup>
<col style="width: 14%" />
<col style="width: 12%" />
<col style="width: 7%" />
<col style="width: 5%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 11%" />
<col style="width: 9%" />
<col style="width: 9%" />
</colgroup>
<thead>
<tr class="header">
<th colspan="10"><strong>Table 4. Summary of Residue Data from Canola
Field Trials with Pyraclostrobin.</strong></th>
</tr>
<tr class="odd">
<th rowspan="2">Commodity</th>
<th rowspan="2"><p>Total Applic. Rate</p>
<p>(lb ai/A)</p></th>
<th rowspan="2">PHI (days)</th>
<th colspan="7">Combined Residue Levels of Pyraclostrobin and its
Metabolite BF 500-3 (ppm)</th>
</tr>
<tr class="header">
<th>n</th>
<th>Min.</th>
<th>Max.</th>
<th>HAFT</th>
<th><p>Median</p>
<p>(STMdR)</p></th>
<th><p>Mean</p>
<p>(STMR)</p></th>
<th>Std. Dev.</th>
</tr>
</thead>
<tbody>
<tr class="odd">
<td colspan="10">Proposed use pattern: Four foliar sprays at 0.10 lb
ai/A/application for a seasonal rate of 0.39 lb ai/A with a 21-day
PHI.</td>
</tr>
<tr class="even">
<td rowspan="2">Canola seed</td>
<td>0.39-0.41</td>
<td>20-22</td>
<td>32</td>
<td>&lt;0.04</td>
<td>0.27</td>
<td>0.25</td>
<td>0.05</td>
<td>0.08</td>
<td>0.06</td>
</tr>
<tr class="odd">
<td>0.20</td>
<td>21-22</td>
<td>10</td>
<td>&lt;0.04</td>
<td>0.11</td>
<td>0.10</td>
<td>0.04</td>
<td>0.06</td>
<td>0.03</td>
</tr>
</tbody>
</table>

*Conclusions*: The proposed use patterns of pyraclostrobin on canola and
flax include foliar and seed treatments. The residue data included in
the canola field study only reflect foliar use, and no seed treatment
data were submitted. Based on the seeding rate typically used for canola
(4-8 lb of seed per acre) and flax (28-84 lb of seed per acre), the
proposed maximum seed treatment rate of 0.04 lb ai/100 lb of seed per
acre would be equivalent to maximums of 0.012 lb ai/A for flax and
0.0032 lb ai/A for canola, which are negligible compared to the maximum
proposed seasonal rate of \~0.4 lb ai/A for foliar uses.

[]{.mark}

The submitted field trial data reflecting foliar uses for canola seed
are adequate. The number and locations of field trials are in accordance
with OPPTS Guideline 860.1500, and the conducted field trials reflect
the maximum proposed foliar use pattern.

[Oats]{.underline} - DER Reference: 46902226.der.doc

[]{.mark}

BASF Corporation has submitted field trial data for pyraclostrobin on
oats. A summary of residue data from the oat field trials is presented
in Table 5. The decline data show that pyraclostrobin residues remain
relatively constant in oat commodities with increasing preharvest
intervals.

[]{.mark}

<table>
<colgroup>
<col style="width: 14%" />
<col style="width: 12%" />
<col style="width: 7%" />
<col style="width: 5%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 11%" />
<col style="width: 9%" />
<col style="width: 9%" />
</colgroup>
<thead>
<tr class="header">
<th colspan="10"><strong>Table 5. Summary of Residue Data from Oat Field
Trials with Pyraclostrobin</strong></th>
</tr>
<tr class="odd">
<th rowspan="2">Commodity</th>
<th rowspan="2"><p>Total Applic. Rate</p>
<p>(lb ai/A)</p></th>
<th rowspan="2">PHI (days)</th>
<th colspan="7">Combined Residue Levels of Pyraclostrobin and its
Metabolite BF 500-3 (ppm)</th>
</tr>
<tr class="header">
<th>n</th>
<th>Min.</th>
<th>Max.</th>
<th>HAFT</th>
<th><p>Median</p>
<p>(STMdR)</p></th>
<th><p>Mean</p>
<p>(STMR)</p></th>
<th>Std. Dev.</th>
</tr>
</thead>
<tbody>
<tr class="odd">
<td colspan="10">Proposed use pattern: Two foliar sprays at 0.15 lb
ai/A/application for a seasonal rate of 0.3 lb ai/A. The proposed PHIs
are 14 days for hay and green chopped oats (forage). No PHIs are
proposed for grain and straw.</td>
</tr>
<tr class="even">
<td>Grain</td>
<td rowspan="2">0.29-0.31</td>
<td rowspan="2">20-26</td>
<td>24</td>
<td>0.10</td>
<td>0.75</td>
<td>0.64</td>
<td>0.35</td>
<td>0.33</td>
<td>0.18</td>
</tr>
<tr class="odd">
<td>Straw</td>
<td>24</td>
<td>1.33</td>
<td>14.90</td>
<td>13.40</td>
<td>3.92</td>
<td>4.70</td>
<td>3.07</td>
</tr>
<tr class="even">
<td>Hay</td>
<td>0.29-0.31</td>
<td>6-8</td>
<td>24</td>
<td>2.38</td>
<td>14.83</td>
<td>14.46</td>
<td>6.00</td>
<td>6.25</td>
<td>3.20</td>
</tr>
</tbody>
</table>

*Conclusions*: The proposed use patterns of pyraclostrobin on oats
include foliar and seed treatments. The supporting residue data included
in the current petition only reflect foliar use, and no seed treatment
data were submitted. Based on the seeding rate typically used for oats
(50-120 lb of seed per acre), the proposed seed treatment rate of
0.005-0.01 lb ai/100 lb of seed per acre would be equivalent to
0.005-0.012 lb ai/A which is negligible compared to the maximum proposed
seasonal rate of \~0.3 lb ai/A for foliar use.

The submitted field trial data reflecting foliar uses for oat grain,
straw, and hay are adequate to fulfill data requirements pending
submission of revised Sections B and F. Based on the available data, a
revised Section B is required to specify PHIs of 20-26 days for oat
grain and straw and 6-8 days for oat hay. A revised Section F is
required to amend the proposed tolerances as determined by the Agency's
tolerance spreadsheet.

Geographic representation of residue data for oat grain, straw, and hay
is not in full compliance with GLN 860.1500 requirements since only 12
trials were conducted; the guideline requires a total of 16 trials to
establish individual tolerances for oat commodities. However, the
petitioner has included Appendix J in the study report which documents
correspondence between EPA and BASF regarding the "Proposal to EPA and
PMRA for Reduction of the Number of Field Residue Sites Required to Set
a Fungicide Tolerance in Small Grains (Wheat, Barley, Oats, and Rye)".
Based on the total number of field trials conducted for small grains, it
was reported that the conducted trials for oats should be adequate to
set individual tolerances on wheat, barley, oats, and rye.

No residue data are submitted for oat forage. The petitioner did not
provide residue data or propose a tolerance for oat forage because
applications are made after the growth stages at which oat is foraged.
Based on the current proposed use patterns, the Agency will not require
residue data or a tolerance for oat forage.

The field trial data for oat grain, straw, and hay were entered into the
Agency's tolerance spreadsheet as specified by the *Guidance for Setting
Pesticide Tolerances Based on Field Trial Data* SOP to determine
appropriate tolerance levels. The tolerance spreadsheet recommends
tolerances of 1.2 ppm for oat grain, 15 ppm for oat straw, and 18 ppm
for hay. These recommended levels vary slightly from the petitioner's
tolerance proposals of 1.0 ppm for oat grain and 17 ppm each for oat hay
and straw.

**Field Trial Data Submitted Under PP#6E7165**

[]{.mark}

[Herbs subgroup 19A]{.underline}

[]{.mark}

[Basil]{.underline} - DER Reference: 47014803.der.doc

[]{.mark}

IR-4 has submitted field trial data for pyraclostrobin on basil. A
summary of residue data from the basil field trials is presented in
Table 6. The processing of fresh basil to dried basil resulted in an
increase of total residues, and the calculated processing factors of
total residues ranged 4.6-9.0x with an average factor of 6.5x.

<table>
<colgroup>
<col style="width: 13%" />
<col style="width: 12%" />
<col style="width: 7%" />
<col style="width: 5%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 11%" />
<col style="width: 9%" />
<col style="width: 11%" />
</colgroup>
<thead>
<tr class="header">
<th colspan="10"><strong>Table 6. Summary of Residue Data from Basil
Field Trials with Pyraclostrobin.</strong></th>
</tr>
<tr class="odd">
<th rowspan="2">Commodity</th>
<th rowspan="2"><p>Total Applic. Rate</p>
<p>(lb ai/A)</p></th>
<th rowspan="2">PHI (days)</th>
<th colspan="7">Combined Residue Levels of Pyraclostrobin and its
Metabolite BF 500-3 (ppm)</th>
</tr>
<tr class="header">
<th>n</th>
<th>Min.</th>
<th>Max.</th>
<th>HAFT</th>
<th><p>Median</p>
<p>(STMdR)</p></th>
<th><p>Mean</p>
<p>(STMR)</p></th>
<th>Std. Dev.</th>
</tr>
</thead>
<tbody>
<tr class="odd">
<td colspan="10">Proposed use pattern: Two foliar sprays at 0.15 lb
ai/A/application for a seasonal rate of 0.3 lb ai/A with a 0-day
PHI.</td>
</tr>
<tr class="even">
<td rowspan="2">Fresh basil</td>
<td rowspan="3">0.80-0.83</td>
<td>0</td>
<td>8</td>
<td>7.2</td>
<td>21.1</td>
<td>16.1</td>
<td>8.9</td>
<td>10.9</td>
<td>4.5</td>
</tr>
<tr class="odd">
<td>3-4</td>
<td>8</td>
<td>1.3</td>
<td>7.5</td>
<td>7.4</td>
<td>4.9</td>
<td>4.8</td>
<td>2.6</td>
</tr>
<tr class="even">
<td>Dried basil</td>
<td>0</td>
<td>4</td>
<td>40.1</td>
<td>80.6</td>
<td>80.6</td>
<td>74.7</td>
<td>67.5</td>
<td>18.5</td>
</tr>
</tbody>
</table>

[]{.mark}

[Chives]{.underline} - DER Reference: 47014802.der.doc

[]{.mark}

IR-4 has submitted field trial data for pyraclostrobin on chives. A
summary of residue data from the chive field trials is presented in
Table 7.

<table>
<colgroup>
<col style="width: 13%" />
<col style="width: 11%" />
<col style="width: 7%" />
<col style="width: 5%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 11%" />
<col style="width: 9%" />
<col style="width: 12%" />
</colgroup>
<thead>
<tr class="header">
<th colspan="10"><strong>Table 7. Summary of Residue Data from Chive
Field Trials with Pyraclostrobin.</strong></th>
</tr>
<tr class="odd">
<th rowspan="2">Commodity</th>
<th rowspan="2"><p>Total Applic. Rate</p>
<p>(lb ai/A)</p></th>
<th rowspan="2">PHI (days)</th>
<th colspan="7">Combined Residue Levels of Pyraclostrobin and its
Metabolite BF 500-3 (ppm)</th>
</tr>
<tr class="header">
<th>n</th>
<th>Min.</th>
<th>Max.</th>
<th>HAFT</th>
<th><p>Median</p>
<p>(STMdR)</p></th>
<th><p>Mean</p>
<p>(STMR)</p></th>
<th>Std. Dev.</th>
</tr>
</thead>
<tbody>
<tr class="odd">
<td colspan="10">Proposed use pattern: Two foliar sprays at 0.15 lb
ai/A/application for a seasonal rate of 0.3 lb ai/A with a 0-day
PHI.</td>
</tr>
<tr class="even">
<td>Chives</td>
<td>0.81-0.83</td>
<td>0</td>
<td>8</td>
<td>0.7</td>
<td>8.8</td>
<td>7.8</td>
<td>6.9</td>
<td>5.8</td>
<td>3.1</td>
</tr>
</tbody>
</table>

[Dill]{.underline} - DER Reference: 47014801.der.doc

[]{.mark}

IR-4 has submitted field trial data for pyraclostrobin on dill. A
summary of residue data from the dill field trials is presented in Table
8.

[]{.mark}

<table>
<colgroup>
<col style="width: 13%" />
<col style="width: 11%" />
<col style="width: 7%" />
<col style="width: 5%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 11%" />
<col style="width: 10%" />
<col style="width: 10%" />
</colgroup>
<thead>
<tr class="header">
<th colspan="10"><strong>Table 8. Summary of Residue Data from Dill
Field Trials with Pyraclostrobin.</strong></th>
</tr>
<tr class="odd">
<th rowspan="2">Commodity</th>
<th rowspan="2"><p>Total Applic. Rate</p>
<p>(lb ai/A)</p></th>
<th rowspan="2">PHI (days)</th>
<th colspan="7">Combined Residue Levels of Pyraclostrobin and its
Metabolite BF 500-3 (ppm)</th>
</tr>
<tr class="header">
<th>n</th>
<th>Min.</th>
<th>Max.</th>
<th>HAFT</th>
<th><p>Median</p>
<p>(STMdR)</p></th>
<th><p>Mean</p>
<p>(STMR)</p></th>
<th>Std. Dev.</th>
</tr>
</thead>
<tbody>
<tr class="odd">
<td colspan="10">Proposed use pattern: Two foliar sprays at 0.15 lb
ai/A/application for a seasonal rate of 0.3 lb ai/A with a 0-day
PHI.</td>
</tr>
<tr class="even">
<td>Fresh Dill</td>
<td>0.81-0.82</td>
<td>0</td>
<td>8</td>
<td>3.98</td>
<td>19.54</td>
<td>19.01</td>
<td>9.66</td>
<td>10.46</td>
<td>5.79</td>
</tr>
<tr class="odd">
<td>Dill Seed</td>
<td>0.80-0.83</td>
<td>0</td>
<td>6</td>
<td>3.60</td>
<td>22.60</td>
<td>21.20</td>
<td>18.30</td>
<td>14.45</td>
<td>8.34</td>
</tr>
</tbody>
</table>

*Conclusions*: The submitted residue data for basil (fresh and dried)
and chives, the representative commodities of Herbs subgroup 19A, along
with those data submitted for dill (fresh and seed) are adequate with
respect to geographic representation of data. However, the field trials
were conducted at an exaggerated total application rate of \~0.8 lb ai/A
(2.7x the maximum proposed seasonal rate of 0.3 lb ai/A). As a result,
these data are not indicative of the magnitude of the residue following
applications at the proposed use pattern.

The petitioner has submitted a product label for Pristine® Fungicide and
this supplemental label directions state, "Do not apply more than 37
oz/A per season", which equals 0.3 lb pyraclostrobin. HED, at times,
allows a revised Section B to reflect this different rate. However, the
proposed formulation contains two active ingredients, i.e.,
pyraclostrobin (12.8%) and boscalid (25.2%). A review of the boscalid
data (See memo of 11/27/2007, C. Olinger), shows that boscalid was
applied only twice but by using a different formulation, for a total of
0.59 lb a.i./A. This matches the proposed use rate for boscalid. If
applied at the proposed label rate for pyraclostrobin (2
applications/season, 0.3 lb ai/A/season), then boscalid would be applied
at the proposed rate (2 applications/season, 0.58 lb ai/A/season).
However, if this combined formulation is applied at the exaggerated rate
as representative of the submitted field trials, pyraclostrobin would be
applied at 0.8 lb/ai/A/season, while boscalid would be applied at 1.58
lb ai/A/season (2.7x). Although the recommended pyraclostrobin tolerance
would cover any pyraclostrobin residues at four (4) applications/season,
boscalid residues at this treatment rate would probably exceed the
recommended tolerance for boscalid. Thus, if it is the intent of the
petitioner to propose this combined formulation for herbs (subgroup
19A), then a simple label revision will not solve the problem. The data
only support two (2) applications of boscalid, and not four (4)
applications. The proposed label cannot be revised to match the
submitted pyraclostrobin residue field trial data.

Residue decline data were not submitted and are not required for the
purpose of this petition since GLN 860.1500 states that decline data
will typically not be required for each minor crop needing three or
fewer total trials to establish an individual tolerance.

The field trial data for all fresh herbs (basil, chives, and dill)
reflecting the [exaggerated rate]{.underline} were entered into the
Agency's tolerance spreadsheet as specified by the *Guidance for Setting
Pesticide Tolerances Based on Field Trial Data* SOP to determine an
appropriate tolerance level. The tolerance spreadsheet recommends a
tolerance of 25.0 ppm for Herbs subgroup 19A. This tolerance level is
slightly lower than the level (30.0 ppm) initially proposed by the
petitioner. Additional data from the basil and dill field trials suggest
that tolerances are needed for dried basil leaves at 85 ppm and dill
seed at 25 ppm. Based on the above discussion, this recommended
tolerance would be higher than needed when the proposed label directions
(2 applications/season) are followed.

[Avocado]{.underline} - DER Reference: 47014804.der.doc

IR-4 has submitted field trial data for pyraclostrobin on avocados. A
summary of residue data from the avocado field trials is presented in
Table 9.

<table>
<colgroup>
<col style="width: 13%" />
<col style="width: 11%" />
<col style="width: 7%" />
<col style="width: 5%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 11%" />
<col style="width: 9%" />
<col style="width: 11%" />
</colgroup>
<thead>
<tr class="header">
<th colspan="10"><strong>Table 9. Summary of Residue Data from Avocado
Field Trials with Pyraclostrobin.</strong></th>
</tr>
<tr class="odd">
<th rowspan="2">Commodity</th>
<th rowspan="2"><p>Total Applic. Rate</p>
<p>(lb ai/A)</p></th>
<th rowspan="2">PHI (days)</th>
<th colspan="7">Combined Residue Levels of Pyraclostrobin and its
Metabolite BF 500-3 (ppm)</th>
</tr>
<tr class="header">
<th>n</th>
<th>Min.</th>
<th>Max.</th>
<th>HAFT</th>
<th><p>Median</p>
<p>(STMdR)</p></th>
<th><p>Mean</p>
<p>(STMR)</p></th>
<th>Std. Dev.</th>
</tr>
</thead>
<tbody>
<tr class="odd">
<td colspan="10">Proposed use pattern: Two foliar sprays at 0.15 lb
ai/A/application for a seasonal rate of 0.3 lb ai/A with a 0-day
PHI.</td>
</tr>
<tr class="even">
<td>Avocado</td>
<td>0.73-0.78</td>
<td>0</td>
<td>14</td>
<td>0.08</td>
<td>0.48</td>
<td>0.40</td>
<td>0.16</td>
<td>0.18</td>
<td>0.11</td>
</tr>
</tbody>
</table>

*Conclusions*: The submitted residue data for avocado are inadequate to
fulfill data requirements because the field trials were conducted at
exaggerated rates. Not only were the individual application rates higher
than the label maximum, but two additional applications beyond what is
specified on the label were applied, resulting in a seasonal application
rates \~2.5 -- 2.7x the maximum proposed seasonal label rate. While the
submitted data represent an overestimate of the residues expected from
the proposed use, the degree of exaggeration can not be determined. The
use of the proportionality concept (See CHEMSAC, minutes, 05/09/2007) to
adjust residues downward is not considered appropriate since the data
included more applications than the desired use. Given that the proposed
use is for late season foliar application, and includes a 0-day
preharvest interval, for the purpose of this IR-4 petition, HED will use
the submitted data to support a tolerance for avocado. However, since
HED considers that the tolerance may need to be reduced, and further
since this data is being translated to support a wide number of
tropical/subtropical fruits, HED requests that the petitioner provide an
additional two to three field trials at the label rate (2 applications,
total 0.3 lb ai/season) as a condition of registration.

The field trial data for avocado reflecting the exaggerated rate were
entered into the Agency's tolerance spreadsheet as specified by the
*Guidance for Setting Pesticide Tolerances Based on Field Trial Data*
SOP to determine an appropriate tolerance level. The tolerance
spreadsheet recommends a tolerance of 0.6 ppm for avocado which is
slightly lower than the level (0.7 ppm) initially proposed by the
petitioner.

The submitted data for avocado may be translated to other tropical
fruits for which uses are proposed pending label revision as specified
above. HED is in the process of revising the Commodity Definitions
listed under 40 CFR §180.1(h) to make the tropical/subtropical fruit
avocado a general commodity; see 6/14/06 memo by B. Schneider entitled
"Reviewer's Guide and Summary of HED ChemSAC Approvals for Amending Crop
Groups/Subgroups \[40 CFR §180.41\] and Commodity Definitions \[40 CFR
§180.1(h)\]". The specific commodities included in the general
definition for avocado include black sapote, canistel, mamey sapote,
mango, papaya, sapodilla, and star apple. Until the regulations have
been finalized in the Federal Register, separate tolerances are needed
for each specific commodity, at the same level as the respective general
commodity tolerance. Therefore, the petitioner is required to submit a
revised Section F to propose a tolerance of 0.6 ppm for each of the
following commodities: avocado, black sapote, canistel, mamey sapote,
mango, papaya, sapodilla, and star apple.

**Field Trial Data Submitted Under PP#7E7245**

[Barley]{.underline} - DER Reference List 47190501.der.doc

IR-4 has submitted field trial data for pyraclostrobin on barley. A
summary of residue data from the barley field trials is presented in
Table 10.

[]{.mark}

<table>
<colgroup>
<col style="width: 13%" />
<col style="width: 11%" />
<col style="width: 7%" />
<col style="width: 5%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 10%" />
<col style="width: 10%" />
<col style="width: 13%" />
</colgroup>
<thead>
<tr class="header">
<th colspan="10"><strong>Table 10. Summary of Residue Data from Barley
Field Trials with Pyraclostrobin</strong></th>
</tr>
<tr class="odd">
<th rowspan="2">Commodity</th>
<th rowspan="2"><p>Total Applic. Rate</p>
<p>(lb ai/A)</p></th>
<th rowspan="2">PHI (days)</th>
<th colspan="7">Combined Residue Levels of Pyraclostrobin and its
Metabolite BF 500-3 (ppm)</th>
</tr>
<tr class="header">
<th>n</th>
<th>Min.</th>
<th>Max.</th>
<th>HAFT</th>
<th><p>Median</p>
<p>(STMdR)</p></th>
<th><p>Mean</p>
<p>(STMR)</p></th>
<th>Std. Dev.</th>
</tr>
</thead>
<tbody>
<tr class="odd">
<td colspan="10">Proposed use pattern: Two foliar sprays at 0.15 lb
ai/A/application for a seasonal rate of 0.3 lb ai/A with a 14-day
PHI.</td>
</tr>
<tr class="even">
<td>Grain</td>
<td rowspan="2">0.29-0.30</td>
<td rowspan="2">14-15</td>
<td>8</td>
<td>0.54</td>
<td>0.98</td>
<td>0.93</td>
<td>0.85</td>
<td>0.80</td>
<td>0.16</td>
</tr>
<tr class="odd">
<td>Straw</td>
<td>8</td>
<td>1.7</td>
<td>4.0</td>
<td>3.8</td>
<td>2.8</td>
<td>2.7</td>
<td>0.79</td>
</tr>
<tr class="even">
<td>Grain</td>
<td rowspan="2">0.29-0.30</td>
<td rowspan="2">21-23</td>
<td>8</td>
<td>0.11</td>
<td>0.49</td>
<td>0.45</td>
<td>0.39</td>
<td>0.34</td>
<td>0.14</td>
</tr>
<tr class="odd">
<td>Straw</td>
<td>8</td>
<td>0.65</td>
<td>2.2</td>
<td>1.8</td>
<td>1.4</td>
<td>1.3</td>
<td>0.50</td>
</tr>
</tbody>
</table>

*Conclusions*: The submitted field trial data for barley grain and straw
are adequate to fulfill data requirements pending submission of a
revised Section F to amend the proposed tolerances as determined by the
Agency's tolerance spreadsheet.

Geographic representation of residue data for barley grain and straw are
adequate. No residue data were submitted for barley forage, and these
data are normally required to support the amended use pattern. However,
the petitioner did not provide residue data or propose a tolerance for
barley hay because applications are made after the growth stages at
which barley hay is harvested. Based on the current proposed use
patterns, the Agency will not require residue data or a tolerance for
barley hay.

The field trial data for barley grain and straw were entered into the
Agency's tolerance spreadsheet as specified by the *Guidance for Setting
Pesticide Tolerances Based on Field Trial Data* SOP to determine
appropriate tolerance levels. The tolerance spreadsheet recommends
tolerances of 1.4 ppm for barley grain and 6.0 ppm for barley straw.
These recommended levels vary slightly from the petitioner's tolerance
proposals of 1.3 ppm for barley grain and 9.0 ppm for barley straw.

**Amended Registration Request for At Planting Use on Corn, Soybean &
Sugar Beet**

BASF Corporation submitted a supplemental label to add an in-furrow
spray application at planting for corn, soybean and sugar beet onto the
Headline^®^ label (EPA Reg. No. 7969-186) at 0.2 lb ai/acre and a
maximum seasonal of 0.29 lb ai/acre. Currently, Headline® is registered
for foliar use on corn, soybean and sugar beet. No residue data
reflecting in-furrow at planting applications were submitted. However,
based on the confined accumulation studies in rotational crops and field
rotational crop studies, HED determined (DP Barcode 340585, L. Cheng,
9/13/07) that the established tolerances in/on corn, soybean and sugar
beet commodities will be adequate to cover the proposed supplemental use
pattern and no new residue data are needed.

**5.1.6 Magnitude of the Residue in Processed
Food/Feed**[]{#__RefHeading___Toc191365834 .anchor}

[Basil]{.underline} - Residue data on dried basil leaves are included
and summarized in the Magnitude of the Residue section for fresh basil.

[Barley]{.underline} - No residue data for the barley processed
commodities (bran and pearled) are submitted. However, data from the
wheat processing studies (MRID #'s 45118620 and 45321101) can be
translated to adequately support the proposed use on barley. Based on
the wheat studies, residues are not expected to concentrate in barley
processed commodities.

[Canola]{.underline} - DER Reference: 46925301.de1.doc

BASF Corporation has Number range CHAPTERNumber range CHAPTERsubmitted a
processing study with pyraclostrobin on canola. A summary of residue
data from the canola processing study is presented in Table 11. The
results indicate that the combined residues of pyraclostrobin and its
metabolite BF 500-3 averaged 0.05 ppm in/on canola seed treated at a
total rate of 1.2 lb ai/A. Following processing, combined residues were
\<0.04 ppm in meal and 0.06 ppm in refined oil. The equivalent
processing factors from these data are 0.8x for meal and 1.2x for
refined oil. The maximum theoretical concentration factors for canola
processed commodities, based on separation into components, are 1.9x for
meal and 3.0x for oil (OPPTS GLN 860.1520, Table 3).

+------+----------+------+-----+----------+--------+-------+--------+
| **T  |          |      |     |          |        |       |        |
| able |          |      |     |          |        |       |        |
| 11.  |          |      |     |          |        |       |        |
| Res  |          |      |     |          |        |       |        |
| idue |          |      |     |          |        |       |        |
| Data |          |      |     |          |        |       |        |
| from |          |      |     |          |        |       |        |
| Ca   |          |      |     |          |        |       |        |
| nola |          |      |     |          |        |       |        |
| Pr   |          |      |     |          |        |       |        |
| oces |          |      |     |          |        |       |        |
| sing |          |      |     |          |        |       |        |
| S    |          |      |     |          |        |       |        |
| tudy |          |      |     |          |        |       |        |
| with |          |      |     |          |        |       |        |
| P    |          |      |     |          |        |       |        |
| yrac |          |      |     |          |        |       |        |
| lost |          |      |     |          |        |       |        |
| robi |          |      |     |          |        |       |        |
| n.** |          |      |     |          |        |       |        |
+======+==========+======+=====+==========+========+=======+========+
| RAC  | P        | T    | PHI | Combined |        |       | Proc   |
|      | rocessed | otal |     | Residues |        |       | essing |
|      | C        | Rate | (da | of       |        |       |        |
|      | ommodity |      | ys) | Pyracl   |        |       | Factor |
|      |          | (lb  |     | ostrobin |        |       |        |
|      |          | a    |     | and its  |        |       |        |
|      |          | i/A) |     | BF 500-3 |        |       |        |
|      |          |      |     | Me       |        |       |        |
|      |          |      |     | tabolite |        |       |        |
|      |          |      |     | (ppm)    |        |       |        |
+------+----------+------+-----+----------+--------+-------+--------+
|      |          |      |     | Pyracl   | BF     | Com   |        |
|      |          |      |     | ostrobin | -500-3 | bined |        |
+------+----------+------+-----+----------+--------+-------+--------+
| Ca   | Seed     | 1.2  | 21  | 0.02,    | \      | \<    | \--    |
| nola |          |      |     | 0.03     | <0.02, | 0.04, |        |
| seed |          |      |     |          | \<0.02 | 0.05  |        |
+------+----------+------+-----+----------+--------+-------+--------+
|      | Meal     |      |     | \<0.02,  | \      | \<    | 0.8x   |
|      |          |      |     | 0.03     | <0.02, | 0.04, |        |
|      |          |      |     |          | \<0.02 | \     |        |
|      |          |      |     |          |        | <0.04 |        |
+------+----------+------+-----+----------+--------+-------+--------+
|      | Refined  |      |     | 0.04,    | 0.02,  | 0.05, | 1.2x   |
|      | oil      |      |     | 0.04     | 0.03   | 0.07  |        |
+------+----------+------+-----+----------+--------+-------+--------+

*Conclusions*: The canola processing study is acceptable to satisfy data
requirements. The treated samples of canola seed (RAC) used for
processing bore average combined residues of 0.05 ppm. Following
processing of the RAC, total residues concentrated marginally in refined
oil (1.2x) but reduced in meal (0.8x). The maximum expected combined
residues in refined oil, resulting from the proposed use, is 0.3 ppm.
This value was calculated by multiplying the processing factor of 1.2x
by the HAFT residue of 0.25 ppm (see Table 4). The maximum expected
residue in refined oil is identical to the recommended tolerance for the
RAC (canola seed). Based on this determination, tolerances need not be
established for the processed commodities of canola.

[Oat]{.underline} - No residue data for the oat processed commodities
(flour and groats/rolled oats) are submitted. However, data from the
wheat processing studies (MRID #'s 45118620 and 45321101) can be
translated to adequately support the proposed use on oat. Based on the
wheat studies, residues are not expected to concentrate in oat processed
commodities.

**5.1.7 Magnitude of the Residue in Meat, Milk, Poultry, and
Eggs**[]{#__RefHeading___Toc191365835 .anchor}

[Livestock dietary burdens]{.underline}

The potential for secondary transfer of pyraclostrobin residues of
concern in meat, milk, poultry, and eggs exists because there are
several livestock feedstuffs (canola meal, oat grain, oat forage, oat
straw, and oat hay) that are associated with the proposed uses in the
current petitions. The livestock dietary burdens of pyraclostrobin are
presented in Table 12, and reflect the most recent guidance from HED
concerning revisions of feedstuff percentages in Table 1 Feedstuffs
(October 2006) and constructing reasonably balanced livestock diets
(RBDs). The calculated dietary burdens of pyraclostrobin are 4.7 for
beef cattle, 11.9 ppm for dairy cattle, 1.0 ppm for poultry, and 0.2 ppm
for swine.

<table style="width:100%;">
<colgroup>
<col style="width: 21%" />
<col style="width: 6%" />
<col style="width: 0%" />
<col style="width: 9%" />
<col style="width: 8%" />
<col style="width: 5%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 6%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="13"><strong>Table 12. Livestock Dietary Burdens for
Pyraclostrobin<sup>a</sup>.</strong></td>
</tr>
<tr class="even">
<td colspan="5"></td>
<td colspan="4"><strong>% Diet <sup>b</sup></strong></td>
<td colspan="4"><strong>Residue (ppm)</strong></td>
</tr>
<tr class="odd">
<td><strong>Feedstuff</strong></td>
<td><strong>Type</strong></td>
<td colspan="2"><p><strong>Tolerance,</strong></p>
<p><strong>ppm</strong></p></td>
<td><strong>% Dry Matter</strong></td>
<td><strong>Beef</strong></td>
<td><strong>Dairy</strong></td>
<td><strong>Poultry</strong></td>
<td><strong>Swine</strong></td>
<td><strong>Beef</strong></td>
<td><strong>Diary</strong></td>
<td><strong>Poultry</strong></td>
<td><strong>Swine</strong></td>
</tr>
<tr class="even">
<td colspan="13"></td>
</tr>
<tr class="odd">
<td><strong>almond hulls</strong></td>
<td colspan="2">R</td>
<td>1.6</td>
<td>90</td>
<td>-</td>
<td>5</td>
<td>-</td>
<td>-</td>
<td>-</td>
<td>0.89</td>
<td>-</td>
<td>-</td>
</tr>
<tr class="even">
<td><strong>barley, hay (oat, hay)</strong></td>
<td colspan="2">R</td>
<td>25 (18)</td>
<td>88</td>
<td>10</td>
<td>5</td>
<td>-</td>
<td>-</td>
<td>2.8</td>
<td>2.8 (1.0)</td>
<td>-</td>
<td>-</td>
</tr>
<tr class="odd">
<td><strong>corn, field, forage (silage)</strong></td>
<td colspan="2">R</td>
<td>5.0</td>
<td>40</td>
<td>-</td>
<td>30</td>
<td>-</td>
<td>-</td>
<td>-</td>
<td>3.8</td>
<td>-</td>
<td>-</td>
</tr>
<tr class="even">
<td><strong>cotton gin byproducts</strong></td>
<td colspan="2">R</td>
<td>30.</td>
<td>90</td>
<td>5</td>
<td>-</td>
<td>-</td>
<td>-</td>
<td>1.7</td>
<td>-</td>
<td>-</td>
<td>-</td>
</tr>
<tr class="odd">
<td><strong>legume, hay (cowpea)</strong></td>
<td colspan="2">R</td>
<td>25</td>
<td>30</td>
<td>-</td>
<td>5</td>
<td>-</td>
<td>-</td>
<td>-</td>
<td>4.2</td>
<td>-</td>
<td>-</td>
</tr>
<tr class="even">
<td colspan="13"></td>
</tr>
<tr class="odd">
<td><strong>barley, grain</strong></td>
<td>CC</td>
<td colspan="2">0.4</td>
<td>88</td>
<td>20</td>
<td>20</td>
<td>10</td>
<td>20</td>
<td>0.09</td>
<td>0.09</td>
<td>0.08</td>
<td>0.08</td>
</tr>
<tr class="even">
<td><strong>corn, field, grain</strong></td>
<td>CC</td>
<td colspan="2">0.1</td>
<td>88</td>
<td>50</td>
<td>20</td>
<td>-</td>
<td>65</td>
<td>0.057</td>
<td>0.023</td>
<td></td>
<td>0.065</td>
</tr>
<tr class="odd">
<td><strong>oat, grain</strong></td>
<td>CC</td>
<td colspan="2">1.2</td>
<td>88</td>
<td>-</td>
<td>-</td>
<td>70</td>
<td>-</td>
<td>-</td>
<td>-</td>
<td>0.84</td>
<td>-</td>
</tr>
<tr class="even">
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td><strong>cotton, undelinted seed</strong></td>
<td>PC</td>
<td colspan="2">0.3</td>
<td>85</td>
<td>-</td>
<td>15</td>
<td>-</td>
<td>-</td>
<td>-</td>
<td>0.049</td>
<td>-</td>
<td>-</td>
</tr>
<tr class="even">
<td><strong>sunflower/canola (meal)</strong></td>
<td>PC</td>
<td colspan="2">0.3</td>
<td>92</td>
<td>15</td>
<td>-</td>
<td>20</td>
<td>15</td>
<td>0.049</td>
<td>-</td>
<td>0.06</td>
<td>0.045</td>
</tr>
<tr class="odd">
<td colspan="13"></td>
</tr>
<tr class="even">
<td><strong>Totals</strong></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td>100</td>
<td>100</td>
<td>100</td>
<td>100</td>
<td><strong>4.7</strong></td>
<td><strong>11.9 (10.1)</strong></td>
<td><strong>1.0</strong></td>
<td><strong>0.2</strong></td>
</tr>
</tbody>
</table>

**^a^** All data are based on Table 1 Feedstuffs (October 2006), a
revision of feedstuffs data found in Table 1 (180.1000 OPPTS Test
Guidelines). Residue levels for beef and dairy are corrected for
moisture content and are determined by formula: tolerance / %DM x % in
diet. Residue levels for poultry and swine are considered "as-is" and
are determined by formula: tolerance x % in diet. R: roughage; CC:
carbohydrate concentrate; PC: protein concentrate.

**^b^** Typical compositions of daily rations for the animals of choice
for Table 1 data follow:

Feedlot beef have a daily ration of 15-40 % R, 45-80 % CC, and 10-15 %
PC. As the slaughter time (last 3 months) gets closer, then the beef
cattle are fed higher amounts of CC (up to 80 %), and lower amounts of R
(15-20 %) and PC (5-10 %). The average life span for feedlot beef is
16-18 months Most of feedlot beef are slaughtered in 4 major centers
located in the Midwest and the processed meat is "boxed" and shipped to
distributors for sale to local grocers. Commercial ground beef (75-93 %
lean) is produced from the combination of feedlot beef (60-70 % lean)
and other lean meat sources, i.e., beef cows and bulls from cow-calf
operations, imported lean meat trimmings, and replacement non-lactating
dairy cows.

High volume milk-producing lactating dairy cows have a daily ration of
45 % R, 40-45 % CC, and 10-15 % PC. Dairy cows usually produce 2-3
calves before slaughter. The average life span of the lactating dairy
cow is 3-4 years. Upon slaughter, much of the meat is used in ground
beef and processed foods e.g., deli meats, soups, frozen
dinners/entrees.

A laying hen that will give a steady egg production is fed 75-80 % CC
and 20-25 % PC. The life span can be up to 18 months. In general, laying
hens are not processed and marketed as whole or cut-up chickens. Much of
the layer meat is used in processed food products, e.g., deli meats,
soups, canned chicken, etc. (Note: The laying hen is the animal of
choice. Frying and rotisserie chickens come from the broiler, a fast
food chicken, weighing 3.5-4.0 lb.), and an animal that is raised in a
very short time. The average life span is 38-42 days. The broiler diet
contains 85-90 % CC and 10-15 % PC.

A marketable hog diet that will give steady growth would have 80-85 % CC
and 15-20 % PC. Most of the US hog production is confined to "mega"
operations. Animals are born in in-house nurseries, and simply moved to
connecting buildings as the animal grows until slaughter (250 lb
finished animal in 6 months). These animals provide meat for the "fresh
pork" market.

[Note]{.underline}: These guidelines [are not]{.underline} to be used
for pesticide residues that bioaccumulate. Contact Health Effects
Division, OPP, EPA for these types of pesticides.

[Animal feeding studies]{.underline}

Residue Chemistry Memo, DP# 269668, 11/28/01, L. Cheng (PP#0F6139)

Adequate feeding studies were reviewed in PP#0F6139. The current
pyraclostrobin tolerances for livestock commodities were established
based on results from these studies and the Agency's estimated dietary
burdens for pyraclostrobin residues, which were originally calculated to
be 36.3 ppm for beef cattle, 35.4 ppm for dairy cattle, and 0.35 ppm for
poultry.

In the ruminant feeding study, dairy cows were dosed orally for 28 days
with pyraclostrobin at levels equivalent to 8.8 ppm (0.7x the
recalculated dietary burden), 27.2 ppm (2.3x), and 89.6 ppm (7.5x) in
their diet. The study results from the 27.2 ppm-dose level were
reproduced from the initial petition review and are presented in below
Table 13.

Number range CHAPTER

+------+---------------+---------------+---------------+---------------+
| **T  |               |               |               |               |
| able |               |               |               |               |
| 13.  |               |               |               |               |
| Resi |               |               |               |               |
| dues |               |               |               |               |
| of   |               |               |               |               |
| py   |               |               |               |               |
| racl |               |               |               |               |
| ostr |               |               |               |               |
| obin |               |               |               |               |
| and  |               |               |               |               |
| its  |               |               |               |               |
| met  |               |               |               |               |
| abol |               |               |               |               |
| ites |               |               |               |               |
| hydr |               |               |               |               |
| olyz |               |               |               |               |
| able |               |               |               |               |
| to   |               |               |               |               |
| BF   |               |               |               |               |
| 5    |               |               |               |               |
| 00-5 |               |               |               |               |
| and  |               |               |               |               |
| BF   |               |               |               |               |
| 5    |               |               |               |               |
| 00-8 |               |               |               |               |
| in   |               |               |               |               |
| milk |               |               |               |               |
| and  |               |               |               |               |
| tis  |               |               |               |               |
| sues |               |               |               |               |
| from |               |               |               |               |
| cows |               |               |               |               |
| d    |               |               |               |               |
| osed |               |               |               |               |
| t    |               |               |               |               |
| wice |               |               |               |               |
| d    |               |               |               |               |
| aily |               |               |               |               |
| with |               |               |               |               |
| py   |               |               |               |               |
| racl |               |               |               |               |
| ostr |               |               |               |               |
| obin |               |               |               |               |
| at   |               |               |               |               |
| le   |               |               |               |               |
| vels |               |               |               |               |
| eq   |               |               |               |               |
| uiva |               |               |               |               |
| lent |               |               |               |               |
| to   |               |               |               |               |
| 27.2 |               |               |               |               |
| ppm  |               |               |               |               |
| for  |               |               |               |               |
| 28   |               |               |               |               |
| con  |               |               |               |               |
| secu |               |               |               |               |
| tive |               |               |               |               |
| day  |               |               |               |               |
| s.** |               |               |               |               |
+======+===============+===============+===============+===============+
| Do   | Mid Dose      |               |               |               |
| sing | (27.2 ppm)    |               |               |               |
| or   |               |               |               |               |
|      |               |               |               |               |
| Samp |               |               |               |               |
| ling |               |               |               |               |
| Day  |               |               |               |               |
+------+---------------+---------------+---------------+---------------+
|      | HPLC/UV       | GC/MS (milk)  |               |               |
|      | Method 439    | Method 446/0  |               |               |
|      |               | or LC/MS/MS   |               |               |
|      |               | (tissues)     |               |               |
|      |               | Method 446/1  |               |               |
+------+---------------+---------------+---------------+---------------+
|      | P             | Residues      | Residues      | Total         |
|      | yraclostrobin | hydrolyzable  | hydrolyzable  | residues, ppm |
|      | *per se*      | to BF 500-5,  | to BF 500-8,  | p             |
|      | (ppm)         | ppm           | ppm           | yraclostrobin |
|      |               | p             | p             | equivalents   |
|      |               | yraclostrobin | yraclostrobin | ^3^           |
|      |               | equivalents   | equivalents   |               |
|      |               | ^1^           | ^2^           |               |
+------+---------------+---------------+---------------+---------------+
| **W  |               |               |               |               |
| hole |               |               |               |               |
| Mi   |               |               |               |               |
| lk** |               |               |               |               |
+------+---------------+---------------+---------------+---------------+
| 1    | \<0.01,       | \<0.01,       | \<0.01,       | \<0.02,       |
|      | \<0.01,       | \<0.01,       | \<0.01,       | \<0.02,       |
|      | \<0.01        | \<0.01        | \<0.01        | \<0.02        |
+------+---------------+---------------+---------------+---------------+
| 4    | \--           | \<0.01,       | \<0.01,       | \<0.02,       |
|      |               | \<0.01,       | \<0.01,       | \<0.02,       |
|      |               | \<0.01        | \<0.01        | \<0.02        |
+------+---------------+---------------+---------------+---------------+
| 7    | \--           | \<0.01,       | \<0.01,       | \<0.02,       |
|      |               | \<0.01,       | \<0.01,       | \<0.02,       |
|      |               | \<0.01        | 0.0124        | \<0.0224      |
+------+---------------+---------------+---------------+---------------+
| 10   | \--           | \<0.01,       | \<0.01,       | \<0.02,       |
|      |               | \<0.01,       | \<0.01, 0.011 | \<0.02,       |
|      |               | \<0.01        |               | \<0.021       |
+------+---------------+---------------+---------------+---------------+
| 12   | \<0.01,       | \<0.01,       | \<0.01,       | \<0.02,       |
|      | \<0.01,       | \<0.01,       | \<0.01,       | \<0.02,       |
|      | \<0.01        | \<0.01        | 0.0119        | \<0.0219      |
+------+---------------+---------------+---------------+---------------+
| 15   | \--           | \<0.01,       | \<0.01,       | \<0.02,       |
|      |               | \<0.01,       | 0.0126,       | \<0.0226,     |
|      |               | \<0.01        | 0.0135        | \<0.0235      |
+------+---------------+---------------+---------------+---------------+
| 18   | \--           | \<0.01,       | \<0.01,       | \<0.02,       |
|      |               | \<0.01,       | 0.0104,       | \<0.0204,     |
|      |               | \<0.01        | 0.0130        | \<0.0230      |
+------+---------------+---------------+---------------+---------------+
| 21   | \--           | \<0.01,       | \<0.01,       | \<0.02,       |
|      |               | \<0.01,       | \<0.01,       | \<0.02,       |
|      |               | \<0.01        | \<0.01        | \<0.02        |
+------+---------------+---------------+---------------+---------------+
| 24   | \--           | \<0.01,       | \<0.01,       | \<0.02,       |
|      |               | \<0.01,       | \<0.01,       | \<0.02,       |
|      |               | \<0.01        | \<0.01        | \<0.02        |
+------+---------------+---------------+---------------+---------------+
| 27   | \<0.01,       | \<0.01,       | \<0.01,       | \<0.02,       |
|      | \<0.01,       | \<0.01,       | \<0.01,       | \<0.02,       |
|      | \<0.01        | \<0.01        | 0.0108        | \<0.0208      |
+------+---------------+---------------+---------------+---------------+
| **   |               |               |               |               |
| Skim |               |               |               |               |
| Mi   |               |               |               |               |
| lk** |               |               |               |               |
+------+---------------+---------------+---------------+---------------+
| 26   | \<0.01,       | \<0.01,       | \<0.01,       | \<0.02,       |
|      | \<0.01,       | \<0.01,       | \<0.01,       | \<0.02,       |
|      | \<0.01        | \<0.01        | \<0.01        | \<0.02        |
+------+---------------+---------------+---------------+---------------+
| **   |               |               |               |               |
| Milk |               |               |               |               |
| F    |               |               |               |               |
| at** |               |               |               |               |
+------+---------------+---------------+---------------+---------------+
| 26   | \<0.01,       | \<0.01,       | \<0.01,       | \<0.02,       |
|      | \<0.01,       | \<0.01,       | 0.0368,       | \<0.0468,     |
|      | \<0.01        | \<0.01        | 0.0461        | \<0.0561      |
+------+---------------+---------------+---------------+---------------+
| **F  |               |               |               |               |
| at** |               |               |               |               |
+------+---------------+---------------+---------------+---------------+
| 29   | \<0.05,       | \<0.05,       | \<0.05,       | \<0.1, \<0.1, |
|      | \<0.05,       | \<0.05,       | \<0.05,       | \<0.1         |
|      | \<0.05        | \<0.05        | \<0.05        |               |
+------+---------------+---------------+---------------+---------------+
| **   |               |               |               |               |
| Kidn |               |               |               |               |
| ey** |               |               |               |               |
+------+---------------+---------------+---------------+---------------+
| 29   | \<0.05,       | \<0.05,       | \<0.05,       | \<0.1, \<0.1, |
|      | \<0.05,       | \<0.05,       | \<0.05,       | \<0.1         |
|      | \<0.05        | \<0.05        | \<0.05        |               |
+------+---------------+---------------+---------------+---------------+
| *    |               |               |               |               |
| *Liv |               |               |               |               |
| er** |               |               |               |               |
+------+---------------+---------------+---------------+---------------+
| 29   | \<0.05,       | 0.0645,       | 0.399, 0.426, | 0.464, 0.502, |
|      | \<0.05,       | 0.0761,       | 0.510         | 0.607         |
|      | \<0.05        | 0.0973        |               |               |
+------+---------------+---------------+---------------+---------------+
| **   |               |               |               |               |
| Musc |               |               |               |               |
| le** |               |               |               |               |
+------+---------------+---------------+---------------+---------------+
| 29   | \<0.05,       | \<0.05,       | \<0.05,       | \<0.1, \<0.1, |
|      | \<0.05,       | \<0.05,       | \<0.05,       | \<0.1         |
|      | \<0.05        | \<0.05        | \<0.05        |               |
+------+---------------+---------------+---------------+---------------+

^1^ Pyraclostrobin and its metabolites hydrolyzable to BF 500-5 were
determined in milk using the GC/MS method and in tissues using the
LC/MS/MS method.

^2^ Metabolites hydrolyzable to BF 500-8 were determined in milk using
the GC/MS method and in tissues using the LC/MS/MS method.

^3^ Total BF 500-5 and BF 500-8 residues, expressed as pyraclostrobin
equivalents.

In the poultry feeding study, lNumber range CHAPTERaying hens were
orally dosed once daily for 30 consecutive days with pyraclostrobin at
dose levels equivalent to 0.28 ppm (0.3x), 0.88 ppm (1.1x), and 3.01 ppm
(3.0x). At the highest feeding level of 3.01 ppm, residues of
pyraclostrobin and its metabolites hydrolyzable to BF 500-5 were less
than the method LOQ (0.05 ppm) in all egg and tissue samples, except for
one egg sample (Day 17) where residues of pyraclostrobin were detected
at 0.064 ppm and \<0.05 ppm upon re-analysis. Residue analysis of BF
500-8 was not conducted (the metabolism data show all metabolites
hydrolyzable to BF 500-8 would be less than 10% TRR), but instead an
isomeric compound (BF 500-9) was measured. Levels of BF 500-9 also were
all \<0.05 ppm.

*Conclusions*: Based on these dietary exposure levels and the residue
data from the ruminant feeding study, the existing pyraclostrobin
tolerances for milk (0.1 ppm), meat (0.1 ppm), fat (0.1 ppm), meat
byproducts except liver (0.2 ppm), and liver (1.5 ppm) of cattle, goats,
hogs, horses, and sheep are adequate to support the proposed uses.
Tolerances for eggs and poultry are not needed based on data from the
poultry feeding and metabolism studies \[Category 180.6(a)(3)\]. If in
the future, if a petitioner proposes a use which increases the dietary
burdens of poultry, then the Category 3 situation will be re-evaluated.

**5.1.8 Confined and Field Rotational Accumulation in Rotational
Crops**[]{#__RefHeading___Toc191365836 .anchor}

An adequate confined rotational crop study is available on
pyraclostrobin (PP#0F6139, D269668, L. Cheng, 11/28/01; D314519, L.
Cheng, 05/05/05). The confined study indicates that the metabolism of
pyraclostrobin in rotated crops is similar but more extensive than that
in primary crops. Pyraclostrobin undergoes demethoxylation to yield BF
500-3, followed by further degradation to medium polar and polar
metabolites, and subsequent conjugation reactions and incorporation into
natural products. The MARC (D278044, L. Cheng, 10/09/01) concluded that
the residues of concern in rotational crops consist of pyraclostrobin
and metabolite BF 500-3.

An adequate limited field rotational crop study is available (PP#0F6139,
D269668, L. Cheng, 11/28/01) reflecting six broadcast foliar
applications of pyraclostrobin (EC) to cucumber at 0.19-0.20 lb
ai/A/application and RTIs of 6-8 days, for a total of 1.2 lb
ai/A/season. This rate is 1x the maximum use rate of any rotated crop.
Average residues of pyraclostrobin and BF 500-3 were each \<LOQ in/on
RAC samples from all representative rotational crops (radish, cabbage
and wheat) planted 14 days following the final application to the
primary crop. These data indicate that the label specified 14-day
plant-back restriction is acceptable for all crops that are not
registered for direction application.

**5.1.9 Drinking Water Residue Profile**[]{#__RefHeading___Toc191365837
.anchor}

Reference: *Tier II Drinking Water Assessment for the use of
Pyraclostrobin (P.C. Code: 099100) on Oats and Oilseed (canola and flax)
(Headline Fungcide); Corn, Soybean, and Sugar beets (Headline Fungcide);
Fresh Herbs (crop group 19) and Tropical Fruits (avocado, black sapote,
canistel, mamey sapote, mango, papaya, sapodilla, and star apple)
(Pristine Fungicide); and Turf and Ornamentals (Insignia Fungicide) (DP
Barcodes 336190, 340588, 342584). G. Rothman, 9/6/07.*

The Environmental Fate and Effects Division (EFED) reviewed the proposed
use rates associated with the Section 3 requests for the use of
pyraclostrobin on oats and oilseed crops (canola and flax), fresh herbs
(crop group 19), and tropical fruits (avocado, black sapote, canistel,
mamey sapote, mango, papaya, sapodilla, and star apple). Additionally,
EFED reviewed the proposal to add aerial applications to existing turf
and ornamentals use sites and the proposal to add in-furrow use to the
existing corn, soybean, and sugar beets use sites.

This assessment was based on the application of the highest seasonal use
rate (proposed or registered) of pyraclostrobin. The aerial application
on turf and ornamentals contains the highest seasonal application at 0.5
lbs a.i./acre with 6 maximum seasonal applications at 14 day intervals.
The proposed use rate for the aerial application on turf and ornamentals
is the same as for the registered use of pyraclostrobin for ground
application on turf (please see the,"Environmental Fate and Ecological
Risk Assessment for the Registration of Pyraclostrobin", submitted
February 6, 2002.). However, EFED believes that the aerial use of
pyraclostrobin on turf and ornamentals will pose the upper-bound
concentrations in surface and ground water since spray drift increases
and application efficiency decreases in an aerial application technique.

Measures of exposure for pyraclostrobin in the drinking water assessment
were obtained through modeling efforts only, since national-scale
monitoring data were not identified. The Tier II drinking water
assessment was performed using the Tier II PRZM/EXAMS (PE4V01 perl shell
with PRZM 3.12 beta dated 5/24/01 and EXAMS version 2.98, 7/18/02) to
assess surface water. Ground water concentrations were estimated using a
Tier I SCI-GROW model (version 2.3, May 16, 2006) since a Tier II model
has not been developed to assess ground water.

Acute effects of pyraclostrobin residues in drinking water are expressed
in annual peak one-in-ten year concentrations, chronic effects in annual
average one-in-ten year concentrations, and cancer effects in 30-year
average concentrations. The upper-bound Tier II modeling predicts that
the concentrations of pyraclostrobin in surface water are not likely to
exceed 35.6 µg/L for the peak concentration, 2.3 µg/L for the annual
average concentration, and 1.5 µg/L for the 30-year average
concentrations. The SCI-GROW model predicts the acute and chronic
concentrations of pyraclostrobin in shallow ground water to be 0.02 µg
/L (0.02 ppb).

**5.1.10 Proposed Tolerances**[]{#__RefHeading___Toc191365838 .anchor}

For purposes of both the tolerance expression and dietary risk
assessment, HED has concluded that the residues of concern in plant
commodities include pyraclostrobin and its desmethoxy metabolite, BF
500-3 (D278044, L. Cheng, 10/9/01), and the residues of concern in
livestock commodities include pyraclostrobin and its metabolites
convertible to 1-(4-chlorophenyl)-1H-pyrazol-3-ol (BF 500-5) and
1-(4-chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol (BF 500-8).

Number range CHAPTERPyraclostrobin tolerances for plant commodities are
listed in 40 CFR §180.582 (a)(1) and are expressed in terms of the
combined residues of the fungicide pyraclostrobin (carbamic acid,
\[2-\[\[\[1-(4-chlorophenyl)-1H-
pyrazol-3-yl\]oxy\]methyl\]phenyl\]methoxy-, methyl ester) and its
desmethoxy metabolite (methyl
N-\[\[\[1-(4-chlorophenyl)-1H-pyrazol-3-yl\]oxy\]methyl\]phenyl
carbamate), expressed as parent compound.

Pyraclostrobin tolerances for animal commodities are listed in 40 CFR
§180.582 (a)(2) and are expressed in terms of the combined residues of
the fungicide pyraclostrobin and its metabolites convertible to
1-(4-chlorophenyl)-1H-pyrazol-3-ol and
1-(4-chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol, expressed as parent
compound.

The tolerance expression proposed by BASF in PP#6F7105 is consistent
with the tolerance definition for plant commodities listed in 40 CFR
§180.582 (a)(1). The tolerance expression proposed by IR-4 in PP#6E7165
is expressed as pyraclostrobin *per se* and should be amended to include
all pyraclostrobin residues of concern.

The petitioner, BASF Corp., is currently proposing a crop group
tolerance of 0.4 ppm for "Oilseed, group 20". According to a 6/14/06
memo by B. Schneider entitled "Reviewer's Guide and Summary of HED
ChemSAC Approvals for Amending Crop Groups/Subgroups \[40 CFR §180.41\]
and Commodity Definitions \[40 CFR §180.1(h)\]", the new Oilseed Crop
Group 20 is being established to harmonize with Canada's Crop Group 20.
The representative commodities for the crop group are rapeseed (canola
varieties only) and sunflower seed. Flax seed, for which uses are being
proposed as part of this petition, is a member of this crop group. The
memo further states that until the Federal Register Notice is published
revising the Crop Group Regulation to establish the Oilseed Crop Group
20, tolerances for the representative commodities \[rapeseed (canola
seed) and sunflower seed\] as well as all members of the crop group will
be listed individually, and the tolerances will be identical.

The submitted residue data for canola seed are adequate and indicate
that the maximum combined residues were 0.27 ppm in/on samples treated
at 1x. An individual pyraclostrobin tolerance for sunflower has already
been established at 0.3 ppm in 40 CFR §180.582. Although adequate
residue data have been submitted and a tolerance of 0.3 ppm has been
established for sunflower seed, the other representative member of the
new Oilseed Crop Group 20, a crop group tolerance will not be
appropriate at this time until the Federal Register is issued revising
the Crop Group Regulation to establish the Oilseed Crop Group 20. The
field trial data for canola seed were entered into the Agency's
tolerance spreadsheet as specified by the *Guidance for Setting
Pesticide Tolerances Based on Field Trial Data* SOP to determine
appropriate tolerance levels. The tolerance spreadsheet recommends a
tolerance of 0.45 ppm for canola seed. Based on the submitted field
trial data, HED is recommending individual tolerances of 0.45 ppm for
all oilseeds in 3 subgroups: 1) [rapeseed]{.underline} (i.e., borage,
crambe, cuphea, echium, flax seed, gold of pleasure, hare's ear mustard,
lesquerella, lunaria, meadowfoam, milkweed, mustard seed, oil radish,
poppy seed, rapeseed, sesame, and sweet rocket); 2)
[sunflower]{.underline} (i.e., Castor oil plant, Chinese tallowtree,
Euphorbia, Evening primrose, Jojoba, Niger seed, Rose hip, Safflower,
Stokes aster, Sunflower, Tallowwood, Tea oil plant, Vernonia ); 3)
[cotton]{.underline} (only entry presently in this subgroup). The canola
seed data will be translated to all oilseeds in the rapeseed subgroup,
and the sunflower data will be translated to all oilseeds in the
sunflower subgroup. The petitioner is required to submit a revised
Section F to propose individual tolerances for all above oilseeds at
0.45 ppm each.

[]{.mark}

The submitted field trial data for oat grain, straw, and hay are
adequate pending label revision to specify PHIs of 20-26 days for oat
grain and straw and 6-8 days for oat hay. The field trial data for oat
grain, straw, and hay were entered into the Agency's tolerance
spreadsheet as specified by the *Guidance for Setting Pesticide
Tolerances Based on Field Trial Data* SOP to determine appropriate
tolerance levels. The tolerance spreadsheet recommends tolerances of 1.2
ppm for oat grain, 15 ppm for oat straw, and 18 ppm for hay. The
petitioner did not provide residue data or propose a tolerance for oat
forage because applications are made after the growth stages at which
oat is foraged. Based on the current proposed use patterns, the Agency
will not require residue data or a tolerance for oat forage.

The submitted field trial data for basil (fresh and dried) and chives,
the representative commodities of Herbs subgroup 19A, along with those
data submitted for dill (fresh and seed) are inadequate because the
trials were conducted at an exaggerated rate of \~0.8 lb ai/A (2.7x).
The submitted data may, however, be used to support the recommended
subgroup tolerance. The field trial data for all fresh herbs (basil,
chives, and dill) reflecting the exaggerated rate were entered into the
Agency's tolerance spreadsheet to determine an appropriate tolerance
level. The tolerance spreadsheet recommends a tolerance of 25.0 ppm for
Herbs subgroup 19A. Additional data from the basil and dill field trials
suggest that tolerances are needed for dried basil leaves at 85 ppm and
dill seed at 25 ppm. However, a withdrawal letter for withdrawal of the
fresh herbs section of petition #6E7165 has recently been received by
OPP. Therefore, at this time HED is not recommending for tolerances on
any herbs in the Herbs subgroup 19A.

The submitted field trial data for avocado are inadequate because the
trials were conducted at an exaggerated rate (\~2.6x) and no residue
decline data were submitted. The submitted data may, however, be used to
support the proposed tolerance for avocado. The field trial data for
avocado reflecting the exaggerated rate were entered into the Agency's
tolerance spreadsheet to determine an appropriate tolerance level. The
tolerance spreadsheet recommends a tolerance of 0.6 ppm for avocado.
Because of the exaggerated rate, the recommended tolerance would
probably be higher than needed.

The submitted data for avocado may be translated to other tropical
fruits (black sapote, canistel, mamey sapote, mango, papaya, sapodilla,
and star apple) for which uses are proposed pending label revisions. HED
is in the process of revising the Commodity Definitions listed under 40
CFR §180.1(h) to make the tropical/subtropical fruit avocado a general
commodity. The specific commodities included in the proposed general
definition for avocado include black sapote, canistel, mamey sapote,
mango, papaya, sapodilla, and star apple. Until the regulations have
been finalized in the Federal Register, separate tolerances are needed
for each specific commodity, at the same level as the respective general
commodity tolerance.

The submitted field trial data for barley grain and straw are adequate.
The field trial data for barley grain and straw were entered into the
Agency's tolerance spreadsheet as specified by the *Guidance for Setting
Pesticide Tolerances Based on Field Trial Data* SOP to determine
appropriate tolerance levels. The tolerance spreadsheet recommends
tolerances of 1.4 ppm for barley grain and 6.0 ppm for barley straw. No
residue data were submitted for barley forage, and these data are
normally required to support the amended use pattern. However, the
petitioner did not provide residue data or propose a tolerance for
barley hay because applications are made after the growth stages at
which barley hay is harvested. Based on the current proposed use
patterns, the Agency will not require residue data or a tolerance for
barley hay.

An acceptable canola processing study has been submitted, and the
results suggest that no tolerances are required for the processed
commodities of canola. An oat processing study is required to support
the proposed use on oats.

An acceptable limited field rotational crop study is available. No
rotational crop tolerances are required pending label revision to
specify a plantback interval of 14 days for all annual crops that are
not registered.

Adequate cattle and poultry feeding studies are available. The existing
pyraclostrobin tolerances for milk, meat, fat, meat byproducts except
liver, and liver of cattle, goats, hogs, horses, and sheep were
reassessed, and no adjustments are needed. Tolerances for eggs and
poultry are not needed at this time based on data from the poultry
feeding and metabolism studies \[Category 180.6(a)(3)\].

The Codex Alimentarius Commission has established maximum residue limits
(MRLs) for residues of pyraclostrobin at 0.5 ppm for oats and at 0.05
ppm for papaya (see Appendix I). The US tolerance level and residue
definition both differ from Codex. There are no Canadian or Mexican MRLs
for pyraclostrobin for the crop commodities discussed in this Summary
Document.

A summary of the recommended tolerances for the crop commodities
discussed in this document is presented in Table 14. The petitioner
should submit a revised Section F reflecting the recommended tolerances
and commodity definitions presented in Table 14.

[]{.mark}

+----------------+----------+------------+----------------------------+
| **Table 14.    |          |            |                            |
| Tolerance      |          |            |                            |
| Summary for    |          |            |                            |
| Pyr            |          |            |                            |
| aclostrobin.** |          |            |                            |
+================+==========+============+============================+
| Commodity      | Proposed | R          | Comments; *Correct         |
|                | T        | ecommended | Commodity Definition*      |
|                | olerance | Tolerance  |                            |
|                | (ppm)    | (ppm)      |                            |
+----------------+----------+------------+----------------------------+
| **Tolerances   |          |            |                            |
| Proposed Under |          |            |                            |
| PP#6E7105**    |          |            |                            |
+----------------+----------+------------+----------------------------+
| Oats grain     | 1.0      | 1.2        | Tolerance recommendations  |
|                |          |            | are tentative pending      |
|                |          |            | submission of a revised    |
|                |          |            | Section B to specify PHIs  |
|                |          |            | of 20-26 days for oat      |
|                |          |            | grain and straw and 6-8    |
|                |          |            | days for oat hay.          |
|                |          |            |                            |
|                |          |            | *Oat, grain; oat, hay, and |
|                |          |            | oat straw.*                |
+----------------+----------+------------+----------------------------+
| Oats, hay      | 17       | 18         |                            |
+----------------+----------+------------+----------------------------+
| Oats, straw    | 17       | 15         |                            |
+----------------+----------+------------+----------------------------+
| Oilseed, group | 0.4      | Canola,    | A crop group tolerance     |
| 20             |          | seed at    | will not be appropriate at |
|                |          | 0.45       | this time until the        |
|                |          |            | Federal Register is issued |
|                |          | Flax, seed | revising the Crop Group    |
|                |          | at 0.45    | Regulation to establish    |
|                |          |            | the Oilseed Crop Group 20. |
|                |          |            | In the interim, HED is     |
|                |          |            | recommending individual    |
|                |          |            | tolerances on all oilseeds |
|                |          |            | to be listed in the        |
|                |          |            | rapeseed subgroup.         |
+----------------+----------+------------+----------------------------+
| **Tolerances   |          |            |                            |
| Proposed Under |          |            |                            |
| PP#6E7165**    |          |            |                            |
+----------------+----------+------------+----------------------------+
| Avocado        | 0.7      | 0.6        | Tolerance recommended, but |
|                |          |            | additional field trial     |
|                |          |            | data required as a         |
|                |          |            | condition of registration. |
+----------------+----------+------------+----------------------------+
| **Tolerances   |          |            |                            |
| Proposed Under |          |            |                            |
| PP#7E7245**    |          |            |                            |
+----------------+----------+------------+----------------------------+
| Barley, grain  | 1.3      | 1.4        | Adequate field trial data  |
|                |          |            | are available on barley    |
|                |          |            | based on regional use.     |
+----------------+----------+------------+----------------------------+
| Barley, straw  | 9.0      | 6.0        |                            |
+----------------+----------+------------+----------------------------+
| Sapote, black  | 0.7      | 0.6        | Tolerance recommendations  |
|                |          |            | are based on residue data  |
|                |          |            | translated from avocado.   |
+----------------+----------+------------+----------------------------+
| Canistel       | 0.7      | 0.6        |                            |
+----------------+----------+------------+----------------------------+
| Sapote, mamey  | 0.7      | 0.6        |                            |
+----------------+----------+------------+----------------------------+
| Mango          | 0.7      | 0.6        |                            |
+----------------+----------+------------+----------------------------+
| Papaya         | 0.7      | 0.6        |                            |
+----------------+----------+------------+----------------------------+
| Sapodilla      | 0.7      | 0.6        |                            |
+----------------+----------+------------+----------------------------+
| Star Apple     | 0.7      | 0.6        |                            |
+----------------+----------+------------+----------------------------+
| **Additional   |          |            |                            |
| Tolerances     |          |            |                            |
| That Need to   |          |            |                            |
| be Proposed    |          |            |                            |
| Under          |          |            |                            |
| PP#6E7105**    |          |            |                            |
+----------------+----------+------------+----------------------------+
| Borage,        | none     | 0.45       | HED is recommending        |
| Crambe,        |          |            | individual tolerances on   |
| Cuphea,        |          |            | all oilseeds to be listed  |
| Echium, Flax   |          |            | in the rapeseed subgroup.  |
| seed, Gold of  |          |            |                            |
| pleasure,      |          |            |                            |
| Hare's ear     |          |            |                            |
| mustard,       |          |            |                            |
| Lesquerella,   |          |            |                            |
| Lunaria,       |          |            |                            |
| Meadowfoam,    |          |            |                            |
| Milkweed,      |          |            |                            |
| Mustard seed,  |          |            |                            |
| Oil radish,    |          |            |                            |
| Poppy seed,    |          |            |                            |
| Rapeseed,      |          |            |                            |
| Sesame, Sweet  |          |            |                            |
| rocket         |          |            |                            |
| (rapeseed      |          |            |                            |
| subgroup);     |          |            |                            |
|                |          |            |                            |
| Castor oil     |          |            |                            |
| plant, Chinese |          |            |                            |
| tallowtree,    |          |            |                            |
| Euphorbia,     |          |            |                            |
| Evening        |          |            |                            |
| primrose,      |          |            |                            |
| Jojoba, Niger  |          |            |                            |
| seed, Rose     |          |            |                            |
| hip,           |          |            |                            |
| Safflower,     |          |            |                            |
| Stokes aster   |          |            |                            |
|                |          |            |                            |
| Sunflower,     |          |            |                            |
| Tallowwood,    |          |            |                            |
| Tea oil plant, |          |            |                            |
| Vernonia       |          |            |                            |
| (sunflower     |          |            |                            |
| subgroup);     |          |            |                            |
|                |          |            |                            |
| Cotton (cotton |          |            |                            |
| subgroup)      |          |            |                            |
+----------------+----------+------------+----------------------------+

**5.2 Dietary Exposure and Risk**[]{#__RefHeading___Toc191365839
.anchor}

Reference: *Pyraclostrobin. Acute and Chronic Aggregate Dietary and
Drinking Water Exposure and Risk Assessments to Support New Use on Oat
Grain, Barley Grain, Oilseed (Crop Group 20), Fresh Herbs (Herbs
Subgroup 19A), Avocado, Black Sapote, Canistel, Mamey Sapote, Mango,
Papaya, Sapodilla, and Star Apple. PC Code: 099100; Decision Number:
370224; DP Number: 348308; S. Piper; 02/11/08.*

Dietary risk assessment incorporates both exposure and toxicity of a
given pesticide. The risk is expressed as a percentage of a maximum
acceptable dose (i.e., the dose which HED has concluded will result in
no unreasonable adverse health effects). This dose is referred to as the
population adjusted dose (PAD). HED is concerned when estimated dietary
risk exceeds 100% of the PAD.

**[DEEM-FCID™ Program and Consumption Information]{.underline}**

Pyraclostrobin acute and chronic dietary exposure assessments were
conducted using the Dietary Exposure Evaluation Model software with the
Food Commodity Intake Database (DEEM-FCID™, Version 2.03), which
incorporates consumption data from USDA's Continuing Surveys of Food
Intakes by Individuals (CSFII), 1994-1996 and 1998. The 1994-96, 98 data
are based on the reported consumption of more than 20,000 individuals
over two non-consecutive survey days. Foods "as consumed" (e.g., apple
pie) are linked to EPA-defined food commodities (e.g. apples, peeled
fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or
N/S, baked) using publicly available recipe translation files developed
jointly by USDA/ARS and EPA. For chronic exposure assessment,
consumption data are averaged for the entire U.S. population and within
population subgroups, but for acute exposure assessment are retained as
individual consumption events. Based on analysis of the 1994-96, 98
CSFII consumption data, which took into account dietary patterns and
survey respondents, HED concluded that it is most appropriate to report
risk for the following population subgroups: the general U.S.
population, all infants (\<1 year old), children 1-2, children 3-5,
children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+
years old.

For chronic dietary exposure assessment, an estimate of the residue
level in each food or food-form (e.g., orange or orange juice) on the
food commodity residue list is multiplied by the average daily
consumption estimate for that food/food form to produce a residue intake
estimate. The resulting residue intake estimate for each food/food form
is summed with the residue intake estimates for all other food/food
forms on the commodity residue list to arrive at the total average
estimated exposure. Exposure is expressed in mg/kg body weight/day and
as a percent of the cPAD. This procedure is performed for each
population subgroup.

For acute exposure assessments, individual one-day food consumption data
are used on an individual-by-individual basis. The reported consumption
amounts of each food item can be multiplied by a residue point estimate
and summed to obtain a total daily pesticide exposure for a
deterministic exposure assessment, or "matched" in multiple random
pairings with residue values and then summed in a probabilistic
assessment. The resulting distribution of exposures is expressed as a
percentage of the aPAD on both a user (i.e., only those who reported
eating relevant commodities/food forms) and a per-capita (i.e., those
who reported eating the relevant commodities as well as those who did
not) basis. In accordance with HED policy, per capita exposure and risk
are reported for all tiers of analysis. However, for tiers 1 and 2, any
significant differences in user vs. per capita exposure and risk are
specifically identified and noted in the risk assessment.

**[Drinking Water Inputs]{.underline}**

The drinking water residues used in the dietary risk assessment were
provided by EFED in the following memorandum: "*Tier II Drinking Water
Assessment for the use of Pyraclostrobin (P.C. Code: 099100) on Oats and
Oilseed (canola and flax) (Headline Fungcide); Corn, Soybean, and Sugar
beets (Headline Fungcide); Fresh Herbs (crop group 19) and Tropical
Fruits (avocado, black sapote, canistel, mamey sapote, mango, papaya,
sapodilla, and star apple) (Pristine Fungicide); and Turf and
Ornamentals (Insignia Fungicide) (DP Barcodes 336190, 340588, 342584).
G. Rothman, 9/6/07"* and incorporated directly into this dietary
assessment. EFED selected the proposed aerial application on turf and
ornamentals as the use site to base their drinking water assessment
upon, since it provided the highest seasonal use rate (proposed or
registered) of pyraclostrobin (0.5 lbs a.i./acre with 6 maximum seasonal
applications at 14 day intervals). Additionally, EFED believes that the
aerial use of pyraclostrobin on turf and ornamentals will pose the
upper-bound concentrations in surface and ground water since spray drift
increases and application efficiency decreases in an aerial application
technique.

The drinking water assessment provides Tier II (PRZM 3.12/EXAMS 2.98)
surface water modeling and Tier I (SCI-GROW, version 2.3) groundwater
modeling. The modeling was conducted for the parent compound only. The
residue concentrations from Tier II surface water modeling are not
expected to exceed 35.6 µg/L for the peak concentration, 2.3 µg/L for
the annual average concentration, and 1.5 µg/L for the 30 year average
concentration. Residue concentration from Tier I groundwater modeling is
not expected to exceed 0.02 µg/L. For acute exposures the 35.6 µg/L peak
concentration was used. For chronic exposures the 2.3 µg/L annual
average concentration was used. These drinking water residues were
incorporated in the DEEM-FCID into the food categories "water, direct,
all sources" and "water, indirect, all sources."

**[Residue Data Used for Acute and Chronic Assessments]{.underline}**

For the acute dietary analysis, tolerance level or highest field trial
residues were used for all crops. The crops for which the highest field
trial residues were used are as follows: Amaranth, leafy; Arugula;
Chrysanthemum; Cress, garden; Cress, upland; Dandelion, leaves; Fennel;
Parsley, leaves; Radicchio; Rhubarb; Spinach; Swiss chard; Beans, dry;
Celery; Lettuce, head; Lettuce, leaf; and Pea, dry. One hundred percent
crop treated was assumed for all commodities in the assessment. For the
chronic dietary analysis, anticipated residues were derived for certain
crops (apple, broccoli, celery, collard, grape, lettuce, citrus, pepper,
mustard green and tomato), which are the major dietary contributors
based on preliminary runs. Experimentally derived processing factors for
apple juice, grape juice, citrus juices, tomato paste, tomato puree,
wheat flour, and wheat germ were applied.

**[Results of Acute Dietary Exposure Analysis]{.underline}**

The results of the aggregate acute dietary analysis for food and water
indicate that acute dietary risks do not exceed Agency's level of
concern (\< 100% of the aPAD) for the U.S. population and all subgroups.
At the 95^th^ percentile, the U.S. population has an exposure from food
and drinking water that results in a risk estimate for the general U.S.
population at 1% of the aPAD. The most highly exposed subpopulation is
"females 13-49 years" at 80% of the aPAD. The results of the acute
dietary exposure analysis at the 95^th^ percentile of exposure are
reported in Table 15 below.

**[Results of Chronic Dietary Exposure Analysis]{.underline}**

The results of the aggregate chronic dietary analysis for food and
drinking water indicate that chronic dietary risks (food and drinking
water) do not exceed HED's level of concern (\<100% cPAD) for the U.S.
population and all subgroups. The U.S. population exposure from food and
water results in a risk estimated at 19% of the cPAD. The most highly
exposed population subgroup is "children 1 -2" with an exposure
estimated at 48% of the cPAD. The results of the chronic dietary
exposure analysis are reported in Table 15, below.

+-----------------+--------+-------+--------+-------+--------+-------+
| **Table 15.     |        |       |        |       |        |       |
| Summary of      |        |       |        |       |        |       |
| Dietary         |        |       |        |       |        |       |
| Exposure and    |        |       |        |       |        |       |
| Risk for        |        |       |        |       |        |       |
| Pyraclostrobin  |        |       |        |       |        |       |
| -- Food &       |        |       |        |       |        |       |
| Water**         |        |       |        |       |        |       |
+=================+========+=======+========+=======+========+=======+
| Population      | Acute  |       | C      |       | Cancer |       |
| Subgroup        | D      |       | hronic |       |        |       |
|                 | ietary |       | D      |       |        |       |
|                 |        |       | ietary |       |        |       |
|                 | (95th  |       |        |       |        |       |
|                 | Perce  |       |        |       |        |       |
|                 | ntile) |       |        |       |        |       |
+-----------------+--------+-------+--------+-------+--------+-------+
|                 | D      | \%    | D      | \%    | D      | Risk  |
|                 | ietary | aPAD  | ietary | cPAD  | ietary |       |
|                 | Ex     |       | Ex     |       | Ex     |       |
|                 | posure |       | posure |       | posure |       |
|                 | (mg/k  |       |        |       |        |       |
|                 | g/day) |       | (mg/k  |       | (mg/k  |       |
|                 |        |       | g/day) |       | g/day) |       |
+-----------------+--------+-------+--------+-------+--------+-------+
| General U.S.    | 0.043  | 1.4   | 0.0061 | 19    | A      |       |
| Population      |        |       |        |       | se     |       |
|                 |        |       |        |       | parate |       |
|                 |        |       |        |       | quanti |       |
|                 |        |       |        |       | tative |       |
|                 |        |       |        |       | cancer |       |
|                 |        |       |        |       | risk   |       |
|                 |        |       |        |       | asse   |       |
|                 |        |       |        |       | ssment |       |
|                 |        |       |        |       | is not |       |
|                 |        |       |        |       | req    |       |
|                 |        |       |        |       | uired. |       |
+-----------------+--------+-------+--------+-------+--------+-------+
| All Infants (\< | 0.055  | 1.8   | 0.011  | 33    |        |       |
| 1 year old)     |        |       |        |       |        |       |
+-----------------+--------+-------+--------+-------+--------+-------+
| Children 1-2    | 0.072  | 2.4   | 0.016  | *     |        |       |
| years old       |        |       |        | *48** |        |       |
+-----------------+--------+-------+--------+-------+--------+-------+
| Children 3-5    | 0.064  | 2.2   | 0.012  | 36    |        |       |
| years old       |        |       |        |       |        |       |
+-----------------+--------+-------+--------+-------+--------+-------+
| Children 6-12   | 0.046  | 1.5   | 0.0074 | 22    |        |       |
| years old       |        |       |        |       |        |       |
+-----------------+--------+-------+--------+-------+--------+-------+
| Youth 13-19     | 0.035  | 1.2   | 0.0043 | 13    |        |       |
| years old       |        |       |        |       |        |       |
+-----------------+--------+-------+--------+-------+--------+-------+
| Adults 20-49    | 0.039  | 1.3   | 0.0050 | 15    |        |       |
| years old       |        |       |        |       |        |       |
+-----------------+--------+-------+--------+-------+--------+-------+
| Adults 50+      | 0.041  | 1.4   | 0.0057 | 17    |        |       |
| years old       |        |       |        |       |        |       |
+-----------------+--------+-------+--------+-------+--------+-------+
| Females 13-49   | 0.040  | *     | 0.0047 | 14    |        |       |
| years old       |        | *80** |        |       |        |       |
+-----------------+--------+-------+--------+-------+--------+-------+

**[Conclusions]{.underline}**

Acute and chronic exposures and risks do not exceed HED's level of
concern for the U.S. population and for all relevant population
subgroups. Since risk estimates are below HED's level of concern, a more
highly refined analysis is not needed at this time. Of note is that
contribution from drinking water is minimal. HED concludes that the
acute and chronic exposure estimates are unlikely to underestimate
actual acute or chronic exposure.

**5.3 Anticipated Residue and Percent Crop Treated (%CT)
Information**[]{#__RefHeading___Toc191365840 .anchor}

The acute analysis was conducted using tolerance level residues or the
highest residues for all commodities. These tolerance level or highest
residues were derived from field trial data conducted at the maximum
application rate and minimum PHI permitted on the proposed or existing
labels. For all commodities 100% crop treated was assumed. A limited
number of experimentally derived processing factors were used to refine
the acute and chronic analyses.

The chronic dietary assessment was conducted using tolerance level
residues for all crops except for apple, celery, grape, head lettuce,
leaf lettuce, orange, pepper, spinach, tomato and additional crops in
the leafy vegetables group where anticipated average residue values were
derived from crop field trials. These field trials represent maximum
application rates and minimum PHIs. For all commodities 100% crop
treated was assumed.

**6.0 Residential (Non-Occupational) Exposure/Risk
Characterization**[]{#__RefHeading___Toc191365841 .anchor}

A product containing pyraclostrobin (i.e., Insignia^®^) is registered
for application to residential turf grass and recreational sites. It may
be applied to turf at rates ranging from 0.28 to 0.5 lb ai/A, at
intervals of 14 to 28 days; and the maximum seasonal application rate is
3 lb ai/A. The residential exposure assessment was prepared in an HED
memorandum dated 8/19/04 (D298017, K. O'Rourke). Residential and
recreational turf applications are applied by professional pest control
operators (PCOs) only, and therefore, residential handler exposures do
not occur. There is, however, a potential for exposure to homeowners in
residential settings from entering previously treated lawns where
children might play and adults might work or play. As a result, risk
assessments have been completed for postapplication scenarios. The
short-term MOEs for each postapplication scenario resulted in MOEs above
100, and therefore are not of concern. For toddlers, the short-term
dermal MOE is 180 (0.027 mg/kg/day) and the combined incidental oral MOE
is 620 (0.009425 mg/kg/day; hand-to-mouth activities), and combined
dermal and oral exposures result in and MOE of 140. Dermal and
incidental oral exposures are combined because they share common toxic
effects; i.e., decreased body weight gain and decreased food
intake/efficiency. For adults, the short-term dermal MOE is 260 (0.019
mg/kg/day).

Recreational exposures to turf are expected to be similar to, or in many
cases less than, those evaluated for residential postapplication
exposure and risk; and therefore, a separate recreational exposure
assessment was not conducted.

Spray drift is always a potential source of exposure to residents nearby
to spraying operations. This is particularly the case with aerial
application, but, to a lesser extent, could also be a potential source
of exposure from the ground application method employed for
pyraclostrobin. The Agency has been working with the Spray Drift Task
Force, EPA Regional Offices and State Lead Agencies for pesticide
regulation and other parties to develop the best spray drift management
practices. The Agency is now requiring interim mitigation measures for
aerial applications that must be placed on product labels/labeling. The
Agency has completed its evaluation of the new data base submitted by
the Spray Drift Task Force, a membership of U.S. pesticide registrants,
and is developing a policy on how to appropriately apply the data and
the AgDRIFT computer model to its risk assessments for pesticides
applied by air, orchard airblast and ground hydraulic methods. After the
policy is in place, the Agency may impose further refinements in spray
drift management practices to reduce off-target drift and risks
associated with aerial as well as other application types where
appropriate.

**7.0 Aggregate Risk Assessments and Risk
Characterization**[]{#__RefHeading___Toc191365842 .anchor}

In accordance with the FQPA, HED must consider and aggregate (add)
pesticide exposures and risks from three major sources: food, drinking
water, and residential exposures. In an aggregate assessment, exposures
from relevant sources are added together and compared to quantitative
estimates of hazard (e.g., a NOAEL or PAD), or the risks themselves can
be aggregated. When aggregating exposures from various sources, HED
considers both the route and duration of exposure. Common effects (i.e.,
decreased body weight gain, food intake, and food efficiency) were seen
in the studies selected to evaluate dietary, dermal and incidental oral
ingestion exposures; and therefore, route-specific exposures can be
aggregated.

Based on the proposed Section 3 food crop uses, aggregate assessments
were conducted for acute and chronic dietary exposures (food + drinking
water), and existing short-/intermediate-term residential exposures
(i.e., chronic dietary, plus incidental oral and dermal exposures for
kids, and chronic dietary, plus dermal exposures for adults). Both
short- and intermediate-term exposures may occur during postapplication
activities for adults and children. However, because the toxicity
endpoints and points of departure are identical for short- and
intermediate-term exposures, separate risk estimates for short- and
intermediate-term exposures were not calculated.

To assess aggregate acute and chronic dietary risks, estimates of
pesticide residues in drinking water (EDWCs) were incorporated directly
into the dietary exposure analysis. **Refer to section 5.2 for these
risk estimates.**

The short-/intermediate-term aggregate risk assessment takes into
account average exposure estimates from dietary consumption of
pyraclostrobin (food and drinking water) and
non-occupational/residential uses (turf). Postapplication exposures from
the use on turf are considered predominantly short-term (1-30 days). To
calculate the short-/intermediate-term aggregate risk estimates, the
chronic dietary exposure (food + drinking water) is added to the
residential exposures using the inverse MOE methodology described below
(see Table 16 below). The total combined MOE from dietary (food + water)
and non-occupational/residential exposure is 100 for children 1-2 years
old, which is not of concern to HED. For adults the total combined MOE
is 200, which also is not of concern to HED. These aggregate exposure
risk assessments are considered conservative estimates, that should not
underestimate risks, because of the following inputs: 1) dietary inputs
primarily used tolerance level residues; 2) crop specific (turf)
screening level drinking water modeling data were used (i.e., Tier II
surface water model); 3) maximum application rates and minimum
application intervals were used; and 4) conservative SOPs and upper
level estimates of exposure were employed.

+--------+-------+-------+----+-------+---------+-------+----+-------+
| *      |       |       |    |       |         |       |    |       |
| *Table |       |       |    |       |         |       |    |       |
| 16.    |       |       |    |       |         |       |    |       |
| S      |       |       |    |       |         |       |    |       |
| hort-/ |       |       |    |       |         |       |    |       |
| Interm |       |       |    |       |         |       |    |       |
| ediate |       |       |    |       |         |       |    |       |
| Term   |       |       |    |       |         |       |    |       |
| Agg    |       |       |    |       |         |       |    |       |
| regate |       |       |    |       |         |       |    |       |
| Risk   |       |       |    |       |         |       |    |       |
| Ca     |       |       |    |       |         |       |    |       |
| lculat |       |       |    |       |         |       |    |       |
| ions** |       |       |    |       |         |       |    |       |
+--------+-------+-------+----+-------+---------+-------+----+-------+
| Popu   | D     |       |    | Oral  |         |       |    | Total |
| lation | ermal |       |    | Exp   |         |       |    | Com   |
|        | Exp   |       |    | osure |         |       |    | bined |
|        | osure |       |    |       |         |       |    | M     |
|        |       |       |    |       |         |       |    | OE^2^ |
+--------+-------+-------+----+-------+---------+-------+----+-------+
|        | NOAEL | Exp   | MO | NOAEL | Inc     | Ch    | MO |       |
|        |       | osure | E^ | mg/k  | idental | ronic | E^ |       |
|        | mg/k  |       | 1^ | g/day | Oral    | Di    | 1^ |       |
|        | g/day | mg/k  |    |       | E       | etary |    |       |
|        |       | g/day |    |       | xposure | (F    |    |       |
|        |       |       |    |       | mg      | ood + |    |       |
|        |       |       |    |       | /kg/day | W     |    |       |
|        |       |       |    |       |         | ater) |    |       |
|        |       |       |    |       |         | mg/k  |    |       |
|        |       |       |    |       |         | g/day |    |       |
+--------+-------+-------+----+-------+---------+-------+----+-------+
| Ch     | 5     | 0.027 | 1  | 5.8   | 0       | 0     | 2  | 100   |
| ildren |       |       | 80 |       | .009425 | .0164 | 20 |       |
| 1-2    |       |       |    |       |         |       |    |       |
| yrs    |       |       |    |       |         |       |    |       |
+--------+-------+-------+----+-------+---------+-------+----+-------+
| Adults | 5     | 0.019 | 2  | 5     | NA      | 0.    | 8  | 200   |
|        |       |       | 60 |       |         | 00613 | 20 |       |
+--------+-------+-------+----+-------+---------+-------+----+-------+

^1^ The Level of Concern MOE is 100.

^2^ Total Combined MOE = 1/ \[(1/MOE~Dermal~) + (1/MOE~Oral~)\]

**8.0 Cumulative Risk
Characterization/Assessment**[]{#__RefHeading___Toc191365843 .anchor}

Unlike other pesticides for which EPA has followed a cumulative risk
approach based on a common mechanism of toxicity, EPA has not made a
common mechanism of toxicity finding as to pyraclostrobin and any other
substances and pyraclostrobin does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that pyraclostrobin has
a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a common
mechanism on EPA's website at
<http://www.epa.gov/pesticides/cumulative/>.

**9.0 Occupational Exposure/Risk
Pathway**[]{#__RefHeading___Toc191365844 .anchor}

Reference: *Pyraclostrobin**:** Occupational and Residential Risk
Assessment to Support Request for Section 3 Registrations on Oats and
Oilseed Crop group (Foliar and Seed Treatment), Herbs, and Tropical
Fruits. (DP#: 348792; PC#: 099100) K. O'Rourke; 01/31/08.*

**9.1 Short-/Intermediate-Term Handler
Risk**[]{#__RefHeading___Toc191365845 .anchor}

***Foliar and In-Furrow Treatment***

Occupational handlers may experience short-/intermediate-term exposure
to pyraclostrobin while mixing/loading and applying sprays to
agricultural crops. No chemical-specific handler exposure data were
submitted in support of this use pattern. It is the policy of the HED to
use data from the Pesticide Handlers Exposure Database (PHED) Version
1.1 as presented in PHED Surrogate Exposure Guide (8/98) to assess
handler exposures when chemical-specific monitoring data are not
available ( HED Science Advisory Council for Exposure Draft Policy \# 7,
dated 1/28/99).

The results of the occupational handler exposure and risk assessment
indicate that risks are not of concern with baseline clothing, or in
some cases, when gloves and respirator are used to mitigate exposure.
\[Note: The respirator unit exposure value represents a PF 5
NIOSH-approved filtering face-piece respirator (e.g., dust mask), which
is considered to provide an 80% reduction in inhalation exposure.\]
Exposure assumptions and MOE estimates are summarized in Table 17.

It is feasible for the same individual to mix/load and apply
formulations, especially for groundboom and airblast applications,
however, appropriate data are not available in PHED for which unit
exposures for these combined activities can be derived. HED does not
recommend simply adding the unit exposure values for each job function
because any extrapolation error (i.e., exposure from the amount ai
handled in the study to that of a real-life application) would be
magnified, leading to greater uncertainty. For information and
characterization purposes, even with the over-estimation uncertainty,
the MOEs for these combined activities for groundboom and airblast
application of pyraclostrobin would be above the LOC of 100, and not of
concern (i.e., dermal/inhalation MOEs of 1,400/210 and 1,200/510,
respectively).

The proposed Headline® Fungicide label requires chemical resistant
gloves, however, a respirator is not indicated. In addition, the minimum
level of PPE for handlers is based on acute toxicity for the end-use
products. The Registration Division (RD) is responsible for ensuring
that PPE listed on the label is in compliance with the Worker Protection
Standard (WPS).

<table>
<colgroup>
<col style="width: 25%" />
<col style="width: 7%" />
<col style="width: 7%" />
<col style="width: 10%" />
<col style="width: 8%" />
<col style="width: 7%" />
<col style="width: 7%" />
<col style="width: 7%" />
<col style="width: 7%" />
<col style="width: 9%" />
</colgroup>
<thead>
<tr class="header">
<th colspan="10"><strong>Table 17. Summary of MOEs for Occupational
Handlers of Pyraclostrobin (Foliar Treatment)</strong></th>
</tr>
<tr class="odd">
<th rowspan="2"><strong>Exposure Scenario (Scenario #)</strong></th>
<th rowspan="2"><strong>Dermal Unit Exposure (mg/lb ai)
<sup>1</sup></strong></th>
<th rowspan="2"><p><strong>Inhalation</strong></p>
<p><strong>Unit</strong></p>
<p><strong>Exposure</strong></p>
<p><strong>(mg/lb ai) <sup>1</sup></strong></p></th>
<th rowspan="2"><strong>Use Site</strong></th>
<th rowspan="2"><p><strong>Application</strong></p>
<p><strong>Rate</strong></p>
<p><strong>(lb ai/A) <sup>2</sup></strong></p></th>
<th rowspan="2"><p><strong>Area Treated</strong></p>
<p><strong>(A/day) <sup>3</sup></strong></p></th>
<th colspan="2"><p><strong>Daily Dose</strong></p>
<p><strong>(mg/kg/day) <sup>4</sup></strong></p></th>
<th colspan="2"><p><strong>Short-/Int-term</strong></p>
<p><strong>MOE <sup>5</sup></strong></p></th>
</tr>
<tr class="header">
<th><strong>Dermal</strong></th>
<th><strong>Inhalation</strong></th>
<th><strong>Dermal</strong></th>
<th><strong>Inhalation</strong></th>
</tr>
</thead>
<tbody>
<tr class="odd">
<td colspan="10"><strong>Mixer/Loader</strong></td>
</tr>
<tr class="even">
<td rowspan="2">(1) Mixing/Loading Liquid for Aerial application or
Chemigation</td>
<td rowspan="5"><p>2.9</p>
<p>or</p>
<p>0.023</p>
<p>(w/gloves)</p></td>
<td rowspan="5"><p>0.0012</p>
<p>or</p>
<p>0.00024</p>
<p>(w/</p>
<p>respirator)</p></td>
<td>Oats</td>
<td>0.15</td>
<td>1,200</td>
<td><p>1.2</p>
<p>0.0097</p>
<p>(gloves)</p></td>
<td><p>0.0031</p>
<p>0.00062</p>
<p>(respirator)</p></td>
<td><p>4.1</p>
<p>520</p>
<p>(gloves)</p></td>
<td><p>75</p>
<p>370</p>
<p>(respirator)</p></td>
</tr>
<tr class="odd">
<td>Canola &amp; Flax</td>
<td>0.10</td>
<td>350</td>
<td><p>0.24</p>
<p>0.0019</p>
<p>(gloves)</p></td>
<td>0.00060</td>
<td><p>21</p>
<p>2,700</p>
<p>(gloves)</p></td>
<td>380</td>
</tr>
<tr class="even">
<td rowspan="3">(2) Mixing/Loading Liquid for Groundboom application or
Chemigation</td>
<td>In-Furrow tmt</td>
<td>0.20</td>
<td>200</td>
<td><p>0.27</p>
<p>0.0021</p>
<p>(gloves)</p></td>
<td>0.00069</td>
<td><p>18</p>
<p>2,300</p>
<p>(gloves)</p></td>
<td>340</td>
</tr>
<tr class="odd">
<td>Oats</td>
<td>0.15</td>
<td>200</td>
<td><p>0.20</p>
<p>0.0016</p>
<p>(gloves)</p></td>
<td>0.00051</td>
<td><p>25</p>
<p>3,100</p>
<p>(gloves)</p></td>
<td>450</td>
</tr>
<tr class="even">
<td>Canola &amp; Flax</td>
<td>0.10</td>
<td>80</td>
<td><p>0.054</p>
<p>0.00043</p>
<p>(gloves)</p></td>
<td>0.00014</td>
<td><p>92</p>
<p>12,000</p>
<p>(gloves)</p></td>
<td>1,700</td>
</tr>
<tr class="odd">
<td rowspan="2">(3) Mixing/Loading Dry Flowables for Aerial application
or Chemigation</td>
<td rowspan="4">0.066</td>
<td rowspan="4">0.00077</td>
<td>Turf &amp; Ornamentals</td>
<td>0.50</td>
<td>350</td>
<td>0.027</td>
<td>0.0019</td>
<td>190</td>
<td>120</td>
</tr>
<tr class="even">
<td>Herbs &amp; Tropical Fruit</td>
<td>0.15</td>
<td>350</td>
<td>0.0081</td>
<td>0.00058</td>
<td>620</td>
<td>400</td>
</tr>
<tr class="odd">
<td>(4) Mixing/Loading Dry Flowables for Groundboom application</td>
<td>Herbs</td>
<td>0.15</td>
<td>80</td>
<td>0.0018</td>
<td>0.00013</td>
<td>2,700</td>
<td>1,700</td>
</tr>
<tr class="even">
<td>(5) Mixing/Loading Dry Flowables for Airblast application</td>
<td>Tropical Fruit</td>
<td>0.15</td>
<td>40</td>
<td>0.00092</td>
<td>0.000066</td>
<td>5,400</td>
<td>3,500</td>
</tr>
<tr class="odd">
<td colspan="10"><strong>Applicator</strong></td>
</tr>
<tr class="even">
<td rowspan="4">(6) Applying Sprays with Fixed-wing Aircraft</td>
<td rowspan="4">0.005</td>
<td rowspan="4">0.000068</td>
<td>Turf &amp; Ornamentals</td>
<td>0.50</td>
<td>350</td>
<td>0.0020</td>
<td>0.00017</td>
<td>2,400</td>
<td>1,400</td>
</tr>
<tr class="odd">
<td>Oats</td>
<td>0.15</td>
<td>1,200</td>
<td>0.0021</td>
<td>0.00017</td>
<td>2,400</td>
<td>1,300</td>
</tr>
<tr class="even">
<td>Herbs &amp; Tropical Fruit</td>
<td>0.15</td>
<td>350</td>
<td>0.00061</td>
<td>0.000051</td>
<td>8,200</td>
<td>4,500</td>
</tr>
<tr class="odd">
<td>Canola &amp; Flax</td>
<td>0.10</td>
<td>350</td>
<td>0.00041</td>
<td>0.000034</td>
<td>12,000</td>
<td>6,800</td>
</tr>
<tr class="even">
<td rowspan="4">(7) Applying Sprays with Open Cab Groundboom</td>
<td rowspan="4">0.014</td>
<td rowspan="4">0.00074</td>
<td>In-Furrow tmt</td>
<td>0.20</td>
<td>200</td>
<td>0.0013</td>
<td>0.00042</td>
<td>3,800</td>
<td>540</td>
</tr>
<tr class="odd">
<td>Oats</td>
<td>0.15</td>
<td>200</td>
<td>0.00098</td>
<td>0.00032</td>
<td>5,100</td>
<td>730</td>
</tr>
<tr class="even">
<td>Herbs</td>
<td>0.15</td>
<td>80</td>
<td>0.00039</td>
<td>0.00013</td>
<td>13,000</td>
<td>1,800</td>
</tr>
<tr class="odd">
<td>Canola &amp; Flax</td>
<td>0.10</td>
<td>80</td>
<td>0.00026</td>
<td>0.000085</td>
<td>19,000</td>
<td>2,700</td>
</tr>
<tr class="even">
<td>(8) Applying Sprays with Open Cab Airblast Sprayer</td>
<td>0.36</td>
<td>0.0045</td>
<td>Tropical Fruit</td>
<td>0.15</td>
<td>40</td>
<td>0.0050</td>
<td>0.00039</td>
<td>990</td>
<td>600</td>
</tr>
<tr class="odd">
<td colspan="10"><strong>Flagger</strong></td>
</tr>
<tr class="even">
<td rowspan="3">(9) Flagging to Support Aerial Applications</td>
<td rowspan="3">0.011</td>
<td rowspan="3">0.00035</td>
<td>Turf &amp; Ornamentals</td>
<td>0.50</td>
<td>350</td>
<td>0.0045</td>
<td>0.00088</td>
<td>1,100</td>
<td>260</td>
</tr>
<tr class="odd">
<td>Oats, Herbs &amp; Tropical Fruit</td>
<td>0.15</td>
<td>350</td>
<td>0.0013</td>
<td>0.00026</td>
<td>3,700</td>
<td>880</td>
</tr>
<tr class="even">
<td>Canola &amp; Flax</td>
<td>0.10</td>
<td>350</td>
<td>0.00090</td>
<td>0.00018</td>
<td>5,600</td>
<td>1,300</td>
</tr>
</tbody>
</table>

^1^ Dermal unit exposure values represent long pants, long sleeved
shirts, shoes, and socks; values representing the addition of
chemical-resistant gloves are shown for those scenarios in which the
MOEs do not reach 100 at baseline. Inhalation unit exposure values
represent no respirator, except for "Oats" in Scenario #1, for which a
dust-mist respirator was added. Values are reported in the PHED
Surrogate Exposure Guide dated August 1998.

^2^ Application rates are based on maximum values found in proposed
labels (See Table 1)

^3^ Daily area treated is based on the area that can be reasonably
applied in a single day for each exposure scenario, based on the
application method and formulation/packaging type. (standard EPA/OPP/HED
values).

^4^ Daily Dose (mg/kg/day) = (Unit Exposure \* % Absorption \*
Application rate \* Area treated) / Body Weight of 60-kg for dermal or
70-kg for inhalation; where dermal absorption is 14%..

^5^ Short-/Intermediate-Term MOE = NOAEL / Daily Dose. The dermal NOAEL
is 5 mg/kg/day, and the inhalation NOAEL is 0.23 mg/kg/day. The LOC is
100.

***Seed Treatment***

Occupational handlers may experience short-/intermediate-term exposure
to pyraclostrobin while performing seed treatment activities, including
several distinct handling activities, each with its own exposure
potential. These activities are: (1) loader/applicator; (2) sewer; (3)
bagger; (4) multiple activities (including cleaning and forklift
operation); and, (5) seed planters.

No chemical-specific handler exposure data were submitted in support of
this use pattern. For assessing seed treatment activities, unit exposure
data were taken from HED Science Advisory Council for Exposure Policy
14: Standard Operating Procedures for Seed Treatment. The amount of ai
handled depends on the application rate (lb ai/100 lb seed) and the
pounds of seed treated in a day (or the pounds of seed that can be
planted in a day), all of which may vary, depending upon the seed type.
Values for the amount of seed treated and planted per day were obtained
from HED's Standard Operating Procedure (SOP) #15. Exposure and risk
estimates for seed treatment handlers were calculated based on canola
data (commercial rate assumed to be 718,000 lb seed/day) for seed
treatment, and flax data for seed planting, which represent the maximum
combination of application rate and amount handled for the proposed
crops. The results are presented in Table 18.

For the proposed seed treatment uses, all seed treatment activities
result in MOEs greater than the LOC of 100 with baseline clothing, or
baseline plus gloves and respirator, and therefore, are not of concern.
While there is a data gap for on-farm seed treatment (i.e., the data
available for on-farm seed treatment represents a dust formulation in a
planter box, which is not applicable) this scenario is not likely to
result in risks of concern because seed treatment activities in the
commercial setting (estimated in Table 18), which handle much greater
quantities of seed, are not of concern. \[Note: The respirator unit
exposure value represents a PF 5 NIOSH-approved filtering face-piece
respirator (e.g., dust mask), which is considered to provide an 80%
reduction in inhalation exposure.\]

The proposed BAS 500 ST label is a supplemental label only, and does not
provide information regarding personal protective equipment (PPE) (i.e.,
whether gloves and a respirator are currently required). In addition,
the minimum level of PPE for handlers is based on acute toxicity for the
end-use product. The Registration Division (RD) is responsible for
ensuring that PPE listed on the label is in compliance with the Worker
Protection Standard (WPS).

+-------+------+-------+------+------+-----+-------+-----+--------+
| **    |      |       |      |      |     |       |     |        |
| Table |      |       |      |      |     |       |     |        |
| 18.   |      |       |      |      |     |       |     |        |
| Su    |      |       |      |      |     |       |     |        |
| mmary |      |       |      |      |     |       |     |        |
| of    |      |       |      |      |     |       |     |        |
| MOEs  |      |       |      |      |     |       |     |        |
| for   |      |       |      |      |     |       |     |        |
| Seed  |      |       |      |      |     |       |     |        |
| Trea  |      |       |      |      |     |       |     |        |
| tment |      |       |      |      |     |       |     |        |
| Ac    |      |       |      |      |     |       |     |        |
| tivit |      |       |      |      |     |       |     |        |
| ies** |      |       |      |      |     |       |     |        |
+=======+======+=======+======+======+=====+=======+=====+========+
| **    | **De | **In  | **A  | **   | *   |       | *   |        |
| Activ | rmal | halat | ppli | Seed | *Da |       | *Sh |        |
| ity** | Unit | ion** | cati | Han  | ily |       | ort |        |
|       | Expo |       | on** | dled | Dos |       | -/I |        |
|       | sure | **U   |      | per  | e** |       | nt- |        |
|       | (m   | nit** | **Ra | D    |     |       | ter |        |
|       | g/lb |       | te** | ay** | *   |       | m** |        |
|       | ai)  | **    |      |      | *(m |       |     |        |
|       | ^    | Expos | *    | *    | g/k |       | **  |        |
|       | 1^** | ure** | *(lb | *(lb | g/d |       | MOE |        |
|       |      |       | a    | s    | ay) |       | ^5  |        |
|       |      | **(   | i/** | eed) | ^4  |       | ^** |        |
|       |      | mg/lb |      | ^    | ^** |       |     |        |
|       |      | ai)   | **lb | 3^** |     |       |     |        |
|       |      | ^1^** | s    |      |     |       |     |        |
|       |      |       | eed) |      |     |       |     |        |
|       |      |       | ^    |      |     |       |     |        |
|       |      |       | 2^** |      |     |       |     |        |
+-------+------+-------+------+------+-----+-------+-----+--------+
|       |      |       |      |      | *   | **In  | *   | **     |
|       |      |       |      |      | *De | halat | *De | Inhala |
|       |      |       |      |      | rma | ion** | rma | tion** |
|       |      |       |      |      | l** |       | l** |        |
+-------+------+-------+------+------+-----+-------+-----+--------+
| **Lo  | 0    | 0.    | 0.   | 718  | 0.  | 0     | 320 | 160    |
| ader/ | .023 | 00034 | 0004 | ,000 | 015 | .0014 |     |        |
| Ap    |      |       |      |      |     |       |     |        |
| plica | (w   |       |      |      |     |       |     |        |
| tor** | /glo |       |      |      |     |       |     |        |
|       | ves) |       |      |      |     |       |     |        |
+-------+------+-------+------+------+-----+-------+-----+--------+
| **Se  | 0.   | 0.    |      |      | 0.0 | 0.    | 1,  | 240    |
| wer** | 0062 | 00023 |      |      | 042 | 00094 | 200 |        |
+-------+------+-------+------+------+-----+-------+-----+--------+
| **Bag | 0.   | 0.    |      |      | 0.0 | 0.    | 820 | 350    |
| ger** | 0091 | 00016 |      |      | 061 | 00066 |     |        |
+-------+------+-------+------+------+-----+-------+-----+--------+
| **    | 0    | 0     |      |      | 0.  | 0     | 180 | 35     |
| Multi | .042 | .0016 |      |      | 028 | .0066 |     |        |
| ple** |      |       |      |      |     |       |     | or     |
|       | (w   | or    |      |      |     | or    |     |        |
| **    | /glo |       |      |      |     |       |     | 180    |
| Activ | ves) | 0.    |      |      |     | 0     |     |        |
| ity** |      | 00032 |      |      |     | .0013 |     | (w     |
|       |      |       |      |      |     |       |     | /respi |
|       |      | (w/r  |      |      |     | (w/r  |     | rator) |
|       |      | espir |      |      |     | espir |     |        |
|       |      | ator) |      |      |     | ator) |     |        |
+-------+------+-------+------+------+-----+-------+-----+--------+
| *     | No   | No    |      | 6    | \-- | \--   | \-- | \--    |
| *On-F | data | data  |      | ,700 |     |       |     |        |
| arm** |      |       |      |      |     |       |     |        |
+-------+------+-------+------+------+-----+-------+-----+--------+
| *     | 0.25 | 0     |      |      | 0.0 | 0.    | 3,  | 1,800  |
| *Seed |      | .0034 |      |      | 016 | 00013 | 200 |        |
| Plan  | (w   |       |      |      |     |       |     |        |
| ter** | /glo |       |      |      |     |       |     |        |
|       | ves) |       |      |      |     |       |     |        |
+-------+------+-------+------+------+-----+-------+-----+--------+

^1^ Dermal unit exposure values represent baseline clothing (long pants,
long sleeved shirts, shoes, and socks), except where gloves are
indicated (for planting, gloves are for loading only). Inhalation unit
exposure values represent no respirator, except for "multiple activity"
scenario. There is a data gap for on-farm seed treatment; the
formulation is a water-dispersible granule for which the label indicates
standard slurry or mist-type seed treatment equipment should be used.
The data available for on-farm seed treatment represents a dust
formulation in a planter box scenario, which is not applicable.

^2^ Application rates are based on maximum values in proposed seed
treatment label (See Table 1)

^3^ Number range CHAPTERValues for amount of seed handled for all
activities are based on an assumed rate for canola, except the on-farm
and planter scenarios, which were based on flax.

^4^ Daily Dose (mg/kg/day) = (Unit Exposure \* % Absorption \*
Application rate \* Seed Handled) / Body Weight of 60-kg for dermal or
70-kg for inhalation; where dermal absorption is 14%.

^5^ Short-/Intermediate-Term MOE = NOAEL / Daily Dose. The dermal NOAEL
is 5 mg/kg/day, and the inhalation NOAEL is 0.23 mg/kg/day. The LOC is
100.

**9.2 Short-/Intermediate-Term Postapplication
Risk**[]{#__RefHeading___Toc191365846 .anchor}

This Section 3 action for pyraclostrobin involves foliar applications to
agricultural crops. Therefore, postapplication exposure is possible for
workers entering treated fields. Chemical-specific dislodgeable foliar
residue (DFR) data had previously been submitted by the registrant to
support earlier registration requests for food crops (MRID#s: 45118727,
45118724, 45118726, and 45118728 and 45118729). An overview of each
study was provided in a previous assessment (D269670, K. O'Rourke,
9/30/2002); a summary of the results is provided in Table 19.

The DFR data were used to estimate restricted entry intervals (REIs) by
extrapolating, where possible, to the proposed crops. It was found that
the type of formulation used influences the DFR profile; therefore, DFR
data for both the emulsifiable concentrate and water-dispersible granule
formulations were considered. Average percent initial DFR values were
calculated (i.e., 18% for emulsifiable concentrate and 20% for
water-dispersible granule) and used to estimate surrogate residue values
for each crop, according to its proposed formulation. Although
uncertainties are introduced into the assessment when crop-specific
residues are used to estimate residues for other types of crops, it is
believed to be more realistic than using default assumptions

In addition to these residue data, transfer coefficients (Tc) are used
to relate the foliage residues to activity patterns (e.g., scouting) to
estimate potential human exposure. The transfer coefficients used in
this assessment are from an interim transfer coefficient policy
developed by HED's Science Advisory Council for Exposure using
proprietary data from the Agricultural Re-entry Task Force (ARTF)
database (policy \# 3.1).

The estimated short-/intermediate-term MOEs are presented in Table 20.
The results of the postapplication exposure and risk assessment indicate
that MOEs of 100 are achieved on Day 0 for all scenarios and, therefore,
are not of concern.

The pyraclostrobin technical material has been classified in Toxicity
Category III for acute dermal, primary eye irritation, and primary skin
irritation. Per the Worker Protection Standard (WPS), a 12-hr restricted
entry interval (REI) is required for chemicals classified under Toxicity
Category III or IV. The proposed labels indicate an REI of 12 hrs, which
is in compliance with the WPS.

<table>
<colgroup>
<col style="width: 11%" />
<col style="width: 9%" />
<col style="width: 10%" />
<col style="width: 11%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 7%" />
<col style="width: 10%" />
<col style="width: 11%" />
<col style="width: 8%" />
</colgroup>
<thead>
<tr class="header">
<th colspan="10"><strong>Table 19. Summary of DFR Study
Results</strong></th>
</tr>
<tr class="odd">
<th><strong>Crop</strong></th>
<th><p><strong>Location</strong></p>
<p><strong>(state)</strong></p></th>
<th><strong>Formu-lation</strong></th>
<th><p><strong>Application Rate</strong></p>
<p><strong>(lb ai/A)</strong></p></th>
<th><p><strong>Number</strong></p>
<p><strong>of Apps.</strong></p></th>
<th><strong>Interval</strong></th>
<th><strong>r<sup>2</sup></strong></th>
<th><p><strong>Initial DFR</strong></p>
<p><strong>(% of</strong></p>
<p><strong>Appl. Rate)</strong></p></th>
<th><p><strong>Dissipation</strong></p>
<p><strong>(% per day)</strong></p></th>
<th><strong>Half-life (days)</strong></th>
</tr>
</thead>
<tbody>
<tr class="odd">
<td>peaches</td>
<td>CA</td>
<td>WDG</td>
<td>0.12</td>
<td>5</td>
<td>7 days</td>
<td>0.84</td>
<td>22</td>
<td>2</td>
<td>27.8</td>
</tr>
<tr class="even">
<td>peaches</td>
<td>GA</td>
<td>WDG</td>
<td>0.12</td>
<td>5</td>
<td>7 days</td>
<td>0.97</td>
<td>15</td>
<td>11</td>
<td>6</td>
</tr>
<tr class="odd">
<td>peaches</td>
<td>PA</td>
<td>WDG</td>
<td>0.12</td>
<td>5</td>
<td>7 days</td>
<td>0.94</td>
<td>22</td>
<td>9</td>
<td>7.7</td>
</tr>
<tr class="even">
<td colspan="2">Peaches Average</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>20</td>
<td>7</td>
<td></td>
</tr>
<tr class="odd">
<td>strawberries</td>
<td>NC</td>
<td>WDG</td>
<td>0.18</td>
<td>5</td>
<td>7 days</td>
<td>0.77</td>
<td>26</td>
<td>15</td>
<td>4.2</td>
</tr>
<tr class="even">
<td>strawberries</td>
<td>CA</td>
<td>WDG</td>
<td>0.18</td>
<td>5</td>
<td>7 days</td>
<td>0.98</td>
<td>25</td>
<td>15</td>
<td>4.4</td>
</tr>
<tr class="odd">
<td>strawberries</td>
<td>OR</td>
<td>WDG</td>
<td>0.18</td>
<td>5</td>
<td>7 days</td>
<td>0.91</td>
<td>12</td>
<td>13</td>
<td>4.9</td>
</tr>
<tr class="even">
<td colspan="2">Strawberry Average</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>21</td>
<td>14</td>
<td></td>
</tr>
<tr class="odd">
<td>peanuts</td>
<td>NC</td>
<td>EC</td>
<td>0.25</td>
<td>5</td>
<td>14 days</td>
<td>0.91</td>
<td>18</td>
<td>26</td>
<td>2.3</td>
</tr>
<tr class="even">
<td>peanuts</td>
<td>GA</td>
<td>EC</td>
<td>0.25</td>
<td>5</td>
<td>14 days</td>
<td>0.77</td>
<td>17</td>
<td>61*</td>
<td>0.74</td>
</tr>
<tr class="odd">
<td>peanuts</td>
<td>TX</td>
<td>EC</td>
<td>0.25</td>
<td>5</td>
<td>14 days</td>
<td>0.91</td>
<td>18</td>
<td>24</td>
<td>2.5</td>
</tr>
<tr class="even">
<td colspan="2">Peanuts Average</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>18</td>
<td>25*</td>
<td></td>
</tr>
<tr class="odd">
<td>grapes</td>
<td>CA</td>
<td>WDG</td>
<td>0.18</td>
<td>3</td>
<td>14 days</td>
<td>0.97</td>
<td>22</td>
<td>6</td>
<td>11.1</td>
</tr>
<tr class="even">
<td>grapes</td>
<td>WA</td>
<td>WDG</td>
<td>0.18</td>
<td>3</td>
<td>14 days</td>
<td>0.94</td>
<td>25</td>
<td>6</td>
<td>11.8</td>
</tr>
<tr class="odd">
<td>grapes</td>
<td>PA</td>
<td>WDG</td>
<td>0.18</td>
<td>3</td>
<td>14 days</td>
<td>0.82</td>
<td>14</td>
<td>4</td>
<td>15.6</td>
</tr>
<tr class="even">
<td colspan="2">Grapes WDG Average</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>20</td>
<td>5</td>
<td></td>
</tr>
<tr class="odd">
<td>grapes</td>
<td>CA</td>
<td>EC</td>
<td>0.18</td>
<td>3</td>
<td>14 days</td>
<td>0.95</td>
<td>14</td>
<td>9</td>
<td>7.4</td>
</tr>
<tr class="even">
<td>grapes</td>
<td>WA</td>
<td>EC</td>
<td>0.18</td>
<td>3</td>
<td>14 days</td>
<td>0.9</td>
<td>22</td>
<td>9</td>
<td>7.5</td>
</tr>
<tr class="odd">
<td>grapes</td>
<td>PA</td>
<td>EC</td>
<td>0.18</td>
<td>3</td>
<td>14 days</td>
<td>0.79</td>
<td>12</td>
<td>5</td>
<td>13.9</td>
</tr>
<tr class="even">
<td>grapes</td>
<td>CA</td>
<td>EC</td>
<td>0.15</td>
<td>6</td>
<td>10 days</td>
<td>0.9</td>
<td>6</td>
<td>6</td>
<td>12</td>
</tr>
<tr class="odd">
<td>grapes</td>
<td>NY</td>
<td>EC</td>
<td>0.15</td>
<td>6</td>
<td>10 days</td>
<td>0.92</td>
<td>28</td>
<td>6</td>
<td>11.2</td>
</tr>
<tr class="even">
<td>grapes</td>
<td>WA</td>
<td>EC</td>
<td>0.15</td>
<td>6</td>
<td>10 days</td>
<td>0.9</td>
<td>24</td>
<td>4</td>
<td>17.3</td>
</tr>
<tr class="odd">
<td colspan="2">Grapes EC Average</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>18</td>
<td>7</td>
<td></td>
</tr>
<tr class="even">
<td colspan="2"><strong>EC Average</strong></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><strong>18</strong></td>
<td><strong>13</strong></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="2">WDG Average</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>20</td>
<td>9</td>
<td></td>
</tr>
</tbody>
</table>

WDG = water dispersible granule

EC = emulsifiable concentrate

\* The results from the Georgia site reflect uncharacteristically high
rainfall during the monitoring period. This is not representative of
typical conditions, therefore, the dissipation from this site was not
included in the average.

+------+-------+----+------+------+------------------------+---------+
| **T  |       |    |      |      |                        |         |
| able |       |    |      |      |                        |         |
| 20.  |       |    |      |      |                        |         |
| Sum  |       |    |      |      |                        |         |
| mary |       |    |      |      |                        |         |
| of   |       |    |      |      |                        |         |
| E    |       |    |      |      |                        |         |
| stim |       |    |      |      |                        |         |
| ated |       |    |      |      |                        |         |
| Pos  |       |    |      |      |                        |         |
| tapp |       |    |      |      |                        |         |
| lica |       |    |      |      |                        |         |
| tion |       |    |      |      |                        |         |
| MOEs |       |    |      |      |                        |         |
| for  |       |    |      |      |                        |         |
| Fo   |       |    |      |      |                        |         |
| liar |       |    |      |      |                        |         |
| Trea |       |    |      |      |                        |         |
| tmen |       |    |      |      |                        |         |
| ts** |       |    |      |      |                        |         |
+======+=======+====+======+======+========================+=========+
| **Cr | **A   | *  | *    | **TC | **Activity ^4^**       | *       |
| op** | pplic | *D | *DFR | ^    |                        | *Short- |
|      | ation | AT | ^    | 4^** |                        | /Int-** |
|      | R     | ^  | 3^** |      |                        |         |
|      | ate** | 2^ |      | **   |                        | **Term  |
|      |       | ** | **   | (cm^ |                        | MOE     |
|      | **(lb |    | (μg/ | 2^/h |                        | ^5^**   |
|      | ai/A) |    | cm^2 | r)** |                        |         |
|      | ^1^** |    | ^)** |      |                        |         |
+------+-------+----+------+------+------------------------+---------+
| Ca   | 0.10  | 0  | 0.20 | 100  | Irrigating and         | 13,000  |
| nola |       |    |      |      | scouting immature/low  |         |
| &    |       |    |      |      | foliage plants         |         |
| Flax |       |    |      |      |                        |         |
+------+-------+----+------+------+------------------------+---------+
|      |       |    |      | 1    | Irrigating and         | 890     |
|      |       |    |      | ,500 | scouting mature/high   |         |
|      |       |    |      |      | foliage plants         |         |
+------+-------+----+------+------+------------------------+---------+
| Oats | 0.15  | 0  | 0.30 | 100  | Irrigating and         | 8,900   |
|      |       |    |      |      | scouting immature/low  |         |
|      |       |    |      |      | foliage plants         |         |
+------+-------+----+------+------+------------------------+---------+
|      |       |    |      | 1    | Irrigating and         | 590     |
|      |       |    |      | ,500 | scouting mature/high   |         |
|      |       |    |      |      | foliage plants         |         |
+------+-------+----+------+------+------------------------+---------+
| H    |       | 0  | 0.34 | 500  | Irrigation, scouting,  | 1,600   |
| erbs |       |    |      |      | thinning, weeding      |         |
|      |       |    |      |      | immature plants        |         |
+------+-------+----+------+------+------------------------+---------+
|      |       |    |      | 1    | Irrigating and         | 530     |
|      |       |    |      | ,500 | scouting mature plants |         |
+------+-------+----+------+------+------------------------+---------+
|      |       |    |      | 2    | Hand harvesting,       | 320     |
|      |       |    |      | ,500 | pruning, and thinning  |         |
|      |       |    |      |      | mature plants          |         |
+------+-------+----+------+------+------------------------+---------+
| Trop |       | 0  | 0.34 | 100  | Propping               | 8,000   |
| ical |       |    |      |      |                        |         |
| F    |       |    |      |      |                        |         |
| ruit |       |    |      |      |                        |         |
+------+-------+----+------+------+------------------------+---------+
|      |       |    |      | 1    | Irrigation, scouting,  | 800     |
|      |       |    |      | ,000 | weeding                |         |
+------+-------+----+------+------+------------------------+---------+
|      |       |    |      | 1    | Harvesting, pruning,   | 530     |
|      |       |    |      | ,500 | training, tying        |         |
+------+-------+----+------+------+------------------------+---------+
|      |       |    |      | 3    | Thinning               | 270     |
|      |       |    |      | ,000 |                        |         |
+------+-------+----+------+------+------------------------+---------+

> ^1^ Maximum application rate indicated on proposed labels (see Table
> 1).
>
> ^2^ DAT = Days after treatment needed to reach the LOC of 100; DAT 0 =
> the day of treatment, after sprays have dried; assumed to be
> approximately 12 hours.
>
> ^3^ DFR (µg/cm^2^) = Application rate (lb ai/A) x CF (4.54E+8 ug/lb) x
> CF (2.47E-8 A/cm^2^) x Initial Fraction of ai Retained on the Foliage
> (from Table 19, used EC average \[18%\] for canola, flax and oats, and
> WDG average \[20%\] for herbs and tropical fruits).
>
> ^4^ TC (cm^2^/hr) = transfer coefficients and associated activities
> from ExpoSAC Policy Memo #003.1 "Agricultural Transfer Coefficients",
> 8/17/2000.
>
> ^5^ MOE = MOE on the corresponding DAT. MOE = NOAEL / Daily Dose.
>
> Daily Dose = \[(DFR x TC x 14% Dermal absorption x 8-hr Exposure
> Time)\] / \[(CF: 1000 µg/mg) x (60-kg Body Weight)\]
>
> Short-/intermediate-term Dermal NOAEL = 5 mg/kg/day. The LOC is 100.

**10.0 Data Needs and Label
Recommendations**[]{#__RefHeading___Toc191365847 .anchor}

**10.1 Residue Chemistry Data Needs and Label
Recommendations**[]{#__RefHeading___Toc191365848 .anchor}

**For Petition #6F7105**

[860.1500 Crop Field Trials]{.underline}

[]{.mark}

[Oats]{.underline}: No residue data are submitted for oat forage. The
petitioner did not provide residue data or propose a tolerance for oat
forage because applications are made after the growth stages at which
oat is foraged. Based on the current proposed use patterns, the Agency
will not require residue data or a tolerance for oat forage.

[860.1900 Field Accumulation in Rotational Crops]{.underline}

Label revisions are required to specify a 14-day plantback interval
restriction for all annual crops that are not registered.

[860.1550 Proposed Tolerances]{.underline}

The petitioner should submit a revised Section F reflecting the
recommended tolerances and commodity definitions presented in Table 14.

The petitioner should submit a revised Section F to propose individual
tolerances of 0.45 ppm for all oilseeds in subgroups rapeseed,
sunflower, and cotton, as follows: 1) [rapeseed]{.underline} (i.e.,
borage, crambe, cuphea, echium, flax seed, gold of pleasure, hare's ear
mustard, lesquerella, lunaria, meadowfoam, milkweed, mustard seed, oil
radish, poppy seed, rapeseed, sesame, and sweet rocket); 2)
[sunflower]{.underline} (i.e., Castor oil plant, Chinese tallowtree,
Euphorbia, Evening primrose, Jojoba, Niger seed, Rose hip, Safflower,
Stokes aster, Sunflower, Tallowwood, Tea oil plant, Vernonia ); and 3)
[cotton]{.underline} (only entry presently in this subgroup).

Note: The existing tolerances on sunflower at 0.3 ppm and cotton,
undelinted seed at 0.3 ppm should be removed from 40 CFR §180.582.

[860.1520 Processed Food and Feed]{.underline}

[Oats]{.underline}: No residue data for the oat processed commodities
(flour and groats/rolled oats) are submitted. However, data from the
wheat processing studies (MRID #'s 45118620 and 45321101) can be
translated to adequately support the proposed use on oat. Based on the
wheat studies, residues are not expected to concentrate in oat processed
commodities.

[Barley]{.underline}: No residue data for the barley processed
commodities (bran and pearled) are submitted. However, data from the
wheat processing studies (MRID #'s 45118620 and 45321101) can be
translated to adequately support the proposed use on barley. Based on
the wheat studies, residues are not expected to concentrate in barley
processed commodities.

**For Petition #6E7165**

[860.1500 Crop Field Trials]{.underline}

The submitted residue data for avocado are inadequate to fulfill data
requirements because the field trials were conducted at exaggerated
rates (ca 2.6x). Since the submitted data represent an overestimate of
the residues expected from the proposed use, HED considers that the
tolerance for avocado may need to be reduced. Also, since the proposed
use is for late season foliar application, includes a 0-day preharvest
interval, and these data are being translated to support a wide number
of tropical/subtropical fruits, HED requests that the petitioner provide
additional, bridging field trial data (i.e., two to three field trials
at the proposed label rate of 2 applications, total 0.3 lb ai/season) as
a condition of registration.

[860.1900 Field Accumulation in Rotational Crops]{.underline}

Label revisions are required to specify a 14-day plantback interval
restriction for all annual crops that are not registered.

[860.1550 Proposed Tolerances]{.underline}

The petitioner should submit a revised Section F to correct the
tolerance residue definition (parent + metabolite) and to make it
consistent with the definition listed in 40 CFR §180.582 (a)(1). The
revised Section F should also incorporate the recommended tolerances and
commodity definitions presented in Table 14.

**For Petition #7E7245**

[860.1500 Crop Field Trials]{.underline}

[]{.mark}

[Barley:]{.underline} No residue data were submitted for barley forage,
and these data are normally required to support the amended use pattern.
However, the petitioner did not provide residue data or propose a
tolerance for barley hay because applications are made after the growth
stages at which barley hay is harvested. Based on the current proposed
use patterns, the Agency will not require residue data or a tolerance
for barley hay.

[860.1520 Processed Food and Feed]{.underline}

[Barley]{.underline}: Residue data for the barley processed commodities
(pearled barley and bran) are normally required. However, data from the
wheat processing studies (MRID #'s 45118620 and 45321101) can be
translated to adequately support the proposed use on barley. Based on
the wheat studies, residues are not expected to concentrate in barley
processed commodities.

[860.1900 Field Accumulation in Rotational Crops]{.underline}

Label revisions are required to specify a 14-day plantback interval
restriction for all annual crops that are not registered.

[860.1550 Proposed Tolerances]{.underline}

The petitioner should submit a revised Section F reflecting the
recommended tolerances and commodity definitions presented in Table 14.

**10.2 Occupational Label
Recommendations**[]{#__RefHeading___Toc191365849 .anchor}

The proposed Headline® Fungicide label requires chemical resistant
gloves; however, a respirator is not indicated and is needed for the
handler scenario of mixing/loading liquids for aerial application or
chemigation.

The proposed BAS 500 ST label is a supplemental label only, and does not
provide information regarding personal protective equipment (PPE). Such
PPE information should be added to the label. Gloves are needed for
several seed treatment scenarios, and a respirator is needed for the
multiple activity scenario.

**11.0 International Residue Limit
Status**[]{#__RefHeading___Toc191365850 .anchor}

The Codex Alimentarius Commission, Mexico and Canada have not
established any maximum residue limits (MRLs) for residues of
pyraclostrobin in or on raw agricultural commodities, although a variety
of MRLs are pending in Canada. Therefore, there are no questions of
compatibility of U.S. tolerances with International MRLs at the present
time.

+-------------------+--------------+-------------------+--------------+
| INTERNATIONAL     |              |                   |              |
| RESIDUE LIMIT     |              |                   |              |
| STATUS            |              |                   |              |
+===================+==============+===================+==============+
| > Chemical Name:  | > Common     | >  Proposed      | > Date:      |
| > methyl          | > Name:      | > tolerances      | > 12/20/07   |
| > \[2-\[\[        | >            | >                 |              |
| \[1-(4-chlorophen | > Py         | >  Reevaluated   |              |
| yl)-1*H*-pyrazol- | raclostrobin | > tolerance       |              |
| 3-yl\]oxy\]methyl |              | >                 |              |
| \]phenyl\]methoxy |              | >  Other         |              |
| > carbamate       |              |                   |              |
+-------------------+--------------+-------------------+--------------+
| > Codex Status    |              | > U. S.           |              |
| > (Maximum        |              | > Tolerances      |              |
| > Residue Limits) |              |                   |              |
+-------------------+--------------+-------------------+--------------+
| > No Codex      |              | > Petition        |              |
| > proposal step 6 |              | > Numbers:        |              |
| > or above        |              | > 6E7105, 6E7165, |              |
| >                 |              | > and 7E7245      |              |
| > No Codex      |              | >                 |              |
| > proposal step 6 |              | > DP#s: 334535,   |              |
| > or above for    |              | > 336189, and     |              |
| > the crops       |              | > 343754          |              |
| > requested       |              | >                 |              |
|                   |              | > Other           |              |
|                   |              | > Identifier:     |              |
+-------------------+--------------+-------------------+--------------+
| > Residue         |              | >                 |              |
| > definition      |              | Reviewers/Branch: |              |
| > (step 8/CXL):   |              | > B.              |              |
| > pyraclostrobin  |              | >                 |              |
| > (fat soluble)   |              |  Cropp-Kohlligan, |              |
|                   |              | > G. Otakie, J.   |              |
|                   |              | > Stokes / RRB4   |              |
+-------------------+--------------+-------------------+--------------+
|                   |              | > Residue         |              |
|                   |              | > definition in   |              |
|                   |              | > PP#6E7105,      |              |
|                   |              | > PP#6E7165,and   |              |
|                   |              | > PP#7E7245:      |              |
|                   |              | > Combined        |              |
|                   |              | > residues of     |              |
|                   |              | > pyraclostrobin  |              |
|                   |              | > and BF 500-3,   |              |
|                   |              | > expressed as    |              |
|                   |              | > pyraclostrobin. |              |
+-------------------+--------------+-------------------+--------------+
| > Crop (s)        | > MRL        | > Crop(s)         | >            |
|                   | > (mg/kg)    |                   |  Recommended |
|                   |              |                   | > Tolerance  |
|                   |              |                   | > (ppm)      |
+-------------------+--------------+-------------------+--------------+
| > Oats            | > 0.5        | PP#6E7105         |              |
+-------------------+--------------+-------------------+--------------+
| > Papaya          | > 0.05       | Oats grain        | 1.2          |
+-------------------+--------------+-------------------+--------------+
| > Barley          | > 0.5        | Oats, hay         | 18           |
+-------------------+--------------+-------------------+--------------+
|                   |              | Oats, straw       | 15           |
+-------------------+--------------+-------------------+--------------+
|                   |              | Canola, seed      | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Flax, seed        | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Borage            | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Crambe            | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Cuphea            | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Echium            | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Flax seed         | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Gold of pleasure  | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Hare's ear        | 0.45         |
|                   |              | mustard           |              |
+-------------------+--------------+-------------------+--------------+
|                   |              | Lesquerella       | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Lunaria           | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Meadowfoam        | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Milkweed          | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Mustard seed      | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Oil radish        | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Poppy seed        | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Rapeseed          | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Sesame            | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Sweet rocket      | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Castor oil plant  | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Chinese           | 0.45         |
|                   |              | tallowtree        |              |
+-------------------+--------------+-------------------+--------------+
|                   |              | Euphorbia         | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Evening primrose  | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Jojoba            | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Niger seed        | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Rose hip          | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Safflower         | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Stokes aster      | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Sunflower         | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Tallowwood        | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Tea oil plant     | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Vernonia          | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Cotton            | 0.45         |
+-------------------+--------------+-------------------+--------------+
|                   |              | PP#6E7165         |              |
+-------------------+--------------+-------------------+--------------+
|                   |              | Avocado           | 0.6          |
+-------------------+--------------+-------------------+--------------+
|                   |              | Sapote, black     | 0.6          |
+-------------------+--------------+-------------------+--------------+
|                   |              | Canistel          | 0.6          |
+-------------------+--------------+-------------------+--------------+
|                   |              | Sapote, mamey     | 0.6          |
+-------------------+--------------+-------------------+--------------+
|                   |              | Mango             | 0.6          |
+-------------------+--------------+-------------------+--------------+
|                   |              | Papaya            | 0.6          |
+-------------------+--------------+-------------------+--------------+
|                   |              | Sapodilla         | 0.6          |
+-------------------+--------------+-------------------+--------------+
|                   |              | Star Apple        | 0.6          |
+-------------------+--------------+-------------------+--------------+
|                   |              | PP#7E7245         |              |
+-------------------+--------------+-------------------+--------------+
|                   |              | Barley, grain     | 1.4          |
+-------------------+--------------+-------------------+--------------+
|                   |              | Barley, straw     | 6.0          |
+-------------------+--------------+-------------------+--------------+
| > **Limits for    |              | > **Limits for    |              |
| > Canada**        |              | > Mexico**        |              |
+-------------------+--------------+-------------------+--------------+
| > No Limits      |              | > No Limits      |              |
| >                 |              | >                 |              |
| > No Limits for  |              | > No Limits for  |              |
| > the crops       |              | > the crops       |              |
| > requested       |              | > requested       |              |
+-------------------+--------------+-------------------+--------------+
| > Residue         |              | > Residue         |              |
| > definition:     |              | > definition:     |              |
+-------------------+--------------+-------------------+--------------+
| > Crop(s)         | > MRL        | > Crop(s)         | > MRL (ppm)  |
|                   | > (mg/kg)    |                   |              |
+-------------------+--------------+-------------------+--------------+
|                   |              |                   |              |
+-------------------+--------------+-------------------+--------------+
|                   |              |                   |              |
+-------------------+--------------+-------------------+--------------+
|                   |              |                   |              |
+-------------------+--------------+-------------------+--------------+
| > Notes/Special   |              |                   |              |
| > Instructions:   |              |                   |              |
+-------------------+--------------+-------------------+--------------+

**12.0 Appendix: Toxicity Profile**[]{#__RefHeading___Toc191365851
.anchor}

**12.1 Appendix 1.: Pyraclostrobin Toxicology Requirements and Available
Studies for Food Uses**[]{#__RefHeading___Toc191365852 .anchor}

**Appendix 1: Pyraclostrobin Toxicology Requirements and Available
Studies for Food Uses.**

+-----------------------------------------+-------------+-------------+
| Number range CHAPTER**Test**            | **          |             |
|                                         | Technical** |             |
+=========================================+=============+=============+
|                                         | *           | **          |
|                                         | *Required** | Satisfied** |
+-----------------------------------------+-------------+-------------+
| 870.1100 Acute Oral Toxicity            | yes         | yes         |
|                                         |             |             |
| 870.1200 Acute Dermal Toxicity          | yes         | yes         |
|                                         |             |             |
| 870.1300 Acute Inhalation Toxicity      | yes         | yes         |
|                                         |             |             |
| 870.2400 Primary Eye Irritation         | yes         | yes         |
|                                         |             |             |
| 870.2500 Primary Dermal Irritation      | yes         | yes         |
|                                         |             |             |
| 870.2600 Dermal Sensitization           | yes         | yes         |
+-----------------------------------------+-------------+-------------+
| 870.3100 Oral Subchronic (rodent)       | yes         | yes         |
|                                         |             |             |
| 870.3150 Oral Subchronic (dog)          | yes         | yes         |
|                                         |             |             |
| 870.3200 28-Day Dermal                  | yes         | yes         |
|                                         |             |             |
| 870.3465 28-Day Inhalation              | yes         | yes         |
+-----------------------------------------+-------------+-------------+
| 870.3700a Developmental Toxicity (rat)  | yes         | yes         |
|                                         |             |             |
| 870.3700b Developmental Toxicity        | yes         | yes         |
| (rabbit)                                |             |             |
|                                         | yes         | yes         |
| 870.3800 Reproduction                   |             |             |
+-----------------------------------------+-------------+-------------+
| 870.4100a Chronic Toxicity (rat)        | yes         | yes         |
|                                         |             |             |
| 870.4100b Chronic Toxicity (dog)        | yes         | yes         |
|                                         |             |             |
| 870.4200a Oncogenicity (rat)            | yes         | yes         |
|                                         |             |             |
| 870.4200b Oncogenicity (mouse)          | yes         | yes         |
+-----------------------------------------+-------------+-------------+
| 870.5100 Mutagenicity---Gene Mutation - | yes         | yes         |
| bacterial                               |             |             |
|                                         | yes         | yes         |
| 870.5300 Mutagenicity---Gene Mutation - |             |             |
| mammalian                               | yes         | yes         |
|                                         |             |             |
| 870.5375 Mutagenicity---Structural      | yes         | yes         |
| Chromosomal Aberrations                 |             |             |
|                                         | yes         | yes         |
| 870.5395 Mutagenicity---Microneucleus - |             |             |
| mammalian                               |             |             |
|                                         |             |             |
| 870.5550 Mutagenicity---Unscheduled     |             |             |
| DNA - mammalian                         |             |             |
+-----------------------------------------+-------------+-------------+
| 870.6100a Acute Delayed Neurotox. (hen) | no          | \-          |
|                                         |             |             |
| 870.6100b 90-Day Neurotoxicity (hen)    | no          | \-          |
|                                         |             |             |
| 870.6200a Acute Neurotox. Screening     | yes         | yes         |
| Battery (rat)                           |             |             |
|                                         | yes         | yes         |
| 870.6200b 90 Day Neuro. Screening       |             |             |
| Battery (rat)                           | no          | \-          |
|                                         |             |             |
| 870.6300 Develop. Neuro                 |             |             |
+-----------------------------------------+-------------+-------------+
| 870.7485 General Metabolism             | yes         | yes         |
|                                         |             |             |
| 870.7600 Dermal Penetration             | yes         | yes         |
+-----------------------------------------+-------------+-------------+

**12.2 Appendix 2.: Acute Toxicity Data on Pyraclostrobin
Technical**[]{#__RefHeading___Toc191365853 .anchor}

Number range CHAPTER**Appendix 2. Acute Toxicity Profile:**

  --------------------------------- ---------- ----------------------- ----------
  Number range CHAPTER**Table 1.                                       
  Acute Toxicity Data on                                               
  Pyraclostrobin Technical**                                           

  Study/ Species                    MRID       Results                 Toxicity
                                                                       Category

  870.1100 Acute Oral, Rats         45118302   LD~50~ = \> 5000 mg/kg  IV

  870.1200 Acute Dermal, Rabbits    45118305   LD~50~ = \>2000mg/kg    III

  870.1300 Acute Inhalation, Rats   45118308   0.31 mg/L \< LC~50~ \<  II
                                               1.07 mg/L               

  870.2400 Primary Eye Irritation,  45118311   Moderate eye            III
  Rabbits                                      irritation; MAS 4.6/110 

  870.2500 Primary Skin Irritation, 45118314   Moderate skin           III
  Rabbits                                      irritation; MAS 2.2/8.0 

  870.2600 Dermal Sensitization,    45118317   Not a skin sensitizer   N/A
  Guinea pig                                                           
  --------------------------------- ---------- ----------------------- ----------

**12.3 Appendix 3.: Subchronic, Chronic and Other Toxicity
Profile**[]{#__RefHeading___Toc191365854 .anchor}

+--------------+-------------------+----------------------------------+
| Number range |                   |                                  |
| CHAPT        |                   |                                  |
| ER**Appendix |                   |                                  |
| 3.           |                   |                                  |
| Subchronic,  |                   |                                  |
| Chronic and  |                   |                                  |
| Other        |                   |                                  |
| Toxicity     |                   |                                  |
| Profile**    |                   |                                  |
+==============+===================+==================================+
| **Guideline  | **MRID No.        | **Results**                      |
| No./Study    | (year)/           |                                  |
| Type**       | Class             |                                  |
|              | ification/Doses** |                                  |
+--------------+-------------------+----------------------------------+
| 870.3100     | 45118321 (1999)   | NOAEL = 10.7 mg/kg/day           |
|              |                   |                                  |
| 90-Day oral  | Acc               | LOAEL = 34.7 mg/kg/day based on  |
| toxicity     | eptable/guideline | ↓body weight/ weight gain in     |
| (rat)        |                   | males, ↓food intake (both        |
|              | 0, 50, 150, 500,  | sexes), ↑ relative liver wt and  |
|              | 1000, 1500 ppm    | spleen wt in females and         |
|              |                   | histopathology of duodenum and   |
|              | M: 0, 3.5, 10.7,  | liver in males, and spleen in    |
|              | 34.7, 68.8, 105.8 | both sexes.                      |
|              | mg/kg/day;        |                                  |
|              |                   |                                  |
|              | F: 0, 4.2 12.6,   |                                  |
|              | 40.8, 79.7,118.9  |                                  |
|              | mg/kg/day         |                                  |
+--------------+-------------------+----------------------------------+
| 870.3100     | 45118320 (1999)   | NOAEL = 9.2 mg/kg/day            |
|              |                   |                                  |
| 90-Day oral  | Acc               | LOAEL = 30.4 mg/kg/day based on  |
| toxicity     | eptable/guideline | ↓body weight/ weight gain in     |
|              |                   | males, changes in clinical       |
| (mouse)      | 0, 50, 150, 500,  | chemistry in both sexes          |
|              | 1000, 1500 ppm    | (increased urea and decreased    |
|              |                   | triglycerides), and increased    |
|              | M: 0, 9.2, 30.4,  | incidences in females of lymph   |
|              | 119.4, 274.4,     | node apoptosis, thymus atrophy,  |
|              | 475.5 mg/kg/day   | and ulcer/erosion in the         |
|              |                   | glandular stomach.               |
|              | F:0, 12.9, 40.4,  |                                  |
|              | 162.0, 374.1,     |                                  |
|              | 634.8 mg/kg/day   |                                  |
+--------------+-------------------+----------------------------------+
| 870.3150     | 45118323 (1999)   | NOAEL = 5.8 mg/kg/day            |
|              |                   |                                  |
| 90-Day oral  | Acc               | LOAEL = 12.9 mg/kg/day based on  |
| toxicity     | eptable/guideline | ↑diarrhea, clinical chem.        |
| (dog)        |                   | changes, and increased incidence |
|              | 0, 100, 200, 450  | of thickening/ mucosal           |
|              | ppm               | hypertrophy of the duodenum in   |
|              |                   | both sexes; body weight loss,    |
|              | M: 0, 2.8, 5.8,   | and ↓food intake/efficiency in   |
|              | 12.9 mg/kg/day    | females.                         |
|              |                   |                                  |
|              | F: 0, 3.0, 6.2,   |                                  |
|              | 13.6 mg/kg/day    |                                  |
+--------------+-------------------+----------------------------------+
| 870.3050     | MRID 45118322     | NOAEL = 9.0 mg/kg/day            |
|              | (1999)            |                                  |
| 28-Day oral  |                   | LOAEL = 42.3 mg/kg/day based on  |
| toxicity     | Acc               | changes in hematology            |
| (rat)        | eptable/guideline | parameters, increased absolute   |
|              |                   | and relative spleen weight,      |
|              | 0, 20, 100, 500,  | histopathology in spleen and     |
|              | 1500 ppm          | liver, in addition to increased  |
|              |                   | duodenal mucosal hyperplasia in  |
|              | M: 0, 1.8, 9.0,   | both sexes.                      |
|              | 42.3, 120.2       |                                  |
|              | mg/kg/day         |                                  |
|              |                   |                                  |
|              | F: 0, 2.0 9.6,    |                                  |
|              | 46.6, 126.3       |                                  |
|              | mg/kg/day         |                                  |
+--------------+-------------------+----------------------------------+
| 870.3200     | 45118324 (1999)   | Dermal NOAEL = 40 mg/kg/day      |
|              | Unacc             |                                  |
| 28-Day       | eptable/guideline | Dermal LOAEL = 100 mg/kg/day     |
| dermal       | (a higher dose    | based on scale formation,        |
| toxicity     | could be          | hyperkeratosis, and epidermal    |
| (rat)        | tolerated and the | thickening.                      |
|              | limit dose is     |                                  |
|              | 1000 mg/kg/day)   | Systemic NOAEL = 250 mg/kg/day   |
|              |                   |                                  |
|              | 0, 40, 100, 250   | Systemic LOAEL \> 250 mg/kg/day  |
|              | mg/kg for 5       |                                  |
|              | days/wk           | The HIARC (TXR 0051553)          |
|              |                   | determined that a repeat study   |
|              |                   | at a higher dose is not needed   |
|              |                   | since an oral end-point          |
|              |                   | (developmental toxicity NOAEL of |
|              |                   | 5.0 mg/kg/day) with a 14% dermal |
|              |                   | absorption rate yields a dermal  |
|              |                   | equivalent dose of 36 mg/kg/day  |
|              |                   | (5 ÷ 0.14) which is well below   |
|              |                   | the apparent systemic toxicity   |
|              |                   | NOAEL of 250 mg/kg/day in the    |
|              |                   | dermal study.                    |
+--------------+-------------------+----------------------------------+
| 870.3465     | 46638801 (2005)   | Inhalation NOAEL = 0.001 mg/L    |
|              |                   | (oral equivalent dose = 0.23     |
| 28-Day       | Acc               | mg/kg/day)                       |
| inhalation   | eptable/guideline |                                  |
| toxicity     |                   | Inhalation LOAEL = 0.030 mg/L    |
| (rat)        | 0.001, 0.030, or  | (oral equivalent dose = 6.9      |
|              | 0.300 mg/L for 6  | mg/kg/day) based on findings of  |
|              | hours per day, 5  | hyperplasia in the duodenum,     |
|              | days/week (20     | alveolar histiocytosis in the    |
|              | exposure days) -- | lungs, and olfactory             |
|              | Test substance    | atrophy/necrosis in the nasal    |
|              | was dissolved in  | tissues.                         |
|              | acetone and       |                                  |
|              | administered as   |                                  |
|              | an aerosol        |                                  |
+--------------+-------------------+----------------------------------+
| 870.3700a    | 45118325 (1999)   | **Maternal** NOAEL = 10          |
|              |                   | mg/kg/day                        |
| Prenatal     | Acc               |                                  |
| d            | eptable/guideline | LOAEL = 25 mg/kg/day based on    |
| evelopmental |                   | ↓body wt/ wt gain and ↓food      |
| (rat)        | 0, 10, 25, 50     | intake/efficiency.               |
|              | mg/kg/day         |                                  |
|              |                   | **Developmental** NOAEL = 25     |
|              |                   | mg/kg/day                        |
|              |                   |                                  |
|              |                   | LOAEL = 50 mg/kg/day based on ↑  |
|              |                   | incidences of dilated renal      |
|              |                   | pelvis and cervical ribs with no |
|              |                   | cartilage.                       |
+--------------+-------------------+----------------------------------+
| 870.3700b    | 45118326 and      | **Materna**l NOAEL = 5 mg/kg/day |
|              | 45437001 (1999)   |                                  |
| Prenatal     | Acc               | LOAEL = 10 mg/kg/day based on ↓  |
| d            | eptable/guideline | body wt gain and ↓food           |
| evelopmental |                   | intake/efficiency.               |
| (rabbit)     | 0, 1, 3, 5, 10,   |                                  |
|              | 20 mg/kg/day      | **Developmenta**l NOAEL = 5      |
|              |                   | mg/kg/day                        |
|              |                   |                                  |
|              |                   | LOAEL =10 mg/kg/day based on ↑   |
|              |                   | resorption/post-implantation     |
|              |                   | loss.                            |
+--------------+-------------------+----------------------------------+
| 870.3800     | **Two             | **Parental/Systemic** NOAEL = 29 |
|              | Generation**:     | mg/kg/day                        |
| Reproduction | MRID 45118327     |                                  |
| and          | (1999)            | LOAEL \> 29 mg/kg/day based on   |
| fertility    | Acc               | no effects.                      |
| effects      | eptable/guideline |                                  |
|              | when combined     | **Reproductive** NOAEL = 29      |
| (rat)        | with the one      | mg/kg/day                        |
|              | generation        |                                  |
|              | preliminary study | LOAEL \> 29 mg/kg/day based on   |
|              | (below)           | no effects.                      |
|              |                   |                                  |
|              | 0, 25, 75, 300    | **Offspring** NOAEL = 29         |
|              | ppm               | mg/kg/day                        |
|              |                   |                                  |
|              | F0 M/F: 0,        | LOAEL \> 29 mg/kg/day based on   |
|              | 2.5/2.6, 7.4/7.8, | no effects.                      |
|              | 29.0/30.4         |                                  |
|              | mg/kg/day         | **Offspring** NOAEL \< 20.5      |
|              |                   | mg/kg/day                        |
|              | F1 M/F: 0,        |                                  |
|              | 2.8/3.0, 8.6/9.0, | **Offspring** LOAEL = 20.5       |
|              | 35.0/36.0         | mg/kg/day based on decreased pup |
|              | mg/kg/day         | body weight and body weight gain |
|              |                   | on and after post-natal day 7.   |
|              | **One             |                                  |
|              | Generation**:     |                                  |
|              | MRID 45596210     |                                  |
|              | (2002)            |                                  |
|              |                   |                                  |
|              | 0, 200, 400, 600  |                                  |
|              | ppm               |                                  |
|              |                   |                                  |
|              | F0 M/F: 0,        |                                  |
|              | 20.5/21.3,        |                                  |
|              | 39.9/42.5,        |                                  |
|              | 59.1/60.4         |                                  |
|              | mg/kg/day         |                                  |
+--------------+-------------------+----------------------------------+
| 870.4100a    | 45118329 (1999)   | NOAEL = 9.0 mg/kg/day            |
|              | Unacc             |                                  |
| Chronic      | eptable/guideline | LOAEL \> 9.0 mg/kg/day.          |
| toxicity     |                   |                                  |
|              | 0, 25, 75, 200    |                                  |
| (rat)        | ppm               |                                  |
|              |                   |                                  |
|              | M: 0, 1.1, 3.4,   |                                  |
|              | 9.0 mg/kg/day     |                                  |
|              |                   |                                  |
|              | F: 0, 1.5, 4.6,   |                                  |
|              | 12.3 mg/kg/day    |                                  |
+--------------+-------------------+----------------------------------+
| 870.4100b    | 45118328 (1999)   | NOAEL = 5.4 mg/kg/day            |
|              |                   |                                  |
| Chronic      | Acc               | LOAEL = 10.8 mg/kg/day based on  |
| toxicity     | eptable/guideline | ↑ diarrhea and clinical          |
| (dog)        |                   | chemistry changes in both sexes  |
|              | 0, 100, 200, 400  | (decreased cholesterol, protein, |
|              | ppm               | albumin, and globulin), and ↓    |
|              |                   | body weight gain and ↓food       |
|              | M: 0, 2.7, 5.4,   | intake/efficiency in females.    |
|              | 10.8 mg/kg/day    |                                  |
|              |                   |                                  |
|              | F: 0, 2.7, 5.4,   |                                  |
|              | 11.2 mg/kg/day    |                                  |
+--------------+-------------------+----------------------------------+
| 870.4200     | 45118331 (1999)   | NOAEL = 3.4 mg/kg/day            |
|              |                   |                                  |
| Car          | Acc               | LOAEL = 9.2 mg/kg/day based on ↓ |
| cinogenicity | eptable/guideline | body weight and body weight      |
|              |                   | gain, and kidney atrophy/tubular |
| (rat)        | 0, 25, 75, 200    | casts in both sexes; hepatic     |
|              | ppm               | necrosis and gross/ microscopic  |
|              |                   | ulcerations/lesions in the       |
|              | M: 0, 1.2, 3.4,   | glandular and fore-stomachs in   |
|              | 9.2 mg/kg/day     | males.                           |
|              |                   |                                  |
|              | F: 0, 1.5, 4.7,   | **No evidence of                 |
|              | 12.6 mg/kg/day    | carcinogenicity**                |
+--------------+-------------------+----------------------------------+
| 870.4300     | 45118330 (1999)   | NOAEL = M: 4.1 mg/kg/day         |
|              | Unacc             |                                  |
| Car          | eptable/guideline | F: 32.8 mg/kg/day                |
| cinogenicity |                   |                                  |
|              | M: 0, 10, 30, 120 | LOAEL = M: 17.1 mg/kg/day based  |
| (mouse)      | ppm               | on decrease in body weight gain  |
|              |                   | (20%) at 13 weeks which was      |
|              | 0, 1.4, 4.1, 17.2 | supported by the results of a    |
|              | mg/kg/day         | 90-day study.                    |
|              |                   |                                  |
|              | F: 0, 10, 30,     | F \>32.8 mg/kg/day               |
|              | 120, 180 ppm      |                                  |
|              |                   | Inadequate dosing in females     |
|              | 0, 1.6, 4.8,      | based on CARC Report dated       |
|              | 20.5, 32.8        | 10/22/03 (TXR \# 0051445)        |
|              | mg/kg/day         |                                  |
|              |                   | **No evidence of                 |
|              |                   | carcinogenicity**                |
+--------------+-------------------+----------------------------------+
| Gene         | 45118332 (1997)   | **Negative** ± S9 up to 5,000    |
| Mutation     |                   | μg/plate by standard plate and   |
|              | Acc               | tube preincubation. No           |
| 870.870.5100 | eptable/guideline | cytotoxicity at any dose but     |
|              |                   | there was precipitation at       |
| Bacterial    |                   | ≥2,500 μg/plate.                 |
| reverse      |                   |                                  |
| mutation     |                   |                                  |
| assay        |                   |                                  |
+--------------+-------------------+----------------------------------+
| Gene         | 45118335 (1998)   | **Negative** ± S9 up to          |
| Mutation     |                   | cytotoxic and precipitating      |
|              | Acc               | concentration of 20 μg/mL        |
| 870.5300     | eptable/guideline |                                  |
|              |                   |                                  |
| Mammalian    |                   |                                  |
| cell culture |                   |                                  |
+--------------+-------------------+----------------------------------+
| Cytogenetics | 45118333 (1999)   | **Negative** ± S9 for            |
| (*in vitro*) |                   | clastogenic/aneugenic activity   |
|              | Acc               | up to 25 μg/mL. Precipitation    |
| 870.5375     | eptable/guideline | and cytotoxicity (reduced cell   |
| Chromosomal  |                   | attachment and poor quality of   |
| aberrations  |                   | metaphases) were seen at         |
|              |                   | concentrations ≥50 μg/mL.        |
+--------------+-------------------+----------------------------------+
| Cytogenetics | 45118334 (1998)   | **Negative** for                 |
|              |                   | clastogenic/aneugenic activity   |
| 870.5395     | Acc               | up to the highest dose tested    |
|              | eptable/guideline | (300 mg/kg). In a preliminary    |
| Micronucleus |                   | study, doses ≥400 mg/kg caused   |
| test in      |                   | death.                           |
| mouse        |                   |                                  |
+--------------+-------------------+----------------------------------+
| Unscheduled  | 45118336 (1998)   | **Negative** up to a cytotoxic   |
| DNA          |                   | concentration of 1.0 µg/mL.      |
| synthesis    | Acc               |                                  |
|              | eptable/guideline |                                  |
| 870.5550     |                   |                                  |
|              |                   |                                  |
| Rat          |                   |                                  |
| hepatocyte   |                   |                                  |
| culture      |                   |                                  |
+--------------+-------------------+----------------------------------+
| 870.6200a    | 45118337(1999)    | **Neurotoxicity** NOAEL = 1000   |
|              |                   | mg/kg                            |
| Acute        | Acc               |                                  |
| n            | eptable/guideline | M/F LOAEL \>1000 mg/kg           |
| eurotoxicity |                   |                                  |
| screening    | 0, 100, 300, 1000 | **Systemic** M/F NOAEL =         |
| (rat)        | mg/kg             | 300/1000 mg/kg                   |
|              |                   |                                  |
|              |                   | M/F LOAEL 1000/ \>1000 mg/kg     |
|              |                   | based on ↓body weight gain in    |
|              |                   | males.                           |
+--------------+-------------------+----------------------------------+
| 870.6200b    | 45118401 (1999)   | **Neurotoxicity** M/F NOAEL =    |
|              |                   | 49.9/111.9 mg/kg/day             |
| Subchronic   | Acc               |                                  |
| n            | eptable/guideline | M/F LOAEL \>49.9/111.9           |
| eurotoxicity |                   | mg/kg/day.                       |
| screening    | 0, 50, 250, 750   |                                  |
| (rat)        | (M)/1500 (F) ppm  | **Systemic** M/F NOAEL =         |
|              |                   | 16.9/20.4 mg/kg/day              |
|              | M: 0, 3.5, 16.9,  |                                  |
|              | 49.9 mg/kg/day    | M/F LOAEL = 49.9/111.9 mg/kg/day |
|              |                   | based on ↓ body weight gain, and |
|              | F: 0, 4.0, 20.4,  | ↓ food intake/efficiency.        |
|              | 111.9 mg/kg/day   |                                  |
+--------------+-------------------+----------------------------------+
| 870.7485     | 45118403 (1998)   | Nearly 35% of an oral dose of    |
|              |                   | pyraclostrobin is absorbed with  |
| Metabolism   | 45118404 (1999)   | urinary and fecal excretions     |
| and          |                   | accounting for about 15% and     |
| phar         | Acc               | 85%, respectively, and bile      |
| macokinetics | eptable/guideline | elimination accounted for about  |
|              |                   | 30%. Two peak plasma             |
| (rat)        |                   | concentrations were reached at   |
|              |                   | 0.5-1 and 8 hours with lower     |
|              |                   | plasma concentrations in males   |
|              |                   | than females (by 16-38%) during  |
|              |                   | the early peak phase.            |
|              |                   | Elimination was biphasic at a    |
|              |                   | low dose with plasma half lives  |
|              |                   | of nearly 10/35 hours and        |
|              |                   | monophasic at a high dose with a |
|              |                   | half-life of nearly 20 hours.    |
|              |                   | Tissue distribution was fast,    |
|              |                   | peaking at 0.5 hours, and was    |
|              |                   | slightly higher among females.   |
|              |                   | Some of the highest              |
|              |                   | concentrations were found in the |
|              |                   | liver, thyroid, kidney, lung,    |
|              |                   | adrenal glands, and pancreas but |
|              |                   | all levels dropped by more than  |
|              |                   | 20-fold within 72 hours. About   |
|              |                   | 33 metabolites were identified   |
|              |                   | in urine, feces, and bile with   |
|              |                   | no sex- or dose-related          |
|              |                   | differences but the position of  |
|              |                   | the label seemed to alter the    |
|              |                   | profile, particularly in the     |
|              |                   | urine. Desmethoxy pyraclostrobin |
|              |                   | (500M07) is one of the major     |
|              |                   | metabolites in rat and is also   |
|              |                   | found in large amounts in plants |
|              |                   | (BF 500-3) and livestock         |
|              |                   | (500M07). The rat metabolic      |
|              |                   | pathway included phase-I         |
|              |                   | reactions such as                |
|              |                   | N-demethoxylation, various       |
|              |                   | hydroxylations, and cleavage of  |
|              |                   | the ether bond with subsequent   |
|              |                   | oxidation; these reactions were  |
|              |                   | followed by phase II             |
|              |                   | glucuronidation and sulfation.   |
+--------------+-------------------+----------------------------------+
| 870.7600     | 45118402 (1999)   | The HIARC calculated and         |
|              | Unacc             | recommended a dermal penetration |
| Dermal       | eptable/guideline | rate of 14% (report dated        |
| penetration  | (most of the test | 2/10/03; TXR \# 0051553)         |
|              | material was      |                                  |
| (rat)        | retained on the   |                                  |
|              | dressing and was  |                                  |
|              | unavailable for   |                                  |
|              | absorption;       |                                  |
|              | therefore, actual |                                  |
|              | dose cannot be    |                                  |
|              | determined.       |                                  |
+--------------+-------------------+----------------------------------+