Document ID: EPA-HQ-OPP-2008-0713-0008
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-10-07T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

Date:		August 19, 2004

Subject:	Occupational and Residential Risk Assessment to Support Request
for a Section 3 Registration of Pyraclostrobin on a Variety of Crops and
Residential Turf

 

DP Barcode:	

PC Code:	

Trade Names:	

EPA Reg#s	

MRID#s	

PRAT Case	

Class

D298017	

099100	

Headline® 

Cabrio® EG

Insignia®	

7969-186

7969-187

7969-184	

N/A	

N/A	

Fungicide

 

To:		Barry O’Keefe, Risk Assessor

Health Effects Division

Registration Action Branch 3 (7509C)

From:		Kelly O’Rourke, Biologist

Health Effects Division

Registration Action Branch 3 (7509C)

Thru:		Stephen Dapson, Branch Senior Scientist

and

Jack Arthur, Occ. & Res. Exposure Team Leader

Health Effects Division

Registration Action Branch 3 (7509C)

Introduction

The registrant, BASF Corporation, requests the establishment of
tolerances for residues of the fungicide pyraclostrobin on Brassica,
citrus, corn, hops, leafy vegetables, mint, pome fruit, soybeans,
succulent peas and beans, and sunflower, as well as registration on sod
and residential/ recreational turf.  This memorandum addresses risk from
occupational and residential exposure only; an aggregate human risk
assessment for pyraclostrobin is included as a separate HED memorandum. 

1.0  Executive Summary

Pyraclostrobin is a fungicidal active ingredient (ai) currently
registered on berries, bulb vegetables, cucurbit vegetables, fruiting
vegetables, grapes, pistachios, root vegetables, tree nuts, stone
fruits, citrus, dried peas and beans, grass grown for seed, peanuts,
potatoes, sugarbeets, tuberous and corm vegetables, barley, rye, and
wheat, as well as golf course turf.  The formulated end use products
evaluated in this assessment are labeled under the trade names
Headline®, Cabrio® EG, and Insignia®.  In this memorandum, the name
pyraclostrobin will be used for the active ingredient (ai) in these
products.  

The agricultural formulations of pyraclostrobin evaluated in this
assessment are a water dispersible granule product, also called dry
flowable, (i.e., Cabrio® EG 20% ai) and an emulsifiable concentrate
(i.e., Headline® 2.09 lb ai/gallon).  The registrant proposes multiple
foliar sprays using ground, aerial, or chemigation equipment. 
Applications are proposed to begin prior to disease development and
continue throughout the season, with PHIs ranging from 0 to 21 days. 
Proposed use rates are 0.15-0.20 lb ai/A/application, with seasonal
maximums of up to 1.2 lbs ai/A  The target crops may receive from 2 to 6
applications during a season (with limits for sequential applications),
at intervals ranging from 7 to 21 days.

A non-agricultural water dispersible granule product (Insignia® 20% ai)
is proposed for use on turfgrass including residential, institutional,
commercial, and municipal lawns, parks, recreational areas, cemeteries,
and sod farms at use rates ranging from 0.28 to 0.5 lb ai/A, at
intervals of 14 to 28 days; the maximum seasonal application rate is 3
lb ai/A.

Occupational Exposure

There is potential for occupational exposure to pyraclostrobin during
mixing, loading, application, and postapplication activities.   For
short-/intermediate-term dermal and inhalation exposure, the Hazard
Identification Assessment Review Committee (HIARC) selected an endpoint
from a rabbit prenatal developmental toxicity study (NOAEL = 5
mg/kg/day), based on developmental toxicity findings of increased
resorptions at 10 mg/kg/day.  Because this is an oral study, daily
dermal doses were adjusted to account for 14% dermal absorption and,
daily inhalation doses were calculated assuming 100% absorption. 
Resulting dermal and inhalation MOEs were combined into Total MOEs
because the same endpoint was chosen to evaluate both routes of
exposure.  The target MOE for short-/intermediate-term exposure is 100. 
Chronic exposures are not expected for handlers or postapplication
workers for the proposed use patterns associated with pyraclostrobin.

The Cancer Assessment Review Committee (CARC) concluded that
pyraclostrobin should be classified into the category “data are
inadequate to assess the human carcinogenic potential” because the
female mice were not tested at adequate dose levels in the
carcinogenicity study.  In the absence of a complete data base for
carcinogenicity, HED management decided that a Margin of Exposure (MOE)
method to assess cancer would be appropriate.  In an ad hoc meeting
which occurred on August 10, 2004, this decision was reaffirmed, along
with the conclusion that this approach is applicable to long-term
exposure only, for the following reasons: 1) genotoxicity data indicate
that pyraclostrobin is not mutagenic; 2) there was no treatment related
increase in tumors in male and female rats, or in male mice; and 3) two
structural analogs of pyraclostrobin were found “not likely to be
carcinogenic to humans”.  Because there is no long-term non-dietary
exposure associated with the use of pyraclostrobin,
occupational/residential cancer assessments were not conducted.

No chemical-specific handler exposure data were submitted in support of
this registration.  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 for
regulatory actions when chemical-specific monitoring data are not
available (HED Science Advisory Council for Exposure Standard Operating
Procedure (SOP) #7, dated 1/28/99).  The handgun sprayer exposure data
used in this assessment are from the Outdoor Residential Exposure Task
Force (ORETF) submission of proprietary data for hose-end sprayers,
push-type granular spreaders, and handgun sprayers (MRID # 44972201). 

The results of the handler occupational exposure and risk assessment
indicate that risks are not of concern when gloves are used to mitigate
exposure.  The Total short-/intermediate-Term MOEs with this PPE range
from 280 to 6,400; which exceed the target of 100, and are not of
concern. 

Chemical-specific dislodgeable foliar residue (DFR) data had previously
been submitted by the registrant to support earlier registration
requests for food crops.  The studies were conducted on peaches,
peanuts, strawberries, grapes (MRID#s: 45118727, 45118724, 45118726, and
45118728, respectively), and one study comparing the effect of two
different formulations of pyraclostrobin on grape DFR (MRID#: 45118729).
 Turf transferrable residue (TTR) data (MRID#: 45118725) are also
available from an earlier submission in support of a request for use on
golf course turf.  In addition to these residue data, 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 Target MOEs are met (i.e., reach or exceed 100) on Day 0 for all
crops except sweet corn, for which an REI of 7 days was calculated.  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 Headline® and Cabrio® labels
indicate an REI of 12 hours, and therefore, are in compliance with the
WPS.  The Insignia® label is for non-agricultural use sites to which
the WPS does not apply, it appropriately contains language cautioning
unprotected persons to keep out of treated areas until sprays have
dried.

Residential Exposure

Residential handler exposure was not evaluated because the registrant
indicated that turf applications are intended to be made by professional
pest control operators (PCOs) only (although the label does not state
this).  

Residential postapplication exposure via the dermal route is likely for
adults and children entering treated lawns.  Toddlers may also
experience exposure via incidental non-dietary ingestion (i.e.,
hand-to-mouth, object-to-mouth (turfgrass), and soil ingestion) during
postapplication activities on treated turf.  The postapplication risk
assessment is based on generic assumptions as specified by the
Recommended Revisions to the Residential SOPs and recommended approaches
by HED’s Science Advisory Council for Exposure (ExpoSAC).

Residential short-/intermediate-term dermal exposure was assessed using
the NOAEL (5 mg/kg/day) from the rabbit developmental study that was
selected for occupational exposure.  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 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 and
food efficiency) was seen in the studies selected to evaluate toddler
dermal and incidental ingestion exposure; therefore, route-specific MOEs
were combined into a Total MOE for toddlers.

On December 17, 2002, the HIARC reevaluated the potential for increased
susceptibility of infants and children according to the 2002 OPP FQPA
10X Guidance Document, and recommended that the special FQPA factor
should be removed [1X] for all potential exposure scenarios for
pyraclostrobin because there are no residual uncertainties for pre-
and/or postnatal toxicity.  Therefore, the target MOE for residential
exposure is 100.

Residential short-/intermediate-term postapplication MOEs were estimated
for “Day 0" exposure (i.e., the day of application).  The Total
short-/intermediate-term MOE is 140, which is greater than the target of
100 on the day of application, and therefore, is not of concern. 

2.0  Hazard Profile

On April 5, 2001, the Health Effects Division (HED) Hazard
Identification Assessment Review Committee (HIARC) reviewed the
recommendations of the toxicology reviewer for pyraclostrobin with
regard to the acute and chronic Reference Doses (RfDs) and the
toxicological endpoint selection for use as appropriate in
occupational/residential exposure risk assessments.  The potential for
increased susceptibility of infants and children from exposure to
pyraclostrobin  was also evaluated as required by the Food Quality
Protection Act (FQPA) of 1996.  On October 1, 2001, the FQPA Committee
met and confirmed that the safety factor of 3X, applicable to females
ages 13 to 50, is appropriate to address the potential for increased
susceptibility.  However, on December 17, 2002, the HIARC reevaluated
the potential for increased susceptibility of infants and children
according to the 2002 OPP FQPA 10X Guidance Document, and recommended
that the special FQPA factor should be removed [1X] for all potential
exposure scenarios to pyraclostrobin because there are no residual
uncertainties for pre- and/or postnatal toxicity.  The acute toxicity
data for the pyraclostrobin technical formulation are presented in Table
1.  The doses and toxicological endpoints selected by the HIARC for
various exposure scenarios are summarized in Table 2.

On October 24, 2001, the Cancer Assessment Review Committee (CARC)
concluded that pyraclostrobin should be classified into the category
“data are inadequate to assess the human carcinogenic potential”
because of inadequate dose levels for female rats and mice in the
carcinogenicity studies.  On September 10, 2003, the CARC reevaluated
the carcinogenicity data and reaffirmed the cancer classification based
on the determination of inadequate dose levels in the carcinogenicity
study for female mice only.  The CARC now considers the doses tested in
both sexes of the rat carcinogenicity study adequate, and confirmed that
the tumor data from the combined results of carcinogenicity and chronic
toxicity studies (in rats) showed neither a significant increasing trend
nor a significant difference in the pari-wise comparison of the dosed
groups with the controls.  In the absence of a complete data base for
carcinogenicity, HED management decided that a Margin of Exposure (MOE)
method to assess cancer risk would be appropriate.  In an ad hoc meeting
with HED senior scientists, which occurred on August 10, 2004, this
decision was reaffirmed, along with the conclusion that this approach is
applicable to long-term exposure only, for the following reasons: 1)
genotoxicity data indicate that pyraclostrobin is not mutagenic; 2)
there was no treatment related increase in tumors in male and female
rats, or in male mice; and 3) two structural analogs of pyraclostrobin
were found “not likely to be carcinogenic to humans”.  Because there
is no long-term non-dietary exposure associated with the use of
pyraclostrobin, occupational/residential cancer assessments were not
conducted.



Table 1.  Acute Toxicity Data on Pyraclostrobin Technical

Guideline

 No.	

Study Type	

MRID #	

Results	

Toxicity Category

870.1100	

Acute Oral	

45118302	

LD50 =  > 5000 mg/kg	

IV

870.1200	

Acute Dermal	

45118305	

LD50 =  > 2000 mg/kg	

III

870.1300	

Acute Inhalation	

45118308	

0.31< LC50 < 1.07  mg/L	

II

870.2400	

Primary Eye Irritation	

45118311	

minimal eye irritation; MAS 4.6/110	

III

870.2500	

Primary Skin Irritation	

45118314	

moderate skin irritation; MAS 2.2/8.0	

III

870.2600	

Dermal Sensitization	

45118317	

not a dermal sensitizer	

N/A

Table 2.  Summary of Toxicological Doses and Endpoints for
Pyraclostrobin for Use in Human Risk Assessment 

Exposure

Scenario	

Dose

(mg/kg/day)	

Endpoint	

Study

Incidental Oral, Short and Intermediate-Term 	

NOAEL= 5.8	

Increased incidence of diarrhea, clinical chemistry changes, duodenum
mucosal hypertrophy, and decreased body weight and food
intake/efficiency at 12.9 mg/kg/day (LOAEL).	

13-Week Feeding Dog Study (MRID 45118323)

Dermal, Short- and Intermediate-Term 	

Oral NOAEL= 5.0	

Developmental toxicity findings of increased resorptions at 10.0
mg/kg/day (LOAEL).1 	

Rabbit Prenatal Developmental Toxicity (MRID 45118326)

Dermal, Long-Term 	

Oral NOAEL= 3.4	

Decreased body weight/gain, kidney tubular casts and atrophy in both
sexes; increased incidence of  liver necrosis and erosion/ulceration of
the glandular stomach and forestomach in males in addition to
hemolymphoreticular tumors in males and mammary adenocarcinoma in
females at 9.2 mg/kg/day (LOAEL).1	

Rat Oral Carcinogenicity (MRID 45118331)

Inhalation, Short- and Intermediate-Term	

Oral NOAEL= 5.0	

Developmental toxicity findings of increased resorptions at 10.0
mg/kg/day (LOAEL).2	

Rabbit Prenatal Developmental Toxicity (MRID 45118326)

Inhalation, Long-Term	

Oral NOAEL= 3.4	

Decreased body weight/gain, kidney tubular casts and atrophy in both
sexes; increased incidence of  liver necrosis and erosion/ulceration of
the glandular stomach and forestomach in males in addition to
hemolymphoreticular tumors in males and mammary adenocarcinoma in
females at 9.2 mg/kg/day (LOAEL).2	

Rat Oral Carcinogenicity2 (MRID 45118331)

Cancer

(MOE Approach)	

NOAEL = 32.8	

Mortality, clinical signs, body weight, body weight gain, food
consumption, food efficiency, hematology, organ weights, and gross and
microscopic findings for both sexes at all doses were unaffected by
treatment.  The highest tested dose was 32.8 mg/kg/day in females.1, 2	

Mouse Oral Carcinogenicity (MRID 45118330)

1 The dermal absorption factor of 14% should be applied to extrapolate
from the oral route to the dermal route.

2 100% absorption rate (default value) should be used to extrapolate
from the oral route to the inhalation route.		



3.0  Use Profile

Pyraclostrobin is currently registered on berries, bulb vegetables,
cucurbit vegetables, fruiting vegetables, grapes, pistachios, root
vegetables, tree nuts, stone fruits, citrus, dried peas and beans, grass
grown for seed, peanuts, potatoes, sugarbeets, tuberous and corm
vegetables, barley, rye, and wheat, as well as golf course turf.  The
proposed uses evaluated in this assessment are summarized in Table 3.

Table 3.  Summary of Use Patterns/Formulation Information Relevant to
Occupational and Residential Exposure/Risk Assessment

Formulation Type (% ai)	

Application Method	

Use Site	

Maximum

Application Rate 

(lb ai/A)	

Frequency of Application 

(at max rate)*	

Application Interval

Headline® Emulsifiable Concentrate

(2.09 lb ai/gal)	

Groundboom, Aerial, and Chemigation	

corn	

0.2	

6 applications	

7 to 14 days

mint	

0.2	

4 applications

	

soybean	

0.2	

2 applications

	

succulent shelled

peas & beans,

edible podded legumes	

0.15	

2 applications

	

sunflower	

0.2	

2 applications

	

Cabrio®

Water Dispersible Granule 

(i.e., Dry Flowable)

(20% ai)	

Groundboom, Aerial, and Chemigation	

Brassica, head & stem vegetables	

0.2	

4 applications	

7 to 14 days

Brassica, leafy greens	

0.2	

4 applications	

7 to 10 days

leafy vegetables	

 0.2	

4 applications	

7 to 14  days

leaves of root & tuber vegetables	

 0.2	

3 applications	

7 to 14  days

	

Airblast, Aerial	

hops	

0.2	

3 applications	

10 to 21 days

pome fruit	

0.15	

4 applications	

7 to 10 days

Insignia®

Water Dispersible Granule 

(i.e., Dry Flowable)

(20% ai)	

Groundboom, Handgun, Low-pressure Handwand, and Backpack Sprayer	

turf 

(residential lawns, recreational areas, and sod farms)	

0.28 - 0.50	

6 applications 	

14 to 28 days

  * The label recommends no more than 2 (or 3, in the case of some
diseases on turf) sequential applications.

4.0  Occupational Exposure

4.1   Handler Exposure and Risk			

There is a potential for exposure to pyraclostrobin during mixing,
loading, and application  activities.  An exposure/risk assessment using
applicable endpoints was performed.  Handler’s exposure and risk were
estimated for the following scenarios:  (1 and 2) mixing/loading
emulsifiable concentrate formulation (i.e., liquids) for
aerial/chemigation and groundboom application, respectively, (3, 4, and
5) mixing/loading water dispersible granule formulation (i.e., dry
flowable) for aerial/chemigation, groundboom, and airblast application,
respectively, (6) applying sprays with fixed-wing aircraft, (7) applying
sprays with a groundboom sprayer, (8) applying sprays with an airblast
sprayer, (9) mixing/loading dry flowable formulation and applying sprays
with a handgun sprayer, (10 and 11) mixing/loading/applying liquids with
a low-pressure handwand and backpack sprayer, respectively, and (12)
flagging for aerial spray operations.  

Flaggers for aerial application are assessed for a maximum of 350 acres
per day, because a larger area would likely require pilot-activated
mechanical flagging or global positioning systems (GPS), rather than
human flaggers.

No chemical-specific handler exposure data were submitted in support of
this registration.  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 for
regulatory actions when chemical-specific monitoring data are not
available (HED Science Advisory Council for Exposure Standard Operating
Procedure #7, dated 1/28/99).  There are two scenarios
(mixing/loading/applying dry flowable with a low pressure handwand and
mixing/loading/applying dry flowable with a back pack sprayer) for which
no PHED unit exposure data exists.  Because the dry flowable unit
exposure data for mixing/loading is lower than the unit exposure data
for mixing/loading for liquids, it is assumed that the exposure from
mixing/loading/applying a dry flowable for both the backpack and the low
pressure handwand would be less than the exposure from
mixing/loading/applying liquids for both the backpack sprayer and the
low pressure handwand.  Thus, the use of the data for the liquid
formulation would not be underprotective.  The handler exposure data for
the handgun sprayer scenario are from the Outdoor Residential Exposure
Task Force (ORETF), rather than from PHED.  The task force recently
submitted proprietary data to the Agency on hose-end sprayers, push-type
granular spreaders, and handgun sprayers (MRID # 44972201).  The ORETF
data were designed to replace the present PHED data with
higher-confidence, higher quality data that contain more replicates than
the PHED data for those scenarios.

For short-/intermediate-term dermal and inhalation exposure, the HIARC
selected an endpoint from a rabbit prenatal developmental toxicity study
(NOAEL = 5 mg/kg/day), based on developmental toxicity findings of
increased resorptions at the LOAEL of 10 mg/kg/day.  Because this is an
oral study, daily dermal doses were adjusted to account for 14% dermal
absorption and, daily inhalation doses were converted to oral equivalent
doses, assuming 100% absorption.  Resulting dermal and inhalation MOEs
were combined into Total MOEs because the same endpoint was chosen to
evaluate both routes of exposure.  The target MOE for
short-/intermediate-term exposure is 100.  Chronic exposures are not
expected for handlers or postapplication workers for the proposed use
patterns associated with pyraclostrobin.

The results of the handler occupational exposure and risk assessment
indicate that risks are not of concern when gloves are used to mitigate
exposure.  The Total Short-/Intermediate-Term MOEs with this PPE range
from 280 to 6,400; which exceed the target of 100, and are not of
concern.  Exposure assumptions and MOE estimates for occupational
handlers are summarized in Table 4. 

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
exposure values 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 well above the target MOE of 100
(i.e., 1,100 and 2,000, respectively). 

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 4.  Summary of  MOEs for Occupational Handlers of Pyraclostrobin

Exposure Scenario (Scenario #)	

Dermal Unit Exposure (mg/lb ai) 1	

Inhalation Unit Exposure   (μg/lb ai) 2	

Application 

Rate

(lb ai/A) 3	

Amount Treated

(A/day) 4	

Total Short-/Intermediate-term MOE 5

	

Baseline	

PPE

(gloves)

Baseline	

PPE

(gloves)

Mixer/Loader

Mixing/Loading Liquids for Aerial/Chemigation application (1)	

2.9	

0.023	

1.2	

0.20	

1200	

3.1	

280

	

350	

11	

970

Mixing/Loading Liquids for Groundboom application (2)	

2.9	

0.023	

1.2	

0.20	

200	

18	

1,700

	

80	

46	

4,200

Dry Flowables for Aerial/Chemigation (3)	

0.066	

0.066	

0.77	

0.20	

350	

430	

-

Dry Flowables for Groundboom application (4)	

0.066	

0.066	

0.77	

0.50	

80	

750	

-

Dry Flowables for Airblast application (5)	

0.066	

0.066	

0.77	

0.20	

40	

3,700	

-

Applicator

Sprays for Aerial application (6)	

0.005	

-	

0.068	

0.20	

1200	

1,600	

-

	

350	

5,600	

-

Sprays for Groundboom application (7)	

0.014	

0.014	

0.74	

0.20	

200	

2,800	

-

0.50	

80	

2,800	

-

Sprays for Airblast application (8)	

0.36	

0.24	

4.5	

0.20	

40	

680	

-

Mixer/Loader/Applicator

Mixing/Loading Dry Flowables and Applying with Handgun Sprayer (9) 	

no data	

0.59	

2.2	

0.5	

5	

no data	

1,400

Mixing/Loading Dry Flowables and Applying with Low-Pressure Handwand
(10) 	

100	

0.43	

30	

0.0031

(lb ai/gal)	

40

(gal/day)	

170	

-

Mixing/Loading Dry Flowables and Applying with Backpack Sprayer (11) 	

no data	

2.5	

30	

0.0031

(lb ai/gal)	

40

(gal/day)	

no data	

6,400

Flagger

Flagging for Sprays application (12)	

0.011	

-	

0.35	

0.20	

350	

2,300	

-

1 Baseline dermal unit exposure values represent long pants, long
sleeved shirts, shoes, and socks; PPE values represent the addition of
chemical-resistant gloves; for aerial spray application, the unit
exposure for closed cockpit was used because reliable data for open
cockpit are not available.  Values are reported in the PHED Surrogate
Exposure Guide dated August 1998, except for the handgun value which was
obtained from ORETF..

2 Inhalation unit exposure values represent no respirator; for aerial
spray application, the unit exposure for closed cockpit was used because
reliable data for open cockpit are not available.  Values are reported
in the PHED Surrogate Exposure Guide dated August 1998.

3 Application rates are based on maximum values found in pyraclostrobin
labels Headline® (Reg No:  7969-186), Cabrio® EG (Reg No:  7969-187),
and Insignia® (Reg No:  7969-184).

4 Amount treated is the area or gallons that can be reasonably applied
in a single day for each exposure scenario of concern, based on the
application method and formulation/packaging type. (standard EPA/OPP/HED
values).

5 Short-/Intermediate-Term MOE = NOAEL (5 mg/kg/day) / Total Daily
Absorbed Short-/Intermediate-Term Dose.  The Target MOE is 100.

Total Daily Absorbed Dose (mg/kg/day) = {[(Dermal unit exposure * 14%
Dermal absorption) + (Inhalation unit exposure * 100% absorption)] *
Application rate * Area treated} / 60-kg Body weight.

4.2   Post-Application Exposure and Risk

This Section 3 action for pyraclostrobin involves foliar applications. 
Therefore, postapplication exposure is possible for workers entering
treated fields to tend or harvest crops.  Chemical-specific dislodgeable
foliar residue (DFR) data had previously been submitted by the
registrant to support earlier registration requests for food crops.  The
studies were conducted on peaches, peanuts, strawberries, grapes
(MRID#s: 45118727, 45118724, 45118726, and 45118728, respectively), and
one study comparing the effect of two different formulations of
pyraclostrobin on grape DFR (MRID#: 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 5.  Turf
transferrable residue (TTR) data (MRID#: 45118725) are also available
from an earlier submission in support of a request for use on golf
course turf; the results are summarized below:

Turf Transferrable Residue (TTR) Study:

BAS 500 00 F( formulated as an emulsifiable concentrate containing 23.4%
pyraclostrobin was applied six times to turf, with a 14-day application
interval, at three test sites (California, North Carolina, and
Pennsylvania) at the maximum label application rate of 0.5 lbs ai per
acre using ground application equipment.  Transferable turf residues
(TTR) were collected using the modified California Roller Technique. 
The application method and frequency (number and timing) were relevant
to the use pattern proposed by the product label.  Triplicate samples
were collected at each sampling interval.  At all three sites, the
maximum average TTR values occurred immediately after the application of
the test substance (0.035 µg ai/cm2 for California, 0.011 µg ai/cm2
for North Carolina, and 0.013 µg ai/cm2 for Pennsylvania).  The
estimated half-life values were 1.9 days (r2=0.84), 1.4 days (r2=0.82),
and 3.8 days (r2=0.73) for turf at the California, North Carolina, and
Pennsylvania sites, respectively. 

The DFR data were used to estimate restricted entry intervals (REIs) for
the proposed crops by extrapolating, where possible, to corresponding
general crop groups (i.e., peach DFR data were considered representative
of other tree fruit).  In order to estimate REIs for the other crops, an
average percent initial DFR value was calculated (i.e., the average of
the calculated initial DFR percentages for each crop, presented in Table
5) and used to estimate surrogate residue values for those crops.  An
average daily dissipation rate was also estimated based on the
individual daily dissipation rates for each of the crops tested.  It was
found that the type of formulation used influences the DFR profile;
therefore, separate average DFR percentages were calculated for the
water dispersible granular and emulsifiable concentrate formulations. 
Although uncertainties are introduced into the assessment when
crop-specific residues are used to estimate residues from other types of
crops, it is believed to be more realistic than using default
assumptions.  These results are also shown in Table 5, and the
assignment of the DFR data to crops is included in Table 6. 



Table 5.  Summary of DFR Study Results

Crop	

Location

(state)	

Formu-lation	

Application Rate

(lb ai/A)	

Number 

of Apps.	

Interval	

r2	

Initial DFR

(% of 

Appl. Rate)	

Dissipation

(% per day)	

Half-life (days)

peaches	

CA	

WDG	

0.12	

5	

7 days	

0.84	

22	

2	

27.8

peaches	

GA	

WDG	

0.12	

5	

7 days	

0.97	

15	

11	

6

peaches	

PA	

WDG	

0.12	

5	

7 days	

0.94	

22	

9	

7.7

Peaches Average	

	

	

	

	

	

20	

7	

strawberries	

NC	

WDG	

0.18	

5	

7 days	

0.77	

26	

15	

4.2

strawberries	

CA	

WDG	

0.18	

5	

7 days	

0.98	

25	

15	

4.4

strawberries	

OR	

WDG	

0.18	

5	

7 days	

0.91	

12	

13	

4.9

      Strawberry Average	

	

	

	

	

	

21	

14	

peanuts	

NC	

EC	

0.25	

5	

14 days	

0.91	

18	

26	

2.3

peanuts	

GA	

EC	

0.25	

5	

14 days	

0.77	

17	

61*	

0.74

peanuts	

TX	

EC	

0.25	

5	

14 days	

0.91	

18	

24	

2.5

  Peanuts Average	

	

	

	

	

	

18	

25*	

grapes	

CA	

WDG	

0.18	

3	

14 days	

0.97	

22	

6	

11.1

grapes	

WA	

WDG	

0.18	

3	

14 days	

0.94	

25	

6	

11.8

grapes	

PA	

WDG	

0.18	

3	

14 days	

0.82	

14	

4	

15.6

      Grapes WDG Average	

	

	

	

	

	

20	

5	

grapes	

CA	

EC	

0.18	

3	

14 days	

0.95	

14	

9	

7.4

grapes	

WA	

EC	

0.18	

3	

14 days	

0.9	

22	

9	

7.5

grapes	

PA	

EC	

0.18	

3	

14 days	

0.79	

12	

5	

13.9

grapes	

CA	

EC	

0.15	

6	

10 days	

0.9	

6	

6	

12

grapes	

NY	

EC	

0.15	

6	

10 days	

0.92	

28	

6	

11.2

grapes	

WA	

EC	

0.15	

6	

10 days	

0.9	

24	

4	

17.3

      Grapes EC Average	

	

	

	

	

	

18	

7	

EC Average	

	

	

	

	

	

18	

13	

    WDG Average	

	

	

	

	

	

20	

9	

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. 

Regarding the turf data, there is a slight data gap in that the study
used an emulsifiable concentrate formulation, rather than the water
dispersible granule formulation that is proposed in this action.  The
effect of formulation type on residue values can be significant.  Based
on data from the grape DFR study mentioned previously, residues
associated with the water dispersible granule formulation can be as much
as two times higher than those associated with the emulsifiable
concentrate formulation.  Thus, using the results from the TTR study
(even when the residues from California, which had the highest values,
are used as a screen) may be underprotective.  Because of this
uncertainty, the assessment was conducted with the SOP default
assumption for the initial fraction of residue available.

In addition to these residue data, transfer coefficients (Tc) are used
to relate the foliage residue values to activity patterns (e.g.,
harvesting) 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).

Table 6 reports the transfer coefficients used to estimate potential
exposure levels for all crops treated with pyraclostrobin to determine
the margin of exposure (MOE).  Low transfer coefficients generally
represent low contact activities such as weeding, scouting, and
irrigating.  High transfer coefficients generally represent activities
with more foliar contact such as thinning, hand harvesting, etc.  The
estimated short-/intermediate-term MOEs are presented in Table 6.

The Short-/Intermediate-term Target MOE was met on reentry Day 0 for all
crops except sweet corn (hand harvesting or detasseling), for which an
REI of 7 days was calculated.  In the case where two REIs have been
estimated for the same crop (e.g., corn - 7 days for hand harvesting
activity, and day 0 for irrigating), the longer, more protective,
estimate should be used to establish the REI for that crop (i.e., 7
days).   Please note that the minimum REI required under the Worker
Protection Standard (WPS), based on the acute toxicity categories for
pyraclostrobin, is 12 hours for crops for which MOEs are not
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(μg/cm2)	

TC 4

(cm2/hr)	

Activity 4	

MOE 5

Short-/ Int-

Term

Brassica, head and stem	

WDG

average	

0	

0.45	

2,000	

Irrigation, scouting, thinning, weeding immature plants	

300

0

5,000	

Hand harvesting, irrigation, pruning, topping, tying mature plants	

120

Brassica, leafy greens

Leafy Vegetables	

WDG

average	

0	

0.45	

500	

Irrigation, scouting, thinning, weeding immature plants	

1,200

0

2,500	

Hand harvesting, pruning, and thinning mature plants	

240

Corn

Sunflower	

EC

average	

0	

0.40	

100	

Scouting, weeding  immature/low foliage plants	

6,600

0

1,000	

Scouting, irrigation, weeding mature/full foliage plants	

660

0

17,000	

Sweetcorn hand harvest or detasseling	

39

7	

0.13

	

100

Hops	

WDG

average	

0	

0.34	

100	

Irrigation, scouting immature/low foliage plants	

8,000

0

2,000	

Training, mechanical harvest	

400

Pome fruit	

Peach

average	

0	

0.45	

100	

Propping	

6,000

0

1,500	

Harvesting	

400

0

3,000	

Thinning	

200

Mint,

Soybean	

EC

average	

0	

0.40	

100	

Irrigation, scouting, thinning, weeding  immature/low foliage 	

6,600

0

1,500	

Hand harvesting	

440

Succulent Shelled

Peas & Beans	

EC

average	

0	

0.30	

100	

Irrigation, scouting, thinning, weeding  immature/low foliage 	

8,900

0

2,500	

Hand harvesting	

350

Sod	

Turf &

default	

0	

0.28	

3,400	

Mowing	

280

0

6,800	

	Transplanting, harvesting	

140

1 Studies from which Dislodgeable Foliar Residue (DFR) data were used as
surrogate DFR values for the crop group - see Table 5 for values. 

2 DAT = Days after treatment needed to reach the Target MOE; DAT 0 = The
day of treatment, after sprays have dried; assumed to be approximately
12 hours.

3 DFR (ug/cm2) = Application rate (lb ai/A) x CF (4.54E+8 ug/lb) x CF
(2.47E-8 A/cm2) x Initial Fraction of ai Retained on the Foliage (see
Table 5) x [(1- Fraction of Residue That Dissipates Daily - see Table 5)
Postapplication day].  See Table 3 for application rate.

4 TC (cm2/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 ug/mg) x 60-kg Body weight

The Short-/Int-term NOAEL is 5 mg/kg/day, with a Target MOE of 100.

5.0  Non-Occupational/Residential Exposure

A product containing pyraclostrobin (i.e., Insignia®) is proposed for
application to residential turfgrass 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; the maximum seasonal application rate is 3 lb ai/A.

The registrant indicated that turf applications are intended to be made
by professional pest control operators (PCOs) only (although the label
does not state this).  Therefore, residential handler exposure was not
evaluated.  Residential postapplication exposure via the dermal route is
likely for adults and children entering treated lawns.  Toddlers may
also experience exposure via incidental non-dietary ingestion (i.e.,
hand-to-mouth, object-to-mouth (turfgrass), and soil ingestion) during
postapplication activities on treated turf.  The postapplication risk
assessment is based on generic assumptions as specified by the
Recommended Revisions to the Residential SOPs and recommended approaches
by HED’s Science Advisory Council for Exposure (ExpoSAC).

Residential short-/intermediate-term dermal exposure was assessed using
the NOAEL (5 mg/kg/day) from the rabbit developmental study that was
selected for occupational exposure.  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 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 and
food efficiency) was seen in the studies selected to evaluate toddler
dermal and incidental ingestion exposure; therefore, route-specific MOEs
were combined into a Total MOE for toddlers.

On December 17, 2002, the HIARC reevaluated the potential for increased
susceptibility of infants and children according to the 2002 OPP FQPA
10X Guidance Document, and recommended that the special FQPA factor
should be removed [1X] for all potential exposure scenarios for
pyraclostrobin because there are no residual uncertainties for pre-
and/or postnatal toxicity.  Therefore, the target MOE for residential
exposure is 100.

5.1   Residential Handler Exposure and Risk			

As mentioned previously, the registrant indicated that turf applications
are intended to be made by professional pest control operators (PCOs)
only (although the label does not state this).  Therefore, residential
handler exposure was not evaluated.

5.2   Residential Postapplication Exposure and Risk			

The following postapplication exposure scenarios resulting from lawn
treatment were assessed: (1) adult and toddler postapplication dermal
exposure, (2) toddlers’ incidental ingestion of pesticide residues on
lawns from hand-to-mouth transfer, (3) toddlers’ object-to-mouth
transfer from mouthing of pesticide-treated turfgrass, and (4)
toddlers’ incidental ingestion of soil from pesticide-treated
residential areas. 

Turf transferrable residue (TTR) data (MRID#: 45118725) are available
from an earlier submission in support of a request for use on golf
course turf.  However, the study used an emulsifiable concentrate
formulation, rather than the water dispersible granule formulation that
is proposed in this action.  Using the results from the TTR study may be
underprotective, for the reason discussed previously, as well as the
fact that the study was conducted using a modified version of the
California roller, which was found to have a much lower transfer
efficiency than the original version.  Therefore, these TTRs are not
compatible with the transfer coefficients used in this assessment (which
were derived using the original method).  Because of these
uncertainties, the assessment was conducted with the SOP default
assumption for the initial fraction of residue available for turf, in
addition to other generic assumptions presented in the Recommended
Revisions to the Residential SOPs.

The exposure and risk estimates for the residential exposure scenarios
are assessed for the day of application (day “0") because it is
assumed that adults and toddlers could contact the lawn immediately
after application.  The equations used for the exposure calculations and
the results are presented in Tables 7 through 10.

The exposure estimates are based on some upper-percentile (i.e., maximum
application rate, initial amount of transferrable residue and duration
of exposure) and some central tendency (i.e., surface area and body
weight) assumptions and are considered to be representative of high-end
exposures.  The uncertainties associated with this assessment stem from
the use of an assumed amount of pesticide available from turf, and
assumptions regarding transfer of chemical residues and hand-to mouth
activity.  The estimated exposures are believed to be reasonable
high-end estimates based on observations from chemical-specific field
studies and professional judgement.

The short-/intermediate-term MOEs for each scenario are above the target
of 100, and are not of concern.  As mentioned previously, a common
effect (i.e., decreased body weight gain and food efficiency) was
observed in the studies selected for the endpoints for all routes of
exposure; therefore, the MOEs were combined.  The Total
short-/intermediate-term MOE resulting from the combined MOEs for
children (shown in Table 11) is 140, which is also above the target of
100, and not of concern. 



Table 7.  Postapplication Dermal Exposure and Risk From Treated Lawns

Subgroup Exposed	

Application Rate

 (lb ai/A)	

Dislodgeable 

Foliar Residue

(ug/cm2)	

Dermal Transfer Coefficient

(cm2/hr)	

Body Wt

(kg)	

 Daily Dose2

(mg/kg/day)	

Dermal MOE3

	

Short-/ Int-term	

Short-/Int-term

Adults	

0.50	

0.28	

14,500	

60 / 70	

0.019	

260

Children

	

5,200 	

15	

0.027	

180

1 Dislodgeable Foliar Residue Postapplication day zero (ug/cm2) =
Application rate (lb ai/A) x Fraction of ai Retained on the Foliage
(0.05) x [(1- Fraction of Residue That Dissipates Daily (0.1)]
Postapplication day x  4.54E+8  µg/lb x 2.47E-8 A/cm2

2 Daily Dose = [Dislodgeable Foliar Residue x  Absorption Factor (0.14)
x 0.001 mg/ug  x Dermal Transfer Coefficient x Exposure Time (2
hrs/day)]/Body weight 

3 Dermal MOE = Dermal NOAEL/Daily Dose; where Short-/Intermediate-term
NOAEL = 5 mg/kg/day.

Table 8.  Postapplication Oral Hand-to-Mouth Exposure and Risk for
Children from Treated Lawns

Application Rate

 (lb ai/A)	

Post-application day (t)	

Fraction of ai Retained on the Foliage	

Saliva Extraction Factor	

Dislodgeable Foliar Residue

(ug/cm2)	

Hand Surface Area 

(cm2/event)	

 Frequency

(events/ hr)	

Body Weight

(kg)	

 Daily Dose2

(mg/kg/day)

	

Oral MOE3

	

Short/Int-term

0.50	

0	

0.05	

50%	

0.28	

20 	

20	

15	

0.0075	

780

1 Dislodgeable Foliar Residue Postapplication day (ug/cm2)=App.lication
rate (lb ai/A) x Fraction of ai Retained on the Foliage x (1- Fraction
of Residue That Dissipates Daily, 0.1) Postapplication day x  4.54E+8 
µg/lb x 2.47E-8 A/cm2

2 Daily Dose = (Dislodgeable Foliar Residue (ug/cm2) x Hand Surface Area
(cm2/event) x Extraction factor x Frequency (events/hr) x 0.001 mg/ ug 
x  Exposure time (2 hrs/day)] / [Body Weight (kg)]

3 Oral MOE = Oral NOAEL/Daily Dose; where Short-/Intermediate-term NOAEL
= 5.8 mg/kg/day.

Table 9. Postapplication Oral Object-to-Mouth (Turfgrass) Exposure and
Risk for Children from Treated Lawns 

Application Rate

 (lb ai/A)	

Post-

application day 

(t)	

Fraction of ai Retained on the Foliage

	

Grass

Residue 1

(ug/cm2)	

Ingestion Rate

(cm2/day)	

Body 

Weight

(kg)	

 Daily Dose2

(mg/kg/day)	

Oral MOE3

	

Short/Int-term

0.50	

0	

0.20	

1.1	

25	

15	

0.0019	

3,100

1Grass residue Postapplication day (ug/cm2) = Application rate (lb ai/A)
x Fraction of ai Retained on the Foliage x (1- Fraction of Residue That
Dissipates Daily) Postapplication day x  4.54E+8  µg/lb x 2.47E-8 A/cm2

2 Daily Dose  = [Grass reside (ug/cm2) x Ingestion rate (cm2/day) x
0.001 mg/ug] / [Body Weight (kg)]]

3Oral MOE = Oral NOAEL/Daily Dose; where Short-/Intermediate-term NOAEL
= 5.8 mg/kg/day.



Table 10. Postapplication Incidental Soil Ingestion Exposure and Risk
for Children from Treated Lawns 

Application Rate

 (lb ai/A)	

Post-

application day (t)	

Fraction of ai Retained in the Soil	

Soil

Residue 1

(ug/g)	

Ingestion Rate

(mg/day)	

Body 

Weight

(kg)	

 Daily Dose2

(mg/kg/day)	

Oral MOE3

	

Short/Int-term

0.50	

0	

1	

3.8	

100	

15	

0.000025	

230,000

1 Soil residue Postapplication day (ug/cm2) = Application rate (lb ai/A)
x Fraction of ai Retained on the Soil x (1- Fraction of Residue That
Dissipates Daily) Postapplication day x  4.54E+8  µg/lb x 2.47E-8 A/cm2
x 0.67 cm3/g soil

2 Daily Dose  = [Soil reside (ug/g) x Ingestion rate (mg/day) x 0.000001
g/ug] / [Body Weight (kg)]]

3 Oral MOE = Oral NOAEL/Daily Dose; where Short-/Intermediate-term NOAEL
= 5.8 mg/kg/day.

	Table 11.  Children’s Aggregate Exposure and Risk Estimates from
Residential Lawns

Children’s Scenarios	

TTR/GR/SR0 (ug/cm2 or g) 1	

PDR0-norm

(mg/kg/day) 2	

Short-/

Int-Term

 MOE	

Total

Short-/

Int-Term

 MOE 3

(1) Dermal Contact	

0.28	

0.027	

180	

140

(2) Hand-to-Mouth	

0.28	

0.0075	

780

	

(3) Mouthing Grass	

1.1	

0.0019	

3,100

	

(4) Soil Ingestion	

3.8	

0.000025	

230,000

	1 TTR=turf transferable residue on day “0"; GR=grass residue on day
“0"; SR0=soil residue on day “0".

2 PDR0norm=potential dose rate on day “0”.

3 Total MOE = 1/ [(1/MOEDermal) + (1/MOEHand-to-Mouth) + (1/MOEGrass) +
(1/MOESoil)]

5.3   Recreational Postapplication Exposure and Risk			

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Recreational exposures to turf are expected to be similar to, or in many
cases less than, those evaluated in section 5.2 Residential
Postapplication Exposure and Risk; therefore, a separate recreational
exposure assessment was not included.

5.4   Off Target Non-Occupational Exposure

Spray drift is always a potential source of exposure to residents nearby
to spraying operations.  This is particularly the case with aerial
applications, but, to a lesser extent, could also be a potential source
of exposure from ground application methods.   As indicated in this
assessment, pyraclostrobin is directly applied to residential turf and
does not result in exposures of concern.  Based on this assessment, HED
believes that it is unlikely that there is a higher potential for risk
of exposure to spray drift from agricultural uses of this chemical.

CC:     RAB3 RF

SignOff Date: 8/19/2004

DP Barcode: D298017

 PAGE  19