	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:		June 23, 2003

Subject:	Occupational and Residential Exposure/Risk Assessment for Use of BAS 510F on Potatoes, Bulb Vegetables, Lettuce, Dry/Succulent Beans, Fruiting Vegetables, Stone Fruits, Small Berries, Tree Nuts, Pistachio, Grapes, Strawberries, Peanuts, Canola, Brassica Leafy Vegetables, Cucurbits, Edible Peas, Mint, Root Vegetables, Sunflower, and Golf Course Turfgrass.

PC Code: 128008        	DP Barcode: D290072

    To:		Maria Rodriguez

Registration Division/Fungicide Branch (7505C)

From:		Shih-Chi Wang, Biologist

                        Margarita Collantes, Biologist

                        Gary Bangs, Industrial Hygienist

Health Effects Division/Registration Action Branch 2 (7509C)

Thru:		Richard Loranger, Branch Senior Scientist

Health Effects Division/Registration Action Branch 2 (7509C)

The enclosed document is an assessment of potential occupational and residential exposures/ risk to support the proposed Section 3 registration for a new chemical, BAS 510F.  The proposed registration includes fungicidal uses on the following crops: potatoes, bulb vegetables, lettuce, dry/succulent beans, fruiting vegetables, stone fruits, small berries, tree nuts, pistachio, grapes, strawberries, peanuts, canola, brassica leafy vegetables, cucurbits, edible peas, mint, root vegetables, sunflower, and golf course turfgrass.

	Table of Contents

 TOC \f

1.0  Executive Summary	3

2.0  Hazard Information	4

Acute Toxicity of BAS 510F	4

Toxicological Endpoints Selected by the HIARC for BAS 510F	5

3.0  Product Use information/Application Timing	5

4.0  Non-Occupational Exposure 	6

5.0  Occupational Exposure	10

5.1 Handlers 	10

5.2 Post-Application 	16

 6.0  Appendix 	26

1.0  Executive Summary tc \l1 "1.0  Executive Summary

This assessment addresses occupational/residential exposures and risk for the use of a new fungicidal chemical, BAS 510F, on the following crops:  potatoes, bulb vegetables, lettuce, dry/succulent beans, fruiting vegetables, stone fruits, small berries, tree nuts, pistachio, grapes, strawberries, peanuts, canola, brassica leafy vegetables, cucurbits, edible peas, mint, root vegetables, sunflower, and golf course turfgrass.

The number of exposure days per year was not provided.  Based on the frequency of applications and application interval, EPA assumes that both application handlers and post-application workers would be exposed for less than 6 months per year (short- and intermediate-term exposures).  Long-term exposure is not expected.

Since no chemical-specific data for assessing human exposures during pesticide handling activities were submitted to the Agency in support of the registration of BAS 510F, HED used surrogate data from the PHED Version 1.1.  Defaults established by the HED Science Advisory Council for Exposure were used for acres treated per day and body weight.  Four chemical-specific dislodgeable foliar residue (DFR) and one turf transferable residue (TTR) studies were submitted for the evaluation of post-application exposures/risks.

Toxicological endpoints from the Hazard Identification Assessment Review Committee report (3/07/03) were used to assess dermal and inhalation risks.  The oral NOAEL (21.8 mg/kg/day, all durations) is based on  the liver/thyroid effects observed from the chronic toxicity rat, carcinogenicity rat and 1-year dog studies.  The dermal and inhalation absorption rates used were 15 and 100%.  Daily dermal and inhalation doses were combined and then compared to the NOAEL to determine the level of risks.  The target margin of exposure (MOE) is 100.  BAS 510F is classified as “suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential”, and, therefore, the human cancer risk was not evaluated.

Occupational handler assessments were based primarily on surrogate unit exposures from the PHED, as presented in the PHED Surrogate Exposure Guide (8/98).  All MOEs for the handlers performing agricultural crop uses were greater than the target of 100 at the baseline level (ranging from 460 to 31,000).  All MOEs for the handlers performing golf course turfgrass uses were also greater than the target of 100 at the baseline level (ranging from 7,300 to 27,000).

The occupational post-application exposure/risk were calculated by coupling crop specific DFR values with activity specific transfer coefficient (Tc) values from the HED Science Advisory Council For Exposure Policy Number 3.1.  Except for grapes with girdling, all post-application MOEs were greater than the target MOE of 100.  The MOE for grapes with girdling was 95 on the day of application.  Due to the statistical uncertainty in estimating the MOE, 95 is considered equivalent to the target of 100 for risk assessment in this case.  Therefore, the WPS required 12 hour REI is appropriate for this chemical.  However, HED does not concur with the proposed 4-hour REI because the determination as to whether BAS 510F is or is not a dermal sensitizer could not be made.

The short-term residential dermal post-application exposure/risk for golfing was calculated by coupling TTR values with activity specific Tc values from the HED Science Advisory Council For Exposure Policy Number 3.1.  All MOEs for the residential dermal post-application exposure were greater than the target MOE of 100.

2.0  Hazard Information tc \l1 "2.0  Hazard Information

On September 5, 2002 and January 23, 2003, the Health Effects Division (HED) Hazard Identification Assessment Review Committee (HIARC) selected endpoints for chronic dietary exposure (all populations), incidental oral short- and intermediate-term residential only, dermal (all durations) and inhalation (all durations).  There was no appropriate endpoint identified for acute dietary.  A dermal toxicity study was submitted and no endpoint was selected at the limit dose (1000 mg/kg/day).  For all of the endpoints selected, liver and thyroid effects were chosen from the chronic toxicity study in rats, the carcinogenicity study in rats and the 1-year study in dogs.  The NOAEL was 21.8 mg/kg/day.  For the dermal route, the absorption rate was 15%.  For the inhalation route, the absorption rate was assumed to be 100%.

The potential for increased susceptibility of infants and children from exposure to BAS 510F was also evaluated as required by the Food Quality Protection Act (FQPA) of 1996.  The special FQPA safety factor is reduced to 1X because the existing data indicate that there are no/low concerns and no residual uncertainties with regard to pre- and/or postnatal toxicity.  The Cancer Assessment Review Committee (CARC) classified BAS 510 F as, “suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential”, and, therefore, the quantification of human cancer risk is not recommended.

 The acute toxicity categories for the technical material are summarized in Table 1.  The HIARC’s conclusions, the doses and toxicological endpoints for various exposure scenarios are summarized and presented in Table 2 (from the HIARC document on BAS 510F 03/07/03).

Table 1.  Acute Toxicity Profile - BAS 510 F Technical.

Test Material

GDLN

Study Type

MRID

Results

Tox

Category

Technical

870.1100

Acute Oral - rat

45404814

LD50 > 5000 mg/kg

IV

Technical

870.1200

Acute Dermal - rat

45404815

LD50 > 2000 mg/kg

III

Technical

870.1300

Acute Inhalation

45404816

LC50 (M & F): > 6.7 mg/L

IV

Technical

870.2400

Primary Eye Irritation

45404817

Not irritating to the eye

IV

Technical

870.2500

Primary Dermal Irritation

45404818

Not irritating to the skin

IV

Technical

870.2600

Dermal Sensitization

45404819

Study unacceptable as challenge dose was inadequate

N/A

Table 2.  Summary of Toxicological Dose and Endpoints for BAS 510 F.

Exposure

Scenario

Dose Used in Risk Assessment, UF

Special FQPA SF and Level of Concern for Risk Assessment

Study and Toxicological Effects

Acute Dietary

No appropriate endpoint identified

NA

NA

Chronic Dietary

(All populations)

 NOAEL= 21.8

UF = 100

Chronic RfD = 0.218 mg/kg/day

FQPA SF = 1

cPAD =

chronic RfD

 FQPA SF

= 0.218 mg/kg/day

Chronic rat, carcinogenicity rat and 1-year dog studies

LOAEL = 57-58 mg/kg/day based on liver and thyroid effects

Incidental Oral (Short and intermediate term residential only)

NOAEL= 21.8  mg/kg/day

Residential LOC for MOE = 100

Occupational LOC for MOE = 100

Chronic rat, carcinogenicity rat and 1-year dog studies

LOAEL = 57-58 mg/kg/day based on liver and thyroid effects

Dermal (All Durations)

Oral study NOAEL=21.8 mg/kg/day

(dermal absorption rate = 15%)

Residential LOC for MOE = 100

Occupational LOC for MOE = 100

Chronic rat, carcinogenicity rat and 1-year dog studies

LOAEL = 57-58 mg/kg/day based on liver and thyroid effects

Inhalation (All Durations)

Oral study NOAEL= 21.8 mg/kg/day

(inhalation absorption rate = 100%)

Residential LOC for MOE = 100

Occupational LOC for MOE = 100

Chronic rat, carcinogenicity rat and 1-year dog studies

LOAEL = 57-58 mg/kg/day based on liver and thyroid effects

Cancer (oral, dermal, inhalation)

Classification: “Suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential.”

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure, LOC = level of concern, NA = Not Applicable

For the purpose of conducting risk assessments for occupational workers, dermal and inhalation exposures may be combined because the same studies (with the same endpoints) were used for each route of exposure for each of the respective exposure scenarios.

3.0  Product Use information/Application Timing tc \l1 "3.0  Product Use information/Application Timing

Proposed use patterns for BAS 510F are summarized in Table 3.

Table 2.  Proposed Use Patterns for BAS 510F.

Crop

Product, Formulation

Treatment Type

Applications Per Season 1

Maximum Application Rate2

(lb ai/acre)

PHI3

(days)

Per Application

Per Season

Carrots

BAS 510 02F, water-dispersible granule

ground,

or aerial

5

0.20

1.00

0

Stone Fruits

5

0.23

1.15

0

Tree Nuts

4

0.92

14

Pistachio

4

0.92

14

Canola

2

0.26

0.52

21

Bulb

Vegetables

6

0.30

1.80

7

Cucurbits

ground

4

1.20

0

Root Vegetables

3

0.34

1.02

0

Small Berries

ground,

or aerial

4

0.35

1.40

0

Grapes

3

1.05

14

Strawberries

5

1.75

0

Brassica Leafy Vegetables

ground

2

        0.40

0.80

14

 Mint

4

1.60

15

Sunflower

2

0.80

21

Peanuts

ground,

or aerial

3

0.44

1.32

14

Potatoes

2

0.88

30

Dry/Succulent Beans

2

0.48

0.96

21/7

Lettuce

2

0.96

14

Edible Peas

ground

2

0.50

1.00

21

Turfgrass

6

3.00

NA4

 Fruiting Vegetables

ground,

or aerial

2

0.55

1.10

0

1 Maximum number of applications allowed on label.

2 Rate = Maximum application rates specified on proposed labels.

3 PHI = Pre-harvest Interval

4 NA= Not Applicable

4.0 Non-Occupational Exposure

In the process of joint review with Health Canada, potential non-occupational exposure scenarios were identified for golfers and persons harvesting fruit at "U-pick" farms and orchards.  Residues may be contacted from treated golf course turf or while picking strawberries, caneberries, and tree fruit.  Based on low vapor pressure, outdoor uses and the weight of evidence from many residue studies, no post-application inhalation exposures are anticipated for BAS-510F.  Because “U-pick” is a “one-time” event (duration<1-day) and the HIARC found that the oral studies used to select endpoints were not appropriate to quantitate acute risk, “U-pick” exposure/risk was not evaluated.  Therefore, only the golfing scenario is evaluated in this assessment with respect to non-occupational exposures.

4.1	Non-Occupational Handler tc \l2 "4.1	Non-Occupational Handler

The BAS 510 02F label specifies that this product is intended for golf course use only, and not for use on residential turfgrass or turfgrass being grown for sale or other commercial use such as sod production.  Although the label does not indicate that the product is applied by licensed or commercial applicators, it is acknowledged that the homeowner will not be applying the product to golf courses and therefore, a risk assessment for handler exposure is not required.   BAS 510F is not packaged or marketed for home orchard use, and therefore that use is not assessed.  Specific label language could be added to exclude this use.

4.2	Non-Occupational Post-application

The Agency uses the term “post-application” to describe exposures to individuals that occur as a result of being in an environment that has been previously treated with a pesticide.  It has been determined that there is a potential for exposure from entering areas previously treated with BAS 510F.  As indicated previously, there is only one potential non-occupational post-application scenario associated with BAS 510F: adults golfing (Table 4).  Duration of such exposure is anticipated to be short-term.

Table 4: Non-Occupational Post-application Exposure Scenario for BAS 510F

Scenario, Product,

Formulation

Method of Application

Use Sites

Application Rate

BAS 510 02F Turf Fungicide, EPA Reg No. 7969-Pending

ground equipment only

golf course use only

0.5 lb ai/A

4.2.1   Dermal Post-application Exposure tc \l3 "   Dermal Post-application Exposure

Turf Transferable Residue Data:

The Registrant, BASF Corporation submitted a turf transferable residue (TTR) study using BAS 510F in support of this registration action.  The Health Canada Pest Management Regulatory Agency (PMRA) performed primary review on the study and HED performed secondary review.  HED concurred with the TTR study review done by PMRA.  A summary of the study is provided below.

BAS 510F UCF Turf Transferable Residue Study, D.W. Haughey and J. E. Jones III, March 21, 2001, MRID# 45405301

The TTR study was designed to collect data to calculate dislodgeable residue dissipation curves for BAS 510 F after application to turf at three sites in the United States: Pennsylvania, Georgia and California.  At each site, BAS 510 F was applied 3 times at a rate of 0.35 lb ai/A, with a target spray interval of 14 days (± 1).  The interval between the 2nd and 3rd applications at the Pennsylvania site was 24 days due to rain and adverse weather conditions.  Dislodgeable residues were sampled from turf using the modified California Roller Technique.  Cloth samples were collected in triplicate from the treated plot before and after each application, and at 1, 2, 3, 4, 7, 10, 14, 21, 28 and 35 (± 1) days after the last application (DALA).  An additional sample was collected at 84, 92, and 78 DALA for Pennsylvania, Georgia and California, respectively, however, they were never analyzed.  In addition, samples collected pre- and post-application 1 and 2 were not analyzed.  A control plot at each site was used to sample untreated turf for field recovery.  Except for minor limitations, the study design was considered acceptable for regulatory use.

After 3 applications of BAS 510F, residues reached a peak at day 0 in Georgia/California and at day 2 in Pennsylvania.  For all three sites, Pennsylvania had the highest peak residue value of 0.1313 µg/cm2 2 DALA.  The residues in California and Georgia were considerably lower, with peak residue levels of 0.039 µg/cm2 and 0.0172 µg/cm2, respectively.  Regression lines were plotted using the natural log (ln) of the residue values vs the days after the final application.  R2 values were 0.8763, 0.9261 and 0.8634 and the residue half lives were 2.2 days, 2.2 days and 0.64 days at the Pennsylvania, Georgia and California sites, respectively.  Although samples were collected and analyzed up to 35 DALA (±1), dissipation occurred rapidly and values were below the LOQ at all three locations before the last sampling time point.  Residues reached the LOQ by day-14 in Pennsylvania, day-10 in Georgia, and day-4 in California.

Assumptions:

adult transfer coefficient is 500 cm2/hr (based on HED SOP 3.1)

duration of exposure is estimated to be 4 hours (assuming chemical is used on all parts of a course [greens, tees and fairways] and an adult plays 18 holes of golf)

Equations and Calculations:

PDRo = TTRo x CF1 x Tc x ET x % DA

where

PDRo	=	potential dose rate on day 0 (mg/day)

TTRo	=	turf transferable residue on day 0 (ug/cm2); note highest TTR used, which may have occurred on day of application

CF1	=	unit conversion factor to convert ug units in the TTR to mg for daily exposure (0.001 mg/ug)

Tc	=	transfer coefficient (500 cm2/hr)

ET	=	exposure time (4 hr/day)

%DA	=	percent dermal absorption (15%)

4.2.2   Oral Post-application Exposure/Risk

There is the potential for oral exposure due to hand-to-mouth transfer of pesticide residues from picking your own fruit.  However, HED does not have an applicable database for estimating consumption of U-Pick fruits in the field or hand-to-mouth activity during fruit picking.  In addition, as noted previously, HIARC did not select an acute dietary endpoint that would be appropriate for this type of exposure.

4.2.3   Post-application Exposure/Risk and Characterization

The non-occupational dermal post-application exposure/risk were calculated by coupling turf specific TTR values with activity specific transfer coefficient (Tc) values from the HED Science Advisory Council For Exposure Policy Number 3.1: Agricultural Transfer Coefficients, Aug. 2000.

The TTR study provided two residue values, both from Pennsylvania, which were selected to estimate high end exposure from turf. The highest turf average daily residue value (0.1313 ug/cm2) was collected from a sampling site when the turf was wet, which is assumed to have resulted in higher than normal transferable residues.  The other turf residue value (0.048 ug/cm2) was collected when the turf was dry and resulted in lower transferable residues.  It should be noted that the Tc used to estimate dermal exposure to turf is based on samples collected on dry surfaces.  However, golf courses are often automatically sprayed by built in sprinkler systems in the morning.  Therefore, HED deemed it appropriate to assess dermal exposure in both dry and wet conditions.  The TTR values were normalized (adjusted) to the maximum label application rate.

Table 5 provides a summary of short-term dermal post-application exposure and risk for golfing adults.  All MOEs were above the target MOE of 100 and therefore did not exceed HED’s level of concern.  Although specific MOEs were not calculated for youth playing golf, the adult MOEs are considered representative since the body surface area to weight ratios do not vary significantly between adolescents and adults.

	Table 5: Short-term Dermal  Post-application Exposure for Adults

Scenario & Product

DFR/TTR 1 (ug/cm2)

CF1 (mg/ug)

Tc (cm2/hr)

ET (hr/day)

% DA

BW (kg)

Daily Dose 2

(mg/kg/day)

Dermal MOE 3

Golfing

BAS 510 02F Turf Fungicide

TTR Study MRID# 45405301

0.069 a

0.001

500

4

15

70

0.000295

74000

0.188 b

0.0008

27000

1a.  The highest daily average Transferable Turf Residue for dry turf resulting from Pennsylvania TTR study data (Adjusted for difference in application rate from 0.35 to 0.5 lb ai/A max rate)

1b.  The highest daily average Transferable Turf Residue for wet turf resulting from Pennsylvania TTR study data (Adjusted for difference in application rate from 0.35 to 0.5 lb ai/A max rate)

2.    DD (mg/kg/day)  = DFR x CF1 x Tc x ET x %DA/BW

3.    Dermal MOE = NOAEL (21.8 mg/kg/day)/ Daily Dose (mg/kg/day)

4.3	Spray Drift

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 BAS 510F.  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.

5.0   Occupational Exposure tc \l1 "5.0   Occupational Exposure

5.1   Handlers  tc \l2 "5.1   Handlers

Equations/Calculations

The following equations were used to calculate handler exposure and risk:

Dermal Dose (mg/kg/day) 	=	Rate (lb ai/A) x UE (mg/lb ai) x DA x Acres Treated (A/day)

BW (kg)

Inhalation Dose (mg/kg/day)	=	 Rate (lb ai/acre) x UE (mg/lb ai) x Acres Treated (A/day)

        BW (kg)

Where:

Rate (Application Rate)		=	Maximum application rate on product label (lb ai/acre)

UE (Unit Exposure)		=	Exposure value derived from August 1998 PHED Surrogate Exposure Table (mg/lb ai handled)

DA (dermal absorption factor)	=	Factor to account for dermal absorption (15%) when endpoint is selected from an oral study.

Acres Treated			=	Maximum number of acres treated per day (acres/day)

             BW				=	Body weight (kg)

Combined Daily Dose (mg/kg/day) 	=	Dermal Dose (mg/kg/day)+Inhalation Dose (mg/kg/day)

MOE		=	NOAEL (21.8 mg/kg/day)

                                    Combined Daily Dose (mg/kg/day)

Exposure Scenarios

There are 7 handler scenarios that are expected to result in the highest exposure for the proposed uses:

Mixing/Loading Dry Flowable for Ground-boom Applications (Scenario 1)

Mixing/Loading Dry Flowable for Air Blast Applications (Scenario 2)

Mixing/Loading Dry Flowable for Aerial Applications (Scenario 3)

Applying Sprays with Ground-boom Equipment (Scenario 4)

Applying Sprays with Air Blast Equipment (Scenario 5)

Applying Sprays with a Fixed Wing Aircraft (Scenario 6)

Flagging during Aerial Applications (Scenario 7)

Application Rate

The maximum application rates listed on the proposed labels provided by the Registration Division were used for all exposure assessments.  The maximum rates are 0.20 lb ai/A for carrots, 0.23 lb ai/A for stone fruits/tree nuts/pistachio, 0.26 lb ai/A for canola, 0.30 lb ai/A for bulb vegetables/cucurbits, 0.34 lb ai/A for root vegetables, 0.35 lb ai/A for small berries/grapes/ strawberries, 0.40 lb ai/A for brassica leafy vegetables/mint/sunflower, 0.44 lb ai/A for peanuts/potatoes, 0.48 lb ai/A for dry & succulent beans/lettuce, 0.50 lb ai/A for edible peas/turfgrass, and 0.55 lb ai/A for fruiting vegetables.

Area or the Amount Treated

Based on HED’s Exposure Science Advisory Council Policy Number 9.1, the following acres per day treated, or gallons of spray solution per day treated were assumed:

1200 acres/day for applications on canola/sunflower using aerial equipment & flagging;

350 acres/day for applications on other ag. crops using aerial equipment & flagging;

200 acres/day for applications on canola/sunflower using ground-boom equipment;

80 acres/day for applications on other ag. crops using ground-boom equipment;

40 acres/day for applications on tree crops using air blast equipment;

40 acres/day for application on turfgrass using ground-boom equipment.

Body Weight

The average body weight for general population (70 kg) was used for all assessments.

Exposure Frequency

No data on the number of exposure days per year was provided   For this risk assessment,  it was assumed that handlers would be exposed for less than 6 months per year.  Long-term exposure is not expected.

Unit Exposures

The unit exposures used for assessments to plant protection uses are based on the PHED Version 1.1 as presented in the August 1998 PHED Surrogate Exposure Guide.  PHED was designed by a task force of representatives from the U.S. EPA, Health Canada, the California Department of Pesticide Regulation, and member companies of the American Crop Protection Association.  PHED is a software system consisting of two parts–a database of measured exposure values for workers involved in the handling of pesticides under actual field conditions and a set of computer algorithms used to subset and statistically summarize the selected data.  Currently, the database contains values for over 1,700 monitored individuals (i.e., replicates).

Users select criteria to subset the PHED database to reflect the exposure scenario being evaluated.  The subsetting algorithms in PHED are based on the central assumption that the magnitude of handler exposures to pesticides is primarily a function of activity (e.g., mixing/loading, applying), formulation type (e.g., wettable powders, granulars), application method (e.g., aerial, groundboom), and clothing scenarios (e.g., gloves, double layer clothing).

Once the data for a given exposure scenario have been selected, the data are normalized (i.e., divided by) by the amount of pesticide handled resulting in standard unit exposures (milligrams of exposure per pound of active ingredient handled).  Following normalization, the data are statistically summarized.  The distribution of exposure values for each body part (e.g., chest, upper arm) is categorized as normal, lognormal, or “other” (i.e., neither normal nor lognormal).  A central tendency value is then selected from the distribution of the exposure values for each body part.  These values are the arithmetic mean for normal distributions, the geometric mean for lognormal distributions, and the median for all “other” distributions.  Once selected, the central tendency values for each body part are composited into a “best fit” exposure” value representing the entire body.

There are three basic risk mitigation approaches considered appropriate for controlling occupational exposures.  These include administrative controls, the use of personal protective equipment or PPE, and the use of engineering controls.  Occupational handler exposure assessments were completed by HED using baseline, PPE, and engineering controls. [Note: Administrative controls available generally involve altering application rates for handler exposure scenarios.  These are typically not utilized for completing handler exposure assessments.] The baseline clothing level scenario for occupational exposure scenarios is generally an individual wearing long pants, a long-sleeved shirt, no chemical resistant gloves, and no respirator.  The first level of mitigation generally applied is PPE.  As reflected in the calculations included herein, PPE may involve the use of an additional layer of clothing, chemical-resistant gloves, and a respirator.  The next level of mitigation considered in the risk assessment process is the use of appropriate engineering controls which, by design, attempt to eliminate the possibility of human exposure.  Examples of commonly used engineering controls include enclosed tractor cabs and cockpits, closed mixing/loading/transfer systems, and water-soluble packets.

Handlers’ Exposure and Risk

All MOEs for the handlers performing agricultural crop uses were greater than the target of 100 at the baseline level (ranging from 460 to 31,000).  All MOEs for the handlers performing golf course turfgrass uses were also greater than the target of 100 at the baseline level (ranging from 7,300 to 27,000).  Summaries of the risks for handlers are presented in Table 6.

The handler exposure estimates in this assessment are based on a central tendency estimate of unit exposure and an upper-percentile assumptions for the application rate and acres treated, and are assumed to be representative of high-end exposures.  The uncertainties associated with this assessment stem from the use of surrogate exposure data (e.g., differences in use scenario and data confidence), and assumptions regarding that amount of chemical handled.  The estimated exposures are believed to be reasonable high-end estimates based on observations from field studies and professional judgement.

Table 6.  Non-Cancer Short- and Intermediate-Term Risk for BAS 510 F Handlers.

Exposure Scenario (Scenario #)

Mitigation Levela

Dermal Unit Exposureb (mg/lb ai)

Inhalation Unit Exposurec   (ug/lb ai)

Crop

Application Rate

(lb ai/A)

Amount Treatedd

(A/day)

Daily

Dermal

Dosee (mg/kg/day)

Daily

Inhalation

Dosef (mg/kg/day)

Combined

Daily Doseg (mg/kg/day)

MOEh

Mixer/Loader

Dry Flowables for Ground-boom application (1)

Baseline

0.066

0.77

Carrots

0.20

80

0.0023

0.0002

0.0025

8,700

Bulb Vegs,

Cucurbits

0.30

0.0034

0.0003

0.0037

5,900

Root Vegs

0.34

0.0039

0.0003

0.0042

5,200

Sm. Berries,

Grapes,

Strawberries

0.35

0.0040

0.0003

0.0043

5,100

Brassica Leafy Vegs.,

Mint

0.40

0.0045

0.0004

0.0049

4,500

Peanuts,

Potatoes

0.44

0.0050

0.0004

0.0054

4,000

Dry/Succul.

Beans,

Lettuce

0.48

0.0054

0.0004

0.0058

3,800

Edible Peas

0.50

0.0057

0.0004

0.0061

3,600

Turfgrass

40

0.0028

0.0002

0.0030

7,300

Fruit. Vegs

0.55

80

0.0062

0.0005

0.0067

3,300

Canola

0.26

200

0.0074

0.0006

0.0080

2,700

Sunflower

0.40

0.0113

0.0009

0.0122

1,800

Dry Flowables for

Air Blast

application (2)

Baseline

0.066

0.77

Stone Fruits,

Tree Nuts,

Pistachio

0.23

40

0.0013

0.0001

0.0014

15,600

Dry Flowables for Aerial application (3)

Baseline

0.066

0.77

Carrots

0.20

350

0.0099

0.0008

0.0107

2,000

Stone Fruits,

Tree Nuts,

Pistachio

0.23

0.0114

0.0009

0.0123

1,800

Bulb Veg.

0.30

0.0149

0.0012

0.0161

1,400

Sm. Berries,

Grapes,

Strawberries

0.35

0.0173

0.0014

0.0187

1,200

Peanuts,

Potatoes

0.44

0.0218

0.0017

0.0235

930

Dry/Succul.

Beans,

Lettuce

0.48

0.0238

0.0019

0.0257

850

Fruit. Vegs

0.55

0.0272

0.0021

0.0293

740

Canola

0.26

1,200

0.0441

0.0034

0.0475

460

Applicator

Sprays with

Ground-boom (4)

Baseline

0.014

0.74

Carrots

0.20

80

0.0005

0.0002

0.0007

31,000

Bulb Vegs,

Cucurbits

0.30

0.0007

0.0003

0.0010

22,000

Root Vegs

0.34

0.0008

0.0003

0.0011

20,000

Sm. Berries,

Grapes,

Strawberries

0.35

0.0008

0.0003

0.0011

20,000

Brassica Leafy Vegs.,

Mint

0.40

0.0010

0.0003

0.0013

17,000

Peanuts,

Potatoes

0.44

0.0011

0.0004

0.0015

15,000

Dry/Succul.

Beans,

Lettuce

0.48

0.0012

0.0004

0.0016

14,000

Edible Peas

0.50

0.0012

0.0004

0.0016

14,000

Turfgrass

40

0.0006

0.0002

0.0008

27,000

Fruit. Vegs

0.55

80

0.0013

0.0005

0.0018

12,000

Canala

0.26

200

0.0016

0.0006

0.0022

9,900

Sunflower

0.40

0.0024

0.0008

0.0032

6,800

Sprays with

Air Blast (5)

Baseline

0.36

4.5

Stone Fruits,

Tree Nuts,

Pistachio

0.23

40

0.0071

0.0006

0.0077

2,800

Sprays with fixed wing Aircraft (6)

Engineer. Control

0.0050

0.068

Carrots

0.20

350

0.0008

0.0001

0.0009

24,000

Stone Fruits,

Tree Nuts,

Pistachio

0.23

0.0009

0.0001

0.0010

21,800

Bulb Veg.

0.30

0.0011

0.0001

0.0012

18,000

Sm. Berries,

Grapes,

Strawberries

0.35

0.0013

0.0001

0.0014

16,000

Peanuts,

Potatoes

0.44

0.0017

0.0002

0.0019

12,000

Dry/Succul.

Beans,

Lettuce

0.48

0.0018

0.0002

0.0020

11,000

Fruit. Vegs

0.55

0.0021

0.0002

0.0023

9,500

Canola

0.26

1,200

0.0033

0.0003

0.0036

6,100

Flagger

Flagging for

Aerial Application (7)

Baseline

0.011

0.35

Carrots

0.20

350

0.0017

0.0004

0.0021

10,000

Stone Fruits,

Tree Nuts,

Pistachio

0.23

0.0019

0.0004

0.0023

9,500

Bulb Veg.

0.30

0.0025

0.0005

0.0030

7,300

Sm. Berries,

Grapes,

Strawberries

0.35

0.0029

0.0006

0.0035

6,200

Peanuts,

Potatoes

0.44

0.0036

0.0008

0.0044

5,000

Dry/Succul.

Beans,

Lettuce

0.48

0.0040

0.0008

0.0048

4,500

Fruit. Vegs

0.55

0.0045

0.0010

0.0055

4,000

Canola

0.26

1,200

0.0074

0.0016

0.0090

2,400

a	Baseline consists of long-sleeve shirt, long pants, shoes, and socks and no respirator.  PPE consists of long-sleeve shirt, long pants, shoes, socks, chemical-resistant gloves, and no respirator.

b	Baseline Dermal Unit Exposure represents long pants, long sleeved shirt, no gloves, open mixing/loading, and open cab tractors, as appropriate.

c	Baseline Inhalation Exposure represents no respiratory protection, open mixing/loading, and open cab tractors, as appropriate.

d	Daily acres treated values are from EPA estimates of acreage that could be treated or volume handled in a single day for each exposure scenario of concern, based on the application method and formulation/packaging type.

e	Daily dermal dose (mg/kg/d) =  [unit dermal exposure (mg/lb ai) * dermal absorption (0.15) * application rate (lb ai/acre) * daily acres treated /  body weight (70 kg).

f	Daily inhalation dose (mg/kg/d) = (unit exposure (µg/lb ai) * (1mg/1000 µg) conversion * appl. rate (lb ai/acre) * daily acres treated / body weight (70 kg).

g	Combined daily dose = daily dermal dose + daily inhalation dose.

h	MOE = NOAEL (21.8 mg/kg/d) / combined daily dose.  UF = 100.

5.2   Post-application  tc \l2 "5.2   Post-application

It has been determined that there is a potential for occupational exposure from entering areas previously treated with BAS 510 F.  Table 7 summarizes the post-application exposure scenarios associated with BAS 510F.  The residue transfer coefficients (TCs) used in this assessment are from an interim TC policy developed by HED Science Advisory Council (SAC) for Exposure using proprietary data from the Agricultural Re-entry Task Force (ARTF) database (Exposure SAC Policy No. 3.1).  It is the intention of HED Exposure SAC that this policy will be periodically updated to incorporate additional information about agricultural practices in crops and new data on transfer coefficients.  Much of this information will originate from exposure studies currently being conducted by the ARTF, from further analysis of studies already submitted to the Agency, and from studies in the published scientific literature.  Occupational post-application exposure is expected to be short- and intermediate-term in duration.

5.2.1   Post-application Data, Assumptions and Calculations

Dislodgeable Residue Data:

Four dislodgeable foliar residue (DFR) studies were submitted in support of this registration action.  The Health Canada Pest Management Regulatory Agency (PMRA) performed primary reviews on the studies and HED performed secondary reviews.  HED concurred with the DFR study reviews done by PMRA.  A summary of each study and the assumptions used to estimate post-application exposure for these crops are provided below.  The DFR values selected and dissipation rate calculations are detailed in the appended REI estimation summaries.

BAS 510F UCF Dislodgeable Foliar Residue Study in Tomatoes, D.W. Haughey and J. E. Jones III, March 9, 2001, MRID# 45405302

This study shows a dissipation curve for BAS 510F after application to tomatoes at Pennsylvania/Georgia/California.  At each site, BAS 510F was applied 2 times at 0.55 lba.i./A using ground boom with a 7-day interval between applications.  Dislodgeable residues were sampled from the leaves using a Birkestrand leaf puncher.  Each sample consisted of 40 leaf punches, and was taken in triplicate.  Samples were taken before and after each application, and at 1, 3, 4, 7, 10, 14, 21, 28, and 35 days after the last application (DALA) at the Georgia/California sites.  At the Pennsylvania site, samples were taken before and after each application and at 1, 2, 3, 6, 9, 13, 20, 27 and 34 DALA.  Analyses were not performed  for the samples taken before and after the first application at the Georgia and California sites.  A control plot at each site was used to sample untreated leaves for field recovery.  Except for minor limitations, the study design was considered acceptable.

After 2 BAS 510F applications, the peak residue value was observed on day 0, immediately after the final application at Pennsylvania/California, and on day 3 post-application at Georgia.  Residues did not reach the LOQ by 35 days post-application at Pennsylvania or Georgia.  At the California site, values of two replicates were below the LOQ on days 14, 28 and 35.  Peak values were 1.06 µg/cm2 in Pennsylvania, 0.71 µg/cm2 in Georgia, and 0.66 µg/cm2 in California.

California had the most rapid decline with rep. values below the LOQ by day 14 followed by Pennsylvania/Georgia.  Precipitation records showed that dry weather prevailed at California during the monitoring period and the irrigation systems did not result in any foliar contact.  No rationale or explanation was given in the study report for these results.

Regression lines were plotted using the natural log (ln) of the residue values vs the days after the final application.  R2 values were 0.9149, 0.6585 and 0.7647 and the half life (t½) was 9.4 days at the Pennsylvania site.  As R2 were low at the Georgia and California sites, half lives could not be determined.

BAS 510F UCF Dislodge able Foliar Residue Study in Grapes, D.W. Haughey and J. E. Jones III, March 16, 2001, MRID# 45405303

This study shows a dissipation curve for BAS 510F after application to grape at Pennsylvania/California/Washington.  At each site, BAS 510F was applied 3 times at 0.37 lba.i./A, with a 14-day interval between applications.  Dislodgeable residues were sampled from the grape leaves using a Birkestrand leaf puncher.  Each sample consisted of 40 leaf punches, and was taken in triplicate.  Samples were taken before and after each application, and as follows: at 1, 3, 4, 7, 11, 14, 21, 28, 35 and 89 days after the last application (DALA) in Pennsylvania; at 1, 3, 4, 7, 10, 14, 21, 28, 35 and 88 DALA in California; and at 1, 3, 4, 7, 10, 14, 21 and 28 DALA in Washington.  In Washington, an early season killing frost prohibited sampling after the 28 DALA time point.  Analyses were performed only for the samples taken prior to the last application, and at the time intervals after the last application.  A control plot at each site was used to sample untreated leaves for field recovery.  Except for minor limitations, the study design was considered acceptable.

After 3 applications of BAS 510 F, residues reached a peak on day 1 in Pennsylvania and Washington.  Residues in California reached a peak 10 DALA.   Peak values were 0.72 µg/cm2 in Pennsylvania, 1.17 µg/cm2 in California and 1.42 µg/cm2 in Washington.  Residues did not reach the LOQ by 89, 88 and 28 days post-application at Pennsylvania, California and Washington.  Residues declined to 0.26 µg/cm2 in Pennsylvania, 0.23 µg/cm2 in California, and 1.13 µg/cm2 in Washington.  Regression lines were plotted using the natural log (ln) of the residue values vs the days after the final application.  R2 values were all below 0.53, thus residue half lives could not be determined.

BAS 510F UCF Dislodge able Foliar Residue Study in Peaches, D.W. Haughey and J. E. Jones III, January 5, 2001, MRID# 45405304

This study shows a dissipation curve for BAS 510F after application to peach at California/Georgia/Pennsylvania.  At each site, BAS 510F was applied 5 times at 0.23 lba.i./A using airblast with a 7-day interval between applications.  Dislodgeable residues were sampled from the peach tree leaves using a Birkestrand leaf puncher.  Each sample consisted of 40 leaf punches, and was taken in triplicate.  Samples were taken before and after each application, and at 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, and 35 days after the last application; however, analyses were not performed for the samples taken before and after the first 4 applications.  A control plot at each site was used to sample untreated leaves for field recovery.  Except for minor limitations, the study design was considered acceptable.

Peak residues were measured 2, 3 or 14 days after the last application.  The highest peak residue was 1.3 µg/cm2 in Pennsylvania (day 3), followed by 1.19 µg/cm2 in California (day 14), and 0.58 µg/cm2 in Georgia (day 2).  A gradual decline in dislodgeable residues was observed in California/Georgia/Pennsylvania after the peak value, with residue values of 0.66, 0.21, and 0.26 µg/cm2 after 35 days, respectively.  Regression lines were plotted using the natural log (ln) of the residue values vs the days after the final application.  R2 values were 0.1417, 0.8312, and 0.8684 for California/Georgia/Pennsylvania sites.  The half life (t½ ) was 14.5 days for Pennsylvania but could not be determined for California or Georgia due to low R2 values.  The limitations of the study were not significant enough to affect the overall outcome.

BAS 510F UCF Dislodge able Foliar Residue Study in Strawberries, D.W. Haughey and J. E. Jones III, January 5, 2001, MRID# 45405305.

This study shows a dissipation curve for BAS510F after application to strawberries at N. Carolina/California/Oregon.  At each site, BAS 510F was applied 5 times at 0.37 lba.i./A using ground boom with a 7-day interval between applications.  Dislodgeable residues were sampled from the leaves using a Birkestrand leaf puncher.  Each sample consisted of 40 leaf punches, and was taken in triplicate.  Samples were taken before and after each application, and at 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, and 35 days after the last application; however, analyses were not performed for the samples taken before and after the first 4 applications.  A control plot at each site was used to sample untreated leaves for field recovery.  Except for minor limitations, the study design was considered acceptable.

After 5 applications of BAS 510F, the peak residue value was observed on day 0, immediately after the final application at N. Carolina/Oregon, and on days 2 and 3 post-application at California.  Peak values were 1.63 µg/cm2 in N. Carolina, 1.83 µg/cm2 in California, and only 0.76 µg/cm2 in Oregon.  In N. Carolina, the peak value was followed by a rapid decrease (from 1.63 µg/cm2 to 0.86  µg/cm2) on day 1.  Residues did not reach the LOQ by 35 days post-application at any of the three sites.  Regression lines were plotted using the natural log (ln) of the residue values vs the days after the final application.  R2 values were 0.8958, 0.8434, and 0.8665 and half lives (t½) were 5.7 days, 21.9 days, and 8.7 days at N. Carolina/California/Oregon sites, respectively.

Table 7.  Anticipated Post-application Activities and Dermal Transfer Coefficients for BAS 510 F

Proposed Crops

Policy Crop Group Category

Application Rate

 (lb ai/A)

Exposure Potential

Transfer Coefficients (cm2/hr)

Activities

Reference

strawberry

low berries

0.35

low

400

hand weeding, harvesting and pruning, scouting, irrigation, mulching, thinning

DFR Strawberry Study MRID# 45405305

high

1500

hand harvesting, and pruning, pinching, and training

peas and beans (dry & succulent), canola, mint, peanuts

field row low/medium

0.48

low

100

irrigation, scouting, thinning, hand weeding

Central value from MRID 426891 - hoeing in cotton and beans

medium

1500

irrigation, scouting, hand weeding,

Central value from ARF021 - scouting dry peas

high

2500

hand harvesting

high end value from ARF021 - scouting dry peas

Tall field row (sunflower seeds) crop

field row

crop, tall

0.40

low

400

scouting

low value from ARF009- scouting sweet corn

high

1000

 scouting

central value from ARF009- scouting sweet corn

stone fruits (apricot, cherry, nectarine, peach, plum & prune)

trees, fruit, deciduous

0.23

very low

100

propping

Peach DFR Study (MRID#4540304)

low

1000

scouting, irrigation, hand weeding

high

1500

hand harvesting &pruning, propping, training, tying

very high

3000

thinning

Tree Nuts (almond, pecan, walnut, pistachio

tree, nuts

0.23

low

500

scouting, thinning, irrigation, hand weeding

Peach DFR Study (MRID#4540304)

high

2500

hand pruning, harvesting, netting, and thinning

cucurbit vegetables

cucurbit vegetables

0.31

low

500

irrigation, scouting, thinning, hand weeding

1. DFR Tomato Study MRID# 45405302

2.  HED default DFR and dissipation rates

medium

1500

irrigation, scouting, hand weeding

high

2500

hand harvesting and  pruning, thinning, turning, leaf pulling

tomato, bell pepper, chilli pepper, eggplant

fruiting vegetables

0.55

low

500

hand weeding, scouting, thinning, irrigation

DFR Tomato Study MRID# 45405302

medium

700

irrigating, scouting, hand pruning, staking, tying

high

1000

hand harvest & pruning, staking, tying, thinning, training

cole crops

head and stem brassica

0.42

low

2000

irrigation, scouting, thinning, weeding immature plants

1.  DFR Tomato Study MRID# 45405302

2.  HED default DFR and dissipation rates

medium

4000

scouting mature plants

high

5000

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

Lettuce

leafy vegetables

0.48

low

500

hand weeding, irrigation, scouting, thinning

1.  DFR Tomato Study MRID# 45405302

2.   HED default DFR and dissipation rates

medium

1500

irrigation, scouting

high

2500

hand harvesting & pruning, thinning

carrots, potatoes, onions, garlic and leeks

vegetable, root

0.44

low

300

irrigation, scouting, thinning, hand weeding and pruning

1.  DFR Tomato Study MRID# 45405302

2.   HED default DFR and dissipation rates

medium

1500

irrigation and scouting

high

2500

hand harvest, thinning

grapes

blueberry, caneberry, raspberry

vine/trellis (w/ and w/o girdling)

0.35

low

500

irrigation, hand weeding, scouting, hedging

DFR Grape Study MRID#5405303

medium

1000

training, scouting, tying

high

5000

hand harvesting & pruning, training, tying, thinning, leaf pulling

(w/girdling)

very high

10,000

cane turning & tying, and girdling

Turf

mowing

0.5

low

500

mowing, irrigation

Turf TTR Study MRID# 45405301

jazzercise

high

16,500

hand weeding, transplanting

	The information in the table is based on  proprietary and non-proprietary data.

Equations/Calculations:

The following equations were used to calculate risks for workers performing post-application activities:

DFRt (ug/cm2)	=	Application Rate (lb ai/acre) x F x (1-D)t x 4.54E8 µg/lb x 24.7E-9 acre/cm2

Where:

DFRt 	=	dislodgeable foliage residue on day "t" (ug/cm2)

          	Rate	=	application rate (lb ai/acre)

F	=	fraction of ai retained on foliage (unitless)

D	=	fraction of residue that dissipates daily (unitless)

Note that DFR and TTR (transferable turf residue) may be used interchangeably in this equation to determine exposure to residues on crop foliage or turf leaves, respectively.

Daily dermal dose t  =  DFRt (µg/cm2) x 1E-3 mg/µg x Tc (cm2/hr) x DA x ET (hrs)								BW (kg)

             Where,

t	= 	number of days after application day (days)

DFRt 	=	dislodgeable foliage residue on day "t" (ug/cm2)

Tc	=	transfer coefficient (cm2/hr)

     	DA	=     	dermal absorption factor (0.15)

ET	=	exposure time ( 8 hr/day)

BW	=	body weight (70 kg)

MOE = 	NOAEL (21.8 mg/kg/day)

Dermal Daily Dose (mg/kg/day)

5.2.2   Post-application Exposure, Risk and Characterization

The occupational dermal post-application exposure and risk were calculated by coupling crop specific DFR values or turf TTR values with activity specific transfer coefficient (Tc) values from the HED Science Advisory Council For Exposure Policy Number 3.1: Agricultural Transfer Coefficients, August 2000.

For each DFR/TTR study, the site with the highest residue was selected for use in the risk assessment. The DFR studies were used to assess both crop specific as well as chemical specific surrogate data for determining post-application exposure for various other crops (i.e. leafy and root vegetables, cole crops and cucurbits).  Table 8 summarizes the post-application exposure estimates for all crops.  Post-application exposure estimates except for one, grapes with girdling, were all greater than the target MOE of 100 and therefore did not exceed HED’s level of concern.  The MOE for grapes with girdling was 95 on the day of application.  The MOE did not reach the target MOE of 100 till day 9.

TABLE 8: Post-application Exposure and Risk for BAS 510 F Using DFR Study Data

Crops

DAT

DFR 1 (ug/cm2)

Daily Dose 2 (mg/kg/day)

MOE 3

Pre-harvest Interval

low

high

low

high

strawberry, blueberry, caneberry, rasberry

0

1.731 *

0.012

0.045

1800

490

0-days

Low/medium field row crops (peas, beans, canola, mint, and peanuts)

0

0.925 *

0.0016

0.040

14000

550

6-8 days - succulent peas

7-days - succulent beans

14 days - peanuts, mint

21 days - dry beans & peas, and canola,

Tall row crop (sunflower seeds)

0

0.920

0.0016

0.016

14000

1400

20-21 days

Deciduous fruit trees (stone fruits)

0

1.3

0.0022

0.067

9800

330

0-days

tree nuts

0

1.3

0.011

0.056

2000

390

14-days

cucurbits

0

0.597 *

0.0051

0.026

4300

850

0-days

fruiting vegetables

0

1.06

0.0091

0.018

2400

1200

0-days

cole crops

0

0.809 *

0.028

0.069

790

310

0-days

14-days

leafy vegetables

0

0.925 *

0.0079

0.04

2700

550

14-days

root vegetables

0

0.848 *

0.0044

0.036

5000

600

0-days - carrots and immature plants

7-days - onions, garlic, leeks

30-days - potatoes

grapes w/girdling

0

1.343 *

0.012

0.23

1900

95

14-days

2

1.327 *

0.011

96

4

1.31 *

0.22

97

5

1.3    *

2000

98

7

1.286 *

99

9

1.27    *

100

blueberry, caneberry, rasberry;  grapes w/o girdling

0

1.343 *

0.012

0.12

1900

190

golf course turf

0

0.188

0.0016

0.053

14,000

410

N/A

1. * The highest daily average Dislodgeable Foliar Residues were adjusted for differences in application rates between the DFR studies and the proposed label rates

2.  Daily dermal dose t  =  DFRt (µg/cm2) x 1E-3 mg/µg x Tc (cm2/hr) x DA x ET (hrs)								                                              BW (kg)

3.  MOE =	NOAEL (21.8 mg/kg/day)

Dermal Daily Dose (mg/kg/day)

Re-Entry Interval (REI)

 Due to the statistical uncertainty in estimating the MOE, 95 is considered equivalent to the target of 100 for risk assessment in this case.  Therefore, the Restricted Entry Interval (REI) may be based on acute toxicity of the active ingredient.

A 4-hour REI is proposed on the BAS 510 02F label.  In accordance with the Federal Register Notice: Worker Protection Standard (WPS), Reduced REIs for Certain Pesticides (May 3, 1995), 4-hour REI active ingredients cannot be dermal sensitizers.  The submitted dermal sensitization study on guinea pigs (MRID# 45404819) was considered unacceptable and therefore the determination as to whether BAS 510F is or is not a dermal sensitizer could not be made.  In addition, the data demonstrate that residues are highly persistent, dissipate slowly, and, for grape girdling, result in a MOE close to the level of concern.  The technical material has a Toxicity Category III or IV.  Per the WPS, a 12-hr REI is required. Therefore, HED recommends use of the WPS required 12 hour REI based on acute toxicity categories and does not concur with the proposed 4-hour REI.  Should an acceptable dermal sensitizer study be submitted in the future, HED will revisit the REI issue.

APPENDIX

Post-application Worker Exposure & Risk Estimates

Using BAS 510F DFR/TTR Study Data

Appendix 1. Occupational Post-Application Risk Assessment Calculator (12/7/01) Short-term Results—1

Chemical:				BAS510 wet turf

Date:					5/16/03

Assessor:				M Collantes

Transfer Coefficient Group:		Turf / sod

Specific Crop Considered:		Golf courses

Application Rate of Crop (lb ai/A):		0.5

DFR Data Summary

Source:					TTR Study

Slope of Semilog Regression:		-0.3188

Day 0 Concentration (ug/cm):		0.048

Study Application Rate (lb ai/A):		0.35

Limit of Quantification (ug/cm2):		0.00179

Exposure Inputs Summary

Exposure Potential

Transfer Coefficients (cm2/hr) (1)

Activities (1)

Used for RA

Range

Very Low

N/A

N/A

N/A

Low

500

N/A

Mowing

Medium

N/A

N/A

N/A

High

16500

N/A

Transplanting, Weeding (hand), Harvest (hand), Harvest (mechanical)

Very High

N/A

N/A

N/A

DAT (3)

DFR LEVELS (ug/cm2)

DOSE (mg/kg/day) (4)

MOEs (5)

Not Adjusted

Adjusted for Rate

Very Low

Low

Medium

High

Very High

Very Low

Low

Medium

High

Very High

0

0.048

0.069

N/A

0.00059

N/A

0.019

N/A

N/A

37000

N/A

1100

N/A

Footnote:

  1. Crop groupings and transfer coefficients from Science Advisory Council for Exposure: Policy Memo #003.1 'Agricultural Transfer Coefficients', 8/17/00.

  2. Maximum label rates from end use product labels.

  3. DAT = Days after treatment; DAT0 = On the day of treatment, after sprays have dried; assumed approximately 12 hours.

  4. The absorbed dermal dose = DFR (ug/cm2) x TC (cm2/hr) x conversion factor (1 mg/1,000 ug) x exposure time (hrs) x dermal absorption / body weight (kg).

  5. MOE = Dermal toxicity endpoint (mg/kg-day)/absorbed dermal dose (mg/kg-d).

Appendix 2. Occupational Post-Application Risk Assessment Calculator (12/7/01) Short-term Results—2

Chemical:				BAS510 dry turf

Date:

Assessor:

Transfer Coefficient Group:		Turf / sod

Specific Crop Considered:		Golf courses

Application Rate of Crop (lb ai/A):		0.5

DFR Data Summary

Source:					TTR study

Slope of Semilog Regression:		-0.3188

Day 0 Concentration (ug/cm):		0.1313

Study Application Rate (lb ai/A):		0.35

Limit of Quantification (ug/cm2):		0.00179

Exposure Inputs Summary

Exposure Potential

Transfer Coefficients (cm2/hr) (1)

Activities (1)

Used for RA

Range

Very Low

N/A

N/A

N/A

Low

500

N/A

Mowing

Medium

N/A

N/A

N/A

High

16500

N/A

Transplanting, Weeding (hand), Harvest (hand), Harvest (mechanical)

Very High

N/A

N/A

N/A

DAT (3)

DFR LEVELS (ug/cm2)

DOSE (mg/kg/day) (4)

MOEs (5)

Not Adjusted

Adjusted for Rate

Very Low

Low

Medium

High

Very High

Very Low

Low

Medium

High

Very High

0

0.131

0.188

N/A

0.0016

N/A

0.053

N/A

N/A

14000

N/A

410

N/A

Footnote:

  1. Crop groupings and transfer coefficients from Science Advisory Council for Exposure: Policy Memo #003.1 'Agricultural Transfer Coefficients', August 17, 2000.

  2. Maximum label rates from end use product labels.

  3. DAT = Days after treatment; DAT0 = On the day of treatment, after sprays have dried; assumed approximately 12 hours.

  4. The absorbed dermal dose = DFR (ug/cm2) x TC (cm2/hr) x conversion factor (1 mg/1,000 ug) x exposure time (hrs) x dermal absorption / body weight (kg).

  5. MOE = Dermal toxicity endpoint (mg/kg-day)/absorbed dermal dose (mg/kg-d).

Appendix 3. BAS 510 Agricultural Crop Reentry Crop Groupings, Selected Transfer Coefficients, Treated Crops, and Rates

Transfer Coefficient Group (1)

Specific Transfer Coefficient (cm2/hr) (1)

BAS510 Specific Crops (2)

Max Foliar Rate (lb ai/acre)

High end activities

Low end activities

Berry, low

1500

400 - 1,800

400

400 - 1,800

Berry, low

0.35

Field / row crops, low / medium

2500

486 - 2,760

100

TBD

Field / row crops, low / medium

0.48

Field / row crops, tall

1000

418 - 1,980

100

TBD

Field / row crops, tall

0.41

Trees, fruit, deciduous

1500

1,421 - 4,393

1000

197 - 2,302

Trees, fruit, deciduous

0.23

Trees, nut

2500

1,121 - 4,929

500

197 - 2,302

Trees, nut

0.23

Vegetable, cucurbit

2500

486 - 2,760

500

486 - 2,760

Vegetable, cucurbit

0.31

Vegetable, fruiting

1000

364 - 1,908

500

486 - 2,760

Vegetable, fruiting

0.55

Vegetable, head and stem Brassica

5000

2,862 - 7,584

2000

1,672 - 8,147

Vegetable, head and stem Brassica

0.42

Vegetable, leafy

2500

486 - 2,760

500

486 - 2,760

Vegetable, leafy

0.48

Vegetable, root

2500

486 - 2,760

300

140 - 290

Vegetable, root

0.44

Vine / trellis (w/ girdling)

5000

TBD

500

197 - 2,302

Vine / trellis (w/ girdling)

0.35

Vine / trellis (w/o girdling)

5000

TBD

500

197 - 2,302

Vine / trellis (w/o girdling)

0.35

Footnote:

  1. Crop groupings and transfer coefficients from Science Advisory Council for Exposure: Policy Memo #003.1 'Agricultural Transfer Coefficients', August 17, 2000.

  2. Maximum label rates from end use product labels.

Appendix 4. Summary of 'Days After Treatment' to Reach the Target MOE for Short-term Exposure

Crop Grouping (1)

BAS510 Specific Crops (2)

Max Foliar Rate (lb ai/acre) (2)

Days After Treatment Target MOE Achieved (Target MOE = 100)

Exposure Activity Levels (3,4)

Very Low

Low

Medium

High

Very High

Berry, low

Berry, low

0.35

N/A

0

N/A

0

N/A

Field / row crops, low / medium

Field / row crops, low / medium

0.48

N/A

0

0

0

N/A

Field / row crops, tall

Field / row crops, tall

0.41

N/A

0

0

0

2

Trees, fruit, deciduous

Trees, fruit, deciduous

0.23

0

0

N/A

0

0

Trees, nut

Trees, nut

0.23

N/A

0

N/A

0

N/A

Vegetable, cucurbit

Vegetable, cucurbit

0.31

N/A

0

0

0

N/A

Vegetable, fruiting

Vegetable, fruiting

0.55

N/A

0

0

0

N/A

Vegetable, head and stem Brassica

Vegetable, head and stem Brassica

0.42

N/A

0

0

0

N/A

Vegetable, leafy

Vegetable, leafy

0.48

N/A

0

0

0

N/A

Vegetable, root

Vegetable, root

0.44

N/A

0

0

0

N/A

Vine / trellis (w/ girdling)

Vine / trellis (w/ girdling)

0.35

N/A

0

0

0

9

Vine / trellis (w/o girdling)

Vine / trellis (w/o girdling)

0.35

N/A

0

0

0

N/A

Footnote:

  1. Crop groupings and transfer coefficients from Science Advisory Council for Exposure: Policy Memo #003.1 'Agricultural Transfer Coefficients', August 17, 2000.

  2. Maximum label rates from end use product labels.

  3. DAT = Days after treatment; DAT0 = On the day of treatment, after sprays have dried; assumed approximately 12 hours.

  4. MOE = Dermal toxicity endpoint (mg/kg-day)/absorbed dermal dose (mg/kg-d) where the absorbed dose = DFR (ug/cm2) x TC (cm2/hr) x conversion factor (1 mg/1,000 ug) x exposure time (hrs) x dermal absorption / body weight (kg).

Appendix 5. Occupational Post-Application Risk Assessment Calculator (12/7/01) Short-term Results—3

Chemical:				BAS510

Date:					050803

Assessor:				Margarita Collantes

Transfer Coefficient Group:		Berry, low

Specific Crop Considered:		Berry, low

Application Rate of Crop (lb ai/A):		0.35

DFR Data Summary

Source:					strawberry study

Slope of Semilog Regression:		-0.0317

Day 0 Concentration (ug/cm):		1.83

Study Application Rate (lb ai/A):		0.37

Limit of Quantification (ug/cm2):		0.0125

Exposure Inputs Summary

Exposure Potential

Transfer Coefficients (cm2/hr) (1)

Activities (1)

Used for RA

Range

Very Low

N/A

N/A

N/A

Low

400

400 - 1,800

Scouting, Weeding (hand), Irrigation, Pruning (hand), Thinning, Harvest (hand) (raking), Pruning (hand) (shears), Mulching

Medium

N/A

N/A

N/A

High

1500

400 - 1,800

Harvest (hand), Pruning (hand), Pinching, Training

Very High

N/A

N/A

N/A

DAT (3)

DFR LEVELS (ug/cm2)

DOSE (mg/kg/day) (4)

MOEs (5)

Not Adjusted

Adjusted for Rate

Very Low

Low

Medium

High

Very High

Very Low

Low

Medium

High

Very High

0

1.830

1.731

N/A

0.012

N/A

0.045

N/A

N/A

1800

N/A

490

N/A

Footnote:

  1. Crop groupings and transfer coefficients from Science Advisory Council for Exposure: Policy Memo #003.1 'Agricultural Transfer Coefficients', 8/17/00.

  2. Maximum label rates from end use product labels.

  3. DAT = Days after treatment; DAT0 = On the day of treatment, after sprays have dried; assumed approximately 12 hours.

  4. The absorbed dermal dose = DFR (ug/cm2) x TC (cm2/hr) x conversion factor (1 mg/1,000 ug) x exposure time (hrs) x dermal absorption / body weight (kg).

  5. MOE = Dermal toxicity endpoint (mg/kg-day)/absorbed dermal dose (mg/kg-d).

Appendix 6.   Occupational Post-Application Risk Assessment Calculator (12/7/01) Short-term Results-4

Chemical:				BAS510

Date:					050803

Assessor:				Margarita Collantes

Transfer Coefficient Group:		Field / row crops, low / medium

Specific Crop Considered:		Field / row crops, low / medium

Application Rate of Crop (lb ai/A):		0.48

DFR Data Summary

Source:					tomato study

Slope of Semilog Regression:		-0.0739

Day 0 Concentration (ug/cm):		1.06

Study Application Rate (lb ai/A):		0.55

Limit of Quantification (ug/cm2):		0.0125

Exposure Inputs Summary

Exposure Potential

Transfer Coefficients (cm2/hr) (1)

Activities (1)

Used for RA

Range

Very Low

N/A

N/A

N/A

Low

100

TBD

Irrigation, Scouting, Weeding (hand), Thinning

Medium

1500

486 - 2,760

Irrigation, Scouting, Weeding (hand)

High

2500

486 - 2,760

Harvest (hand)

Very High

N/A

N/A

N/A

DAT (3)

DFR LEVELS (ug/cm2)

DOSE (mg/kg/day) (4)

MOEs (5)

Not Adjusted

Adjusted for Rate

Very Low

Low

Medium

High

Very High

Very Low

Low

Medium

High

Very High

0

1.060

0.925

N/A

0.0016

0.024

0.040

N/A

N/A

14000

920

550

N/A

Footnote:

  1. Crop groupings and transfer coefficients from Science Advisory Council for Exposure: Policy Memo #003.1 'Agricultural Transfer Coefficients', August 17, 2000.

  2. Maximum label rates from end use product labels.

  3. DAT = Days after treatment; DAT0 = On the day of treatment, after sprays have dried; assumed approximately 12 hours.

  4. The absorbed dermal dose = DFR (ug/cm2) x TC (cm2/hr) x conversion factor (1 mg/1,000 ug) x exposure time (hrs) x dermal absorption / body weight (kg).

  5. MOE = Dermal toxicity endpoint (mg/kg-day)/absorbed dermal dose (mg/kg-d).

Appendix 7.   Occupational Post-Application Risk Assessment Calculator (12/7/01) Short-term Results-5

Chemical:				BAS510

Date:					050803

Assessor:				Margarita Collantes

Transfer Coefficient Group:		Field / row crops, tall

Specific Crop Considered:		Field / row crops, tall

Application Rate of Crop (lb ai/A):		0.41

DFR Data Summary

Source:					tomato study

Slope of Semilog Regression:		-0.0739

Day 0 Concentration (ug/cm):		1.06

Study Application Rate (lb ai/A):		0.55

Limit of Quantification (ug/cm2):		0.0125

Exposure Inputs Summary

Exposure Potential

Transfer Coefficients (cm2/hr) (1)

Activities (1)

Used for RA

Range

Very Low

N/A

N/A

N/A

Low

100

TBD

Scouting, Weeding (hand)

Medium

400

418 - 1,980

Scouting

High

1000

418 - 1,980

Irrigation, Scouting, Weeding (hand)

Very High

17000

6,748 - 25,254

Detasseling, Harvest (hand)

DAT (3)

DFR LEVELS (ug/cm2)

DOSE (mg/kg/day) (4)

MOEs (5)

Not Adjusted

Adjusted for Rate

Very Low

Low

Medium

High

Very High

Very Low

Low

Medium

High

Very High

0

1.060

0.790

N/A

0.0014

0.0054

0.014

0.23

N/A

16000

4000

1600

95

1

0.984

0.734

N/A

0.0013

0.0050

0.013

0.21

N/A

17000

4300

1700

100

Footnote:

  1. Crop groupings and transfer coefficients from Science Advisory Council for Exposure: Policy Memo #003.1 'Agricultural Transfer Coefficients', August 17, 2000.

  2. Maximum label rates from end use product labels.

  3. DAT = Days after treatment; DAT0 = On the day of treatment, after sprays have dried; assumed approximately 12 hours.

  4. The absorbed dermal dose = DFR (ug/cm2) x TC (cm2/hr) x conversion factor (1 mg/1,000 ug) x exposure time (hrs) x dermal absorption / body weight (kg).

  5. MOE = Dermal toxicity endpoint (mg/kg-day)/absorbed dermal dose (mg/kg-d).

Appendix 8. Occupational Post-Application Risk Assessment Calculator (12/7/01) Short-term Results—6

Chemical:				BAS510

Date:					050803

Assessor:				Margarita Collantes

Transfer Coefficient Group:		Trees, fruit, deciduous

Specific Crop Considered:		Trees, fruit, deciduous

Application Rate of Crop (lb ai/A):		0.23

DFR Data Summary

Source:					strawberry study

Slope of Semilog Regression:		-0.0317

Day 0 Concentration (ug/cm):		1.83

Study Application Rate (lb ai/A):		0.37

Limit of Quantification (ug/cm2):		0.0125

Exposure Inputs Summary

Exposure Potential

Transfer Coefficients (cm2/hr) (1)

Activities (1)

Used for RA

Range

Very Low

100

TBD

Propping

Low

1000

197 - 2,302

Scouting, Weeding (hand), Irrigation

Medium

N/A

N/A

N/A

High

1500

1,421 - 4,393

Harvest (hand), Propping, Pruning (hand), Training, Tying

Very High

3000

2,177 - 3,688

Thinning

DAT (3)

DFR LEVELS (ug/cm2)

DOSE (mg/kg/day) (4)

MOEs (5)

Not Adjusted

Adjusted for Rate

Very Low

Low

Medium

High

Very High

Very Low

Low

Medium

High

Very High

0

1.830

1.138

0.0020

0.020

N/A

0.029

0.059

11000

1100

N/A

750

370

Footnote:

  1. Crop groupings and transfer coefficients from Science Advisory Council for Exposure: Policy Memo #003.1 'Agricultural Transfer Coefficients', August 17, 2000.

  2. Maximum label rates from end use product labels.

  3. DAT = Days after treatment; DAT0 = On the day of treatment, after sprays have dried; assumed approximately 12 hours.

  4. The absorbed dermal dose = DFR (ug/cm2) x TC (cm2/hr) x conversion factor (1 mg/1,000 ug) x exposure time (hrs) x dermal absorption / body weight (kg).

  5. MOE = Dermal toxicity endpoint (mg/kg-day)/absorbed dermal dose (mg/kg-d).

Appendix 9. Occupational Post-Application Risk Assessment Calculator (12/7/01) Short-term Results—7

Chemical:				BAS510

Date:					050803

Assessor:				Margarita Collantes

Transfer Coefficient Group:		Trees, nut

Specific Crop Considered:		Trees, nut

Application Rate of Crop (lb ai/A):		0.23

DFR Data Summary

Source:					peach data

Slope of Semilog Regression:		-0.0477

Day 0 Concentration (ug/cm):		1.3

Study Application Rate (lb ai/A):		0.23

Limit of Quantification (ug/cm2):		0.0125

Exposure Inputs Summary

Exposure Potential

Transfer Coefficients (cm2/hr) (1)

Activities (1)

Used for RA

Range

Very Low

N/A

N/A

N/A

Low

500

197 - 2,302

Scouting, Thinning, Irrigation, Weeding (hand)

Medium

N/A

N/A

N/A

High

2500

1,121 - 4,929

Harvest (hand), Pruning (hand), Thinning, Harvest (hand) (net)

Very High

N/A

N/A

N/A

DAT (3)

DFR LEVELS (ug/cm2)

DOSE (mg/kg/day) (4)

MOEs (5)

Not Adjusted

Adjusted for Rate

Very Low

Low

Medium

High

Very High

Very Low

Low

Medium

High

Very High

0

1.300

1.300

N/A

0.011

N/A

0.056

N/A

N/A

2000

N/A

390

N/A

Footnote:

  1. Crop groupings and transfer coefficients from Science Advisory Council for Exposure: Policy Memo #003.1 'Agricultural Transfer Coefficients', August 17, 2000.

  2. Maximum label rates from end use product labels.

  3. DAT = Days after treatment; DAT0 = On the day of treatment, after sprays have dried; assumed approximately 12 hours.

  4. The absorbed dermal dose = DFR (ug/cm2) x TC (cm2/hr) x conversion factor (1 mg/1,000 ug) x exposure time (hrs) x dermal absorption / body weight (kg).

  5. MOE = Dermal toxicity endpoint (mg/kg-day)/absorbed dermal dose (mg/kg-d).

Appendix 10. Occupational Post-Application Risk Assessment Calculator (12/7/01) Short-term Results—8

Chemical:				BAS510

Date:					050803

Assessor:				Margarita Collantes

Transfer Coefficient Group:		Vegetable, cucurbit

Specific Crop Considered:		Vegetable, cucurbit

Application Rate of Crop (lb ai/A):		0.31

DFR Data Summary

Source:					tomato study

Slope of Semilog Regression:		-0.0739

Day 0 Concentration (ug/cm):		1.06

Study Application Rate (lb ai/A):		0.55

Limit of Quantification (ug/cm2):		0.0125

Exposure Inputs Summary

Exposure Potential

Transfer Coefficients (cm2/hr) (1)

Activities (1)

Used for RA

Range

Very Low

N/A

N/A

N/A

Low

500

486 - 2,760

Irrigation, Scouting, Thinning, Weeding (hand)

Medium

1500

486 - 2,760

Irrigation, Scouting, Weeding (hand)

High

2500

486 - 2,760

Harvest (hand), Leaf Pulling, Pruning (hand), Thinning, Turning

Very High

N/A

N/A

N/A

DAT (3)

DFR LEVELS (ug/cm2)

DOSE (mg/kg/day) (4)

MOEs (5)

Not Adjusted

Adjusted for Rate

Very Low

Low

Medium

High

Very High

Very Low

Low

Medium

High

Very High

0

1.060

0.597

N/A

0.0051

0.015

0.026

N/A

N/A

4300

1400

850

N/A

Footnote:

  1. Crop groupings and transfer coefficients from Science Advisory Council for Exposure: Policy Memo #003.1 'Agricultural Transfer Coefficients', August 17, 2000.

  2. Maximum label rates from end use product labels.

  3. DAT = Days after treatment; DAT0 = On the day of treatment, after sprays have dried; assumed approximately 12 hours.

  4. The absorbed dermal dose = DFR (ug/cm2) x TC (cm2/hr) x conversion factor (1 mg/1,000 ug) x exposure time (hrs) x dermal absorption / body weight (kg).

  5. MOE = Dermal toxicity endpoint (mg/kg-day)/absorbed dermal dose (mg/kg-d).

Appendix 11. Occupational Post-Application Risk Assessment Calculator (12/7/01) Short-term Results—9

Chemical:				BAS510

Date:					050803

Assessor:				Margarita Collantes

Transfer Coefficient Group:		Vegetable, fruiting

Specific Crop Considered:		Vegetable, fruiting

Application Rate of Crop (lb ai/A):		0.55

DFR Data Summary

Source:					tomato study

Slope of Semilog Regression:		-0.0739

Day 0 Concentration (ug/cm):		1.06

Study Application Rate (lb ai/A):		0.55

Limit of Quantification (ug/cm2):		0.0125

Exposure Inputs Summary

Exposure Potential

Transfer Coefficients (cm2/hr) (1)

Activities (1)

Used for RA

Range

Very Low

N/A

N/A

N/A

Low

500

486 - 2,760

Weeding (hand), Irrigation, Scouting, Thinning

Medium

700

TBD

Irrigation, Scouting, Pruning (hand), Staking, Tying

High

1000

364 - 1,908

Harvest (hand), Pruning (hand), Staking, Thinning, Training, Tying

Very High

N/A

N/A

N/A

DAT (3)

DFR LEVELS (ug/cm2)

DOSE (mg/kg/day) (4)

MOEs (5)

Not Adjusted

Adjusted for Rate

Very Low

Low

Medium

High

Very High

Very Low

Low

Medium

High

Very High

0

1.060

1.060

N/A

0.0091

0.013

0.018

N/A

N/A

2400

1700

1200

N/A

Footnote:

  1. Crop groupings and transfer coefficients from Science Advisory Council for Exposure: Policy Memo #003.1 'Agricultural Transfer Coefficients', August 17, 2000.

  2. Maximum label rates from end use product labels.

  3. DAT = Days after treatment; DAT0 = On the day of treatment, after sprays have dried; assumed approximately 12 hours.

  4. The absorbed dermal dose = DFR (ug/cm2) x TC (cm2/hr) x conversion factor (1 mg/1,000 ug) x exposure time (hrs) x dermal absorption / body weight (kg).

  5. MOE = Dermal toxicity endpoint (mg/kg-day)/absorbed dermal dose (mg/kg-d).

Appendix 12. Occupational Post-Application Risk Assessment Calculator (12/7/01) Short-term Results—10

Chemical:				BAS510

Date:					050803

Assessor:				Margarita Collantes

Transfer Coefficient Group:		Vegetable, head and stem Brassica

Specific Crop Considered:		Vegetable, head and stem Brassica

Application Rate of Crop (lb ai/A):		0.42

DFR Data Summary

Source:					tomato study

Slope of Semilog Regression:		-0.0739

Day 0 Concentration (ug/cm):		1.06

Study Application Rate (lb ai/A):		0.55

Limit of Quantification (ug/cm2):		0.0125

Exposure Inputs Summary

Exposure Potential

Transfer Coefficients (cm2/hr) (1)

Activities (1)

Used for RA

Range

Very Low

N/A

N/A

N/A

Low

2000

1,672 - 8,147

Weeding (hand), Scouting, Thinning, Irrigation, Pruning (hand)

Medium

4000

1,672 - 8,147

Scouting

High

5000

2,862 - 7,584

Harvest (hand), Irrigation, Pruning (hand), Thinning, Topping, Tying

Very High

N/A

N/A

N/A

DAT (3)

DFR LEVELS (ug/cm2)

DOSE (mg/kg/day) (4)

MOEs (5)

Not Adjusted

Adjusted for Rate

Very Low

Low

Medium

High

Very High

Very Low

Low

Medium

High

Very High

0

1.060

0.809

N/A

0.028

0.056

0.069

N/A

N/A

790

390

310

N/A

Footnote:

  1. Crop groupings and transfer coefficients from Science Advisory Council for Exposure: Policy Memo #003.1 'Agricultural Transfer Coefficients', 8/17/00.

  2. Maximum label rates from end use product labels.

  3. DAT = Days after treatment; DAT0 = On the day of treatment, after sprays have dried; assumed approximately 12 hours.

  4. The absorbed dermal dose = DFR (ug/cm2) x TC (cm2/hr) x conversion factor (1 mg/1,000 ug) x exposure time (hrs) x dermal absorption / body weight (kg).

  5. MOE = Dermal toxicity endpoint (mg/kg-day)/absorbed dermal dose (mg/kg-d).

Appendix 13. Occupational Post-Application Risk Assessment Calculator (12/7/01) Short-term Results—11

Chemical:				BAS510

Date:					050803

Assessor:				Margarita Collantes

Transfer Coefficient Group:		Vegetable, leafy

Specific Crop Considered:		Vegetable, leafy

Application Rate of Crop (lb ai/A):		0.48

DFR Data Summary

Source:					tomato study

Slope of Semilog Regression:		-0.0739

Day 0 Concentration (ug/cm):		1.06

Study Application Rate (lb ai/A):		0.55

Limit of Quantification (ug/cm2):		0.0125

Exposure Inputs Summary

Exposure Potential

Transfer Coefficients (cm2/hr) (1)

Activities (1)

Used for RA

Range

Very Low

N/A

N/A

N/A

Low

500

486 - 2,760

Weeding (hand), Irrigation, Scouting, Thinning

Medium

1500

486 - 2,760

Irrigation, Scouting

High

2500

486 - 2,760

Harvest (hand), Pruning (hand), Thinning

Very High

N/A

N/A

N/A

DAT (3)

DFR LEVELS (ug/cm2)

DOSE (mg/kg/day) (4)

MOEs (5)

Not Adjusted

Adjusted for Rate

Very Low

Low

Medium

High

Very High

Very Low

Low

Medium

High

Very High

0

1.060

0.925

N/A

0.0079

0.024

0.040

N/A

N/A

2700

920

550

N/A

Footnote:

  1. Crop groupings and transfer coefficients from Science Advisory Council for Exposure: Policy Memo #003.1 'Agricultural Transfer Coefficients', August 17, 2000.

  2. Maximum label rates from end use product labels.

  3. DAT = Days after treatment; DAT0 = On the day of treatment, after sprays have dried; assumed approximately 12 hours.

  4. The absorbed dermal dose = DFR (ug/cm2) x TC (cm2/hr) x conversion factor (1 mg/1,000 ug) x exposure time (hrs) x dermal absorption / body weight (kg).

  5. MOE = Dermal toxicity endpoint (mg/kg-day)/absorbed dermal dose (mg/kg-d).

Appendix 14. Occupational Post-Application Risk Assessment Calculator (12/7/01) Short-term Results—12

Chemical:				BAS510

Date:					050803

Assessor:				Margarita Collantes

Transfer Coefficient Group:		Vegetable, root

Specific Crop Considered:		Vegetable, root

Application Rate of Crop (lb ai/A):		0.44

DFR Data Summary

Source:					tomato study

Slope of Semilog Regression:		-0.0739

Day 0 Concentration (ug/cm):		1.06

Study Application Rate (lb ai/A):		0.55

Limit of Quantification (ug/cm2):		0.0125

Exposure Inputs Summary

Exposure Potential

Transfer Coefficients (cm2/hr) (1)

Activities (1)

Used for RA

Range

Very Low

N/A

N/A

N/A

Low

300

140 - 290

Irrigation, Scouting, Thinning, Weeding (hand), Pruning (hand)

Medium

1500

486 - 2,760

Irrigation, Scouting

High

2500

486 - 2,760

Harvest (hand), Thinning

Very High

N/A

N/A

N/A

DAT (3)

DFR LEVELS (ug/cm2)

DOSE (mg/kg/day) (4)

MOEs (5)

Not Adjusted

Adjusted for Rate

Very Low

Low

Medium

High

Very High

Very Low

Low

Medium

High

Very High

0

1.060

0.848

N/A

0.0044

0.022

0.036

N/A

N/A

5000

1000

600

N/A

Footnote:

  1. Crop groupings and transfer coefficients from Science Advisory Council for Exposure: Policy Memo #003.1 'Agricultural Transfer Coefficients', August 17, 2000.

  2. Maximum label rates from end use product labels.

  3. DAT = Days after treatment; DAT0 = On the day of treatment, after sprays have dried; assumed approximately 12 hours.

  4. The absorbed dermal dose = DFR (ug/cm2) x TC (cm2/hr) x conversion factor (1 mg/1,000 ug) x exposure time (hrs) x dermal absorption / body weight (kg).

  5. MOE = Dermal toxicity endpoint (mg/kg-day)/absorbed dermal dose (mg/kg-d).

Appendix 15. Occupational Post-Application Risk Assessment Calculator (12/7/01) Short-term Results—13

Chemical:				BAS510

Date:					050803

Assessor:				Margarita Collantes

Transfer Coefficient Group:		Vine / trellis (w/ girdling)

Specific Crop Considered:		Vine / trellis (w/ girdling)

Application Rate of Crop (lb ai/A):		0.35

DFR Data Summary

Source:					grape study

Slope of Semilog Regression:		-0.0062

Day 0 Concentration (ug/cm):		1.42

Study Application Rate (lb ai/A):		0.37

Limit of Quantification (ug/cm2):		0.0125

Exposure Inputs Summary

Exposure Potential

Transfer Coefficients (cm2/hr) (1)

Activities (1)

Used for RA

Range

Very Low

N/A

N/A

N/A

Low

500

197 - 2,302

Irrigation, Weeding (hand), Scouting, Hedging

Medium

1000

197 - 2,302

Scouting, Training, Tying

High

5000

TBD

Harvest (hand), Pruning (hand), Training, Tying, Thinning, Leaf Pulling

Very High

10000

TBD

Girdling, Turning (Cane turning), Tying (Cane turning)

DAT (3)

DFR LEVELS (ug/cm2)

DOSE (mg/kg/day) (4)

MOEs (5)

Not Adjusted

Adjusted for Rate

Very Low

Low

Medium

High

Very High

Very Low

Low

Medium

High

Very High

0

1.420

1.343

N/A

0.012

0.023

0.12

0.23

N/A

1900

950

190

95

1

1.411

1.335

N/A

0.011

0.023

0.11

0.23

N/A

1900

950

190

95

2

1.403

1.327

N/A

0.011

0.023

0.11

0.23

N/A

1900

960

190

96

3

1.394

1.318

N/A

0.011

0.023

0.11

0.23

N/A

1900

960

190

96

4

1.385

1.310

N/A

0.011

0.022

0.11

0.22

N/A

1900

970

190

97

5

1.377

1.302

N/A

0.011

0.022

0.11

0.22

N/A

2000

980

200

98

6

1.368

1.294

N/A

0.011

0.022

0.11

0.22

N/A

2000

980

200

98

7

1.360

1.286

N/A

0.011

0.022

0.11

0.22

N/A

2000

990

200

99

8

1.351

1.278

N/A

0.011

0.022

0.11

0.22

N/A

2000

990

200

99

9

1.343

1.270

N/A

0.011

0.022

0.11

0.22

N/A

2000

1000

200

100

Footnote:

  1. Crop groupings and transfer coefficients from Science Advisory Council for Exposure: Policy Memo #003.1 'Agricultural Transfer Coefficients', August 17, 2000.

  2. Maximum label rates from end use product labels.

  3. DAT = Days after treatment; DAT0 = On the day of treatment, after sprays have dried; assumed approximately 12 hours.

  4. The absorbed dermal dose = DFR (ug/cm2) x TC (cm2/hr) x conversion factor (1 mg/1,000 ug) x exposure time (hrs) x dermal absorption / body weight (kg).

  5. MOE = Dermal toxicity endpoint (mg/kg-day)/absorbed dermal dose (mg/kg-d).

Appendix 16. Occupational Post-Application Risk Assessment Calculator (12/7/01) Short-term Results—14

Chemical:				BAS510

Date:					050803

Assessor:				Margarita Collantes

Transfer Coefficient Group:		Vine / trellis (w/o girdling)

Specific Crop Considered:		Vine / trellis (w/o girdling)

Application Rate of Crop (lb ai/A):		0.35

DFR Data Summary

Source:					grape study

Slope of Semilog Regression:		-0.0062

Day 0 Concentration (ug/cm):		1.42

Study Application Rate (lb ai/A):		0.37

Limit of Quantification (ug/cm2):		0.0125

Exposure Inputs Summary

Exposure Potential

Transfer Coefficients (cm2/hr) (1)

Activities (1)

Used for RA

Range

Very Low

N/A

N/A

N/A

Low

500

197 - 2,302

Irrigation, Weeding (hand), Scouting, Hedging

Medium

1000

197 - 2,302

Scouting, Training, Tying

High

5000

TBD

Harvest (hand), Pruning (hand), Training, Tying, Thinning, Leaf Pulling

Very High

N/A

N/A

N/A

DAT (3)

DFR LEVELS (ug/cm2)

DOSE (mg/kg/day) (4)

MOEs (5)

Not Adjusted

Adjusted for Rate

Very Low

Low

Medium

High

Very High

Very Low

Low

Medium

High

Very High

0

1.420

1.343

N/A

0.012

0.023

0.12

N/A

N/A

1900

950

190

N/A

Footnote:

  1. Crop groupings and transfer coefficients from Science Advisory Council for Exposure: Policy Memo #003.1 'Agricultural Transfer Coefficients', August 17, 2000.

  2. Maximum label rates from end use product labels.

  3. DAT = Days after treatment; DAT0 = On the day of treatment, after sprays have dried; assumed approximately 12 hours.

  4. The absorbed dermal dose = DFR (ug/cm2) x TC (cm2/hr) x conversion factor (1 mg/1,000 ug) x exposure time (hrs) x dermal absorption / body weight (kg).

  5. MOE = Dermal toxicity endpoint (mg/kg-day)/absorbed dermal dose (mg/kg-d).

CC:   RAB2 RF, M. Collantes, G. Bangs, S. Wang

 PAGE  31


[Federal Register Volume 78, Number 100 (Thursday, May 23, 2013)]
[Notices]
[Pages 30919-30920]
[FR Doc No: 2013-12322]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[FRL 9801-5]

Proposed Consent Decree, Clean Air Act Citizen Suit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Proposed Consent Decree; Request for Public Comment.

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

SUMMARY: In accordance with section 113(g) of the Clean Air Act, as
amended (``CAA'' or the ``Act''), notice is hereby given of a proposed
consent decree to address a lawsuit filed by Sierra Club in the United
States District Court for the Northern District of California: Sierra
Club v. Perciasepe, No. 3:12-cv-4078-JST (N.D. CA). On August 2, 2012,
Plaintiff filed a complaint alleging that EPA failed to take action on
certain state implementation plan (``SIP'') submissions from the State
of Nevada by the statutory deadline established by CAA section
110(k)(2). EPA has since taken final action on most of these SIP
submissions, and the proposed consent decree establishes a deadline for
EPA to take action on the one remaining SIP submission.

DATES: Written comments on the proposed consent decree must be received
by June 24, 2013.

ADDRESSES: Submit your comments, identified by Docket ID number EPA-HQ-
OGC-2013-0391, online at www.regulations.gov (EPA's preferred method);
by email to<EMAIL_ADDRESS>by mail to EPA Docket Center,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-0001; or by hand delivery or courier to
EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday,
excluding legal holidays. Comments on a disk or CD-ROM should be
formatted in Word or ASCII file, avoiding the use of special characters
and any form of encryption, and may be mailed to the mailing address
above.

FOR FURTHER INFORMATION CONTACT: Geoffrey L. Wilcox, Air and Radiation
Law Office (2344A), Office of General Counsel, U.S. Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460;
telephone:<PHONE_NUMBER>; fax number<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Additional Information About the Proposed Consent Decree

    The proposed consent decree would resolve a lawsuit filed by the
Sierra Club seeking to compel the Administrator to take final action
under sections 110(k) of the CAA, 42 U.S.C. 7410(k), to approve or
disapprove, in whole or in part, five regulations submitted by the
State of Nevada for inclusion in the Clark County portion of Nevada's
state implementation plan (``SIP''). EPA has already taken final action
on four of these regulations and notice of such final action was
published in the Federal Register on October 18, 2012. The proposed
consent decree only addresses the fifth regulation identified in the
Complaint as ``Section 25 of the Clark County Air Quality Regulations,
as amended May 18, 2010 and submitted to EPA on September 1, 2010''
(``Section 25''). Section 25 pertains generally to the treatment of
excess emissions during startup, shutdown, and malfunction events.
    The proposed consent decree provides that no later than December 2,
2013, EPA shall sign a notice of the Agency's final action on the SIP
submission with respect to Section 25 pursuant to section 110(k) of the
CAA, 42 U.S.C. 7410(k). The proposed consent decree requires that
following signature of EPA's final action, EPA shall promptly send the
notice to the Office of the Federal Register for publication in the
Federal Register. After EPA fulfills its obligations under the proposed
consent decree, the consent decree shall be terminated and the case
dismissed with prejudice.
    For a period of thirty (30) days following the date of publication
of this notice, the Agency will accept written comments relating to the
proposed consent decree from persons who were not named as parties or
intervenors to the litigation in question. EPA or the Department of
Justice may withdraw or withhold consent to the proposed consent decree
if the comments disclose facts or considerations that indicate that
such consent is inappropriate, improper, inadequate, or inconsistent
with the requirements of the Act. Unless EPA or the Department of
Justice determines that consent to this consent decree should be
withdrawn, the terms of the decree will be affirmed.

II. Additional Information About Commenting on the Proposed Consent
Decree

A. How can I get a copy of the consent decree?

    The official public docket for this action (identified by Docket ID
No. EPA-HQ-OGC-2013-0391) contains a copy of the proposed consent
decree. The official public docket is available for public viewing at
the Office of Environmental Information (OEI) Docket in the EPA Docket
Center, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington,
DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal

holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OEI Docket is (202) 566-
1752.
    An electronic version of the public docket is available through
www.regulations.gov. You may use www.regulations.gov to submit or view
public comments, access the index listing of the contents of the
official public docket, and to access those documents in the public
docket that are available electronically. Once in the system, key in
the appropriate docket identification number then select ``search''.
    It is important to note that EPA's policy is that public comments,
whether submitted electronically or in paper, will be made available
for public viewing online at www.regulations.gov without change, unless
the comment contains copyrighted material, CBI, or other information
whose disclosure is restricted by statute. Information claimed as CBI
and other information whose disclosure is restricted by statute is not
included in the official public docket or in the electronic public
docket. EPA's policy is that copyrighted material, including
copyrighted material contained in a public comment, will not be placed
in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. Although not all
docket materials may be available electronically, you may still access
any of the publicly available docket materials through the EPA Docket
Center.

B. How and to whom do I submit comments?

    You may submit comments as provided in the ADDRESSES section.
Please ensure that your comments are submitted within the specified
comment period. Comments received after the close of the comment period
will be marked ``late.'' EPA is not required to consider these late
comments.
    If you submit an electronic comment, EPA recommends that you
include your name, mailing address, and an email address or other
contact information in the body of your comment and with any disk or
CD-ROM you submit. This ensures that you can be identified as the
submitter of the comment and allows EPA to contact you in case EPA
cannot read your comment due to technical difficulties or needs further
information on the substance of your comment. Any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
    Use of the www.regulations.gov Web site to submit comments to EPA
electronically is EPA's preferred method for receiving comments. The
electronic public docket system is an ``anonymous access'' system,
which means EPA will not know your identity, email address, or other
contact information unless you provide it in the body of your comment.
In contrast to EPA's electronic public docket, EPA's electronic mail
(email) system is not an ``anonymous access'' system. If you send an
email comment directly to the Docket without going through
www.regulations.gov, your email address is automatically captured and
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.

    Dated: May 15, 2013.
Lorie J. Schmidt,
Associate General Counsel.
[FR Doc. 2013-12322 Filed 5-22-13; 8:45 am]
BILLING CODE 6560-50-P