	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:		November 2, 2007

Subject:	Occupational and Residential Exposure/Risk Assessment of Boscalid for Crop Protection Uses on Tropical Fruits, Herbs, & Cotton; and for Seed Treatment Use on Cotton

PC Code: 128008         	DP Barcode: D336634

    To:		Daniel Rosenblatt , RM 05

Registration Division/Fungicide Branch (7509P)

From:		Shih-Chi Wang, Biologist

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

Thru:		Richard Loranger, Branch Senior Scientist

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

The enclosed document is an assessment of potential occupational and residential exposures/risks to support the proposed Section 3 registration for new crop protection uses of boscalid on tropical fruits, herbs, & cotton; and for new seed treatment use on cotton.

	Table of Contents

 TOC \f

1.0  Executive Summary	3

2.0  Hazard Information	4

3.0  Product Use information	5

4.0  Non-Occupational/Residential Exposure 	6

5.0  Occupational Exposure	8

            5.1  For Crop Protection Uses 	8

              5.1.1  Handlers 	8

              5.1.2  Post-application 	11

5.2  For Seed Treatment Uses 	15

              5.2.1  Handlers 	15

              5.2.2  Secondary Handler 	16

1.0  Executive Summary

A Section 3 registration is being requested for the end-use products containing boscalid as active ingredient.  The proposed uses include: (1) Pristine( fungicide (boscalid 25.2%, water dispersable granule) on tropical fruits/herbs (0.29 lb ai/A) and cotton (0.4 lb ai/A) by ground or aerial equipment, and (2) BAS 510 ST( seed treatment fungicide (boscalid 70.0%, water dispersable granule) on  cotton (0.12 lb ai/100 lb seed) .

An oral NOAEL (21.8 mg/kg/day, all durations) was used to assess dermal and inhalation risks.  The NOAEL 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%, respectively.  Daily dermal and inhalation doses were combined and then compared to the NOAEL to determine the level of risks.  The level of concern for the margin of exposure (MOE) is 100.  Boscalid is classified as “suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential”, and, therefore, the human cancer risk was not evaluated.

The number of exposure days per year was not provided.  Based on the frequency/interval of applications on the crops and the seasonal nature of seed treatment operation, EPA assumes that all exposures would be less than 6 months per year (short- and intermediate-term exposures).

Since no chemical-specific data for assessing human exposures during  pesticide handling activities were submitted to the Agency in support of the registration of boscalid, HED used surrogate data from the PHED Version 1.1 (PHED Surrogate Exposure Guide, 8/98) to assess exposures for crop protection uses.  Defaults established by the HED Science Advisory Council for Exposure were used for acres treated per day and body weight.  For seed treatment uses, handler assessments were based on the unit exposure data from the Science Advisory Council for Exposure (Exposure SAC) Policy #14 (May 1, 2003) and based on the treating/planting data from the Exposure SAC Policy #15 (March 2, 2004).

No MOEs for handlers performing crop protection uses exceed the level of concern at the baseline or engineering control level (300 ~ 23,000).  No MOEs for handlers performing seed treatment use exceed the level of concern at the single layer level (1,000 ~ 6,800).  The HED level of concern is an MOE of <100.  The MOE for secondary handler (seed planter) is also greater than 100 (8,700) and does not exceed HED’s  level of concern.

All post-application MOEs for crop protection uses are greater than 100 on the day of application (650~20,000).  These MOEs do not exceed HED’s level of concern (MOE<100).

The technical material has a Toxicity Category IV for eye irritation/skin irritation, and a  Category III for acute dermal Toxicity.  Per the Worker Protection Standard (WPS), a 12-hr restricted entry interval (REI) is required.  The 12 hour REI appearing on the labels is appropriate.

The non-occupational/residential exposure/risk assessment is based on the previous HED’s assessment for BAS 510F (D290072).  No MOEs exceed HED’s level of concern (<100).

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) exposures to boscalid (also called as BAS 510F).  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 boscalid was also evaluated as required by the Food Quality Protection Act (FQPA) of 1996.  The FQPA safety factor was reduced to 1X because the existing data indicate that there are no/low concerns and no residual uncertainties with regard to pre- and/or post-natal toxicity.  The Cancer Assessment Review Committee (CARC) classified boscalid 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 - Boscalid 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 Boscalid.

Exposure

Scenario

Dose Used in Risk Assessment, UF

 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 = 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 tc \l1 "3.0  Product Use information

Proposed use patterns for boscalid are summarized in Table 3.

Table 3.  Proposed Use Patterns for Boscalid.

Crop

Product, Formulation

Treatment Type

Applications Per Season 1

Maximum Application Rate2

(lb ai/acre) or (lb ai/100 lb seed)

PHI3

(days)

Per Application

Per Season

Tropical

Herbs

Pristine,

water-dispersable granule

Ground or Aerial

equipment	2	0.29	0.58	0

Tropical

Fruits

Pristine,

water-dispersable granule

Ground or Aerial

equipment	2	0.29	0.58	0

       Cotton	Pristine,

water-dispersable granule	Ground or Aerial

     equipment	            2	            0.4          	          0.8	         30

Cotton

BAS 510 ST, water-dispersable granule

Treating seeds with commercial equipment	                                  NA                             	0.12	          NA

	         NA

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/Residential Exposure

The non-occupational/residential exposure/risk assessment is based on the previous HED’s assessment for BAS 510F (D290072, by S. Wang, M. Collantes, G. Bangs 6/18/03; Boscalid is also called as BAS 510F).

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 boscalid.  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.  Only golfing scenario is evaluated in this assessment.

The Boscalid 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.   Boscalid is not packaged or marketed for home orchard use, and therefore that use is not assessed.

It has been determined that there is a potential for exposure from entering areas previously treated with boscalid that could lead to exposures for adults and children.  Based on the discussion presented in the Exposure SAC document (Child Golfer Exposure Characterization 9/29/03) the child golfer’s exposure is likely to be similar to that of the adult golfer.  Hence, there is only one potential non-occupational post-application scenario associated with boscalid: adults golfing (Table 4).  Duration of exposure is anticipated to be short-term.

Table  4.  Non-Occupational Post-application Exposure Scenario for Boscalid

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

Turf Transferable Residue Data:

The Registrant, BASF Corporation submitted a turf transferable residue (TTR) study using boscalid in support of previous registration action (D290072).  Since the TTR study was performed using the modified California roller, the collected TTR values from this study are not compatible with the HED’s transfer coefficient of 500 cm2/hr for golfer (HED SOP 3.1).  Hence, the TTR values collected from the study were not used to estimate dermal post-application exposure.

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)

CF1	=	unit conversion factor to convert ug units in the DFR 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%)

Table 5 provides a summary of dermal post-application exposure for golfing.  The MOE was greater than 100 and therefore did not exceed HED’s level of concern.

	Table  5.  Dermal  Post-application Exposure for Adults and Youth

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

0.05

0.001

500

4

15

70

0.000214

100,000

1     Based on HED SOP 3.1

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)

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 boscalid.  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

5.1   For Crop Protection Uses

5.1.1.  Handlers  tc \l2 "5.1   For Crop Protection Uses   5.1.1.  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)

Total 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 Airblast Applications (Scenario 2)

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

Applying Sprays with Ground-boom Equipment (Scenario 4)

Applying Sprays with Airblast Equipment (Scenario 5)

Applying Sprays with Aerial Equipment (Scenario 6)

Flagging during Aerial Application (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 were 0.29 lb ai/A for tropical fruits and herbs and 0.4 lb ai/A for cotton.

Area or the Amount Treated

Based on HED’s Exposure Science Advisory Council Policy Number 9.1, 80 acres/day for applications on tropical herbs using ground-boom equipment, 40 acres/day for applications on tropical fruits using airblast equipment, and 350 acres/day for applications using fix-wing aerial equipment on tropical fruits and herbs were assumed.  For cotton, 200 acres/day for applications using ground-boom equipment, and 1200 acres/day for applications using fix-wing aerial equipment, were assumed.

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 (short- and intermediate-term exposures).  Long-term exposure is not expected.

Unit Exposures

The unit exposures 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

No MOEs for handlers performing crop protection uses exceed the level of concern at the baseline or engineering control level (300 ~ 23,000).  The HED level of concern is an MOE of <100.  Summaries of the exposures/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 assumption for the application rate, 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.

5.1.2  Post-application

Equations/Calculations

The following equations were used to calculate post-application exposure and risk:

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” (µg/cm2)

Tc	=	transfer coefficient (cm2/hr)

DA	=	dermal absorption factor (unitless)

ET	=	exposure time (hr/day)

BW	=	body weight (kg)

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

Where:

Rate	=	application rate (lb ai/acre)

F	=	fraction of ai retained on foliage or 20% (unitless)

D	=	fraction of residue that dissipates daily or 10% (unitless)

MOE		=	NOAEL (21.8 mg/kg/day)

                                           Daily dermal dose t (mg/kg/day)

Post-application Activities and Transfer Coefficients

Anticipated post-application activities and their respective dermal transfer coefficients (TCs) are summarized in Table 7.  The information in the table is based on the Science Advisory Council for Exposure Policy Number 3.1 and is based on proprietary and non-proprietary data.

Application Rate

The maximum application rates listed on the proposed label provided by the Registration Division were used for all assessments.  The maximum rates were 0.29 lb ai/A for herbs/tropical fruits and 0.4 lb ai/A for cotton.

Exposure Frequency

No data on the number of exposure days per year was provided   For this risk assessment,  it was assumed that post-application workers would be exposed for less than 30 days per year.

Exposure Duration

Workers were assumed to be exposed 8 hours per day.

Body Weight

The average body weight of an adult (70 kg) was assumed.

Table 7.  Anticipated Post-application Activities and Dermal Transfer Coefficients.

Proposed Crops

Policy Crop Group Category

Exposure Potential

Transfer Coefficients (cm2/hour)

Activities

       Herbs	Vegetable, leafy

Low

500

irrigation, scouting, thinning, weeding immature plants

Medium

1500

irrigation, and scouting mature plants

High

2500

hand harvesting, pruning, thinning mature plants

Tropical Fruits	   Tree, fruit,           evergreen

Very Low

100

propping

        Low 	         1000	irrigation, scouting, hand weeding

Medium

1500

harvesting

High

3000

thinning

       Cotton

	Field/row crop,

  Low/medium

Low

100

irrigation, scouting

Medium

1500

irrigation, and scouting thinning, weeding immature/low plants

      Post-application Exposure and Risk

All post-application MOEs on the day of application are greater than 100 (650~20,000), and do not exceed HED’s level of concern (MOE<100).  A summary of the post-application exposures/risks is presented in Table 8.

The technical material has a Toxicity Category IV for eye irritation/skin irritation, and a  Category III for acute dermal Toxicity.  Per the Worker Protection Standard (WPS), a 12-hr restricted entry interval (REI) is required.  The 12 hour REI appearing on the labels is appropriate.

           Table 6.  Non-Cancer Risks for Boscalid Handlers.

Exposure Scenario (Scenario #)

Mitigation Levela

Dermal Unit Exposureb (mg/lb ai)

Inhalation Unit Exposurec   (Ug/lb ai)

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)

Total

MOEh

Mixer/Loader

Dry Flowables for

Ground application (1)	Baseline	0.066	0.77	0.29

0.4 (Cotton)	80

200 (Cotton)	0.0033

0.0113 (Cotton)	0.00026

0.00088 (Cotton) 	0.0036

0.0122 (Cotton)	6,100

1,800 (Cotton)

Dry Flowables for

Airblast application (2)

	Baseline	0.066	0.77	0.29	40	0.0016	0.00013	0.0017	13,000

Dry Flowables for

Aerial application (3)	Baseline	0.066	0.77	0.29

0.4 (Cotton)	350

1200 (Cotton)	0.014

0.0678 (Cotton) 	0.0011

0.0053 (Cotton)	0.015

0.073 (Cotton)	1,500

300 (Cotton)

Applicator

Sprays with       Groundboom (4)

Baseline	0.014	0.74	0.29

0.4 (Cotton)	80

200 (Cotton)	0.00070

0.0024 (Cotton)	0.00025

0.00084 (Cotton)	0.00095

0.0032 (Cotton)	23,000

6,800 (Cotton)

Sprays with               Airblast (5)

	Baseline                      	0.36	4.5	0.29	40	0.0089	0.00075	0.0097 2,200

Sprays with

Fix-Wing aircraft (6)

Eng. Cont.	0.0050	0.068	0.29

0.4 (Cotton)	350

1200 (Cotton)	0.0011

0.0051 (Cotton)	0.000099

0.00046 (Cotton)	0.0012

0.0056 (Cotton)	18,000

3,900 (Cotton)

Flagger

Flagging during                  aerial applications (7)

Baseline	0.011	0.35	0.29

0.4 (Cotton)	350	0.0024

0.0033 (Cotton)	0.00051

0.0007 (Cotton)	0.0029

0.004 (Cotton)	7,500

5,500 (Cotton)

a	Baseline consists of long-sleeve shirt, long pants, shoes, and socks and no respirator.  Eng. Cont. consists of enclosed cockpit.

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

c	Baseline Inhalation Unit Exposure represents no respiratory protection, open mixing/loading, and open cab tractors, as appropriate.  Eng. Cont. Inhalation Unit Exposure represents enclosed cockpit.

d	Daily acres treated values are from EPA estimates of acreage that could be treated in a single day for each exposure scenario of concern.  Exposure SAC Policy 9, 7/5/2000.

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 (70kg).

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 (70kg).

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

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

Table  8.  Post-application Exposure and Risk for Crop Protection Uses

Crop

Application Rate

(lb ai/A)

Work Activity

Transfer Coefficientsa (cm2/hr)

Post-application Dayb

DFRc

(µg/cm2)

Daily Dosed (mg/kg/day)

 MOE e

Herbs	0.29	irrigation, scouting, thinning, weeding immature plants	500	0 0.651	0.0056	3,900

irrigation, and scouting mature plants	1500	0	0.651	0.0167	1,300

hand harvesting, pruning, thinning mature plants	2500	0	0.651	0.0279	780

  Tropical        Fruits	     0.29	 propping	       100	         0	0.651          0.0011	      20,000

irrigation, scouting, hand weeding	      1000	         0	0.651	          0.011	        2,000

harvesting	      1500	0	0.651	          0.017	        1,300

thinning 	      3000	0	       0.651	          0.033	         650

   Cotton	     0.4

irrigation, scouting

        100	0	       0.898	         0.0015	     14,000

irrigation, and scouting thinning, weeding immature/low plants

      1500	         0	       0.898 	        0.0231	       940

a	Transfer coefficient from Science Advisory Council for Exposure: Policy Memo #003 "Agricultural Transfer Coefficients," 05/07/98.

b	Day after treatment represents approximately 12 hours following application  when sprays have dried.

c	DFR = Application Rate (lb ai/acre) x Fraction of active ingredient that remains on the foliage when sprays have dried  x 4.54E8 µg/lb x 24.7E-9 acre/cm2.

d	Daily dose = DFR (µg/cm2) x TC (cm2/hr) x conversion factor (1 mg/1,000 µg) x exposure time (8 hrs/day) x dermal absorption (0.15) / body weight (70 kg).

e	MOE = NOAEL (21.8 mg/kg/day) / daily dose (mg/kg/day).

5.2   For Seed Treatment Uses

5.2.1  Handlers

Equations/Calculations

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

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

BW (kg)

Inhalation Dose (mg/kg/day)	=	 Rate (lb ai/lb seed) x UE (mg/lb ai) x lb. Treated (lb/day)

        BW (kg)

Where:

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

UE (Unit Exposure)		=	Exposure value derived from Exposure SAC Policy # 14; May 1, 2003

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

lb. Treated			=	Maximum number of pounds (of seeds) treated per day                                                                                (lb/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 four commercial seed handler scenarios that are expected to result in the highest exposure for the  proposed uses:

Loading (Open)/Applying Liquid for Seed Treatment (Scenario 1)

Sewing Seeds after Seed Treatment (Scenario 2)

Bagging Seeds after Seed Treatment (Scenario 3)

Multiple Activities Worker for Seed Treatment (Scenario 4)

Application Rate

The maximum application rate listed on the proposed labels provided by the Registration Division was used for all exposure assessments.  The maximum rate is 0.12 lb ai/100 lbs seed.

Treating Capacity

The treating capacity, amount of seeds treated per day in a commercial seed treatment facility, were based on the data shown in the Science Advisory Council for Exposure (Exposure SAC) Policy #15. The treating capacity is 160,000 lbs/day for treating cotton seeds.

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 were provided.  Due to the seasonal nature of seed treatment operation, it was assumed that handlers would be exposed for less than 6 months per year (i.e. short-/intermediate- term in duration).

Unit Exposures

The unit exposures used for assessing seed treatment exposures were based on the exposure data (Table 5) obtained from the Exposure SAC Policy #14: Standard Operating Procedures (SOP) for Seed Treatment (May 1, 2003).

Table 9.  Unit Exposure Values from Exposure SAC Policy #14

Scenario

Dermal (mg/lb ai)

Inhalation (mg/lb ai)

PPE Level

Loader/Operator

0.023

0.00034

single layer, glove

Sewer

0.0062

0.00023

single layer, no glove

Bagger

0.0091

0.00016

single layer, no glove

Multiple Activities

0.042

0.0016

single layer, glove

The engineering controls level assessment for the loader/applicator to support seed treatment use is based on the unit exposure values (for closed mixing liquids) given in the PHED Version 1.1 as presented in the August 1998 PHED Surrogate Exposure Guide.

Handlers’ Exposure and Risk

No MOEs for handlers performing seed treatment use exceed the level of concern at the single layer level (1,000 ~ 6,800).  The HED level of concern is an MOE of <100.  A summary of the risks for handlers is presented in Table 10.

The handler exposure estimates in this assessment are based on a central tendency estimate of unit exposure and an upper-percentile assumption for the application rate, and are assumed to be representative of high-end exposures.  The uncertainties associated with this assessment stem from the assumptions regarding that amount of chemical handled and the amount of seed treated per day.  The estimated exposures are believed to be reasonable high-end estimates based on observations from field studies and professional judgement.

5.2.2  Secondary Handler  tc \l2 "5.2.2  Post-application

Scenario and Unit Exposure

The secondary handler exposure scenario for seed treatment consists of the farmer purchasing bags of treated seed, placing the seed in the hopper, and applying seed to fields.  Secondary handler’s exposure associated with seed treatment was calculated using unit exposures given from the Science Advisory Council For Exposure Policy #14 (May 1, 2003)

Assumptions and Factors

Policy #14 HED dermal unit exposure = 0.25 mg/lb ai; inhalation unit exposure  = 0.0034 mg/lb ai

amount of seed planted per day (lb seed/day) is based on the data shown in Exposure SAC Policy # 15 (3,600 lb seed/day for cotton).

exposure frequency - 60 days/year and 8 hour/day exposure

body weight  = 70 kg

dermal absorption = 15%, inhalation absorption = 100%

Equations and Calculations

Daily Dermal Dose 	= Dermal UE x Amount of Seed Planted/day x Application Rate x DA

Body Weight (kg)

Daily Inhalation Dose      = Inhalation UE x Amount of Seed Planted/day x Application Rate x IA

Body Weight (kg)

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

MOE		 =	 NOAEL (21.8 mg/kg/day)

                                                          Combined Daily Dose (mg/kg/day)

Secondary Handler’s Exposure and Risk

The secondary handler’s MOE for seed planters does not exceed the level of concern at the single layer level (8,700). The HED level of concern is an MOE of <100.  These exposure/risk values are presented in Table 11.

The secondary handler exposure estimates in this assessment are based on a central tendency estimate of unit exposure, an upper-percentile assumption for the application rate, and a conservative estimate of exposure frequency; 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.

Due to the nature of the use pattern (seed treatment), the REI is based on the acute toxicity of the active ingredient.  Boscalid is classified in Acute Toxicity Category III for acute dermal toxicity; and in Acute Toxicity Category IV for primary eye irritation, acute inhalation toxicity, and primary skin irritation.  The labels list a 12 hour REI.

Title 40 of the Code of Federal Regulations, § 156.208 (c) (2) states:  If a product contains only one active ingredient and it is in Toxicity Category I by the criteria in paragraph (c) (1) of this section, the restricted-entry interval shall be 48 hours.”   The Federal Register Vol. 57, No. 163,  21 August 1992  page 38104 and 38142 (For 40 CFR Parts 156 and 170) indicates that “...a 48-hour REI is established for any product containing an active ingredient that is in Acute Toxicity Category I (most acutely toxic category) because of dermal toxicity or skin or eye irritation.”  Boscalid is not classified in Acute Toxicity Category I, but in Category III and IV; hence, the 12 hour REI is appropriate.

Table 10.  Non-Cancer Risk for Seed-Treatment Handlers.

Exposure Scenario (Scenario #)

Mitigation Level

Dermal Unit Exposure (mg/lb ai)

Inhalation Unit Exposure   (mg/lb ai)

Seed Species

Application Rate

(lb ai  per 100 lb seed)

Amount Treateda

(lb seed trt per day)

Daily

Dermal

Dose b (mg/kg/day)

Daily

Inhalation

Dosec (mg/kg/day)

Combined Daily Dosed  (mg/kg/day)

Total

MOEe

Loader/Applicator

Loading/Applying

Liquids for

Seed Treatment (1)

Single Layer, Gloves

0.023

0.00034	cotton	0.12	160,000	0.0095	0.00093	0.010	2,200

Sewer

Sewing Seeds after Seed treatment (2)

Single Layer,

No Gloves

0.0062

0.00023	cotton	0.12	160,000	0.0026	0.00063	0.0032	6,800

Bagger

Bagging Seeds after Seed treatment (3)

Single Layer,

No Gloves

0.0091

0.00016	cotton	0.12	160,000	0.0037	0.00044	0.0041	5,300

Multiple Activities Worker

Multiple Activities for Seed treatment (4)

Single Layer, Gloves

0.042

0.0016	cotton	0.12	160,000	0.017	0.0044	0.021	1,000

a	Daily amounts treated values are based on the information provided by the Registrant through Registration Division.

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

c	Daily inhalation dose (mg/kg/d) = (unit exposure (mg/lb ai) * application. rate (lb ai/lb seed) * daily amounts treated / body weight (70 kg).

d	Combined daily dose (mg/kg/d) =  Daily dermal dose (mg/kg/d) + Daily inhalation dose (mg/kg/d).

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

Table 11.  Non-Cancer Risk for Secondary Handler-Seed Planters.

Exposure Scenario (Scenario #)

Mitigation Level

Dermal Unit Exposure (mg/lb ai)

Inhalation Unit Exposure   (mg/lb ai)

Seed  Category--Representative

Seed Species

Application Rate

(lb ai  per 100lb seed)

Amount Planteda

(lb seed pnted/day)

Daily

Dermal

Dose b (mg/kg/day)

Daily

Inhalation

Dosec (mg/kg/day)

Combined Daily Dosed

(mg/kg/day)

Total

MOEe

Seed Planters

Post-application:

planting seeds in the field

Single Layer, Gloves

0.25

0.0034	cotton	0.12	3,600	0.0023	0.00021	0.0025	8,700

a	Daily amounts planted values are based on the information provided by the Registrant through Registration Division.

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

c	Daily inhalation dose (mg/kg/d) = (unit exposure (mg/lb ai) * application. rate (lb ai/lb seed) * daily amounts treated / body weight (70 kg).

d	Combined daily dose (mg/kg/d) =  Daily dermal dose (mg/kg/d) + Daily inhalation dose (mg/kg/d).

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

CC:   RAB2 RF, D. Davis, S. Wang

 PAGE

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[Federal Register Volume 76, Number 161 (Friday, August 19, 2011)]
[Proposed Rules]
[Pages 51927-51929]
[FR Doc No: 2011-21224]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2011-0474; FRL-9453-4]

Approval and Promulgation of Air Quality Implementation Plans;
West Virginia; Determination of Clean Data for the 2006 Fine
Particulate Standard for the Charleston Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to determine that the Charleston, West
Virginia nonattainment area for the 2006 fine particulate matter
(PM2.5) National Ambient Air Quality Standard (NAAQS) has
clean data for the 24-hour 2006 PM2.5 NAAQS. This proposed
determination is based upon quality assured, quality controlled, and
certified ambient air monitoring data showing that this area has
monitored attainment of the 2006 PM2.5 NAAQS based on the
2007-2009 data and data available to date for 2010 in EPA's Air Quality
System (AQS) database that show the area continues to attain. If this
proposed determination is made final, the requirements for this area to
submit an attainment demonstration, associated reasonably available
control measures, a reasonable further progress plan, contingency
measures, and other planning State Implementation Plans (SIPs) related
to attainment of the standard shall be suspended for so long as the
area continues to meet the 24-hour 2006 PM2.5 NAAQS.

DATES: Written comments must be received on or before September 19,
2011.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2011-0474 by one of the following methods:
    A. http://www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. E-mail<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2011-0474, Cristina Fernandez, Associate
Director, Office of Air Program Planning, Mailcode 3AP30, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2011-0474. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. 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. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in http://www.regulations.gov or in hard copy during normal business hours at the
Air Protection Division, U.S. Environmental Protection Agency, Region
III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.

FOR FURTHER INFORMATION CONTACT: Asrah Khadr,<PHONE_NUMBER>, or by e-
mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.
    The following outline is provided to aid in locating information in
this preamble.

I. What action is EPA taking?
II. What is the effect of this action?
III. What is the Background for this action?
IV. What is EPA's analysis of the relevant air quality data?
V. Proposed Action
VI. Statutory and Executive Order Reviews

I. What action is EPA taking?

    EPA is proposing to determine that Charleston, West Virginia
PM2.5 nonattainment area has clean data for the 24-hour 2006
PM2.5 NAAQS. This

determination is based upon quality assured, quality controlled, and
certified ambient air monitoring data showing that these areas have
monitored attainment of the 2006 PM2.5 NAAQS based on the
2007-2009 data and data available to date for 2010 in EPA's AQS
database.

II. What is the effect of this action?

    If this determination is made final, under the provisions of EPA's
PM2.5 implementation rule (see 40 CFR section 51.1004(c)),
the requirements for the Charleston nonattainment area to submit an
attainment demonstration, associated reasonably available control
measures (RACM) (including reasonably available control technology
(RACT)), a reasonable further progress (RFP) plan, contingency
measures, and any other planning SIPs related to attainment of the 2006
PM2.5 NAAQS would be suspended for so long as the area
continues to meet the 24-hour 2006 PM2.5 NAAQS. Furthermore,
as described below, a final clean data determination would not be
equivalent to the redesignation of this area to attainment of the 24-
hour 2006 PM2.5 NAAQS.
    If this rulemaking is finalized and EPA subsequently determines,
after notice-and-comment rulemaking in the Federal Register, this area
has violated the 24-hour 2006 PM2.5 NAAQS, the basis for the
suspension of the specific requirements, set forth at 40 CFR
51.1004(c), would no longer exist and this area would thereafter have
to address the pertinent requirements.
    This clean data determination that EPA proposes with this Federal
Register notice, that the air quality data shows attainment of the 24-
hour 2006 PM2.5 NAAQS, is not equivalent to the
redesignation of this area to attainment. This proposed action, if
finalized, will not constitute a redesignation to attainment under
section 107(d)(3) of the Clean Air Act (CAA), because we would not yet
have an approved maintenance plan for this area as required under
section 175A of the CAA, nor a determination that this area has met the
other requirements for redesignation. The designation status of this
area would remain nonattainment for the 2006 PM2.5 NAAQS
until such time as EPA determines that this area meets the CAA
requirements for redesignation to attainment.

III. What is the background for this action?

    The 2006 PM2.5 NAAQS set forth at 40 CFR 50.13 became
effective on December 18, 2006 (71 FR 61144) and promulgated a 24-hour
standard of 35 micrograms per cubic meter ([micro]g/m[sup3]) based on a
3-year average of the 98th percentile of 24-hour concentration. On
December 14, 2009, (74 FR 58688), EPA made designation determinations,
as required by CAA section 107(d)(1), for the 24-hour 2006
PM2.5 NAAQS. The Charleston area is designated as
nonattainment for the 24-hour 2006 PM2.5 NAAQS.

IV. What is EPA's analysis of the relevant air quality data?

    EPA has reviewed the ambient air monitoring data, consistent with
the requirements contained in 40 CFR part 50 and recorded in EPA's AQS
database for the Charleston PM2.5 nonattainment area from
2007 through the present time. On the basis of that review, EPA has
concluded that this area meets the 24-hour 2006 PM2.5 NAAQS
based on the 2007-2009 data and data available to date for 2010 in
EPA's AQS database.
    Under EPA regulations in 40 CFR part 50, section 50.13 and in
accordance with Appendix N, the 24-hour primary and secondary
PM2.5 standards are met when the 98th percentile 24-hour
concentration is less than or equal to 35 [micro]g/m\3\. Table 1 shows
the design values for the 2006 24-hour PM2.5 NAAQS for the
years 2007-2009 and Table 2 shows the preliminary design values for the
2006 24-hour PM2.5 NAAQS for the year 2010. EPA's review of
the data indicates that the Charleston, West Virginia PM2.5
nonattainment area meets the 2006 PM2.5 NAAQS.

                    Table 1--2007-2009 Daily Average Concentrations in the Charleston Area\1\
----------------------------------------------------------------------------------------------------------------
                                                                                Design value
                   Site name                                 County                  Site No.      ([mu]g/m\3\)
----------------------------------------------------------------------------------------------------------------
Charleston....................................  Kanawha.........................     54-039-0010              29
South Charleston..............................  Kanawha.........................     54-039-1005              32
----------------------------------------------------------------------------------------------------------------
\1\ The publicly available PM2.5 AQS data and information is available as part of EPA's AirTrends Site at: http://www.epa.gov/airtrends/values.html.

                        Table 2--2010 Daily Average Concentrations in the Charleston Area
----------------------------------------------------------------------------------------------------------------
                                                                                Preliminary
                   Site name                                 County                  Site No.      design value
                                                                                ([mu]g/m\3\)
----------------------------------------------------------------------------------------------------------------
Charleston....................................  Kanawha.........................     54-039-0010              25
South Charleston..............................  Kanawha.........................     54-039-1005              28
----------------------------------------------------------------------------------------------------------------

V. What's EPA's proposed action?

    EPA is proposing to determine that the Charleston nonattainment
area has clean data for the 24-hour 2006 PM2.5 NAAQS. As
provided in 40 CFR 51.1004(c), if EPA finalizes this determination, it
will suspend the requirements for this area to submit an attainment
demonstration, associated reasonably available control measures, a
reasonable further progress plan, contingency measures, and any other
planning SIPs related to the attainment of the 2006 PM2.5
NAAQS, so long as these areas continues to meet the standard. EPA is
soliciting public comments on the issues discussed in this document.
These comments will be considered before taking final action.

VI. What are the statutory and executive order reviews?

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:

     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rulemaking that the Charleston, West
Virginia PM2.5 nonattainment area has clean data for the 24-
hour 2006 PM2.5 standard does not have tribal implications
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian Country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Particulate matter, Reporting and recordkeeping.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: August 8, 2011.
W.C. Early,
Acting Regional Administrator, Region III.
[FR Doc. 2011-21224 Filed 8-18-11; 8:45 am]
BILLING CODE 6560-50-P