UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

March 3, 2009

SUBJECT:	Acibenzolar-S-Methyl – Revised Acute and Chronic Dietary and Drinking Water Exposure and Risk Assessments

PC Code:  061402	DP Barcode: 362208

Decision No.:  393110	Registration No.: 100-922

Petition No.:  PP#8F7352, PP8E7337	Regulatory Action:  Section 3

Risk Assessment Type:  Dietary	Case No.:  NA

TXR No.:  NA	CAS No.:  135158-54-2

MRID No.:  NA	40 CFR:  180.561

FROM:	Becky Daiss, Biologist

Risk Assessment Branch IV

Health Effects Division (7509P)

THROUGH:	Thurston Morton and Anant Parmar

Dietary Exposure Science Advisory Council (DESAC),

Health Effects Division (7509P)

TO:		Tony Kish, Product Manager

		Fungicide Branch

		Susan Stanton, Product Manager

		RIMUER Branch

Registration Division (7505P)

This document provides a revised acute and chronic dietary and drinking water risk analyses of exposures resulting from use of acibenzolar-S-methyl as a plant activator on food crops.  This assessment supports a Section 3 requests for use of acibenzolar-S-methyl on cucurbit vegetables and bulb onions.  Executive Summary

Acute and chronic dietary risk assessments were conducted for acibenzolar-S-methyl using the Dietary Exposure Evaluation Model (DEEM-FCID, Version 2.03), which uses food consumption data from the USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analyses were performed to support Section 3 requests for use of acibenzolar-S-methyl on cucurbit vegetables and bulb onions.

Acute Dietary Exposure Results and Characterization

A refined (probabilistic) acute dietary exposure analysis was performed for the population subgroup females 13-49 only.  No acute endpoint was identified for the remaining population subgroups.  The acute analysis assumed a distribution of residues based on field trial data.  DEEM default and empirical processing factors were used to modify the field trial data.  Maximum screening-level percent crop treated estimates were used for commodities for which data were available.  If no percent crop treated data were available, 100% crop treated was assumed.  The acute analysis incorporated the 1 in 10 year peak surface drinking water estimate from application of acibenzolar-S-methyl to cucurbit vegetables.    SEQ CHAPTER \h \r 1 The resulting 99.9th percentile acute exposure estimate for females 13-49 years old is not of concern to HED (12% acute population adjusted dose (aPAD)).

Chronic Dietary Exposure Results and Characterization

A conservative chronic dietary exposure analysis was performed for the general U.S. population and various population subgroups.  Tolerance level residues and 100 crop treated assumptions were used.  DEEM default and empirical processing factors were used to modify the tolerance values.  The chronic analysis incorporated the 10 year average surface drinking water estimate from application of acibenzolar-S-methyl to cucurbit vegetables.  The population subgroup females 13-49 had a more protective chronic population adjusted dose (cPAD, 0.082 mg/kg/day) than the general U.S. population and all other population subgroups (0.25 mg/kg/day).  Chronic dietary risk estimates are not of concern for general population or other population subgroups.  The subgroup with the highest risk estimate was females 13-49 with a cPAD of 5%.  The cPAD for the general U.S. population was 2%.

I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population adjusted dose (PAD).  The PAD is equivalent to the Reference Dose (RfD) divided by the FQPA Safety Factor.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  References that discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site:  “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 6/21/2000, web link:    HYPERLINK "http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf"  http://www.epa.gov/fedrgstr/EPA_PEST/2000/July/Day_12/6061.pdf  ; or see SOP 99.6 (8/20/99).

II.	Residue Information

Residues of Concern

The HED Metabolism Assessment Review Committee (MARC) reviewed lettuce, tomato, cotton, lemon, poultry, and ruminant metabolism studies and the environmental fate data.  Table 1 provides a summary of the MARC decisions regarding residues of concern for acibenzolar-S-methyl.  (D261037, M. Doherty, 4/26/00)

Table 1:  Summary of MARC Decisions for Acibenzolar-S-methyl

Matrix	Residues of Concern 1

	For Risk Assessment 2	For Tolerance Expression

Plants	Residues of acibenzolar-S-methyl, benzo(1,2,3) thiadiazole-7-carbothioic acid-S-methyl ester, convertible to benzo(1,2,3)thiadiazole-7-carboxylic acid (CGA-210007), expressed as acibenzolar-S-methyl &

4-hydroxy CGA-210007 (CGA-323060)

5-hydroxy CGA-210007 (CGA-324041)	Residues of acibenzolar-S-methyl, benzo(1,2,3) thiadiazole-7-carbothioic acid-S-methyl ester, convertible to benzo(1,2,3)thiadiazole-7-carboxylic acid (CGA-210007), expressed as acibenzolar-S-methyl

1 The residues of concern for drinking water are the same as those listed in the tolerance expression

2 If a future petition is received for rice, residues of CGA-379019 should be included in the risk assessment

Established/Recommended Tolerances

Tolerances have been established (40CFR 180.561) for residues of acibenzolar-S- methyl (benzo(1,2,3)thiadiazole-7-carbothioic acid-S-methyl ester) in/on spinach at 1.0 ppm, leafy vegetables (Crop Group 4, other than spinach, at 0.25 ppm), Brassica (cole) leafy vegetables (Crop Group 5 at 1.0 ppm), fruiting vegetables (Crop Group 8 at 1.0 ppm), and tomato paste at 3.0 ppm.  There is also an import tolerance for bananas at 0.1 ppm.  Tolerances have been proposed for the bulb onion subgroup 3-07A and the curcurbit vegetable crop group 9.   Tolerances have been established and/or recommended for individual crop groups based on field trial data for representative commodities in accordance with HED SOP 2000.1 (9/12/2000).  Recommended tolerances for the proposed new uses are as follows.

Onion, bulb, subgroup 3-07A 	0.1 ppm

Vegetable, cucurbit, group 9 	2.0 ppm

The tolerance expression for acibenzolar-S-methyl is for residues convertible to benzo(1,2,3)thiadiazole-7-carboxylic acid (CGA-210007), expressed as acibenzolar-S-methyl.

Residues Used in the Chronic Analysis

In the chronic dietary exposure analysis, tolerance level residues were used and 100 percent crop treated was assumed for all commodities.  DEEM default processing factors were used for dried onion, dried banana, dried plantain, and dried tomato.  A processing factor was not used for tomato paste because a separate tolerance has been established for this processed commodity.  In the submitted tomato processing study (D246673, M. Doherty, 3/15/2000), reported processing factors of 1.0 and 2.9 for tomato juice and tomato puree were used.

Available lettuce metabolism data for a 7-day PHI were used to determine the relative abundance of the hydroxy metabolites (CGA-323060 and CGA-324041) and residues convertible to the carboxylic acid metabolite (CGA-210007).  Based on the lettuce metabolism data, a factor of 1.5x was applied to estimates of acibenzolar-S-methyl residues to account for all of the residues of concern for dietary risk (including CGA-210007, CGA-323060 and CGA-324041).  Lettuce metabolism data are provided in Table 2.

Table 2.  Lettuce metabolism data (Washed, 7-day PHI)

Compound	% Residues

Acibenzolar-S-Methyl	17

CGA-210007	25

CGA-323060	20

CGA-324041	0.06

Residues Used in the Acute Analysis

A probabilistic assessment was performed for the acute analysis.  The acute analysis assumed a distribution of residues based on field trial data for nonblended and partially blended commodities.  For blended commodities, the mean field trial values were used as a point estimate. A value of ½ LOQ was used for samples that contained less than LOQ residues.  Foods were classified as blended, partially blended, or nonblended based on guidance given in the Draft DEEM-FCID Classification of Food Forms with Respect to Blending (F. Fort, 4/9/2003).  DEEM default processing factors were used for dried onion, dried banana, dried plantain, and dried tomato.  Empirical processing factors were used for tomato paste (7.1), tomato puree (2.9), and tomato juice (1.0).  The acute analysis used available maximum percent crop treated estimates from the Biological and Economic Analysis Division’s (BEAD’s) screening-level analysis (D353541, J. Alsadek, 6/18/08).  If no percent crop treated data were available 100% crop treated was assumed.  As previously noted, a factor of 1.5X was applied to the estimate of residues convertible to CGA-210007 for all commodities to account for all of the residues of concern for dietary risk.

Residues used in the acute and chronic dietary analyses are provided in Table 3.

Table 3.  Data and Residue Estimates Used in Acibenzolar-S-Methyl Dietary and Drinking Water Analyses

Commodity	Blended

Status 1

	Data

Source	%CT	Process

Factors	Anticipated Residue Estimates/Tolerance 2

	Avg	Max

Acute	Chronic

(Tolerance)

Crop Group 3-07A Onions

Onion, dry bulb and

dry bulb-babyfood	NB/PB	Field Trials

14 samples

1 detectable residue MRID47375301

	100	100	NA	RDF# 23

Onion (100% CT)

TOTALZ=0

TOTALNZ=7	1.0

Onion , dry bulb dried, and dried-babyfood	B

9	Tolerance 1.0

	Onion , Green Onion

	NA

Crop Group 4A – Leafy Greens

Amaranth, Arugula, Cress Chrysanthemum , Endive, Dandelions, Parsley	PB Field Trails

11 samples

11 detectable residues

MRID 44537062	100	100	NA	RDF# 18

SpinichOth (100% CT)

TOTALZ=0

TOTALNZ=11	0.25

Lettuce, head               	NB/PB	Field Trails

12 samples

12 detectable residues

MRID 44537062	8	12	NA	RDF# 6

LettuceH (12% CT)

TOTALZ=88

TOTALNZ=12	0.25

Lettuce, leaf                      	PB	Field Trails

11 samples

11 detectable residues

MRID 44537062	8	12	NA	RDF# 8

LettuceL (12% CT)

TOTALZ=81

TOTALNZ=11	0.25

Radicchio	PB	Field Trails

12 samples

12 detectable residues

MRID 44537062	100	100	NA	RDF# 16

LettuceHRad(12% CT)

TOTALZ=0

TOTALNZ=12	0.25

Spinach	PB	Field Trails

11 samples

11 detectable residues

MRID 44537062	15	30	NA	RDF# 10

Spinach (30% CT)

TOTALZ=26

TOTALNZ=11	1.0

Crop Group 4B – Leafy Petioles

Cardoon

Celtuce

Fennel

Rhubarb

Swiss chard	NB	Field Trails

9 samples

9detectable residues

MRID 44537062	100	100	NA	RDF# 15

CeleryOth (100% CT)

TOTALZ=0

TOTALNZ=9	0.25

Celery	NB/PB	Field Trails

9 samples

9detectable residues

MRID 44828007	1	1	NA	RDF# 15

Celery (1% CT)

TOTALZ=0

TOTALNZ=9	0.25

Crop Group 5A – Brassica Head & Stem

Broccoli

Cauliflower 	NB/PB	Field Trails

11 samples

11detectable residues

MRID 44828007	5	5	NA	RDF# 3

Broccoli (5% CT)

TOTALZ=209

TOTALNZ=11	1.0

Cabbage	NB/PB	Field Trails

11 samples

11detectable residues

MRID 44828007	2.5	1	NA	RDF# 4

Cabbage (2.5% CT)

TOTALZ=429

TOTALNZ=11	1.0

Cabbage Chinese Mustard

Brocolli Chinese	NB	Field Trails

11 samples

11detectable residues

MRID 44828007	100	100	NA	RDF# 13

BroccoliOth (100% CT)

TOTALZ=0

TOTALNZ=11	1.0

Kohlrabi

Brussels sprouts

Cabbage Chinese Napa	NB	Field Trails

11 samples

11detectable residues

MRID 44828007	100	100	NA	RDF# 14

CabbageOth (100% CT)

TOTALZ=0

TOTALNZ=11	1.0

Crop Group 5B– Brassica Leafy Greens

Cabbage Chinese bok choy

Collards

Kale

Mustard Greens

Rape greens

Turnip greens    	NB	Field Trails

9 samples

9detectable residues

MRID 44828007	100	100	NA	RDF# 9

Mustard (100% CT)

TOTALZ=0

TOTALNZ=9	1.0

Crop Group 8 – Fruiting Vegetables

Eggplant,  	NB/PB	Field Trails

9 samples

9detectable residues

MRID 44537060	100	100	NA	RDF# 12

BellPepOth (100% CT)

TOTALZ=0

TOTALNZ=9	1.0

Okra	NB/PB	Field Trails

9 samples

9detectable residues

MRID 44537060	100	100	NA	RDF# 17

HotPepOth (100% CT)

TOTALZ=0

TOTALNZ=9	1.0

Pepper nonbell   	NB/PB	Field Trails

5 samples

5 detectable residues

MRID 44537060	5	5	NA	RDF# 7

HotPep (5% CT)

TOTALZ=95

TOTALNZ=5	1.0	5

Pepper nonbell , dried	B	Field Trails

5 samples

5 detectable residues

MRID 44537060	5	5	NA	Mean field trial (0.321)	1.0

	Pepper, bell  	NB/PB	Field Trails

9 samples

9detectable residues

MRID 44537060	5	5	NA	RDF# 2

BellPep (5% CT)

TOTALZ=179

TOTALNZ=9	1.0	5

Tomatillo	NB/PB	Field Trails

23 samples

23detectable residues

MRID 44537060	100	100	NA	RDF# 19

TomatoOth(100% CT)

TOTALZ=0

TOTALNZ=23	1.0

Tomato	NB/PB	Field Trails

23 samples

23detectable residues

MRID 44537060	5	5	NA	RDF# 11

Tomato(5% CT)

TOTALZ=437

TOTALNZ=23	1.0

Tomato, paste, 	B	Field Trails

23 samples

23detectable residues

MRID 44537060	5	5	7.1	Mean field trial: 0.164	1.0

Tomato, puree  	B	Field Trails

23 samples

23detectable residues

MRID 44537060	5	5	2.9	Mean field trial: 0.164	1.0

Tomato, dried                      	B	Field Trails

23 samples

23detectable residues

MRID 44537060	5	5	14.3	Mean field trial: 0.164	1.0

Crop Group 9A– Cucurbit Vegetables - Melon

Cantaloupe,

Casaba,

Honeydew melon,

Watermelon                     	NB/PB	Field Trails

12samples

12detectable residues

MRID 45105301	100	100	NA	RDF# 20

Cantaloupe(100% CT)

TOTALZ=0

TOTALNZ=6	2.0

Crop Group 9B – Cucurbit Vegetables – Squash Cucumbers

Chayote, fruit, Chinese waxgourd    	NB

NA

2.0

Cucumber, Balsam pear                        	NB	Field Trails

16 samples

16 detectable residues

MRID 45105301	6	3	NA	RDF# 21

Cucumber(100% CT)

TOTALZ=0

TOTALNZ=8	2.0

Pumpkin, Squash   	NB/PB	Field Trails

10 samples

10 detectable residues

MRID 45105301	100	100	NA	RDF# 22

Squash(100% CT)

TOTALZ=0

TOTALNZ=5	2.0

Crop Group O - Other

Banana, Plantain	NB/PB	Field Trails

30 samples

8 detectable residues

MRID 44828004	100	100	NA	RDF#1

Banana(100%CT)

Total Z=0

TotalNZ=30	0.1

Banana, Plantain,  dried	B	Field Trails

30 samples

8 detectable residues

MRID 44828004	100	100	3.9	Mean field trial (0.0107)	0.1

Water	NA	D351609	100	100	NA	0.017	0.011

1 Classification of blended (B), partially blended (PB), not blended (NB).

2  A factor of 1.5X was applied to estimate residues convertible to CGA-210007 for all commodities to account for all of the residues of concern for dietary risk.

III.	Water Data

Drinking water residues were incorporated directly into the acute and chronic dietary analyses (“water, direct, all sources” and “water, indirect, all sources”) and were provided by the Environmental Fate and Effects Division (EFED) (D351609, R. Miller, 8-Aug-2008).  EFED generated the surface water and ground water estimates using the   SEQ CHAPTER \h \r 1 Pesticide Root Zone Model 3 (PRZM3; ver. 3.12.2; 2-May-2005)/Exposure Analysis Modeling System (EXAMS; ver. <IP_ADDRESS>; 25-Apr-2005) and Screening Concentration in Ground Water (SCIGROW; Tier 1) models, respectively.  The residues of concern for drinking water include acibenzolar-S-methyl and residues convertible to CGA-210007.  EFED provided estimates for the proposed use of acibenzolar-S-methyl on cucurbits because this use represents the highest use rate of the proposed registered uses.  The SCI-GROW estimated ground water drinking water concentrations for acibenzolar-S-methyl is not expected to exceed 4.08 x 10-5 µg/L and CGA 210007 is not expected to exceed 0.557 µg/L.  Surface water EDWCs for acibenzolar-S-methyl, which were used in the exposure assessment, are provided in Table 4.

Acute (μg/L)	NonCancer Chronic (μg/L)	Cancer Chronic(μg/L)

Surface Water	Acibenzolar-S-Methyl1	0.74	0.10	0.05

Surface Water	CGA 2100072	14.21	9.48	5.47

1 Aerial application method

2 Degradation product formed after application

CGA-210007 drinking water residues were included in the dietary exposure assessment as acibenzolar-S-methyl equivalents.  CGA 210007 residues were converted based on molecular weight as follows.

Acute: 210 (acibenzolar-S-methyl MW) ÷ 180 (CGA 210007) x 14.21 (μg/L) = 17 μg/L CGA 210007

Chronic: 210 ÷ 180 x 9.48 (μg/L) = 11 μg/L CGA 210007

IV.	DEEM-FCID™ Program and Consumption Information

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

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

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

V.	Toxicological Information

HED evaluated the toxicology data base for acibenzolar-S-methyl and selected the following doses and endpoints for acute and chronic dietary and drinking water risk assessments.

Table 5. Summary of Toxicological Doses and Endpoints for Acibenzolar-S-methyl  for Use in Dietary and Non-Occupational Human Health Risk Assessments

Exposure/Scenario	Point of Departure	Uncertainty/FQPA Safety Factors RfD, PAD, LOC for Risk Assessment	Study and Toxicological Effects

Acute Dietary (General Population)	An acute RfD for the general population or any population subgroups was not selected  because no effect attributable to a single (or few) day(s) oral exposure was observed in animal studies.

Acute Dietary

(Females 13-49 years)	NOAEL = 8.2 mg/kg/day	UFA= 10x

UFH=10x

FQPA SF= 1x	Acute RfD = 0.082 mg/kg/day

aPAD = 0.082 mg/kg/day	Developmental Neurotoxicity Toxicity Study - Rat

Developmental LOAEL = 82 mg/kg/day based on changes in brain morphometrics in the cerebellum in offspring.

Maternal LOAEL = was not observed NOAEL  = 4000 mg/kg/day HDT

Chronic Dietary

(Females 13-49 years)	NOAEL = 8.2 mg/kg/day	UFA= 10x

UFH=10x

FQPA SF= 1x	Acute RfD = 0.082 mg/kg/day

aPAD = 0.082 mg/kg/day	Developmental Neurotoxicity Toxicity Study - Rat

Developmental LOAEL = 82 mg/kg/day based on changes in brain morphometrics in the cerebellum in offspring.

Maternal LOAEL = was not observed

NOAEL  = 4000 mg/kg/day HDT

Chronic Dietary

(All Populations)	NOAEL = 25 mg/kg/day	UFA= 10x

UFH=10x

FQPA SF= 1x	Chronic RfD = 0.025

mg/kg/day

cPAD = 0.25 mg/kg/day	Chronic Toxicity - Dog; Co-critical; Chronic/Cancer - Rat & Mouse, Reproduction Toxicity - Rat

LOAEL = 25 mg/kg/day based on hemolytic anemia with compensatory response.

Cancer (all routes)	Not a Human Carcinogen

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and  used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.  NOAEL = no observed adverse effect level.

NOAEL = no observed adverse effect level.

LOAEL = lowest observed adverse effect level.

UF = uncertainty factor.

UFA = extrapolation from animal to human (interspecies).

UFH = potential variation in sensitivity among members of the human population (intraspecies).

FQPA SF = FQPA Safety Factor.

PAD = population adjusted dose (a = acute, c = chronic).

RfD = reference dose.

VI.	Results/Discussion

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID™ analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The results reported in Tables 3 and 4 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years.

Results of Acute Dietary Exposure Analysis

The results of the acute dietary exposure analysis at the 99.9th percentile of exposure are reported in Table 6.

Table 6:  Summary of Acute Dietary Exposure and Risk for Acibenzolar-S-Methyl

Population Subgroup	aPAD (mg/kg/day)	Acute (99th Percentile)

Exposure (mg/kg/day)	%aPAD

Females 13-49 years old	0.082	0.0010	12

Results of Chronic Dietary Exposure Analysis

The results of the chronic dietary exposure analysis are reported in Tables 7 and 8.

Table 7:  Summary of Chronic Dietary Exposure and Risk for Acibenzolar-S-Methyl

Population Subgroup	aPAD (mg/kg/day)	Chronic

Exposure (mg/kg/day)	% cPAD

Females 13-49 years old	0.082	0.0038	5

Table 8:  Summary of Chronic Dietary Exposure and Risk for Acibenzolar-S-Methyl

Population Subgroup	cPAD (mg/kg/day)	Chronic

Exposure (mg/kg/day)	% cPAD

General U.S. Population	0.25	0.0045	2

All Infants (< 1 year old)

0.0043	2

Children 1-2 years old

0.0093	4

Children 3-5 years old

0.0088	3.5

Children 6-12 years old

0.0059	2

Youth 13-19 years old

0.0043	2

Adults 20-49 years old

0.0038	1.5

Adults 50+ years old

0.0040	2

VI.	Characterization of Inputs/Outputs

The chronic dietary analysis is very conservative.  Tolerance level residues used in the analysis are expected to exceed the residues actually consumed.  In addition, the 100% crop treated estimate used for all crops in the assessment will considerably overestimate the actual percent  crop treated.

The acute dietary analysis is refined.  The use of field trial data and BEAD’s maximum

percent crop treated estimates in a probabilistic assessment provided exposure estimates that are more likely to be representative of actual exposures.  These estimates could be further refined, however by use of percent crop treated estimates for the crops for which 100% crop treated assumptions were made, use of monitoring data, market basket surveys, washing factors, and cooking factors.

VII.	Conclusions

A conservative chronic dietary exposure analysis was performed for the general U.S. population and various population subgroups.  The risk estimates for the general U.S. population and all population subgroups are below HED’s level of concern.  The subgroup with the highest risk estimate was females 13-49 with a cPAD of 5%.  The cPAD for the general U.S. population was 2%.   A refined probabilistic acute dietary exposure analysis was performed for the population subgroup Females 13-49.  The resulting 99.9th percentile acute exposure estimate for females 13-49 years old is not of concern to HED (11% acute population adjustment dose (aPAD)).   HED is confident that acute and chronic dietary exposures to acibenzolar-S-methyl are not underestimated.

VIII.	List of Attachments

1.  Acute DEEM-FCID Residue Input File.

2.  Results of Acute DEEM-FCID Dietary Exposure Analysis.

3.  Chronic DEEM-FCID Residue Input File.

4.  Results of Chronic DEEM-FCID Dietary Exposure Analysis.

5.  Percent Crop Treated Estimates Provided by BEAD

6.  RDF Files Used in Acute Analysis

Attachment 1 Acute DEEM-FCID Residue Input File

Filename: F:\Acibenzolar\061402Acute1-21-09.R98  Chemical: Acibenzolar-S-Methyl

RfD(Chronic): .082 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): .082 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day

Date created/last modified: 01-21-2009/14:26:36/8          Program ver. 2.03

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

RDL indices and parameters for Monte Carlo Analysis:

Index Dist Parameter #1        Param #2  Param #3  Comment

  #   Code

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

  1    6   Banana.rdf

  2    6   BellPep.rdf

  3    6   Broccoli.rdf

  4    6   Cabbage.rdf

  5    6   Celery.rdf

  6    6   LettuceH.rdf

  7    6   HotPep.rdf

  8    6   LettuceL.rdf

  9    6   Mustard.rdf

  10   6   Spinach.rdf

  11   6   Tomato.rdf

  12   6   BellPepOth.rdf

  13   6   BroccoliOth.rdf

  14   6   CabbageOth.rdf

  15   6   CeleryOth.rdf

  16   6   LettuceHRad.rdf

  17   6   HotPepOth.rdf

  18   6   SpinachOth.rdf

  19   6   TomatoOth.rdf

  20   6   Cantaloupe.rdf

  21   6   Cucumber.rdf

  22   6   Squash.rdf

  23   6   Onion.rdf

  EPA    Crop Commodity Name                    Def Res     Adj.Factors  RDL  Comment

  Code    Grp                                    (ppm)       #1     #2   Pntr

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

95000230 O    Banana                             0.100000   1.000  1.500   1  Adjustment Factor 2

95000231 O    Banana-babyfood                    0.100000   1.000  1.500      1.5X for Metabolites

95000240 O    Banana, dried                      0.010700   3.900  1.500

95000241 O    Banana, dried-babyfood             0.010700   3.900  1.500

95002830 O    Plantain                           0.100000   1.000  1.500   1

95002840 O    Plantain, dried                    0.010700   3.900  1.500

86010000 O    Water, direct, all sources         0.017000   1.000  1.000

86020000 O    Water, indirect, all sources       0.017000   1.000  1.000

03002370 3    Onion, dry bulb                    0.070000   1.000  1.500  23

03002371 3    Onion, dry bulb-babyfood           0.070000   1.000  1.500  23

03002380 3    Onion, dry bulb, dried             0.029000   9.000  0.015

03002381 3    Onion, dry bulb, dried-babyfood    0.029000   9.000  0.015

03002390 3    Onion, green                       0.050000   1.000  1.500

03003380 3    Shallot                            0.050000   1.000  1.500

04010050 4A   Amaranth, leafy                    0.250000   1.000  1.500  18

04010180 4A   Arugula                            0.250000   1.000  1.500  18

04020760 4B   Cardoon                            0.250000   1.000  1.500  15

04020850 4B   Celery                             0.250000   1.000  1.500   5

04020851 4B   Celery-babyfood                    0.250000   1.000  1.500   5

04020860 4B   Celery, juice                      0.250000   1.000  1.500   5

04020870 4B   Celtuce                            0.250000   1.000  1.500  15

04011040 4A   Chrysanthemum, garland             0.250000   1.000  1.500  18

04011330 4A   Cress, garden                      0.250000   1.000  1.500  18

04011340 4A   Cress, upland                      0.250000   1.000  1.500  18

04011380 4A   Dandelion, leaves                  0.250000   1.000  1.500  18

04011500 4A   Endive                             0.250000   1.000  1.500  18

04021520 4B   Fennel, Florence                   0.250000   1.000  1.500  15

04012040 4A   Lettuce, head                      0.250000   1.000  1.500   6

04012050 4A   Lettuce, leaf                      0.250000   1.000  1.500   8

04012480 4A   Parsley, leaves                    0.250000   1.000  1.500  18

04013130 4A   Radicchio                          0.250000   1.000  1.500  16

04023220 4B   Rhubarb                            0.250000   1.000  1.500  15

04013550 4A   Spinach                            1.000000   1.000  1.500  10

04013551 4A   Spinach-babyfood                   1.000000   1.000  1.500  10

04023670 4B   Swiss chard                        0.250000   1.000  1.500  15

05010610 5A   Broccoli                           1.000000   1.000  1.500   3

05010611 5A   Broccoli-babyfood                  1.000000   1.000  1.500   3

05010620 5A   Broccoli, Chinese                  1.000000   1.000  1.500  13

05020630 5B   Broccoli raab                      1.000000   1.000  1.500   9

05010640 5A   Brussels sprouts                   1.000000   1.000  1.500  14

05010690 5A   Cabbage                            1.000000   1.000  1.500   4

05020700 5B   Cabbage, Chinese, bok choy         1.000000   1.000  1.500   9

05010710 5A   Cabbage, Chinese, napa             1.000000   1.000  1.500  14

05010720 5A   Cabbage, Chinese, mustard          1.000000   1.000  1.500  13

05010830 5A   Cauliflower                        1.000000   1.000  1.500   3

05021170 5B   Collards                           1.000000   1.000  1.500   9

05021940 5B   Kale                               1.000000   1.000  1.500   9

05011960 5A   Kohlrabi                           1.000000   1.000  1.500  14

05022290 5B   Mustard greens                     1.000000   1.000  1.500   9

05023180 5B   Rape greens                        1.000000   1.000  1.500   9

05023890 5B   Turnip, greens                     1.000000   1.000  1.500   9

08001480 8    Eggplant                           1.000000   1.000  1.500  12

08002340 8    Okra                               1.000000   1.000  1.500  17

08002700 8    Pepper, bell                       1.000000   1.000  1.500   2

08002701 8    Pepper, bell-babyfood              1.000000   1.000  1.500   2

08002710 8    Pepper, bell, dried                0.321000   1.000  0.015

08002711 8    Pepper, bell, dried-babyfood       0.321000   1.000  0.015

08002720 8    Pepper, nonbell                    1.000000   1.000  1.500   7

08002721 8    Pepper, nonbell-babyfood           1.000000   1.000  1.500   7

08002730 8    Pepper, nonbell, dried             0.321000   1.000  0.015

08003740 8    Tomatillo                          1.000000   1.000  1.500  19

08003750 8    Tomato                             1.000000   1.000  1.500  11

08003751 8    Tomato-babyfood                    1.000000   1.000  1.500  11

08003760 8    Tomato, paste                      0.164000   7.100  0.015

08003761 8    Tomato, paste-babyfood             0.164000   7.100  0.015

08003770 8    Tomato, puree                      0.164000   2.900  0.015

08003771 8    Tomato, puree-babyfood             0.164000   2.900  0.015

08003780 8    Tomato, dried                      0.164000  14.300  0.015

08003781 8    Tomato, dried-babyfood             0.164000  14.300  0.015

08003790 8    Tomato, juice                      1.000000   1.000  1.500  11

09020210 9B   Balsam pear                        1.000000   1.000  1.500  21

09010750 9A   Cantaloupe                         1.000000   1.000  1.500  20

09010800 9A   Casaba                             1.000000   1.000  1.500  20

09020880 9B   Chayote, fruit                     1.000000   1.000  1.500  22

09021020 9B   Chinese waxgourd                   1.000000   1.000  1.500  21

09021350 9B   Cucumber                           1.000000   1.000  1.500  21

09011870 9A   Honeydew melon                     1.000000   1.000  1.500  20

09023080 9B   Pumpkin                            1.000000   1.000  1.500  22

09023090 9B   Pumpkin, seed                      1.000000   1.000  1.500  22

09023560 9B   Squash, summer                     1.000000   1.000  1.500  22

09023561 9B   Squash, summer-babyfood            1.000000   1.000  1.500  22

09023570 9B   Squash, winter                     1.000000   1.000  1.500  22

09023571 9B   Squash, winter-babyfood            1.000000   1.000  1.500  22

09013990 9A   Watermelon                         1.000000   1.000  1.500  20

09014000 9A   Watermelon, juice                  1.000000   1.000  1.500  20

Attachment 2  Results of Acute DEEM-FCID Dietary Exposure Analysis

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for ACIBENZOLAR-S-METHYL                (1994-98 data)

Residue file: 061402Acute2-3-09.R98                   Adjustment factor #2 used.

Analysis Date: 03-03-2009/08:06:25    Residue file dated: 03-03-2009/07:52:46/8

Daily totals for food and foodform consumption used.

MC iterations = 5000      MC list in residue file     MC seed = 1128

Run Comment: ""

======================================================================== =======

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th Percentile

                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD

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

Females 13-49 yrs:

                    0.001487     1.81    0.003473     4.24    0.009785    11.93

Attachment 3  Chronic DEEM-FCID Residue Input File.

Filename: F:\Acibenzolar\061402Chron1-21-09.R98  Chemical: Acibenzolar-S-Methyl

RfD(Chronic): .0367 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): .0033 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day

Date created/last modified: 01-27-2009/09:03:15/8          Program ver. 2.03

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

95000230 O    Banana                             0.100000   1.000  1.500

95000231 O    Banana-babyfood                    0.100000   1.000  1.500

95000240 O    Banana, dried                      0.100000   3.900  1.500

95000241 O    Banana, dried-babyfood             0.100000   3.900  1.500

95002830 O    Plantain                           0.100000   1.000  1.500

95002840 O    Plantain, dried                    0.100000   3.900  1.500

86010000 O    Water, direct, all sources         0.017000   1.000  1.000

86020000 O    Water, indirect, all sources       0.017000   1.000  1.000

03002370 3    Onion, dry bulb                    0.100000   1.000  1.500

03002371 3    Onion, dry bulb-babyfood           0.100000   1.000  1.500

03002380 3    Onion, dry bulb, dried             0.100000   9.000  1.500

03002381 3    Onion, dry bulb, dried-babyfood    0.100000   9.000  1.500

03002390 3    Onion, green                       0.100000   1.000  1.500

03003380 3    Shallot                            0.100000   1.000  1.500

04010050 4A   Amaranth, leafy                    0.250000   1.000  1.500

04010180 4A   Arugula                            0.250000   1.000  1.500

04020760 4B   Cardoon                            0.250000   1.000  1.500

04020850 4B   Celery                             0.250000   1.000  1.500

04020851 4B   Celery-babyfood                    0.250000   1.000  1.500

04020860 4B   Celery, juice                      0.250000   1.000  1.500

04020870 4B   Celtuce                            0.250000   1.000  1.500

04011040 4A   Chrysanthemum, garland             0.250000   1.000  1.500

04011330 4A   Cress, garden                      0.250000   1.000  1.500

04011340 4A   Cress, upland                      0.250000   1.000  1.500

04011380 4A   Dandelion, leaves                  0.250000   1.000  1.500

04011500 4A   Endive                             0.250000   1.000  1.500

04021520 4B   Fennel, Florence                   0.250000   1.000  1.500

04012040 4A   Lettuce, head                      0.250000   1.000  1.500

04012050 4A   Lettuce, leaf                      0.250000   1.000  1.500

04012480 4A   Parsley, leaves                    0.250000   1.000  1.500

04013130 4A   Radicchio                          0.250000   1.000  1.500

04023220 4B   Rhubarb                            0.250000   1.000  1.500

04013550 4A   Spinach                            1.000000   1.000  1.500

04013551 4A   Spinach-babyfood                   1.000000   1.000  1.500

04023670 4B   Swiss chard                        0.250000   1.000  1.500

05010610 5A   Broccoli                           1.000000   1.000  1.500

05010611 5A   Broccoli-babyfood                  1.000000   1.000  1.500

05010620 5A   Broccoli, Chinese                  1.000000   1.000  1.500

05020630 5B   Broccoli raab                      1.000000   1.000  1.500

05010640 5A   Brussels sprouts                   1.000000   1.000  1.500

05010690 5A   Cabbage                            1.000000   1.000  1.500

05020700 5B   Cabbage, Chinese, bok choy         1.000000   1.000  1.500

05010710 5A   Cabbage, Chinese, napa             1.000000   1.000  1.500

05010720 5A   Cabbage, Chinese, mustard          1.000000   1.000  1.500

05010830 5A   Cauliflower                        1.000000   1.000  1.500

05021170 5B   Collards                           1.000000   1.000  1.500

05021940 5B   Kale                               1.000000   1.000  1.500

05011960 5A   Kohlrabi                           1.000000   1.000  1.500

05022290 5B   Mustard greens                     1.000000   1.000  1.500

05023180 5B   Rape greens                        1.000000   1.000  1.500

05023890 5B   Turnip, greens                     1.000000   1.000  1.500

08001480 8    Eggplant                           1.000000   1.000  1.500

08002340 8    Okra                               1.000000   1.000  1.500

08002700 8    Pepper, bell                       1.000000   1.000  1.500

08002701 8    Pepper, bell-babyfood              1.000000   1.000  1.500

08002710 8    Pepper, bell, dried                1.000000   1.000  1.500

08002711 8    Pepper, bell, dried-babyfood       1.000000   1.000  1.500

08002720 8    Pepper, nonbell                    1.000000   1.000  1.500

08002721 8    Pepper, nonbell-babyfood           1.000000   1.000  1.500

08002730 8    Pepper, nonbell, dried             1.000000   1.000  1.500

08003740 8    Tomatillo                          1.000000   1.000  1.500

08003750 8    Tomato                             1.000000   1.000  1.500

08003751 8    Tomato-babyfood                    1.000000   1.000  1.500

08003760 8    Tomato, paste                      3.000000   1.000  1.500

08003761 8    Tomato, paste-babyfood             3.000000   1.000  1.500

08003770 8    Tomato, puree                      1.000000   2.900  1.500

08003771 8    Tomato, puree-babyfood             1.000000   2.900  1.500

08003780 8    Tomato, dried                      1.000000  14.300  1.500

08003781 8    Tomato, dried-babyfood             1.000000  14.300  1.500

08003790 8    Tomato, juice                      1.000000   1.000  1.500

09020210 9B   Balsam pear                        2.000000   1.000  1.500

09010750 9A   Cantaloupe                         2.000000   1.000  1.500

09010800 9A   Casaba                             2.000000   1.000  1.500

09020880 9B   Chayote, fruit                     2.000000   1.000  1.500

09021020 9B   Chinese waxgourd                   2.000000   1.000  1.500

09021350 9B   Cucumber                           2.000000   1.000  1.500

09011870 9A   Honeydew melon                     2.000000   1.000  1.500

09023080 9B   Pumpkin                            2.000000   1.000  1.500

09023090 9B   Pumpkin, seed                      2.000000   1.000  1.500

09023560 9B   Squash, summer                     2.000000   1.000  1.500

09023561 9B   Squash, summer-babyfood            2.000000   1.000  1.500

09023570 9B   Squash, winter                     2.000000   1.000  1.500

09023571 9B   Squash, winter-babyfood            2.000000   1.000  1.500

09013990 9A   Watermelon                         2.000000   1.000  1.500

09014000 9A   Watermelon, juice                  2.000000   1.000  1.500

Attachment 4  Results of Chronic DEEM-FCID Dietary Exposure Analysis.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for ACIBENZOLAR-S-METHYL             (1994-98 data)

Residue file name: C:\Documents and Settings\rdaiss\My Documents\Acibenzolar\061402Chron1-15-09.R98                                                     Adjustment factor #2 used.

Analysis Date 01-21-2009/14:35:21     Residue file dated: 01-15-2009/14:45:30/8

Reference dose (RfD, Chronic) = .082 mg/kg bw/day

======================================================================== =======

                    Total exposure by population subgroup

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

Females 13-49 yrs                           0.003765                 4.6%

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for ACIBENZOLAR-S-METHYL             (1994-98 data)

Residue file name: C:\Documents and Settings\rdaiss\My Documents\Acibenzolar\061402Chron1-21-09.R98                                                      Adjustment factor #2 used.

Analysis Date 01-27-2009/09:04:26     Residue file dated: 01-27-2009/09:02:50/8

Reference dose (RfD, Chronic) = .25 mg/kg bw/day

======================================================================== =======

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.004487                 1.8%

Northeast region                            0.004675                 1.9%

All infants (< 1 year)                      0.004307                 1.7%

Children 1-2 yrs                            0.009328                 3.7%

Children 3-5 yrs                            0.008826                 3.5%

Children 6-12 yrs                           0.005906                 2.4%

Youth 13-19 yrs                             0.003981                 1.6%

Adults 20-49 yrs                            0.003775                 1.5%

Adults 50+ yrs                              0.003977                 1.6%

Females 13-49 yrs                           0.003765                 1.5%

Attachment 5  Percent Crop Treated Estimates Provided by BEAD

6.  RDF Files Used in Acute Analysis

RDF #1

Banana

%CT = 100

TOTALNZ = 30

TOTALZ = 0

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.02

0.04

0.03

0.04

0.07

0.02

0.04

0.05	RDF #2

Bell Pepper

% CT=	5

TOTALNZ=9

TOTALZ=171

0.16

0.28

0.34

0.40

0.53

0.29

0.27

0.30

0.32	RDF #3

Broccoli

% CT=	5

TOTALNZ=11

TOTALZ=209

0.58

0.28

0.34

0.42

0.52

0.17

0.22

0.32

0.60

0.60

0.63	RDF #4

Cabbage

% CT=	2.5

TOTALNZ=11

TOTALZ=429

0.57

0.19

0.22

0.12

0.14

0.28

0.36

0.06

0.09

0.27

0.35

	RDF #5

Celery

% CT=	1

TOTALNZ=9

TOTALZ=891

0.045

0.018

0.016

0.050

0.043

0.058

0.042

0.077

0.063

RDF #6

Head Lettuce

% CT=	12

TOTALNZ=12

TOTALZ=88

0.081

0.075

0.049

0.074

0.033

0.041

0.044

0.039

0.105

0.093

0.043

0.055	RDF #7

Hot Pepper

% CT=	5

TOTALNZ=5

TOTALZ=95

0.50

0.41

0.35

0.21

0.32

	RDF #8

Leaf Lettuce

% CT=	12

TOTALNZ=11

TOTALZ=81

0.099

0.151

0.136

0.073

0.035

0.112

0.183

0.185

0.175

0.037

0.044	RDF #9

Mustard Greens

 % CT=	100

TOTALNZ=9

TOTALZ=0

0.74

0.53

0.64

0.71

0.80

0.26

0.32

0.14

0.18	RDF #10

Spinach

% CT=	30

TOTALNZ=11

TOTALZ=26

0.273

0.326

0.247

0.418

0.538

0.110

0.138

0.232

0.262

0.230

0.190

RDF #11

Tomato

% CT=	5

TOTALNZ=23

TOTALZ=437

0.13

0.21

0.21

0.06

0.08

0.46

0.25

0.11

0.16

0.09

0.09

0.09

0.09

0.06

0.08

0.14

0.08

0.16

0.20

0.22

0.32

0.22

0.27

	RDF #12

BellPepperOth

% CT=	100

TOTALNZ=9

TOTALZ=0

0.16

0.28

0.34

0.40

0.53

0.29

0.27

0.30

0.32	RDF #13

BroccoliOth

% CT=	100

TOTALNZ=11

TOTALZ=0

0.58

0.28

0.34

0.42

0.52

0.17

0.22

0.32

0.60

0.60

0.63	RDF #14

CabbageOth

% CT=	100

TOTALNZ=11

TOTALZ=0

0.57

0.19

0.22

0.12

0.14

0.28

0.36

0.06

0.09

0.27

0.35

	RDF #15

CeleryOth

% CT=	100

TOTALNZ=9

TOTALZ=0

0.045

0.018

0.016

0.050

0.043

0.058

0.042

0.077

0.063

RDF #16

LettuceHRad

% CT=	100

TOTALNZ=12

TOTALZ=0

0.081

0.075

0.049

0.074

0.033

0.041

0.044

0.039

0.105

0.093

0.043

0.055	RDF #17

HotPepperOth

hK

/

8

‡

‹

Œ

‘

©

³

¹

Å

Í

à

-

@

a

q

‘

’

 à

å

ñ

û

ý

h

@

将

@

&

@

¶

@

¶

@

¶

@

¶

@

¶

@

愀Ĥ摧檒

愀Ĥ摧ཌྷæ

愀Ĥ摧檒

愀Ĥ摧檒

h

#

ó

&

@

100

TOTALNZ=5

TOTALZ=0

0.50

0.41

0.35

0.21

0.32	RDF #18

SpinachOth

% CT=	100

TOTALNZ=11

TOTALZ=0

0.273

0.326

0.247

0.418

0.538

0.110

0.138

0.232

0.262

0.230

0.190	RDF #19

TomatoOth

% CT=	100

TOTALNZ=23

TOTALZ=0

0.13

0.21

0.21

0.06

0.08

0.46

0.25

0.11

0.16

0.09

0.09

0.09

0.09

0.06

0.08

0.14

0.08

0.16

0.20

0.22

0.32

0.22

0.27	RDF #20

Cantaloupe

 % CT=	100

TOTALNZ=6

TOTALZ=0

0.235

0.759

0.240

0.279

0.278

0.134

RDF #21

Cucumber

 % CT=	100

TOTALNZ=8

TOTALZ=0

0.166

0.508

0.183

0.210

0.218

0.215

0.155

0.132	RDF #22

Squash

% CT=	100

TOTALNZ=5

TOTALZ=0

0.152

0.418

0.151

0.187

0.172

	RDF #23

Onion

 % CT=	100

TOTALNZ=7

TOTALZ=0

0.025

0.025

0.025

0.056

0.025

0.025

0.025

Acibenzolar-S-Methyl (PC Code 061402)	Dietary Exposure and Risk Assessment                    DP #:  362208

Page  PAGE  8  of  NUMPAGES  23


[Federal Register Volume 86, Number 2 (Tuesday, January 5, 2021)]
[Notices]
[Pages 350-353]
[FR Doc No: 2020-29138]

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Exchange LLC; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend Its Fee Schedule

December 29, 2020.
    Pursuant to the provisions of Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on December 21, 2020, Miami International
Securities Exchange LLC (``MIAX Options'' or ``Exchange'') filed with
the Securities and Exchange Commission (``Commission'') a proposed rule
change as described in Items I, II, and III below, which Items have
been prepared by the Exchange. The Commission is publishing this notice
to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing a proposal to amend the MIAX Options Fee
Schedule (the ``Fee Schedule'').
    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings, at MIAX's principal
office, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend the Fee Schedule to extend the cap
waiver of 1,000 contracts per leg for complex PRIME (``cPRIME'') \3\
Agency Order rebates for all tiers under the Priority Customer Rebate
Program (``PCRP'') \4\ until March 31, 2021.
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    \3\ ``cPRIME'' is the process by which a Member may
electronically submit a ``cPRIME Order'' (as defined in Rule
518(b)(7)) it represents as agent (a ``cPRIME Agency Order'')
against principal or solicited interest for execution (a ``cPRIME
Auction''), subject to the restrictions set forth in Exchange Rule
515A, Interpretation and Policy .12. See Exchange Rule 515A.
    \4\ Under the PCRP, MIAX credits each Member the per contract
amount resulting from each Priority Customer order transmitted by
that Member which is executed electronically on the Exchange in all
multiply-listed option classes (excluding, in simple or complex as
applicable, QCC and cQCC Orders, mini-options, Priority Customer-to-
Priority Customer Orders, C2C and cC2C Orders, PRIME and cPRIME AOC
Responses, PRIME and cPRIME Contra-side Orders, PRIME and cPRIME
Orders for which both the Agency and Contra-side Order are Priority
Customers, and executions related to contracts that are routed to
one or more exchanges in connection with the Options Order
Protection and Locked/Crossed Market Plan referenced in Exchange
Rule 1400), provided the Member meets certain percentage thresholds
in a month as described in the PCRP table. See Fee Schedule, Section
1(a)(iii). ``Priority Customer'' means a person or entity that (i)
is not a broker or dealer in securities, and (ii) does not place
more than 390 orders in listed options per day on average during a
calendar month for its own beneficial accounts(s). A ``Priority
Customer Order'' means an order for the account of a Priority
Customer. See Exchange Rule 100.
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Background
    Exchange Rule 518(b)(7) defines a cPRIME Order as a type of complex
order \5\ that is submitted for participation in a cPRIME Auction and
trading of cPRIME Orders is governed by Rule 515A, Interpretation and
Policy .12.\6\ cPRIME Orders are processed and executed in the
Exchange's PRIME mechanism, the same mechanism that the Exchange uses
to process and execute simple PRIME orders, pursuant to Exchange Rule
515A.\7\ PRIME is a process by which a Member may electronically submit
for execution an order it represents as agent (an ``Agency Order'')
against principal interest and/or solicited interest. The Member that
submits the Agency Order (``Initiating Member'') agrees to guarantee
the execution of the Agency Order by submitting a contra-side order
representing principal interest or solicited interest (``Contra-Side
Order''). When the Exchange receives a properly designated Agency Order
for Auction processing, a request for response (``RFR'') detailing the
option, side, size and initiating price is broadcasted to MIAX
participants up to an optional designated limit price. Members may
submit responses to the RFR, which can be either an Auction or Cancel
(``AOC'') order or an AOC eQuote. A cPRIME

Auction is the price-improvement mechanism of the Exchange's System
pursuant to which an Initiating Member electronically submits a complex
Agency Order into a cPRIME Auction. The Initiating Member, in
submitting an Agency Order, must be willing to either (i) cross the
Agency Order at a single price against principal or solicited interest,
or (ii) automatically match against principal or solicited interest,
the price and size of a RFR that is broadcast to MIAX participants up
to an optional designated limit price. Such responses are defined as
cPRIME AOC Responses or cPRIME eQuotes. The PRIME mechanism is used for
orders on the Exchange's Simple Order Book.\8\ The cPRIME mechanism is
used for Complex Orders \9\ on the Exchange's Strategy Book,\10\ with
the cPRIME mechanism operating in the same manner for processing and
execution of cPRIME Orders that is used for PRIME Orders on the Simple
Order Book.
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    \5\ A ``complex order'' is any order involving the concurrent
purchase and/or sale of two or more different options in the same
underlying security (the ``legs'' or ``components'' of the complex
order), for the same account, in a ratio that is equal to or greater
than one-to-three (.333) and less than or equal to three-to-one
(3.00) and for the purposes of executing a particular investment
strategy. A complex order can also be a ``stock-option'' order,
which is an order to buy or sell a stated number of units of an
underlying security coupled with the purchase or sale of options
contract(s) on the opposite side of the market, subject to certain
contingencies set forth in the proposed rules governing complex
orders. For a complete definition of a ``complex order,'' see
Exchange Rule 518(a)(5). See also Securities Exchange Act Release
No. 78620 (August 18, 2016), 81 FR 58770 (August 25, 2016) (SR-MIAX-
2016-26).
    \6\ See Securities Exchange Act Release No. 81131 (July 12,
2017), 82 FR 32900 (July 18, 2017) (SR-MIAX-2017-19) (Order Granting
Approval of a Proposed Rule Change to Amend MIAX Options Rules 515,
Execution of Orders and Quotes; 515A, MIAX Price Improvement
Mechanism (``PRIME'') and PRIME Solicitation Mechanism; and 518,
Complex Orders).
    \7\ Id.
    \8\ The ``Simple Order Book'' is the Exchange's regular
electronic book of orders and quotes. See Exchange Rule 518(a)(15).
    \9\ A ``complex order'' is any order involving the concurrent
purchase and/or sale of two or more different options in the same
underlying security (the ``legs'' or ``components'' of the complex
order), for the same account, in a ratio that is equal to or greater
than one-to-three (.333) and less than or equal to three-to-one
(3.00) and for the purposes of executing a particular investment
strategy. Mini-options may only be part of a complex order that
includes other mini-options. Only those complex orders in the
classes designated by the Exchange and communicated to Members via
Regulatory Circular with no more than the applicable number of legs,
as determined by the Exchange on a class-by-class basis and
communicated to Members via Regulatory Circular, are eligible for
processing. See Exchange Rule 518(a)(5).
    \10\ The ``Strategy Book'' is the Exchange's electronic book of
complex orders and complex quotes. See Exchange Rule 518(a)(17).
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    The Exchange proposes to amend footnote ``*'' in Section 1(a)(iii)
of the Fee Schedule to extend the waiver of the contracts cap per leg
for cPRIME Agency Order rebates for all tiers under the PCRP until
March 31, 2021. Prior to a rule filing by the Exchange (described
below), the Exchange limited the cPRIME Agency Order Credit to be
payable only to the first 1,000 contracts per leg for each cPRIME
Agency Order in all tiers under the PCRP. On February 28, 2020, the
Exchange filed, and the Commission approved, the Exchange's proposal to
waive the 1,000 contracts cap per leg for cPRIME Agency Order rebates
for all tiers under the PCRP from March 1, 2020 until May 31, 2020.\11\
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    \11\ See Securities Exchange Act Release No. 88349 (March 10,
2020), 85 FR 14995 (March 15, 2020) (SR-MIAX-2020-05).
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    On May 29, 2020, the Exchange filed, and the Commission approved,
the Exchange's proposal to extend the waiver of the 1,000 contracts cap
per leg for cPRIME Agency Order rebates for all tiers under the PCRP
from June 1, 2020 until July 31, 2020.\12\ On July 31, 2020, the
Exchange filed, and the Commission approved, the Exchange's proposal to
extend the waiver of the 1,000 contracts cap per leg for cPRIME Agency
Order rebates for all tiers under the PCRP from August 1, 2020 until
August 31, 2020.\13\ On August 25, 2020, the Exchange filed, and the
Commission approved, the Exchange's proposal to extend the waiver of
the 1,000 contracts cap per leg for cPRIME Agency Order rebates for all
tiers under the PCRP from August 31, 2020 until December 31, 2020.\14\
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    \12\ See Securities Exchange Act Release No. 89035 (June 9,
2020), 85 FR 36249 (June 15, 2020) (SR-MIAX-2020-12).
    \13\ See Securities Exchange Act Release No. 89530 (August 12,
2020), 85 FR 50845 (August 18, 2020) (SR-MIAX-2020-26).
    \14\ See Securities Exchange Act Release No. 89771 (September 4,
2020), 85 FR 55873 (September 10, 2020) (SR-MIAX-2020-28).
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    The Exchange now proposes to extend the cap waiver of 1,000
contracts per leg for cPRIME Agency Order rebates for all tiers under
the PCRP until March 31, 2021. The purpose of this proposed change is
for business and competitive reasons and to continue to entice market
participants to submit larger-sized cPRIME Agency Orders.
    The Commission has repeatedly expressed its preference for
competition over regulatory intervention in determining prices,
products, and services in the securities markets. In Regulation NMS,
the Commission highlighted the importance of market forces in
determining prices and self-regulatory organization (``SRO'') revenues
and, also, recognized that current regulation of the market system
``has been remarkably successful in promoting market competition in its
broader forms that are most important to investors and listed
companies.'' \15\ There are currently 16 registered options exchanges
competing for order flow. Based on publicly-available information, and
excluding index-based options, as of December 14, 2020, no single
exchange has more than approximately 14% of the market share of
executed volume of multiply-listed equity options trades for the month
of December 2020.\16\ Therefore, no exchange possesses significant
pricing power in the execution of multiply-listed equity options order
flow. More specifically, for the month of November 2020, the Exchange
had a total market share of 3.90% of all equity options volume.\17\
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    \15\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496 (June 29, 2005).
    \16\ The OCC publishes options and futures volume in a variety
of formats, including daily and monthly volume by exchange,
available at: https://www.theocc.com/market-data/volume/default.jsp.
    \17\ See id.
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    The Exchange believes that the ever-shifting market shares among
the exchanges from month to month demonstrates that market participants
can shift order flow (as further described below), or discontinue or
reduce use of certain categories of products, in response to
transaction and non-transaction fee changes. For example, on March 1,
2019, the Exchange filed with the Commission an immediately effective
filing to decrease certain credits assessable to Members pursuant to
the PCRP.\18\ The Exchange experienced a decrease in total market share
between the months of February and March of 2019. Accordingly, the
Exchange believes that the March 1, 2019 fee change may have
contributed to the decrease in the Exchange's market share and, as
such, the Exchange believes competitive forces constrain options
exchange transaction and non-transaction fees.
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    \18\ See Securities Exchange Act Release No. 85301 (March 13,
2019), 84 FR 10166 (March 19, 2019) (SR-MIAX-2019-09).
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2. Statutory Basis
    The Exchange believes that its proposal to amend its Fee Schedule
is consistent with Section 6(b) of the Act \19\ in general, and
furthers the objectives of Section 6(b)(4) of the Act \20\ in
particular, in that it is an equitable allocation of reasonable fees
and other charges among its members and issuers and other persons using
its facilities. The Exchange also believes the proposal furthers the
objectives of Section 6(b)(5) of the Act in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest and is not designed to permit unfair discrimination between
customers, issuers, brokers and dealers.
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    \19\ 15 U.S.C. 78f(b).
    \20\ 15 U.S.C. 78f(b)(4) and (5).
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    The Exchange believes its proposal to extend the waiver of the cap
of 1,000 contracts per leg for cPRIME Agency Order rebates for all
tiers under the PCRP until March 31, 2021 provides for the equitable
allocation of reasonable dues and fees and is not unfairly
discriminatory for the following reasons. The Exchange operates in a
highly competitive market. The Commission has repeatedly expressed its
preference for competition over regulatory intervention in determining

prices, products, and services in the securities markets. In Regulation
NMS, the Commission highlighted the importance of market forces in
determining prices and SRO revenues and, also, recognized that current
regulation of the market system ``has been remarkably successful in
promoting market competition in its broader forms that are most
important to investors and listed companies.'' \21\ There are currently
16 registered options exchanges competing for order flow. Based on
publicly-available information, and excluding index-based options, as
of December 14, 2020, no single exchange has more than approximately
14% of the market share of executed volume of multiply-listed equity
options trades for the month of December 2020.\22\ Therefore, no
exchange possesses significant pricing power in the execution of
multiply-listed equity and ETF options order flow. More specifically,
for the month of November 2020, the Exchange had a total market share
of 3.90% of all equity options volume.\23\
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    \21\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496 (June 29, 2005).
    \22\ See supra note 16.
    \23\ See id.
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    The Exchange believes that the ever-shifting market shares among
the exchanges from month to month demonstrates that market participants
can shift order flow, or discontinue or reduce use of certain
categories of products, in response to transaction and/or non-
transaction fee changes. For example, on March 1, 2019, the Exchange
filed with the Commission an immediately effective filing to decrease
certain credits assessable to Members pursuant to the PCRP.\24\ The
Exchange experienced a decrease in total market share between the
months of February and March of 2019. Accordingly, the Exchange
believes that the March 1, 2019 fee change may have contributed to the
decrease in the Exchange's market share and, as such, the Exchange
believes competitive forces constrain options exchange transaction and
non-transaction fees and market participants can shift order flow based
on fee changes instituted by the exchanges.
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    \24\ See supra note 18.
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    The Exchange believes that its proposal to continue to waive the
1,000 contracts cap per leg for cPRIME Agency Order rebates for all
tiers in the PCRP until March 31, 2021 is reasonable, equitably
allocated and not unfairly discriminatory because this change is for
business and competitive reasons and available equally to all market
participants. The Exchange cannot predict with certainty whether any
market participant would submit additional cPRIME Agency Orders in
excess of 1,000 contracts per leg in light of the proposal to continue
to waive the cap of 1,000 contracts per leg for cPRIME Agency Order
rebates for all tiers under the PCRP, but believes that market
participants would continue to be encouraged to submit larger orders to
obtain the additional credits. The Exchange believes that this proposed
change would encourage increased cPRIME Agency Order flow, which will
bring greater volume and liquidity to the Exchange, which benefits all
market participants by providing more trading opportunities and tighter
spreads.

B. Self-Regulatory Organization's Statement on Burden on Competition

    In accordance with Section 6(b)(8) of the Act,\25\ the Exchange
believes that the proposed rule changes would not impose any burden on
competition that are not necessary or appropriate in furtherance of the
purposes of the Act. Instead, as discussed above, the Exchange believes
that the proposed change would continue to encourage the submission of
additional liquidity to a public exchange, thereby promoting market
depth, price discovery and transparency and enhancing order execution
opportunities for all market participants. As a result, the Exchange
believes that the proposed change furthers the Commission's goal in
adopting Regulation NMS of fostering integrated competition among
orders.
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    \25\ 15 U.S.C. 78f(b)(8).
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    The Exchange does not believe that other market participants at the
Exchange would be placed at a relative disadvantage by the proposed
change to continue to waive the cap of 1,000 contracts per leg for
cPRIME Agency Order rebates for all tiers under the PCRP until March
31, 2021. The proposed change is designed to attract additional order
flow to the Exchange. The Exchange believes that this proposal will
continue to encourage Members to submit Priority Customer cPRIME Agency
Orders, which will increase liquidity and benefit all market
participants by providing more trading opportunities and tighter
spreads. Accordingly, the Exchange believes that the proposed change
will not impose any burden on competition not necessary or appropriate
in furtherance of the purposes of the Act because it will continue to
encourage order flow, which provides greater volume and liquidity,
benefiting all market participants by providing more trading
opportunities and tighter spreads.
    The Exchange operates in a highly competitive market in which
market participants can readily favor competing venues if they deem fee
levels at a particular venue to be excessive. There are currently 16
registered options exchanges competing for order flow. Based on
publicly-available information, and excluding index-based options, as
of December 14, 2020, no single exchange has more than approximately
14% of the market share of executed volume of multiply-listed equity
options trades for the month of December 2020.\26\ Therefore, no
exchange possesses significant pricing power in the execution of
multiply-listed equity options order flow. More specifically, for the
month of November 2020, the Exchange had a total market share of 3.90%
of all equity options volume.\27\
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    \26\ See supra note 16.
    \27\ See id.
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    In such an environment, the Exchange must continually adjust its
transaction and non-transaction fees to remain competitive with other
exchanges and to attract order flow. The Exchange believes that the
proposed rule change reflects this competitive environment because it
continues to encourage market participants to provide and send order
flow to the Exchange. To the extent this is achieved, all the
Exchange's market participants should benefit from the improved market
quality.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act,\28\ and Rule 19b-4(f)(2) \29\ thereunder.
At any time within 60 days of the filing of the proposed rule change,
the Commission summarily may temporarily suspend such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act. If the Commission takes such
action, the Commission shall institute proceedings to determine

whether the proposed rule should be approved or disapproved.
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    \28\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \29\ 17 CFR 240.19b-4(f)(2).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-MIAX-2020-40 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-MIAX-2020-40. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-MIAX-2020-40 and should be submitted on
or before January 26, 2021.
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    \30\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\30\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-29138 Filed 1-4-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 204 (Monday, October 22, 2012)]
[Notices]
[Pages 64549-64551]
[FR Doc No: 2012-25938]

=======================================================================
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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2012-0019]

National Advisory Committee on Occupational Safety and Health
(NACOSH)

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Announcement of meetings of the National Advisory Committee on
Occupational Safety and Health (NACOSH) and a NACOSH Work Group.

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SUMMARY: NACOSH will meet November 15, 2012, in Washington, DC. In
conjunction with the committee meeting, the NACOSH Effectiveness
Measures Work Group will meet on November 14, 2012.

DATES: NACOSH meeting: NACOSH will meet from 9 a.m. to 5 p.m. on
Thursday, November 15, 2012.
    NACOSH Work Group meeting: The NACOSH Effectiveness Measures Work
Group will meet from 1-4 p.m., Wednesday, November 14, 2012.
    Submission of comments, requests to speak, speaker presentations
and requests for special accommodation: You must submit (postmark,
send, transmit, deliver) comments, requests to speak at the NACOSH
meeting, speaker presentations, and requests for special accommodations
for the NACOSH and NACOSH Work Group meetings by November 2, 2012.

ADDRESSES: NACOSH and NACOSH Work Group meetings: NACOSH and NACOSH
Work Group meetings will meet in Room S-4215 A/B/C U.S. Department of
Labor, 200 Constitution Avenue NW., Washington, DC 20210.
    Submission of comments, requests to speak and speaker
presentations: You may submit comments, requests to speak at the NACOSH
meeting and speaker presentations, which you must identify by the
docket number in this Federal Register notice (Docket No. OSHA-2012-
0019), by one of the following methods:
    Electronically: You may submit materials, including attachments,
electronically at http://www.regulations.gov, the Federal eRulemaking
Portal. Follow the online instructions for making submissions.
    Facsimile: If your submission, including attachments, does not
exceed 10 pages, you may fax it to the OSHA Docket Office at (202) 693-
1648.
    Mail, express delivery, messenger or courier service: You may
submit your materials to the OSHA Docket Office, Docket No. OSHA-2012-
0019, Room N-2625, U.S. Department of Labor, 200 Constitution Avenue
NW., Washington, DC 20210; telephone<PHONE_NUMBER> (TTY (887) 889-
5627). Deliveries (hand, express mail, messenger, courier service) are
accepted during the Department of Labor's and OSHA Docket Office's
normal business hours, 8:15 a.m. to 4:45 p.m., e.t., weekdays.
    Requests for special accommodation: Please submit requests for
special

accommodations for the NACOSH and NACOSH Work Group meetings to Ms.
Veneta Chatmon, OSHA, Office of Communications, Room N-3647, U.S.
Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210;
telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>    Instructions: All submissions must include the Agency name and
docket number for this Federal Register notice (Docket No. OSHA-2012-
0019). Because of security-related procedures, submission by regular
mail may result in significant delay in receipt. Please contact the
OSHA Docket Office for information about security procedures for making
submissions. For additional information about submitting comments,
requests to speak and speaker presentations see the SUPPLEMENTARY
INFORMATION section of this notice.
    OSHA will place in the public docket comments, requests to speak
and speaker presentations, including any personal information you
provide, and they may be available online. Therefore, OSHA cautions
individuals about submitting personal information such as Social
Security numbers and birthdates.

FOR FURTHER INFORMATION CONTACT: For press inquiries: Mr. Frank
Meilinger, OSHA, Office of Communications, U.S. Department of Labor,
Room N-3647, 200 Constitution Avenue NW., Washington, DC 20210;
telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>    For general information: Ms. Deborah Crawford, OSHA, Directorate of
Evaluation and Analysis, U.S. Department of Labor, Room N-3641, 200
Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-
1932; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

NACOSH Meeting

    NACOSH will meet Thursday, November 15, 2012, in Washington, DC.
NACOSH meetings are open to the public.
    Section 7(a) of the Occupational Safety and Health Act of 1970 (OSH
Act) (29 U.S.C. 651, 656) authorizes NACOSH to advise the Secretaries
of Labor and Health and Human Services on matters relating to the
administration of the OSH Act. NACOSH is a continuing advisory body and
operates in compliance with the OSH Act, the Federal Advisory Committee
Act (5 U.S.C. App. 2), and regulations issued pursuant to those laws
(29 CFR 1912a, 41 CFR Part 102-3).
    The tentative agenda of the NACOSH meeting includes:
     Remarks from the Assistant Secretary of Labor for
Occupational Safety and Health (OSHA);
     Remarks from the Director of the National Institute for
Occupational Safety and Health (NIOSH);
     NACOSH Work Group report and discussion;
     NACOSH and NACOSH Work Group administrative business; and
     Public comments.
    OSHA transcribes NACOSH meetings and prepares detailed minutes of
the meetings. OSHA places the meeting transcripts and minutes in the
public record of the NACOSH meeting. The public record also includes
Work Group reports, speaker presentations, comments and other materials
submitted to NACOSH.

NACOSH Work Group

    The NACOSH Effectiveness Measures Work Group meeting on November
14, 2012, is open to the public. The purpose of the Work Group is to
provide recommendations to the full NACOSH committee on approaches for
measuring the effectiveness of OSHA's strategies, programs and
activities. The Work Group will report to NACOSH at the November 15,
2012, meeting for discussion by the full Committee.

Public Participation

    NACOSH and NACOSH Work Group meetings: NACOSH and NACOSH Work Group
meetings are open to the public. Any individual attending meetings at
the U.S. Department of Labor must enter the building at the Visitors'
Entrance, 3rd and C Streets NW., and pass through Building Security.
Attendees must have valid photo identification to enter the building.
Please contact Ms. Crawford for additional information about building
security measures for attending the NACOSH and NACOSH Work Group
meetings.
    Individuals requesting special accommodation to attend NACOSH and
NACOSH Work Group meetings must contact Ms. Chatmon by November 7,
2012.
    Submission of comments, requests to speak and speaker
presentations: Interested persons must submit written comments,
requests to speak at the NACOSH meeting and speaker presentations by
November 7, 2012, using one of the methods listed in the ADDRESSES
section. All submissions must include the Agency name and docket number
for this Federal Register notice (Docket No. OSHA-2012-0019). OSHA will
provide submissions to NACOSH members prior to the meeting.
    Because of security-related procedures, submission by regular mail
may result in significant delay in receipt. Please contact the OSHA
Docket Office for information about security procedures for making
submissions by hand delivery, express delivery, messenger or courier
service.
    Requests to speak must state the amount of time requested to speak,
the interest the individual represents (e.g., organization name), if
any, and a brief outline of the presentation. Electronic speaker
presentations (e.g., PowerPoint) must be compatible with PowerPoint
2010 and other Microsoft 2010 formats. Requests to address NACSOH may
be granted as at the discretion of the NACOSH chair and as time
permits.
    Public docket of the NACOSH and NACOSH Work Group meetings: OSHA
puts comments, requests to speak and speaker presentations, including
any personal information you provide, in the public record of this
NACOSH meeting without change and those documents may be available
online at http://www.regulations.gov. Therefore, OSHA cautions
individuals about submitting certain personal information such as
Social Security numbers and birthdates.
    OSHA also puts the meeting transcripts and minutes, Work Group
reports and other documents from the NACOSH meeting in the public
record of the NACOSH meeting. Although all submissions are listed in
the http://www.regulations.gov index, some documents (e.g., copy
righted materials) are not publicly available to read or download
through that Web page. All submissions, including copyrighted material,
are available for inspection and copying in the OSHA Docket Office.
    To read or download documents in the public record of the NACOSH
meeting, go to Docket No. OSHA-2012-0019 at http://www.regulations.gov.
Please contact the OSHA Docket Office for information about materials
not available through that Web page and for assistance in using the
Internet to locate submissions and other documents in the public
record.
    Electronic copies of this Federal Register notice are available at
http://www.regulations.gov. This notice, as well as news releases and
other relevant information, also is available on the OSHA Web page at
http://www.osha.gov.

Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this notice
under the authority granted by Section

7 of the Occupational Safety and Health Act of 1970 (U.S.C. 656), the
Federal Advisory Committee Act (5 U.S.C. App. 2); 29 CFR Part 1912a; 41
CFR Part 102-3; and Secretary of Labor's Order No. 1-2012 (77 FR 3912
1/25/2012).

    Signed at Washington, DC, on October 17, 2012.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2012-25938 Filed 10-19-12; 8:45 am]
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