UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:  3-JAN-2008

Subject:	PP#:  7E7204.  Spirodiclofen - Chronic and Cancer Aggregate Dietary Exposure and Risk Assessments for the Section 3 Registration Request for Hops.

PC Code: 124871.  DP#: D346757.  Decision#: 378132

Reviewer:  	Mohsen Sahafeyan, Chemist

Registration Action Branch 1/Health Effects Division (RAB1/HED; 7509P)

Through:	George F. Kramer, Ph.D., Senior Chemist

		RAB1/HED (7509P)

			And

		David Soderberg, Chemist

		Toiya Goodlow, Chemist

Dietary Exposure Science Advisory Council (DESAC)

HED (7509P)

To:		Mary Clock-Rust, Biologist

RAB1/HED (7509P)

Executive Summary

Aggregate (food + water) chronic and cancer dietary risk assessments were conducted using the Dietary Exposure Evaluation Model - Food Consumption Intake Database (DEEM-FCID(, ver. 2.03) in support of Section 3 registration of acaricide spirodiclofen, 3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl 2,2-dimethylbutanoate on hops.  These assessments update the previously conducted dietary risk analyses (T. Bloem, D315255, 18-Apr-2005).  The changes made to those analyses include addition of the new requested use (hops), modification of the processing factors for apples and grapes based on the review of the new submissions (T. Bloem, D341847, 25-Oct-2007), more recent projected average percent crop treated (%CT) estimates and using the new no-observed adverse-effect level (NOAEL) for chronic population adjusted dose (cPAD) (0.014 mg/kg/day instead of 0.0065 mg/kg/day).  DEEM-FCID uses food consumption data from the USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII; 1994-1996 and 1998).  Acute dietary risk assessment was not conducted since an appropriate endpoint attributable to a single dose was not identified for U.S. general population and its population subgroups.

The chronic and cancer analyses incorporated average field trial residues, experimental and DEEM default processing factors, and projected average %CT estimates and drinking water estimates using Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) model.

The resulting chronic (food + water) exposure estimates were not of concern to HED [<100% of the chronic population adjusted dose (cPAD)] for U.S. general population (1.8 % cPAD) and all population sub-groups; the most highly exposed population subgroup was all infants (<1 year old) with 3.2% cPAD.

The cancer risk estimate (food + water) for the U.S. population was 3 x 10-6 for the general U.S. population, which is not considered to be exceeding HED’s level of concern (see discussion section for more details); HED generally conducts cancer dietary risk for U.S. general population only.  Hops, water, and orange juice were major contributors to the cancer risk.

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 point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.  For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  HED is generally concerned when estimated cancer risk exceeds one in one million. References which 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,” 21-JUN-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 (20-AUG-1999).

The most recent dietary risk assessment for spirodiclofen was conducted by Tom Bloem (D315255, 18-Apr-2005).

II.	Residue Information

Residues of Concern in Plants and Livestock:  Table 1 is a summary of the conclusion made by HED concerning the residues of concern in plant, livestock, and drinking water (Risk Assessment Documents, D285047 and D341847).

Table 1.  Residues for Tolerance Expression and Risk Assessment.

Matrix

Residues included in Risk Assessment

Residues included in Tolerance Expression

Citrus fruit, Pome Fruit, Stone Fruit, Tree Nut 1

spirodiclofen

spirodiclofen

Grape1

spirodiclofen

spirodiclofen, BAJ 2510

Livestock - Ruminants

spirodiclofen, BAJ 2510

spirodiclofen, BAJ 2510

Livestock - Poultry

no data submitted

Rotational Crops

no data submitted

Drinking Water

spirodiclofen, BAJ 2510, BAJ 2740-dihydroxy, BAJ 2740-ketohydroxy

not applicable

1	See reference: T. Bloem, D341847, 25-Oct-2007.

Established/Recommended Tolerances:  The current petition is for hops (maximum 0.39 lb ai/A with 14 day PHI) with no associated feed crops.  HED also reviewed the documents submitted by the registrant addressing the previously identified deficiencies recently (T. Bloem, D341847, 25-Oct-2007).  Based on the review of the residue chemistry data associated with the current petition (M. Sahafeyan, D339672), HED is recommending for establishment of a tolerance on hops at 30 ppm.  Tolerances for spirodiclofen are listed in 40 CFR § 180.608.  Table 2 contains established/recommended tolerances for all spirodiclofen uses (livestock tolerances for spirodiclofen and BAJ 2150).

Table 2.  Recommended Tolerances.

Commodity

Established/Recommended Tolerance (ppm)1

grape

2.0

grape, raisin

4.0

grape, juice

2.4

fruit, citrus, crop group 10

0.50

citrus, oil

20

citrus, juice

0.60

fruit, pome, crop group 11

0.80

apple, wet pomace

2.0

fruit, stone, crop group 12

1.0

nut, tree, crop group 14

0.10

almond, hulls

20

pistachio

0.10

hops	30

cattle, fat

0.02

cattle, meat byproducts

0.10

cattle, meat

0.02

goat, fat

0.02

goat, meat byproducts

0.10

1	Plant tolerances for residues of spirodiclofen (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutanoate) and livestock tolerances for residues of  spirodiclofen and BAJ 2510 (3-(2,4-dichlorophenyl)-4-hydroxy-1-oxaspiro[4,5]dec-3-en-2-one).

Plant Residues Used in the Chronic/Cancer Risk Assessments:  The chronic and cancer dietary analyses incorporated projected average percent crop treated estimates (see attachment 1), average field trial residues (see Table 3), and experimentally determined processing factors when available (see Table 3).  The HED Chemistry Science Advisory Committee (ChemSAC) expressed concern that spirodiclofen may be hydrolyzing/degrading to BAJ 2510, 3-OH-enol, and/or 4-OH-enol during processing procedures that involve high temperatures (i.e. pasteurization).  Recently submitted and reviewed apple and grape processing studies (T. Bloem, D341847, 25-Oct-2007) showed new processing factors for apples and grapes processed commodities and also demonstrated degradation of spirodiclofen to BAJ 2510 in grapes processing commodities; the new processing factors for apple and grape are used in this dietary exposure analyses.  HED is requesting that the petitioner submit an orange processing study monitoring for residues of spirodiclofen, BAJ 2510, 3-OH-enol, and 4-OH-enol.  Pending the submission of these data, human-health risk assessments should assume default processing factors for all processed commodities excluding the processed commodities for apple and grape.

Livestock Residues Used in the Chronic/Cancer Risk Assessments:  The recommended ruminant tolerances were based on maximum theoretical dietary burdens (no poultry/hog feed commodities proposed/registered).  A more realistic dietary burden was calculated for ruminants in the previous dietary risk assessment (T. Bloem, D315255, 18-Apr-2005) and were also used in the current analyses; see Tables 4 and 5.

Table 3.  Summary of Average Crop Residues, Crop Processing Factors, Average Projected Percent Crop Treated Estimates, and Projected Ruminant Residues used in the Chronic and Cancer Dietary Exposure Analyses.

Matrix

Avg Fld Trl Res and Projected Ruminant Residues (ppm)

Average % Crop Treated Estimates1

Processing Factors

Crop Translation and/or Comments

pome fruit

apple - 0.146

15

apple sauce (0.07x)2, dried apple (0.18x)2;

peeled apple (0.15x)

apple RAC residue translated to crabapple and pear RAC residue translated to loquat, mayhaw, Oriental pear, and quince3.

dried apple and apple juice processing factors were translated to dried pear and pear juice respectively.

per the suggestion of BEAD, the 15% projected average apple percent crop treated estimate was translated to all crops in the pome fruit crop group.

apple juice - 0.102

15

juice (0.03x)4

pear - 0.239

15

dried pear (0.18x);

pear juice (0.03x);

citrus fruit

orange - 0.104

14 (except temple)

peeled fruit (0.06x)2, juice (1.8x)4, oil (69x)2, peel (1.2x)2

orange RAC residue translated to calamondin, citron, citrus hybrids (tangelo), kumquat, mandarin, and tangerine (tangerine juice processing factor of 2.3x4); lemon RAC residue translated to lime (juice processing factor of 2.0x4) and citrus oil (69x2); and grapefruit RAC residue translated to pummelo3.

per the suggestion of BEAD the orange peeled fruit processing factor was translated to all citrus RACs.

per the suggestion of BEAD, orange %CT data was translated to all citrus except grapefruit (see attachment 1).

lemon - 0.121

14

juice (2.0x)4, peeled fruit (0.06x), peel (1.2x)2, oil (69x) 2

grapefruit - 0.103

13

juice (2.1x)4, peeled fruit (0.06x

tree nut

almond - 0.023

100

--

almond RAC residue translated to beech nut, chestnut, chinquapin, and pistachio and pecan RAC residue translated to brazil nut, butternut, cashew, filbert, hickory nut, macadamia nut, and walnut3.

pecan -0.019

100

--

stone fruit

peach - 0.368

10

dried peach (7.0x)4

peach RAC residue translated to apricot (dried apricot processing factor of 6.0)4 and nectarine and plum RAC residue translated to chickasaw plum, damson plum, Japanese plum, plumcot, and fresh prune3.

per the suggestion of BEAD, the 10% projected average peach percent crop treated estimate was translated to all crops in the stone fruit crop group.

plum - 0.068

10

prune fresh (2.5x)2, prune dried (5.0x)4, prune juice (1.4x)4

cherry - 0.286

10

juice (1.5x)4

grape

grape - 0.697

7

raisin (4.3x)2	- New experimental processing factor was determined for juice.

grape juice - 0.488

7

juice (0.17x)4

	hop	hop -  11.6	92	--	- average residue from German field trial data with 14-day PHI.

cattle, goat, sheep, horse

liver - 0.0009

--

--

-  see Tables 4 and 5.

residue in meat byproducts translated from fat.

since spirodiclofen may concentrate in milk fat (Kow=5.83), residues in milk fat were estimated using the 25x milk fat concentration factor (0.0002 ppm x 25 = 0.005 ppm).

kidney - 0.004

--

--

muscle - 0.0001

--

dried beef (1.92x)4

fat - 0.0007

--

--

meat bypdcts - 0.0007

--

--

whole milk - 0.0002

--

--

milk fat - 0.005

--

--

	1	See attachment 1.

2	Experimentally determined processing factors;  apple: 47168602.der.doc; grape: 47168601.der.doc (also see: T. Bloem, D341847, 25-Oct-2007); citrus: 45696516.der.wpd; plum - 45696520.der.wpd.

3	HED SOP 2000.1; Guidance for Translation of Field Trial Data from Rep. Comm. in the Crop Group Regulation to Other Commodities in Each Crop Group/Subgroup.

4	DEEM (ver. 7.76) default processing factor.

Table 4.	 Calculation of Spirodiclofen Dietary Brudens.

Feed Commodity

% Dry Matter1

% Diet2

Average Residue (ppm)3

Dietary Contribution (ppm)4

Beef Cattle

dried citrus pulp

91

5

0.16

0.01

almond hull

90

5

7.20

0.40

MTDB

--

10

--

0.41

Diary Cattle

dried citrus pulp

91

5

0.16

0.01

almond hull

90

5

7.20

0.40

MTDB

--

10

--

0.41

1	OPPTS 860.1000 Table 1 (August 1996).

2	Comments from J. Stokes; see previous dietary risk memorandum (T. Bloem, D315255, 18-Apr-2005).

3	Average almond hull field trial residue; average citrus field trial residue (0.121 ppm from lemon) multiplied by the 1.3x dried citrus pulp processing factor.

4	Dietary contribution = tolerance ( % dry matter x % diet.

Table 5.	 Summary of Cattle Feeding Study and Projected Residue.

Dose; ppm (MTDBx)

Residue (ppm)

Projected Residue Assuming  a 0.41 ppm dietary burden

Spirodiclofen

BAJ 2510

Total

liver

1.38 (3.4x)

not analyzed

4.12 (10.0x)

not analyzed

13.75 (33.5x)

<0.01

0.01-0.02

<0.02-<0.03

0.0009

kidney

1.38 (3.4x)

not analyzed

4.12 (10.0x)

<0.01

<0.01-0.03

<0.01-<0.04

0.004

13.75 (33.5x)

<0.01

0.04-0.09

<0.05-<0.10

0.003

muscle

1.38 (3.4x)

not analyzed

4.12 (10.0x)

not analyzed

13.75 (33.5x)

<0.002

<0.002

<0.004

0.0001

fat

1.38 (3.4x)

not analyzed

4.12 (10.0x)

<0.002

<0.002

<0.004

0.0004

13.75 (33.5x)

0.003-0.021

<0.002-0.008

<0.005-0.024

0.0007

whole milk (days 4, 8, 12, 16, 20, 24, 26, and 28)1

1.38 (3.4x)

not analyzed

4.12 (10.0x)

not analyzed

13.75 (33.5x)

<0.001-0.003

<0.001-0.003

<0.002-0.006

0.0002

whey2

1.38 (3.4x)

not analyzed

4.12 (10.0x)

not analyzed

13.75 (33.5x)

<0.001

<0.001-0.001

<0.002

0.00006

cream2

1.38 (3.4x)

not analyzed

4.12 (10.0x)

not analyzed

13.75 (33.5x)

0.005-0.012

<0.002- 0.002

<0.008- <0.014

0.0004

1	In milk collected from animals dosed at 6.2x, combined residues of spirodiclofen and BAJ 2510 reached a plateau within the first week of treatment ((0.004 ppm); however, a peak of 0.006 ppm was observed in a single animal on day 20 of dosing.

2	A milk sample collected from animals dosed at 6.2x with combined residues of 0.004 ppm was processed into whey and cream.

III.  Drinking Water Data

The recent memorandum from Environmental Fate and Effects Division (EFED) (L. Liu, D339673 and D337172, 10/18/07), stated that the previously generated residue data using the PRZM-EXAMS and Screening Concentration In Ground Water (SCI-GROW) models (D311291, F. Khan, 4-Jan-2005) can be used for the current uses.

Surface and ground estimated drinking water concentrations were generated using the PRZM-EXAMS and SCI-GROW models, respectively.  The SCI-GROW model was run using the highest application rate (1 x 0.53 lb ai/acre) and resulted in a point estimate of 0.44 ppb.  Multiple crop scenarios were modeled using the PRZM-EXAMS (citrus, pecan, apple, peach, and grape; 87% crop treated assumed) with citrus resulting in the highest 1-in-10-year peak concentration (23.86 ppb), 1-in-10-year yearly average (4.99 ppb), and 30-year average (1.67 ppb).  Therefore, the citrus distribution is considered to be the most conservative.  The citrus PRZM-EXAMS 1-in-10-year yearly average and 30-year average were used for the chronic and cancer analyses, respectively (these point estimates are greater than the ground water estimate and therefore more conservative).

IV.   DEEM-FCID( Program and Consumption Information

Spirodiclofen chronic dietary exposure assessments were conducted using the DEEM-FCID( (ver. 2.03), which incorporates consumption data from USDA’s 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” (i.e., apple pie) are linked to EPA-defined food commodities (i.e., 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 (i.e., 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.

IV.	Toxicological Information

The risk assessment team in November 2007 (D339672) reevaluated the chronic dietary endpoint based on the recently submitted toxicological studies.  Table 6 below summarizes the selected endpoints and rational; for more detailed discussion on endpoints see the previous dietary risk assessment (T. Bloem, D315255, 18-Apr-2005).

Table 6  Summary of Toxicological Doses and Endpoints for Spirodiclofen for Use in Dietary Exposure Risk Assessments.

Exposure/

Scenario	Point of Departure	Uncertainty/FQPA Safety Factors	RfD, PAD, Level of Concern 	Study and Toxicological Effects

Acute Dietary	An appropriate endpoint attributable to a single dose was not identified.

Chronic Dietary (All Populations)	NOAEL= 1.38 mg/kg/day

mg/kg/day	UF = 100

FQPA SF= [1]x

	Chronic RfD =

0.014 mg/kg/day

cPAD = [0.014 ] mg/kg/day	Chronic Oral Toxicity Study in Dogs

LOAEL= 4.7 mg/kg/day based on increased relative adrenal weights in both sexes, increased relative testis weight in males and histopathology findings in the adrenal gland of both sexes.

Cancer

Classification: “Likely to be Carcinogenic to Humans” with Q1* (mg/kg/day)-1 = 1.49 x 10-2.

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and  used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.  NOAEL = no observed adverse effect level.  LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.  FQPA SF = FQPA Safety Factor.  RfD = reference dose.

V.	Results/Discussion

For chronic dietary risk assessments, HED is concerned when dietary risk exceeds 100% of cPAD.  Cancer risks are expressed to one significant figure to allow better characterization of changes in risk which might result from potential risk mitigation.  Also, the risk should generally not be assumed to exceed the benchmark level of concern of 10-6 until the calculated risks exceed approximately 3 x 10-6.  Calculated risks ranging from approximately 3 x10-x-13 to 3 x 10-x (e.g., 3 x 10-7 to 3 x 10-6) are indistinguishable from 10-x (e.g., 10-6).  Therefore, risks should not be identified as exceeding the benchmark level of concern of 10-6 until the calculated risks exceed approximately 3 x 10-6.  HED performs cancer analyses for only the general U.S. population.  The results are summarized in Tables 7 and 8 below for chronic and cancer analyses, respectively.

The resulting chronic (food + water) exposure estimates were not of concern to HED (<100% of the cPAD) for U.S. general population (1.8 % cPAD) and all population sub-groups; the most highly exposed population subgroup was all infants (<1 year old) with 3.2% cPAD.

The cancer risk estimates for the U.S. general population with and without water were 3 x 10-6 and 2 x 10-6 respectively which are not considered to be exceeding HED’s level of concern.  HED also notes that the cancer risk estimates were generated using average residues derived from crop field trial studies (maximum application rate and minimum preharvest interval), incorporated maximum theoretical processing factors for juice, and incorporated surface drinking water estimates which assumed 87% of the basin was cropped and 100% of the cropped area was treated at the maximum rate.  Based on a critical commodity analysis conducted in DEEM-FCID(, the major contributors to the cancer risk were hops (41% of the total exposure), water (19% of the total exposure), and orange juice (17% of the total exposure).

Table 7.	Summary of Chronic Dietary Exposure and Risk for Spirodiclofen (drinking water included).

Population Subgroup

cPAD (mg/kg/day)

Exposure (mg/kg/day)

%cPAD

General U.S. Population

0.014

0.000253	1.8

All Infants (< 1 year old)

0.000452	3.2

Children 1-2 years old

0.000424	3.0

Children 3-5 years old

0.000345	2.5

Children 6-12 years old

0.000210	1.5

Youth 13-19 years old

0.000160	1.1

Females 13-49 years old

0.000197	1.4

Adults 20-49 years old

0.000280	2.0

Adults 50+ years old

0.000211	1.5

The bolded %cPAD is the highest.

Table 8.  Summary of Cancer Dietary Exposure and Risk for Spirodiclofen.

Population Subgroup	Q1*	Exposure (mg/kg/day)	Risk

with drinking water

General U.S. Population	0.0149	0.000183	3 x 10-6

without drinking water

General U.S. Population	0.0149	0.000148	2 x 10-6

VI.	Characterization of Inputs/Outputs

The chronic and cancer analyses were refined through the use of average field trial residues, experimentally determined processing factors, and BEAD projected average percent crop treated estimates.  BEAD provided projected average percent crop treated estimates for apple, peach, grape, orange, and grapefruit (see attachment 1).  These averages were based on the typical average of all insecticides used to control all pests on the specific crop.  In response to an HED inquiry, BEAD indicated that it is appropriate to translate the projected percent crop treated estimates for peach, apple, and orange to the remaining crops in the stone fruit, pome fruit, and citrus crop groups, respectively.

Since the analysis made use of average residues derived from crop field trial studies (maximum application rate and minimum preharvest interval), incorporated maximum theoretical processing factors for juice, and incorporated surface drinking water estimates which assumed 87% of the basin was cropped and 100% of the cropped are was treated at the maximum rate, HED concludes that the exposure estimates provided in this document are unlikely to underestimate actual exposure.

Based on a critical commodity analysis conducted in DEEM-FCID(, the major contributors to the cancer risk were hops (41% of the total exposure), water (19% of the total exposure), and orange juice (17% of the total exposure).

 VII.	Conclusions

Aggregate (food + water) chronic and cancer dietary risk analyses for spirodiclofen were updated using DEEM-FCID to support the Section 3 registration of spirodiclofen on hops.  Other modifications to the previous dietary risk analyses include using new processing factors for apples and grapes based on the review of the new submissions, more recent projected average %CT estimates and using the new chronic dietary endpoint (0.014 mg/kg/day instead of 0.0065 mg/kg/day).  These analyses are considered conservative since they used (average) field trial residues, average model-generated residues in drinking water using worst-case scenario and conservative default processing factors for most commodities.  The resulting chronic (food + water) exposure estimates were not of HED concern; the most highly exposed population subgroup was all infants (<1 year old) with 3.2% cPAD.  The cancer risk estimates for the U.S. population with drinking water included was 3 x 10-6 and therefore, the cancer risk is not of concern.  Hop, water, and orange with 41%, 19%, and 17% of the exposure, respectively, were the major contributors to the cancer risk.

VIII.		List of Attachments

Attachment 1:	BEAD Projected Percent Crop Treated Estimates

Attachment 2:	DEEM-FCID( chronic (food + water) residue file

Attachment 3:	DEEM-FCID( chronic (food + water) exposure estimates

Attachment 4:	DEEM-FCID( cancer (food + water) residue file

Attachment 5:	DEEM-FCID( cancer exposure estimates with and without drinking water

Attachment 6:	DEEM-FCID( critical commodity analysis for cancer

cc with all attachments:  M. Sahafeyan (RAB1)

RDI: DESAC (19-NOV-2007)

Petition Number(s): PP#7E7204

DP#: 346757

PC Code: 124871

M. Sahafeyan:S10944:PY1:(703)-305-0776

Attachment 1:  BEAD Projected Percent Crop Treated Estimates

(J. Alsadek, DP # 340691, August 2007)

Crop/New Use	Market Leader	AVG. PCT/Chronic	Max. PCT/Acute

Year	ML	Avg.

	Hops	Abamectin

Abamectin	97

92

	99

84

92	99

Oranges, excluding Temples	Abamectin

Abamectin

Abamectin	05

03

01	16

12

14

14	16

Grapes, All	Fenpropathrin/Imidacloprid

Abamectin

Propargite	05

03

01	8

5

9

7	9

Peaches	Hexythiazox

Fenbutatin-oxide

Fenbutatin-oxide	05

03

01	7

11

13

10	13

Apples	Pyridaben

Fenpropathrin/Formetanate

Pyridaben 	05

03

01	16

12

17

15	17

References:

National Center for Food & Agricultural Policy (NCFAP), 1992 and 1997

Agricultural Chemical Usage 2001 Fruit Summary, August 2002

Agricultural Chemical Usage 2003 Fruit Summary, August 2004

Agricultural Chemical Usage 2005 Fruit Summary, July 2006

Note: Average %CT of 13% for grapefruit, based on its use in 2005 was recommended by J. Alsadek (personal communication, 11/20/07)

Attachment 2:  DEEM-FCID( chronic residue file (food + water).

Filename: C:\Documents and Settings\msahafey\My Documents\spirodiclofen\124871 chronic with water-122007.R98

Chemical: spirodiclofen

RfD(Chronic): .014 mg/kg bw/day  NOEL(Chronic): 1.38 mg/kg bw/day

RfD(Acute): 0 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day Q*= .0149

Date created/last modified: 12-20-2007/13:02:51/8          Program ver. 2.03

Comment: no acute endpoint identified; 100x uncertainity factor for chronic

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

14000030 14   Almond                             0.023000   1.000  1.000

14000031 14   Almond-babyfood                    0.023000   1.000  1.000

14000040 14   Almond, oil                        0.023000   1.000  1.000

14000041 14   Almond, oil-babyfood               0.023000   1.000  1.000

11000070 11   Apple, fruit with peel             0.146000   1.000  0.150

11000080 11   Apple, peeled fruit                0.146000   0.150  0.150

11000081 11   Apple, peeled fruit-babyfood       0.146000   0.150  0.150

11000090 11   Apple, dried                       0.146000   0.180  0.150

11000091 11   Apple, dried-babyfood              0.146000   0.180  0.150

11000100 11   Apple, juice                       0.146000   0.030  0.150

11000101 11   Apple, juice-babyfood              0.146000   0.030  0.150

11000110 11   Apple, sauce                       0.146000   0.070  0.150

11000111 11   Apple, sauce-babyfood              0.146000   0.070  0.150

12000120 12   Apricot                            0.368000   1.000  0.100

12000121 12   Apricot-babyfood                   0.368000   1.000  0.100

12000130 12   Apricot, dried                     0.368000   6.000  0.100

12000140 12   Apricot, juice                     0.368000   1.000  0.100

12000141 12   Apricot, juice-babyfood            0.368000   1.000  0.100

21000440 M    Beef, meat                         0.000100   1.000  1.000

21000441 M    Beef, meat-babyfood                0.000100   1.000  1.000

21000450 M    Beef, meat, dried                  0.000100   1.920  1.000

21000460 M    Beef, meat byproducts              0.000700   1.000  1.000

21000461 M    Beef, meat byproducts-babyfood     0.000700   1.000  1.000

21000470 M    Beef, fat                          0.000700   1.000  1.000

21000471 M    Beef,fat-babyfood                  0.000700   1.000  1.000

21000480 M    Beef, kidney                       0.004000   1.000  1.000

21000490 M    Beef, liver                        0.000900   1.000  1.000

21000491 M    Beef, liver-babyfood               0.000900   1.000  1.000

14000590 14   Brazil nut                         0.019000   1.000  1.000

14000680 14   Butternut                          0.019000   1.000  1.000

14000810 14   Cashew                             0.019000   1.000  1.000

12000900 12   Cherry                             0.286000   1.000  0.100

12000901 12   Cherry-babyfood                    0.286000   1.000  0.100

12000910 12   Cherry, juice                      0.286000   1.500  0.100

12000911 12   Cherry, juice-babyfood             0.286000   1.500  0.100

14000920 14   Chestnut                           0.023000   1.000  1.000

10001060 10   Citrus citron                      0.104000   1.000  0.140

10001070 10   Citrus hybrids                     0.104000   0.060  0.140

10001080 10   Citrus, oil                        0.121000  69.000  0.140

11001290 11   Crabapple                          0.146000   1.000  0.150

14001550 14   Filbert                            0.019000   1.000  1.000

14001560 14   Filbert, oil                       0.019000   1.000  1.000

23001690 M    Goat, meat                         0.000100   1.000  1.000

23001700 M    Goat, meat byproducts              0.000700   1.000  1.000

23001710 M    Goat, fat                          0.000700   1.000  1.000

23001720 M    Goat, kidney                       0.004000   1.000  1.000

23001730 M    Goat, liver                        0.000900   1.000  1.000

95001750 O    Grape                              0.697000   1.000  0.070

95001760 O    Grape, juice                       0.697000   0.170  0.070

95001761 O    Grape, juice-babyfood              0.697000   0.170  0.070

95001770 O    Grape, leaves                      0.697000   1.000  0.070

95001780 O    Grape, raisin                      0.697000   4.300  0.070

95001790 O    Grape, wine and sherry             0.697000   1.000  0.070

10001800 10   Grapefruit                         0.103000   0.060  0.130

10001810 10   Grapefruit, juice                  0.103000   2.100  0.130

14001850 14   Hickory nut                        0.019000   1.000  1.000

95001880 O    Hop                               11.600000   1.000  0.920

24001890 M    Horse, meat                        0.000100   1.000  1.000

10001970 10   Kumquat                            0.104000   0.060  0.140

10001990 10   Lemon                              0.121000   0.060  0.140

10002000 10   Lemon, juice                       0.121000   2.000  0.140

10002001 10   Lemon, juice-babyfood              0.121000   2.000  0.140

10002010 10   Lemon, peel                        0.121000   1.200  0.140

10002060 10   Lime                               0.121000   0.060  0.140

10002070 10   Lime, juice                        0.121000   2.000  0.140

10002071 10   Lime, juice-babyfood               0.121000   2.000  0.140

11002100 11   Loquat                             0.239000   1.000  0.150

14002130 14   Macadamia nut                      0.019000   1.000  1.000

27002220 D    Milk, fat                          0.005000   1.000  1.000

27002221 D    Milk, fat - baby food/infant for   0.005000   1.000  1.000

27012230 D    Milk, nonfat solids                0.000200   1.000  1.000

27012231 D    Milk, nonfat solids-baby food/in   0.000200   1.000  1.000

27022240 D    Milk, water                        0.000200   1.000  1.000

27022241 D    Milk, water-babyfood/infant form   0.000200   1.000  1.000

27032251 D    Milk, sugar (lactose)-baby food/   0.000200   1.000  1.000

12002300 12   Nectarine                          0.368000   1.000  0.100

10002400 10   Orange                             0.104000   0.060  0.140

10002410 10   Orange, juice                      0.104000   1.800  0.140

10002411 10   Orange, juice-babyfood             0.104000   1.800  0.140

10002420 10   Orange, peel                       0.104000   1.200  0.140

12002600 12   Peach                              0.368000   1.000  0.100

12002601 12   Peach-babyfood                     0.368000   1.000  0.100

12002610 12   Peach, dried                       0.368000   7.000  0.100

12002611 12   Peach, dried-babyfood              0.368000   7.000  0.100

12002620 12   Peach, juice                       0.368000   1.000  0.100

12002621 12   Peach, juice-babyfood              0.368000   1.000  0.100

11002660 11   Pear                               0.239000   1.000  0.150

11002661 11   Pear-babyfood                      0.239000   1.000  0.150

11002670 11   Pear, dried                        0.239000   0.180  0.150

11002680 11   Pear, juice                        0.239000   0.030  0.150

11002681 11   Pear, juice-babyfood               0.239000   0.030  0.150

14002690 14   Pecan                              0.019000   1.000  1.000

14002820 14   Pistachio                          0.023000   1.000  1.000

12002850 12   Plum                               0.068000   1.000  0.100

12002851 12   Plum-babyfood                      0.068000   1.000  0.100

12002860 12   Plum, prune, fresh                 0.068000   2.500  0.100

12002861 12   Plum, prune, fresh-babyfood        0.068000   2.500  0.100

12002870 12   Plum, prune, dried                 0.068000   5.000  0.100

12002871 12   Plum, prune, dried-babyfood        0.068000   5.000  0.100

12002880 12   Plum, prune, juice                 0.068000   1.400  0.100

12002881 12   Plum, prune, juice-babyfood        0.068000   1.400  0.100

10003070 10   Pummelo                            0.103000   0.060  0.140

11003100 11   Quince                             0.239000   1.000  0.150

26003390 M    Sheep, meat                        0.000100   1.000  1.000

26003391 M    Sheep, meat-babyfood               0.000100   1.000  1.000

26003400 M    Sheep, meat byproducts             0.000700   1.000  1.000

26003410 M    Sheep, fat                         0.000700   1.000  1.000

26003411 M    Sheep, fat-babyfood                0.000700   1.000  1.000

26003420 M    Sheep, kidney                      0.004000   1.000  1.000

26003430 M    Sheep, liver                       0.000900   1.000  1.000

10003690 10   Tangerine                          0.104000   0.060  0.140

10003700 10   Tangerine, juice                   0.104000   2.300  0.140

14003910 14   Walnut                             0.019000   1.000  1.000

86010000 O    Water, direct, all sources         0.004990   1.000  1.000

86020000 O    Water, indirect, all sources       0.004990   1.000  1.000

Attachment 3:  DEEM-FCID( chronic (food + Water) exposure estimates.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for SPIRODICLOFEN                    (1994-98 data)

Residue file name: C:\Documents and Settings\msahafey\My Documents\spirodiclofen\124871 chronic with water-122007.R98

                                                     Adjustment factor #2 used.

Analysis Date 12-20-2007/13:14:19     Residue file dated: 12-20-2007/13:02:51/8

Reference dose (RfD, Chronic) = .014 mg/kg bw/day

COMMENT 1: no acute endpoint identified; 100x uncertainity factor for chronic

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.000253                 1.8%

U.S. Population (spring season)             0.000267                 1.9%

U.S. Population (summer season)             0.000271                 1.9%

U.S. Population (autumn season)             0.000237                 1.7%

U.S. Population (winter season)             0.000238                 1.7%

Northeast region                            0.000247                 1.8%

Midwest region                              0.000262                 1.9%

Southern region                             0.000228                 1.6%

Western region                              0.000290                 2.1%

Hispanics                                   0.000263                 1.9%

Non-hispanic whites                         0.000258                 1.8%

Non-hispanic blacks                         0.000217                 1.6%

Non-hisp/non-white/non-black                0.000261                 1.9%

All infants (< 1 year)                      0.000452                 3.2%

Nursing infants                             0.000191                 1.4%

Non-nursing infants                         0.000551                 3.9%

Children 1-6  yrs                           0.000360                 2.6%

Children 7-12 yrs                           0.000197                 1.4%

Females 13-19 (not preg or nursing)         0.000139                 1.0%

Females 20+ (not preg or nursing)           0.000202                 1.4%

Females 13-50 yrs                           0.000210                 1.5%

Females 13+ (preg/not nursing)              0.000165                 1.2%

Females 13+ (nursing)                       0.000226                 1.6%

Males 13-19 yrs                             0.000180                 1.3%

Males 20+ yrs                               0.000313                 2.2%

Seniors 55+                                 0.000202                 1.4%

Children 1-2 yrs                            0.000424                 3.0%

Children 3-5 yrs                            0.000345                 2.5%

Children 6-12 yrs                           0.000210                 1.5%

Youth 13-19 yrs                             0.000160                 1.1%

Adults 20-49 yrs                            0.000280                 2.0%

Adults 50+ yrs                              0.000211                 1.5%

Females 13-49 yrs                           0.000197                 1.4%

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

Attachment 4:  DEEM-FCID( cancer residue file (food + water).

Filename: C:\Documents and Settings\msahafey\My Documents\spirodiclofen\124871-cancer with water-122007.R98

Chemical: spirodiclofen

RfD(Chronic): .014 mg/kg bw/day  NOEL(Chronic): 1.38 mg/kg bw/day

RfD(Acute): 0 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day Q*= .0149

Date created/last modified: 12-20-2007/13:07:51/8          Program ver. 2.03

Comment: no acute endpoint identified; 100x uncertainity factor for chronic

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

14000030 14   Almond                             0.023000   1.000  1.000

14000031 14   Almond-babyfood                    0.023000   1.000  1.000

14000040 14   Almond, oil                        0.023000   1.000  1.000

14000041 14   Almond, oil-babyfood               0.023000   1.000  1.000

11000070 11   Apple, fruit with peel             0.146000   1.000  0.150

11000080 11   Apple, peeled fruit                0.146000   0.150  0.150

11000081 11   Apple, peeled fruit-babyfood       0.146000   0.150  0.150

11000090 11   Apple, dried                       0.146000   0.180  0.150

11000091 11   Apple, dried-babyfood              0.146000   0.180  0.150

11000100 11   Apple, juice                       0.146000   0.030  0.150

11000101 11   Apple, juice-babyfood              0.146000   0.030  0.150

11000110 11   Apple, sauce                       0.146000   0.070  0.150

11000111 11   Apple, sauce-babyfood              0.146000   0.070  0.150

12000120 12   Apricot                            0.368000   1.000  0.100

12000121 12   Apricot-babyfood                   0.368000   1.000  0.100

12000130 12   Apricot, dried                     0.368000   6.000  0.100

12000140 12   Apricot, juice                     0.368000   1.000  0.100

12000141 12   Apricot, juice-babyfood            0.368000   1.000  0.100

21000440 M    Beef, meat                         0.000100   1.000  1.000

21000441 M    Beef, meat-babyfood                0.000100   1.000  1.000

21000450 M    Beef, meat, dried                  0.000100   1.920  1.000

21000460 M    Beef, meat byproducts              0.000700   1.000  1.000

21000461 M    Beef, meat byproducts-babyfood     0.000700   1.000  1.000

21000470 M    Beef, fat                          0.000700   1.000  1.000

21000471 M    Beef,fat-babyfood                  0.000700   1.000  1.000

21000480 M    Beef, kidney                       0.004000   1.000  1.000

21000490 M    Beef, liver                        0.000900   1.000  1.000

21000491 M    Beef, liver-babyfood               0.000900   1.000  1.000

14000590 14   Brazil nut                         0.019000   1.000  1.000

14000680 14   Butternut                          0.019000   1.000  1.000

14000810 14   Cashew                             0.019000   1.000  1.000

12000900 12   Cherry                             0.286000   1.000  0.100

12000901 12   Cherry-babyfood                    0.286000   1.000  0.100

12000910 12   Cherry, juice                      0.286000   1.500  0.100

12000911 12   Cherry, juice-babyfood             0.286000   1.500  0.100

14000920 14   Chestnut                           0.023000   1.000  1.000

10001060 10   Citrus citron                      0.104000   1.000  0.140

10001070 10   Citrus hybrids                     0.104000   0.060  0.140

10001080 10   Citrus, oil                        0.121000  69.000  0.140

11001290 11   Crabapple                          0.146000   1.000  0.150

14001550 14   Filbert                            0.019000   1.000  1.000

14001560 14   Filbert, oil                       0.019000   1.000  1.000

23001690 M    Goat, meat                         0.000100   1.000  1.000

23001700 M    Goat, meat byproducts              0.000700   1.000  1.000

23001710 M    Goat, fat                          0.000700   1.000  1.000

23001720 M    Goat, kidney                       0.004000   1.000  1.000

23001730 M    Goat, liver                        0.000900   1.000  1.000

95001750 O    Grape                              0.697000   1.000  0.070

95001760 O    Grape, juice                       0.697000   0.170  0.070

95001761 O    Grape, juice-babyfood              0.697000   0.170  0.070

95001770 O    Grape, leaves                      0.697000   1.000  0.070

95001780 O    Grape, raisin                      0.697000   4.300  0.070

95001790 O    Grape, wine and sherry             0.697000   1.000  0.070

10001800 10   Grapefruit                         0.103000   0.060  0.130

10001810 10   Grapefruit, juice                  0.103000   2.100  0.130

14001850 14   Hickory nut                        0.019000   1.000  1.000

95001880 O    Hop                               11.600000   1.000  0.920  for PH

          Full comment: for PHI=14 day, German Trial

24001890 M    Horse, meat                        0.000100   1.000  1.000

10001970 10   Kumquat                            0.104000   0.060  0.140

10001990 10   Lemon                              0.121000   0.060  0.140

10002000 10   Lemon, juice                       0.121000   2.000  0.140

10002001 10   Lemon, juice-babyfood              0.121000   2.000  0.140

10002010 10   Lemon, peel                        0.121000   1.200  0.140

10002060 10   Lime                               0.121000   0.060  0.140

10002070 10   Lime, juice                        0.121000   2.000  0.140

10002071 10   Lime, juice-babyfood               0.121000   2.000  0.140

11002100 11   Loquat                             0.239000   1.000  0.150

14002130 14   Macadamia nut                      0.019000   1.000  1.000

27002220 D    Milk, fat                          0.005000   1.000  1.000

27002221 D    Milk, fat - baby food/infant for   0.005000   1.000  1.000

27012230 D    Milk, nonfat solids                0.000200   1.000  1.000

27012231 D    Milk, nonfat solids-baby food/in   0.000200   1.000  1.000

27022240 D    Milk, water                        0.000200   1.000  1.000

27022241 D    Milk, water-babyfood/infant form   0.000200   1.000  1.000

27032251 D    Milk, sugar (lactose)-baby food/   0.000200   1.000  1.000

12002300 12   Nectarine                          0.368000   1.000  0.100

10002400 10   Orange                             0.104000   0.060  0.140

10002410 10   Orange, juice                      0.104000   1.800  0.140

10002411 10   Orange, juice-babyfood             0.104000   1.800  0.140

10002420 10   Orange, peel                       0.104000   1.200  0.140

12002600 12   Peach                              0.368000   1.000  0.100

12002601 12   Peach-babyfood                     0.368000   1.000  0.100

12002610 12   Peach, dried                       0.368000   7.000  0.100

12002611 12   Peach, dried-babyfood              0.368000   7.000  0.100

12002620 12   Peach, juice                       0.368000   1.000  0.100

12002621 12   Peach, juice-babyfood              0.368000   1.000  0.100

11002660 11   Pear                               0.239000   1.000  0.150

11002661 11   Pear-babyfood                      0.239000   1.000  0.150

11002670 11   Pear, dried                        0.239000   0.180  0.150

11002680 11   Pear, juice                        0.239000   0.030  0.150

11002681 11   Pear, juice-babyfood               0.239000   0.030  0.150

14002690 14   Pecan                              0.019000   1.000  1.000

14002820 14   Pistachio                          0.023000   1.000  1.000

12002850 12   Plum                               0.068000   1.000  0.100

12002851 12   Plum-babyfood                      0.068000   1.000  0.100

12002860 12   Plum, prune, fresh                 0.068000   2.500  0.100

12002861 12   Plum, prune, fresh-babyfood        0.068000   2.500  0.100

12002870 12   Plum, prune, dried                 0.068000   5.000  0.100

12002871 12   Plum, prune, dried-babyfood        0.068000   5.000  0.100

12002880 12   Plum, prune, juice                 0.068000   1.400  0.100

12002881 12   Plum, prune, juice-babyfood        0.068000   1.400  0.100

10003070 10   Pummelo                            0.103000   0.060  0.140

11003100 11   Quince                             0.239000   1.000  0.150

26003390 M    Sheep, meat                        0.000100   1.000  1.000

26003391 M    Sheep, meat-babyfood               0.000100   1.000  1.000

26003400 M    Sheep, meat byproducts             0.000700   1.000  1.000

26003410 M    Sheep, fat                         0.000700   1.000  1.000

26003411 M    Sheep, fat-babyfood                0.000700   1.000  1.000

26003420 M    Sheep, kidney                      0.004000   1.000  1.000

26003430 M    Sheep, liver                       0.000900   1.000  1.000

10003690 10   Tangerine                          0.104000   0.060  0.140

10003700 10   Tangerine, juice                   0.104000   2.300  0.140

14003910 14   Walnut                             0.019000   1.000  1.000

86010000 O    Water, direct, all sources         0.001670   1.000  1.000

86020000 O    Water, indirect, all sources       0.001670   1.000  1.000

Attachment 5:  DEEM-FCID( cancer exposure estimates

Food + Water :

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for SPIRODICLOFEN                    (1994-98 data)

Residue file name: C:\Documents and Settings\msahafey\My Documents\spirodiclofen\124871-cancer with water-122007.R98

                                                     Adjustment factor #2 used.

Analysis Date 12-20-2007/13:16:10     Residue file dated: 12-20-2007/13:07:51/8

Q* = 0.0149

COMMENT 1: water included

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg         Lifetime risk

           Subgroup                       body wt/day       (Q*= .0149)

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

U.S. Population (total)                     0.000183         2.73E-06

Food Only:

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for SPIRODICLOFEN                    (1994-98 data)

Residue file name: C:\Documents and Settings\msahafey\My Documents\spirodiclofen\124871-cancer without water-122007.R98

                                                     Adjustment factor #2 used.

Analysis Date 12-20-2007/13:17:13     Residue file dated: 12-20-2007/13:08:58/8

Q* = 0.0149

COMMENT 1: Water is not included.

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg         Lifetime risk

           Subgroup                       body wt/day       (Q*= .0149)

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

U.S. Population (total)                     0.000148         2.21E-06

Attachment 6:  DEEM-FCID( critical commodity analysis for cancer.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for SPIRODICLOFEN                    (1994-98 data)

Residue file name: C:\Documents and Settings\msahafey\My Documents\spirodiclofen\124871-cancer with water-112607.R98

                                                     Adjustment factor #2 used.

Analysis Date 11-27-2007/09:57:39     Residue file dated: 11-27-2007/09:18:34/8

Q* = 0.0149

COMMENT 1: no acute endpoint identified; 100x uncertainity factor for chronic

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

                 Critical Commodity Contribution Analysis for

                            U.S. Population (total)

                 Total Exposure =.0001845 mg/kg bw/day

            Crop groups with total exposure contribution > 99%

              Foods/Foodforms with exposure contribution > 1%

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

Crop group                               -----------Exposure analysis----------

   Food                                     mg/kg   | % of Total| Lifetime Risk

      Foodform                           body wt/day|  Exposure |(Q*= .0149)

--------------------------------------   -----------|-----------|--------------

Crop Group = (O)  Other

   Grape (95001750):

        FoodForm N/S                       0.0000048     2.59%        7.11E-08

   Grape, juice (95001760):

        FoodForm N/S                       0.0000020     1.11%        3.05E-08

   Grape, raisin (95001780):

        FoodForm N/S                       0.0000058     3.15%        8.65E-08

   Grape, wine and sherry (95001790):

        FoodForm N/S                       0.0000075     4.06%        1.12E-07

   Hop (95001880):

        FoodForm N/S                       0.0000746    40.46%        1.11E-06

   Water, direct, all sources (86010000):

        FoodForm N/S                       0.0000203    10.98%        3.02E-07

   Water, indirect, all sources (86020000):

        FoodForm N/S                       0.0000149     8.10%        2.23E-07

--------------------------------------   -----------|-----------|--------------

  Total for crop group                     0.0001300    70.49%        1.94E-06

Crop Group = (10) Citrus Fruits

   Orange, juice (10002410):

        FoodForm N/S                       0.0000307    16.62%        4.57E-07

--------------------------------------   -----------|-----------|--------------

  Total for crop group                     0.0000341    18.46%        5.07E-07

Crop Group = (11) Pome Fruits

   Apple, fruit with peel (11000070):

        FoodForm N/S                       0.0000067     3.64%        1.00E-07

   Pear (11002660):

        FoodForm N/S                       0.0000027     1.46%        4.01E-08

--------------------------------------   -----------|-----------|--------------

  Total for crop group                     0.0000106     5.73%        1.57E-07

                                       1

Crop group                               -----------Exposure analysis----------

   Food                                     mg/kg   | % of Total| Lifetime Risk

      Foodform                           body wt/day|  Exposure |(Q*= .0149)

--------------------------------------   -----------|-----------|--------------

Crop Group = (12) Stone Fruits

   Peach (12002600):

        FoodForm N/S                       0.0000034     1.85%        5.07E-08

--------------------------------------   -----------|-----------|--------------

  Total for crop group                     0.0000064     3.46%        9.51E-08

Total for crop groups listed above:        0.0001811    98.14%        2.70E-06

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

Spirodiclofen	Dietary Exposure and Risk Assessment	             DP Number: 346757

PC Code: 124871

Page   PAGE  2  of   NUMPAGES  21


[Federal Register: February 3, 2006 (Volume 71, Number 23)]
[Notices]
[Page 5828-5830]
[DOCID:fr03fe06-48]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application Accepted for Filing, Soliciting Motions To
Intervene and Protests; Ready for Environmental Analysis, and
Soliciting Comments, Terms and Conditions, Recommendations, and
Prescriptions; Paper Scoping and Soliciting Scoping Comments

January 27, 2006.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Major License, 5 MW or Less.
    b. Project No.: 12597-002.\1\
---------------------------------------------------------------------------

    \1\ The applicant has split its Turnbull Drop Project No. 12539,
for which it holds a preliminary permit, into the Lower Turnbull
Drop Project No. 12597 and the Upper Turnbull Drop Project No.
12598.
---------------------------------------------------------------------------

    c. Date filed: November 28, 2005.
    d. Applicant: Birch Power Company.
    e. Name of Project: Lower Turnbull Drop Hydroelectric Project.
    f. Location: On the Spring Valley Canal, in Teton County, Montana,
about 4 miles west of Fairfield, Montana. The project would occupy
lands of the United States administered by the Bureau of Reclamation.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Ted Sorenson, Sorenson Engineering, 5203
South 11th East, Idaho Falls, ID 83404;<PHONE_NUMBER>.
    i. FERC Contact: Dianne Rodman, Federal Energy Regulatory
Commission,

888 First Street, NE., Washington, DC 20426; telephone<PHONE_NUMBER>
or by e-mail at<EMAIL_ADDRESS>    j. Deadline for filing scoping comments: 30 days from the issuance
date of this notice; deadline for filing motions to intervene and
protests, comments, terms and conditions, recommendations, and
prescriptions: 60 days from the issuance of this notice.
    All documents (original and eight copies) should be filed with:
Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    Scoping comments, motions to intervene, comments, terms and
conditions, recommendations, prescriptions, and protests may be filed
electronically via the Internet in lieu of paper. The Commission
strongly encourages electronic filings. See 18 CFR 385.2001(a)(1)(iii)
and the instructions on the Commission's Web site (http://www.ferc.gov)

under the ``e-Filing'' link.
    k. This application has been accepted for filing, and is now ready
for environmental analysis.
    l. The proposed Lower Turnbull Drop Project would be built at the
Spring Valley Canal's Lower Turnbull drop structure, which is a
reinforced concrete structure 2,332 feet long, with a total drop of
146.5 feet. The applicant proposes to construct: (1) A check structure,
consisting of a spillway gate panel anchored to a ballast concrete
structure spanning the full width of the canal floor between new
concrete abutment walls; (2) an intake structure to divert flows from
the left side of the canal; (3) 84-inch-diameter, 2,340-feet-long steel
or polyethylene penstock that would be completely buried; (4) a
powerhouse containing two horizontal Francis turbines and one generator
with a rated output of 5 MW; (5) a draft tube and tailrace discharging
flows into the canal about 40 feet downstream of the drop structure's
existing stilling basin; (6) a 0.8-mile-long, 12.5-kilovolt (kV)
transmission line; (7) a switchyard; and (8) a 1.7-mile-long, 69-kV
transmission line extending from the switchyard to interconnect with an
existing Sun River Electric Cooperative transmission line. The project
would use flows as they are provided in accordance with the needs of
the Greenfield Irrigation District, which operates the canal. The
project would not impound water and would be operated strictly as a
run-of-river plant. Average annual generation would be 13,350,000
kilowatt-hours.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''

link. Enter the docket number, excluding the last three digits, in the
docket number field to access the document. For assistance, contact
FERC Online Support at<EMAIL_ADDRESS>or toll-free at 1-
866-208-3676, or for TTY,<PHONE_NUMBER>. A copy is also available for
inspection and reproduction at the address in item h above.
    Register online at http://www.ferc.gov/docs-filings/esubscription.asp
 to be notified via e-mail of new filings and

issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    n. Any qualified applicant desiring to file a competing application
must submit to the Commission on or before the specified deadline date
for the particular application, a competing development application, or
a notice of intent to file such an application. Submission of a timely
notice of intent allows an interested person to file the competing
development application no later than 120 days after the specified
deadline date for the particular application. Applications for
preliminary permits will not be accepted in response to this notice.
    A notice of intent must specify the exact name, business address,
and telephone number of the prospective applicant, and must include an
unequivocal statement of intent to submit, if such an application may
be filed, either a preliminary permit application or a development
application (specify which type of application). A notice of intent
must be served on the applicant(s) named in this public notice.
    Anyone may submit comments, a protest, or a motion to intervene in
accordance with the requirements of Rules of Practice and Procedure, 18
CFR 385.210, 385.211, and 385.214. In determining the appropriate
action to take, the Commission will consider all protests or other
comments filed, but only those who file a motion to intervene in
accordance with the Commission's Rules may become a party to the
proceeding. Any comments, protests, or motions to intervene must be
received on or before the specified comment date for the particular
application.
    The Commission directs, pursuant to section 4.34(b) of the
Regulations (see Order No. 533 issued May 8, 1991, 56 FR 23108, May 20,
1991) that all comments, recommendations, terms and conditions, and
prescriptions concerning the application be filed with the Commission
within 60 days from the issuance date of this notice. All reply
comments must be filed with the Commission within 105 days from the
date of this notice.
    All filings must (1) bear in all capital letters the title
``PROTEST,'' ``MOTION TO INTERVENE,'' ``NOTICE OF INTENT TO FILE
COMPETING APPLICATION,'' ``COMPETING APPLICATION,'' ``COMMENTS,''
``REPLY COMMENTS,'' ``RECOMMENDATIONS,'' ``TERMS AND CONDITIONS,'' or
``PRESCRIPTIONS;'' (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person protesting or intervening; and (4) otherwise comply with the
requirements of 18 CFR 385.2001 through 385.2005. All comments,
recommendations, terms and conditions or prescriptions must set forth
their evidentiary basis and otherwise comply with the requirements of
18 CFR 4.34(b). Agencies may obtain copies of the application directly
from the applicant. A copy of any protest or motion to intervene must
be served upon each representative of the applicant specified in the
particular application. A copy of all other filings in reference to
this application must be accompanied by proof of service on all persons
listed in the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
    o. Scoping Process: The Commission intends to prepare an
Environmental Assessment (EA) on the project in accordance with the
National Environmental Policy Act.\2\ The EA will consider both site-
specific and cumulative environmental impacts and reasonable
alternatives to the proposed action.
---------------------------------------------------------------------------

    \2\ One EA will be prepared for the Lower Turnbull Drop Project
and two other projects proposed to be constructed on nearby canals,
the Upper Turnbull Drop Project No. 12598 and the Mill Coulee Drops
Project No. 12599.
---------------------------------------------------------------------------

    Commission staff does not propose to conduct any on-site scoping
meetings at this time. Instead, we will solicit comments,
recommendations,

information, and alternatives in the Scoping Document (SD).\3\
---------------------------------------------------------------------------

    \3\ One SD has been prepared for the Lower Turnbull Drop
Project, the Upper Turnbull Drop Project, and the Mill Coulee Drops
Project.
---------------------------------------------------------------------------

    Copies of the SD outlining the subject areas to be addressed in the
EA were distributed to the parties on the Commission's mailing list.
Copies of the SD may be viewed on the Web at http://www.ferc.gov using

the ``eLibrary'' link (see item m above).

Magalie R. Salas,
Secretary.
 [FR Doc. E6-1443 Filed 2-2-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 248 (Thursday, December 26, 2013)]
[Notices]
[Pages 78349-78350]
[FR Doc No: 2013-30834]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12790-002-CT]

Andrew Peklo III; Notice of Availability of Draft Environmental
Assessment

    In accordance with the National Environmental Policy Act of 1969
and

the Federal Energy Regulatory Commission's (Commission) regulations, 18
CFR Part 380 (Order No. 486, 52 FR 47897), the Office of Energy
Projects has reviewed the application for an original license for the
Pomperaug Hydro Project, to be located on the Pomperaug River, in the
town of Woodbury, Litchfield County, Connecticut, and has prepared a
draft Environmental Assessment (EA).
    The draft EA contains the staff's analysis of the potential
environmental impacts of the project and concludes that licensing the
project, with appropriate environmental protective measures, would not
constitute a major federal action that would significantly affect the
quality of the human environment.
    A copy of the draft EA is on file with the Commission and is
available for public inspection. The draft EA may also be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number, excluding the last three digits in the
docket number field, to access the document. For assistance, contact
FERC Online Support at<EMAIL_ADDRESS>or toll-free at 1-
866-208-3676, or for TTY,<PHONE_NUMBER>. You may also register online
at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via
email of new filings and issuances related to this or other pending
projects. For assistance, contact FERC Online Support.
    Any comments should be filed within 30 days from the date of this
notice. Comments may be filed electronically via the Internet. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments.
    For assistance, please contact FERC Online Support. Although the
Commission strongly encourages electronic filing, documents may also be
paper-filed. To paper-file, mail comments to: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-12790-002.
    For further information, contact Steve Kartalia at<PHONE_NUMBER>
or<EMAIL_ADDRESS>
    Dated: December 19, 2013.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2013-30834 Filed 12-24-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 97 (Thursday, May 19, 2011)]
[Notices]
[Pages 28999-29000]
[FR Doc No: 2011-12353]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1971-DR; Docket ID FEMA-2011-0001]

Alabama; Amendment No. 10 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Alabama (FEMA-1971-DR), dated April 28, 2011, and
related determinations.

DATES: Effective Date: May 6, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Alabama is hereby amended to include the following
area among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of April 28, 2011.

    Monroe County for Individual Assistance (already designated for
debris removal and emergency protective measures [Categories A and
B], including direct Federal assistance, under the Public Assistance
program).

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

    May 13, 2011.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-12353 Filed 5-18-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 77, Number 180 (Monday, September 17, 2012)]
[Notices]
[Page 57168]
[FR Doc No: 2012-22785]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67825; SR-Phlx-2012-27; SR-Phlx-2012-54]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Designation of Longer Period for Commission Action on Proceedings To
Determine Whether To Approve or Disapprove Proposed Rule Relating to
Complex Order Fees and Rebates for Adding and Removing Liquidity in
Select Symbols

September 11, 2012.
    On March 1, 2012 and April 23, 2012, NASDAQ OMX PHLX LLC (``Phlx''
or ``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ two
proposed rule changes relating to the transaction fees for certain
Complex Order transactions.\3\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ A Complex Order is any order involving the simultaneous
purchase and/or sale of two or more different options series in the
same underlying security, priced at a net debit or credit based on
the relative prices of the individual components, for the same
account, for the purpose of executing a particular investment
strategy. A Complex Order may also be a stock-option order, which is
an order to buy or sell a stated number of units of an underlying
stock or exchange-traded fund (``ETF'') coupled with the purchase or
sale of options contract(s). See Exchange Rule 1080, Commentary
.08(a)(i).
---------------------------------------------------------------------------

    In SR-Phlx-2012-27 (filed on March 1, 2012), Phlx proposed to amend
the Exchange's Fee Schedule to increase the transaction fees and
rebates for certain Complex Order transactions and create a new rebate
for certain Complex Orders. The proposed rule change was immediately
effective upon filing with the Commission pursuant to Section
19(b)(3)(A) of the Act.\4\ Notice of filing of the proposed rule change
was published for comment in the Federal Register on March 15, 2012.\5\
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(3)(A).
    \5\ See Securities Exchange Act Release No. 66551 (March 9,
2012) 77 FR 15400.
---------------------------------------------------------------------------

    In SR-Phlx-2012-54 (filed on April 23, 2012), Phlx proposed to
replace a portion of SR-Phlx-2012-27 to provide additional information
concerning the Directed Participant and Market Maker fees for removing
liquidity in Complex orders (``Second Proposal,'' and, together with
SR-Phlx-2012-27, the ``Phlx Proposals''). The proposed rule change was
immediately effective upon filing with the Commission pursuant to
Section 19(b)(3)(A) of the Act.\6\ Notice of filing of the proposed
rule change was published for comment in the Federal Register on May 4,
2012. \7\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ See Securities Exchange Act Release No. 66883 (April 30,
2012) 77 FR 26591.
---------------------------------------------------------------------------

    The Commission received no comment letters on the Phlx Proposals.
    On April 30, 2012, the Commission instituted proceedings to
determine whether to approve or disapprove the proposed rule
changes.\8\ Thereafter, NASDAQ OMX Group, Inc. submitted a response
letter in support of the Phlx Proposals on July 26, 2012.\9\
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release No. 66884, 77 FR
26595(May 4, 2012) (``Order Instituting Proceedings'').
    \9\ See Letter to Elizabeth M. Murphy, Secretary, Commission,
from Joan C. Conley, Senior Vice President & Corporate Secretary,
NASDAQ OMX Group, Inc., dated July 26, 2012.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \10\ provides that, after initiating
disapproval proceedings, the Commission shall issue an order approving
or disapproving the proposed rule change not later than 180 days after
the date of publication of notice of the filing of the proposed rule
change. The Commission may extend the period for issuing an order
approving or disapproving the proposed rule change, however, by not
more than 60 days if the Commission determines that a longer period is
appropriate and publishes the reasons for such determination. The
proposed rule changes were published for notice and comment in the
Federal Register on March 15, 2012 and May 4, 2012, respectively.
September 11, 2012 is 180 days from March 15, 2012 and November 10,
2012 is an additional 60 days from that date.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to issue an order approving or disapproving the Phlx
Proposals so that it has sufficient time to consider the Phlx Proposals
and the issues raised by those proposals, and the Exchange's response
to such issues in its response letter.\11\ The Commission also finds it
appropriate to designate a longer period within which to issue an order
approving or disapproving the proposed rule changes so that it has
sufficient time to consider data that has been provided by the Exchange
in support of its proposals, including additional data that it
anticipates will be provided by the Exchange.\12\
---------------------------------------------------------------------------

    \11\ For example, in the order instituting proceedings to
determine whether to approve or disapprove the proposed rule
changes, the Commission sought comment on whether discrimination on
the basis of whether a market maker has an off-exchange arrangement
to pay an order flow provider to direct its orders to that market
maker is a ``fair'' basis for discrimination among exchange members
with respect to the fees charged by the exchange. The Commission
also sought comment on whether the Phlx Proposals adequately
addressed the reasonableness of the proposed fees (and thus the
proposed fee differential).
    \12\ To date, the Exchange has provided data on price
improvement for directed customer complex orders, and the rates of
interaction with customer complex orders by types of market
participant, among other things.
---------------------------------------------------------------------------

    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\13\ designates November 10, 2012, and December 30, 2012, as the
respective dates by which the Commission should either approve or
disapprove the proposed rule changes (SR-Phlx-2012-27 and SR-Phlx-2012-
54).
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-22785 Filed 9-14-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 137 (Wednesday, July 19, 2017)]
[Notices]
[Pages 33192-33194]
[FR Doc No: 2017-15102]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81142; File No. SR-NYSEArca-2017-73]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend NYSE Arca
Equities Rule 7.38 To Specify the Ranking of an Odd Lot Order That Has
a Display Price That Is Better Than Its Working Price

July 13, 2017.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on June 30, 2017, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend NYSE Arca Equities Rule 7.38 (Odd
and Mixed Lots) to specify the ranking of an odd lot order that has a
display price that is better than its working price. The proposed rule
change is available on the Exchange's Web site at www.nyse.com, at the
principal office of the Exchange, 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 self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    The Exchange proposes to amend NYSE Arca Equities Rule 7.38 (Odd
and Mixed Lots) (``Rule 7.38'') to specify the ranking of an odd lot
order that has a display price that is better than its working price.
    Rule 7.38 provides that the working price of an odd lot order will
be adjusted both on arrival and when resting on the NYSE Arca Book
based on the limit price of the order as follows:
     If the limit price of an odd lot order is equal to or
worse than the contra-side PBBO, it will have a working price equal to
the limit price.
     If the limit price of an odd lot order is better than the
contra-side PBBO, it will have a working price equal to the contra-side
PBBO.
     If the PBBO is crossed, the odd lot order will have a
working price equal to the same-side PBB or PBO.
    By moving the working price, an odd lot order to buy (sell) will
not trade at a price above (below) the PBO (PBB), or if the PBBO is
crossed, above (below) the PBB (PBO). In either case, if the odd lot
order is ranked Priority 2--Display Orders,\4\ its display price would
not change when its working price is adjusted.
---------------------------------------------------------------------------

    \4\ As described in Rule 7.36(e)(2), Priority 2--Display Orders
are non-marketable Limit Orders with a displayed working price.
---------------------------------------------------------------------------

    Exchange rules are currently silent regarding how a resting odd lot
order that has a display price that is better than its working price
would be ranked for trading at that working price.\5\ This scenario
would only occur if a resting odd lot order is displayed at a price,
and then an Away Market PBBO crosses that display price. In that
limited scenario, pursuant to Rule 7.38(b)(1) described above, the
working price of the odd-lot order would be adjusted to a price
inferior to the display price, but it would remain displayed at the now
crossed price.
---------------------------------------------------------------------------

    \5\ Pursuant to Rule 7.38(b)(1), on arrival, an odd lot order's
working price may be adjusted consistent with the terms of the
order. However, an arriving odd-lot order would not be assigned a
working price that would be inferior to the price at which the
arriving odd lot order would be displayed.
---------------------------------------------------------------------------

    The Exchange proposes to specify that in such case, the ranking and
priority category applicable to such an order at its display price,
i.e., the price it is displayed and Priority 2--Display Orders, would
govern its ranking for purposes of a trade at its different, inferior
working price.\6\ This ranking would differ from the Exchange's general
rule that an order is ranked based on its working price.\7\ However,
the Exchange believes that if the display price of an order is better
than its working price, such order has already demonstrated a public
willingness to trade at a more aggressive price because it continues to
be published in a market data feed at the more aggressive display
price.\8\ In such case, the order should receive the benefit of the
ranking (both price and priority category) associated with its better
display price when determining how that order would be traded at its
working price. In other words, an odd-lot order with a better display
price than its working price would not be ranked based on its working
price, including that it would not be assigned Priority 3--Non-Display
Orders at its working price.
---------------------------------------------------------------------------

    \6\ As described in Rule 7.36(c), an order is ranked based on
price, priority category, and time. Such ranking is only applicable
once an order is resting on the NYSE Arca Book.
    \7\ Rule 7.36(d) provides than [sic] all orders are ranked based
on the working price of an order. Rule 7.36(e)(3) generally provides
that non-marketable orders for which the working price is not
displayed have third priority behind Market Orders and non-
marketable Limit Orders that are displayed at their working price.
This proposed rule change would be an exception to these rules.
    \8\ See Rule 7.36(b)(1) (odd-lot sized orders are considered
displayed for ranking purposes).
---------------------------------------------------------------------------

    The Exchange further believes that if an odd-lot order is assigned
a new working price that is worse than its display price, such order
should not be assigned a new working time. In other words, when trading
at its working price, its time ranking would be based on the working
time associated with its display price.\9\ Maintaining the original
working time of such order would ensure that it maintains its original
ranking, even if it trades at a different price.
---------------------------------------------------------------------------

    \9\ Rule 7.36(f)(2) provides that an order is assigned a new
working time any time the working price of the order changes. This
proposed rule change would be an exception to this general rule.
---------------------------------------------------------------------------

    To effect this change, the Exchange proposes to amend Rule
7.38(b)(1) to provide that an odd-lot order ranked Priority 2--Display
Orders would not be assigned a new working time if its working price is
adjusted under Rule 7.38(b)(1). In addition, if the display price of an
odd lot order to buy (sell) is above (below) its working price, it
would be ranked based on its display price.\10\
---------------------------------------------------------------------------

    \10\ For example, assume the PBBO is 10.07 x 10.10 and the
Exchange receives orders ranked Priority 2--Display Orders in the
following sequence: T1 to buy 25 shares displayed at 10.08, T2 to
buy 25 shares displayed at 10.09, T3 to buy 25 shares displayed at
10.08, and T4 to buy 100 shares displayed at 10.07. Assume next that
the PBO changes to 10.07. The working price of T1, T2, and T3 will
be adjusted to 10.07, but they would keep their original working
time. Next, the Exchange receives an incoming order to sell 100
shares at 10.07. The Exchange would trade the incoming order with
the resting orders in the following sequence: T2, T1, T3, and then
T4 would be allocated the remaining 25 shares. T2 would trade before
T1 because it has a better price ranking based on its display price.
If the incoming order to sell were for 50 shares, only T2 and T1
would trade.
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    Because an odd lot order with a display price better than its
working price currently trades in this manner, these changes will be in
effect when this proposed rule change is operative.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Securities Exchange Act of 1934 (the ``Act''),\11\ in general, and
furthers the objectives of Section 6(b)(5),\12\ in particular, because
it is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, 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.
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    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
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    Specifically, the Exchange believes that the proposed rule change
would remove impediments to and perfect the mechanism of a free and
open market and a national market system because the Exchange believes
that an order that has been displayed should receive the benefit of the
ranking of that displayed price if it trades at a less aggressive
working price. This scenario would only occur if a resting odd-lot
order has been displayed at a price, and then an Away Market PBBO
crosses that price and then the working price of that order is adjusted
to a price inferior to its display price. In such case, while the odd
lot order would be executed at its working price, because it was both
willing to trade at a better price and is still displayed at that
better price, the Exchange proposes that it would be ranked based on
its display price for purposes of its execution at the working price.
If the PBBO had not crossed the odd-lot order, such order would have
had the benefit of the ranking based on its display price and the
Exchange believes it would be consistent with the protection of
investors and the public for the odd-lot order to retain such ranking
when its working price is moved to an inferior price. The Exchange
further believes that the

proposed rule change would promote fair and orderly markets that would
protect investors and the public interest because it would promote the
display of liquidity by ensuring that a displayed odd lot order
maintains its ranking even if it trades at a less aggressive price.
    The Exchange further believes that the proposed rule change would
remove impediments to and perfect the mechanism of a free and open
market and a national market system because it would promote
transparency in Exchange rules and reduce potential confusion regarding
how an odd-lot order would be ranked and execute [sic] in the limited
scenario when the display price of a resting odd lot has been crossed,
and it has been assigned a working price inferior to its display price.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange believes that
the proposed rule change is not designed to address any competitive
issues but rather to provide an incentive for market participants to
enter aggressively-priced displayed liquidity.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \13\ and Rule 19b-
4(f)(6) thereunder.\14\
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    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
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    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.

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-NYSEArca-2017-73 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2017-73. 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 Web site (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 Web site 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; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEArca-2017-73 and should
be submitted on or before August 9, 2017.
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    \15\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2017-15102 Filed 7-18-17; 8:45 am]
 BILLING CODE 8011-01-P