                          UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                        WASHINGTON, D.C.  20460

                                                     OFFICE OF CHEMICAL SAFETY
                                                       AND POLLUTION PREVENTION

MEMORANDUM

Date:		15-October-2011

            Subject:	Spirodiclofen.  Dietary Risk Assessment in Support of the Requested use on Sugar Apple, Cherimoya, Atemoya, Custard Apple, Ilama, Soursop, Biriba, Lychee, Longan, Spanish Lime, Rambutan, Pulasan, Guava, Feijoa, Jaboticaba, Wax Jambu, Starfruit, Passionfruit, Persimmon, and Acerola.

PC Code:  124871
DP Barcode:  D387338
Decision No.:  443557
Registration No.:  264-831
Petition No.:  0E7820
Regulatory Action:  Section 3
Risk Assessment Type:  dietary
Case No.:  7443
TXR No.:  not applicable
CAS No.:  148477-71-8
MRID No.:  none
40 CFR:  180.608

From:		Tom Bloem, Chemist
      Risk Assessment Branch 1/Health Effects Division (RAB1/HED; 7509P)

Through:		Kristin Rury, Biologist, RAB3/HED
		Julie Van Alstine, Environmental Health Scientist, RAB1/HED
		Dietary Exposure Science Advisory Council (DESAC)

				George F. Kramer, Ph.D., Senior Chemist
				HED/RAB1 (7509P)

To:				Jennifer Tyler, Chemist
				HED/RAB1 (7509P)

Executive Summary

In support of the proposed Section 3 Registration for application of spirodiclofen to several tropical fruits, chronic and cancer dietary risk assessments were conducted using the Dietary Exposure Evaluation Model - Food Consumption Intake Database (DEEM-FCID, ver. 2.03) which incorporates consumption data from United States Department of Agriculture (USDA) Continuing Survey of Food Intake by Individuals (CSFII; 1994-1996 and 1998).  An acute dietary risk assessment was not conducted as an endpoint attributable to a single dose was not identified.

The chronic and cancer analyses assumed the following:  (1) average field trial residues (food and feed commodities); (2) experimentally determined processing factors for citrus fruit, pome fruit, and grape (DEEM (ver 7.81) defaults assumed for the remaining processed commodities); (3) Biological and Economic Analysis Division (BEAD) new use percent crop treated estimates for hops (92%) and blueberry (2%), and screening level usage analysis (SLUA) data when available; (4) livestock residues which incorporated average field trial residues for determination of the livestock dietary burdens; and (5) drinking water estimates derived from the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS; citrus application scenario; 1 x 0.31 lb ai/acre; citrus yielded the highest chronic/cancer drinking water estimates).  The resulting chronic risk estimates (food and water) were <=3.2% the chronic population-adjusted dose (cPAD) and are not of concern to HED (children 1-2 years old were the most highly exposed population).  The cancer risk estimate (food and water) for the U.S. population was 3 x 10[-6].  The major contributors to the cancer analysis were hops (44%; assumes 100% transfer of residues from hops to beer; spirodiclofen Log KOW = 5.83) and water (21%; 87% of the basin cropped and 100% crop treated at the maximum labeled rate).

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:  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 can be found in D371644 (T. Bloem, 28-Jul-2010).

II.	Residue Information

Residues of Concern in Plants and Livestock:  Based on the results of the citrus, grape, and apple metabolism studies (Risk Assessment Document:  D285047, M Clock-Rust et al., 22-Jun-2005); the apple, grape, and orange processing studies (D341847, T. Bloem, 22-Jun-2005; D359773, T. Bloem, 24-Jun-2009; D390192, T. Bloem, 20-Jun-2011); and previous conclusions relating to the residues of concern in hops (D346710, M. Sahafeyan, 3-Jan-2008); HED concludes that the residues of concern in the currently-registered/proposed crops are as follows (see Table 1 for a summary):  pome fruit, tree nut, and hops - the residue of concern for risk assessment and tolerance enforcement is spirodiclofen per se and grape, citrus fruit, stone fruit, berry (crop group (CG) 13), and tropical fruit - the residue of concern for tolerance enforcement is spirodiclofen per se and residues of concern for risk assessment are spirodiclofen and BAJ 2510.  HED notes that following:  (1) BAJ 2510 is included as a residue of concern in grape, citrus fruit, stone fruit, berry (CG 13), and tropical fruit due to the demonstrated (grape and citrus fruit) degradation of parent to BAJ 2510 during processing or due to the lack of data eliminating this possibility (stone fruit, berry CG 13, and tropical fruit); (2) BAJ 2510 is only a residue of concern in the processed commodities of grape, citrus fruit, stone fruit, berry (CG 13), and tropical fruit; and (3) if processing data for the combined residues of spirodiclofen and BAJ 2510 are not available, then the dietary analysis should incorporate default processing factors.  Based on the results of the grape and orange processing studies, HED requested that all future processing studies monitor for residues of spirodiclofen, BAJ 2510, 3-OH-enol, and 4-OH-enol.

Table 1 is a summary of these conclusions and conclusion relating to the residues of concern in ruminants and drinking water (Risk Assessment Document:  D285047, M Clock-Rust et al., 22-Jun-2005); data relating to the residues of concern in poultry and rotational crops are not available.

Table 1:  Residues of Concern for Tolerance Expression and Risk Assessment.
                                    Matrix
                             Residues included in
                                Risk Assessment
                             Residues included in
                             Tolerance Expression
Pome Fruit, Tree Nut, and Hops
                                 spirodiclofen
                                 spirodiclofen
Grape, Citrus Fruit, Stone Fruit, Berry (CG 13), and Tropical Fruit[1]
                            spirodiclofen, BAJ 2510
                                 spirodiclofen
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]  BAJ 2510 is included as a residue of concern in grape, citrus fruit, stone fruit, berry (CG 13), and tropical fruit due to the demonstrated (grape and citrus fruit) degradation of parent to BAJ 2510 during processing or due to the lack of data eliminating this possibility (stone fruit, berry (CG-13), and tropical fruit).  BAJ 2510 is only a residue of concern in the processed commodities of grape, citrus fruit, stone fruit, berry (CG 13), and tropical fruit.  If processing data for the combined residues of spirodiclofen and BAJ 2510 are not available, then the dietary analysis should incorporate default processing factors.

Recommended Tolerances:  Based on the data submitted in support of the current petition, HED concluded that the following tolerances for residues of spirodiclofen per se are appropriate (D387339, T. Bloem, 15-Oct-2011):  lychee - 4.0 ppm; longan - 4.0 ppm; Spanish lime - 4.0 ppm; rambutan - 4.0 ppm; pulasan - 4.0 ppm; sugar apple - 0.40 ppm; atemoya - 0.40 ppm; custard apple - 0.40 ppm; cherimoya - 0.40 ppm; ilama - 0.40 ppm; soursop - 0.40 ppm; birida - 0.40 ppm; guava - 0.50 ppm; feijoa - 0.50 ppm; jaboticaba - 0.50 ppm; wax jambu - 0.50 ppm; starfruit - 0.50 ppm; passionfruit - 0.50 ppm; acerola - 0.50 ppm; and persimmon - 0.50 ppm.

Plant Residues Used in the Chronic/Cancer Risk Assessments:  The chronic and cancer dietary analyses incorporated the following:  (1) average field trial residues (see Table 2), (2) new use percent crop treated estimates for blueberry (2%) and hops (92% (see attachments 1 and 2); (3) SLUA data when available (see attachment 3); and (4) default processing factors for all commodities excluding the processed commodities derived from pome fruit, citrus fruit, and grape where experimentally determined processing factors were incorporated (see Table 2).  HED notes that attachment 2 includes new use percent crop treated estimates for apple, grape, peach, and orange; based on advice from BEAD, HED incorporated the SLUA data for these crops rather than the new use estimates.

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 (DB) was calculated for ruminants using the revised OPPTS 860.1000 Table 1 feedstuffs.  Guidance provided along with the revised Table 1 indicates that all three feed commodities associated with spirodiclofen (dried citrus pulp (beef and dairy), wet apple pomace (dairy only), and almond hulls (dairy only)) are considered alternative feedstuffs and dietary burdens should include only one alternative feedstuff.  Of these three commodities, almond hulls and wet apple pomace yields the highest dietary burden estimates for dairy and beef cattle, respectively.  The guidance associated with revised Table 1 indicates that almond hulls can be fed at up to 10% of the dairy cattle diet but 5% is more likely.  Since the refined livestock residue estimates are for a chronic analysis, HED concluded that almond hulls will be consumed at 5% of the dairy cattle diet.  In addition, the dietary burden calculations for dairy cattle were used for determination of residues in tissues as dairy cattle are ultimately slaughtered for meat (dairy cattle has a higher dietary burden).  Tables 3 and 4 are summaries of the dietary burden calculations and ruminant residue estimate, respectively.

Table 2:  Summary of Residue Estimates for the Chronic and Cancer Dietary Exposure Analyses.
                                    Matrix
                Avg Fld Trl Res and Proj. Rumt, Residues (ppm)
                          % Crop Treated Estimates[1]
                              Processing Factors
                       Crop Translation and/or Comments
pome fruit
apple[2] - 0.146
                                       5
apple sauce - 0.07x; dried apple - 0.18x; peeled apple - 0.15x; juice - 0.03x
-Apple and pear residues - D285249, T. Bloem, 18-Apr-2005.
-Apple processing study - D341847, T. Bloem, 25-Oct-2007; dried apple and apple juice processing factors translated to dried pear and pear juice.

pear[2] - 0.239
                                      10
dried pear - 0.18x; pear juice - 0.03x

citrus fruit
orange[2] - 0.104
                                      10
peeled fruit - 0.14x; juice - 0.06x; oil - 123x; peel - 2.2x
-Orange, lemon, and grapefruit residues - D285249, T. Bloem, 18-Apr-2005.
-Orange processing studies - D285249, T. Bloem, 18-Apr-2005 and D390192, T. Bloem, 20-Jun-2011; orange processing data translated to all citrus commodities.

lemon[2] - 0.121
                                       1

grapefruit[2] - 0.103
                                      50

tree nut
almond[2] - 0.023
                                       5
                                      --
-Almond and pecan residues -D285249, T. Bloem, 18-Apr-2005.

pecan[2] -0.019
                                       2
                                      --

filbert - 0.019
                                       2
                                      --

pistachio - 0.023
                                       1
                                      --

walnut - 0.019
                                       5
                                      --

stone fruit
peach[2] - 0.368
                                       5
dried peach - 7.0x (default)
-Peach, plum and cherry residues - D285249, T. Bloem, 18-Apr-2005.

plum[2] - 0.068
                                       5
prune dried - 5.0x (default)
prune juice - 1.4x (default)

cherry[2] - 0.286
                                       2
juice - 1.5x (default)

apricot - 0.368
                                       5
apricot dried - 6.0

nectarines - 0.368
                                      10
                                      --

grape
grape - 0.697
                                  raisin - 10
                                  table - 30
                                   wine - 5
raisin - 4.3x; juice - 0.17x
-Grape residues - D285249, T. Bloem, 18-Apr-2005; grape processing factors - D341847, T. Bloem, 25-Oct-2007.  The table grape percent crop treated was translated to juice grape (table grape was the highest)
hops
hops - 11.6
                                      92
                                      --
-Hops residues - 47105301.der.doc (14-day PHI).
avocado
avocado - 0.110
                                      100
papaya dried - 1.8x (default)
papaya juice - 1.5x (default
-Avocado residue data (D363343, T. Bloem, 23-Sep-2009) translated to black sapote, canistel, mamey sapote, mango, papaya, sapodilla, and star apple based on Reviewer's Guide and Summary of HED ChemSAC Approvals for Amending Commodity Definitions [40CFR § 180.1(h)] and Crop Group/Subgroups [40 CFR § 180.41] (B. Schneider; 14-Jun-2002).  Default processing factors assumed for papaya.
bushberry 13-07B
lowbush blueberry - 1.305
                                 blueberry - 2
                                      --
-Lowbush blueberry residue translated to the remaining members of the bushberry subgroup 13-07B (47886201.der.doc)
cattle, goat, sheep, horse
liver - 0.0009
                                      --
                                      --
-See Tables 3 and 4.
-Residue in kidney translated to meat byproducts (highest of liver, kidney, and fat).
-Since spirodiclofen may concentrate in milk fat (Kow=5.83), residues in milk fat were estimated using the default 25x milk fat concentration factor (0.0002 ppm x 25 = 0.005 ppm).

kidney - 0.004
                                      --
                                      --

muscle - 0.0001
                                      --
dried beef - 1.92x (default)

fat - 0.0007
                                      --
                                      --

meat bypdcts - 0.004
                                      --
                                      --

whole milk - 0.0002
                                      --
                                      --

milk fat - 0.005
                                      --
                                      --

[1]  See attachments 1, 2, and 3.
[2]  Residues in the representative crops translated to the remaining crops according to HED SOP 2000.1.

Table 3:  Calculation of Spirodiclofen Dietary Burdens.
                                Feed Commodity
                                % Dry Matter[1]
                                   % Diet[1]
                           Average Residue (ppm)[2]
                         Dietary Contribution (ppm)[3]
Beef Cattle
dried citrus pulp
                                      91
                                      10
                                     0.16
                                     0.018
MTDB
                                      --
                                      --
                                      --
                                     0.018
Dairy Cattle
almond hull
                                      90
                                       5
                                     7.205
                                     0.40
MTDB
                                      --
                                      --
                                      --
                                     0.40
[1]  Revised Table 1 Feedstuffs (June 2008).
[2]  Average almond hull dried citrus pulp residue (D285249, T. Bloem, 18-Apr-2005)
[3]  Dietary contribution = tolerance  % dry matter x % diet.

Table 4:  Summary of Cattle Feeding Study and Projected Residue.
                                Dose; ppm (DBx)
                                 Residue (ppm)
             Projected Residue Assuming a 0.40 ppm dietary burden

                                 Spirodiclofen
                                   BAJ 2510
                                     Total

liver
                                  1.38 (3.4x)
                                 not analyzed
                                 4.12 (10.3x)
                                 not analyzed
                                 13.75 (34.4x)
                                   <0.01
                                   0.01-0.02
                               <0.02-<0.03
                                    0.0009
kidney
                                  1.38 (3.4x)
                                 not analyzed
                                 4.12 (10.3x)
                                   <0.01
                                 <0.01-0.03
                               <0.01-<0.04
                                     0.004
                                 13.75 (34.4x)
                                   <0.01
                                   0.04-0.09
                               <0.05-<0.10
                                     0.003
muscle
                                  1.38 (3.4x)
                                 not analyzed
                                 4.12 (10.3x)
                                 not analyzed
                                 13.75 (34.4x)
                                   <0.002
                                   <0.002
                                   <0.004
                                    0.0001
fat
                                  1.38 (3.4x)
                                 not analyzed
                                 4.12 (10.3x)
                                   <0.002
                                   <0.002
                                   <0.004
                                    0.0004
                                 13.75 (34.4x)
                                  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 (10.3x)
                                 not analyzed
                                 13.75 (34.4x)
                                <0.001-0.003
                                <0.001-0.003
                                <0.002-0.006
                                    0.0002
whey[2]
                                  1.38 (3.4x)
                                 not analyzed
                                 4.12 (10.3x)
                                 not analyzed
                                 13.75 (34.4x)
                                   <0.001
                                <0.001-0.001
                                   <0.002
                                    0.00006
cream[2]
                                  1.38 (3.4x)
                                 not analyzed
                                 4.12 (10.3x)
                                 not analyzed
                                 13.75 (34.4x)
                                  0.005-0.012
                               <0.002- 0.002
                             <0.008- <0.014
                                    0.0004
 [1]  In milk collected from animals dosed at 13.75 ppm, 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 13.75 ppm with combined residues of 0.004 ppm was processed into whey and cream.

III.  Drinking Water Data

Surface and ground estimated drinking water concentrations were previously generated by the Environmental Fate and Effects Division (EFED) using PRZM-EXAMS and Screening Concentration in Ground Water Model (SCI-GROW), respectively (D311291, F. Kahn, 4-Jan-2005).  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 PRZM-EXAMS (citrus, pecan, apple, peach, and grape; 87% cropped and 100% crop treated assumed) with citrus (1 x 0.31 lb ai/acre) 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).  Since the application rates proposed as part of the current petition (1 x 0.31 lb ai/acre) are equal to the citrus application rate, EFED concluded that the previously generated water estimates remain relevant (D386204, L. Liu, 14-Apr-2011).  Therefore, the chronic and cancer analyses employed the citrus 1-in-10-year yearly average (4.99 ppb) and 30-year average (1.67 ppb), respectively.

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.
IV.	Toxicological Information

Table 5 below summarizes the endpoints selected for dietary exposure analyses; for more detailed discussion on these endpoints see the HED risk assessment D386201 (in draft).

Table 5:  Summary of Toxicological Doses and Endpoints.
                                   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
UF = 100
FQPA SF= 1x
cRfD = 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

The chronic risk estimates (food and water) were <=3.2% cPAD and are not of concern to HED (children 1-2 years old were the most highly exposed population; see Table 6).  The cancer risk estimate (food and water) for the U.S. population was 3 x 10[-6] (see Table 7)

Table 6:  Summary of Chronic Dietary Exposure and Risk.
Population Subgroup
                               cPAD (mg/kg/day)
                             Exposure (mg/kg/day)
                                   %cPAD[1]
General U.S. Population
                                     0.014
                                   0.000241
                                      1.7
All Infants (< 1 year old)

                                   0.000434
                                      3.1
Children 1-2 years old

                                   0.000444
                                      3.2
Children 3-5 years old

                                   0.000348
                                      2.5
Children 6-12 years old

                                   0.000193
                                      1.4
Youth 13-19 years old

                                   0.000136
                                      1.0
Adults 20-49 years old

                                   0.000268
                                      1.9
Adults 50+ years old

                                   0.000198
                                      1.4
Females 13-49 years old

                                   0.000183
                                      1.3
[1]  The bolded %cPAD represents the population with highest risk.

Table 7:  Summary of Cancer Dietary Exposure and Risk.
Population Subgroup
                                      Q1*
                             Exposure (mg/kg/day)
                                     Risk
General U.S. Population
                                    0.0149
                                   0.000171
                                 2.6 x 10[-6]

VI.	Characterization of Inputs/Outputs

The chronic and cancer analyses assumed the following:  (1) average field trial residues (food and feed commodities); (2) experimentally determined processing factors for citrus fruit, pome fruit, and grape (DEEM (ver 7.81) defaults assumed for the remaining processed commodities); (3) BEAD new use percent crop treated estimates for hops (92%) and blueberry (2%) and the following SLUA data:  almond - 5%; apple - 5%; apricot - 5%; cherry - 2%; grapefruit - 50%; grapes, raisin - 10%; grape, table - 30%; grape, wine - 5% - ; hazelnuts - 2%; lemon - 1%; nectarine - 10%; orange - 10%; peach - 5%; pear - 10%; pecan - 2%; pistachio - 1%; plum/prune - 5%; and walnuts - 5%; (4) livestock residues which incorporated average field trial residues for determination of the livestock dietary burdens; and (5) drinking water estimates derived from the PRZM/EXAMS model (citrus application scenario; 1 x 0.31 lb ai/acre; citrus yielded the highest chronic/cancer drinking water estimates).

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

HED is generally concerned when the cancer risk exceeds 10[-6].  Based on a critical commodity analysis conducted in DEEM-FCID, the major contributors to the cancer risk were hops (44% of the total exposure) and water (21% of the total exposure).  HED notes the following concerning the assumptions incorporated into the cancer analysis for hops and water:  (1) hops - DEEM-FCID assumes that 100% of the residue in hops are transferred to beer during the brewing process (no residues remain in/on the spent hops); based on the spirodiclofen log KOW of 5.83, this is a conservative assumption; in addition, assumed 92% crop treated for hops (new use percent crop treated estimates which is designed to provide a conservative estimate of actual percent crop treated) and (2) water - the water residue estimate assumed 87% of the basin is cropped with 100% of the crops treated at the maximum labeled rate.  Therefore, HED concludes that the cancer risk estimate provided in this assessment is conservative and actual cancer risk will be lower than the estimate provided in this document (2.6 x 10[-6]).
VII.	Conclusions

Chronic and cancer dietary risk assessments were conducted using the DEEM-FCID (ver. 2.03) which incorporates consumption data from USDA CSFII (1994-1996 and 1998).  The chronic and cancer analyses assumed the following:  (1) average field trial residues (food and feed commodities); (2) experimentally determined processing factors for citrus fruit, pome fruit, and grape (DEEM (ver 7.81) defaults assumed for the remaining processed commodities); (3) BEAD new use percent crop treated estimates for hops (92%) and blueberry (2%), and screening level usage analysis (SLUA) data when available; (4) livestock residues which incorporated average field trial residues for determination of the livestock dietary burdens; and (5) drinking water estimates derived from the PRZM/EXAMS model (citrus application scenario; 1 x 0.31 lb ai/acre).  The resulting chronic risk estimates (food and water) were <=3.2% the cPAD and are not of concern to HED (children 1-2 years old were the most highly exposed population).  The cancer risk estimate (food and water) for the U.S. population was 3 x 10[-6].  The major contributors to the cancer analysis were hops (44%; assumes 100% transfer of residues from hops to beer; spirodiclofen Log KOW = 5.83) and water (21%; 87% of the basin cropped and 100% crop treated at the maximum labeled rate).

VIII.		List of Attachments

            Attachment 1:	BEAD New Use Percent Crop Treated Estimates (D387916, J. Alsadek).
            Attachment 2:	BEAD New Use Percent Crop Treated Estimates (D340691, J. Alsadek).
Attachment 3:	BEAD Spirodiclofen SLUA.
Attachment 4:	DEEM-FCID Chronic Residue File.
Attachment 5:	DEEM-FCID Chronic Exposure Estimates.
Attachment 6:	DEEM-FCID Cancer Residue File.
Attachment 7:	DEEM-FCID Cancer Exposure Estimates.
Attachment 8:	DEEM-FCID Critical Commodity Analysis for Cancer.

cc with all attachments:  B. Madden/Laura Nollen (RD; RM 05; 7505P)
T. Bloem:S10945:Potomac Yard 1:703-605-0217:7509P:RAB1
            Attachment 1:	BEAD New Use Percent Crop Treated Estimates  -  Blueberry (D387916, J. Alsadek).

              OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460

MEMORANDUM

SUBJECT:	Percent Crop Treated for Proposed New Use of Spirodiclofen on Blueberries
		(PC# 124871, DP# 387916)

FROM:	Jihad Alsadek, Ph.D., Economist
		Science Information and Analysis Branch

		David W. Brassard, Senior Entomologist
		Biological Analysis Branch
		Biological and Economic Analysis Division (7503P)

THRU:	Diann Sims, Chief
		Science Information and Analysis Branch

		Arnet Jones, Chief
		Biological Analysis Branch
		Biological and Economic Analysis Division (7503P)

TO:		Laura Nollen, Biologist
			Barbara Madden, Team Leader
		Risk Integration, Minor Use, and Emergency Response Branch
		Registration Division (7505P)

Product Review Panel:  June 8th, 2011

I. SUMMARY

 In this memorandum, BEAD is providing a percent crop treated estimate for the proposed new
 use (PCTn) of the miticide spirodiclofen on blueberries as shown in Table 1.   BEAD has examined the relevant data and concludes that it is unlikely that the actual percent crop treated (PCT) with spirodiclofen will exceed the PCTn for blueberries within the next five years.  The general methodology used to produce these estimates is described in the recommended Federal Register (FR) language, and an analysis of biological information describes relevant information that supports the likelihood that the PCTn estimates for spirodiclofen are not likely to be exceeded.
II. FEDERAL REGISTER LANGUAGE

The EPA estimate of the percent crop treated for the new use (PCTn) of spirodiclofen represents the upper bound of use expected during the pesticide's initial five years of registration; that is, the PCTn for spirodiclofen is a threshold of use that EPA is reasonably certain will not be exceeded for this registered use site.  The PCTn recommended for use in the chronic dietary assessment is calculated as the average percent crop treated (PCT) of the miticide with the highest usage (i.e., the miticides with the greatest PCT) on that crop over the three most recent years of available data.  The PCTn recommended for use in the chronic dietary assessment is 2% for blueberries.  The PCTn recommended for use in the acute dietary assessment is the maximum observed PCT over the same period, which in this case is 2%.  Comparisons are only made among pesticides of the same pesticide type (i.e., the miticide with the highest usage on the use crop is selected for comparison with a new miticide).  The highest miticide PCT included in the estimation may not be the same for each year since different miticides may have the highest usage in different years.

Typically, EPA uses USDA/National Agricultural Statistics Service (NASS) surveys as the source data because they are publicly available and directly report values for PCT.  When a specific use crop is not reported by USDA/NASS, EPA uses proprietary data and calculates the PCT based on reported data on acres treated and acres grown.  If no proprietary data are available, EPA may extrapolate PCTn from other crops if the production area and pest spectrum are substantially similar.

A retrospective analysis to validate this approach shows few cases where the PCT for the highest miticides were exceeded, (EPA, 2006).  Further review of these cases identified factors contributing to the exceptionally high use of a new pesticide.  To evaluate whether the PCTn for spirodiclofen could be exceeded, EPA considered whether or not there may be unusually high pest pressure, as indicated in emergency exemption requests for spirodiclofen, the pest spectrum of the new pesticide in comparison with the highest miticides, whether or not the highest miticides are well-established for that use, and whether or not pest resistance issues with past miticides provide spirodiclofen with significant market potential.  Given currently available information, BEAD concludes that it is unlikely that actual PCT for spirodiclofen will exceed the estimated PCT for new uses during the next five years.

III.	PROJECTIONS BASED ON THE MARKET LEADER APPROACH

 For this analysis, BEAD used the market leader approach to derive the PCT values for blueberries as shown in Table 1.  In this approach market leaders were selected from the pool of miticides currently used on blueberries instead of across all insecticides.  BEAD believes this approach is more appropriate in this instance since spirodiclofen is a miticide.  The approach utilizes PCT data for the chemicals that dominate the miticide market to assign a conservative upper bound PCT value for the new use.

The market leader approach is backed by an analysis conducted by EPA in 2006 which compared the PCT of newly registered pesticides (from tolerances established over a 10 year period) to the PCT of the pesticides with the highest usage over that same period.  In this analysis, BEAD found that over 95% of the time, the proportion of usage of a new pesticide or new use of a registered pesticide is not likely to exceed the usage observed in the most widely used pesticide type (i.e. miticide in this case) and crop within the first five years following registration, (EPA, 2006).

The PCT value is taken directly from NASS data, or if proprietary data are used, BEAD calculates the PCT value by dividing the base area treated (the area treated at least one time by a given pesticide) by the crop acres grown and multiplying the value by 100.  The miticide with the highest PCT for each data year was designated as the market leader and the PCT values associated with the miticide market leader were used to derive the PCTn values for the new crop use of spirodiclofen.  The PCTn values to be used in chronic risk assessments for new uses are derived by taking the average of the highest PCT values and the PCTn value to be used in acute risk assessments is the highest value among the available years of PCT data.

BEAD reviewed USDA/ NASS for miticide usage data on blueberries (2003-2009) to derive the PCTn values as shown in Table 1.

      Table 1.  Spirodiclofen Percent Crop Treated for a New Use (PCTn) for Blueberries
Crop/New Use
 Miticide
Year
Miticide
% (PCT)
Chronic Risk/
Avg. PCT
Acute Risk/
Max. PCT
Blueberries
Endosulfan
Endosulfan
Endosulfan
2003
2005
2009
2
2
1
2
2

Sources: USDA/NASS, Agricultural Chemical Usage 2003, 2005, and 2009 Fruit Summaries

IV.	ADDITIONAL FACTORS

There are three main factors that BEAD considers in evaluating the likelihood that use of a newly registered chemical or a new use will exceed the PCT for new uses:  (1) the extent of pest pressure on the crops in question; (2) the pest spectrum of the new miticide in comparison with the miticides with the highest usage as well as whether the miticides with the highest usage are well-established for this use; and (3) resistance concerns with the new miticide and the miticides with the highest usage.  High pest pressure with the lack of registered controls could indicate significant potential demand for a new chemical.  Emergency exemptions under Section 18 of FIFRA are a good indicator in regard to these situations.  On the other hand, it would be relatively difficult for a new active ingredient to gain a large portion of the market if a) it competes with the miticides with the highest usage or others that have been extensively used for pest control including the same target pest(s), b) its new use is limited, for example, registered only for a single pest, and/or c) it is labeled for pest(s) of minor economic concern.  Finally, if the target pests are developing resistance to the market leader(s), it could indicate an advantage for the new active ingredient in the market.

Spirodiclofen is a tetronic acid with acaricidal action. It acts by interfering with mite development, and is labeled for control of spider mites, rust mites, European red mite, citrus red mite, and grape erineum mite. Spirodiclofen displays contact activity to mite eggs, all nymphal stages, and adult females (adult males are not affected).   Spirodiclofen also suppresses San Jose scales.

Spirodiclofen is currently registered for use on avocado, Christmas trees, citrus crops, grapes, papaya, pome fruits, stone fruits, and tree nuts.

   oo Pest pressure:  No FIFRA Section 18 Emergency Exemptions have been issued for the use of spirodiclofen on blueberry.

   oo Pest spectrum:  The market leader miticides/ insecticide, endosulfan, is effective against a wide variety of insect and mite pests but, like spirodiclofen, is only registered to control blueberry bud mite in blueberry.  Endosulfan is the most commonly used acaricide for the control of blueberry bud mites (Jenkins et. al., 2008).  Historically, endosulfan has been applied to 1 to 2% of U.S. blueberries (USDA/NASS, 2011).  Bifenazate and spiromesifen are also registered for control of mites on blueberries (NPIRS 2011).

   oo Resistance:  There is no documented resistance to the blueberry bud mite in the U.S.  (Arthropod Pesticide Resistance Database).

IV.	CONCLUSIONS/RECOMMENDATIONS

BEAD recommends that the average PCTn value for blueberries be used in the chronic dietary risk assessment for spirodiclofen and the maximum PCTn value be used for acute risk assessment as shown in Table 1.

BEAD has considered all available relevant information and believes it is unlikely that the above PCT values will be exceeded during the next five years.

   VI. REFERENCES:

Arthropod Pesticide Resistance Database. 2011. Available at:  http://www.pesticideresistance.org/search/1/ Accessed: May 5, 2011.

EPA 2006, Memorandum: "BEAD Approach to Providing Projected Percent Crop Treated Estimates for Use in Dietary Risk Assessment in OPP", December 14, 2006.  Unpublished

Jenkins, P. et. al. 2008.  Pest Management Strategic Plan for the North Central Region Blueberry Industry.  http://www.ipmcenters.org/pmsp/pdf/MI-INblueberryPMSP.pdf

NPIRS 2011.  National Pesticide Information Retrieval System.  http://npirs.ceris.purdue.edu

USDA/ NASS.  Agricultural Chemical Usage 2003, 2005, and 2009 Fruit Summaries http://www.pestmanagement.info/nass/app_usage.cfm
http://quickstats.nass.usda.gov/results/1B5A8EE8-DD63-337C-BF3C-62B4038A8B3F#0484BA58-FC01-3CF4-AC4B-9314BAF11D08
Attachment 2:  BEAD New Use Percent Crop Treated Estimates (J. Alsadek, D340691, Aug-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
Attachment 3:  BEAD Spirodiclofen SLUA.

Attachment 4:  DEEM-FCID Chronic Residue File.

Filename: C:\Documents and Settings\tbloem\spirodiclofen\tropical fruit 2\124871chronic.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: 09-21-2011/08:59:51/8          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
-------- ---- -------------------------------  ----------  ------ ------  -------
10001060 10   Citrus citron                      0.104000   0.140  1.000
10001070 10   Citrus hybrids                     0.104000   0.140  1.000
10001080 10   Citrus, oil                        0.121000  123.    1.000
10001800 10   Grapefruit                         0.103000   0.140  0.500
10001810 10   Grapefruit, juice                  0.103000   0.060  0.500
10001970 10   Kumquat                            0.104000   0.140  1.000
10001990 10   Lemon                              0.121000   0.140  0.010
10002000 10   Lemon, juice                       0.121000   0.060  0.010
10002001 10   Lemon, juice-babyfood              0.121000   0.060  0.010
10002010 10   Lemon, peel                        0.121000   2.200  0.010
10002060 10   Lime                               0.121000   0.140  1.000
10002070 10   Lime, juice                        0.121000   0.060  1.000
10002071 10   Lime, juice-babyfood               0.121000   0.060  1.000
10002400 10   Orange                             0.104000   0.140  0.100
10002410 10   Orange, juice                      0.104000   0.060  0.100
10002411 10   Orange, juice-babyfood             0.104000   0.060  0.100
10002420 10   Orange, peel                       0.104000   2.200  0.100
10003070 10   Pummelo                            0.103000   0.140  1.000
10003690 10   Tangerine                          0.104000   0.140  1.000
10003700 10   Tangerine, juice                   0.104000   0.060  1.000
11000070 11   Apple, fruit with peel             0.146000   1.000  0.050
11000080 11   Apple, peeled fruit                0.146000   0.150  0.050
11000081 11   Apple, peeled fruit-babyfood       0.146000   0.150  0.050
11000090 11   Apple, dried                       0.146000   0.180  0.050
11000091 11   Apple, dried-babyfood              0.146000   0.180  0.050
11000100 11   Apple, juice                       0.146000   0.030  0.050
11000101 11   Apple, juice-babyfood              0.146000   0.030  0.050
11000110 11   Apple, sauce                       0.146000   0.070  0.050
11000111 11   Apple, sauce-babyfood              0.146000   0.070  0.050
11001290 11   Crabapple                          0.146000   1.000  1.000
11002100 11   Loquat                             0.239000   1.000  1.000
11002660 11   Pear                               0.239000   1.000  0.100
11002661 11   Pear-babyfood                      0.239000   1.000  0.100
11002670 11   Pear, dried                        0.239000   0.180  0.100
11002680 11   Pear, juice                        0.239000   0.030  0.100
11002681 11   Pear, juice-babyfood               0.239000   0.030  0.100
11003100 11   Quince                             0.239000   1.000  1.000
12000120 12   Apricot                            0.368000   1.000  0.050
12000121 12   Apricot-babyfood                   0.368000   1.000  0.050
12000130 12   Apricot, dried                     0.368000   6.000  0.050
12000140 12   Apricot, juice                     0.368000   1.000  0.050
12000141 12   Apricot, juice-babyfood            0.368000   1.000  0.050
12000900 12   Cherry                             0.286000   1.000  0.020
12000901 12   Cherry-babyfood                    0.286000   1.000  0.020
12000910 12   Cherry, juice                      0.286000   1.500  0.020
12000911 12   Cherry, juice-babyfood             0.286000   1.500  0.020
12002300 12   Nectarine                          0.368000   1.000  0.100
12002600 12   Peach                              0.368000   1.000  0.050
12002601 12   Peach-babyfood                     0.368000   1.000  0.050
12002610 12   Peach, dried                       0.368000   7.000  0.050
12002611 12   Peach, dried-babyfood              0.368000   7.000  0.050
12002620 12   Peach, juice                       0.368000   1.000  0.050
12002621 12   Peach, juice-babyfood              0.368000   1.000  0.050
12002850 12   Plum                               0.068000   1.000  0.050
12002851 12   Plum-babyfood                      0.068000   1.000  0.050
12002860 12   Plum, prune, fresh                 0.068000   1.000  0.050
12002861 12   Plum, prune, fresh-babyfood        0.068000   1.000  0.050
12002870 12   Plum, prune, dried                 0.068000   5.000  0.050
12002871 12   Plum, prune, dried-babyfood        0.068000   5.000  0.050
12002880 12   Plum, prune, juice                 0.068000   1.400  0.050
12002881 12   Plum, prune, juice-babyfood        0.068000   1.400  0.050
13020570 13B  Blueberry                          1.305000   1.000  0.020
13020571 13B  Blueberry-babyfood                 1.305000   1.000  0.020
13021360 13B  Currant                            1.305000   1.000  1.000
13021370 13B  Currant, dried                     1.305000   1.000  1.000
13021490 13B  Elderberry                         1.305000   1.000  1.000
13021740 13B  Gooseberry                         1.305000   1.000  1.000
13021910 13B  Huckleberry                        1.305000   1.000  1.000
14000030 14   Almond                             0.023000   1.000  0.050
14000031 14   Almond-babyfood                    0.023000   1.000  0.050
14000040 14   Almond, oil                        0.023000   1.000  0.050
14000041 14   Almond, oil-babyfood               0.023000   1.000  0.050
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
14000920 14   Chestnut                           0.023000   1.000  1.000
14001550 14   Filbert                            0.019000   1.000  0.020
14001560 14   Filbert, oil                       0.019000   1.000  0.020
14001850 14   Hickory nut                        0.019000   1.000  1.000
14002130 14   Macadamia nut                      0.019000   1.000  1.000
14002690 14   Pecan                              0.019000   1.000  0.020
14002820 14   Pistachio                          0.023000   1.000  0.010
14003910 14   Walnut                             0.019000   1.000  0.050
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              0.004000   1.000  1.000
21000461 M    Beef, meat byproducts-babyfood     0.004000   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
23001690 M    Goat, meat                         0.000100   1.000  1.000
23001700 M    Goat, meat byproducts              0.004000   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
24001890 M    Horse, meat                        0.000100   1.000  1.000
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             0.004000   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
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
86010000 O    Water, direct, all sources         0.004990   1.000  1.000
86020000 O    Water, indirect, all sources       0.004990   1.000  1.000
95000010 O    Acerola                            0.500000   1.000  1.000
95000200 O    Avocado                            0.110000   1.000  1.000
95000740 O    Canistel                           0.110000   1.000  1.000
95000890 O    Cherimoya                          0.400000   1.000  1.000
95001510 O    Feijoa                             0.500000   1.000  1.000
95001750 O    Grape                              0.697000   1.000  0.300
95001760 O    Grape, juice                       0.697000   0.170  0.300
95001761 O    Grape, juice-babyfood              0.697000   0.170  0.300
95001770 O    Grape, leaves                      0.697000   1.000  0.300
95001780 O    Grape, raisin                      0.697000   4.300  0.100
95001790 O    Grape, wine and sherry             0.697000   1.000  0.050
95001830 O    Guava                              0.500000   1.000  1.000
95001831 O    Guava-babyfood                     0.500000   1.000  1.000
95001880 O    Hop                               11.600000   1.000  0.920
95001920 O    Jaboticaba                         0.500000   1.000  1.000
95002090 O    Longan                             4.000000   1.000  1.000
95002110 O    Lychee                             4.000000   1.000  1.000
95002120 O    Lychee, dried                      4.000000   1.000  1.000
95002150 O    Mango                              0.110000   1.000  1.000
95002151 O    Mango-babyfood                     0.110000   1.000  1.000
95002160 O    Mango, dried                       0.110000   1.000  1.000
95002170 O    Mango, juice                       0.110000   1.000  1.000
95002171 O    Mango, juice-babyfood              0.110000   1.000  1.000
95002450 O    Papaya                             0.110000   1.000  1.000
95002451 O    Papaya-babyfood                    0.110000   1.000  1.000
95002460 O    Papaya, dried                      0.110000   1.800  1.000
95002470 O    Papaya, juice                      0.110000   1.500  1.000
95002520 O    Passionfruit                       0.500000   1.000  1.000
95002521 O    Passionfruit-babyfood              0.500000   1.000  1.000
95002530 O    Passionfruit, juice                0.500000   1.000  1.000
95002531 O    Passionfruit, juice-babyfood       0.500000   1.000  1.000
95002770 O    Persimmon                          0.500000   1.000  1.000
95003330 O    Sapote, Mamey                      0.110000   1.000  1.000
95003460 O    Soursop                            0.400000   1.000  1.000
95003510 O    Spanish lime                       4.000000   1.000  1.000
95003580 O    Starfruit                          0.500000   1.000  1.000
95003610 O    Sugar apple                        0.400000   1.000  1.000
Attachment 5:  DEEM-FCID Chronic 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\tbloem\spirodiclofen\tropical fruit 2\124871chronic.R98
                                                     Adjustment factor #2 used.
Analysis Date 09-21-2011/09:00:51     Residue file dated: 09-21-2011/08:59:51/8
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)                     0.000241                 1.7%

U.S. Population (spring season)             0.000252                 1.8%
U.S. Population (summer season)             0.000269                 1.9%
U.S. Population (autumn season)             0.000221                 1.6%
U.S. Population (winter season)             0.000222                 1.6%

Northeast region                            0.000222                 1.6%
Midwest region                              0.000251                 1.8%
Southern region                             0.000216                 1.5%
Western region                              0.000287                 2.0%

Hispanics                                   0.000246                 1.8%
Non-hispanic whites                         0.000246                 1.8%
Non-hispanic blacks                         0.000197                 1.4%
Non-hisp/non-white/non-black                0.000263                 1.9%

All infants (< 1 year)                      0.000434                 3.1%
Nursing infants                             0.000178                 1.3%
Non-nursing infants                         0.000531                 3.8%
Children 1-6  yrs                           0.000365                 2.6%
Children 7-12 yrs                           0.000182                 1.3%

Females 13-19 (not preg or nursing)         0.000119                 0.9%
Females 20+ (not preg or nursing)           0.000189                 1.3%
Females 13-50 yrs                           0.000197                 1.4%
Females 13+ (preg/not nursing)              0.000172                 1.2%
Females 13+ (nursing)                       0.000222                 1.6%

Males 13-19 yrs                             0.000151                 1.1%
Males 20+ yrs                               0.000301                 2.1%
Seniors 55+                                 0.000189                 1.4%

Children 1-2 yrs                            0.000444                 3.2%
Children 3-5 yrs                            0.000348                 2.5%
Children 6-12 yrs                           0.000193                 1.4%
Youth 13-19 yrs                             0.000136                 1.0%
Adults 20-49 yrs                            0.000268                 1.9%
Adults 50+ yrs                              0.000198                 1.4%
Females 13-49 yrs                           0.000183                 1.3%

-------------------------------------------------------------------------------
Attachment 6:  DEEM-FCID Cancer Residue File.

Filename: C:\Documents and Settings\tbloem\spirodiclofen\tropical fruit 2\124871cancer.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: 09-21-2011/09:00:33/8          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
-------- ---- -------------------------------  ----------  ------ ------  -------
10001060 10   Citrus citron                      0.104000   0.140  1.000
10001070 10   Citrus hybrids                     0.104000   0.140  1.000
10001080 10   Citrus, oil                        0.121000  123.    1.000
10001800 10   Grapefruit                         0.103000   0.140  0.500
10001810 10   Grapefruit, juice                  0.103000   0.060  0.500
10001970 10   Kumquat                            0.104000   0.140  1.000
10001990 10   Lemon                              0.121000   0.140  0.010
10002000 10   Lemon, juice                       0.121000   0.060  0.010
10002001 10   Lemon, juice-babyfood              0.121000   0.060  0.010
10002010 10   Lemon, peel                        0.121000   2.200  0.010
10002060 10   Lime                               0.121000   0.140  1.000
10002070 10   Lime, juice                        0.121000   0.060  1.000
10002071 10   Lime, juice-babyfood               0.121000   0.060  1.000
10002400 10   Orange                             0.104000   0.140  0.100
10002410 10   Orange, juice                      0.104000   0.060  0.100
10002411 10   Orange, juice-babyfood             0.104000   0.060  0.100
10002420 10   Orange, peel                       0.104000   2.200  0.100
10003070 10   Pummelo                            0.103000   0.140  1.000
10003690 10   Tangerine                          0.104000   0.140  1.000
10003700 10   Tangerine, juice                   0.104000   0.060  1.000
11000070 11   Apple, fruit with peel             0.146000   1.000  0.050
11000080 11   Apple, peeled fruit                0.146000   0.150  0.050
11000081 11   Apple, peeled fruit-babyfood       0.146000   0.150  0.050
11000090 11   Apple, dried                       0.146000   0.180  0.050
11000091 11   Apple, dried-babyfood              0.146000   0.180  0.050
11000100 11   Apple, juice                       0.146000   0.030  0.050
11000101 11   Apple, juice-babyfood              0.146000   0.030  0.050
11000110 11   Apple, sauce                       0.146000   0.070  0.050
11000111 11   Apple, sauce-babyfood              0.146000   0.070  0.050
11001290 11   Crabapple                          0.146000   1.000  1.000
11002100 11   Loquat                             0.239000   1.000  1.000
11002660 11   Pear                               0.239000   1.000  0.100
11002661 11   Pear-babyfood                      0.239000   1.000  0.100
11002670 11   Pear, dried                        0.239000   0.180  0.100
11002680 11   Pear, juice                        0.239000   0.030  0.100
11002681 11   Pear, juice-babyfood               0.239000   0.030  0.100
11003100 11   Quince                             0.239000   1.000  1.000
12000120 12   Apricot                            0.368000   1.000  0.050
12000121 12   Apricot-babyfood                   0.368000   1.000  0.050
12000130 12   Apricot, dried                     0.368000   6.000  0.050
12000140 12   Apricot, juice                     0.368000   1.000  0.050
12000141 12   Apricot, juice-babyfood            0.368000   1.000  0.050
12000900 12   Cherry                             0.286000   1.000  0.020
12000901 12   Cherry-babyfood                    0.286000   1.000  0.020
12000910 12   Cherry, juice                      0.286000   1.500  0.020
12000911 12   Cherry, juice-babyfood             0.286000   1.500  0.020
12002300 12   Nectarine                          0.368000   1.000  0.100
12002600 12   Peach                              0.368000   1.000  0.050
12002601 12   Peach-babyfood                     0.368000   1.000  0.050
12002610 12   Peach, dried                       0.368000   7.000  0.050
12002611 12   Peach, dried-babyfood              0.368000   7.000  0.050
12002620 12   Peach, juice                       0.368000   1.000  0.050
12002621 12   Peach, juice-babyfood              0.368000   1.000  0.050
12002850 12   Plum                               0.068000   1.000  0.050
12002851 12   Plum-babyfood                      0.068000   1.000  0.050
12002860 12   Plum, prune, fresh                 0.068000   1.000  0.050
12002861 12   Plum, prune, fresh-babyfood        0.068000   1.000  0.050
12002870 12   Plum, prune, dried                 0.068000   5.000  0.050
12002871 12   Plum, prune, dried-babyfood        0.068000   5.000  0.050
12002880 12   Plum, prune, juice                 0.068000   1.400  0.050
12002881 12   Plum, prune, juice-babyfood        0.068000   1.400  0.050
13020570 13B  Blueberry                          1.305000   1.000  0.020
13020571 13B  Blueberry-babyfood                 1.305000   1.000  0.020
13021360 13B  Currant                            1.305000   1.000  1.000
13021370 13B  Currant, dried                     1.305000   1.000  1.000
13021490 13B  Elderberry                         1.305000   1.000  1.000
13021740 13B  Gooseberry                         1.305000   1.000  1.000
13021910 13B  Huckleberry                        1.305000   1.000  1.000
14000030 14   Almond                             0.023000   1.000  0.050
14000031 14   Almond-babyfood                    0.023000   1.000  0.050
14000040 14   Almond, oil                        0.023000   1.000  0.050
14000041 14   Almond, oil-babyfood               0.023000   1.000  0.050
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
14000920 14   Chestnut                           0.023000   1.000  1.000
14001550 14   Filbert                            0.019000   1.000  0.020
14001560 14   Filbert, oil                       0.019000   1.000  0.020
14001850 14   Hickory nut                        0.019000   1.000  1.000
14002130 14   Macadamia nut                      0.019000   1.000  1.000
14002690 14   Pecan                              0.019000   1.000  0.020
14002820 14   Pistachio                          0.023000   1.000  0.010
14003910 14   Walnut                             0.019000   1.000  0.050
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              0.004000   1.000  1.000
21000461 M    Beef, meat byproducts-babyfood     0.004000   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
23001690 M    Goat, meat                         0.000100   1.000  1.000
23001700 M    Goat, meat byproducts              0.004000   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
24001890 M    Horse, meat                        0.000100   1.000  1.000
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             0.004000   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
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
86010000 O    Water, direct, all sources         0.001670   1.000  1.000
86020000 O    Water, indirect, all sources       0.001670   1.000  1.000
95000010 O    Acerola                            0.500000   1.000  1.000
95000200 O    Avocado                            0.110000   1.000  1.000
95000740 O    Canistel                           0.110000   1.000  1.000
95000890 O    Cherimoya                          0.400000   1.000  1.000
95001510 O    Feijoa                             0.500000   1.000  1.000
95001750 O    Grape                              0.697000   1.000  0.300
95001760 O    Grape, juice                       0.697000   0.170  0.300
95001761 O    Grape, juice-babyfood              0.697000   0.170  0.300
95001770 O    Grape, leaves                      0.697000   1.000  0.300
95001780 O    Grape, raisin                      0.697000   4.300  0.100
95001790 O    Grape, wine and sherry             0.697000   1.000  0.050
95001830 O    Guava                              0.500000   1.000  1.000
95001831 O    Guava-babyfood                     0.500000   1.000  1.000
95001880 O    Hop                               11.600000   1.000  0.920
95001920 O    Jaboticaba                         0.500000   1.000  1.000
95002090 O    Longan                             4.000000   1.000  1.000
95002110 O    Lychee                             4.000000   1.000  1.000
95002120 O    Lychee, dried                      4.000000   1.000  1.000
95002150 O    Mango                              0.110000   1.000  1.000
95002151 O    Mango-babyfood                     0.110000   1.000  1.000
95002160 O    Mango, dried                       0.110000   1.000  1.000
95002170 O    Mango, juice                       0.110000   1.000  1.000
95002171 O    Mango, juice-babyfood              0.110000   1.000  1.000
95002450 O    Papaya                             0.110000   1.000  1.000
95002451 O    Papaya-babyfood                    0.110000   1.000  1.000
95002460 O    Papaya, dried                      0.110000   1.800  1.000
95002470 O    Papaya, juice                      0.110000   1.500  1.000
95002520 O    Passionfruit                       0.500000   1.000  1.000
95002521 O    Passionfruit-babyfood              0.500000   1.000  1.000
95002530 O    Passionfruit, juice                0.500000   1.000  1.000
95002531 O    Passionfruit, juice-babyfood       0.500000   1.000  1.000
95002770 O    Persimmon                          0.500000   1.000  1.000
95003330 O    Sapote, Mamey                      0.110000   1.000  1.000
95003460 O    Soursop                            0.400000   1.000  1.000
95003510 O    Spanish lime                       4.000000   1.000  1.000
95003580 O    Starfruit                          0.500000   1.000  1.000
95003610 O    Sugar apple                        0.400000   1.000  1.000
Attachment 7:  DEEM-FCID Cancer 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\tbloem\spirodiclofen\tropical fruit 2\124871cancer.R98
                                                     Adjustment factor #2 used.
Analysis Date 09-21-2011/09:02:38     Residue file dated: 09-21-2011/09:00:33/8
Q* = 0.0149
COMMENT 1: no acute endpoint identified; 100x uncertainity factor for chronic
===============================================================================
                    Total exposure by population subgroup
-------------------------------------------------------------------------------
                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg         Lifetime risk
           Subgroup                       body wt/day       (Q*= .0149)
--------------------------------------   -------------     -------------
U.S. Population (total)                     0.000171         2.55E-06

-------------------------------------------------------------------------------
Attachment 8:  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\tbloem\spirodiclofen\tropical fruit 2\124871cancer.R98
                                                     Adjustment factor #2 used.
Analysis Date 09-21-2011/09:03:30     Residue file dated: 09-21-2011/09:00:33/8
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 =.0001709 mg/kg bw/day
            Crop groups with total exposure contribution > 5%
              Foods/Foodforms with exposure contribution > 5%
-------------------------------------------------------------------------------
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                       0.0000205    11.97%        3.05E-07
   Grape, juice (95001760):
        FoodForm N/S                       0.0000088     5.12%        1.31E-07
   Hop (95001880):
        FoodForm N/S                       0.0000746    43.67%        1.11E-06
   Water, direct, all sources (86010000):
        FoodForm N/S                       0.0000203    11.86%        3.02E-07
   Water, indirect, all sources (86020000):
        FoodForm N/S                       0.0000149     8.74%        2.23E-07
--------------------------------------   -----------|-----------|--------------
  Total for crop group                     0.0001575    92.16%        2.35E-06

Total for crop groups listed above:        0.0001575    92.16%        2.35E-06
-------------------------------------------------------------------------------


[Federal Register: March 14, 2008 (Volume 73, Number 51)]
[Notices]
[Page 13941-13942]
[DOCID:fr14mr08-107]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57455; File No. SR-NYSE-2008-03]

Self-Regulatory Organizations; New York Stock Exchange LLC; Order
Approving a Proposed Rule Change, as Modified by Amendment No. 1
Thereto, To Rescind NYSE Rule 97 (Limitation on Member's Trading
Because of Block Positioning)

March 7, 2008

I. Introduction

    On January 11, 2008, the New York Stock Exchange LLC (``NYSE'' 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\ a
proposed rule change to rescind NYSE Rule 97 (Limitation on Member's
Trading Because of Block Positioning). The proposed rule change was
published for comment in the Federal Register on February 6, 2008.\3\
On February 20, 2008, NYSE filed Amendment No. 1 to the proposed rule
change.\4\ The Commission received one comment on the proposed rule
change.\5\ This order approves the proposed rule change, as modified.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 57236 (January 30,
2008), 73 FR 7022.
    \4\ In Amendment No. 1, the Exchange made conforming amendments
to NYSE Rules 123C and 800 to remove references to NYSE Rule 97, and
corrected typographical errors in NYSE Rule 800. Because Amendment
No. 1 is technical in nature, it is not subject to notice and
comment.
    \5\ See letter from Ann L. Vlcek, Securities Industry and
Financial Markets Association (``SIFMA''), dated February 27, 2008
(``SIFMA Letter'').
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

    NYSE Rule 97 governs block facilitation transactions by NYSE member
organizations on behalf of customers. The rule states that if, as a
result of facilitating one or more customer sell orders in a stock
during the trading day, a member organization ends up holding a long
position in the stock in a proprietary account, then

during the last 20 minutes of trading, the member organization is
prohibited from buying such stock as principal on a ``plus tick'' if
the transaction would take place at a price above the lowest price at
which it acquired the long position. The Exchange states that Rule 97
was originally adopted to address concerns that a member firm might
engage in manipulative practices by attempting to ``mark-up'' the price
of a stock to enable the position acquired in the course of block
positioning to be liquidated at a profit, or to maintain the market at
the price at which the position was acquired. The rule has been since
amended to reduce its scope and provide certain exceptions.\6\
---------------------------------------------------------------------------

    \6\ See, e.g., Securities Exchange Act Release No. 46566
(September 27, 2002), 67 FR 62278 (October 4, 2002) (SR-NYSE-2001-
24) (narrowing the scope of the prohibitions to transactions
executed within the last 20 minutes of the trading day, and
providing exceptions to the rule for member organizations that
establish information barriers and certain hedging transactions).
---------------------------------------------------------------------------

    The Rule was last amended in July 2007 to resolve a conflict
between Regulation NMS under the Act (``Regulation NMS'') \7\ and NYSE
Rule 97, to add an exemption to Rule 97 so that when facilitating a
customer order that would otherwise require the firm to either violate
Rule 97 or trade through protected quotations, member organizations can
comply with their Regulation NMS obligations without also violating
Rule 97.\8\ The Exchange now proposes to rescind Rule 97 in its
entirety.
---------------------------------------------------------------------------

    \7\ 17 CFR 242.600 et. seq.
    \8\ See Securities Exchange Act Release No. 56024 (July 6,
2007), 72 FR 38643 (July 13, 2007) (SR-NYSE-2007-61).
---------------------------------------------------------------------------

III. Summary of Comments

    The Commission received one letter on the proposed rule change.\9\
The commenter supports the proposed rule change, agreeing with the
Exchange's rationale for rescinding NYSE Rule 97. Specifically, the
commentator agrees with the Exchange's view that the rule ``no longer
serves a useful purpose and may in fact hinder legitimate trading
activity.'' \10\ Furthermore, SIFMA believes that changes in the
markets and new regulations, such as Regulation NMS, render the rule no
longer viable.\11\
---------------------------------------------------------------------------

    \9\ See SIFMA Letter, supra note 5.
    \10\ See SIFMA Letter, supra note 5, at 1.
    \11\ See id. at 2.
---------------------------------------------------------------------------

IV. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change, as amended, is consistent with the requirements of the Act and
the rules and regulations thereunder applicable to a national
securities exchange.\12\ In particular, the Commission finds that the
proposal is consistent with Section 6(b)(5) of the Act,\13\ which
requires, among other things, that the rules of an exchange be designed
to promote just and equitable principles of trade, remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general, protect investors and the public
interest. The Commission notes that other venues are available for
market participants to effect block position transactions without the
restrictions currently imposed by NYSE Rule 97. The Commission further
notes that NYSE represented that NYSE Regulation, Inc. will continue to
surveil in NYSE-listed securities for possible manipulative activity,
including marking the close, which could be in violation of federal
securities laws or Exchange Rules.\14\
---------------------------------------------------------------------------

    \12\ In approving this proposed rule change, the Commission
notes that it has considered the proposed rule's impact on
efficiency, competition, and capital formation. 15 U.S.C. 78c(f).
    \13\ 15 U.S.C. 78f(b)(5).
    \14\ See Notice, supra note 3, at 7023.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\15\ that the proposed rule change (SR-NYSE-2008-03), as modified
by Amendment No. 1 thereto, is approved.
---------------------------------------------------------------------------

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

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-5097 Filed 3-13-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Notices]
[Page 47563]
[FR Doc No: 2017-22031]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2017-0001]

Notice of Adjustment of Countywide Per Capita Impact Indicator

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: FEMA gives notice that the countywide per capita impact
indicator under the Public Assistance program for disasters declared on
or after October 1, 2017, will be increased.

DATES: This adjustment applies to major disasters declared on or after
October 1, 2017.

FOR FURTHER INFORMATION CONTACT: Christopher Logan, Recovery
Directorate, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In assessing damages for area designations
under 44 CFR 206.40(b), FEMA uses a countywide per capita indicator to
evaluate the impact of the disaster at the county level. FEMA will
adjust the countywide per capita impact indicator under the Public
Assistance program to reflect annual changes in the Consumer Price
Index for All Urban Consumers published by the Department of Labor.
    FEMA gives notice of an increase in the countywide per capita
impact indicator to $3.68 for all disasters declared on or after
October 1, 2017.
    FEMA bases the adjustment on an increase in the Consumer Price
Index for All Urban Consumers of 1.9 percent for the 12-month period
that ended in August 2017. The Bureau of Labor Statistics of the U.S.
Department of Labor released the information on September 14, 2017.

Catalog of Federal Domestic Assistance No. 97.036, Disaster Grants--
Public Assistance (Presidentially Declared Disasters).

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-22031 Filed 10-11-17; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register: April 17, 2006 (Volume 71, Number 73)]
[Notices]
[Page 19722-19723]
[DOCID:fr17ap06-57]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application Accepted for Filing and Soliciting Motions
To Intervene and Protests

April 10, 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.
    b. Project No.: P-11910-002.
    c. Date filed: August 31, 2004.
    d. Applicant: Symbiotics, LLC.
    e. Name of Project: Applegate Dam Hydroelectric Project.
    f. Location: On the Applegate River, near the town of Medford,
Jackson County, Oregon. The proposed project would be located at the
existing Applegate dam and reservoir, which are owned and operated by
the Department of the Army, Corps of Engineers. The proposed project
boundary would include approximately 8.3 acres of U.S. lands.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Brent L. Smith, Northwest Power Services,
Inc. P.O. Box 535, Rigby, Idaho 83442,<PHONE_NUMBER>.
    i. FERC Contact: Tim Looney,<PHONE_NUMBER><EMAIL_ADDRESS>    j. Cooperating agencies: We are asking Federal, state, local, and
tribal agencies with jurisdiction and/or special expertise with respect
to environmental issues to cooperate with us in the preparation of the
environmental document. Agencies who would like to request cooperating
status should follow the instructions for filing documents described in
item k below. Cooperating agencies should note the Commission's policy
that agencies that cooperate in the preparation of the environmental
document cannot also intervene. See, 94 FERC ] 61,076 (2001).
    k. Deadline for filing motions to intervene and protests and
requests for cooperating agency status: 60 days from the issuance date
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 and Procedures 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.
    Motions to intervene and protests and requests for cooperating
agency status 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.

    l. This application has been accepted for filing, but is not ready
for environmental analysis at this time.
    m. The Applicant proposes to utilize the existing Applegate Dam,
Applegate Reservoir, outlet works, and spillway, owned and operated by
the Department of the Army, Corps of Engineers. The Applicant proposes
to construct a powerhouse with an installed capacity of 10 megawatts at
the area downstream from the dam. The Applicant also proposes to
construct a new 15-mile-long, 69-kilovolt overhead power transmission
line to connect the powerhouse with a substation located at Ruch,
Oregon. The average annual generation is estimated to be 44,300,000
kilowatt-hours.
    n. 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.
    You may also register online at http://www.ferc.gov/docs-filing/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.
    o. 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 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 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 protests or motions to
intervene must be received on or before the specified deadline date for
the particular application.
    When the application is ready for environmental analysis, the
Commission will issue a public notice requesting comments,
recommendations, terms and conditions, or prescriptions.
    All filings must (1) bear in all capital letters the title
``PROTEST'' or ``MOTION TO INTERVENE,'' ``NOTICE OF INTENT TO FILE
COMPETING APPLICATION,'' or ``COMPETING APPLICATION;'' (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. 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.
    p. Procedural schedule and final amendments: Revisions to the
schedule will be made as appropriate. The schedule given in the
September 7, 2004 tendering notice is revised as follows:

Issue Acceptance Letter...................  April 2006.
Issue Scoping Document 1..................  April 2006.
Request Additional Information (if          June 2006.
 necessary).
Issue Scoping Document 2 (if necessary)...  July 2006.
Notice that application is ready for        July 2006.
 environmental analysis (EA).
Notice of the availability of the EA......  Jan. 2007.

Ready for Commission's decision on the      May 2007.
 application.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-5617 Filed 4-14-06; 8:45 am]

BILLING CODE 6717-01-P