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

                                                 	OFFICE OF CHEMICAL SAFETY AND
                                                                                POLLUTION PREVENTION

MEMORANDUM

Date:	26 September 2012

SUBJECT:	Clothianidin  -  Acute and Chronic Dietary Exposure and Risk Estimates for Requested Amended Registration on Peppers and New Uses on Strawberry, Citrus, Pistachio, and Tea.

PC Code:  044309
DP Barcode:  D397690
Decision No.:  455249
Registration Nos.:  59639-150, 59639-152
Petition No.:  1E7923, 2F8008
Regulatory Action:  Amended Registration and New Section 3 Registrations
Risk Assessment Type:  Dietary
Case No.:  7620
TXR No.:  NA
CAS No.:  210880-92-5
MRID No.:  NA
40 CFR:  §180.586

FROM:	Michael A. Doherty, Ph.D., Chemist
	Risk Assessment Branch II
	Health Effects Division (7509P)

THROUGH:	David Hrdy, Branch Chief (acting), RAB I
	Jennifer R. Tyler, Chemist
	Dietary Exposure Science Advisory Council (DESAC)

	Christina Swartz, Branch Chief
	Risk Assessment Branch II
	Health Effects Division (7509P)

TO:	Marianne Lewis/Venus Eagle (RM 01)
	Insecticide/Rodenticide Branch
	Registration Division (7505P)

	Barbara Madden
	Risk Integration, Minor Use, and Emergency Response Branch
	Registration Division (7505P)

Executive Summary

Acute and chronic aggregate dietary (food + drinking water) exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 3.16, which uses food consumption data from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).  This dietary survey was conducted from 2003 to 2008.  The analyses were conducted in support of a human health risk assessment of the proposed new Section 3 registrations on strawberry, citrus (Crop Group 10-10), pistachio, and tea as well as proposed a requested increase in the tolerance for residues in/on Crop Subgroup 8-10B due to a label amendment to shorten the pre-harvest interval.

The acute and chronic assessments are based on the screening-level input assumptions, including tolerance-level residues, 100% crop treated, and high-end estimates of residues in drinking water based on estimated concentrations of clothianidin in rice paddy water.  These inputs resulted in risk estimates that are, at most, 28% of the population-adjusted dose for all population subgroups for both the acute and chronic assessments; the maximum risk estimate is for children 1-2 years of age.  All dietary risk estimates are below HED's level of concern.

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 that HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population adjusted dose (PAD).  The PAD is equivalent to the 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 that discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site:  "Available Information on Assessing Exposure from Pesticides, A User's Guide," 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 clothianidin was conducted by M. Doherty (1 Feb 2012, D395798).  This is the first assessment conducted using the NHANES/WWEIA consumption database.

II.  Residue Information

The acute and chronic assessments rely on tolerance-level residues (40 CFR 180.586) for all crops with registered and/or requested clothianidin uses (Table 1).  For crops except leafy vegetables, the residue of concern for risk assessment purposes is the parent compound.  For root crops and leafy vegetables, the residues of concern are the parent compound and the TMG metabolite.  Field trial data show no detectable residues of TMG in root crops and that TMG does not exceed 10% of the parent compound residue level in leafy vegetables.  A factor of 1.1 (entered into the model as Adjustment Factor 1) has been incorporated into the assessment for leafy vegetables to account for the presence of TMG.  For livestock commodities, the residues of concern are the parent compound as well as the metabolites TZU, TZG, TZNG, ATMG-pyruvate, and ATG-acetate.  Milk is currently the only livestock-derived commodity with a tolerance for clothianidin.  A factor of 1.5, which is based on metabolism data, has been incorporated into the assessment to account for the residues of concern in milk.

There are a number of crops for which uses of both clothianidin and thiamethoxam have been registered.  The labels for the various end-use products containing these active ingredients prohibit the application of both active ingredients to the same crop during a growing cycle.  Due to that restriction and the assumption of 100% crop treated, a single value reflecting the greatest clothianidin residue from either active ingredient has been used for crops listed for use with both active ingredients (versus combined estimates from clothianidin and from thiamethoxam).  Generally, this assessment uses the established or recommended clothianidin tolerance for crops having tolerances for both compounds.  For foods with thiamethoxam tolerances but without clothianidin tolerances, maximum residues of clothianidin observed in thiamethoxam residue trials have been used in these assessments.  These include meats, meat by-products, artichoke, tropical fruits, coffee, hop, and mint.

Orange processing study data show that clothianidin does not concentrate in citrus oil or juice.  Relative to the whole fruit, there is a modest increase in residues in pulp (1.8X).  These empirical processing factors, as well as those derived previously, have been included in these analyses.  Complete listings of the residue estimates, metabolite factors, and processing factors used in these analyses may be found in Attachment 1.

The USDA's Pesticide Data Program included clothianidin as a target analyte in its 2008-2010 survey of pesticide residues in catfish.  Over the course of those three years, there were no detectable residues of clothianidin in any of the 1479 samples of catfish.  While there is no specific expectation of clothianidin residues in fish as a result of the compound's agricultural uses, there is a use in food handling establishments; therefore, fish have been included as a source of clothianidin exposure in these analyses.

Table 1.  Summary of Recommended Tolerance Levels for the Proposed New Uses and Label Amendments for Clothianidin.
Commodity
Recommended Tolerance, ppm
Comments
Pistachio
0.01
Translated from existing tree nut listing
Strawberry
1.50
From acceptable field trial data
Fruit, citrus, group 10-10
0.60
From acceptable field trial data
Tea, fresh
70
From acceptable field trial data
Vegetables, fruiting, group 8-10, except pepper/eggplant subgroup 8-10B
0.20
From existing Group 8 listing
Vegetables, fruiting, pepper/eggplant subgroup 8-10B
0.80
From acceptable field trial data

III.  Percent Crop Treated Information

HED has assumed 100% crop treated for these analyses.

IV.  Drinking Water Data

The Environmental Fate and Effects Division (EFED) has supplied HED with Tier I estimated drinking water concentrations (EDWC) for clothianidin in surface water resulting from foliar application to rice (R. Baris, 15 September 2011, D393235).

EFED used the Tier I Rice Model (v 1.0) as a screening model to calculate the surface water EDWC resulting from a single foliar application of clothianidin to a flooded field (as proposed on the label).  This concentration represents the estimated concentration that would be expected in the release water downstream of the treated rice paddy.  FIRST (FQPA Index Reservoir Screening Tool, version 1.1, 01/01/07) was used to calculate the surface water EDWC resulting from a single foliar application to leafy vegetables.  These concentrations are presented in Table 2.

Table 2.  Tier I EDWCs for drinking water risk assessment based on the proposed clothianidin use on rice and leafy vegetables
Use (application rate, lbs a.i./A)
Model
Acute
Chronic
Surface water drinking water sources, downstream of rice paddy (0.084 lb a.i./A)
Tier I Rice Model (v1.0)
                                    72 ppb
                                  <72 ppb

The EDWC of 72 ppb has been used to account for residues of clothianidin in both the acute and chronic dietary risk assessments.  This is the same EDWC that was used in the most recent dietary assessment.  EFED has confirmed that it is the appropriate value to use in this assessment (e-mail from R. Baris; 16 July 2012, 3:12:46 pm).

V.  DEEM-FCID Program and Consumption Information

Clothianidin acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID, Version 3.16, which incorporates consumption data from USDA's NHANES/WWEIA.  This dietary survey was conducted from 2003 to 2008.  The data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods "as consumed" (e.g., apple pie) are linked to EPA-defined food commodities (e.g., apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups.  However, for acute exposure assessment, consumption data are retained as individual consumption events.  Based on analysis of the 2003-2008 WWEIA 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 a chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate.  The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

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

VI.  Toxicological Information

The doses and endpoints for human health dietary risk assessments are summarized in Table 3.

Table 3.  Clothianidin Toxicological Doses and Endpoints for Use in Human Health Dietary Risk Assessments
Exposure/
Scenario
Point of Departure
Uncertainty/ FQPA Safety Factors
Level of Concern for Risk Assessment
Study and Toxicological Effects
Acute Dietary
Females age
13-49
NOAEL =
25 mg/kg/day
UFA = 10x
UFH = 10x
SFFQPA =1

aRfD =
0.25 mg/kg/day
aPAD =
0.25 mg/kg/day
Rabbit developmental  study
LOAEL = 75 mg/kg/day based on increased litter incidence of a missing lobe of the lung
Acute Dietary
General population
NOAEL =
25
mg/kg/day
UFA = 10x
UFH = 10x
SFFQPA  = 1
aRfD =
0.25 mg/kg/day
aPAD =
0.25 mg/kg/day
Special neurotoxicity/pharmacol
study in mice
LOAEL = 50 mg/kg/day based on transient signs of decreased spontaneous motor activity, tremors and deep respirations
Chronic Dietary
All populations including infants and children
NOAEL=
9.8 mg/kg/day
UFA = 10x
UFH = 10x
SFFQPA =1
cRfD=0.098 mg/kg/day
cPAD=0.098 mg/kg/day
2-Generation reproduction study
LOAEL = 31.2 mg/kg/day based on decreased body weight gains and delayed sexual maturation, decreased absolute thymus weights in F1 pups and increased stillbirths in both generations
Cancer
"Not Likely to be Carcinogenic to Humans"
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.  UFA = extrapolation from animal to human (interspecies).  UFH = potential variation in sensitivity among members of the human population (intraspecies).  FQPA SF = FQPA Safety Factor.  PAD = population-adjusted dose (a = acute, c = chronic).  RfD = reference dose.

VII.  Results/Discussion

For acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The results reported in Table 4 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50-99 years.  All estimates are below HED's level of concern.

Table 4.  Summary of Acute and Chronic Dietary Exposure and Risk Estimates for Clothianidin.
Population Subgroup
                           Acute (95[th] Percentile)
                                    Chronic

                              Exposure, mg/kg/day
                                    % aPAD
                              Exposure, mg/kg/day
                                    % cPAD
Total US Population
0.020913
8
0.007458
8
All Infants
0.051461
21
0.016683
17
Children 1-2 years old
0.069586
28
0.027256
28
Children 3-5 years old
0.048260
19
0.018444
19
Children 6-12 years old
0.024264
10
0.009165
9
Youth 13-19 years old
0.014341
6
0.005346
6
Adults 20-49 years old
0.015090
6
0.005822
6
Adults 50-99 years old
0.014403
6
0.006109
6
Female 13-49 years old
0.015390
6
0.005974
6
 The population subgroup(s) with the highest exposure/risk estimates are shown in bold.

 VIII.  Characterization of Inputs/Outputs

 The acute and chronic assessments are based on highly conservative, health-protective assumptions regarding residue levels in food and percentage of crops treated.  Likewise, the estimated concentration in drinking water is highly conservative, especially given that it represents residues in rice paddy tail water and no adjustment was made to take into account the portion of the watershed that would be cropped to rice.  The analyses resulting from these assumptions should be considered screening-level analyses that likely overestimate actual dietary exposure to clothianidin.

 IX.  Conclusions

 There are no dietary exposure or risk considerations that would preclude making the label amendment shortening the PHI for Crop Subgroup 8-10B, registering the clothianidin end-use products as requested, and establishing tolerances commensurate with those registration actions.

 X.  List of Attachments

1.  Inputs for the Acute and Chronic Dietary Exposure Assessment of Clothianidin.
2.  Summary of the Results of the Acute Dietary Exposure Assessment of Clothianidin.
3.  Summary of the Results of the Chronic Dietary Exposure Assessment of Clothianidin.

Attachment 1.  Inputs for the Acute and Chronic Dietary Exposure Assessment of Clothianidin.

Filename: C:\Documents and Settings\mdoherty\My Documents\Chemistry Reviews\!DEEM Runs\Clothianidin\2012\044309 (2012).R08
Chemical: Clothianidin
RfD(Chronic): .098 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day
RfD(Acute): .25 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day
Date created/last modified: 09-18-2012/10:16:01       Program ver. 3.16, 03-08-d
-----------------------------------------------------------------------------------
   EPA     Crop                                   Def Res     Adj.Factors   Comment
   Code     Grp  Commodity Name                    (ppm)       #1    #2
---------- ---- -------------------------------  ----------  ------ ------  -------
9500001000 O    Acerola                            0.005000   1.000  1.000  From FHE Thiamethoxam
9500006000 O    Amaranth, grain                    0.005000   1.000  1.000  From FHE Thiamethoxam
9500016000 O    Artichoke, globe                   0.029000   1.000  1.000  From thiamethoxam
9500019000 O    Asparagus                          0.005000   1.000  1.000  From FHE Thiamethoxam
9500020000 O    Avocado                            0.020000   1.000  1.000  From thiamethoxam
9500022000 O    Bamboo, shoots                     0.005000   1.000  1.000  From FHE Thiamethoxam
9500023000 O    Banana                             0.005000   1.000  1.000  From FHE Thiamethoxam
9500024000 O    Banana, dried                      0.005000   3.900  1.000  From FHE Thiamethoxam
9500024001 O    Banana, dried-babyfood             0.005000   3.900  1.000  From FHE Thiamethoxam
9500023001 O    Banana-babyfood                    0.005000   1.000  1.000  From FHE Thiamethoxam
9500054000 O    Belgium endive                     0.005000   1.000  1.000  From FHE Thiamethoxam
9500060000 O    Breadfruit                         0.005000   1.000  1.000  From FHE Thiamethoxam
9500073000 O    Cactus                             0.005000   1.000  1.000  From FHE Thiamethoxam
9500074000 O    Canistel                           0.005000   1.000  1.000  From FHE Thiamethoxam
9500077000 O    Carob                              0.005000   1.000  1.000  From FHE Thiamethoxam
9500089000 O    Cherimoya                          0.005000   1.000  1.000  From FHE Thiamethoxam
9500109000 O    Cocoa bean, chocolate              0.005000   1.000  1.000  From FHE Thiamethoxam
9500110000 O    Cocoa bean, powder                 0.005000   1.000  1.000  From FHE Thiamethoxam
9500112000 O    Coconut, dried                     0.005000   2.100  1.000  From FHE Thiamethoxam
9500111000 O    Coconut, meat                      0.005000   1.000  1.000  From FHE Thiamethoxam
9500111001 O    Coconut, meat-babyfood             0.005000   1.000  1.000  From FHE Thiamethoxam
9500113000 O    Coconut, milk                      0.005000   1.000  1.000  From FHE Thiamethoxam
9500114000 O    Coconut, oil                       0.005000   1.000  1.000  From FHE Thiamethoxam
9500116000 O    Coffee, instant                    0.040000   1.000  1.000  From thiamethoxam
9500115000 O    Coffee, roasted bean               0.040000   1.000  1.000  From thiamethoxam
9500141000 O    Date                               0.005000   1.000  1.000  From FHE Thiamethoxam
9500151000 O    Feijoa                             0.005000   1.000  1.000  From FHE Thiamethoxam
9500153000 O    Fig                                0.050000   1.000  1.000
9500154000 O    Fig, dried                         0.050000   1.000  1.000
9500177000 O    Grape, leaves                      0.600000   1.000  1.000
9500178000 O    Grape, raisin                      0.600000   2.500  1.000
9500183000 O    Guava                              0.005000   1.000  1.000  From FHE Thiamethoxam
9500183001 O    Guava-babyfood                     0.005000   1.000  1.000  From FHE Thiamethoxam
9500186000 O    Honey                              0.005000   1.000  1.000  From FHE Thiamethoxam
9500186001 O    Honey-babyfood                     0.005000   1.000  1.000  From FHE Thiamethoxam
9500188000 O    Hop                                0.028000   1.000  1.000  From thiamethoxam
9500193000 O    Jackfruit                          0.005000   1.000  1.000  From FHE Thiamethoxam
9500209000 O    Longan                             0.005000   1.000  1.000  From FHE Thiamethoxam
9500211000 O    Lychee                             0.005000   1.000  1.000  From FHE Thiamethoxam
9500212000 O    Lychee, dried                      0.005000   1.850  1.000  From FHE Thiamethoxam
9500214000 O    Mamey apple                        0.005000   1.000  1.000  From FHE Thiamethoxam
9500215000 O    Mango                              0.020000   1.000  1.000  From thiamethoxam
9500216000 O    Mango, dried                       0.020000   1.000  1.000  From thiamethoxam
9500217000 O    Mango, juice                       0.020000   1.000  1.000  From thiamethoxam
9500217001 O    Mango, juice-babyfood              0.020000   1.000  1.000  From thiamethoxam
9500215001 O    Mango-babyfood                     0.020000   1.000  1.000  From thiamethoxam
9500219000 O    Maple syrup                        0.005000   1.000  1.000  From FHE Thiamethoxam
9500218000 O    Maple, sugar                       0.005000   1.000  1.000  From FHE Thiamethoxam
9500235000 O    Olive                              0.005000   1.000  1.000  From FHE Thiamethoxam
9500236000 O    Olive, oil                         0.005000   1.000  1.000  From FHE Thiamethoxam
9500243000 O    Palm heart, leaves                 0.005000   1.000  1.000  From FHE Thiamethoxam
9500244000 O    Palm, oil                          0.005000   1.000  1.000  From FHE Thiamethoxam
9500244001 O    Palm, oil-babyfood                 0.005000   1.000  1.000  From FHE Thiamethoxam
9500245000 O    Papaya                             0.020000   1.000  1.000  From thiamethoxam
9500246000 O    Papaya, dried                      0.020000   1.800  1.000  From thiamethoxam
9500247000 O    Papaya, juice                      0.020000   1.500  1.000  From thiamethoxam
9500245001 O    Papaya-babyfood                    0.020000   1.000  1.000  From thiamethoxam
9500252000 O    Passionfruit                       0.005000   1.000  1.000  From FHE Thiamethoxam
9500253000 O    Passionfruit, juice                0.005000   1.000  1.000  From FHE Thiamethoxam
9500253001 O    Passionfruit, juice-babyfood       0.005000   1.000  1.000  From FHE Thiamethoxam
9500252001 O    Passionfruit-babyfood              0.005000   1.000  1.000  From FHE Thiamethoxam
9500254000 O    Pawpaw                             0.005000   1.000  1.000  From FHE Thiamethoxam
9500263000 O    Peanut                             0.010000   1.000  1.000
9500264000 O    Peanut, butter                     0.010000   1.890  1.000
9500265000 O    Peanut, oil                        0.010000   0.310  1.000  PF for thiamethoxam
9500275000 O    Peppermint                         0.128000   1.000  1.000  From thiamethoxam
9500276000 O    Peppermint, oil                    0.128000   1.000  1.000  From thiamethoxam
9500277000 O    Persimmon                          0.005000   1.000  1.000  From FHE Thiamethoxam
9500279000 O    Pineapple                          0.005000   1.000  1.000  From FHE Thiamethoxam
9500280000 O    Pineapple, dried                   0.005000   5.000  1.000  From FHE Thiamethoxam
9500281000 O    Pineapple, juice                   0.005000   1.700  1.000  From FHE Thiamethoxam
9500281001 O    Pineapple, juice-babyfood          0.005000   1.700  1.000  From FHE Thiamethoxam
9500279001 O    Pineapple-babyfood                 0.005000   1.000  1.000  From FHE Thiamethoxam
9500283000 O    Plantain                           0.005000   1.000  1.000  From FHE Thiamethoxam
9500284000 O    Plantain, dried                    0.005000   3.900  1.000  From FHE Thiamethoxam
9500289000 O    Pomegranate                        0.200000   1.000  1.000  From thiamethoxam
9500306000 O    Psyllium, seed                     0.005000   1.000  1.000  From FHE Thiamethoxam
9500311000 O    Quinoa, grain                      0.005000   1.000  1.000  From FHE Thiamethoxam
9500333000 O    Sapote, Mamey                      0.020000   1.000  1.000  From thiamethoxam
9500335000 O    Seaweed                            0.005000   1.000  1.000  From FHE Thiamethoxam
9500335001 O    Seaweed-babyfood                   0.005000   1.000  1.000  From FHE Thiamethoxam
9500346000 O    Soursop                            0.005000   1.000  1.000  From FHE Thiamethoxam
9500351000 O    Spanish lime                       0.005000   1.000  1.000  From FHE Thiamethoxam
9500352000 O    Spearmint                          0.128000   1.000  1.000  From thiamethoxam
9500353000 O    Spearmint, oil                     0.128000   1.000  1.000  From thiamethoxam
9500358000 O    Starfruit                          0.005000   1.000  1.000  From FHE Thiamethoxam
9500361000 O    Sugar apple                        0.005000   1.000  1.000  From FHE Thiamethoxam
9500363000 O    Sugarcane, molasses                0.005000   1.000  1.000  From FHE Thiamethoxam
9500363001 O    Sugarcane, molasses-babyfood       0.005000   1.000  1.000  From FHE Thiamethoxam
9500362000 O    Sugarcane, sugar                   0.005000   1.000  1.000  From FHE Thiamethoxam
9500362001 O    Sugarcane, sugar-babyfood          0.005000   1.000  1.000  From FHE Thiamethoxam
9500368000 O    Tamarind                           0.005000   1.000  1.000  From FHE Thiamethoxam
9500372000 O    Tea, dried                        70.000000   1.000  1.000   1E7923 (2012)
9500373000 O    Tea, instant                      70.000000   1.000  1.000   1E7923 (2012)
9500390000 O    Vinegar                            0.005000   1.000  1.000  From FHE Thiamethoxam
9500397000 O    Water chestnut                     0.005000   1.000  1.000  From FHE Thiamethoxam
9500398000 O    Watercress                         0.005000   1.000  1.000  From FHE Thiamethoxam
0103015000 1CD  Arrowroot, flour                   0.300000   1.000  1.000
0103015001 1CD  Arrowroot, flour-babyfood          0.300000   1.000  1.000
0103017000 1CD  Artichoke, Jerusalem               0.300000   1.000  1.000
0101050000 1AB  Beet, garden, roots                0.800000   1.000  1.000
0101050001 1AB  Beet, garden, roots-babyfood       0.800000   1.000  1.000
0101052000 1A   Beet, sugar                        0.020000   1.000  1.000
0101053000 1A   Beet, sugar, molasses              0.050000   1.000  1.000
0101053001 1A   Beet, sugar, molasses-babyfood     0.050000   1.000  1.000
0101052001 1A   Beet, sugar-babyfood               0.020000   1.000  1.000
0101067000 1AB  Burdock                            0.800000   1.000  1.000
0101078000 1AB  Carrot                             0.800000   1.000  1.000
0101079000 1AB  Carrot, juice                      0.800000   1.000  1.000
0101078001 1AB  Carrot-babyfood                    0.800000   1.000  1.000
0103082000 1CD  Cassava                            0.300000   1.000  1.000
0103082001 1CD  Cassava-babyfood                   0.300000   1.000  1.000
0101084000 1AB  Celeriac                           0.800000   1.000  1.000
0101100000 1AB  Chicory, roots                     0.800000   1.000  1.000
0103139000 1CD  Dasheen, corm                      0.300000   1.000  1.000
0103166000 1CD  Ginger                             0.300000   1.000  1.000
0103167000 1CD  Ginger, dried                      0.300000   1.000  1.000
0103166001 1CD  Ginger-babyfood                    0.300000   1.000  1.000
0101168000 1AB  Ginseng, dried                     0.800000   1.000  1.000
0101190000 1AB  Horseradish                        0.800000   1.000  1.000
0101250000 1AB  Parsley, turnip rooted             0.800000   1.000  1.000
0101251000 1AB  Parsnip                            0.800000   1.000  1.000
0101251001 1AB  Parsnip-babyfood                   0.800000   1.000  1.000
0103296000 1C   Potato, chips                      0.600000   1.000  1.000
0103297000 1C   Potato, dry (granules/ flakes)     1.500000   6.500  1.000
0103297001 1C   Potato, dry (granules/ flakes)-b   1.500000   6.500  1.000
0103298000 1C   Potato, flour                      0.300000   1.000  1.000
0103298001 1C   Potato, flour-babyfood             0.300000   1.000  1.000
0103300000 1C   Potato, tuber, w/o peel            0.300000   1.000  1.000
0103300001 1C   Potato, tuber, w/o peel-babyfood   0.300000   1.000  1.000
0103299000 1C   Potato, tuber, w/peel              0.300000   1.000  1.000
0103299001 1C   Potato, tuber, w/peel-babyfood     0.300000   1.000  1.000
0101316000 1AB  Radish, Oriental, roots            0.800000   1.000  1.000
0101314000 1AB  Radish, roots                      0.800000   1.000  1.000
0101327000 1AB  Rutabaga                           0.800000   1.000  1.000
0101331000 1AB  Salsify, roots                     0.800000   1.000  1.000
0103366000 1CD  Sweet potato                       0.300000   1.000  1.000
0103366001 1CD  Sweet potato-babyfood              0.300000   1.000  1.000
0103371000 1CD  Tanier, corm                       0.300000   1.000  1.000
0103387000 1CD  Turmeric                           0.300000   1.000  1.000
0101388000 1AB  Turnip, roots                      0.800000   1.000  1.000
0103407000 1CD  Yam bean                           0.300000   1.000  1.000
0103406000 1CD  Yam, true                          0.300000   1.000  1.000
0200051000 2    Beet, garden, tops                 0.600000   1.000  1.000
0200101000 2    Chicory, tops                      0.600000   1.000  1.000
0200140000 2    Dasheen, leaves                    0.600000   1.000  1.000
0200317000 2    Radish, Oriental, tops             0.600000   1.000  1.000
0200315000 2    Radish, tops                       0.600000   1.000  1.000
0200332000 2    Salsify, tops                      0.600000   1.000  1.000
0302103000 3B   Chive, fresh leaves                0.005000   1.000  1.000  From FHE Thiamethoxam
0301165000 3A   Garlic, bulb                       0.450000   1.000  1.000
0301165001 3A   Garlic, bulb-babyfood              0.450000   1.000  1.000
0302198000 3B   Leek                               0.450000   1.000  1.000
0301237000 3A   Onion, bulb                        0.450000   1.000  1.000
0301238000 3A   Onion, bulb, dried                 0.450000   9.000  1.000
0301238001 3A   Onion, bulb, dried-babyfood        0.450000   9.000  1.000
0301237001 3A   Onion, bulb-babyfood               0.450000   1.000  1.000
0302239000 3B   Onion, green                       0.450000   1.000  1.000
0302338500 3B   Shallot, fresh leaves              0.450000   1.000  1.000
0401005000 4A   Amaranth, leafy                    3.000000   1.100  1.000   1.1 factor to account for TMG metabolite
0401018000 4A   Arugula                            3.000000   1.100  1.000   1.1 factor to account for TMG metabolite
0402076000 4B   Cardoon                            0.400000   1.000  1.000  From Thiamethoxam
0402085000 4B   Celery                             0.400000   1.000  1.000  From Thiamethoxam
0402086000 4B   Celery, juice                      0.400000   1.000  1.000  From Thiamethoxam
0402085001 4B   Celery-babyfood                    0.400000   1.000  1.000  From Thiamethoxam
0402087000 4B   Celtuce                            0.400000   1.000  1.000  From Thiamethoxam
0401104000 4A   Chrysanthemum, garland             3.000000   1.100  1.000   1.1 factor to account for TMG metabolite
0401133000 4A   Cress, garden                      3.000000   1.100  1.000   1.1 factor to account for TMG metabolite
0401134000 4A   Cress, upland                      3.000000   1.100  1.000   1.1 factor to account for TMG metabolite
0401138000 4A   Dandelion, leaves                  3.000000   1.100  1.000   1.1 factor to account for TMG metabolite
0401150000 4A   Endive                             3.000000   1.100  1.000   1.1 factor to account for TMG metabolite
0402152000 4B   Fennel, Florence                   0.400000   1.000  1.000  From Thiamethoxam
0401204000 4A   Lettuce, head                      3.000000   1.100  1.000   1.1 factor to account for TMG metabolite
0401205000 4A   Lettuce, leaf                      3.000000   1.100  1.000   1.1 factor to account for TMG metabolite
0401248000 4A   Parsley, leaves                    3.000000   1.100  1.000   1.1 factor to account for TMG metabolite
0401313000 4A   Radicchio                          3.000000   1.100  1.000   1.1 factor to account for TMG metabolite
0402322000 4B   Rhubarb                            0.400000   1.000  1.000  From Thiamethoxam
0401355000 4A   Spinach                            3.000000   1.100  1.000   1.1 factor to account for TMG metabolite
0401355001 4A   Spinach-babyfood                   3.000000   1.100  1.000   1.1 factor to account for TMG metabolite
0402367000 4B   Swiss chard                        0.400000   1.000  1.000  From Thiamethoxam
0501061000 5A   Broccoli                           1.900000   1.000  1.000
0502063000 5B   Broccoli raab                      1.900000   1.000  1.000
0501062000 5A   Broccoli, Chinese                  1.900000   1.000  1.000
0501061001 5A   Broccoli-babyfood                  1.900000   1.000  1.000
0501064000 5A   Brussels sprouts                   1.900000   1.000  1.000
0501069000 5A   Cabbage                            1.900000   1.000  1.000
0502070000 5B   Cabbage, Chinese, bok choy         1.900000   1.000  1.000
0501072000 5A   Cabbage, Chinese, mustard          1.900000   1.000  1.000
0501071000 5A   Cabbage, Chinese, napa             1.900000   1.000  1.000
0501083000 5A   Cauliflower                        1.900000   1.000  1.000
0502117000 5B   Collards                           1.900000   1.000  1.000
0502194000 5B   Kale                               1.900000   1.000  1.000
0501196000 5A   Kohlrabi                           1.900000   1.000  1.000
0502229000 5B   Mustard greens                     1.900000   1.000  1.000
0502318000 5B   Rape greens                        1.900000   1.000  1.000
0502389000 5B   Turnip, greens                     1.900000   1.000  1.000
0603035000 6C   Bean,  great northern, seed        0.010000   1.000  1.000  From Thiamethoxam
0603030000 6C   Bean, black, seed                  0.010000   1.000  1.000  From Thiamethoxam
0603032000 6C   Bean, broad, seed                  0.010000   1.000  1.000  From Thiamethoxam
0602031000 6B   Bean, broad, succulent             0.010000   1.000  1.000  From Thiamethoxam
0603034000 6C   Bean, cowpea, seed                 0.010000   1.000  1.000  From Thiamethoxam
0602033000 6B   Bean, cowpea, succulent            0.010000   1.000  1.000  From Thiamethoxam
0603036000 6C   Bean, kidney, seed                 0.010000   1.000  1.000  From Thiamethoxam
0603038000 6C   Bean, lima, seed                   0.010000   1.000  1.000  From Thiamethoxam
0602037000 6B   Bean, lima, succulent              0.010000   1.000  1.000  From Thiamethoxam
0603039000 6C   Bean, mung, seed                   0.010000   1.000  1.000  From Thiamethoxam
0603040000 6C   Bean, navy, seed                   0.010000   1.000  1.000  From Thiamethoxam
0603041000 6C   Bean, pink, seed                   0.010000   1.000  1.000  From Thiamethoxam
0603042000 6C   Bean, pinto, seed                  0.010000   1.000  1.000  From Thiamethoxam
0601043000 6A   Bean, snap, succulent              0.010000   1.000  1.000  From Thiamethoxam
0601043001 6A   Bean, snap, succulent-babyfood     0.010000   1.000  1.000  From Thiamethoxam
0603099000 6C   Chickpea, flour                    0.010000   1.000  1.000  From Thiamethoxam
0603098000 6C   Chickpea, seed                     0.010000   1.000  1.000  From Thiamethoxam
0603098001 6C   Chickpea, seed-babyfood            0.010000   1.000  1.000  From Thiamethoxam
0603182000 6C   Guar, seed                         0.010000   1.000  1.000  From Thiamethoxam
0603182001 6C   Guar, seed-babyfood                0.010000   1.000  1.000  From Thiamethoxam
0603203000 6C   Lentil, seed                       0.010000   1.000  1.000  From Thiamethoxam
0603256000 6C   Pea, dry                           0.010000   1.000  1.000  From Thiamethoxam
0603256001 6C   Pea, dry-babyfood                  0.010000   1.000  1.000  From Thiamethoxam
0601257000 6A   Pea, edible podded, succulent      0.010000   1.000  1.000  From Thiamethoxam
0603258000 6C   Pea, pigeon, seed                  0.010000   1.000  1.000  From Thiamethoxam
0602259000 6B   Pea, pigeon, succulent             0.010000   1.000  1.000  From Thiamethoxam
0602255000 6B   Pea, succulent                     0.010000   1.000  1.000  From Thiamethoxam
0602255001 6B   Pea, succulent-babyfood            0.010000   1.000  1.000  From Thiamethoxam
0603348000 6C   Soybean, flour                     0.020000   1.000  1.000  From Thiamethoxam
0603348001 6C   Soybean, flour-babyfood            0.020000   1.000  1.000  From Thiamethoxam
0600350000 6    Soybean, oil                       0.020000   1.000  1.000  From Thiamethoxam
0600350001 6    Soybean, oil-babyfood              0.020000   1.000  1.000  From Thiamethoxam
0600347000 6    Soybean, seed                      0.020000   1.000  1.000  From Thiamethoxam
0600349000 6    Soybean, soy milk                  0.020000   1.000  1.000  From Thiamethoxam
0600349001 6    Soybean, soy milk-babyfood or in   0.020000   1.000  1.000  From Thiamethoxam
0802148000 8BC  Eggplant                           0.800000   1.000  1.000  Incr. tol. due to PHI change
0802234000 8BC  Okra                               0.800000   1.000  1.000  Incr. tol. due to PHI change
0802270000 8B   Pepper, bell                       0.800000   1.000  1.000  Incr. tol. due to PHI change
0802271000 8B   Pepper, bell, dried                0.800000   1.000  1.000  Incr. tol. due to PHI change
0802271001 8B   Pepper, bell, dried-babyfood       0.800000   1.000  1.000  Incr. tol. due to PHI change
0802270001 8B   Pepper, bell-babyfood              0.800000   1.000  1.000  Incr. tol. due to PHI change
0802272000 8BC  Pepper, nonbell                    0.800000   1.000  1.000  Incr. tol. due to PHI change
0802273000 8BC  Pepper, nonbell, dried             0.800000   1.000  1.000  Incr. tol. due to PHI change
0802272001 8BC  Pepper, nonbell-babyfood           0.800000   1.000  1.000  Incr. tol. due to PHI change
0801374000 8A   Tomatillo                          0.200000   1.000  1.000
0801375000 8A   Tomato                             0.200000   1.000  1.000
0801380000 8A   Tomato, Tree                       0.005000   1.000  1.000  From FHE Thiamethoxam
0801378000 8A   Tomato, dried                      0.200000  14.300  1.000
0801378001 8A   Tomato, dried-babyfood             0.200000  14.300  1.000
0801379000 8A   Tomato, juice                      0.200000   1.500  1.000
0801376000 8A   Tomato, paste                      0.200000   5.400  1.000
0801376001 8A   Tomato, paste-babyfood             0.200000   5.400  1.000
0801377000 8A   Tomato, puree                      0.200000   3.300  1.000
0801377001 8A   Tomato, puree-babyfood             0.200000   3.300  1.000
0801375001 8A   Tomato-babyfood                    0.200000   1.000  1.000
0902021000 9B   Balsam pear                        0.060000   1.000  1.000
0901075000 9A   Cantaloupe                         0.060000   1.000  1.000
0902088000 9B   Chayote, fruit                     0.060000   1.000  1.000
0902102000 9B   Chinese waxgourd                   0.060000   1.000  1.000
0902135000 9B   Cucumber                           0.060000   1.000  1.000
0901187000 9A   Honeydew melon                     0.060000   1.000  1.000
0902308000 9B   Pumpkin                            0.060000   1.000  1.000
0902309000 9B   Pumpkin, seed                      0.060000   1.000  1.000
0902356000 9B   Squash, summer                     0.060000   1.000  1.000
0902356001 9B   Squash, summer-babyfood            0.060000   1.000  1.000
0902357000 9B   Squash, winter                     0.060000   1.000  1.000
0902357001 9B   Squash, winter-babyfood            0.060000   1.000  1.000
0901399000 9A   Watermelon                         0.060000   1.000  1.000
0901400000 9A   Watermelon, juice                  0.060000   1.000  1.000
1001106000 10A  Citron                             0.600000   1.000  1.000   1E7923 (2012)
1001107000 10A  Citrus hybrids                     0.600000   1.000  1.000   1E7923 (2012)
1001108000 10A  Citrus, oil                        0.600000   1.000  1.000   1E7923 (2012)
1003180000 10C  Grapefruit                         0.600000   1.000  1.000   1E7923 (2012)
1003181000 10C  Grapefruit, juice                  0.600000   1.000  1.000   1E7923 (2012)
1002197000 10B  Kumquat                            0.600000   1.000  1.000   1E7923 (2012)
1002199000 10B  Lemon                              0.600000   1.000  1.000   1E7923 (2012)
1002200000 10B  Lemon, juice                       0.600000   1.000  1.000   1E7923 (2012)
1002200001 10B  Lemon, juice-babyfood              0.600000   1.000  1.000   1E7923 (2012)
1002201000 10B  Lemon, peel                        0.600000   1.000  1.000   1E7923 (2012)
1002206000 10B  Lime                               0.600000   1.000  1.000   1E7923 (2012)
1002207000 10B  Lime, juice                        0.600000   1.000  1.000   1E7923 (2012)
1002207001 10B  Lime, juice-babyfood               0.600000   1.000  1.000   1E7923 (2012)
1001240000 10A  Orange                             0.600000   1.000  1.000   1E7923 (2012)
1001241000 10A  Orange, juice                      0.600000   1.000  1.000   1E7923 (2012)
1001241001 10A  Orange, juice-babyfood             0.600000   1.000  1.000   1E7923 (2012)
1001242000 10A  Orange, peel                       0.600000   1.000  1.000   1E7923 (2012)
1003307000 10C  Pummelo                            0.600000   1.000  1.000   1E7923 (2012)
1001369000 10A  Tangerine                          0.600000   1.000  1.000   1E7923 (2012)
1001370000 10A  Tangerine, juice                   0.600000   1.000  1.000   1E7923 (2012)
1100009000 11   Apple, dried                       1.000000   8.000  1.000
1100009001 11   Apple, dried-babyfood              1.000000   8.000  1.000
1100007000 11   Apple, fruit with peel             1.000000   1.000  1.000
1100010000 11   Apple, juice                       1.000000   1.300  1.000
1100010001 11   Apple, juice-babyfood              1.000000   1.300  1.000
1100008000 11   Apple, peeled fruit                1.000000   1.000  1.000
1100008001 11   Apple, peeled fruit-babyfood       1.000000   1.000  1.000
1100011000 11   Apple, sauce                       1.000000   1.000  1.000
1100011001 11   Apple, sauce-babyfood              1.000000   1.000  1.000
1100129000 11   Crabapple                          1.000000   1.000  1.000
1100210000 11   Loquat                             1.000000   1.000  1.000
1100266000 11   Pear                               1.000000   1.000  1.000
1100267000 11   Pear, dried                        1.000000   6.250  1.000
1100268000 11   Pear, juice                        1.000000   1.000  1.000
1100268001 11   Pear, juice-babyfood               1.000000   1.000  1.000
1100266001 11   Pear-babyfood                      1.000000   1.000  1.000
1100310000 11   Quince                             1.000000   1.000  1.000
1202012000 12B  Apricot                            0.800000   1.000  1.000  Expected use on whole group
1202013000 12B  Apricot, dried                     0.800000   6.000  1.000  Expected use on whole group
1202014000 12B  Apricot, juice                     0.800000   1.000  1.000  Expected use on whole group
1202014001 12B  Apricot, juice-babyfood            0.800000   1.000  1.000  Expected use on whole group
1202012001 12B  Apricot-babyfood                   0.800000   1.000  1.000  Expected use on whole group
1201090000 12A  Cherry                             0.800000   1.000  1.000  Expected use on whole group
1201091000 12A  Cherry, juice                      0.800000   1.500  1.000  Expected use on whole group
1201091001 12A  Cherry, juice-babyfood             0.800000   1.500  1.000  Expected use on whole group
1201090001 12A  Cherry-babyfood                    0.800000   1.000  1.000  Expected use on whole group
1202230000 12B  Nectarine                          0.800000   1.000  1.000  Expected use on whole group
1202260000 12B  Peach                              0.800000   1.000  1.000
1202261000 12B  Peach, dried                       0.800000   7.000  1.000
1202261001 12B  Peach, dried-babyfood              0.800000   7.000  1.000
1202262000 12B  Peach, juice                       0.800000   1.000  1.000
1202262001 12B  Peach, juice-babyfood              0.800000   1.000  1.000
1202260001 12B  Peach-babyfood                     0.800000   1.000  1.000
1203285000 12C  Plum                               0.800000   1.000  1.000  Expected use on whole group
1203287000 12C  Plum, prune, dried                 0.800000   5.000  1.000  Expected use on whole group
1203287001 12C  Plum, prune, dried-babyfood        0.800000   5.000  1.000  Expected use on whole group
1203286000 12C  Plum, prune, fresh                 0.800000   1.000  1.000  Expected use on whole group
1203286001 12C  Plum, prune, fresh-babyfood        0.800000   1.000  1.000  Expected use on whole group
1203288000 12C  Plum, prune, juice                 0.800000   1.400  1.000  Expected use on whole group
1203288001 12C  Plum, prune, juice-babyfood        0.800000   1.400  1.000  Expected use on whole group
1203285001 12C  Plum-babyfood                      0.800000   1.000  1.000  Expected use on whole group
1301055000 13A  Blackberry                         0.040000   1.000  1.000  From Thiamethoxam
1301056000 13A  Blackberry, juice                  0.040000   1.000  1.000  From Thiamethoxam
1301056001 13A  Blackberry, juice-babyfood         0.040000   1.000  1.000  From Thiamethoxam
1302057000 13B  Blueberry                          0.050000   1.000  1.000  From Thiamethoxam
1302057001 13B  Blueberry-babyfood                 0.050000   1.000  1.000  From Thiamethoxam
1301058000 13A  Boysenberry                        0.040000   1.000  1.000  From Thiamethoxam
1307130000 13G  Cranberry                          0.010000   1.000  1.000
1307131000 13G  Cranberry, dried                   0.010000   1.000  1.000
1307132000 13G  Cranberry, juice                   0.010000   1.100  1.000
1307132001 13G  Cranberry, juice-babyfood          0.010000   1.100  1.000
1307130001 13G  Cranberry-babyfood                 0.010000   1.000  1.000
1302136000 13B  Currant                            0.050000   1.000  1.000  From Thiamethoxam
1302137000 13B  Currant, dried                     0.050000   1.000  1.000  From Thiamethoxam
1302149000 13B  Elderberry                         0.050000   1.000  1.000  From Thiamethoxam
1302174000 13B  Gooseberry                         0.050000   1.000  1.000  From Thiamethoxam
1304175000 13D  Grape                              0.600000   1.000  1.000
1304176000 13D  Grape, juice                       0.600000   1.200  1.000
1304176001 13D  Grape, juice-babyfood              0.600000   1.200  1.000
1304179000 13D  Grape, wine and sherry             0.600000   1.200  1.000
1302191000 13B  Huckleberry                        0.050000   1.000  1.000  From Thiamethoxam
1304195000 13D  Kiwifruit, fuzzy                   0.005000   1.000  1.000  From FHE Thiamethoxam
1301208000 13A  Loganberry                         0.040000   1.000  1.000  From Thiamethoxam
1303227000 13C  Mulberry                           0.005000   1.000  1.000  From FHE Thiamethoxam
1301320000 13A  Raspberry                          0.040000   1.000  1.000  From Thiamethoxam
1301321000 13A  Raspberry, juice                   0.040000   1.000  1.000  From Thiamethoxam
1301321001 13A  Raspberry, juice-babyfood          0.040000   1.000  1.000  From Thiamethoxam
1301320001 13A  Raspberry-babyfood                 0.040000   1.000  1.000  From Thiamethoxam
1307359000 13G  Strawberry                         1.500000   1.000  1.000   1E7923 (2012)
1307360000 13G  Strawberry, juice                  1.500000   1.000  1.000   1E7923 (2012)
1307360001 13G  Strawberry, juice-babyfood         1.500000   1.000  1.000   1E7923 (2012)
1307359001 13G  Strawberry-babyfood                1.500000   1.000  1.000   1E7923 (2012)
1400003000 14   Almond                             0.010000   1.000  1.000
1400004000 14   Almond, oil                        0.010000   1.000  1.000
1400004001 14   Almond, oil-babyfood               0.010000   1.000  1.000
1400003001 14   Almond-babyfood                    0.010000   1.000  1.000
1400059000 14   Brazil nut                         0.010000   1.000  1.000
1400068000 14   Butternut                          0.010000   1.000  1.000
1400081000 14   Cashew                             0.010000   1.000  1.000
1400092000 14   Chestnut                           0.010000   1.000  1.000
1400155000 14   Hazelnut                           0.010000   1.000  1.000
1400156000 14   Hazelnut, oil                      0.010000   1.000  1.000
1400185000 14   Hickory nut                        0.010000   1.000  1.000
1400213000 14   Macadamia nut                      0.010000   1.000  1.000
1400269000 14   Pecan                              0.010000   1.000  1.000
1400278000 14   Pine nut                           0.005000   1.000  1.000  From FHE Thiamethoxam
1400282000 14   Pistachio                          0.010000   1.000  1.000
1400391000 14   Walnut                             0.010000   1.000  1.000
1500027000 15   Barley, bran                       0.020000   1.000  1.000  From thiamethoxam
1500026000 15   Barley, flour                      0.020000   1.000  1.000  From thiamethoxam
1500026001 15   Barley, flour-babyfood             0.020000   1.000  1.000  From thiamethoxam
1500025000 15   Barley, pearled barley             0.020000   1.000  1.000  From thiamethoxam
1500025001 15   Barley, pearled barley-babyfood    0.020000   1.000  1.000  From thiamethoxam
1500065000 15   Buckwheat                          0.010000   1.000  1.000  Grain seed treatment
1500066000 15   Buckwheat, flour                   0.010000   1.000  1.000  Grain seed treatment
1500122000 15   Corn, field, bran                  0.010000   1.000  1.000
1500120000 15   Corn, field, flour                 0.010000   1.000  1.000
1500120001 15   Corn, field, flour-babyfood        0.010000   1.000  1.000
1500121000 15   Corn, field, meal                  0.010000   1.000  1.000
1500121001 15   Corn, field, meal-babyfood         0.010000   1.000  1.000
1500125000 15   Corn, field, oil                   0.010000   1.000  1.000
1500125001 15   Corn, field, oil-babyfood          0.010000   1.000  1.000
1500123000 15   Corn, field, starch                0.010000   1.000  1.000
1500123001 15   Corn, field, starch-babyfood       0.010000   1.000  1.000
1500124000 15   Corn, field, syrup                 0.010000   1.500  1.000
1500124001 15   Corn, field, syrup-babyfood        0.010000   1.500  1.000
1500126000 15   Corn, pop                          0.010000   1.000  1.000
1500127000 15   Corn, sweet                        0.010000   1.000  1.000
1500127001 15   Corn, sweet-babyfood               0.010000   1.000  1.000
1500226000 15   Millet, grain                      0.010000   1.000  1.000  Grain seed treatment
1500231000 15   Oat, bran                          0.010000   1.000  1.000  Grain seed treatment
1500232000 15   Oat, flour                         0.010000   1.000  1.000  Grain seed treatment
1500232001 15   Oat, flour-babyfood                0.010000   1.000  1.000  Grain seed treatment
1500233000 15   Oat, groats/rolled oats            0.010000   1.000  1.000  Grain seed treatment
1500233001 15   Oat, groats/rolled oats-babyfood   0.010000   1.000  1.000  Grain seed treatment
1500326000 15   Rice, bran                         0.010000   1.000  1.000
1500326001 15   Rice, bran-babyfood                0.010000   1.000  1.000
1500324000 15   Rice, brown                        0.010000   1.000  1.000
1500324001 15   Rice, brown-babyfood               0.010000   1.000  1.000
1500325000 15   Rice, flour                        0.010000   1.000  1.000
1500325001 15   Rice, flour-babyfood               0.010000   1.000  1.000
1500323000 15   Rice, white                        0.010000   1.000  1.000
1500323001 15   Rice, white-babyfood               0.010000   1.000  1.000
1500329000 15   Rye, flour                         0.010000   1.000  1.000  Grain seed treatment
1500328000 15   Rye, grain                         0.010000   1.000  1.000  Grain seed treatment
1500344000 15   Sorghum, grain                     0.010000   1.000  1.000
1500345000 15   Sorghum, syrup                     0.010000   1.000  1.000
1500381000 15   Triticale, flour                   0.010000   1.000  1.000  Grain seed treatment
1500381001 15   Triticale, flour-babyfood          0.010000   1.000  1.000  Grain seed treatment
1500404000 15   Wheat, bran                        0.010000   1.000  1.000
1500402000 15   Wheat, flour                       0.010000   1.000  1.000
1500402001 15   Wheat, flour-babyfood              0.010000   1.000  1.000
1500403000 15   Wheat, germ                        0.010000   1.000  1.000
1500401000 15   Wheat, grain                       0.010000   1.000  1.000
1500401001 15   Wheat, grain-babyfood              0.010000   1.000  1.000
1500405000 15   Wild rice                          0.010000   1.000  1.000  Grain seed treatment
1800002000 18   Alfalfa, seed                      0.005000   1.000  1.000  From FHE Thiamethoxam
1901029000 19A  Basil, dried leaves                0.005000   1.000  1.000  From FHE Thiamethoxam
1901029001 19A  Basil, dried leaves-babyfood       0.005000   1.000  1.000  From FHE Thiamethoxam
1901028000 19A  Basil, fresh leaves                0.005000   1.000  1.000  From FHE Thiamethoxam
1901028001 19A  Basil, fresh leaves-babyfood       0.005000   1.000  1.000  From FHE Thiamethoxam
1901118000 19A  Cilantro, leaves                   0.005000   1.000  1.000  From FHE Thiamethoxam
1901118001 19A  Cilantro, leaves-babyfood          0.005000   1.000  1.000  From FHE Thiamethoxam
1902105000 19B  Cinnamon                           0.005000   1.000  1.000  From FHE Thiamethoxam
1902105001 19B  Cinnamon-babyfood                  0.005000   1.000  1.000  From FHE Thiamethoxam
1902119000 19B  Coriander, seed                    0.005000   1.000  1.000  From FHE Thiamethoxam
1902119001 19B  Coriander, seed-babyfood           0.005000   1.000  1.000  From FHE Thiamethoxam
1902143000 19B  Dill, seed                         0.005000   1.000  1.000  From FHE Thiamethoxam
1901144000 19A  Dillweed                           0.005000   1.000  1.000  From FHE Thiamethoxam
1901184000 19A  Herbs, other                       0.005000   1.000  1.000  From FHE Thiamethoxam
1901184001 19A  Herbs, other-babyfood              0.005000   1.000  1.000  From FHE Thiamethoxam
1901202000 19A  Lemongrass                         0.005000   1.000  1.000  From FHE Thiamethoxam
1901220000 19A  Marjoram                           0.005000   1.000  1.000  From FHE Thiamethoxam
1901220001 19A  Marjoram-babyfood                  0.005000   1.000  1.000  From FHE Thiamethoxam
1901249000 19A  Parsley, dried leaves              0.005000   1.000  1.000  From FHE Thiamethoxam
1901249001 19A  Parsley, dried leaves-babyfood     0.005000   1.000  1.000  From FHE Thiamethoxam
1902274000 19B  Pepper, black and white            0.005000   1.000  1.000  From FHE Thiamethoxam
1902274001 19B  Pepper, black and white-babyfood   0.005000   1.000  1.000  From FHE Thiamethoxam
1901334000 19A  Savory                             0.005000   1.000  1.000  From FHE Thiamethoxam
1902354000 19B  Spices, other                      0.005000   1.000  1.000  From FHE Thiamethoxam
1902354001 19B  Spices, other-babyfood             0.005000   1.000  1.000  From FHE Thiamethoxam
2003114001 20C  Coconut, oil-babyfood              0.005000   1.000  1.000  From FHE Thiamethoxam
2003128000 20C  Cottonseed, oil                    0.200000   1.000  1.000
2003128001 20C  Cottonseed, oil-babyfood           0.200000   1.000  1.000
2001163000 20A  Flax seed, oil                     0.010000   1.000  1.000
2001319000 20A  Rapeseed, oil                      0.010000   1.000  1.000
2001319001 20A  Rapeseed, oil-babyfood             0.010000   1.000  1.000
2002330000 20B  Safflower, oil                     0.010000   1.000  1.000
2002330001 20B  Safflower, oil-babyfood            0.010000   1.000  1.000
2001337000 20A  Sesame, oil                        0.005000   1.000  1.000  From FHE Thiamethoxam
2001337001 20A  Sesame, oil-babyfood               0.005000   1.000  1.000  From FHE Thiamethoxam
2001336000 20A  Sesame, seed                       0.005000   1.000  1.000  From FHE Thiamethoxam
2001336001 20A  Sesame, seed-babyfood              0.005000   1.000  1.000  From FHE Thiamethoxam
2002365000 20B  Sunflower, oil                     0.010000   1.000  1.000
2002365001 20B  Sunflower, oil-babyfood            0.010000   1.000  1.000
2002364000 20B  Sunflower, seed                    0.010000   1.000  1.000
2100228000 21   Mushroom                           0.005000   1.000  1.000  From FHE Thiamethoxam
3100047000 31   Beef, fat                          0.005000   1.000  1.000  From FHE Thiamethoxam
3100047001 31   Beef, fat-babyfood                 0.005000   1.000  1.000  From FHE Thiamethoxam
3100048000 31   Beef, kidney                       0.010000   1.000  1.000  From thiamethoxam
3100049000 31   Beef, liver                        0.010000   1.000  1.000  From thiamethoxam
3100049001 31   Beef, liver-babyfood               0.010000   1.000  1.000  From thiamethoxam
3100044000 31   Beef, meat                         0.010000   1.000  1.000  From thiamethoxam
3100046000 31   Beef, meat byproducts              0.010000   1.000  1.000  From thiamethoxam
3100046001 31   Beef, meat byproducts-babyfood     0.010000   1.000  1.000  From thiamethoxam
3100045000 31   Beef, meat, dried                  0.010000   1.920  1.000  From thiamethoxam
3100044001 31   Beef, meat-babyfood                0.010000   1.000  1.000  From thiamethoxam
3200171000 32   Goat, fat                          0.005000   1.000  1.000  From FHE Thiamethoxam
3200172000 32   Goat, kidney                       0.010000   1.000  1.000  From thiamethoxam
3200173000 32   Goat, liver                        0.010000   1.000  1.000  From thiamethoxam
3200169000 32   Goat, meat                         0.010000   1.000  1.000  From thiamethoxam
3200170000 32   Goat, meat byproducts              0.010000   1.000  1.000  From thiamethoxam
3300189000 33   Horse, meat                        0.010000   1.000  1.000  From thiamethoxam
3400293000 34   Pork, fat                          0.005000   1.000  1.000  From FHE Thiamethoxam
3400293001 34   Pork, fat-babyfood                 0.005000   1.000  1.000  From FHE Thiamethoxam
3400294000 34   Pork, kidney                       0.010000   1.000  1.000  From thiamethoxam
3400295000 34   Pork, liver                        0.010000   1.000  1.000  From thiamethoxam
3400290000 34   Pork, meat                         0.010000   1.000  1.000  From thiamethoxam
3400292000 34   Pork, meat byproducts              0.010000   1.000  1.000  From thiamethoxam
3400292001 34   Pork, meat byproducts-babyfood     0.010000   1.000  1.000  From thiamethoxam
3400290001 34   Pork, meat-babyfood                0.010000   1.000  1.000  From thiamethoxam
3400291000 34   Pork, skin                         0.005000   1.000  1.000  From FHE Thiamethoxam
3500341000 35   Sheep, fat                         0.005000   1.000  1.000  From FHE Thiamethoxam
3500341001 35   Sheep, fat-babyfood                0.005000   1.000  1.000  From FHE Thiamethoxam
3500342000 35   Sheep, kidney                      0.010000   1.000  1.000  From thiamethoxam
3500343000 35   Sheep, liver                       0.010000   1.000  1.000  From thiamethoxam
3500339000 35   Sheep, meat                        0.010000   1.000  1.000  From thiamethoxam
3500340000 35   Sheep, meat byproducts             0.010000   1.000  1.000  From thiamethoxam
3500339001 35   Sheep, meat-babyfood               0.010000   1.000  1.000  From thiamethoxam
3600222000 36   Milk, fat                          0.010000   1.500  1.000   1.5 factor to account for metabolites
3600222001 36   Milk, fat-baby food/infant formu   0.010000   1.500  1.000   1.5 factor to account for metabolites
3600223000 36   Milk, nonfat solids                0.010000   1.500  1.000   1.5 factor to account for metabolites
3600223001 36   Milk, nonfat solids-baby food/in   0.010000   1.500  1.000   1.5 factor to account for metabolites
3600225001 36   Milk, sugar (lactose)-baby food/   0.010000   1.500  1.000   1.5 factor to account for metabolites
3600224000 36   Milk, water                        0.010000   1.500  1.000   1.5 factor to account for metabolites
3600224001 36   Milk, water-babyfood/infant form   0.010000   1.500  1.000   1.5 factor to account for metabolites
3800221000 38   Meat, game                         0.010000   1.000  1.000  From thiamethoxam
3900312000 39   Rabbit, meat                       0.010000   1.000  1.000  From thiamethoxam
4000096000 40   Chicken, fat                       0.005000   1.000  1.000  From FHE Thiamethoxam
4000096001 40   Chicken, fat-babyfood              0.005000   1.000  1.000  From FHE Thiamethoxam
4000094000 40   Chicken, liver                     0.005000   1.000  1.000  From FHE Thiamethoxam
4000093000 40   Chicken, meat                      0.005000   1.000  1.000  From FHE Thiamethoxam
4000095000 40   Chicken, meat byproducts           0.005000   1.000  1.000  From FHE Thiamethoxam
4000095001 40   Chicken, meat byproducts-babyfoo   0.005000   1.000  1.000  From FHE Thiamethoxam
4000093001 40   Chicken, meat-babyfood             0.005000   1.000  1.000  From FHE Thiamethoxam
4000097000 40   Chicken, skin                      0.005000   1.000  1.000  From FHE Thiamethoxam
4000097001 40   Chicken, skin-babyfood             0.005000   1.000  1.000  From FHE Thiamethoxam
5000385000 50   Turkey, fat                        0.005000   1.000  1.000  From FHE Thiamethoxam
5000385001 50   Turkey, fat-babyfood               0.005000   1.000  1.000  From FHE Thiamethoxam
5000383000 50   Turkey, liver                      0.005000   1.000  1.000  From FHE Thiamethoxam
5000383001 50   Turkey, liver-babyfood             0.005000   1.000  1.000  From FHE Thiamethoxam
5000382000 50   Turkey, meat                       0.005000   1.000  1.000  From FHE Thiamethoxam
5000384000 50   Turkey, meat byproducts            0.005000   1.000  1.000  From FHE Thiamethoxam
5000384001 50   Turkey, meat byproducts-babyfood   0.005000   1.000  1.000  From FHE Thiamethoxam
5000382001 50   Turkey, meat-babyfood              0.005000   1.000  1.000  From FHE Thiamethoxam
5000386000 50   Turkey, skin                       0.005000   1.000  1.000  From FHE Thiamethoxam
5000386001 50   Turkey, skin-babyfood              0.005000   1.000  1.000  From FHE Thiamethoxam
6000304000 60   Poultry, other, fat                0.005000   1.000  1.000  From FHE Thiamethoxam
6000302000 60   Poultry, other, liver              0.005000   1.000  1.000  From FHE Thiamethoxam
6000301000 60   Poultry, other, meat               0.005000   1.000  1.000  From FHE Thiamethoxam
6000303000 60   Poultry, other, meat byproducts    0.005000   1.000  1.000  From FHE Thiamethoxam
6000305000 60   Poultry, other, skin               0.005000   1.000  1.000  From FHE Thiamethoxam
7000146000 70   Egg, white                         0.005000   1.000  1.000  From FHE Thiamethoxam
7000146001 70   Egg, white (solids)-babyfood       0.005000   1.000  1.000  From FHE Thiamethoxam
7000145000 70   Egg, whole                         0.005000   1.000  1.000  From FHE Thiamethoxam
7000145001 70   Egg, whole-babyfood                0.005000   1.000  1.000  From FHE Thiamethoxam
7000147000 70   Egg, yolk                          0.005000   1.000  1.000  From FHE Thiamethoxam
7000147001 70   Egg, yolk-babyfood                 0.005000   1.000  1.000  From FHE Thiamethoxam
8000157000 80   Fish-freshwater finfish            0.005000   1.000  1.000  From FHE Thiamethoxam
8000158000 80   Fish-freshwater finfish, farm ra   0.005000   1.000  1.000  From FHE Thiamethoxam
8000160000 80   Fish-saltwater finfish, other      0.005000   1.000  1.000  From FHE Thiamethoxam
8000159000 80   Fish-saltwater finfish, tuna       0.005000   1.000  1.000  From FHE Thiamethoxam
8000161000 80   Fish-shellfish, crustacean         0.005000   1.000  1.000  From FHE Thiamethoxam
8000162000 80   Fish-shellfish, mollusc            0.005000   1.000  1.000  From FHE Thiamethoxam
8601000000 86A  Water, direct, all sources         0.072000   1.000  1.000  Based on Rice Use
8602000000 86B  Water, indirect, all sources       0.072000   1.000  1.000  Based on Rice Use

Attachment 2.  Summary of the Results of the Acute Dietary Exposure Assessment of Clothianidin.

Health Effects Division OPP EPA                             Ver. 3.16, 03-08-d
DEEM-FCID ACUTE Analysis for CLOTHIANIDIN                NHANES 2003-2008 2-Day
Residue file: 044309 (2012).R08                   Adjustment factor #2 NOT used.
Analysis Date: 09-27-2012/10:31:30    Residue file dated: 09-27-2012/10:29:09
RAC/FF intake summed over 24 hours
Run Comment: ""
===============================================================================

Summary calculations--per capita:

                   95th Percentile      99th Percentile     99.9th Percentile
                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD
                  ---------- --------  ---------- --------  ---------- --------
Total US Population:
                    0.020913     8.37    0.042688    17.08    0.090403    36.16
All Infants:
                    0.051461    20.58    0.083284    33.31    0.148482    59.39
Children 1-2:
                    0.069586    27.83    0.112708    45.08    0.191457    76.58
Children 3-5:
                    0.048260    19.30    0.071642    28.66    0.108357    43.34
Children 6-12:
                    0.024264     9.71    0.039843    15.94    0.071398    28.56
Youth 13-19:
                    0.014341     5.74    0.021983     8.79    0.038829    15.53
Adults 20-49:
                    0.015090     6.04    0.022554     9.02    0.035057    14.02
Adults 50-99:
                    0.014403     5.76    0.020962     8.38    0.029246    11.70
Female 13-49:
                    0.015390     6.16    0.022581     9.03    0.035021    14.01

Attachment 3.  Summary of the Results of the Chronic Dietary Exposure Assessment of Clothianidin.

Health Effects Division OPP EPA                                 Ver. 3.16, 03-08-d
DEEM-FCID Chronic analysis for CLOTHIANIDIN                NHANES 2003-2008 2-day
Residue file name: C:\Documents and Settings\mdoherty\My Documents\Chemistry Reviews\!DEEM Runs\Clothianidin\2012\044309 (2012).R08
                                                 Adjustment factor #2 NOT used.
Analysis Date 09-27-2012/10:30:23     Residue file dated: 09-27-2012/10:29:09
Reference dose (RfD, Chronic) = .098 mg/kg bw/day
===============================================================================
                    Total exposure by population subgroup
-------------------------------------------------------------------------------

                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg             Percent of
           Subgroup                       body wt/day             Rfd
--------------------------------------   -------------       ----------------
Total US Population                         0.007458                 7.6%
Hispanic                                    0.008116                 8.3%
Non-Hisp-White                              0.007316                 7.5%
Non-Hisp-Black                              0.007063                 7.2%
Non-Hisp-Other                              0.008579                 8.8%
Nursing Infants                             0.009356                 9.5%
Non-Nursing Infants                         0.019955                20.4%
Female 13+ PREG                             0.006687                 6.8%
Children 1-6                                0.020830                21.3%
Children 7-12                               0.008313                 8.5%
Male 13-19                                  0.005242                 5.3%
Female 13-19/NP                             0.005442                 5.6%
Male 20+                                    0.005572                 5.7%
Female 20+/NP                               0.006255                 6.4%
Seniors 55+                                 0.006109                 6.2%
All Infants                                 0.016683                17.0%
Female 13-50                                0.005986                 6.1%
Children 1-2                                0.027256                27.8%
Children 3-5                                0.018444                18.8%
Children 6-12                               0.009165                 9.4%
Youth 13-19                                 0.005346                 5.5%
Adults 20-49                                0.005822                 5.9%
Adults 50-99                                0.006109                 6.2%
Female 13-49                                0.005974                 6.1%

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


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as the wife of a consumer of vape products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited.  As a consumer, I do not get paid to work on my responses - I have to do them during my very little free time.  I have already spent many hours researching and dissecting these issues, but thoughtful consideration of my responses as well as my research takes time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my husband's life.  Reducing smoking by offering attractive alternatives to cigarettes is imperative to the overall health of our nation.  I wish to provide you with my personal story, as well as science-based and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request, and I am happy to discuss this issue with you further.


[Federal Register: May 4, 2010 (Volume 75, Number 85)]
[Notices]
[Page 23825-23827]
[DOCID:fr04my10-135]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61991; File No. SR-NASDAQ-2010-050]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by the NASDAQ Stock Market LLC
Relating to the Opening of Trading in the NASDAQ Options Market

April 27, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 15, 2010, The NASDAQ Stock Market LLC (``Nasdaq'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    Nasdaq is filing a proposal for the NASDAQ Options Market (``NOM''
or ``Exchange'') to to [sic] modify Chapter VI, Section 8 of the
Exchange's rules, dealing with the Nasdaq Opening Cross.
    The text of the proposed rule change is available from Nasdaq's Web
site at http://nasdaq.cchwallstreet.com, at Nasdaq's principal office,
and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    Nasdaq proposes to modify Chapter VI, Section 8 of the rules
governing NOM, and in particular governing the opening of trading in
that market. Currently, pursuant to Chapter VI, Section 8(b) of NOM's
rules, the Nasdaq Opening Cross occurs once certain preconditions are
met. Section 8(b) of Chapter VI permits the Opening Cross to occur at
or after 9:30 if there is no Imbalance \3\, if the dissemination of a
quote or trade by the Market for the Underlying Security \4\ has
occurred (or, in the case of index options, the Exchange has received
the opening price of the underlying index) and if a certain number (as
the Exchange may determine from time to time) of other options
exchanges have disseminated a firm quote on the Options Price Reporting
Authority (``OPRA'').\5\
---------------------------------------------------------------------------

    \3\ ``Imbalance'' is defined in Section 8(a)(1) of Chapter VI as
the number of contracts of Eligible Interest that may not be matched
with other order contracts at a particular price at any given time.
    \4\ Section 8(a)(5) of Chapter VI defines ``Market for the
Underlying Security'' as meaning either the primary listing market,
the primary volume market (defined as the market with the most
liquidity in that underlying security for the previous two calendar
months), or the first market to open the underlying security, as
determined by the Exchange on an issue-by-issue basis and announced
to the membership on the Exchange's Web site.
    \5\ If all the conditions specified in Section 8(b) of Chapter
VI have been met except that there is an Imbalance, Section 8(b)(5)
requires one additional Order Imbalance Indicator message to be
disseminated, after which the Opening Cross occurs, executing the
maximum number of contracts. Any remaining Imbalance that is not
executable in the Opening Cross is canceled.
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    Section 8(c) of Chapter VI governs situations in which the
requisite number of firm quotes have not been disseminated for an
option by other options exchanges. No Opening Cross will occur if firm
quotes are not disseminated for an option by the predetermined number
of options exchanges until such time during the day that the Exchange
determines. In that case, provided dissemination of a quote or trade by
the Market for the Underlying Security has occurred (or, in the case of
index options, the Exchange has received the opening price of the
underlying index) the option will open for trading.\6\
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    \6\ If there is interest in the Opening Cross, the option will
not open for trading in that option until the orders that would be
executed in the Opening Cross are resolved through the cancellation
or modification of the orders by the entering party or parties.
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    The Exchange is proposing to amend both Section 8(b) and 8(c) of
Chapter VI to clarify in each case that the dissemination of a quote or
trade by the Market for the Underlying Security must occur during
regular trading hours in order for the NOM opening cross to occur in
that option. These amendments would establish clearly that this
precondition for opening trading in an option on NOM would not be met
if, for example, the Market for the Underlying Security were to both
open and then halt trading prior to regular trading hours which
currently begin at 9:30 a.m.
    The Exchange is also proposing to amend Section 8(c)(2) of Chapter
VI to clarify that if opening quotes or orders lock or cross each other
such that an Opening Cross can be initiated, the Exchange may open for
trading in that option even if the orders that would be executed in the
Opening Cross are not cancelled or modified so that they no longer lock
or cross each other, if and when the number of options exchanges
required under the introductory language of Section 8(b) of Chapter VI
for the opening of trading of System securities have disseminated a
firm quote on OPRA. This amendment will not make a change in the
operation of the trading system, but will merely clarify the intended
NOM opening process.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \7\ in general, and furthers the objectives of Section
6(b)(5) of the Act \8\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest.
Nasdaq believes that the proposal is consistent with this standard
because the proposed rule change is designed to clarify its rules for
the benefit of all market participants.
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.

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

    No written comments were either solicited or received.

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

    The Exchange believes that the foregoing proposed rule change may
take effect upon filing with the Commission pursuant to Section
19(b)(3)(A) of the Act \9\ and Rule 19b-4(f)(6) \10\ thereunder because
the foregoing proposed rule change does not: (i) Significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days after the date of the filing, or such shorter time as the
Commission may designate.
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    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
Nasdaq has satisfied this requirement.
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2010-050 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2010-050. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission,\11\ all subsequent
amendments, all written statements with respect to the proposed rule
change that are filed with the Commission, and all written
communications relating to the proposed rule change between the
Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for Web site viewing and printing in the Commission's Public
Reference Room, on official business days between the hours of 10 a.m.
and 3 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2010-050 and should
be submitted on or before May 25, 2010.
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    \11\ The text of the proposed rule change is available on the
Commission's Web site at http://www.sec.gov/rules/sro.shtml.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2010-10275 Filed 5-3-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register Volume 75, Number 240 (Wednesday, December 15, 2010)]
[Notices]
[Pages 78239-78240]
[FR Doc No: 2010-31481]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OEI-2010-0746; FRL-9239-5]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Confidentiality Rules (Renewal);
EPA ICR No. 1665.10, OMB Control No. 2020-0003

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that an Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval. This is a request to renew an
existing approved collection. The ICR, which is abstracted below,
describes the nature of the information collection and its estimated
burden and cost.

DATES: Additional comments may be submitted on or before January 18,
2011.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OEI-
2010-0746 to (1) EPA online using www.regulations.gov (our preferred
method), by e-mail to<EMAIL_ADDRESS>or by mail to: EPA Docket
Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Avenue, NW., Washington, DC 20460 and (2) OMB by mail to:
Office of Information and Regulatory Affairs, Office of Management and
Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Larry F. Gottesman, National Freedom
of Information Act Officer, Collection Strategies Division, Office of
Information Collection, Mail Code 2822T, Environmental Protection
Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On September 28, 2010, (75 FR 59708), EPA sought comments on
this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
comments on this ICR should be submitted to EPA and OMB within 30 days
of this notice.
    EPA has established a public docket for this ICR under Docket ID.
No. EPA-HQ-OEI-2010-0746, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Office of
Environmental Information Docket in the EPA Docket Center (EPA/DC), EPA
West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC. The
EPA/DC Public Reading Room is open from 8 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Reading Room is<PHONE_NUMBER>, and the telephone number for the Office
of Environmental Information Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA
receives them and without change, unless the comment contains
copyrighted material, Confidential Business Information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://www.regulations.gov.
    Title: Confidentiality Rules (Renewal).
    ICR numbers: EPA ICR No. 1665.10, OMB Control No. 2020-0003.
    ICR Status: This ICR is scheduled to expire on December 31, 2010.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: In the course of administering environmental protection
statutes, EPA collects data from thousands of facilities in many
sectors of the U.S. economy. In many cases, industry marks the data it
submits to EPA as CBI. In addition, businesses

submit information to EPA without the Agency requesting the
information. EPA established the procedures described in 40 CFR part 2,
subparts A and B, to protect the confidentiality of information as well
as the rights of the public to obtain access to information under the
Freedom of Information Act (FOIA). In accordance with these
regulations, when EPA finds it necessary to make a final
confidentiality determination (e.g., in response to a FOIA request or
in the course of rulemaking or litigation), or in advance
confidentiality determination, it shall notify the affected business
and provides an opportunity to comment (i.e., to submit a
substantiation of confidentiality claim). This ICR relates to the
collection of information that will assist EPA in determining whether
previously submitted information is entitled to confidential treatment.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 1.5
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Entities potentially affected by
this action are businesses and other for-profit companies.
    Estimated Number of Respondents: 1,320.
    Frequency of Response: 1 per year.
    Estimated Total Annual Hour Burden: 1,992.30 hours.
    Estimated Total Annual Cost: $88,825.25 includes $0 annualized
capital or O&M costs.
    Changes in the Estimates: There has been a decrease of 10 hours in
the estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens.

    Dated: December 9, 2010.
John Moses,
Director, Collection Strategies Division.
[FR Doc. 2010-31481 Filed 12-14-10; 8:45 am]
BILLING CODE 6560-50-P