  SEQ CHAPTER \h \r 1

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:  	26-FEB-2009

SUBJECT:	Pyrimethanil: Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for the Section 3 Registration on New Postharvest Uses on Stone Fruits Crop Group 12 and a Preharvest Use on Lemon (Citrus Fruits Crop Group 10) (PP#8E7353).

PC Code:  288201	DP Barcode:  D362715

Decision No.:  393117	Registration No.:  642719-375

Petition No.:  8E7353 	Regulatory Action:  Section 3

Risk Assessment Type: Dietary	Case No.:  NA

TXR No.:   NA	CAS No.:  53112-28-0

MRID No.:  NA	40 CFR:  §180.518

REVIEWER:	Wesley C. Carr, Jr., Associate Toxicologist

Medical Toxicology Branch

California Department of Pesticide Regulation

THROUGH:	Joyce Gee, Ph.D., Senior Toxicologist

Medical Toxicology Branch

		California Department of Pesticide Regulation

And

		William Cutchin, Acting Senior Branch Scientist

Debra Rate, Ph.D., Biologist

ARIA Team

Risk Integration Minor Use, Inerts, Emergency Response Branch (RIMUERB)

Registration Division (RD; 7505P)

TO:		John Redden, Team Leader

ARIA Team

RIMUERB/RD (7505P)

and

Debra Rate, Ph.D., Biologist

ARIA Team

RIMUERB/RD (7505P)

Executive Summary

Aggregate (food + water) acute and chronic dietary exposure and risk assessments were conducted for the general U.S. population and various population subgroups using the Dietary Exposure Evaluation Model - Food Consumption Intake Database (DEEM-FCID(, ver. 2.03) model.  This model uses food consumption data from the United States Department of Agriculture’s (USDA’s) Continuing Surveys of Food Intakes by Individuals (CSFII; 1994-1996 and 1998).  The analyses were performed to support an amended Section 3 registration for use of the fungicide pyrimethanil [4,6-dimethyl-N-phenyl-2-pyrimidinamine] in/on stone fruits and citrus fruits.

Acute Dietary Exposure Results and Characterization

The unrefined acute assessment assumed that pyrimethanil residues are present in all commodities at tolerance levels and that 100% of all crops are treated.  DEEM™ Version 7.81 default processing factors were used to estimate residues in dried fruit (apricot, peach, prune and raisin) and fruit juices (cherry, grape and prune).  Drinking water was incorporated directly into the dietary assessment using the estimated drinking water concentration (EDWC) generated by the Pesticide Root Zone Model (PRZM)/ and Exposure Analysis Modeling System (EXAMS) and Screening Concentration in Ground Water (SCI-GROW) water models.

The resulting acute dietary exposure estimates for food and water combined are well below ARIA’s level of concern (i.e., <100% of the acute population-adjusted dose (aPAD) of 1.0 mg/kg bw/day) for the general U.S. population and all population subgroups except females 13-49 years of age.  Additionally, the acute dietary exposure estimates for food and water combined are below ARIA’s level of concern (i.e., <100% of the aPAD of 0.45 mg/kg bw/day) for the females 13-49 years of age population subgroup.  Using the DEEM-FCID software, dietary exposure is estimated at 0.097656 mg/kg/day for the general U.S. population (ca. 10% of the aPAD), 0.349407 mg/kg/day (ca. 35% of the aPAD) for all infants <1 years old, the population subgroup with the highest estimated acute dietary exposure to pyrimethanil and 0.057646 mg/kg/day for the females 13-49 years of age population (ca. 13% of the aPAD).  Therefore, the acute dietary risk assessment shows that for all included commodities plus drinking water, the acute dietary risk estimates are below ARIA’s level of concern for the general population subgroups and females 13-49 years of age (i.e. <100% aPAD).

Chronic Dietary Exposure Results and Characterization

The unrefined acute and chronic assessments assumed that pyrimethanil residues are present in all commodities at tolerance levels and that 100% of all crops are treated.  DEEM™ Version 7.81 default processing factors were used to estimate residues in dried fruit (apricot, peach, prune and raisin) and fruit juices (cherry, grape and prune).  As in the acute scenario, drinking water was incorporated directly into the chronic dietary assessment using the EDWC values generated by the PRZM/EXAMS and SCI-GROW ground water models.

The resulting chronic dietary exposure estimates for food and water combined are well below ARIA’s level of concern (i.e., <100% of the chronic population-adjusted dose (cPAD) of 0.2 mg/kg bw/day) for the overall U.S. population and all population subgroups.  Using the DEEM-FCID software, dietary exposure is estimated at 0.022477 mg/kg/day for the general U.S. population (13% of the cPAD) and 0.106869 mg/kg/day (ca. 63% of the cPAD) for children 1 to 2 years old, the population subgroup with the highest estimated chronic dietary exposure to pyrimethanil.  The chronic dietary risk assessment shows that for all included commodities plus drinking water, the chronic dietary risk estimates are below ARIA’s level of concern (i.e. <100% cPAD).

Cancer

A separate cancer dietary assessment was not conducted for pyrimethanil as the chronic assessment is considered protective for carcinogenic effects.  The margin of exposure (MOE) for the cancer assessment is 760 which is below the level of concern to ARIA/HED (MOE >100).

Generally, for threshold cancer effects where the mode of action is well understood, like thyroid carcinogens such as pyrimethanil, the MOE that indicates a reasonable certainty of no harm would be 100 (representing 2 factors of 10x for inter-species and intra-species extrapolation).

The most recent previous dietary risk assessment for pyrimethanil was conducted by W. Wassell (6/03/2008, DP# 352813).

I.  Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic (non-cancer) 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, NOAEL).  This dose is referred to as the PAD.  The PAD is equivalent to the point of departure (POD, NOAEL, LOAEL) divided by the required uncertainty factors (UFs).

For acute and chronic (cancer and non-cancer) exposures, ARIA/HED is concerned when estimated dietary risk exceeds 100% of the PAD for acute and non-cancer chronic assessment and MOEs of less than 100 for cancer assessment.  References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site:  “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 21-JUN-2000, web link:      HYPERLINK "http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf"  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf  ; or see SOP 99.6 (20-AUG-1999).

Generally, for threshold cancer effects where the mode of action is well understood, like thyroid carcinogens such as pyrimethanil, the MOE that indicates a reasonable certainty of no harm would be 100 (representing 2 factors of 10x for inter-species and intra-species extrapolation).

The most recent previous dietary risk assessment for pyrimethanil was conducted by W. Wassell (6/03/2008, DP# 352813).  Additionally, there was an earlier pyrimethanil dietary risk assessment conducted by T. Bloem (3/25/2004, DP# 300631).

II.  Residue Information

Residues of Concern in Plants and Livestock:  Table 1 is a summary of the HED Metabolism Assessment Review Committee (MARC) decisions concerning the residues of concern in plants, ruminants, and milk for tolerance expression and risk assessment purposes (Memo, 1/12/2004, J. Morales, et al., DP# 248001).

Table 1. Residues of Concern in Plants and Ruminants.

Matrix

Residues of Concern

For Risk Assessment

For Tolerance Expression

Plants

Parent Only

Parent Only

Ruminant

Parent + AEC614276

Parent + AEC614276

Milk

Parent + AEC614277

Parent + AEC614277

Pyrimethanil tolerances are published in 40 CFR §180.518.  Tolerances are established (40 CFR §180.518(a)(1)) for residues of pyrimethanil in or on the following raw agricultural commodities (RACs):

Table 2.  Existing Tolerances (40 CFR §180.518(a)(1)) for Residues of Pyrimethanil.

Commodity	Establish Tolerance level (ppm)

Almond	0.20

Almond, hulls	12

Apple, wet pomace	40

Banana	0.10

Citrus oil	150

Citrus Fruit (group 10)	10

Pome Fruit (group 11)	14.0

Stone Fruit (group 12)	3.0

Grape	5.0

Grape, raisin	8.0

Onion, bulb	0.10

Onion, green	2.0

Pistachio	0.20

Strawberry	3.0

Tomato	0.50

Tuberous and Corm Vegetables (subgroup 1C)	0.05

Tolerances are established (40 CFR §180.518(a)(2)) for residues of pyrimethanil and its metabolite AEC614276 [4-{4,6-dimethyl-2-pyrimidinyl)amino]phenol] in or on the RACs:

Table 3.  Existing Tolerances (40 CFR §180.518(a)(2)) for Residues of

Pyrimethanil and Its Metabolite AEC614276

Commodity	Establish Tolerance level (ppm)

Fat1	0.01

Kidney1	2.5

Meat1	0.01

Meat byproduct (except kidney)1	0.01

1 of cattle, goats, horse, and sheep

Finally, tolerances are established (40 CFR §180.518(a)(3)) for residues of pyrimethanil and its metabolite AEC614277 [4,6-dimethyl-2-(phenylamino)-pyrimidinol] in or on milk at 0.05 ppm.

Recommended Tolerances:   The current petition recommends the tolerances for residues on citrus fruits group 10 should be increased from 10 ppm to 11 ppm; and stone fruits group 12 should be increased from 3.0 to 10 ppm.

IR-4 has proposed new / modified tolerances for residues of pyrimethanil in or on the following commodities: citrus fruit, group 10; and stone fruits group 12.  The California Department of Pesticide Regulation and ARIA have reviewed residue data submitted (Table 4) to support these tolerances and concluded that the following tolerances are appropriate [DP# 361301, D. Rate, in process].

Table 4.  Summary of Recommended Tolerances for Pyrimethanil

Crop Commodity

Recommended Tolerance (ppm)

Citrus Fruit, Group 10 	11.0

Stone Fruit, Group 12	10.0

Food Residues and processing factors used in the Acute and Chronic Analysis:  The acute and chronic analyses assumed DEEM( (ver. 7.81) default processing factors (as necessary), empirical processing factors for orange and apple juice, tolerance-level residues, and 100% crop-treated (CT) for all commodities.  The empirical processing factors for orange juice and apple juice can be found in DP# 248001 (Memo, 1/12/2004, J. Morales, et al., PP No. 2F06439 & PP No. 2F06480).

  Drinking Water Data

The Environment Fate and Effects Division (EFED) reassessed pyrimethanil for the proposed new uses presented in this memo.  None of the new proposed use scenarios exceeded the estimated drinking water concentrations presented in the memo “Pyrimethanil.  Application for Amended Section 3 Registration of Xedathane A for Postharvest Use on Pome Fruits by Thermafog Application; Acute and Chronic Dietary Exposure and Risk Assessment” (DP# 352813, W. Wassell; 6/03/2008).  EFED studies indicated that pyrimethanil is expected to be moderately persistent in the environment.  Aerobic metabolism is expected to be the major route of degradation for pyrimethanil in the environment.  The only major degradate is 2-amino-4,6-dimethylpyrimidine (degradate 1).  Although it may be less toxic than the parent, degradate 1 is expected to be more mobile and more persistent in the environment than the parent.  MARC recommended that parent and degradate 1 are the residues of concern for drinking water.

EFED provided Tier 1 EDWCs for ground water (SCI-GROW), and Tier 2 EDWCs for surface water (PRZM/EXAMS) for pyrimethanil and its major metabolite (2-amino-4,6-dimethylpyrimidine), for use in the human-health risk assessment.  The models and their descriptions are available at the EPA internet site:   HYPERLINK "http://www.epa.gov/oppefed1/models/water/"  http://www.epa.gov/oppefed1/models/water/ .  Table 5 shows the highest combined residues of pyrimethanil and its major metabolite based on the registered seasonal application rate of 2.1 lb ai/A on strawberry in Florida.

Table 5.  Estimated Drinking Water Concentrations for Combined Total Residues, Parent (Pyrimethanil) Plus Major Degradate (2-amino-4,6-dimethylpyrimidine).

Chemical	Acute (peak) Surface Water Concentration (ppb)	Annual Average Surface Water Concentration (ppb)	Ground Water Concentration (ppb)

Pyrimethanil plus

2-amino-4,6-dimethylpyrimidine.	37.8	5.1	4.8

In this assessment, the annual average surface water concentration (5.1 ppb) and the acute peak surface water concentrations (37.8 ppb) were used for chronic and acute dietary exposure assessments, respectively.

IV.  DEEM-FCID( Program and Consumption Information

Pyrimethanil acute and 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 and 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 years old, children 3-5 years old, children 6-12 years old, youth 13-19 years old, adults 20-49 years old, females 13-49 years old, and adults 50+ years old.

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

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

V.  Toxicological Information

The HIARC met on April 24, 2003 to determine endpoint selection for pyrimethanil.  At this meeting, the HIARC also evaluated the potential for increased susceptibility of infants and children from exposure to pyrimethanil as required by the Food Quality Protection Act (FQPA) of 1996 (TXR No. 0052257, 12/2/03).  The Cancer Peer Review Committee (CPRC) evaluated the data on pyrimethanil on 5/29/96 and concluded that pyrimethanil should be classified as Group C - possible human carcinogen - and recommended that MOE methodology be used for the estimation of human risk (TXR # 0050189, 2/11/97; an acceptable MOE was not defined by CPRC or HIARC).  However, for threshold cancer effects where the mode of action is well understood, like thyroid carcinogens such as pyrimethanil, the general margin of exposure that indicates a reasonable certainty of no harm would be 100 (representing 2 factors of 10 for inter-species and intra-species extrapolation).  Table 6 is a summary of the decisions made by the HIARC and the CPRC concerning dietary exposure assessment.

Based on toxicological considerations (evaluated by HIARC) and the residue assumptions used in the dietary analyses (evaluated by the risk assessment team; RAB1/HED), it was concluded that the FQPA Safety Factor should be reduced to 1x when assessing dietary exposure to pyrimethanil.

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

Exposure/

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

Acute Dietary

(Females 13-49 years of age)	NOAEL= 45 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 1x

	Acute RfD = 0.45 mg/kg/day

aPAD =0.45 mg/kg/day	Developmental Toxicity - Rabbit:

LOAEL = 300 mg/kg/day based on increases in fetuses with 13 thoracic vertebrae and 13 pairs of ribs.

Acute Dietary (General Population, including Infants and Children)  NOAEL = 100 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 1x

	Acute RfD = 1 mg/kg/day	Acute Neurotoxicity- Rat:  LOAEL = 1000 mg/kg/day based on decreased motor activity, ataxia, decreased body temperature, hind limb grip strength, and dilated pupils.

Chronic Dietary (All Populations)	NOAEL= 17 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 1x

	Chronic RfD = 0.17 mg/kg/day

cPAD = 0.17 mg/kg/day	Chronic Toxicity - Rat:

LOAEL = 221 mg/kg/day based on decreased body weight gains; increased serum cholesterol and GGT, increased relative liver/body weight ratios, necropsy and histopathological findings in the liver and thyroid.

Cancer (oral, dermal, inhalation)   	Pyrimethanil was classified as a Group C carcinogen based on thyroid follicular cell tumors in both sexes of the 2-year rat study (NOAEL = 17 mg/kg/day); the CPRC recommended the MOE approach (i.e. threshold consideration; MOE = NOAEL ( chronic exposure) when assessing risk because there appeared to be sufficient evidence for relating thyroid tumors in the rat to a disruption of the thryroid-putitary status (see TXR No. 0052257 for full discussion); acceptable MOE was not defined by the HIARC or CPRC.  However, for threshold cancer effects where the mode of action is well understood, like thyroid carcinogens such as pyrimethanil, the general margin of exposure that indicates a reasonable certainty of no harm would be 100 (representing 2 factors of 10 for inter-species and intra-species  extrapolation).

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 (intraspecies).  UFH = potential variation in sensitivity among members of the human population (interspecies).  UFL = use of a LOAEL to extrapolate a NOAEL.  UFS = use of a short-term study for long-term risk assessment.  UFDB = to account for the absence of key data (i.e., lack of a critical study).  FQPA SF = FQPA Safety Factor.  PAD = population adjusted dose (a = acute, c = chronic).  RfD = reference dose.  MOE = margin of exposure.  LOC = level of concern.  N/A = not applicable.

VI.   Results/Discussion

As stated above, for acute and chronic assessments, ARIA/HED is concerned when dietary risk exceeds 100% of the aPAD or cPAD, respectively.  The following paragraphs are summaries of the DEEM-FCID( (ver. 2.03) acute and chronic exposure analyses.

Acute and chronic aggregate (food + water) analyses were performed using DEEM-FCID( estimating the dietary exposure of the U.S. population and various population subgroups.  The results are summarized in Tables 7 and 8 below for acute and chronic analyses respectively.

The resulting acute food exposure estimates are not of concern to ARIA (<100% aPAD) at the 95th percentile of the exposure distribution for the US general population (ca. 10% aPAD), and all population subgroups; the most highly exposed population subgroup is all infants <1 year old with ca. 35% aPAD.  The resulting chronic food exposure estimates are not of concern to ARIA (<100% cPAD) for U.S. general population (ca. 13% cPAD) and all population subgroups; the most highly exposed population subgroup is children 1-2 years old with 63% cPAD.  A separate cancer dietary assessment was not conducted for pyrimethanil as the chronic assessment is considered protective for carcinogenic effects.  The MOE for cancer assessment is 760 which is below the level of concern to HED (MOE <100).

Table 7.  Summary of Acute Dietary Exposure & Risk for Pyrimethanil at the 95th Percentile.

Population Subgroup	aPAD (mg/kg/day)	Exposure (mg/kg/day)

%aPAD

General U.S. Population	1.0	0.097656	10

All Infants (< 1 year old)

0.349407	35

Children 1-2 years old

0.336523	34

Children 3-5 years old

0.245654	25

Children 6-12 years old

0.128346	13

Youth 13-19 years old

0.060097	6

Adults 20-49 years old

0.053444	5

Adults 50+ years old

0.064689	7

Females 13-49 years old	0.45	0.057646	13

*Population subgroup with the highest exposure and risk is in bold type.

Table 8.  Summary of Chronic Dietary Exposure and Risk for Pyrimethanil.

Population Subgroup	cPAD (mg/kg/day)	Exposure (mg/kg/day)	%cPAD

General U.S. Population	0.17	0.022477	13

All Infants (< 1 year old)

0.090130	53

Children 1-2 years old

0.106869	63

Children 3-5 years old

0.073678	43

Children 6-12 years old

0.033439	20

Youth 13-19 years old

0.013225	8

Adults 20-49 years old

0.011950	7

Adults 50+ years old

0.016453	10

Females 13-49 years old

0.013112	8

*Population subgroup with the highest exposure and risk is in bold type.

VII.	Characterization of Inputs/Outputs

These chronic dietary exposure and risk estimates are conservative since they assume that 100% of crops are treated with pyrimethanil and that residues are present at tolerance levels.  In addition, drinking water exposure estimates were based on screening level estimates generated by the PRZM/EXAMS and SCI-GROW ground water models.  Dietary exposure estimates could be refined through the use of anticipated residues and percent crop treated data, as well as refined estimated drinking water concentrations.  However, since estimated exposures and risks using conservative assumptions are well below ARIA’s level of concern, such refinement is not warranted.

VIII.	Conclusions

The unrefined dietary exposure assessment using DEEM-FCID™ indicates that both acute and chronic dietary (food + drinking water) exposures to pyrimethanil are below ARIA’s level of concern for this pesticide.  Estimated acute dietary exposures are less than or equal to ca. 35% of the aPAD for the general U.S. population subgroups (aPAD = 1.0 mg/kg/day).  The most highly acutely exposed population subgroup is all infants <1 year old.  For the females 13-49 years of age population subgroup, the estimated acute dietary exposure is ca. 13% of the aPAD (aPAD = 0.45 mg/kg/day).  Finally, the estimated chronic dietary exposures are less than or equal to ca. 63% of the cPAD for children 1-2 years of age and all population subgroups.

IX.		List of Attachments

Attachment 1:  Acute Food plus Water Residue Input File

Attachment 2:  Acute Results File

Attachment 3:  Chronic Food plus Water Residue Input File

Attachment 4:  Chronic Results File

**   SEQ CHAPTER \h \r 1 This assessment was developed as part of a cooperative work-share program between the California Department of Pesticide Regulation (CDPR) and the U.S. Environmental Protection Agency (USEPA).  The toxicity studies/endpoints, No Observable Effects Levels (NOELs), exposure assumptions and consumption databases used in this document were selected by the U.S. EPA.

			Attachment 1:  DEEM-FCID( Acute Residue File

U.S. Environmental Protection Agency                                 Ver. 2.10

DEEM-FCID Acute analysis for PYRIMETHANIL

Residue file name: D:\DEEM_FCID residue files\res\IR4\Pyrimethanil EPA FY09 DPR work share ACUTE with H2O Tier 1.R98

Analysis Date 02-25-2009             Residue file dated: 01-20-2009/13:50:02/14

Reference dose: aRfD = 1 mg/kg bw/day  NOEL = 100 mg/kg bw/day

Comment: FQPA SF of 1x for all endpoints; aPAD above for general populations; aPAD females 13-50 = 0.45 mg/kg/day

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Food Name                         (ppm)       #1    #2

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

14000030 14   Almond                             0.200000   1.000  1.000

14000031 14   Almond-babyfood                    0.200000   1.000  1.000

14000040 14   Almond, oil                        0.200000   1.000  1.000

14000041 14   Almond, oil-babyfood               0.200000   1.000  1.000

11000070 11   Apple, fruit with peel            14.000000   1.000  1.000

11000080 11   Apple, peeled fruit               14.000000   1.000  1.000

11000081 11   Apple, peeled fruit-babyfood      14.000000   1.000  1.000

11000090 11   Apple, dried                      14.000000   8.000  1.000

11000091 11   Apple, dried-babyfood             14.000000   8.000  1.000

11000100 11   Apple, juice                      14.000000   0.350  1.000

11000101 11   Apple, juice-babyfood             14.000000   0.350  1.000

11000110 11   Apple, sauce                      14.000000   1.000  1.000

11000111 11   Apple, sauce-babyfood             14.000000   1.000  1.000

12000120 12   Apricot                           10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12000121 12   Apricot-babyfood                  10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12000130 12   Apricot, dried                    10.000000   6.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12000140 12   Apricot, juice                    10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12000141 12   Apricot, juice-babyfood           10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

01030150 1CD  Arrowroot, flour                   0.050000   1.000  1.000

01030151 1CD  Arrowroot, flour-babyfood          0.050000   1.000  1.000

01030170 1CD  Artichoke, Jerusalem               0.050000   1.000  1.000

95000230 O    Banana                             0.100000   1.000  1.000

95000231 O    Banana-babyfood                    0.100000   1.000  1.000

95000240 O    Banana, dried                      0.100000   3.900  1.000

95000241 O    Banana, dried-babyfood             0.100000   3.900  1.000

21000440 M    Beef, meat                         0.010000   1.000  1.000

          Full comment: D284001

21000441 M    Beef, meat-babyfood                0.010000   1.000  1.000

          Full comment: D284001

21000450 M    Beef, meat, dried                  0.010000   1.920  1.000

          Full comment: D284001

21000460 M    Beef, meat byproducts              0.010000   1.000  1.000

          Full comment: D284001

21000461 M    Beef, meat byproducts-babyfood     0.010000   1.000  1.000

          Full comment: D284001

21000470 M    Beef, fat                          0.010000   1.000  1.000

          Full comment: D284001

21000471 M    Beef,fat-babyfood                  0.010000   1.000  1.000

          Full comment: D284001

21000480 M    Beef, kidney                       2.500000   1.000  1.000

          Full comment: DP# 347248

21000490 M    Beef, liver                        0.010000   1.000  1.000

          Full comment: D284001

21000491 M    Beef, liver-babyfood               0.010000   1.000  1.000

          Full comment: D284001

01030820 1CD  Cassava                            0.050000   1.000  1.000

          Full comment: D284001

01030821 1CD  Cassava-babyfood                   0.050000   1.000  1.000

          Full comment: D284001

12000900 12   Cherry                            10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12000901 12   Cherry-babyfood                   10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12000910 12   Cherry, juice                     10.000000   1.500  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12000911 12   Cherry, juice-babyfood            10.000000   1.500  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

10001060 10   Citrus citron                     11.000000   1.000  1.000

          Full comment: D284001

10001070 10   Citrus hybrids                    11.000000   1.000  1.000

          Full comment: D284001

10001080 10   Citrus, oil                      150.000000   1.000  1.000

          Full comment: D284001

11001290 11   Crabapple                         14.000000   1.000  1.000

          Full comment: DP# 347248

01031390 1CD  Dasheen, corm                      0.050000   1.000  1.000

          Full comment: D284001

01031660 1CD  Ginger                             0.050000   1.000  1.000

          Full comment: D284001

01031661 1CD  Ginger-babyfood                    0.050000   1.000  1.000

          Full comment: D284001

01031670 1CD  Ginger, dried                      0.050000   1.000  1.000

          Full comment: D284001

23001690 M    Goat, meat                         0.010000   1.000  1.000

          Full comment: D284001

23001700 M    Goat, meat byproducts              0.010000   1.000  1.000

          Full comment: D284001

23001710 M    Goat, fat                          0.010000   1.000  1.000

          Full comment: D284001

23001720 M    Goat, kidney                       2.500000   1.000  1.000

          Full comment: DP# 347248

23001730 M    Goat, liver                        0.010000   1.000  1.000

          Full comment: D284001

95001750 O    Grape                              5.000000   1.000  1.000

          Full comment: D284001

95001760 O    Grape, juice                       5.000000   1.200  1.000

          Full comment: D284001

95001761 O    Grape, juice-babyfood              5.000000   1.200  1.000

          Full comment: D284001

95001770 O    Grape, leaves                      5.000000   1.000  1.000

          Full comment: D284001

95001780 O    Grape, raisin                      8.000000   1.000  1.000

          Full comment: D284001

95001790 O    Grape, wine and sherry             5.000000   1.000  1.000

          Full comment: D284001

10001800 10   Grapefruit                        11.000000   1.000  1.000

          Full comment: D284001

10001810 10   Grapefruit, juice                 11.000000   2.100  1.000

          Full comment: D284001

24001890 M    Horse, meat                        0.010000   1.000  1.000

          Full comment: D284001

10001970 10   Kumquat                           11.000000   1.000  1.000

          Full comment: D284001

10001990 10   Lemon                             11.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

10002000 10   Lemon, juice                      11.000000   2.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

10002001 10   Lemon, juice-babyfood             11.000000   2.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

10002010 10   Lemon, peel                       11.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

10002060 10   Lime                              11.000000   1.000  1.000

          Full comment: D284001

10002070 10   Lime, juice                       11.000000   2.000  1.000

          Full comment: D284001

10002071 10   Lime, juice-babyfood              11.000000   2.000  1.000

          Full comment: D284001

11002100 11   Loquat                            14.000000   1.000  1.000

          Full comment: DP# 347248

27002220 D    Milk, fat                          0.050000   1.000  1.000

          Full comment: DP# 347248

27002221 D    Milk, fat - baby food/infant for   0.050000   1.000  1.000

          Full comment: DP# 347248

27012230 D    Milk, nonfat solids                0.050000   1.000  1.000

          Full comment: DP# 347248

27012231 D    Milk, nonfat solids-baby food/in   0.050000   1.000  1.000

          Full comment: DP# 347248

27022240 D    Milk, water                        0.050000   1.000  1.000

          Full comment: DP# 347248

27022241 D    Milk, water-babyfood/infant form   0.050000   1.000  1.000

          Full comment: DP# 347248

27032251 D    Milk, sugar (lactose)-baby food/   0.050000   1.000  1.000

          Full comment: DP# 347248

12002300 12   Nectarine                         10.000000   1.000  1.000

          Full comment: D284001

03002370 3    Onion, dry bulb                    0.100000   1.000  1.000

          Full comment: D284001

03002371 3    Onion, dry bulb-babyfood           0.100000   1.000  1.000

          Full comment: D284001

03002380 3    Onion, dry bulb, dried             0.100000   9.000  1.000

          Full comment: D284001

03002381 3    Onion, dry bulb, dried-babyfood    0.100000   9.000  1.000

          Full comment: D284001

03002390 3    Onion, green                       2.000000   1.000  1.000

          Full comment: D284001

10002400 10   Orange                            11.000000   1.000  1.000

          Full comment: D284001

10002410 10   Orange, juice                     11.000000   0.007  1.000

          Full comment: D284001

10002411 10   Orange, juice-babyfood            11.000000   0.007  1.000

          Full comment: D284001

10002420 10   Orange, peel                      11.000000   1.000  1.000

          Full comment: D284001

12002600 12   Peach                             10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002601 12   Peach-babyfood                    10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002610 12   Peach, dried                      10.000000   7.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002611 12   Peach, dried-babyfood             10.000000   7.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002620 12   Peach, juice                      10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002621 12   Peach, juice-babyfood             10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

11002660 11   Pear                              14.000000   1.000  1.000

          Full comment: DP# 347248

11002661 11   Pear-babyfood                     14.000000   1.000  1.000

   Full comment: DP# 347248

11002670 11   Pear, dried                       14.000000   6.250  1.000

          Full comment: DP# 347248

11002680 11   Pear, juice                       14.000000   1.000  1.000

          Full comment: DP# 347248

11002681 11   Pear, juice-babyfood              14.000000   1.000  1.000

          Full comment: DP# 347248

95002830 O    Plantain                           0.100000   1.000  1.000

95002840 O    Plantain, dried                    0.100000   3.900  1.000

12002850 12   Plum                              10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002851 12   Plum-babyfood                     10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002860 12   Plum, prune, fresh                10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002861 12   Plum, prune, fresh-babyfood       10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002870 12   Plum, prune, dried                10.000000   5.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002871 12   Plum, prune, dried-babyfood       10.000000   5.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002880 12   Plum, prune, juice                10.000000   1.400  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002881 12   Plum, prune, juice-babyfood       10.000000   1.400  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

01032960 1C   Potato, chips                      0.050000   1.000  1.000

          Full comment: D284001

01032970 1C   Potato, dry (granules/ flakes)     0.050000   6.500  1.000

          Full comment: D284001

01032971 1C   Potato, dry (granules/ flakes)-b   0.050000   6.500  1.000

          Full comment: D284001

01032980 1C   Potato, flour                      0.050000   1.000  1.000

          Full comment: D284001

01032981 1C   Potato, flour-babyfood             0.050000   1.000  1.000

          Full comment: D284001

01032990 1C   Potato, tuber, w/peel              0.050000   1.000  1.000

          Full comment: D284001

01032991 1C   Potato, tuber, w/peel-babyfood     0.050000   1.000  1.000

          Full comment: D284001

01033000 1C   Potato, tuber, w/o peel            0.050000   1.000  1.000

          Full comment: D284001

01033001 1C   Potato, tuber, w/o peel-babyfood   0.050000   1.000  1.000

   Full comment: D284001

10003070 10   Pummelo                           11.000000   1.000  1.000

   Full comment: D284001

11003100 11   Quince                            14.000000   1.000  1.000

   Full comment: DP# 347248

26003390 M    Sheep, meat                        0.010000   1.000  1.000

   Full comment: D284001

26003391 M    Sheep, meat-babyfood               0.010000   1.000  1.000

   Full comment: D284001

26003400 M    Sheep, meat byproducts             0.010000   1.000  1.000

   Full comment: D284001

26003410 M    Sheep, fat                         0.010000   1.000  1.000

          Full comment: D284001

26003411 M    Sheep, fat-babyfood                0.010000   1.000  1.000

          Full comment: D284001

26003420 M    Sheep, kidney                      2.500000   1.000  1.000

          Full comment: DP# 347248

26003430 M    Sheep, liver                       0.010000   1.000  1.000

          Full comment: D284001

95003590 O    Strawberry                         3.000000   1.000  1.000

          Full comment: D284001

95003591 O    Strawberry-babyfood                3.000000   1.000  1.000

          Full comment: D284001

95003600 O    Strawberry, juice                  3.000000   1.000  1.000

          Full comment: D284001

95003601 O    Strawberry, juice-babyfood         3.000000   1.000  1.000

          Full comment: D284001

01033660 1CD  Sweet potato                       0.050000   1.000  1.000

          Full comment: D284001

01033661 1CD  Sweet potato-babyfood              0.050000   1.000  1.000

          Full comment: D284001

10003690 10   Tangerine                         11.000000   1.000  1.000

          Full comment: D284001

10003700 10   Tangerine, juice                  11.000000   2.300  1.000

          Full comment: D284001

01033710 1CD  Tanier, corm                       0.050000   1.000  1.000

          Full comment: D284001

08003750 8    Tomato                             0.500000   1.000  1.000

          Full comment: D284001

08003751 8    Tomato-babyfood                    0.500000   1.000  1.000

          Full comment: D284001

08003760 8    Tomato, paste                      0.500000   5.400  1.000

          Full comment: D284001

08003761 8    Tomato, paste-babyfood             0.500000   5.400  1.000

          Full comment: D284001

08003770 8    Tomato, puree                      0.500000   3.300  1.000

          Full comment: D284001

08003771 8    Tomato, puree-babyfood             0.500000   3.300  1.000

          Full comment: D284001

08003780 8    Tomato, dried                      0.500000  14.300  1.000

          Full comment: D284001

08003781 8    Tomato, dried-babyfood             0.500000  14.300  1.000

          Full comment: D284001

08003790 8    Tomato, juice                      0.500000   1.500  1.000

          Full comment: D284001

01033870 1CD  Turmeric                           0.050000   1.000  1.000

          Full comment: D284001

86010000 O    Water, direct, all sources         0.037800   1.000  1.000

   Full comment: EPA EFED Memo 01-09-2009

86020000 O    Water, indirect, all sources       0.037800   1.000  1.000

   	   Full comment: EPA EFED Memo 01-09-2009

01034060 1CD  Yam, true                          0.050000   1.000  1.000

          Full comment: D284001

01034070 1CD  Yam bean                           0.050000   1.000  1.000

          Full comment: D284001

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

Attachment 2:  DEEM-FCID( Acute Exposure Estimates

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for PYRIMETHANIL                        (1994-98 data)

Residue file: D:\DEEM_FCID residue files\res\IR4\Pyrimethanil EPA FY09 DPR work share ACUTE with H2O Tier 1.R98               				Adjustment factor #2 NOT used.

Analysis Date 02-25-2009             Residue file dated: 01-20-2009/13:50:02/14

Reference dose: aRfD = 1 mg/kg bw/day  NOEL = 100 mg/kg bw/day

Comment: FQPA SF of 1x for all endpoints; aPAD above for general populations; aPAD females 13-50

 = 0.45 mg/kg/day

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

Summary calculations (per capita):

      95th Percentile             99th Percentile             99.9th Percentile

Exposure  % aRfD     MOE    Exposure  % aRfD     MOE    Exposure  % aRfD   MOE

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

U.S. Population:

0.097656    9.77    1024    0.231700   23.17     431    0.488398   48.84    204

Western Region:

0.106980   10.70     934    0.246545   24.65     405    0.470198   47.02    212

Hispanic:

0.115883   11.59     862    0.258320   25.83     387    0.529939   52.99    188

Non-hispanic whites:

0.094061    9.41    1063    0.224955   22.50     444    0.461494   46.15    216

Non-hispanic blacks:

0.097571    9.76    1024    0.247562   24.76     403    0.541702   54.17    184

Non-hispanic/non-white/non-black:

0.120505   12.05     829    0.235195   23.52     425    0.471533   47.15    212

All infants:

0.349407   34.94     286    0.612770   61.28     163    1.604463  160.45     62

Nursing infants (<1 yr old):

0.270798   27.08     369    0.461882   46.19     216    0.682371   68.24    146

Non-nursing infants (<1 yr old):

0.376210   37.62     265    0.635830   63.58     197    1.607565  160.76     62

Children 1-2 yrs:

0.336523   33.65     297    0.533496   53.35     187    0.837497   83.75    119

Children 3-5 yrs:

0.245654   24.57     407    0.375091   37.51     266    0.607399   60.74    164

Children 6-12 yrs:

0.128346   12.83     779    0.221907   22.19     450    0.376680   37.67    265

Youth 13-19 yrs:

0.060097    6.01    1663    0.117560   11.76     850    0.232181   23.22    430

Adults 20-49 yrs:

0.053444    5.34    1871    0.092643    9.26    1079    0.190359   19.04    525

Adults 50+ yrs:

0.064689    6.47    1545    0.113840   11.38     878    0.220998   22.10    452

Females 13-49 yrs1:

0.057646    12.81    1734   0.101242   22.50     987    0.179366   39.86    557

1 The percent aPAD (or percent aRfD) and MOEs for the subgroup Females 13–49 years were recalculated as the toxicological doses (NOAEL = 45 mg/kg/day) and endpoints (aPAD = aRfd = 0.45 mg/kg/day) for this subgroup are different than that of all other subgroups.

Attachment 3:  DEEM-FCID( Chronic Residue File

U.S. Environmental Protection Agency                                 Ver. 2.10

DEEM-FCID Acute analysis for PYRIMETHANIL

Residue file name: D:\DEEM_FCID residue files\res\IR4\Pyrimethanil EPA FY09 DPR work share CHRONIC with H2O Tier 1.R98

Analysis Date 02-25-2009             Residue file dated: 01-20-2009/13:53:20/14

Reference dose: (RfD, Chronic) = 0.17 mg/kg bw/day  NOEL = 17 mg/kg bw/day

Comment: FQPA SF of 1x for all endpoints; cPAD for all populations is 0.17 mg/kg/day

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Food Name                         (ppm)       #1    #2

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

14000030 14   Almond                             0.200000   1.000  1.000

14000031 14   Almond-babyfood                    0.200000   1.000  1.000

14000040 14   Almond, oil                        0.200000   1.000  1.000

14000041 14   Almond, oil-babyfood               0.200000   1.000  1.000

11000070 11   Apple, fruit with peel            14.000000   1.000  1.000

11000080 11   Apple, peeled fruit               14.000000   1.000  1.000

11000081 11   Apple, peeled fruit-babyfood      14.000000   1.000  1.000

11000090 11   Apple, dried                      14.000000   8.000  1.000

11000091 11   Apple, dried-babyfood             14.000000   8.000  1.000

11000100 11   Apple, juice                      14.000000   0.350  1.000

11000101 11   Apple, juice-babyfood             14.000000   0.350  1.000

11000110 11   Apple, sauce                      14.000000   1.000  1.000

11000111 11   Apple, sauce-babyfood             14.000000   1.000  1.000

12000120 12   Apricot                           10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12000121 12   Apricot-babyfood                  10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12000130 12   Apricot, dried                    10.000000   6.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12000140 12   Apricot, juice                    10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12000141 12   Apricot, juice-babyfood           10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

01030150 1CD  Arrowroot, flour                   0.050000   1.000  1.000

01030151 1CD  Arrowroot, flour-babyfood          0.050000   1.000  1.000

01030170 1CD  Artichoke, Jerusalem               0.050000   1.000  1.000

95000230 O    Banana                             0.100000   1.000  1.000

95000231 O    Banana-babyfood                    0.100000   1.000  1.000

95000240 O    Banana, dried                      0.100000   3.900  1.000

95000241 O    Banana, dried-babyfood             0.100000   3.900  1.000

21000440 M    Beef, meat                         0.010000   1.000  1.000

          Full comment: D284001

21000441 M    Beef, meat-babyfood                0.010000   1.000  1.000

          Full comment: D284001

21000450 M    Beef, meat, dried                  0.010000   1.920  1.000

          Full comment: D284001

21000460 M    Beef, meat byproducts              0.010000   1.000  1.000

          Full comment: D284001

21000461 M    Beef, meat byproducts-babyfood     0.010000   1.000  1.000

          Full comment: D284001

21000470 M    Beef, fat                          0.010000   1.000  1.000

          Full comment: D284001

21000471 M    Beef,fat-babyfood                  0.010000   1.000  1.000

          Full comment: D284001

21000480 M    Beef, kidney                       2.500000   1.000  1.000

          Full comment: DP# 347248

21000490 M    Beef, liver                        0.010000   1.000  1.000

          Full comment: D284001

21000491 M    Beef, liver-babyfood               0.010000   1.000  1.000

          Full comment: D284001

01030820 1CD  Cassava                            0.050000   1.000  1.000

          Full comment: D284001

01030821 1CD  Cassava-babyfood                   0.050000   1.000  1.000

          Full comment: D284001

12000900 12   Cherry                            10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12000901 12   Cherry-babyfood                   10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12000910 12   Cherry, juice                     10.000000   1.500  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12000911 12   Cherry, juice-babyfood            10.000000   1.500  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

10001060 10   Citrus citron                     11.000000   1.000  1.000

          Full comment: D284001

10001070 10   Citrus hybrids                    11.000000   1.000  1.000

          Full comment: D284001

10001080 10   Citrus, oil                      150.000000   1.000  1.000

          Full comment: D284001

11001290 11   Crabapple                         14.000000   1.000  1.000

          Full comment: DP# 347248

01031390 1CD  Dasheen, corm                      0.050000   1.000  1.000

          Full comment: D284001

01031660 1CD  Ginger                             0.050000   1.000  1.000

          Full comment: D284001

01031661 1CD  Ginger-babyfood                    0.050000   1.000  1.000

          Full comment: D284001

01031670 1CD  Ginger, dried                      0.050000   1.000  1.000

          Full comment: D284001

23001690 M    Goat, meat                         0.010000   1.000  1.000

          Full comment: D284001

23001700 M    Goat, meat byproducts              0.010000   1.000  1.000

          Full comment: D284001

23001710 M    Goat, fat                          0.010000   1.000  1.000

          Full comment: D284001

23001720 M    Goat, kidney                       2.500000   1.000  1.000

          Full comment: DP# 347248

23001730 M    Goat, liver                        0.010000   1.000  1.000

          Full comment: D284001

95001750 O    Grape                              5.000000   1.000  1.000

          Full comment: D284001

95001760 O    Grape, juice                       5.000000   1.200  1.000

          Full comment: D284001

95001761 O    Grape, juice-babyfood              5.000000   1.200  1.000

          Full comment: D284001

95001770 O    Grape, leaves                      5.000000   1.000  1.000

          Full comment: D284001

95001780 O    Grape, raisin                      8.000000   1.000  1.000

          Full comment: D284001

95001790 O    Grape, wine and sherry             5.000000   1.000  1.000

          Full comment: D284001

10001800 10   Grapefruit                        11.000000   1.000  1.000

          Full comment: D284001

10001810 10   Grapefruit, juice                 11.000000   2.100  1.000

          Full comment: D284001

24001890 M    Horse, meat                        0.010000   1.000  1.000

          Full comment: D284001

10001970 10   Kumquat                           11.000000   1.000  1.000

          Full comment: D284001

10001990 10   Lemon                             11.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

10002000 10   Lemon, juice                      11.000000   2.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

10002001 10   Lemon, juice-babyfood             11.000000   2.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

10002010 10   Lemon, peel                       11.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

10002060 10   Lime                              11.000000   1.000  1.000

          Full comment: D284001

10002070 10   Lime, juice                       11.000000   2.000  1.000

          Full comment: D284001

10002071 10   Lime, juice-babyfood              11.000000   2.000  1.000

          Full comment: D284001

11002100 11   Loquat                            14.000000   1.000  1.000

          Full comment: DP# 347248

27002220 D    Milk, fat                          0.050000   1.000  1.000

          Full comment: DP# 347248

27002221 D    Milk, fat - baby food/infant for   0.050000   1.000  1.000

          Full comment: DP# 347248

27012230 D    Milk, nonfat solids                0.050000   1.000  1.000

          Full comment: DP# 347248

27012231 D    Milk, nonfat solids-baby food/in   0.050000   1.000  1.000

          Full comment: DP# 347248

27022240 D    Milk, water                        0.050000   1.000  1.000

          Full comment: DP# 347248

27022241 D    Milk, water-babyfood/infant form   0.050000   1.000  1.000

          Full comment: DP# 347248

27032251 D    Milk, sugar (lactose)-baby food/   0.050000   1.000  1.000

          Full comment: DP# 347248

12002300 12   Nectarine                         10.000000   1.000  1.000

          Full comment: D284001

03002370 3    Onion, dry bulb                    0.100000   1.000  1.000

          Full comment: D284001

03002371 3    Onion, dry bulb-babyfood           0.100000   1.000  1.000

          Full comment: D284001

03002380 3    Onion, dry bulb, dried             0.100000   9.000  1.000

          Full comment: D284001

03002381 3    Onion, dry bulb, dried-babyfood    0.100000   9.000  1.000

          Full comment: D284001

03002390 3    Onion, green                       2.000000   1.000  1.000

          Full comment: D284001

10002400 10   Orange                            11.000000   1.000  1.000

          Full comment: D284001

10002410 10   Orange, juice                     11.000000   0.007  1.000

          Full comment: D284001

10002411 10   Orange, juice-babyfood            11.000000   0.007  1.000

          Full comment: D284001

10002420 10   Orange, peel                      11.000000   1.000  1.000

          Full comment: D284001

12002600 12   Peach                             10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002601 12   Peach-babyfood                    10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002610 12   Peach, dried                      10.000000   7.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002611 12   Peach, dried-babyfood             10.000000   7.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002620 12   Peach, juice                      10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002621 12   Peach, juice-babyfood             10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

11002660 11   Pear                              14.000000   1.000  1.000

          Full comment: DP# 347248

11002661 11   Pear-babyfood                     14.000000   1.000  1.000

   Full comment: DP# 347248

11002670 11   Pear, dried                       14.000000   6.250  1.000

          Full comment: DP# 347248

11002680 11   Pear, juice                       14.000000   1.000  1.000

          Full comment: DP# 347248

11002681 11   Pear, juice-babyfood              14.000000   1.000  1.000

          Full comment: DP# 347248

95002830 O    Plantain                           0.100000   1.000  1.000

95002840 O    Plantain, dried                    0.100000   3.900  1.000

12002850 12   Plum                              10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002851 12   Plum-babyfood                     10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002860 12   Plum, prune, fresh                10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002861 12   Plum, prune, fresh-babyfood       10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002870 12   Plum, prune, dried                10.000000   5.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002871 12   Plum, prune, dried-babyfood       10.000000   5.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002880 12   Plum, prune, juice                10.000000   1.400  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002881 12   Plum, prune, juice-babyfood       10.000000   1.400  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

01032960 1C   Potato, chips                      0.050000   1.000  1.000

          Full comment: D284001

01032970 1C   Potato, dry (granules/ flakes)     0.050000   6.500  1.000

          Full comment: D284001

01032971 1C   Potato, dry (granules/ flakes)-b   0.050000   6.500  1.000

          Full comment: D284001

01032980 1C   Potato, flour                      0.050000   1.000  1.000

          Full comment: D284001

01032981 1C   Potato, flour-babyfood             0.050000   1.000  1.000

          Full comment: D284001

01032990 1C   Potato, tuber, w/peel              0.050000   1.000  1.000

          Full comment: D284001

01032991 1C   Potato, tuber, w/peel-babyfood     0.050000   1.000  1.000

          Full comment: D284001

01033000 1C   Potato, tuber, w/o peel            0.050000   1.000  1.000

          Full comment: D284001

01033001 1C   Potato, tuber, w/o peel-babyfood   0.050000   1.000  1.000

   Full comment: D284001

10003070 10   Pummelo                           11.000000   1.000  1.000

   Full comment: D284001

11003100 11   Quince                            14.000000   1.000  1.000

   Full comment: DP# 347248

26003390 M    Sheep, meat                        0.010000   1.000  1.000

   Full comment: D284001

26003391 M    Sheep, meat-babyfood               0.010000   1.000  1.000

   Full comment: D284001

26003400 M    Sheep, meat byproducts             0.010000   1.000  1.000

   Full comment: D284001

26003410 M    Sheep, fat                         0.010000   1.000  1.000

          Full comment: D284001

26003411 M    Sheep, fat-babyfood                0.010000   1.000  1.000

          Full comment: D284001

26003420 M    Sheep, kidney                      2.500000   1.000  1.000

          Full comment: DP# 347248

26003430 M    Sheep, liver                       0.010000   1.000  1.000

          Full comment: D284001

95003590 O    Strawberry                         3.000000   1.000  1.000

          Full comment: D284001

95003591 O    Strawberry-babyfood                3.000000   1.000  1.000

          Full comment: D284001

95003600 O    Strawberry, juice                  3.000000   1.000  1.000

          Full comment: D284001

95003601 O    Strawberry, juice-babyfood         3.000000   1.000  1.000

          Full comment: D284001

01033660 1CD  Sweet potato                       0.050000   1.000  1.000

          Full comment: D284001

01033661 1CD  Sweet potato-babyfood              0.050000   1.000  1.000

          Full comment: D284001

10003690 10   Tangerine                         11.000000   1.000  1.000

          Full comment: D284001

10003700 10   Tangerine, juice                  11.000000   2.300  1.000

          Full comment: D284001

01033710 1CD  Tanier, corm                       0.050000   1.000  1.000

          Full comment: D284001

08003750 8    Tomato                             0.500000   1.000  1.000

          Full comment: D284001

08003751 8    Tomato-babyfood                    0.500000   1.000  1.000

          Full comment: D284001

08003760 8    Tomato, paste                      0.500000   5.400  1.000

          Full comment: D284001

08003761 8    Tomato, paste-babyfood             0.500000   5.400  1.000

          Full comment: D284001

08003770 8    Tomato, puree                      0.500000   3.300  1.000

          Full comment: D284001

08003771 8    Tomato, puree-babyfood             0.500000   3.300  1.000

          Full comment: D284001

08003780 8    Tomato, dried                      0.500000  14.300  1.000

          Full comment: D284001

08003781 8    Tomato, dried-babyfood             0.500000  14.300  1.000

          Full comment: D284001

08003790 8    Tomato, juice                      0.500000   1.500  1.000

          Full comment: D284001

01033870 1CD  Turmeric                           0.050000   1.000  1.000

          Full comment: D284001

86010000 O    Water, direct, all sources         0.005100   1.000  1.000

   Full comment: EPA EFED Memo 01-09-2009

86020000 O    Water, indirect, all sources       0.005100   1.000  1.000

   	   Full comment: EPA EFED Memo 01-09-2009

01034060 1CD  Yam, true                          0.050000   1.000  1.000

          Full comment: D284001

01034070 1CD  Yam bean                           0.050000   1.000  1.000

          Full comment: D284001

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

Attachment 4:	DEEM-FCID( Chronic Exposure Estimates

U.S. Environmental Protection Agency                                 Ver. 2.10

DEEM-FCID Acute analysis for PYRIMETHANIL

Residue file name: D:\DEEM_FCID residue files\res\IR4\Pyrimethanil EPA FY09 DPR work share CHRONIC with H2O Tier 1.R98

Analysis Date 02-25-2009             Residue file dated: 01-20-2009/13:53:20/14

Reference dose: aRfD = 1 mg/kg bw/day  NOEL = 100 mg/kg bw/day

Comment: FQPA SF of 1x for all endpoints; cPAD for all populations is 0.17 mg/kg/day

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.022477                13.2%

U.S. Population (spring season)             0.023104                13.6%

U.S. Population (summer season)             0.020720                12.2%

U.S. Population (autumn season)             0.022512                13.2%

U.S. Population (winter season)             0.023673                13.9%

Northeast region                            0.025252                14.9%

Midwest region                              0.022483                13.2%

Southern region                             0.018923                11.1%

Western region                              0.025624                15.1%

Hispanics                                   0.025656                15.1%

Non-hispanic whites                         0.022150                13.0%

Non-hispanic blacks                         0.020510                12.1%

Non-hisp/non-white/non-black                0.025838                15.2%

All infants (< 1 year)                      0.090130                53.0%

Nursing infants                             0.053341                31.4%

Non-nursing infants                         0.104097                61.2%

Children 1-6  yrs                           0.080645                47.4%

Children 7-12 yrs                           0.030614                18.0%

Females 13-19 (not preg or nursing)         0.013972                 8.2%

Females 20+ (not preg or nursing)           0.014455                 8.5%

Females 13-50 yrs                           0.015246                 9.0%

Females 13+ (preg/not nursing)              0.019072                11.2%

Females 13+ (nursing)                       0.019571                11.5%

Males 13-19 yrs                             0.012512                 7.4%

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RMales 20+ yrs                               0.012468                 7.3%

Seniors 55+                                 0.017084                10.0%

Children 1-2 yrs                            0.106869                62.9%

Children 3-5 yrs                            0.073678                43.3%

Children 6-12 yrs                           0.033439                19.7%

Youth 13-19 yrs                             0.013225                 7.8%

Adults 20-49 yrs                            0.011950                 7.0%

Adults 50+ yrs                              0.016453                 9.7%

Females 13-49 yrs                           0.013112                 7.7%

Pyrimethanil          Dietary Exposure and Risk Assessment         DP Number: 362715        PC Code:  288201

________________________________________________________________________ ______________

Page   PAGE  1  of   NUMPAGES  23


[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Pages 20663-20664]
[FR Doc No: 2011-8870]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2004-0093; FRL-9294-2]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Clean Air Act Tribal Authority
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

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 collection and the estimated burden and
cost.

DATES: Additional comments may be submitted on or before May 13, 2011.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2004-0093, to (1) EPA online using www.regulations.gov (our
preferred method), by e-mail<EMAIL_ADDRESS>or by mail to: EPA
Docket Center, Environmental Protection Agency, Air and Radiation
Docket Information Center, 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: Darrel Harmon, Office of Air and
Radiation, Immediate Office, (6101A), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number:
202-564-7416; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>or Danielle Dixon, Environmental Protection
Agency, Office of Air and Radiation, Office of Air Quality Planning and
Standards, Outreach and Information Division, (C304-01), Research
Triangle Park, North Carolina 27711; 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 November 29, 2010 (75 FR 73076), EPA sought comments on
this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional 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-OAR-2004-0093, which is available for public viewing on-line
at http://www.regulations.gov, or in person viewing at the Air Docket
in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The EPA/DC Docket Center Public
Reading Room is open from 8:30 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 Air Docket is
202-566-1742.
    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: Clean Air Act Tribal Authority (Renewal).
    ICR numbers: EPA ICR No. 1676.06, OMB Control No. 2060-0306.
    ICR Status: This ICR is scheduled to expire on 05/31/2011. 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, and 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: This Information Collection Request (ICR) seeks
authorization for Tribes to demonstrate their eligibility to be treated
in the same manner as states under the Clean Air Act (CAA) and to
submit applications to implement a CAA program. This ICR extends the
current collection of information period for determining eligibility,
which expires May 31, 2011. The ICR also is revising the estimates of
burden costs for Tribes in completing a CAA application.
    The program regulation provides for Indian Tribes, if they so
choose, to assume responsibility for the development and implementation
of CAA programs. The regulation, Indian Tribes: Air Quality Planning
and Management (Tribal Authority Rule [TAR] 40 CFR parts 9, 35, 49, 50
and 81), sets forth how Tribes may seek authority to implement their
own air quality planning and management programs. The rule establishes:
(1) Which CAA provisions Indian Tribes may seek authority to implement,
(2) what requirements the Tribes must meet when seeking such
authorization, and (3) what Federal financial assistance may be
available to help Tribes establish and manage their air quality
programs. The TAR provides Tribes the authority to administer air
quality programs over all air resources, including non-Indian owned fee
lands, within the exterior boundaries of a reservation and other areas
over which the Tribe can demonstrate jurisdiction. An Indian Tribe that
takes responsibility for a CAA program would essentially be treated in
the same way as a state would be treated for that program.
    Responses to the collection of information are required to obtain a
benefit (40 CFR parts 9, 35, 49, 50 and 81). Any information submitted
to the Agency for which a claim of confidentiality is made will be
safeguarded according to the Agency policies set forth in Title 40,
Chapter 1, part 2, subpart B--Confidentiality of Business Information
(see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000,
September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March
23, 1979). There is no sensitive information required.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 40
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: States, locals, Indian Tribes.
    Estimated Number of Respondents: 8.
    Frequency of Response: One-time application.
    Estimated Total Annual Hour Burden: 320.
    Estimated Total Annual Cost: $18,896.00, which includes $0
annualized capital or O&M costs.
    Changes in the Estimates: There is a decrease of 40 hours in the
total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. The total burden hours have been updated to
reflect new estimates that are based on the number of applications the
EPA received under the previous ICR and what EPA estimates it will
receive in the upcoming years. There is no difference between the
active ICR and this ICR in the number of hours per response.

    Dated: April 7, 2011.
John Moses,
Director, Collection Strategies Division.
[FR Doc. 2011-8870 Filed 4-12-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: September 27, 2007 (Volume 72, Number 187)]
[Notices]
[Page 54974-54975]
[DOCID:fr27se07-120]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2004-18667; Notice 2]

Reports, Forms and Record Keeping Requirements

AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION: Notice.

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

SUMMARY: Before a Federal agency can collect certain information from
the public, the agency must receive approval from the Office of
Management and Budget (``OMB''). Under procedures established by the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), before
seeking OMB approval, Federal agencies must solicit public comment on
proposed collections of information, including extensions and
reinstatements of previously approved collections. In compliance with
the Paperwork Reduction Act of 1995, this notice describes one
collection of information for which NHTSA intends to seek OMB approval,
relating to confidential business information.

DATES: Comments must be submitted on or before November 26, 2007.

ADDRESSES: You may submit comments [identified by DOT Docket Number
NHTSA-2004-18667 by any of the following methods:
    If filing comments by September 27, 2007, please use:
     Web Site: http://dms.dot.gov. Follow the instructions for

submitting comments on the Department of Transportation Docket
Management System electronic docket site. No electronic submissions
will be accepted between September 28, 2007, and October 1, 2007.
    If filing comments on or after October 1, 2007, use:
     Federal eRulemaking Portal: Go to http://www.regulations.gov.
 Follow the online instructions for submitting

comments.
    Alternatively, you can file comments using the following methods:
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>
    Instructions: For detailed instructions on submitting comments and
additional information on the rulemaking process, see the Public
Participation heading of the Supplementary Information section of this
document. Note that all comments received will be posted without change
to http://www.dms.dot.gov or http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading
below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: For access to the docket to read background documents or
comments received, go to http://dms.dot.gov until September 27, 2007,

or the street address listed above. The DOT docket may be offline at
times between September 28 through September 30 to migrate to the
Federal Docket Management System (FDMS). On October 1, 2007, the
Internet access to the docket will be at http://www.regulations.gov.

Follow the online instructions for accessing the dockets.

FOR FURTHER INFORMATION CONTACT: For questions contact Michael Kido in
the Office of the Chief Counsel at the National Highway Traffic Safety
Administration, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. The OMB has promulgated regulations describing what must
be included in such a document. Under OMB's regulations (at 5 CFR
1320.8(d)), an agency must ask for public comment on the following:
    (i) Whether the proposed collection of information is necessary for
the proper performance of the functions of the

agency, including whether the information will have practical utility;
    (ii) the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (iii) how to enhance the quality, utility, and clarity of the
information to be collected; and
    (iv) how to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses.
    In compliance with these requirements, NHTSA asks for public
comment on the following extension of clearance for a currently
approved collection of information:

Confidential Business Information

    Type of Request--Extension of clearance.
    OMB Clearance Number--2127-0025.
    Form Number--This collection of information uses no standard forms.
    Requested Expiration Date of Approval--Three (3) years from the
date of approval of the collection.
    Summary of the Collection of Information--Persons who submit
information to the agency and seek to have the agency withhold some or
all of that information from disclosure under the Freedom of
Information Act (``FOIA''), 5 U.S.C. 552, must provide the agency with
sufficient support that justifies the confidential treatment of that
information. In addition, a request for confidential treatment must be
accompanied by: (1) A complete copy of the submission; (2) a copy of
the submission containing only those portions for which confidentiality
is not sought with the confidential portions redacted; and (3) either a
second complete copy of the submission or alternatively those portions
of the submission that contain the information for which
confidentiality is sought. Furthermore, the requestor must submit a
completed certification as provided in 49 CFR Part 512, Appendix A. See
generally 49 CFR Part 512 (NHTSA Confidential Business Information
regulations).
    Part 512 ensures that information submitted under a claim of
confidentiality is properly evaluated in an efficient manner under
prevailing legal standards and, where appropriate, accorded
confidential treatment. To facilitate the evaluation process, in their
requests for confidential treatment, submitters of information may make
reference to certain limited classes of information that are
presumptively treated as confidential, such as blueprints and
engineering drawings, future specific model plans (under limited
conditions), and future vehicle production or sales figures for
specific models (under limited conditions). Certain other information
that the agency collects pursuant to the Early Warning Reporting (EWR)
rule (49 CFR Part 579) would, under a proposed rule, be treated
confidentially under 49 CFR Part 512, Appendix C and submitters would
not need to provide a request for confidential treatment for these
classes of information.
    Description of the Need for the Information and Use of the
Information--NHTSA receives confidential information for use in its
activities, which include investigations, rulemaking actions, program
planning and management, and program evaluation. The information is
needed to ensure the agency has sufficient relevant information for
decision-making in connection with these activities. Some of this
information is submitted voluntarily, as in rulemaking, and some is
submitted in response to compulsory information requests, as in
investigations.
    Description of the Likely Respondents, Including Estimated Number
and Proposed Frequency of Response to the Collection of Information--
This collection of information applies to entities that submit to the
agency information that the entities wish to have withheld from
disclosure under the FOIA. Thus, the collection of information applies
to entities that are subject to laws administered by the agency or
agency regulations and are under an obligation to provide information
to the agency. It also includes entities that voluntarily submit
information to the agency. Such entities would include manufacturers of
motor vehicles and of motor vehicle equipment. Importers are considered
to be manufacturers. It may also include other entities that are
involved with motor vehicles or motor vehicle equipment but are not
manufacturers.
    Estimate of the Total Annual Reporting and Recordkeeping Burdens
Resulting from the Collection of Information--3600 hours.
    The agency receives requests for confidential treatment that vary
in size from requests that ask the agency to withhold as little as a
portion of one page to multiple boxes of documents. NHTSA estimates
that it will take on average approximately eight (8) hours for an
entity to prepare a submission requesting confidential treatment. This
estimate will vary based on the size of the submission, with smaller
and voluntary submissions taking considerably less time to prepare.
This estimate is based on the volume of requests received over the past
three years and the expectation that we will receive requests for
confidentiality of early warning information that would not be resolved
by the rulemaking on the confidentiality of certain EWR data.
    NHTSA estimates that it will receive approximately 450 requests for
confidential treatment annually. This figure is based on the average
number of requests received over the past three years. We selected this
period because it provides an estimate based on incoming requests for
the most recent three years and an estimate of the number of requests
relating to EWR data. The agency estimates that the total burden for
this information collection will be approximately 3600 hours, which is
based on the number of requests (450) multiplied by the estimated
number of hours to prepare each submission (8 hours).
    Since nothing in the rule requires those persons who request
confidential treatment pursuant to Part 512 to keep copies of any
records or requests submitted to us, recordkeeping costs imposed would
be zero hours and zero costs.

    Authority: 44 U.S.C. 3506; delegation of authority at 49 CFR
1.50.

    Issued on: September 24, 2007.
Anthony M. Cooke,
Chief Counsel.
 [FR Doc. E7-19122 Filed 9-26-07; 8:45 am]

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[Federal Register Volume 81, Number 101 (Wednesday, May 25, 2016)]
[Notices]
[Page 33321]
[FR Doc No: 2016-11646]

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DEPARTMENT OF TRANSPORTATION

Bureau of Transportation Statistics

[Docket ID Number: DOT-OST-2014-0031]

Agency Information Collection; Activity Under OMB Review;
Passenger Origin-Destination Survey Report

AGENCY: Office of the Assistant Secretary for Research and Technology
(OST-R), Bureau of Transportation Statistics (BTS), DOT.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, Public
Law 104-13, the Bureau of Transportation Statistics invites the general
public, industry and other governmental parties to comment on the
continuing need for and usefulness of BTS collecting a sample of
airline passenger itineraries with the dollar value of the passenger
ticket. Certificated air carriers that operated scheduled passenger
service with at least one aircraft having a seating capacity of over 60
seats or operates an international route report these data. Comments
are requested concerning whether: (a) The collection is still needed by
the Department of Transportation; (b) BTS accurately estimates the
reporting burden; and (c) there are other ways to enhance the quality,
utility and clarity of the information collected;

DATES: Written comments should be submitted by July 25, 2016.

FOR FURTHER INFORMATION CONTACT: James Bouse, Office of Airline
Information, RTS-42, Room E34-441, OST-R, BTS, 1200 New Jersey Avenue
SE., Washington, DC 20590-0001, Telephone Number<PHONE_NUMBER>, Fax
Number<PHONE_NUMBER> or EMAIL<EMAIL_ADDRESS>    Comments: Comments should identify the associated OMB approval
#2139-0001 and Docket ID Number DOT-OST-2014-0031. Persons wishing the
Department to acknowledge receipt of their comments must submit with
those comments a self-addressed stamped postcard on which the following
statement is made: Comments on OMB #2139-0001, Docket--DOT-OST-2014-
0031. The postcard will be date/time stamped and returned.

ADDRESSES: You may submit comments identified by DOT Docket ID Number
DOT-OST-2014-0031 by any of the following methods:
    Federal eRulemaking Portal: Go to http://www.regulations.gov.
Follow the online instructions for submitting comments.
    Mail: Docket Services: U.S. Department of Transportation, 1200 New
Jersey Avenue SE., West Building Ground Floor, Room W12-140,
Washington, DC 20590-0001.
    Hand Delivery or Courier: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m. ET, Monday
through Friday, except Federal holidays.
    Fax:<PHONE_NUMBER>.
    Instructions: Identify docket number, DOT-OST-2014-0031, at the
beginning of your comments, and send two copies. To receive
confirmation that DOT received your comments, include a self-addressed
stamped postcard. Internet users may access all comments received by
DOT at http://www.regulations.gov. All comments are posted
electronically without charge or edits, including any personal
information provided.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://DocketInfo.dot.gov.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or the street
address listed above. Follow the online instructions for accessing the
dockets.
    Electronic Access: you may access comments received for this notice
at http://www.regulations.gov, by searching docket DOT-OST-2014-0031.

SUPPLEMENTARY INFORMATION:
    OMB Approval No. 2139-0001.
    Title: Passenger Origin-Destination Survey Report.
    Form No.: None.
    Type of Review: Extension of a currently approved collection.
    Respondents: Large certificated air carriers that provide scheduled
passenger service or operate an international route.
    Number of Respondents: 48 certificated air carriers.
    Number of Responses: 192.
    Estimated Time per Response: 60 hours.
    Total Annual Burden: 11,520 hours.
    Needs and Uses: Survey data are used in monitoring the airline
industry, negotiating international agreements, reviewing requests for
the grant of anti-trust immunity for air carrier alliance agreements,
selecting new international routes, selecting U.S. carriers to operate
limited entry foreign routes, and modeling the spread of contagious
diseases.
    The Confidential Information Protection and Statistical Efficiency
Act of 2002 (44 U.S.C. 3501 note), requires a statistical agency to
clearly identify information it collects for non-statistical purposes.
BTS hereby notifies the respondents and the public that BTS uses the
information it collects under this OMB approval for non-statistical
purposes including, but not limited to, publication of both
Respondent's identity and its data, submission of the information to
agencies outside BTS for review, analysis and possible use in
regulatory and other administrative matters.

    Issued in Washington, DC, on May 12, 2016.
William Chadwick, Jr.,
Director, Office of Airline Information, Bureau of Transportation
Statistics.
[FR Doc. 2016-11646 Filed 5-24-16; 8:45 am]
BILLING CODE 4910-9X-P