	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 Date:		21-February-2007

Subject:		Buprofezin - Acute and Chronic Dietary Exposure and Risk Assessments.  		PP#:  5E6981.  PC Code:  275100.  DP Barcode:  335841.  Decision:  360273.

Reviewer/To:	Tom Bloem, Chemist

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

Through:		Yvonne Barnes, Chemist, Reregistration Branch 2 (RRB2)

		Thurston Morton, Chemist, RRB4

		Dietary Exposure Science Advisory Council (DESAC)

		George F. Kramer, Ph.D., Branch Senior Scientist

		RAB1/HED (7509P)

Executive Summary

The acute and chronic dietary risk assessments were conducted using the Dietary Exposure Evaluation Model - Food Consumption Intake Database (DEEM-FCID(, ver. 2.03).  DEEM-FCID( incorporates food consumption data from the United States Department of Agriculture (USDA) Continuing Surveys of Food Intakes by Individuals (CSFII; 1994-1996 and 1998).  The current assessment is being conducted in support of the stone fruit petition and grape and papaya amendments (residue chemistry review - D326792, T. Bloem, 21-Feb-2007)

The acute analysis assumed DEEM™ (ver. 7.81) default processing factors and 100% crop treated for all commodities.  Tolerance-level residues were assumed for all commodities excluding meat and milk.  Since meat and milk (limit of quantitation (LOQ) tolerances) residues were only detected in the feeding study at 6.8-9.3x the maximum theoretical dietary burden (MTDB), residues in these commodities were normalized to 1x the MTDB.  The acute analysis also incorporated the acute Pesticide Root Zone Model 3 (PRZM3; Carsel,1997)/Exposure Analysis Modeling System (EXAMS; Bums, 2002; Tier 2) surface drinking water estimate resulting from application of buprofezin to grapes in New York (highest acute estimate; 2 x 0.50 lb ai/acre; RTI = 14 days).    SEQ CHAPTER \h \r 1 The resulting acute exposure estimate for females 13-49 years old was less than HED’s level of concern (6% aPAD).  No acute endpoint was identified for the remaining population subgroups.

The chronic analysis assumed tolerance level, average field trial, or average USDA Pesticide Data Program (PDP; apple, orange, and orange juice) residues.  Since meat and milk (LOQ tolerances) residues were only detected in the feeding study at 6.8-9.3x the MTDB, residues in these commodities were normalized to 1x the MTDB.  DEEM™ (ver. 7.81) default processing factors were assumed for all commodities excluding orange juice (PDP data therefore processing factor reduced to 1).  The chronic analysis incorporated percent crop treated estimates or projected percent crop treated estimates when available (orange, orange juice, and apple remained at 100% as PDP data were used) and incorporated the PRZM3/EXAMS surface drinking water estimate resulting from application of buprofezin to cherries in Michigan (highest chronic estimate; 2 x 1.5 lb ai/acre; RTI = 14 days).  The resulting chronic exposure estimates less than HED’s level of concern (≤92% cPAD; children 1-2 years old were the most highly exposed population).

I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population adjusted dose (PAD).  The PAD is equivalent to the reference dose (RfD) divided by the Food Quality Protection Act (FQPA) Safety Factor.  For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  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,” 6/21/2000, web link:      HYPERLINK "http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf"  http://www.epa.gov/fedrgstr/ EPA-PEST/2000/July/Day-12/6061.pdf  ; or see SOP 99.6 (8/20/99).  The most recent buprofezin dietary risk assessment was conducted by T. Bloem (D328806, 12-Apr-2006).

II.	Residue Information

jugates, reduction of the DEEM™ (ver. 7.81) default processing factors for fruit crops and in crops with an extended interval from initial application to harvest is inappropriate.

Table 1:  Summary of MARC decisions for Buprofezin

Matrix	Residues of Concern

	For Risk Assessment	For Tolerance Expression

plants	buprofezin1,2	buprofezin

rotational crops	buprofezin	buprofezin, BF9, and BF12

ruminant tissue	buprofezin and  BF2	buprofezin

milk	buprofezin and BF23	buprofezin

poultry and eggs	Due to the limited residues in egg and tissue samples collected from the poultry metabolism study, the MARC determined that a conclusion pertaining to the residues of concern in egg and poultry was not possible.

water	Buprofezin	not applicable

1	the residues of concern in fruit crops and crops with an interval greater than ~50 days from initial application to harvest are buprofezin and BF4 conjugates

2	residues of concern in grape juice are buprofezin, BF4 conjugates, and BF12; BF12 is a residue of concern in grape juice because the BF12 grape juice processing factor (0.75x)  is much greater than the buprofezin grape juice processing factor (0.14x) and residues of BF12 may be significant in grape juice

Established/Recommended Tolerances:    SEQ CHAPTER \h \r 1 Buprofezin is currently registered for application to several fruit and vegetable commodities with tolerances for residues of buprofezin ranging from 0.02 - 80 ppm (40 CFR 180.511).  Tolerances have also been established for residues of buprofezin, as a result of secondary residues, in milk (0.01 ppm) and ruminant and hog fat (0.05 ppm), liver (0.05 ppm), and meat byproducts (0.05 ppm).  The Interregional Research Project No. 4 (IR-4) is requesting a stone fruit registration and is proposing amending the grape and papaya and related tropical fruit registrations.  HED has reviewed the residue chemistry data submitted in support of these requests and concludes that the tolerances listed in Table 2 for residues of buprofezin per se are appropriate (D326792, T. Bloem, 22-Feb-2007).

Table 2:  HED Recommended Tolerance Levels.

Commodity Definition	HED Recommended Tolerance (ppm)

fruit, stone, group 12, except apricot and peach	1.9

apricot	9.0

grape	2.5

papaya	0.90

star apple	0.90

black sapote	0.90

mango	0.90

sapodilla	0.90

canistel	0.90

mamey sapote	0.90

Residues Used in the Acute Analysis:  A 0.01 ppm milk tolerance for residues of buprofezin is currently established (40 CFR 180.511).  The residues of concern in milk, for purposes of risk assessment, are buprofezin and BF23.  HED has reviewed a feeding study in which dairy cows were dosed with buprofezin at 0.9x, 2.9x, and 9.3x the dairy cow MTDB (D273252, T. Bloem, 20-Mar-2001).  Residues of buprofezin (0.02 ppm) and BF23 (0.01 ppm) were only determined in milk samples collected from the 9.3x dosing group (LOQ = 0.01 ppm for both compounds).  Based on these results, an estimate of 0.0032 ppm for the combined residues of buprofezin and BF23 in milk at 1x the MTDB was calculated (0.03 ÷ 9.3 = 0.0032 ppm).  Since the submitted data demonstrated concentration of residues into milk cream (5x) and fat, the default 25x concentration factor was applied for milk fat yielding a residue of 0.081 ppm (0.0032 x 25 = 0.081 ppm).

Tolerances for residues of buprofezin are currently established for ruminant fat, meat byproducts, and liver at 0.05 ppm (40 CFR 180.511).  The residues of concern in ruminant tissues, for purposes of risk assessment, are buprofezin and BF2.  HED has reviewed a feeding study in which dairy cows were dosed with buprofezin at 0.7x, 2.1x, and 6.8x the beef cattle MTDB (D273252, T. Bloem, 20-Mar-2001).  Residues of buprofezin and BF2 were determined in liver, kidney, fat, and muscle (LOQ = 0.05 ppm for each compound).  Residues were <LOQ in kidney and muscle from all three dosing levels.  Residues of buprofezin and BF2 were <LOQ in liver and fat collected from the 0.7x and 2.1x dosing groups and were 0.05 ppm and <0.05 ppm, respectively, in liver and 0.12 ppm and <0.05 ppm, respectively, in fat collected from the 6.8x dosing group.  Based on these results, an estimate of 0.015 ppm for the combined residues of buprofezin and BF2 in meat, kidney, and liver was calculated (0.10 ÷ 6.8 = 0.015 ppm) and an estimate of 0.025 ppm for the combined residues of buprofezin and BF2 in fat and meat byproducts was calculated (0.17 ÷ 6.8 = 0.025 ppm).

 and DEEM™ (ver. 7.81) default processing factors.  Table 3 is a summary of the residues used in the acute analysis.

Residues used in the Chronic Analysis:  The chronic analysis employed the same residue estimates for milk and ruminant tissue as that employed for the acute analysis (see acute section for rationale).  The MARC concluded that the residues of concern in fruit and in crops with an extended interval from initial application to harvest (>50 days) are buprofezin and BF4 conjugates (residues of concern in grape juice are buprofezin, BF4 conjugates, and BF12).  The residue of concern in the remaining crops is only buprofezin.  Since there are no BF4 conjugate residue data (field trial or processing), the MARC determined that BF4 conjugate residues may be estimated using the BF4 conjugate:buprofezin residue ratio from the lemon metabolism study (1.8x) and the buprofezin residues from the field trials.  Excluding apple, orange, and orange juice, tolerance-level or average field trial residues were used for estimation of buprofezin or total buprofezin and BF4 conjugate residues.  For apple, orange, and orange juice, average residues for the 2004 and/or 2005 PDP data were used for estimation of total buprofezin and BF4 conjugate residues.  The chronic analysis incorporated screening-level percent crop treated estimates for several crops (see attachment 1), projected percent crop treated estimates for peach, grape, apricot, nectarine, cherry, and plum (see attachments 2 and 3), and DEEM™ (ver. 7.81) default processing factors.  Since PDP data were used for apple, orange, and orange juice, the percent crop treated estimates were maintained at 100% and the processing factors were maintained/reduced to 1.  Table 3 is a summary of the residues used in the chronic analysis.

Table 3:  Residues in/on Crops Used in the Acute and Chronic Dietary Exposure Analyses

	residue used in acute analysis (ppm)	residue used in chronic analysis (ppm)	residue chemistry reference

	buprofezin	BF4 conjugates1	total	comments2	buprofezin	BF4 conjugates1 total	comments2

	pome fruit - apple4	4.0	7.2	11.2	tolerance	0.37	0.67	1.04	average D293230, T. Bloem, 7-Jan-2004

D320545, T. Bloem, 19-May-2004

D326792, T. Bloem, 21-Feb-2007

pome fruit - pear4	4.0	7.2	11.2	tolerance	1.08	1.94	3.02	average

	apple6	see “pome fruit - apple” above for

acute apple residue	0.0002	0.00036	0.00056	2005 PDP data

	stone fruit - peach4	9.0	16.2	25.2	tolerance	1.68	3.02	4.70	average

	stone fruit - cherry4	1.9	3.42	5.32	tolerance	0.80	1.44	2.24	average

	stone fruit - plum4	1.9	3.42	5.32	tolerance	0.19	0.35	0.54	average

	avocado	0.30	0.54	0.84	tolerance	0.30	0.54	0.84	tolerance

	canistel	0.90	1.62	2.52	tolerance	0.90	1.62	2.52	tolerance

	mango	0.90	1.62	2.52	tolerance	0.90	1.62	2.52	tolerance

	papaya	0.90	1.62	2.52	tolerance	0.90	1.62	2.52	tolerance

	mamey sapote	0.90	1.62	2.52	tolerance	0.90	1.62	2.52	tolerance

	acerola	0.30	0.54	0.84	tolerance	0.30	0.54	0.84	tolerance

	cherimoya	0.30	0.54	0.84	tolerance	0.30	0.54	0.84	tolerance

	feijoa	0.30	0.54	0.84	tolerance	0.30	0.54	0.84	tolerance

	guava	0.30	0.54	0.84	tolerance	0.30	0.54	0.84	tolerance

	jaboticaba	0.30	0.54	0.84	tolerance	0.30	0.54	0.84	tolerance

	passionfruit	0.30	0.54	0.84	tolerance	0.30	0.54	0.84	tolerance

	soursop	0.30	0.54	0.84	tolerance	0.30	0.54	0.84	tolerance

	starfruit	0.30	0.54	0.84	tolerance	0.30	0.54	0.84	tolerance

	sugar apple	0.30	0.54	0.84	tolerance	0.30	0.54	0.84	tolerance

	snap bean	0.02	–3	0.02	tolerance	0.02	–3	0.02	tolerance	D285400, T. Bloem, 9-Oct-2002

logan	0.30	0.54	0.84	tolerance	0.30	0.54	0.84	tolerance

	lychee	0.30	0.54	0.84	tolerance	0.30	0.54	0.84	tolerance

	spanish lime	0.30	0.54	0.84	tolerance	0.30	0.54	0.84	tolerance

	pistachio	0.05	0.09	0.14	tolerance	0.05	0.09	0.14	tolerance

	cucurbit - cantaloupe4	0.50	–3	0.50	tolerance	0.21	–3	0.21	average D261869, T. Bloem, 24-Apr-2000

D271597, T. Bloem, 30-Jan-2001

D296493, T. Bloem, 17-Dec-2003

cucurbit - summer squash4	0.50	–3	0.50	tolerance	0.04	–3	0.04 average

	cucurbit - cucumbers4	0.50	–3	0.50	tolerance	0.06	–3	0.06	average

	head lettuce	5.0	–3	5.0	tolerance	2.04	–3	2.04	average

	leaf lettuce	13.0	–3	13.0	tolerance	6.97	–3	6.97	average

	citrus oil	80	–3	80	tolerance	80	–3	80.00	tolerance	D273252, T. Bloem, 20-Mar-2001

D296492, T. Bloem, 17-Dec-2003

D304845, T. Bloem, 26-Jan-2005

D319815, T. Bloem, 14-Dec-2005

D326792, T. Bloem, 21-Feb-2007

citrus - orange4	2.5	4.5	7	tolerance	1.24	2.23	3.47	average

	citrus - grapefruit4	2.5	4.5	7	tolerance	0.18	0.32	0.49	average

	citrus - lemon4	2.5	4.5	7	tolerance	2.5	4.50	7.00	tolerance

	orange7	see “citrus - orange” above for acute orange and orange juice residues	0.015	0.027	0.042	2004 & 2005 PDP data

	orange juice7

0.015	0.027	0.042

banana	0.20	0.36	0.56	tolerance	0.04	0.07	0.11	average

	cotton	0.40	–3	0.40	tolerance	0.40	–3	0.40	tolerance

	grape5	2.5	4.5	7.0	tolerance	0.29	0.52	0.81	average

	tomato	0.40	–3	0.40	tolerance	0.24	–3	0.24	average

	almond	0.05	0.09	0.14	tolerance	0.05	0.09	0.14	tolerance

	1	BF4 conjugates were estimated by multiplying the buprofezin residue by the BF4 conjugate:buprofezin residue ratio from the lemon metabolism study (1.8x; D273252, T. Bloem, 20-Mar-2001)

2	comments refers to the source of the buprofezin residue; average = average buprofezin residue from the field trials; tolerance = tolerance-level residues

3	the residue of concern in these crops is only buprofezin

4	residues in representative commodities applied to the remaining commodities in the crop group according to HED SOP 2000.1 (12-Aug-2000)

5	BF12 is a residue of concern in grape juice because the grape to grape juice processing factor for BF12 (0.75x) is much greater than the processing factor for buprofezin (0.14x; residue of BF12 may be significant in grape juice); since default processing factors are being assumed for grape juice, inclusion of BF12 residues is unnecessary and the RAC residue was applied to grape juice

6	for the chronic analysis, the average apple residue from the 2005 PDP data was used (n=132; average residue of 0.0002; percent crop treated maintained at 100%)

7	for the chronic analysis, the average orange and orange juice residue estimates from the 2004 and 2005 PDP data was used (2004: orange juice - n=186, orange - n=742; 2005: orange juice n=744, orange n= 741); residues <LOD (LOD = 0.015 ppm) in/on all samples (percent crop treated maintained at 100%)

III.  Water Data

Drinking water residues were incorporated directly into the acute and chronic dietary analyses (“water, direct, all sources” and “water, indirect, all sources”) and were provided by the Environmental Fate and Effects Division (EFED; D321843, J. Wolf, 31-Jan-2007).  EFED generated the surface water and ground water estimates using the   SEQ CHAPTER \h \r 1 PRZM3/EXAMS and Screening Concentration in Ground Water (SCIGROW; Tier 1) models, respectively.  Table 4 is a summary of the modeled water concentrations.  Based on these estimates, the acute and chronic analyses assumed water residue estimates of 23.2 ppb and 7.8 ppb, respectively.

Table 4.  Estimated Drinking Water Concentrations for Buprofezin ( ppb)

	Acute	Chronic	Long-term average

Surface	23.21	7.81	4.7

Ground2	0.1	0.1	0.1

1	acute estimate based on application to NY grape scenario (2 x 0.50 lb ai/acre; RTI = 14 days) and the chronic and long term estimates base on Michigan cherry scenario (2 x 1.5 lb ai/acre; RTI = 14 days); the default 0.87 PCA was assumed for both

2	SCI-GROW estimate assuming 2 x 2.0 lb ai/acre (almond application scenario; RTI = 60 days); from the 8-Dec-	2003 J. 	Wolf memo

IV.	DEEM-FCID( Program and Consumption Information

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

For chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form 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 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., 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 all tiers of analysis.  However, for tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

IV.	Toxicological Information

The Hazard Identification Assessment Review Committee (HIARC; HED Doc. Nos. 014093, 014221, and 051342), Food Quality Protection Act (FQPA) Safety Factor Committee (SFC; HED Doc. No. 014138), and Cancer Assessment Review Committee (CARC; HED Doc. No. 014045) met to discuss endpoint selection for buprofezin.  Since these assessments, HED has reevaluated the uncertainty factors (human health risk assessment; D328804, T. Bloem et al., 20-Nov-2001) and toxicological data gaps (human health risk assessment, D331919, T. Bloem et al., 20-Nov-2001).  Table 5 summarizes the endpoints chosen for the exposure scenarios assessed as part of the current document.

Table 5:  Summary of Toxicological Doses and Endpoints for Buprofezin for Use in Dietary Exposure Assessment

Exposure

Scenario	Dose Used in Risk

Assessment, UF1	FQPA SF and Endpoint for Risk Assessment	Study and Toxicological Effects

Acute Dietary

(gen. US pop.)	No toxicological effect attributable to a single dose identified. This risk assessment is not required.

Acute Dietary

(females 13 - 50 yrs old)	Oral NOAEL = 200  mg/kg/day

UF1 = 100

aRfD = 2.0 mg/kg/day	FQPA SF2 = 1x

aPAD = NOAEL ÷ (UF x FQPA SF) = 2.0 mg/kg/day	Developmental Toxicity Study–Rat; LOAEL = 800 mg/kg/day based on skeletal effects & decreased body weight in offspring

Chronic Dietary

(all populations)	Oral NOAEL = 1.0 mg/kg/day

UF1 = 30

cRfD = 0.033 mg/kg/day	FQPA SF2 = 10x

cPAD = NOAEL ÷ (UF x FQPA SF) = 0.0033 mg/kg/day	Two-year chronic toxicity/ carcinogenicity Study in rat; LOAEL = 8.7 mg/kg/day based on increased incidence of follicular cell hyperplasia and hypertrophy in the thyroid of males.

Cancer	Suggestive Evidence of Carcinogenicity, but not sufficient to assess human carcinogenic potential 	Carcinogenicity study in mice.  Liver tumors observed in female mice.  The CARC  recommended that no quantification of cancer risk is required.

1	UF = intraspecies (10x) and interspecies (10x) uncertainty factor; since it has been established that rats are more susceptible to thyroid effects than humans, the chronic interspecies UF was reduced to 3x (see D328804, T. Bloem et al., 20-Nov-2001)

2	based on the lack of a comparative 28-day thyroid assay (young -vs- old), a FQPA SF of 10x was applied to the chronic endpoint; the FQPA SF was not applied to the acute endpoint since a single dose of a chemical would not be expected to perturb thyroid  homeostasis in the adult or the young due to the buffering of thyroid hormone concentrations by homeostatic mechanisms for compounds with short half lives, like buprofezin (half-life = 1 to 2 days)

V.	Results/Discussion

Acute and chronic analyses were performed using DEEM-FCID( (ver. 2.03).  DEEM-FCID( (ver. 2.03) estimates the dietary exposure of the U.S. population and various population subgroups.  The results reported are for 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, females 13-49 years old, adults 20-49 years old, and adults 50+ years old.  The acute food exposure estimate for females 13-49 years old was less than HED’s level of concern (6% aPAD; see Table 6).  No acute endpoint was identified for the remaining population subgroups.  The chronic food exposure estimates were also less than HED’s level of concern (≤92% cPAD; children 1-2 years old were the most highly exposed population; see Table 7).

Table 6:  Summary of Acute Dietary Exposure and Risk for Buprofezin

Population Subgroup	aPAD (mg/kg/day)	Acute (95th Percentile)

Exposure (mg/kg/day)	%aPAD

Females 13-49 years old	0.67	0.116936	6

Table 7:  Summary of Chronic Dietary Exposure and Risk for Buprofezin

Population Subgroup	cPAD (mg/kg/day)	Chronic

Exposure (mg/kg/day)	%cPAD

General U.S. Population	0.0033	0.001347	41

All Infants (< 1 year old)

0.002259	68

Children 1-2 years old

0.003027	92

Children 3-5 years old

0.002381	72

Children 6-12 years old

0.001519	46

Youth 13-19 years old

0.001035	31

Adults 20-49 years old

0.001201	36

Adults 50+ years old

0.001206	36

Females 13-49 years old

0.001271	38

VI.	Characterization of Inputs/Outputs

The acute analysis is conservative as tolerance-level residues were assumed for the majority of the commodities and 100% crop treated was assumed for all the commodities.  The chronic analysis was refined through the use of average field trial residues, projected percent crop treated estimates, percent crop treated data, and PDP data.  HED notes that the inclusion of BF4 conjugates as a residue of concern in fruit and almond commodities is based on a citrus metabolism study which resulted in the identification of BF4 conjugates in peel at 0.08x and 1.8x that of buprofezin (6% and 34%, respectively, the total radioactive residue).  The current assessment estimated BF4 conjugate residues in the edible portion of fruit and almond commodities using the 1.8x residue ratio.

VII.	Conclusions

Acute and chronic dietary risk assessments were conducted using the DEEM-FCID( (ver. 2.03) model which incorporates consumption data from the USDA’s CSFII (1994-1996 and 1998).  The acute analysis assumed DEEM™ (ver. 7.81) default processing factors and 100% crop treated for all commodities.  Tolerance-level residues were assumed for all commodities excluding meat and milk.  Since meat and milk (LOQ tolerances) residues were only detected in the feeding study at 6.8-9.3x the MTDB, residues in these commodities were normalized to 1x the MTDB.  The acute analysis also incorporated the acute PRZM-EXAMS surface drinking water estimate resulting from application of buprofezin to grapes in New York (highest acute estimate; 2 x 0.50 lb ai/acre; RTI = 14 days).    SEQ CHAPTER \h \r 1 The resulting acute exposure estimate for females 13-49 years old was less than HED’s level of concern (6% aPAD).  No acute endpoint was identified for the remaining population subgroups.

≤92% cPAD; children 1-2 years old were the most highly exposed population).

Attachment 1:  Percent Crop Treated

Attachment 2:  Projected Percent Crop Treated (apple and peach)

Attachment 3:  Projected Percent Crop Treated (grape, apricot, nectarine, sweet cherry, tart cherry, and plum)

Attachment 4:  DEEM-FCID( acute residue file

Attachment 5:  DEEM-FCID( acute exposure estimates

Attachment 6:  DEEM-FCID( chronic residue file

Attachment 7:  DEEM-FCID( chronic exposure estimates

cc with all attachments: B. Madden (RD; RM 05)

T. Bloem:S10945:PY1:(703)605-0217:7509P

Attachment 1:	Percent Crop Treated

The following information was provided by Jihad Alsadek of BEAD.

November 28,2006

Screening Level Estimates of Agricultural Uses of BUPROFEZIN 275100

Sorted Alphabetically

Crop 					Lbs, A.I. 			Percent Crop Ttd.

									Avg.		Max.

Almonds *				<500				N/A		N/A

Cantaloupes				1,000				5		10

Cauliflower				1,000				5		5

Cotton					9,000				<1		<2.5

Grapefruit				<500				<1		<2.5

Grapes					6,000				<1		<2.5

Honeydew				<500				<1		<2.5

Lemons				3,000				<1		<2.5

Oranges				9,000				<1		<2.5

Pears					1,000				<1		<2.5

Pumpkins				<500				<1		<2.5

Tomatoes				2,000				<1		5

watermelons				<500				<1		<2.5

All numbers rounded.

‘<500’ indicates less than 500 pounds of active ingredient.

‘<2.5’ indicates less than 2.5 percent of crop is treated.

‘<1’ indicates less than 1 percent of crop is treated.

* CA data only, but 95% or more of U.S. acres are in California

Attachment 2:  Projected Percent Crop Treated (apple and peach)

The following projected percent crop treated estimates were provided by Jihad Alsadek in the spring of 2004.  Jihad Alsadek indicated that actual percent crop treated data are not available for peach and that these estimates remain appropriate (apple projected percent crop treated estimates were not used as the chronic analysis used PDP data).

Total acres treated (TAT) are same as the base acres treated, per an e-mail from registrant Nichino America, Inc. This is because one application of buprofezin is applied on apples and peaches to control target pests, scales and pear psyllas.  Dividing TAT by the apple/peach total acres grown (440,000 acres for apples and 155,000 acres for peaches) and multiplying by 100 gives the percent crop treated in the fourth column of table 1 and 2.  BEAD projects a range of 1 to 5 percent of apples, and 4 to 13 percent of peaches to be treated during the first four to five years buprofezin is on the market.  The lower end of the range for each crop can be used as a typical value and the upper end of the range as the likely maximum for calculating dietary risk.

Attached are two lotus 123 files  that show all the alternatives for buprofezin to control scales and pear psyllas for apples and peaches.  We compared buprofezin with pyriproxyfen, the only registered IGR.  Buprofezin is more expensive than pyriproxyfen because it has an excellent technical fit as an IPM product for apples. As an IGR, with an alternative mode of action to that of pyriproxyfen, it is expected that buprofezin will capture about 13 percent of the peach market during the fourth year, since they both sell for $46 to $49 an acre to treat scales.

Table 1.  Registrant’s Market Share Estimates and BEAD Projected PCT For Buprofezin on Apples

Sales Year	Acres (TAT)	Market Share	BEAD Projected (PCT) 	Price/A ($)

Year One	5,500	2%	1%

	Year Two	11,500	4%	3%

	Year Three	15,000	5%	3%

	Year Four	18,500	6%	4%

	Year Five	22,000	7%	5%

	Buprofezin	22,000	7%	5%	52

Pyriproxyfen	4,829	2%	1%	33

Source: Nichino America, Inc., “Buprofezin Apple Market Justification” submission.  EPA proprietary data.

Table 2.  Registrant’s Market Share Estimates and BEAD Projected PCT For Buprofezin on Peaches

Sales Year	Acres (TAT)	Market Share	BEAD Projected (PCT) 	Price/A ($)

Year One	6,550	5%	4%

	Year Two	9,825	8%	6%

	Year Three	14,737	11%	10%

	Year Four	19,659	15%	13%

	Buprofezin	19,659	15%	13%	46

Pyriproxyfen	1,531	1%	1%	49

Source: Nichino America, Inc., “Buprofezin Peach Market Justification” submission.   EPA proprietary data.

Attachment 3:  Projected Percent Crop Treated (grape, apricot, nectarine, sweet cherry, tart cherry, and plum)

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

February 7, 2007

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

MEMORANDUM

SUBJECT:	Projected Percent Crop Treated for the Insecticide Buprofezin on Six Crops: Grapes, Apricots, Nectarines, Sweet Cherries, Tart Cherries, and Plums.

			PC Code: 275100. DP Barcode: 334232. Decision #: 360272

FROM:	Jihad 	Alsadek, Economist

Science Information & Analysis Branch

Biological and Economic Analysis Division (7503P)

			Nicole Zinn, Biologist

			Biological Analysis Branch

			Biological and Economic Analysis Division (7503P)

THRU:		Diann Sims, Chief

			Science Information Analysis Branch

			Biological and Economic Analysis Division (7503P)

			Arnet Jones, Chief

			Biological Analysis Branch

			Biological and Economic Analysis Division (7503P)

TO:			Thomas Bloem, Chemist

			RAB1

			Health Effects Division (7509P)

PRP Review: January 31st. 2007

I.	SUMMARY

	This memorandum provides projected percent crop treated (PPCT) values for buprofezin on six crops (Grapes, Apricots, Nectarines, Sweet Cherries, Tart Cherries, and Plums).  The memo also provides BEAD’s determination whether the registrant’s proposed reduction in the pre-harvest interval (PHI) from 30 days to 7 days would impact PPCT for grapes, as well as the corresponding Federal Register (FR) language.  The methodology used to produce the estimates is outlined below, along with the analysis of additional biological in formation that could impact the assessments.  The market leader approach is used with all the above mentioned crops.  We have examined all the relevant data and conclude that it is unlikely that the actual percent crop treated (PCT) values on the above listed crops will exceed the PPCT values provided within the next five years. The values to be used in risk analysis are presented in table 1.

Table 1. PPCT Values to be used in Risk Assessment

Crop	Chronic PPCT	Acute PPCT

Grapes, All	21	32

Apricots, CA	40	49

Nectarines, CA	60	72

Sweet Cherries	44	52

Tart Cherries	76	88

Plums, CA	35	43

II.	FR LANGUAGE

EPA estimates projected percent crop treated (PPCT) for a new pesticide use by assuming that the percent crop treated (PCT) during the pesticide’s initial five years of use on a specific use site will not exceed the average PCT of the market leader (i.e., the one pesticide with the greatest PCT) on that site.

Typically, EPA uses USDA/NASS as the primary source for PCT data.  When a specific use site is not surveyed by USDA/NASS, EPA uses other sources including proprietary data and calculates the PCT.  Comparisons are only made among pesticides of the same pesticide types (i.e., the leading insecticide on the use site is selected for comparison with the new insecticide).  The chronic PPCT values included in the chronic column, table 1, are averages derived from averaging the most recent NASS surveys, may be for the same pesticide, or for different pesticides, since the same or different pesticides, may dominate for each year selected.    The acute PPCT values, table 1, are the highest value of the available values used for the chronic PPCT values.  This PPCT, based on the average PCT of the market leader, is appropriate for use in chronic dietary risk assessment. The method of estimating a PPCT for a new use of a registered pesticide or a new pesticide produces a high-end estimate that is unlikely, in most cases, to be exceeded during the initial five years of actual use.

The predominant factors that bear on whether the estimated PPCT could be exceeded are whether new pesticide use or new pesticide is more efficacious or controls a broader spectrum of pests than the dominant pesticide; and/or whether there are concerns that increasing pest pressure may intensify the use of pesticides as indicated in emergency exemption requests, or other readily available information, and/or other factor based on analysis of additional information.

All information currently available for the predominant factors mentioned above or relevant to the case in question have been considered for this chemical, and it is the opinion of BEAD that it is unlikely that actual PCT for buprofezin will exceed the PPCT projections during the next five years.

III.	PROJECTIONS BASED ON MARKET LEADER APPROACH

The PPCTs for grapes, apricots, nectarines, sweet cherries, tart cherries, and plums are calculated by averaging the PCTs of the leading insecticide(s) for the three most recent available years.

Table 2.  Projected Buprofezin PCT Values for Dietary Risk Assessments

Crop/New Use	Market Leader/Year	Avg. PCT/Chronic	Max. PCT/Acute

Year	ML	Avg.

	Grapes, All	Imidacloprid (99,01)

Fenpropathrin (05)	99

01

05	32

24

  8

	32

21

	Apricots (CA)	Esfenvalerate (99,01)

Lambda-Cyhallothrin (05) 	99

01

05	33

49

38

	49

40

	Nectarines (CA)	Formetanate Hydrochloride (HCL) [99]

Esfenvalerate (01,05)	99

01

05	72

59

49

	72

60

	Sweet Cherries	Azinphos-methyl (99,01)

Spinosad (05)	99

01

05	44

37

52

	52

44

	Tart Cherries	Azinphos-methyl 	99

01

05	79

88

61

	88

76

	Plums (CA)	Esfenvalerate 	99

01

05	21

41

43

	43

35

References:

Agricultural Chemical Usage 1999 Fruit Summary, July 2000

Agricultural Chemical Usage 2001 Fruit Summary, August 2002

Agricultural Chemical Usage 2005 Fruit Summary, July 2006

V.	ADDITIONAL FACTORS

Grapes - Buprofezin is currently registered for use on grapes to control mealy bugs and leafhoppers.   The registrant is proposing to reduce the pre-harvest interval (PHI) from 30 days to 7 days.  BEAD found that a section 18 for chlorpyrifos was granted in the mid-1990s in the state of Washington to control grape mealy bug (and cutworms).  However, in recent years there have been no section 18 exemptions for control of mealy bug control in grapes.  The market leaders for grapes are imidacloprid and fenpropathrin (Table 2).  Imidacloprid is registered to control mealy bug and leafhoppers, and various other pests.  Fenpropathrin is registered to control leafhoppers and numerous other pests. The PHI for imidacloprid ranges between 0 and 30 days, depending on the product.  The PHI for fenpropathrin is 21 days.  Since the market leaders provide broader pest control, and at least some imidaclolprid products will have a shorter PHI, BEAD does not believe that the PPCT will be exceeded.

Stone fruit - Buprofezin is currently registered for use on peaches and the registrant is proposing to add additional stone fruit species to the label.  The label states the buprofezin will control scales.  Scales, such as the San Jose scale, can be major pests of stone fruit (Crop Profile for Nectarines in California, 2001; Crop Profile for Plums in California, 1999).  As noted in the Table 2, petroleum distillate, although it is widely used to control scales, was not included in the market leader approach. BEAD believes that this is appropriate because horticultural oils are often used in conjunction with other pesticides and in organic production. Given the widespread use of these oils, including it in the market leader approach would overestimate the PPCT.  Between 1999 and 2001, Section 18s were granted for pyriproxyfen as an insect growth regulator to control San Jose scale on peaches, plums and nectarines in California.  Pyriproxyfen was registered on stone fruit in 2002; BEAD does not have a record of similar section 18s requested since then.  Since both pyriproxyfen and buprofezin are insect growth regulators and both control scales, BEAD would expect that pyriproxfen use could be an indicator of potential buprofezin use.  However, BEAD did not review the efficacy of these two insecticides.

Apricot – For California apricots, the market leaders are esfenvalerate and lambda-cyhalothrin, both pyrethroids, neither of which is registered for control of scales (CDMS).  For the European fruit lecanium, or brown apricot scale, dormant oil is often used (Coates and Van Steenwyk, 2006).  BEAD did not find any section 18s specifically for apricots, nor was there any information found by BEAD to suggest that the PPCT would be exceeded in the next 5 years.

Nectarine – California is the major nectarine producer in the United States (Crop Profile for Nectarines in California, 2001).  For California nectarines, the market leaders are formetanate HCL and esfenvalerate.  Formetanate hydrochloride is registered to control mites and thrips on nectarines, and is primarily used to control the Western flower thrips (CDMS; Crop Profile for Nectarines in California, 2001).  Esfenvalerate is registered for control of major pests such as the oriental fruit moth (CDMS search; Crop Profile for Nectarines in California, 2001).  These insecticides are not registered for use on scales (CDMS).

Section 18s:  The only section 18s found for control of scale on nectarines was the pyriproxyfen section 18s described above.  A search of usage data did not show pyriproxyfen use on nectarines (NASS search).

Based on the available information, BEAD does not expect that the PPCT for buprofezin will be exceeded over the next five years.

Sweet cherry – Azinphos-methyl and spinosad are the market leaders for sweet cherries.  Azinphos methyl is used to control cherry fruit flies, plum curculio, Syneta beetle (in Oregon), and leafhoppers (Atwood and Alsadek, 2001a).  Spinosad is registered for control of numerous pests, including cherry fruit flies.  BEAD did not find any section 18s for scale control on cherries, nor was BEAD able to find any information to suggest that the PPCT would be exceeded over the next 5 years.

Tart cherry – Azinphos-methyl is the market leader for tart cherries.  Azinphos methyl is used to control cherry fruit flies and plum curcuclio, which are zero tolerance pests for this crop (Atwood and Alsadek, 2001b). BEAD did not find any section 18s for scale control on cherries, nor was BEAD able to find any information to suggest that the PPCT would be exceeded over the next 5 years.

Plum – California is the major producer of plums in the United States (Crop Profile for Plums in California, 1999).  For California plums, the market leader is esfenvalerate, which is registered to control a number of pests, including the oriental fruit moth and the peach twig borer, both major pests of plums (CDMS search; Crop Profile for Plums in California, 1999).  Esfenvalerate is not registered for control of scales (CDMS search).

Section 18s:  The only section 18s found for control of scale on plums was the pyriproxyfen section 18s described above.  In 2001 and 2003, pyriproxyfen was used on 3 and 4 percent of California acreage, respectively (NASS search).  Since BEAD would expect use of buprofezin to be more comparable to pyriproxyfen than esfenvalerate, BEAD does not expect that the PPCT will be exceeded over the next five years.

VI. CONCLUSIONS/RECOMMENDATIONS

BEAD recommends that the average PPCT values given in table 2 be used in the chronic dietary risk assessment for buprofezin, and the maximum PPCTs for acute risk assessment.  BEAD has considered all available relevant information and believes it is unlikely that the above PPCT values will be exceeded during the next five years for grapes, apricots, nectarines, sweet cherries, tart cherries, and plums.

VII. References:

Agricultural Chemical Usage, 1999 Field Crops Summary, July 2000

Agricultural Chemical Usage, 2001 Field Crops Summary, August 2002

Agricultural Chemical Usage, 2005 Field Crops Summary, July 2006

Atwood, D. and J. Alsadek, 2001a, Initial Sweet Cherry Benefits Assessment for Azinphos-methyl and Phosmet, Office of Pesticide Programs, US EPA.

Atwood, D. and J. Alsadek, 2001b, Tart Cherry Initial Benefits Assessment for Azinphos-methyl and Phosmet, Office of Pesticide Programs, US EPA.

Coates, W.W. and R.A. Van Steenwyk, 2006, European Fruit Lecanium, UC IPM Pest Management Guidelines:  Apricot, UC ANR Publication 3433, Web address:   HYPERLINK "http://www.ipm.ucdavis.edu/PMG/r5300811.html"  http://www.ipm.ucdavis.edu/PMG/r5300811.html

Crop Data Management System (CDMS) label search, Web address:    HYPERLINK "https://premier.cdms.net/webapls"  https://premier.cdms.net/webapls

Crop Profile for Nectarines in California, Revised 2001, Web address:    HYPERLINK "http://www.ipmcenters.org/CropProfiles/docs/canectarines.html"  http://www.ipmcenters.org/CropProfiles/docs/canectarines.html

Crop Profile for Plums in California, 1999, Web address:    HYPERLINK "http://www.ipmcenters.org/cropprofiles/docs/caplums.html"  http://www.ipmcenters.org/cropprofiles/docs/caplums.html

USDA/NASS search, Various Years, Web address:    HYPERLINK "http://www.pestmanagement.info/nass/"  http://www.pestmanagement.info/nass/

cc:  	B. Madden

Attachment 4:	DEEM-FCID( acute residue file

Filename: C:\Documents and Settings\tbloem\buprofezin\dietary\275100a.R98

Chemical: buprofezin

RfD(Chronic): .0033 mg/kg bw/day  NOEL(Chronic): 1 mg/kg bw/day

RfD(Acute): 2 mg/kg bw/day  NOEL(Acute):  200 mg/kg bw/day

Date created/last modified: 02-06-2007/13:19:02/8          Program ver. 2.03

Comment: acute endpoint for feamles 13-50 years old only

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

95000010 O    Acerola                            0.840000   1.000  1.000

95000200 O    Avocado                            0.840000   1.000  1.000

95000230 O    Banana                             0.560000   1.000  1.000

95000231 O    Banana-babyfood                    0.560000   1.000  1.000

95000240 O    Banana, dried                      0.560000   3.900  1.000

95000241 O    Banana, dried-babyfood             0.560000   3.900  1.000

95000740 O    Canistel                           2.520000   1.000  1.000

95000890 O    Cherimoya                          0.840000   1.000  1.000

95001280 O    Cottonseed, oil                    0.400000   1.000  1.000

95001281 O    Cottonseed, oil-babyfood           0.400000   1.000  1.000

95001510 O    Feijoa                             0.840000   1.000  1.000

95001750 O    Grape                              7.000000   1.000  1.000

95001760 O    Grape, juice                       7.000000   1.200  1.000

95001761 O    Grape, juice-babyfood              7.000000   1.200  1.000

95001770 O    Grape, leaves                      7.000000   1.000  1.000

95001780 O    Grape, raisin                      7.000000   4.300  1.000

95001790 O    Grape, wine and sherry             7.000000   1.200  1.000

95001830 O    Guava                              0.840000   1.000  1.000

95001831 O    Guava-babyfood                     0.840000   1.000  1.000

95001920 O    Jaboticaba                         0.840000   1.000  1.000

95002090 O    Longan                             0.840000   1.000  1.000

95002110 O    Lychee                             0.840000   1.000  1.000

95002120 O    Lychee, dried                      0.840000   1.850  1.000

95002150 O    Mango                              2.520000   1.000  1.000

95002151 O    Mango-babyfood                     2.520000   1.000  1.000

95002160 O    Mango, dried                       2.520000   1.000  1.000

95002170 O    Mango, juice                       2.520000   1.000  1.000

95002171 O    Mango, juice-babyfood              2.520000   1.000  1.000

95002450 O    Papaya                             2.520000   1.000  1.000

95002451 O    Papaya-babyfood                    2.520000   1.000  1.000

95002460 O    Papaya, dried                      2.520000   1.800  1.000

95002470 O    Papaya, juice                      2.520000   1.500  1.000

95002520 O    Passionfruit                       0.840000   1.000  1.000

95002521 O    Passionfruit-babyfood              0.840000   1.000  1.000

95002530 O    Passionfruit, juice                0.840000   1.000  1.000

95002531 O    Passionfruit, juice-babyfood       0.840000   1.000  1.000

95002830 O    Plantain                           0.560000   1.000  1.000

95002840 O    Plantain, dried                    0.560000   3.900  1.000

95003330 O    Sapote, Mamey                      2.520000   1.000  1.000

95003460 O    Soursop                            0.840000   1.000  1.000

95003510 O    Spanish lime                       0.840000   1.000  1.000

95003580 O    Starfruit                          0.840000   1.000  1.000

95003610 O    Sugar apple                        0.840000   1.000  1.000

86010000 O    Water, direct, all sources         0.023200   1.000  1.000

86020000 O    Water, indirect, all sources       0.023200   1.000  1.000

21000440 M    Beef, meat                         0.015000   1.000  1.000

21000441 M    Beef, meat-babyfood                0.015000   1.000  1.000

21000450 M    Beef, meat, dried                  0.015000   1.920  1.000

21000460 M    Beef, meat byproducts              0.025000   1.000  1.000

21000461 M    Beef, meat byproducts-babyfood     0.025000   1.000  1.000

21000470 M    Beef, fat                          0.025000   1.000  1.000

21000471 M    Beef,fat-babyfood                  0.025000   1.000  1.000

21000480 M    Beef, kidney                       0.015000   1.000  1.000

21000490 M    Beef, liver                        0.015000   1.000  1.000

21000491 M    Beef, liver-babyfood               0.015000   1.000  1.000

23001690 M    Goat, meat                         0.015000   1.000  1.000

23001700 M    Goat, meat byproducts              0.025000   1.000  1.000

23001710 M    Goat, fat                          0.025000   1.000  1.000

23001720 M    Goat, kidney                       0.015000   1.000  1.000

23001730 M    Goat, liver                        0.015000   1.000  1.000

24001890 M    Horse, meat                        0.015000   1.000  1.000

28002210 M    Meat, game                         0.015000   1.000  1.000

25002900 M    Pork, meat                         0.015000   1.000  1.000

25002901 M    Pork, meat-babyfood                0.015000   1.000  1.000

25002910 M    Pork, skin                         0.025000   1.000  1.000

25002920 M    Pork, meat byproducts              0.025000   1.000  1.000

25002921 M    Pork, meat byproducts-babyfood     0.025000   1.000  1.000

25002930 M    Pork, fat                          0.025000   1.000  1.000

25002931 M    Pork, fat-babyfood                 0.025000   1.000  1.000

25002940 M    Pork, kidney                       0.015000   1.000  1.000

25002950 M    Pork, liver                        0.015000   1.000  1.000

29003120 M    Rabbit, meat                       0.015000   1.000  1.000

26003390 M    Sheep, meat                        0.015000   1.000  1.000

26003391 M    Sheep, meat-babyfood               0.015000   1.000  1.000

26003400 M    Sheep, meat byproducts             0.025000   1.000  1.000

26003410 M    Sheep, fat                         0.025000   1.000  1.000

26003411 M    Sheep, fat-babyfood                0.025000   1.000  1.000

26003420 M    Sheep, kidney                      0.015000   1.000  1.000

26003430 M    Sheep, liver                       0.015000   1.000  1.000

27002220 D    Milk, fat                          0.081000   1.000  1.000

27002221 D    Milk, fat - baby food/infant for   0.081000   1.000  1.000

27012230 D    Milk, nonfat solids                0.003200   1.000  1.000

27012231 D    Milk, nonfat solids-baby food/in   0.003200   1.000  1.000

27022240 D    Milk, water                        0.003200   1.000  1.000

27022241 D    Milk, water-babyfood/infant form   0.003200   1.000  1.000

27032251 D    Milk, sugar (lactose)-baby food/   0.003200   1.000  1.000

04012040 4A   Lettuce, head                      5.000000   1.000  1.000

04012050 4A   Lettuce, leaf                     13.000000   1.000  1.000

06010430 6A   Bean, snap, succulent              0.020000   1.000  1.000

06010431 6A   Bean, snap, succulent-babyfood     0.020000   1.000  1.000

08003740 8    Tomatillo                          0.400000   1.000  1.000

08003750 8    Tomato                             0.400000   1.000  1.000

08003751 8    Tomato-babyfood                    0.400000   1.000  1.000

08003760 8    Tomato, paste                      0.400000   5.400  1.000

08003761 8    Tomato, paste-babyfood             0.400000   5.400  1.000

08003770 8    Tomato, puree                      0.400000   3.300  1.000

08003771 8    Tomato, puree-babyfood             0.400000   3.300  1.000

08003780 8    Tomato, dried                      0.400000  14.300  1.000

08003781 8    Tomato, dried-babyfood             0.400000  14.300  1.000

08003790 8    Tomato, juice                      0.400000   1.500  1.000

09020210 9B   Balsam pear                        0.500000   1.000  1.000

09010750 9A   Cantaloupe                         0.500000   1.000  1.000

09010800 9A   Casaba                             0.500000   1.000  1.000

09020880 9B   Chayote, fruit                     0.500000   1.000  1.000

09021020 9B   Chinese waxgourd                   0.500000   1.000  1.000

09021350 9B   Cucumber                           0.500000   1.000  1.000

09011870 9A   Honeydew melon                     0.500000   1.000  1.000

09023080 9B   Pumpkin                            0.500000   1.000  1.000

09023090 9B   Pumpkin, seed                      0.500000   1.000  1.000

09023560 9B   Squash, summer                     0.500000   1.000  1.000

09023561 9B   Squash, summer-babyfood            0.500000   1.000  1.000

09023570 9B   Squash, winter                     0.500000   1.000  1.000

09023571 9B   Squash, winter-babyfood            0.500000   1.000  1.000

09013990 9A   Watermelon                         0.500000   1.000  1.000

09014000 9A   Watermelon, juice                  0.500000   1.000  1.000

10001060 10   Citrus citron                      7.000000   1.000  1.000

10001070 10   Citrus hybrids                     7.000000   1.000  1.000

10001080 10   Citrus, oil                       80.000000   1.000  1.000

10001800 10   Grapefruit                         7.000000   1.000  1.000

10001810 10   Grapefruit, juice                  7.000000   2.100  1.000

10001970 10   Kumquat                            7.000000   1.000  1.000

10001990 10   Lemon                              7.000000   1.000  1.000

10002000 10   Lemon, juice                       7.000000   2.000  1.000

10002001 10   Lemon, juice-babyfood              7.000000   2.000  1.000

10002010 10   Lemon, peel                        7.000000   1.000  1.000

10002060 10   Lime                               7.000000   1.000  1.000

10002070 10   Lime, juice                        7.000000   2.000  1.000

10002071 10   Lime, juice-babyfood               7.000000   2.000  1.000

10002400 10   Orange                             7.000000   1.000  1.000

10002410 10   Orange, juice                      7.000000   1.800  1.000

10002411 10   Orange, juice-babyfood             7.000000   1.800  1.000

10002420 10   Orange, peel                       7.000000   1.000  1.000

10003070 10   Pummelo                            7.000000   1.000  1.000

10003690 10   Tangerine                          7.000000   1.000  1.000

10003700 10   Tangerine, juice                   7.000000   2.300  1.000

11000070 11   Apple, fruit with peel            11.200000   1.000  1.000

11000080 11   Apple, peeled fruit               11.200000   1.000  1.000

11000081 11   Apple, peeled fruit-babyfood      11.200000   1.000  1.000

11000090 11   Apple, dried                      11.200000   8.000  1.000

11000091 11   Apple, dried-babyfood             11.200000   8.000  1.000

11000100 11   Apple, juice                      11.200000   1.300  1.000

11000101 11   Apple, juice-babyfood             11.200000   1.300  1.000

11000110 11   Apple, sauce                      11.200000   1.000  1.000

11000111 11   Apple, sauce-babyfood             11.200000   1.000  1.000

11001290 11   Crabapple                         11.200000   1.000  1.000

11002100 11   Loquat                            11.200000   1.000  1.000

11002660 11   Pear                              11.200000   1.000  1.000

11002661 11   Pear-babyfood                     11.200000   1.000  1.000

11002670 11   Pear, dried                       11.200000   6.250  1.000

11002680 11   Pear, juice                       11.200000   1.000  1.000

11002681 11   Pear, juice-babyfood              11.200000   1.000  1.000

11003100 11   Quince                            11.200000   1.000  1.000

12000120 12   Apricot                           25.200000   1.000  1.000

12000121 12   Apricot-babyfood                  25.200000   1.000  1.000

12000130 12   Apricot, dried                    25.200000   6.000  1.000

12000140 12   Apricot, juice                    25.200000   1.000  1.000

12000141 12   Apricot, juice-babyfood           25.200000   1.000  1.000

12000900 12   Cherry                             5.320000   1.000  1.000

12000901 12   Cherry-babyfood                    5.320000   1.000  1.000

12000910 12   Cherry, juice                      5.320000   1.500  1.000

12000911 12   Cherry, juice-babyfood             5.320000   1.500  1.000

12002300 12   Nectarine                         25.200000   1.000  1.000

12002600 12   Peach                             25.200000   1.000  1.000

12002601 12   Peach-babyfood                    25.200000   1.000  1.000

12002610 12   Peach, dried                      25.200000   7.000  1.000

12002611 12   Peach, dried-babyfood             25.200000   7.000  1.000

12002620 12   Peach, juice                      25.200000   1.000  1.000

12002621 12   Peach, juice-babyfood             25.200000   1.000  1.000

12002850 12   Plum                               5.320000   1.000  1.000

12002851 12   Plum-babyfood                      5.320000   1.000  1.000

12002860 12   Plum, prune, fresh                 5.320000   5.000  1.000

12002861 12   Plum, prune, fresh-babyfood        5.320000   5.000  1.000

12002870 12   Plum, prune, dried                 5.320000   5.000  1.000

12002871 12   Plum, prune, dried-babyfood        5.320000   5.000  1.000

12002880 12   Plum, prune, juice                 5.320000   1.400  1.000

12002881 12   Plum, prune, juice-babyfood        5.320000   1.400  1.000

14000030 14   Almond                             0.140000   1.000  1.000

14000031 14   Almond-babyfood                    0.140000   1.000  1.000

14000040 14   Almond, oil                        0.140000   1.000  1.000

14000041 14   Almond, oil-babyfood               0.140000   1.000  1.000

14002820 14   Pistachio                          0.140000   1.000  1.000

Attachment 5:	DEEM-FCID( acute exposure estimates

U.S. Environmental Protection Agency                                  Ver. 2.02

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

Residue file: 275100a.R98                         Adjustment factor #2 NOT used.

Analysis Date: 02-13-2007/08:08:02    Residue file dated: 02-13-2007/08:07:03/8

NOEL (Acute) = 200.000000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: "acute endpoint for feamles 13-50 years old only"

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

Summary calculations (per capita):

      95th Percentile             99th Percentile             99.9th Percentile

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

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

Females 13+ (preg/not nursing):

  0.153318    7.67    1304    0.290906   14.55     687    0.292677   14.63     683

Females 13+ (nursing):

  0.123992    6.20    1613    0.201094   10.05     994    0.202498   10.12     987

Females 13-19 (not preg or nursing):

  0.141400    7.07    1414    0.271701   13.59     736    0.430994   21.55     464

Females 20+ (not preg or nursing):

  0.106452    5.32    1878    0.171654    8.58    1165    0.289964   14.50     689

Females 13-50 yrs:

  0.116466    5.82    1717    0.199820    9.99    1000    0.339880   16.99     588

Females 13-49 yrs:

  0.116936    5.85    1710    0.201211   10.06     993    0.341553   17.08     585

Attachment 6:	DEEM-FCID( chronic residue file

Filename: C:\Documents and Settings\tbloem\buprofezin\dietary\275100c.R98

Chemical: buprofezin

RfD(Chronic): .0033 mg/kg bw/day  NOEL(Chronic): 1 mg/kg bw/day

RfD(Acute): 2 mg/kg bw/day  NOEL(Acute):  200 mg/kg bw/day

Date created/last modified: 02-08-2007/12:59:56/8          Program ver. 2.03

Comment: acute endpoint for feamles 13-50 years old only

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

95000010 O    Acerola                            0.840000   1.000  1.000

95000200 O    Avocado                            0.840000   1.000  1.000

95000230 O    Banana                             0.110000   1.000  1.000

95000231 O    Banana-babyfood                    0.110000   1.000  1.000

95000240 O    Banana, dried                      0.110000   3.900  1.000

95000241 O    Banana, dried-babyfood             0.110000   3.900  1.000

95000740 O    Canistel                           2.520000   1.000  1.000

95000890 O    Cherimoya                          0.840000   1.000  1.000

95001280 O    Cottonseed, oil                    0.400000   1.000  0.010

95001281 O    Cottonseed, oil-babyfood           0.400000   1.000  0.010

95001510 O    Feijoa                             0.840000   1.000  1.000

95001750 O    Grape                              0.810000   1.000  0.210

95001760 O    Grape, juice                       0.810000   1.200  0.210

95001761 O    Grape, juice-babyfood              0.810000   1.200  0.210

95001770 O    Grape, leaves                      0.810000   1.000  0.210

95001780 O    Grape, raisin                      0.810000   4.300  0.210

95001790 O    Grape, wine and sherry             0.810000   1.200  0.210

95001830 O    Guava                              0.840000   1.000  1.000

95001831 O    Guava-babyfood                     0.840000   1.000  1.000

95001920 O    Jaboticaba                         0.840000   1.000  1.000

95002090 O    Longan                             0.840000   1.000  1.000

95002110 O    Lychee                             0.840000   1.000  1.000

95002120 O    Lychee, dried                      0.840000   1.850  1.000

95002150 O    Mango                              2.520000   1.000  1.000

95002151 O    Mango-babyfood                     2.520000   1.000  1.000

95002160 O    Mango, dried                       2.520000   1.000  1.000

95002170 O    Mango, juice                       2.520000   1.000  1.000

95002171 O    Mango, juice-babyfood              2.520000   1.000  1.000

95002450 O    Papaya                             2.520000   1.000  1.000

95002451 O    Papaya-babyfood                    2.520000   1.000  1.000

95002460 O    Papaya, dried                      2.520000   1.800  1.000

95002470 O    Papaya, juice                      2.520000   1.500  1.000

95002520 O    Passionfruit                       0.840000   1.000  1.000

95002521 O    Passionfruit-babyfood              0.840000   1.000  1.000

95002530 O    Passionfruit, juice                0.840000   1.000  1.000

95002531 O    Passionfruit, juice-babyfood       0.840000   1.000  1.000

95002830 O    Plantain                           0.110000   1.000  1.000

95002840 O    Plantain, dried                    0.110000   3.900  1.000

95003330 O    Sapote, Mamey                      2.520000   1.000  1.000

95003460 O    Soursop                            0.840000   1.000  1.000

95003510 O    Spanish lime                       0.840000   1.000  1.000

95003580 O    Starfruit                          0.840000   1.000  1.000

95003610 O    Sugar apple                        0.840000   1.000  1.000

86010000 O    Water, direct, all sources         0.007800   1.000  1.000

86020000 O    Water, indirect, all sources       0.007800   1.000  1.000

21000440 M    Beef, meat                         0.015000   1.000  1.000

21000441 M    Beef, meat-babyfood                0.015000   1.000  1.000

21000450 M    Beef, meat, dried                  0.015000   1.920  1.000

21000460 M    Beef, meat byproducts              0.025000   1.000  1.000

21000461 M    Beef, meat byproducts-babyfood     0.025000   1.000  1.000

21000470 M    Beef, fat                          0.025000   1.000  1.000

21000471 M    Beef,fat-babyfood                  0.025000   1.000  1.000

21000480 M    Beef, kidney                       0.015000   1.000  1.000

21000490 M    Beef, liver                        0.015000   1.000  1.000

21000491 M    Beef, liver-babyfood               0.015000   1.000  1.000

23001690 M    Goat, meat                         0.015000   1.000  1.000

23001700 M    Goat, meat byproducts              0.025000   1.000  1.000

23001710 M    Goat, fat                          0.025000   1.000  1.000

23001720 M    Goat, kidney                       0.015000   1.000  1.000

23001730 M    Goat, liver                        0.015000   1.000  1.000

24001890 M    Horse, meat                        0.015000   1.000  1.000

28002210 M    Meat, game                         0.015000   1.000  1.000

25002900 M    Pork, meat                         0.015000   1.000  1.000

25002901 M    Pork, meat-babyfood                0.015000   1.000  1.000

25002910 M    Pork, skin                         0.025000   1.000  1.000

25002920 M    Pork, meat byproducts              0.025000   1.000  1.000

25002921 M    Pork, meat byproducts-babyfood     0.025000   1.000  1.000

25002930 M    Pork, fat                          0.025000   1.000  1.000

25002931 M    Pork, fat-babyfood                 0.025000   1.000  1.000

25002940 M    Pork, kidney                       0.015000   1.000  1.000

25002950 M    Pork, liver                        0.015000   1.000  1.000

29003120 M    Rabbit, meat                       0.015000   1.000  1.000

26003390 M    Sheep, meat                        0.015000   1.000  1.000

26003391 M    Sheep, meat-babyfood               0.015000   1.000  1.000

26003400 M    Sheep, meat byproducts             0.025000   1.000  1.000

26003410 M    Sheep, fat                         0.025000   1.000  1.000

26003411 M    Sheep, fat-babyfood                0.025000   1.000  1.000

26003420 M    Sheep, kidney                      0.015000   1.000  1.000

26003430 M    Sheep, liver                       0.015000   1.000  1.000

27002220 D    Milk, fat                          0.081000   1.000  1.000

27002221 D    Milk, fat - baby food/infant for   0.081000   1.000  1.000

27012230 D    Milk, nonfat solids                0.003200   1.000  1.000

27012231 D    Milk, nonfat solids-baby food/in   0.003200   1.000  1.000

27022240 D    Milk, water                        0.003200   1.000  1.000

27022241 D    Milk, water-babyfood/infant form   0.003200   1.000  1.000

27032251 D    Milk, sugar (lactose)-baby food/   0.003200   1.000  1.000

04012040 4A   Lettuce, head                      2.040000   1.000  1.000

04012050 4A   Lettuce, leaf                      6.970000   1.000  1.000

06010430 6A   Bean, snap, succulent              0.020000   1.000  1.000

06010431 6A   Bean, snap, succulent-babyfood     0.020000   1.000  1.000

08003740 8    Tomatillo                          0.240000   1.000  1.000

08003750 8    Tomato                             0.240000   1.000  0.010

08003751 8    Tomato-babyfood                    0.240000   1.000  0.010

08003760 8    Tomato, paste                      0.240000   5.400  0.010

08003761 8    Tomato, paste-babyfood             0.240000   5.400  0.010

08003770 8    Tomato, puree                      0.240000   3.300  0.010

08003771 8    Tomato, puree-babyfood             0.240000   3.300  0.010

08003780 8    Tomato, dried                      0.240000  14.300  0.010

08003781 8    Tomato, dried-babyfood             0.240000  14.300  0.010

08003790 8    Tomato, juice                      0.240000   1.500  0.010

09020210 9B   Balsam pear                        0.060000   1.000  1.000

09010750 9A   Cantaloupe                         0.210000   1.000  0.050

09010800 9A   Casaba                             0.210000   1.000  1.000

09020880 9B   Chayote, fruit                     0.040000   1.000  1.000

09021020 9B   Chinese waxgourd                   0.060000   1.000  1.000

09021350 9B   Cucumber                           0.060000   1.000  1.000

09011870 9A   Honeydew melon                     0.210000   1.000  0.010

09023080 9B   Pumpkin                            0.040000   1.000  0.010

09023090 9B   Pumpkin, seed                      0.040000   1.000  0.010

09023560 9B   Squash, summer                     0.040000   1.000  1.000

09023561 9B   Squash, summer-babyfood            0.040000   1.000  1.000

09023570 9B   Squash, winter                     0.040000   1.000  1.000

09023571 9B   Squash, winter-babyfood            0.040000   1.000  1.000

09013990 9A   Watermelon                         0.210000   1.000  0.010

09014000 9A   Watermelon, juice                  0.210000   1.000  0.010

10001060 10   Citrus citron                      3.470000   1.000  0.010

10001070 10   Citrus hybrids                     3.470000   1.000  0.010

10001080 10   Citrus, oil                       80.000000   1.000  0.010

10001800 10   Grapefruit                         0.490000   1.000  0.010

10001810 10   Grapefruit, juice                  0.490000   2.100  0.010

10001970 10   Kumquat                            3.470000   1.000  1.000

10001990 10   Lemon                              7.000000   1.000  0.010

10002000 10   Lemon, juice                       7.000000   2.000  0.010

10002001 10   Lemon, juice-babyfood              7.000000   2.000  0.010

10002010 10   Lemon, peel                        7.000000   1.000  0.010

10002060 10   Lime                               7.000000   1.000  0.010

10002070 10   Lime, juice                        7.000000   2.000  0.010

10002071 10   Lime, juice-babyfood               7.000000   2.000  0.010

10002400 10   Orange                             0.042000   1.000  1.000

10002410 10   Orange, juice                      0.042000   1.000  1.000

10002411 10   Orange, juice-babyfood             0.042000   1.000  1.000

10002420 10   Orange, peel                       3.470000   1.000  0.010

10003070 10   Pummelo                            0.490000   1.000  1.000

10003690 10   Tangerine                          3.470000   1.000  1.000

10003700 10   Tangerine, juice                   3.470000   2.300  1.000

11000070 11   Apple, fruit with peel             0.000560   1.000  1.000

11000080 11   Apple, peeled fruit                0.000560   1.000  1.000

11000081 11   Apple, peeled fruit-babyfood       0.000560   1.000  1.000

11000090 11   Apple, dried                       0.000560   8.000  1.000

11000091 11   Apple, dried-babyfood              0.000560   8.000  1.000

11000100 11   Apple, juice                       0.000560   1.300  1.000

11000101 11   Apple, juice-babyfood              0.000560   1.300  1.000

11000110 11   Apple, sauce                       0.000560   1.000  1.000

11000111 11   Apple, sauce-babyfood              0.000560   1.000  1.000

11001290 11   Crabapple                          1.040000   1.000  1.000

11002100 11   Loquat                             3.020000   1.000  1.000

11002660 11   Pear                               3.020000   1.000  0.010

11002661 11   Pear-babyfood                      3.020000   1.000  0.010

11002670 11   Pear, dried                        3.020000   6.250  0.010

11002680 11   Pear, juice                        3.020000   1.000  0.010

11002681 11   Pear, juice-babyfood               3.020000   1.000  0.010

11003100 11   Quince                             3.020000   1.000  1.000

12000120 12   Apricot                            4.700000   1.000  0.400

12000121 12   Apricot-babyfood                   4.700000   1.000  0.400

12000130 12   Apricot, dried                     4.700000   6.000  0.400

12000140 12   Apricot, juice                     4.700000   1.000  0.400

12000141 12   Apricot, juice-babyfood            4.700000   1.000  0.400

12000900 12   Cherry                             2.240000   1.000  0.760

12000901 12   Cherry-babyfood                    2.240000   1.000  0.760

12000910 12   Cherry, juice                      2.240000   1.500  0.760

12000911 12   Cherry, juice-babyfood             2.240000   1.500  0.760

12002300 12   Nectarine                          4.700000   1.000  0.600

12002600 12   Peach                              4.700000   1.000  0.130

12002601 12   Peach-babyfood                     4.700000   1.000  0.130

12002610 12   Peach, dried                       4.700000   7.000  0.130

12002611 12   Peach, dried-babyfood              4.700000   7.000  0.130

12002620 12   Peach, juice                       4.700000   1.000  0.130

12002621 12   Peach, juice-babyfood              4.700000   1.000  0.130

12002850 12   Plum                               0.540000   1.000  0.350

12002851 12   Plum-babyfood                      0.540000   1.000  0.350

12002860 12   Plum, prune, fresh                 0.540000   5.000  0.350

12002861 12   Plum, prune, fresh-babyfood        0.540000   5.000  0.350

12002870 12   Plum, prune, dried                 0.540000   5.000  0.350

12002871 12   Plum, prune, dried-babyfood        0.540000   5.000  0.350

12002880 12   Plum, prune, juice                 0.540000   1.400  0.350

12002881 12   Plum, prune, juice-babyfood        0.540000   1.400  0.350

14000030 14   Almond                             0.140000   1.000  0.010

14000031 14   Almond-babyfood                    0.140000   1.000  0.010

14000040 14   Almond, oil                        0.140000   1.000  0.010

14000041 14   Almond, oil-babyfood               0.140000   1.000  0.010

14002820 14   Pistachio                          0.140000   1.000  1.000

Attachment 7:	DEEM-FCID( chronic exposure estimates

U.S. Environmental Protection Agency                                 Ver. 2.00

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

Residue file name: C:\Documents and Settings\tbloem\buprofezin\dietary\275100c.R98

                                                     Adjustment factor #2 used.

Analysis Date 02-08-2007/13:00:23     Residue file dated: 02-08-2007/12:59:56/8

Reference dose (RfD, Chronic) = .0033 mg/kg bw/day

COMMENT 1: acute endpoint for feamles 13-50 years old only

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.001347                40.8%

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U.S. Population (spring season)             0.001339                40.6%

U.S. Population (summer season)             0.001477                44.7%

U.S. Population (autumn season)             0.001237                37.5%

U.S. Population (winter season)             0.001340                40.6%

Northeast region                            0.001371                41.6%

Midwest region                              0.001336                40.5%

Southern region                             0.001156                35.0%

Western region                              0.001640                49.7%

Hispanics                                   0.001498                45.4%

Non-hispanic whites                         0.001362                41.3%

Non-hispanic blacks                         0.001037                31.4%

Non-hisp/non-white/non-black                0.001623                49.2%

All infants (< 1 year)                      0.002259                68.5%

Nursing infants                             0.001173                35.5%

Non-nursing infants                         0.002671                80.9%

Children 1-6  yrs                           0.002516                76.3%

Children 7-12 yrs                           0.001451                44.0%

Females 13-19 (not preg or nursing)         0.001013                30.7%

Females 20+ (not preg or nursing)           0.001293                39.2%

Females 13-50 yrs                           0.001318                40.0%

Females 13+ (preg/not nursing)              0.002176                65.9%

Females 13+ (nursing)                       0.001341                40.6%

Males 13-19 yrs                             0.001045                31.7%

Males 20+ yrs                               0.001089                33.0%

Seniors 55+                                 0.001194                36.2%

Children 1-2 yrs                            0.003027                91.7%

Children 3-5 yrs                            0.002381                72.2%

Children 6-12 yrs                           0.001519                46.0%

Youth 13-19 yrs                             0.001035                31.4%

Adults 20-49 yrs                            0.001201                36.4%

Adults 50+ yrs                              0.001206                36.5%

Females 13-49 yrs                           0.001271                38.5%

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

  Petroleum Distillate was excluded as a market leader and the next insecticide market leader was chosen.

Buprofezin (PC code 275100)	Dietary Exposure and Risk Assessment	DP #:  335841

Page   PAGE  3  of   NUMPAGES  27

Buprofezin (PC code 275100)	Dietary Exposure and RiskAssessment	DP #:  335841

Page   PAGE  12  of   NUMPAGES  27

 PAGE   8

Page   PAGE  18  of   NUMPAGES  27


[Federal Register Volume 86, Number 23 (Friday, February 5, 2021)]
[Notices]
[Page 8356]
[FR Doc No: 2021-02412]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9055-2]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EIS)
Filed January 25, 2021 10 a.m. EST Through February 1, 2021 10 a.m. EST
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

EIS No. 20210013, Final, USAF, NM, Special Use Airspace Optimization to
Support Existing Aircraft at Holloman Air Force Base, New Mexico,
Review Period Ends: 03/08/2021, Contact: Robin Divine<PHONE_NUMBER>.
EIS No. 20210014, Final, USAF, VA, Fifth Generation Formal Training
Unit Optimization, Review Period Ends: 03/08/2021, Contact: Nolan Swick
210-925-3392.
EIS No. 20210015, Final, USFS, OR, Government Camp--Cooper Spur Land
Exchange, Review Period Ends: 04/06/2021, Contact: Michelle Lombardo
971-303-2083.
EIS No. 20210016, Draft, FHWA, OR, Earthquake Ready Burnside Bridge,
Comment Period Ends: 03/22/2021, Contact: Emily Cline<PHONE_NUMBER>.

Amended Notice

EIS No. 20200210, Draft, STB, UT, Uinta Basin Railway, Comment Period
Ends: 02/12/2021, Contact: Joshua Wayland<PHONE_NUMBER>.

    Revision to FR Notice Published 12/18/2020; Extending the Comment
Period from 01/28/2020 to 02/12/2021.

    Dated: February 1, 2021.
Cindy S. Barger,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2021-02412 Filed 2-4-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 57 (Thursday, March 24, 2022)]
[Proposed Rules]
[Pages 16659-16661]
[FR Doc No: 2022-06211]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0292; Project Identifier AD-2021-01297-E]
RIN 2120-AA64

Airworthiness Directives; International Aero Engines, LLC
Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain International Aero Engines, LLC (IAE LLC) PW1122G-JM,
PW1124G1-JM, PW1124G-JM, PW1127G1-JM, PW1127GA-JM, PW1127G-JM, PW1129G-
JM, PW1130G-JM, PW1133GA-JM, and PW1133G-JM model turbofan engines.
This proposed AD was prompted by an analysis of an event involving an
International Aero Engines AG (IAE AG) V2533-A5 model turbofan engine,
which experienced an uncontained failure of a high-pressure turbine
(HPT) 1st-stage disk that resulted in high-energy debris penetrating
the engine cowling. This proposed AD would require performance of an
ultrasonic inspection (USI) of the HPT 1st-stage disk and HPT 2nd-stage
disk and, depending on the results of the inspections, replacement of
the HPT 1st-stage disk or HPT 2nd-stage disk. The FAA is proposing this
AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by May 9,
2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact
International Aero Engines, LLC, 400 Main Street, East Hartford, CT
06118; phone:<PHONE_NUMBER>; email: [email protected]; website: http://fleetcare.prattwhitney.com. You may view this service information at
the FAA, Airworthiness Products Section, Operational Safety Branch,
1200 District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0292; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, any comments
received, and other information. The street address for Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Mark Taylor, Aviation Safety Engineer,
ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone:
(781) 238-7229; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-0292; Project Identifier
AD-2021-01297-E'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Mark
Taylor, Aviation Safety Engineer, ECO Branch, FAA, 1200 District
Avenue, Burlington, MA 01803. Any commentary that the FAA receives
which is not specifically designated as CBI will be placed in the
public docket for this rulemaking.

Background

    On March 18, 2020, an Airbus Model A321-231 airplane, powered by
IAE AG V2533-A5 model turbofan engines, experienced an uncontained HPT
1st-stage disk failure that resulted in high-energy debris penetrating
the engine cowling. Based on a preliminary analysis of this event, on
March 21, 2020, the FAA issued Emergency AD 2020-07-51 (followed by
publication in the Federal Register on April 13, 2020, as a Final Rule,
Request for Comments (85 FR 20402)), which requires the removal from
service of certain HPT 1st-stage disks installed on IAE AG V2522-A5,
V2524-A5, V2525-D5, V2527-A5, V2527E-A5, V2527M-A5, V2528-D5, V2530-A5,
and V2533-A5 model turbofan engines.
    Based on the root cause analysis performed since that March 2020
event, Pratt & Whitney (PW) identified a different population of HPT
1st-stage disks and HPT 2nd-stage disks that are subject to the same
unsafe condition identified in AD 2020-07-51. In response, the FAA
issued AD 2021-19-10 on September 10, 2021 (86 FR 50610), which
requires the removal from service of certain HPT 1st-stage disks and
HPT 2nd-stage disks installed on IAE LLC PW1122G-JM, PW1124G1-JM,
PW1124G-JM, PW1127G1-JM, PW1127GA-JM, PW1127G-JM, PW1129G-JM, PW1130G-
JM, PW1133GA-JM, and PW1133G-JM model turbofan engines.
    Since the FAA issued AD 2021-19-10, PW identified another
subpopulation of HPT 1st-stage disks and HPT 2nd-stage disks that
require inspection and possible removal from service. Included in this
additional subpopulation of HPT 1st-stage disks

and HPT 2nd-stage disks are those installed on the model turbofan
engines affected by this proposed AD. This proposed AD would require
performance of a USI on the remaining high-risk subpopulation of HPT
1st-stage disks and HPT 2nd-stage disks and, depending on the results
of the inspections, replacement of the HPT 1st-stage disk or HPT 2nd-
stage disk. This condition, if not addressed, could result in
uncontained HPT disk failure, release of high-energy debris, damage to
the engine, damage to the airplane, and loss of the airplane.

FAA's Determination

    The FAA is issuing this NPRM after determining that the unsafe
condition described previously is likely to exist or develop on other
products of the same type design.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed PW Service Bulletin (SB) PW1000G-C-72-00-0188-00A-
930A-D, Issue No: 001, dated September 13, 2021 (PW SB PW1000G-C-72-00-
0188-00A-930A-D). This SB specifies procedures for performing a USI of
the HPT 1st-stage disk and the HPT 2nd-stage disk, identified by part
number and serial number, installed on IAE LLC PW1124G1-JM, PW1127G-JM,
PW1127GA-JM, PW1129G-JM, PW1130G-JM, PW1133G-JM, and PW1133GA-JM model
turbofan engines. This service information is reasonably available
because the interested parties have access to it through their normal
course of business or by the means identified in ADDRESSES.

Other Related Service Information

    The FAA reviewed PW SB PW1000G-C-72-00-0112-00A-930A-D, Issue No:
005, dated July 22, 2021. This SB describes procedures for replacing
the HPT 1st-stage disk, HPT 2nd-stage disk, and rotating hardware. This
SB also increases the life limit of the HPT hardware by introducing a
new configuration of rotating hardware.

Proposed AD Requirements in This NPRM

    This proposed AD would require the performance of a USI of the HPT
1st-stage disk and HPT 2nd-stage disk and, depending on the results of
the inspections, replacement of the HPT 1st-stage disk or HPT 2nd-stage
disk.

Differences Between This Proposed AD and the Service Information

    PW SB PW1000G-C-72-00-0188-00A-930A-D, Applicability, identifies
IAE LLC PW1127G-JM, PW1127GA-JM, PW1130G-JM, PW1124G1-JM, PW1129G-JM,
PW1133G-JM, and PW1133GA-JM model turbofan engines. The FAA determined
that IAE LLC PW1122G-JM, PW1124G-JM, and PW1127G1-JM model turbofan
engines are of the same type design and are subject to the same unsafe
condition. Therefore, the FAA included IAE LLC PW1122G-JM, PW1124G-JM,
and PW1127G1-JM model turbofan engines in the applicability of this
proposed AD.
    PW SB PW1000G-C-72-00-0188-00A-930A-D uses the term ``hub'' to
describe the HPT 1st-stage disk and HPT 2nd-stage disk, while this
proposed AD uses the term ``disk.''

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 189 engines installed on airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                         Parts       Cost per      Cost on U.S.
                 Action                            Labor cost             cost        product        operators
----------------------------------------------------------------------------------------------------------------
USI the HPT 1st-stage disk and HPT 2nd-   204 work-hours x $85 per            $0         $17,340      $3,277,260
 stage disk (also includes estimated       hour = $17,340.
 costs for disassembly of the engine and
 removal of the HPT 1st-stage disk and
 HPT 2nd-stage disk).
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary
replacement that would be required based on the results of the proposed
inspection. The agency has no way of determining the number of aircraft
that might need this replacement:

                           On-Condition Costs
------------------------------------------------------------------------
                                                 Parts       Cost per
           Action                Labor cost       cost        product
------------------------------------------------------------------------
Replace the HPT 1st-stage     1 work-hour x     $171,430        $171,515
 disk or HPT 2nd-stage disk.   $85 per hour =
                               $85.
------------------------------------------------------------------------

    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected operators.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government.

    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

International Aero Engines, LLC: Docket No. FAA-2022-0292; Project
Identifier AD-2021-01297-E.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by May 9, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to International Aero Engines, LLC PW1122G-JM,
PW1124G1-JM, PW1124G-JM, PW1127G1-JM, PW1127GA-JM, PW1127G-JM,
PW1129G-JM, PW1130G-JM, PW1133GA-JM, and PW1133G-JM model turbofan
engines with engine serial numbers P770101 through P772647.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7250, Turbine
Section.

(e) Unsafe Condition

    This AD was prompted by an analysis of an event involving an
International Aero Engines AG V2533-A5 model turbofan engine, which
experienced an uncontained failure of a high-pressure turbine (HPT)
1st-stage disk that resulted in high-energy debris penetrating the
engine cowling. The FAA is issuing this AD to prevent failure of the
HPT 1st-stage disk and HPT 2nd-stage disk. The unsafe condition, if
not addressed, could result in uncontained HPT disk failure, release
of high-energy debris, damage to the engine, damage to the airplane,
and loss of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    (1) For affected engines that have not incorporated Pratt &
Whitney (PW) Service Bulletin (SB) PW1000G-C-72-00-0112-00A-930A-D,
Issue No: 005, dated July 22, 2021 (PW SB PW1000G-C-72-00-0112-00A-
930A-D), at the next engine shop visit after the effective date of
this AD, perform the following:
    (i) Ultrasonic inspection (USI) of the HPT 1st-stage disk using
the Accomplishment Instructions, paragraph 9.A. or B., as
applicable, of PW SB PW1000G-C-72-00-0188-00A-930A-D, Issue No: 001,
dated September 13, 2021 (PW SB PW1000G-C-72-00-0188-00A-930A-D);
and
    (ii) USI of the HPT 2nd-stage disk using the Accomplishment
Instructions, paragraph 9.C. or D., as applicable, of PW SB PW1000G-
C-72-00-0188-00A-930A-D.
    (2) For affected engines that have incorporated PW SB PW1000G-C-
72-00-0112-00A-930A-D, with an installed HPT 1st-stage disk having a
serial number (S/N) identified in the Accomplishment Instructions,
Table 2., of PW SB PW1000G-C-72-00-0188-00A-930A-D, at the next
engine shop visit after the effective date of this AD, perform a USI
of the HPT 1st-stage disk using the Accomplishment Instructions,
paragraph 9.A. or B., as applicable, of PW SB PW1000G-C-72-00-0188-
00A-930A-D.
    (3) For affected engines that have incorporated PW SB PW1000G-C-
72-00-0112-00A-930A-D, with an installed HPT 2nd-stage disk having
an S/N identified in the Accomplishment Instructions, Table 3., of
PW SB PW1000G-C-72-00-0188-00A-930A-D, at the next engine shop visit
after the effective date of this AD, perform a USI of the HPT 2nd-
stage disk using the Accomplishment Instructions, paragraph 9.C. or
D., of PW SB PW1000G-C-72-00-0188-00A-930A-D.
    (4) Based on the results of the USIs required by paragraphs
(g)(1) through (3) of this AD, if any HPT 1st-stage disk or HPT 2nd-
stage disk does not pass the USI, as specified in the Accomplishment
Instructions, paragraphs 9.A. through D., of PW SB PW1000G-C-72-00-
0188-00A-930A-D, as applicable, before further flight, remove the
HPT 1st-stage disk or HPT 2nd-stage disk from service and replace
with a part eligible for installation.
    Note 1 to paragraph (g): For affected engines that have
incorporated PW SB PW1000G-C-72-00-0112-00A-930A-D and do not
require an inspection per paragraph (g)(2) or (3) of this AD, no
further action is required.

(h) Definitions

    (1) For the purpose of this AD, a ``part eligible for
installation'' is:
    (i) Any HPT 1st-stage disk that passed the USI required by
paragraphs (g)(1)(i) and (g)(2) of this AD.
    (ii) Any HPT 2nd-stage disk that passed the USI required by
paragraphs (g)(1)(ii) and (g)(3) of this AD.
    (2) For the purpose for this AD, an ``engine shop visit'' is the
induction of an engine into the shop for maintenance involving the
separation of the ``M'' flange. Separation of the ``M'' flange
solely for the purposes of transportation without subsequent engine
maintenance does not constitute an engine shop visit.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
certification office, send it to the attention of the person
identified in paragraph (j)(1) of this AD and email to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(j) Related Information

    (1) For more information about this AD, contact Mark Taylor,
Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; email:
[email protected].
    (2) For service information identified in this AD, contact
International Aero Engines, LLC, 400 Main Street, East Hartford, CT
06118; phone:<PHONE_NUMBER>; email: [email protected]; website:
http://fleetcare.prattwhitney.com. You may view this referenced
service information at the FAA, Airworthiness Products Section,
Operational Safety Branch, 1200 District Avenue, Burlington, MA
01803. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

    Issued on March 18, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-06211 Filed 3-23-22; 8:45 am]
BILLING CODE 4910-13-P