UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES March 18, 2003 MEMORANDUM SUBJECT: Carbaryl. ( Chemical ID No. 056801/ List A Reregistration Case No. 0080). Revised Dietary Exposure Analysis Including Acute Probabilistic Water Analysis for the HED Revised Human Health Risk Assessment. DP Barcode D288479.

FROM: Felecia A. Fort, Chemist Reregistration Branch I Health Effects Division ( 7509C)

THRU: Jennifer Tyler, Chemist and Mohsen Sahafeyan, Chemist Dietary Exposure Science Advisory Council and Whang Phang, Ph. D., Branch Senior Scientist Reregistration Branch I Health Effects Division ( 7509C)

TO: Jeffrey Dawson, Chemist Reregistration Branch I Health Effects Division ( 7509C)

Executive Summary The purpose of this memorandum is to report the results of a dietary exposure analysis for the carbamate insecticide carbaryl. In this analysis the acute, chronic, and cancer dietary exposure and risk estimates resulting from food intake were determined for the general U. S. population and various population subgroups. In addition, a probabilistic assessment including both food and water that incorporates water as a distribution of concentrations into the dietary exposure analysis, is included.

Acute, chronic, and cancer dietary exposure assessments were performed in order to determine the exposure and risk estimates which result from the use of carbaryl on the crops included in the reregistration eligibility decision ( RED). 2 The revised dietary risk analysis for carbaryl was conducted in association with the human health risk assessment for the RED document. These revisions were made to include newer USDA Pesticide Data Program residue data, updated percent crop treated (% CT) data and use of DEEM FCID instead of DEEM 7.76. In response to comments from the registrant, additional translations of residue data were done.

Carbaryl is used on commodities in numerous crop groups in agricultural and home settings. A highly refined exposure assessment is needed for the RED. Detailed usage information, monitoring data, and field trial data are described in appendices to this review.

This is a Tier 3/ 4 assessment, which is the most highly refined assessment that can be conducted at this time. HED has provided revised anticipated residues ( ARs) for carbaryl based on USDA Pesticide Data Program ( PDP) and Food and Drug Administration ( FDA) monitoring data and field trial data for the commodities listed in Table 1a of Attachment 1.

In addition, a separate acute assessment was conducted incorporating the results of the Carbamate Market Basket Survey ( CMBS) ( Table 1b, Attachment 1). CMBS data can be used in dietary risk assessments with appropriate characterization of uncertainties associated with the conduct of the study. The primary concern with the data was that samples were rubbed during the rinsing process which created a potential for residue loss from the mechanical action associated with rubbing. HED used CMBS data for citrus fruit and banana in all acute assessments since these commodities are peeled before consumption. HED has presented assessments which included CMBS and which did not include these data ( except banana and citrus fruit) so that the risk manager may make an informed decision.

The acute and/ or chronic dietary analyses for carbaryl show that....

° Estimated chronic dietary exposures for all population subgroups occupied < 1% of the chronic Population Adjusted Dose ( cPAD); and, consequently, are below HED's level of concern.

° The cancer dietary exposure estimate for the general U. S. population is 2.14 X 10 8 which is also below HED's level of concern.

° Estimated acute dietary exposure ( food only) at the 99.9th percentile of exposure is below HED's level of concern for all population subgroups independent of the data set used i. e., CMBS or PDP/ FDA. The acute dietary assessment when CMBS data are not used ( except for banana and citrus commodities) resulted in risk estimates less than 100% of the acute Population Adjusted Dose ( aPAD). The highest exposed population subgroup incorporating all commodities using PDP and FDA monitoring data was children ( 1 to 2 years old) of which 94% of the aPAD is occupied. When CMBS data were incorporated, the highest exposed population subgroup was also children ( 1 2 years old) at 86% of the aPAD.

° When water modeling residues are included in the probabilistic assessment, HED's level of concern is not exceeded regardless of the data set. The highest exposed population subgroup incorporating all commodities was children ( 1 to 2 years old) which consumed 3 93% of the aPAD. Although it appears that inclusion of water into the acute assessment lowers the risk, this is an artifact of the DEEM FCID model that can occur due to binning a very large number of exposure records and rounding small numbers. These small decreases are interpreted as insignificant.

Although this exposure assessment is the most refined carbaryl assessment performed by HED to date, there are several uncertainties associated with this assessment which are noted in the Characterization/ Uncertainties section of this document.

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. This is the population adjusted dose ( PAD), which HED has concluded will result in no unreasonable adverse health effects. The PAD is the Reference Dose ( RfD) divided by the special FQPA Safety Factor. Dietary risk is expressed as a percentage of the PAD. For acute and non cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. HED is generally concerned when estimated cancer risk exceeds one in one million ( i. e., the risk exceeds 1 x 10 6). 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: http:// www. epa. gov/ fedrgstr/ EPA PEST/ 2000/ July/ Day 12/ 6061. pdf ; or see SOP 99.6 ( 8/ 20/ 99).

The most recent dietary risk assessment for carbaryl was conducted by F. Fort ( 4/ 28/ 02, DP Barcode D281419).

Revisions Made to the Carbaryl Dietary Assessment This revised carbaryl dietary assessment includes changes made as a result of registrant comments submitted to the Agency and updated percent crop treated (% CT) treated information which were provided by the Biological and Economic Analysis Division ( BEAD), included in this document as Attachment 12. The registrant's comments primarily centered around translation of monitoring data to commodities where field trial data were used. Consequently, the following translations were made in accordance with HED SOP 99.3, " Translation of Monitoring Data" dated 3/ 26/ 99.

Table 1. Translation of Monitoring Data 4 Commodity Data Used in Previous Assessment New Data Source Beets, garden, roots Radishes Beet field trial Carrot PDP Turnip, root Rutabagas Turnip field trial Carrot PDP Endive L. Lettuce FDA Spinach PDP Swiss Chard Celery PDP Spinach PDP Collards Kale Mustard greens Mustard Green field trial Spinach PDP Turnip, tops Turnip field trial Spinach PDP Dried Beans and Peas Dried Bean Field trial Soybean PDP Succulent Peas Peas FDA Green Beans PDP Eggplant Nonbell peppers Bell peppers Peppers FDA Tomato PDP Cucumber Cucumber FDA Cucumber PDP Summer Squash Summer Squash FDA Cucumber PDP Cherries Cherries FDA Cherries PDP Rice Rice Field Trial Rice PDP Pineapples Pineapple FDA Pineapple PDP Canned Peaches Peach PDP Canned Peaches PDP DEEM   Program and Consumption Information Carbaryl acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database ( DEEMFCID   , Version 1.3), which incorporates consumption data from USDA's Continuing Surveys of Food Intakes by Individuals ( 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. Consumption data are averaged for the entire U. S. population and within population subgroups for chronic exposure assessment, but are retained as individual consumption events for acute exposure assessment.

For chronic exposure and risk 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. The resulting residue consumption estimate for each food/ food form is summed with the residue consumption 5 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 ( Tier 1 or Tier 2) exposure assessment, or " matched" in multiple random pairings with residue values and then summed in a probabilistic ( Tier 3/ 4) assessment. The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user ( i. e., those who reported eating relevant commodities/ food forms) and a per capita ( i. e., those who reported eating the relevant commodities as well as those who did not) basis. In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis. However, for tiers 1 and 2, significant differences in user vs. per capita exposure and risk are identified and noted in the risk assessment.

Toxicology Information The HED Hazard Identification Assessment Review Committee ( HIARC) on February 19, 2002 reevaluated the toxicology data base of carbaryl and selected toxicology endpoints for chronic and acute dietary as well as occupational exposure risk assessments. The selected toxicological endpoints and the doses for risk assessment and additional relevant details are summarized in Table 2. On November 7, 2001, the CARC reconsidered the cancer classification of carbaryl. In accordance with the EPA Draft Guidelines for Carcinogen Risk Assessment ( July, 1999), the CARC classified carbaryl into the category " Likely to be carcinogenic to humans" and recommended a low dose linear extrapolation approach using all dose levels for the quantification of human cancer risk based on the most potent vascular tumors in mice.

The HED FQPA Safety Factor Committee ( C. Christensen, 2/ 25/ 02) determined that when assessing acute and chronic dietary exposures, the safety factor should be reduced to1x for all population subgroups.

Table 2: Carbaryl Toxicity Endpoints EXPOSURE SCENARIO DOSE ( mg/ kg/ day) RfD PAD ENDPOINT STUDY Acute Dietary ( all populations) NOAEL= 1 mg/ kg UF = 100 FQPA SF = 1 aRfD = 0.01 mg/ kg aPAD = 0.01 mg/ kg/ day Alterations in FOB parameters after a single dose to maternal animals Acute neurotoxicity study  rat Chronic Dietary ( all populations) NOAEL = 3.1 mg/ kg/ day UF = 300 FQPA SF = 1 cRfD = 0.01 mg/ kg/ day cPAD = 0.01 mg/ kg/ day Decrease in brain cholinesterase in females Chronic toxicity  dog 6 Cancer n/ a Q1* = 8.75 x 10 4 [ mg/ kg/ day] 1 Carbaryl was classified as " likely to be carcinogenic to humans" based on an increased incidence of hemangiosarcomas in male mice Carcinogenicity  mice Usage Information BEAD provided information ( F. Hernandez, 12/ 17/ 02, Attachment 12) on the % CT. For the chronic analysis, the weighted average % CT was incorporated; for the acute analysis, the estimated maximum % CT was used when appropriate.

In acute analyses ( except blended commodities) the adjustment for % CT is incorporated in the residue distribution files ( RDFs) via addition of zero residue values corresponding to the percent of crop not treated. For blended/ not further processed commodities where monitoring data are available, the entire distribution of monitoring data with no further adjustment for % CT were used. For blended/ processed commodities where monitoring data are available and for all blended commodities where field trial data were used, % CT is incorporated into a point estimate. For the chronic analyses, the % CT is listed as Adjustment Factor 2 in the DEEM FCID analysis.

Use of usage information for assessments incorporating the CMBS are described in the CMBS section in this document.

Residue Data Tolerances for residues of carbaryl are currently expressed in terms of carbaryl ( 1 naphthyl Nmethylcarbamate including its hydrolysis product 1 naphthol, calculated as carbaryl, for most raw crop commodities [ 40 CFR § 180.169( a)]. The established tolerances for residues in/ on pineapples, pome fruits, avocados, and fresh dill are expressed in terms of carbaryl per se [ 40 CFR § 180.169( d) and ( e)]. Tolerances for residues in livestock commodities are expressed as carbaryl, including its metabolites 1 naphthol ( naphthyl sulfate), 5,6 dihydrodihydroxy carbaryl, and 5,6 dihydrodihydroxy naphthol, calculated as carbaryl [ 40 CFR § 180.169( b) and ( c)]. A tolerance for residues in pineapple bran is expressed in terms of carbaryl per se [ 40 CFR § 186.550]. An interim tolerance has been established for carbaryl and its 1 naphthol metabolite in eggs [ 40 CFR § 180.319].

For the purpose of reregistration, adequate magnitude of the residue data are available on the following crops: alfalfa, almond, asparagus, beans ( dried and succulent), blueberry, broccoli, cabbage, celery, cherry, citrus fruits, clover, corn ( sweet and field), cucurbits ( cantaloupes, cucumbers and squash), cranberry, flax, grape, head and leaf lettuce, mustard greens, okra, peanut, peas ( dried and succulent), pecan, pepper, pistachio, pome fruits, potato, prickly pear cactus, raspberry, rice, sorghum, soybean, spinach, stone fruits, strawberry, sunflower, sweet potato, tobacco, tomato, and walnut. Tolerances of 2 ppm and 10 ppm have been established for residues of carbaryl 7 in pineapples and bananas, respectively. The registrant intends to support the tolerances for residues of carbaryl in/ on these commodities as import tolerances.

Adequate field trial data depicting carbaryl residues following applications made according to the maximum or proposed use patterns have been submitted for these commodities. Geographical representation is adequate and a sufficient number of trials reflecting representative formulation classes were conducted. Carbaryl residues were < LOQ in/ on sweet potato, sugar beets, corn grain, flax seed, and peanuts. Quantifiable residues were detected in all other raw agricultural commodities ( RACs). For a given crop, residue levels were quite variable overall, probably owing to climactic variations, but were generally consistent within any specific field trial location.

Anticipated residue estimates are presented in Table 1a of Attachment 1 of this document. In general PDP data were used if available. Alternatively, FDA surveillance monitoring data from the years 1992 98 were used if sufficient samples were available. Finally, data from crop field trials were used if there were insufficient PDP or FDA monitoring data.

Adequate PDP monitoring data are available for the following commodities: potatoes, carrots, sweet potato, celery, spinach, lettuce ( head), broccoli, succulent peas ( processed) , succulent beans, soybean, tomatoes, cantaloupe, winter squash, orange, orange juice, apple, apple juice, pear, peach, wheat, sweet corn, strawberry, banana, grape, grape juice, pineapple, rice, cherry, cucumber, and milk. FDA monitoring data were used for the commodities, lettuce ( leaf), cabbage, watermelon, raspberry, blueberry, asparagus, and cranberry. Monitoring data were translated to similar crops when possible, generally according to the HED SOP 99.3 " Translation of Monitoring Data". See Table 1a of Attachment 1 for translations. Monitoring data from the years 1994 through 2001 ( PDP) and the years 1992 through 1998 ( FDA) were considered. Field trial data were used for the commodities, almonds, pecans, walnuts, field corn grain, flax seed, okra, olive, peanuts, pistachio, sugar beets, and sunflower. For oysters and dill, tolerances of 2 ppm and 0.2 ppm, respectively was used in the assessment. These data are summarized in Attachment 1.

One half the weighted average of the limits of detection ( LOD) were used in the dietary assessment for all treated non detectable ( ND) residues. Detectable residues from composite monitoring data for non blended food forms were used to generate residue values in single units using the methods described in the H. Allender paper dated 5/ 26/ 99 " Statistical methods for Use of Composite Data in Acute Dietary Risk Assessment." The " decomposited" residues were then included in residue distribution files ( RDF) for the probabilistic analysis. Any generated residue values which were over the tolerance were set back to tolerance level. In this assessment, pear data were decomposited, and one generated residue was over tolerance and set back to 12 ppm, the pear reassessed tolerance. Biological and Economic Analysis Division ( BEAD) supplied % CT which were incorporated into the anticipated residue or residue distribution file when appropriate.

Carbamate Market Basket Survey ( CMBS)

A separate dietary assessment was conducted utilizing the CMBS results. The CMBS Task Force conducted a year long, national survey of carbamate residues on selected food commodities purchased at grocery stores. Residue data from a market basket survey are considered close approximations to residues potentially found at most ` dinner plates' and is generally considered the most appropriate survey type for use in pesticide risk and exposure assessment. The CMBS collected 8 up to 400 single serve samples of 8 different crops ( apple, banana, broccoli, grape, lettuce, orange, peach and tomato). These data are used in the acute dietary analysis directly via RDFs incorporating % CT for all food forms considered to be partially or not blended. For blended commodities, the entire distribution of data with no further adjustment for % CT was done. If CMBS data were not available, then PDP or FDA monitoring or field trial data were used. CMBS data were translated to similar commodities when feasible ( Table 1b, Attachment 1); however, if PDP monitoring data were available for the processed commodity, then CMBS data were not translated ( i. e., PDP orange juice data were used instead of CMBS data for oranges). The RDFs are shown in Attachment 1 of this document.

CMBS data can be used in dietary risk assessments with appropriate characterization of uncertainties associated with the conduct of the study. The primary concern with the data was that samples were rubbed during the rinsing process which created a potential for residue loss from the mechanical action associated with rubbing. HED used CMBS data for citrus fruit and banana in all acute assessments since these commodities are peeled before consumption. HED has presented assessments which included CMBS and which did not include these data ( except banana and citrus fruit) so that the risk manager may make an informed decision.

Water Residue Data The water residues provided by the Environmental Fate and Effects Division ( R. David Jones) are from a PRZM EXAMS analysis. These results have been characterized as conservative, though not unreasonable estimates of possible concentrations in drinking water. Approximately 11000 values were generated based on the maximum carbaryl use pattern in Florida. The values were adjusted for percent crop area ( PCA) using a factor of 0.87. These values represent the complete daily 36 year PRZM EXAMS output distribution. A RDF file was created using these values for the two commodities " Water, direct, all sources" and " Water, indirect, all sources" in the residue file editor for DEEM FCID. These values ranged from 0 to 0.23 ppb. A water monitoring study has been completed by the registrant but was not used quantitatively due to site selection and sample frequency concerns.

Processing Factors Most of the carbaryl processing factors ( see Table 3) were obtained from processing studies submitted by the registrant either in response to the preliminary dietary risk assessment or those compiled in a memo entitled " Carbaryl Anticipated Residues for Carcinogenic Dietary Risk Assessment", S. Hummel, 12/ 3/ 93. The rice processing factors were from a review by Thurston Morton ( D216242, 9/ 17/ 98). Default processing factors from DEEM 7.76 were maintained for all commodities not included in Table 3 in this document.

Table 3. Processing Factors Commodity Type Factor Used for Apple Juice Drying 0.37 2.58 Pear juice apple, pear, dried Commodity Type Factor Used for 9 Cabbage Cooking Washing 0.1 0.25 cabbage, Brussels sprouts, kohlrabi, cooked cabbage, Brussels sprouts, kohlrabi, washed Grapefruit Peel 1.13 Grapefruit peel Lemon Peel 1.16 Lemon peel Orange Peel 1.27 Orange peel Corn Grain oil 0.25 Corn oil Grapes unprocessed raisins processed raisins 2.17 1.37 Grapes  raisins Olive oil 0.81 Olive oil Okra Cooking Cooking/ steaming Washing 0.66 0.18 0.28 Okra Peas Cooking/ boiling Washing 0.15 0.30 Peas  cooked Peanuts oil 0.29 Peanut oil Pineapple flesh 0.54 Pineapple peeled fruit Pineapple juice Plums dried washed 0.15 0.26 Plums( prunes) Plums fresh Potatoes dried fried baked boiled 0.4 0.04 1.2 2.5 Potatoes, dried Potatoes, fried Potatoes, baked Potatoes, boiled Rice polished bran 0.03 0.4 Rice, white Rice, bran Soybean oil 0.005 Soybean oil Sugarbeets sugar molasses 0.04 0.04 Sugarbeets Sugarbeets molasses Sunflowers oil 0.03 Sunflowers oil Tomatoes puree juice dry 0.65 0.52 0.52 Tomatoes puree, paste, catsup Tomatoes juice Tomatoes, dried Wheat Flour Germ Bran 0.10 0.65 1.03 Wheat flour Wheat germ Wheat Bran 10 V. Results/ Discussion This is a Tier 3/ 4 assessment, which is the most highly refined assessment that can be conducted at this time. Processing factors have been incorporated to the fullest extent possible. HED has provided revised ARs for carbaryl based on USDA PDP and FDA monitoring data, field trial data, and CMBS data for the commodities listed in Table 1a and 1b of Attachment 1.

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM FCID   analyses estimate the dietary exposure of the U. S. population and 26 population subgroups. The results reported in Tables 4 and 5 are for the general U. S. Population, all infants (< 1 year old), children 1 2, children 3 5, children 6 12, youth 13 19, females 13 49, adults 20 49, and adults 50+ years. Cancer risk is determined for the general U. S. population only.

Results of Acute Dietary Exposure Analysis Results are reported at the 99.9th percentile of exposure because the assessment incorporated estimates of % CT.

Table 4. Results of Acute Dietary Exposure Analysis ( Market Basket Survey Data Not Included except for citrus and bananas)

Population Subgroup aPAD ( mg/ kg/ day) 95th Percentile 99th Percentile 99.9th Percentile Exposure ( mg/ kg/ day) % aPAD Exposure ( mg/ kg/ day) % aPAD Exposure ( mg/ kg/ day) % aPAD General U. S. Population 0.01 0.000474 5 0.001303 13 0.004294 43 All Infants (< 1 year old) 0.01 0.000761 8 0.002772 28 0.006747 67 Children 1 2 years old 0.01 0.001886 19 0.003526 35 0.009390 94 Children 3 5 years old 0.01 0.001230 12 0.002433 24 0.008084 81 Children 6 12 years old 0.01 0.000748 7 0.001474 15 0.005434 54 Youth 13 19 years old 0.01 0.000367 4 0.000826 8 0.003248 32 Adults 20 49 years old 0.01 0.000299 3 0.000752 8 0.002925 29 Females 13 49 years old 0.01 0.000284 3 0.000751 8 0.003227 32 Adults 50+ years old 0.01 0.000287 3 0.000786 8 0.002971 30 Table 5. Results of Acute Dietary Exposure Analysis ( Market Basket Survey Data Included for apple, banana, broccoli, grape, lettuce, orange, peach and tomato)

Population Subgroup aPAD ( mg/ kg/ day) 95th Percentile 99th Percentile 99.9th Percentile Exposure ( mg/ kg/ day) % aPAD Exposure ( mg/ kg/ day) % aPAD Exposure ( mg/ kg/ day) % aPAD General U. S. Population 0.01 0.000455 5 0.001248 12 0.004003 40 All Infants (< 1 year old) 0.01 0.000688 7 0.002394 24 0.005600 56 Children 1 2 years old 0.01 0.001836 18 0.003371 34 0.008590 86 Population Subgroup aPAD ( mg/ kg/ day) 95th Percentile 99th Percentile 99.9th Percentile Exposure ( mg/ kg/ day) % aPAD Exposure ( mg/ kg/ day) % aPAD Exposure ( mg/ kg/ day) % aPAD 1aPAD/ cPAD = acute/ chronic Population Adjusted Dose = Acute or Chronic RfD FQPA Safety Factor 11 Children 3 5 years old 0.01 0.001189 12 0.002237 22 0.007732 77 Children 6 12 years old 0.01 0.000725 7 0.001382 14 0.005217 52 Youth 13 19 years old 0.01 0.000360 4 0.000801 8 0.003182 32 Adults 20 49 years old 0.01 0.000289 3 0.000728 7 0.002801 28 Females 13 49 years old 0.01 0.000275 3 0.000705 7 0.003016 30 Adults 50+ years old 0.01 0.000272 3 0.000735 7 0.002691 27 The acute dietary assessment resulted in risk estimates less than 100% of the aPAD for all population subgroups at the 99.9th percentile of exposure ( Table 4). The highest exposed population subgroup was children ( 1 to 2 years old) at 94% of the aPAD. When CMBS data are incorporated, the acute risk estimates are again below the Agency's level of concern (< 100% aPAD1) at the 99.9th exposure percentile for the general U. S. population ( 40% of the aPAD) and all population subgroups ( Table 5). The acute dietary exposure estimates for the highest exposed population subgroup, children ( 1  2 years old) drop to 86% of the aPAD. Strawberries were found to be the most significant contributor to the risk estimates. ( Attachments 3, 7, and 8).

Chronic Results of Chronic Dietary Exposure Analysis Table 6. Results of Chronic Dietary Exposure Analysis Population Subgroup cPAD ( mg/ kg/ day) Exposure ( mg/ kg/ day) % cPAD General U. S. Population 0.01 0.000024 < 1 All Infants (< 1 year old) 0.01 0.000055 < 1 Children 1 2 years old 0.01 0.000076 < 1 Children 3 5 years old 0.01 0.000054 < 1 Children 6 12 years old 0.01 0.000029 < 1 Youth 13 19 years old 0.01 0.000015 < 1 Adults 20 49 years old 0.01 0.000020 < 1 Females 13 49 years old 0.01 0.000018 < 1 Adults 50+ years old 0.01 0.000021 < 1 The analyses show that chronic dietary exposure and risk estimates were below HED's level of concern with all population subgroups consuming < 1% of the cPAD.

Results of Cancer Dietary Exposure Analysis 12 The estimated dietary exposure of the general U. S. population to carbaryl is 0.000025 mg/ kg/ day. Applying the Q1* of 8.75 X 10 4.( mg/ kg/ day) 1 to the exposure value results in a cancer risk estimate of 2.2 x 10 8. Therefore, estimated cancer risk is below HED's level of concern.

Table 6. Results of Cancer Dietary Exposure Analysis Population Subgroup Exposure ( mg/ kg/ day) Estimated Cancer Risk General U. S. Population 0.000024 2.14 x 10 8.

Acute Assessment including Drinking Water Table 4. Results of Acute Dietary Exposure Analysis Including Water ( Market Basket Survey Data Not Included except for citrus and bananas)

Population Subgroup aPAD ( mg/ kg/ day) 95th Percentile 99th Percentile 99.9th Percentile Exposure ( mg/ kg/ day) % aPAD Exposure ( mg/ kg/ day) % aPAD Exposure ( mg/ kg/ day) % aPAD General U. S. Population 0.01 0.000471 4.71 0.001296 13 0.004297 43 All Infants (< 1 year old) 0.01 0.000764 7.64 0.002780 28 0.006768 68 Children 1 2 years old 0.01 0.001887 18.87 0.003510 35 0.009257 93 Children 3 5 years old 0.01 0.001228 12.28 0.002423 24 0.008058 81 Children 6 12 years old 0.01 0.000741 7.41 0.001448 14 0.005506 55 Youth 13 19 years old 0.01 0.000368 3.68 0.000831 8 0.003236 32 Adults 20 49 years old 0.01 0.000300 3.00 0.000755 8 0.002940 29 Females 13 49 years old 0.01 0.000284 2.84 0.000754 8 0.003257 33 Adults 50+ years old 0.01 0.000286 2.86 0.000789 8 0.003032 30 The results of the acute assessment indicates that inclusion of water in the analysis had no impact on the dietary assessment. The analyses show that the highest exposed population subgroup was children ( 1 2 years old) of which 93% of the aPAD is occupied. The acute dietary exposure estimate for the general U. S. population was 43% of the aPAD. Although it appears that inclusion of water into the acute assessment lowers the risk, this is an artifact of the DEEM FCID model that can occur due to binning a very large number of exposure records and rounding small numbers. These small decreases are interpreted as insignificant.

VI. Characterization/ Uncertainties In the course of conducting a Tier 3/ 4 dietary exposure analysis, decisions are made regarding the following: the residue data used in the analysis ( e. g., field trials, monitoring data, etc.), refinements 13 incorporated in DEEM FCID   such as % CT and processing factors, sensitivity analyses, and a variety of other issues which may be chemical or crop specific. Characterization of this assessment and associated uncertainties are ....

° The results of the Critical Exposure Contribution analysis showed that strawberries comprised a large percentage of the residues found in the tail end of acute exposure ( Attachment 8) for children. Strawberry residues are from USDA PDP data.

° Detectable residues from composite monitoring data for non blended food forms were used to generate residue values in single units using the methods described in the H. Allender paper dated 5/ 26/ 99 " Statistical methods for Use of Composite Data in Acute Dietary Risk Assessment." The " decomposited" residues were then included in residue distribution files ( RDF) for the probabilistic analysis. Some degree of uncertainty can be associated with this method. In this assessment only pear PDP data were decomposited. A sensitivity analysis which shows the results of the analysis when decomposited residues are not included can be found in Attachment 5. The results as shown in Table 7 reveal that decompositing is not a factor for this assessment; no changes in the % aPAD was seen.

° This assessment is highly refined. Very little field trial data were used and processing, cooking and washing factors were incorporated to the greatest extent possible. Nonetheless, further refinement could be carried out with the submission of additional washing, cooking, canning, and other processing studies and with monitoring data for commodities where field trial data were found to be best source of residue data.

° The drinking water values used in the acute assessment were generated using modeling estimates. Refinement to the risk assessment could be had with the use of water monitoring data. 14 Table 7. Results of the Carbaryl Sensitivity Analyses.

Acute  All Commodities at the 99.9th percentile of exposure ( Market Basket Survey Data Not Included)

Pop. Subgroup All commodities No Decompositing Eliminating Strawberries Exposure ( mg/ kg/ day) % aPAD Exposure ( mg/ kg/ day) % aPAD Exposure ( mg/ kg/ day) % aPAD General U. S. Population 0.004294 43 0.004291 43 0.003614 36 All Infants (< 1 year old) 0.006747 67 0.006747 67 0.006675 67 Children 1 2 years old 0.009390 94 0.009359 93 0.007110 71 Children 3 5 years old 0.008084 81 0.008075 81 0.006126 61 Children 6 12 years old 0.005434 54 0.005434 54 0.003952 40 Youth 13 19 years old 0.003248 32 0.003243 32 0.002359 24 Adults 20 49 years old 0.002925 29 0.002919 29 0.002368 24 Females 13 49 years old 0.003227 32 0.003219 32 0.002424 24 Adults 50+ years old 0.002971 30 0.002961 30 0.002564 26 15 VII. Conclusions The Tier 3/ 4 Monte Carlo acute, chronic, and cancer dietary risk assessments were conducted for all supported carbaryl food uses. For all supported registered commodities, the acute risk estimates are below the Agency's level of concern at the 99.9th exposure percentile for all population subgroups. The acute dietary exposure estimate for the highest exposed population subgroup, Children ( 1 2 years old) is 94% of the aPAD. Use of CMBS data for all commodities where data are available does not significantly change the risk estimate. The most highest exposed population subgroup when CMBS data are used is children ( 1 to 2 years old) of which 86% of the aPAD is occupied. Inclusion of water probabilistically into the acute assessment also has no significant impact on the acute risk estimates.

The chronic risk estimates are below the Agency's level of concern with less than 1% of the chronic Population Adjusted Dose ( cPAD) consumed for all population subgroups. The cancer risk estimate associated with exposure to carbaryl is 2.14 x 10 8 for the general U. S. population, and is below the Agency's level of concern.

Table 8. Summary of Dietary Exposure and Risk for Carbaryl Population Subgroup** Acute Dietary Chronic Dietary Cancer Dietary Exposure ( mg/ kg/ day) % aPAD Dietary Exposure ( mg/ kg/ day) % cPAD Risk General U. S. Population 0.004294 43 0.000024 < 1 2.14 x 10 8.

All Infants (< 1 year old) 0.006747 67 0.000055 < 1 N/ A Children 1 2 years old 0.009390 94 0.000076 < 1 Children 3 5 years old 0.008084 81 0.000054 < 1 Children 6 12 years old 0.005434 54 0.000029 < 1 Youth 13 19 years old 0.003248 32 0.000015 < 1 Adults 20 49 years old 0.002925 29 0.000020 < 1 Females 13 49 years old 0.003227 32 0.000018 < 1 Adults 50+ years old 0.002971 30 0.000021 < 1 ** The values for the highest exposed population for each type of risk assessment are bolded.

VIII. List of Attachments 16 Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files Attachment 2: Chronic and Cancer Dietary Exposure Analysis: All Commodities Attachment 3: Acute Dietary Exposure Analysis : All Commodities Attachment 4: Acute Dietary Exposure Analysis : Market Basket Survey  All Commodities Attachment 5: Acute Dietary Exposure Analysis including Water Attachment 6: Acute Dietary Exposure Analysis: No Decomposited Residues Attachment 7: Acute Dietary Exposure Analysis : Excluding Strawberries Attachment 8: Critical Exposure Contribution Analysis Attachment 9: Quantitative Usage Analysis ( QUA) Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files 17 Table 1a: Summary of Anticipated Residues for Carbaryl ( Market Basket Data not included)

Commodity DEEM Food Form Reassessed Tolerance, ppm 1 Data Source2 Anticipated Residue ( ppm) or RDF # Blended Classification % CT Chronic/ Cancer Acute Avg Max Crop Group 1: Root and Tuber vegetable Beets, garden ( roots) all 2 carrots PDP 0.024 RDF # 1 NB/ PB 16 26 Beets, garden ( roots) babyfood all 2 carrots PDP 0.024 RDF # 1 PB 16 26 Beets, sugar 98 Refined 0.5 sugar beets FT 0.01 0.0003 B 2 3 Beets, sugar babyfood 98 Refined 0.5 sugar beets FT 0.01 0.0003 B 2 3 Beets, sugar, molasses 98 Refined 0.5 sugar beets FT 0.01 0.0003 B 2 3 Beets, sugar, molassesbabyfood 98 Refined 0.5 sugar beets FT 0.01 0.0003 B 2 3 Carrots all 2 carrots PDP 0.0116 RDF # 2 NB/ PB 4 6 Carrots babyfood all 2 carrots PDP 0.0116 RDF # 2 PB 4 6 Carrot juice all 2 carrots PDP 0.0116 RDF # 2 PB 4 6 Horseradish all 2 carrots PDP 0.0116 RDF # 3 NB 13 2 Parsnips all 2 carrots PDP 0.0116 RDF # 3 NB 13 2 Parsnips babyfood all 2 carrots PDP 0.0116 RDF # 3 NB 13 2 Potato, chips all 2 potato PDP 0.0119 0.00036 B 2 3 Potato, dry ( granules/ flakes) all 2 potato PDP 0.0119 0.00036 B 2 3 Potato, dry ( granules/ flakes) babyfood all 2 potato PDP 0.0119 0.00036 B 2 3 Potato, flour all 2 potato PDP 0.0119 0.00036 B 2 3 Potato, flour  babyfood all 2 potato PDP 0.0119 0.00036 B 2 3 Potato, tuber w/ peel all 2 potato PDP 0.0119 RDF # 4 NB/ PB 2 3 Potato, tuber w/ peel babyfood all 2 potato PDP 0.0119 RDF # 4 PB 2 3 Potato, tuber w/ o peel all 2 potato PDP 0.0119 RDF # 4 NB/ PB 2 3 Potato, tuber w/ o peel babyfood all 2 potato PDP 0.0119 RDF # 4 PB 2 3 Radish, roots all 2 carrot PDP 0.0116 RDF # 5 PB 13 2 Radish, Oriental , roots all 2 carrot PDP 0.0116 RDF # 5 NB 13 2 Rutabagas all 2 carrot PDP 0.0116 RDF # 6 NB 13 2 Salsify ( roots) Salsify( oyster plant) 2 carrot PDP 0.0116 RDF # 3 NB 13 2 Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files Commodity DEEM Food Form Reassessed Tolerance, ppm 1 Data Source2 Anticipated Residue ( ppm) or RDF # Blended Classification % CT Chronic/ Cancer Acute Avg Max 18 Sweet potatoes all 0.2 sweet potato PDP 0.0065 RDF # 7 NB 17 38 Sweet potatoes babyfood all 0.2 sweet potato PDP 0.0065 RDF # 7 NB 17 38 Turnips, roots all 2 carrot PDP 0.0116 RDF # 6 NB 13 2 Crop Group 2: Leaves of Root and Tuber Vegetables Beets, garden ( tops) 11 Uncooked 14 Boiled 75 garden beets FT 10.14 RDF # 8 PB 16 26 Radish, Tops Radishes tops 75 garden beets FT 10.14 RDF # 9 PB 13 2 Radish, Oriental, Tops Radishes tops 75 garden beets FT 10.14 RDF # 9 PB 13 2 Salsify  Tops 12 Cooked: NFS 75 Spinach PDP 10.14 RDF # 9 PB 13 2 Crop Group 4: Leafy Vegetables ( except Brassica Vegetables)

Celery all 3 Celery PDP 0.0152 RDF # 11 NB 1 4 Celery babyfood all 3 Celery PDP 0.0152 RDF # 11 NB 1 4 Celery, Juice all 3 Celery PDP 0.0152 RDF # 11 PB 1 4 Dandelions, leaves all 22 Spinach PDP 0.0082 RDF # 12 PB 13 2 Endive all 10 Spinach PDP 0.00082 RDF # 15 PB 13 2 Lettuce  head all 10 Lettuce PDP 0.0169 RDF # 14 NB 2 4 Lettuce  leaf all 10 Leaf Lettuce FDA 0.001 RDF # 15 PB 13 2 Parsley, leaves all 22 Spinach PDP 0.0082 RDF # 12 PB 13 2 Spinach Uncooked Cooked 22 Spinach PDP 0.0082 RDF # 12 PB 13 2 Canned 22 Canned Spinach PDP 0.006 RDF # 13 PB 13 2 Spinach babyfood Canned 22 Canned Spinach PDP 0.006 RDF # 13 PB 13 2 Swiss Chard all 22 Spinach PDP 0.0082 RDF # 12 PB 13 2 Crop Group 5: Brassica Leafy vegetables Broccoli all 10 Broccoli PDP 0.013 RDF # 17 PB 3 6 Broccoli all 10 Broccoli PDP 0.013 RDF # 17 PB 3 6 Brussels Sprouts all 10 Cabbage FDA 0.001 RDF # 18 PB 15 38 Cabbage all 21 Cabbage FDA 0.001 RDF # 19 NB 2 5 Cabbage, Chinese, bok choy all 21 Cabbage FDA 0.001 RDF # 19 NB 2 5 Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files Commodity DEEM Food Form Reassessed Tolerance, ppm 1 Data Source2 Anticipated Residue ( ppm) or RDF # Blended Classification % CT Chronic/ Cancer Acute Avg Max 19 Cabbage, Chines, napa all 21 Cabbage FDA 0.001 RDF # 19 NB 2 5 Cabbage, Chinese, mustard all 21 Cabbage FDA 0.001 RDF # 19 NB 2 5 Cauliflower all 10 Broccoli PDP 0.013 RDF # 20 NB 1 3 Collards all 10 Spinach PDP 0.0082 RDF # 21 PB 5 11 Kale all 10 Spinach PDP 0.0082 RDF # 22 PB 13 2 Kohlrabi all 10 Cabbage FDA 0.001 RDF # 23 NB 13 2 Mustard greens all 10 Spinach PDP 0.0082 RDF # 22 PB 13 2 Rape greens all 12 Spinach PDP 0.0082 RDF # 22 PB 13 2 Turnips greens all 75 Spinach PDP 0.0082 RDF # 10 PB 13 2 Crop Group 6: Legume Vegetables ( Succulent or Dried)

Beans black, seed all 1 Soybeans  PDP 0.0015 0.000015 B 1 3 Beans broad, succulent all 10 Succulent Beans PDP 0.012 RDF # 25 PB 10 14 Bean, broad, seed all 1 Soybeans  PDP 0.0015 0.000015 B 1 3 Bean, cowpea, succulent all 10 Succulent Beans PDP 0.012 RDF # 25 PB 10 14 Bean, cowpea, seed all 1 Soybeans  PDP 0.0015 0.000015 B 1 3 Bean, great northern, seed all 1 Soybeans  PDP 0.0015 0.000015 B 1 3 Bean, kidney, seed all 1 Soybeans  PDP 0.0015 0.000015 B 1 3 Bean, lima, succulent all 10 Succulent Beans PDP 0.012 RDF # 26 PB 3 8 Bean, lima, seed all 1 Soybeans  PDP 0.0015 0.000015 B 1 3 Bean, mung, seed all 1 Soybeans  PDP 0.0015 0.000015 B 1 3 Bean, navy, seed all 1 Soybeans  PDP 0.0015 0.000015 B 1 3 Bean, pink, seed all 1 Soybeans  PDP 0.0015 0.000015 B 1 3 Bean, pinto, seed all 1 Soybeans  PDP 0.0015 0.000015 B 1 3 Bean, snap, succulent Uncooked Cooked: Fresh 10 Succulent Beans PDP .0.023 RDF # 24 PB 10 15 Cooked Canned Cooked Frozen Cooked Dried 10 Succulent Beans PDP 0.012 RDF # 25 PB 10 14 Bean, snap, succulent, babyfood Uncooked Cooked: Fresh 10 Succulent Beans PDP .0.023 RDF # 24 PB 10 14 Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files Commodity DEEM Food Form Reassessed Tolerance, ppm 1 Data Source2 Anticipated Residue ( ppm) or RDF # Blended Classification % CT Chronic/ Cancer Acute Avg Max 20 Cooked Canned Cooked Frozen Cooked Dried 10 Processed Succulent Beans PDP 0.012 RDF # 25 PB 10 14 Chickpea, seed all 1 Soybeans  PDP 0.0015 0.000015 B 1 3 Chickpea, seed babyfood all 1 Soybeans  PDP 0.0015 0.000015 B 1 3 Chickpea, flour all 1 Soybeans  PDP 0.0015 0.000015 B 1 3 Guar, seed all 1 Soybeans  PDP 0.0015 0.000015 B 1 3 Guar, seed babyfood all 1 Soybeans  PDP 0.0015 0.000015 B 1 3 Lentil, seed all 1 Soybeans  PDP 0.0015 0.000015 B 1 3 Pea, succulent Uncooked Cooked: Fresh 10 Succulent Beans PDP .0.023 RDF # 24 PB 1 1 Cooked Canned Cooked Frozen 10 Processed Peas PDP 0.012 RDF # 25 PB 1 2 Pea, succulent babyfood Uncooked Cooked: Fresh 10 Succulent Beans PDP .0.023 RDF # 24 PB 1 1 Cooked Canned Cooked Frozen 10 Processed Peas PDP 0.012 RDF # 25 PB 1 2 Pea, dry All 1 Soybeans  PDP 0.0015 0.000015 B 1 5 Pea, dry babyfood All 1 Soybeans  PDP 0.0015 0.000015 B 1 5 Pea, edible podded, succulent Uncooked Cooked: Fresh 10 Succulent Beans PDP .0.023 RDF # 24 PB 1 1 Cooked Canned Cooked Frozen 10 Processed Peas PDP 0.012 RDF # 25 PB 1 2 Pea, pigeon, seed All 1 Soybeans  PDP 0.0015 0.000015 B 1 5 Pea, pigeon, succulent Uncooked Cooked: Fresh 10 Succulent Beans PDP 0.023 RDF # 24 PB 1 1 Soybean, seed all 0.5 Soybeans  PDP 0.0015 0.000015 B 1 1 Soybeans flour all 0.5 Soybeans  PDP 0.0015 0.000015 B 1 1 Soybeans flour  babyfood all 0.5 Soybeans  PDP 0.0015 0.000015 B 1 1 Soybean, soy milk all 0.5 Soybeans  PDP 0.0015 0.000015 B 1 1 Soybean, soy milk babyfood all 0.5 Soybeans  PDP 0.0015 0.000015 B 1 1 Soybean,  oil all 0.5 Soybeans  PDP 0.0015 0.000015 B 1 1 Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files Commodity DEEM Food Form Reassessed Tolerance, ppm 1 Data Source2 Anticipated Residue ( ppm) or RDF # Blended Classification % CT Chronic/ Cancer Acute Avg Max 21 Soybeans, oil all 0.5 Soybeans  PDP 0.0015 0.000015 B 1 1 Crop Group 8: Fruiting Vegetables ( except Cucurbits) Group Eggplants all 5 Tomato PDP 0.0044 RDF # 29 NB 9 13 Peppers, bell all 5 Tomato PDP 0.0044 RDF # 31 NB/ PB 5 12 Peppers, bell  babyfood all 5 Tomato PDP 0.0044 RDF # 31 PB 5 12 Peppers, bell, dried all 5 Tomato PDP 0.0044 RDF # 31 B 5 12 Peppers, bell, dried  babyfood all 5 Tomato PDP 0.0044 RDF # 31 PB 5 30 Peppers, nonbell all 5 Tomato PDP 0.0044 RDF # 30 NB/ PB 8 14 Peppers, nonbell babyfood all 5 Tomato PDP 0.0044 RDF # 30 PB 8 14 Peppers, nonbell, dried all 5 Tomato PDP 0.0044 RDF # 30 B 8 14 Tomatillo Uncooked 5 Tomato PDP 0.0044 RDF # 33 NB 6 10 Tomato Uncooked 5 Tomato PDP 0.0044 RDF # 33 NB 6 10 31 Canned: NFS 32 Canned: Cooked 33 Canned: Baked 34 Canned: Boiled 42 Frozen: Cooked 5 Tomato PDP 0.0044 RDF # 32 PB 6 9 Tomato, babyfood all 5 Tomato PDP 0.0044 RDF # 32 PB 6 9 Tomato paste all 5 Tomato PDP 0.0044 RDF # 32 PB 6 9 Tomato, paste babyfood all 5 Tomato PDP 0.0044 RDF # 32 PB 6 9 Tomatoes, puree all 5 Tomato PDP 0.0044 RDF # 32 PB 6 9 Tomatoes, puree babyfood all 5 Tomato PDP 0.0044 RDF # 32 PB 6 9 Tomatoes dried all 5 Tomato PDP 0.0044 RDF # 32 PB 6 9 Tomatoes, dried babyfood all 5 Tomato PDP 0.0044 RDF # 32 PB 6 9 Tomatoes juice all 5 Tomato PDP 0.0044 RDF # 32 PB 6 9 Crop Group 9: Cucurbit Vegetables Balsam pear all 3 Cantaloupe  PDP 0.0056 RDF # 35 NB 1 2a Cantaloupe all 3 Cantaloupe  PDP 0.0056 RDF # 36 NB 9 13 Casaba all 3 Cantaloupe  PDP 0.0056 RDF # 35 NB 1 2a Chayote, fruit all 3 Cantaloupe  PDP 0.0056 RDF # 35 NB 1 2a Cucumbers all 3 Cucumbers PDP 0.0033 RDF # 34 NB 7 22 Honeydew melon all 3 Cantaloupe  PDP 0.0056 RDF # 37 NB 11 36 Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files Commodity DEEM Food Form Reassessed Tolerance, ppm 1 Data Source2 Anticipated Residue ( ppm) or RDF # Blended Classification % CT Chronic/ Cancer Acute Avg Max 22 Pumpkin all 3 Winter Squash PDP 0.0063 RDF # 39 NB 18 24 Pumpkin seed all 3 Winter Squash PDP 0.0063 RDF # 39 NB 18 24 Squash, summer all 3 Cucumbers PDP 0.0033 RDF # 41 NB 13 24 Squash, summer babyfood all 3 Cucumbers PDP 0.0033 RDF # 41 NB 13 24 Squash, winter all 3 Winter Squash  PDP 0.0063 RDF # 40 NB 13 24 Squash, winter babyfood all 3 Winter Squash  PDP 0.0063 RDF # 40 NB 13 24 Watermelon all 3 Watermelon  FDA 0.0019 RDF # 38 NB 8 12 Watermelon juice all 3 Watermelon  FDA 0.0019 RDF # 38 PB 8 12 Crop Group 10: Citrus Fruits Citrus citron 13 Baked 14 Boiled 10 Orange MBS 0.013 RDF # 101 NB 13 2 Citrus hybrids all 10 Orange MBS 0.013 RDF # 101 NB 13 2 Citrus oils all 10 Orange MBS 0.013 0.0013 PB 13 2 Grapefruit all 10 Orange MBS 0.013 RDF # 102 NB 6 11 Grapefruit juice all 10 Orange juice  PDP 0.006 RDF # 43 PB 6 11 Kumquats all 10 Orange MBS 0.013 RDF # 101 NB 13 2 Lemon all 10 Orange MBS 0.013 RDF # 103 NB 1 3 Lemon, juice all 10 Orange juice  PDP 0.006 RDF # 44 PB 1 3 Lemon, juice babyfood all 10 Orange juice  PDP 0.006 RDF # 44 PB 1 3 Lemon, peel all 10 Orange MBS 0.013 RDF # 103 PB 1 3 Lime 11 Uncooked 10 Orange MBS 0.013 RDF # 101 NB 13 2 Lime, juice all 10 Orange juice  PDP 0.006 RDF # 46 PB 13 2 Lime, juice babyfood all 10 Orange juice  PDP 0.006 RDF # 46 PB 13 2 Orange all 10 Orange MBS 0.013 RDF # 104 NB 2 4 Orange, juice all 10 Orange juice PDP 0.006 RDF # 47 PB 2 4 Orange juice babyfood all 10 Orange juice PDP 0.006 RDF # 47 PB 2 4 Oranges peel all 10 Orange MBS 0.013 RDF # 104 PB 2 4 Pummelo all 10 Orange MBS 0.013 RDF # 101 NB 13 2 Tangerine all 10 Orange MBS 0.013 RDF # 101 NB 13 2 Tangerine, juice all 10 Orange juice  PDP 0.006 RDF # 46 PB 13 2 Crop Group 11: Pome Fruits Group Apple, fruit with peel all 12 Apple PDP Decomposited 0.03 RDF # 48 NB 24 35 Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files Commodity DEEM Food Form Reassessed Tolerance, ppm 1 Data Source2 Anticipated Residue ( ppm) or RDF # Blended Classification % CT Chronic/ Cancer Acute Avg Max 23 Apple, peeled fruit Uncooked Cooked 12 Apple PDP Decomposited 0.03 RDF # 48 NB 24 35 Dried 12 Apple PDP 0.03 98 B 24 35 Canned 12 Apple PDP 0.03 RDF # 49 PB 24 35 Apple, peeled fruit babyfood all 12 Apple PDP 0.03 RDF # 49 PB 24 35 Apples dried all 12 Apple PDP 0.03 RDF # 49 PB 24 35 Apple, dried babyfood all 12 Apple PDP 0.03 RDF # 49 PB 24 35 Apples juice all 12 Apple juice PDP 0.010 RDF # 50 PB 24 35 Apples, juice babyfood all 12 Apple juice PDP 0.010 RDF # 50 PB 24 35 Loquat 12 Pear PDP 0.0098 RDF # 53 NB 13 2 Crabapples 12 Apple PDP 0.03 RDF # 54 NB 13 2 Pear 11 Uncooked 12 Cooked: NFS 13 Baked 14 Boiled 12 Pear PDP Decomposite 0.0098 RDF # 51 NB 3 5 31 Canned: NFS 12 Pear PDP 0.0098 RDF # 52 PB 3 5 Pear babyfood all 12 Pear PDP 0.0098 RDF # 52 PB 3 5 Pear, dried all 12 Pear PDP 0.0098 RDF # 52 PB 3 5 Pear, juice all 12 Pear PDP 0.0098 RDF # 52 PB 3 5 Pear, juice babyfood all 12 Pear PDP 0.0098 RDF # 52 PB 3 5 Quince 12 Pear PDP 0.0098 RDF # 53 NB 13 2 Crop Group 12: Stone Fruits Group Apricot Uncooked Cooked 10 Peaches PDP 0.07 RDF # 56 NB 13 2 Canned 10 Canned Peaches PDP 0.07 RDF # 106 PB 13 2 Apricot babyfood 31 Canned: NFS 34 Canned: Boiled 10 Canned Peaches PDP 0.07 RDF # 106 PB 13 2 Apricots dried all 10 Peaches PDP 0.07 RDF # 56 PB 13 2 Apricot juice all 10 Peaches PDP 0.07 RDF # 56 PB 13 2 Apricot juice babyfood all 10 Peaches PDP 0.07 RDF # 56 PB 13 2 Cherry all 10 Cherries PDP 0.062 RDF # 57 PB 22 33 Cherry babyfood all 10 Cherries PDP 0.062 RDF # 57 PB 22 33 Cherry juice all 10 Cherries PDP 0.062 RDF # 58 PB 10 20 Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files Commodity DEEM Food Form Reassessed Tolerance, ppm 1 Data Source2 Anticipated Residue ( ppm) or RDF # Blended Classification % CT Chronic/ Cancer Acute Avg Max 24 Cherry, juice babyfood all 10 Cherries PDP 0.062 RDF # 58 PB 10 20 Nectarines all 10 Peaches PDP 0.07 RDF # 59 NB 6 13 Peach Uncooked Cooked 10 Peaches PDP 0.07 RDF # 60 NB 6 13 Canned 10 Canned Peaches PDP 0.07 RDF # 106 PB 6 13 Peach babyfood Canned 10 Canned Peaches PDP 0.07 RDF # 106 PB 6 13 Peach dried 14 Boiled 18 Dried 10 Peaches PDP 0.07 RDF # 61 PB 6 13 Peach, dried babyfood 14 Boiled 18 Dried 10 Peaches PDP 0.07 RDF # 61 PB 6 13 Peach, juice 11 Uncooked 31 Canned: NFS 10 Peaches PDP 0.07 RDF # 61 PB 6 13 Peach, juice babyfood 11 Uncooked 31 Canned: NFS 10 Peaches PDP 0.07 RDF # 61 PB 6 13 Plum 11 Uncooked 12 Cooked: NFS 10 Peaches PDP 0.07 RDF # 96 NB 5 8 31 Canned: NFS 10 Canned Peaches PDP 0.07 RDF # 62 PB 5 8 Plum babyfood 11 Uncooked 12 Cooked: NFS 10 Peaches PDP 0.07 RDF # 96 NB 5 8 31 Canned: NFS 10 Canned Peaches PDP 0.07 RDF # 62 PB 5 8 Plum, prune, fresh all 10 Peaches PDP 0.07 RDF # 62 PB 5 8 Plum, prune, fresh babyfood all 10 Peaches PDP 0.07 RDF # 62 PB 5 8 Plums, prune, dried all 10 Peaches PDP 0.07 RDF # 62 PB 5 8 Plums, prune, dried babyfood all 10 Peaches PDP 0.07 RDF # 62 PB 5 8 Plum, prune, juice all 10 Peaches PDP 0.07 RDF # 62 PB 5 8 Plum, prune, juice babyfood all 10 Peaches PDP 0.07 RDF # 62 PB 5 8 Crop Group 13: Berries Group Blackberry all 12 Raspberry FDA 0.09 RDF # 63 PB 18 30 Blackberry, juice all 12 Raspberry FDA 0.09 RDF # 63 PB 18 30 Blackberry, juice babyfood all 12 Raspberry FDA 0.09 RDF # 63 PB 18 30 Blueberry all 3 Blueberry FDA 0.09 RDF # 64 PB 22 44 Blueberry babyfood all 3 Blueberry FDA 0.09 RDF # 64 PB 22 44 Boysenberry 31 Canned: NFS 34 Canned: Boiled 41 Frozen: NFS 12 Raspberry FDA 0.09 RDF # 65 PB 13 2 Currant 11 Uncooked 3 Blueberry FDA 0.09 RDF # 66 PB 13 2 Currant, dried 11 Uncooked 3 Blueberry FDA 0.09 RDF # 66 PB 13 2 Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files Commodity DEEM Food Form Reassessed Tolerance, ppm 1 Data Source2 Anticipated Residue ( ppm) or RDF # Blended Classification % CT Chronic/ Cancer Acute Avg Max 25 Dewberry Dewberries 12 Raspberry FDA 0.09 RDF # 65 PB 13 2 Elderberry Elderberries 3 Blueberry FDA 0.09 RDF # 66 PB 13 2 Gooseberry Gooseberries 3 Blueberry FDA 0.09 RDF # 66 PB 13 2 Huckleberry Huckleberries 3 Blueberry FDA 0.09 RDF # 66 PB 13 2 Loganberry Loganberries 12 Raspberry FDA 0.09 RDF # 65 PB 13 2 Raspberry all 12 Raspberry FDA 0.09 RDF # 67 PB 3 7 Raspberry babyfood all 12 Raspberry FDA 0.09 RDF # 67 PB 3 7 Raspberry, juice all 12 Raspberry FDA 0.09 RDF # 67 PB 3 7 Raspberry, juice babyfood all 12 Raspberry FDA 0.09 RDF # 67 PB 3 7 Crop Group 14: Tree Nuts Almond all 0.1 Almond FT 0.059 RDF # 68 PB 1 1 Almond babyfood all 0.1 Almond FT 0.059 RDF # 68 PB 1 1 Almond, oil all 0.1 Almond FT 0.059 RDF # 68 PB 1 1 Almond, oil babyfood all 0.1 Almond FT 0.059 RDF # 68 PB 1 1 Chestnut all 0.1 Almond FT 0.059 RDF # 69 PB 13 2 Filbert all 0.1 Pecan FT 0.022 RDF # 70 PB 3 8 Filbert, oil all 0.1 Pecan FT 0.022 0.00176 PB 3 8 Pecans all 0.1 Pecan FT 0.022 RDF # 71 PB 15 18 Walnuts all 1.0 Walnut FT 0.27 RDF # 72 PB 1 2 Crop Group 15: Cereal Grains Corn, field, flour all 0.02 Corn FT 0.01 0.0001 B 1 1 Corn, field, flour babyfood all 0.02 Corn FT 0.01 0.0001 B 1 1 Corn, field, meal all 0.02 Corn FT 0.01 0.0001 B 1 1 Corn, field, meal babyfood all 0.02 Corn FT 0.01 0.0001 B 1 1 Corn, field, bran all 0.02 Corn FT 0.01 0.0001 B 1 1 Corn, field, starch all 0.02 Corn FT 0.01 0.0001 B 1 1 Corn, field, starch, babyfood all 0.02 Corn FT 0.01 0.0001 B 1 1 Corn, field, syrup all 0.02 Corn FT 0.01 0.0001 B 1 1 Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files Commodity DEEM Food Form Reassessed Tolerance, ppm 1 Data Source2 Anticipated Residue ( ppm) or RDF # Blended Classification % CT Chronic/ Cancer Acute Avg Max 26 Corn, field, syrup babyfood all 0.02 Corn FT 0.01 0.0001 B 1 1 Corn, field, oil all 0.02 Corn FT 0.01 0.0001 B 1 1 Corn, field, oil babyfood all 0.02 Corn FT 0.01 0.0001 B 1 1 Corn, pop all 0.02 Corn FT 0.01 0.0001 B 1 1 Corn, sweet all 0.1 Corn PDP 0.0085 RDF # 73 NB 1 1 Corn, sweet babyfood all 0.1 Corn PDP 0.0085 RDF # 73 PB 1 1 Millet, grain all 1 Wheat PDP 0.0015 0.000015 B 1 1 Rice, white all 15 Rice PDP 0.003 0.074 B 1 1 Rice, white babyfood all 15 Rice PDP 0.003 0.074 B 1 1 Rice, brown all 15 Rice PDP 0.003 0.074 B 1 1 Rice, brown babyfood all 15 Rice PDP 0.003 0.074 B 1 1 Rice, flour all 15 Rice PDP 0.003 0.074 B 1 1 Rice, flour babyfood all 15 Rice PDP 0.003 0.074 B 1 1 Rice, bran all 15 Rice PDP 0.003 0.074 B 1 1 Rice, bran babyfood all 15 Rice PDP 0.003 0.074 B 1 1 Sorghum, grain all 10 Wheat PDP 0.0015 0.000015 B 1 1 Sorghum, syrup all 10 Wheat PDP 0.0015 0.000015 B 1 1 Wheat, grain all 1 Wheat PDP 0.0015 RDF# 100 B 1 1 Wheat, grain babyfood all 1 Wheat PDP 0.0015 RDF # 100 B 1 1 Wheat, flour all 1 Wheat PDP 0.0015 0.000015 B 1 1 Wheat, flour babyfood all 1 Wheat PDP 0.0015 0.000015 B 1 1 Wheat, germ all 1 Wheat PDP 0.0015 0.000015 B 1 1 Wheat, bran all 1 Wheat PDP 0.0015 0.000015 B 1 1 Crop Group 19: Herbs ans Spices Dill, seed all 0.2 Tolerance 0.2 0.004 B 13 2 Dillweed all 0.2 Tolerance 0.2 0.004 B 13 2 Miscellaneous Commodities Asparagus all 15 Asparagus FDA 0.0032 RDF # 74 NB/ PB 35 45 Bananas ( Imports only) all TBD Bananas  PDP 0.01 RDF # 75 NB/ PB 100 100 Bananas  babyfood ( Imports only) all TBD Bananas  PDP 0.01 RDF # 75 NB/ PB 100 100 Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files Commodity DEEM Food Form Reassessed Tolerance, ppm 1 Data Source2 Anticipated Residue ( ppm) or RDF # Blended Classification % CT Chronic/ Cancer Acute Avg Max 27 Bananas dried all TBD Bananas  Market Basket 0.01 RDF # 75 B 100 100 Bananas dried  Babyfood all TBD Bananas  Market Basket 0.01 RDF # 75 B 100 100 Plantains all TBD Bananas  Market Basket 0.01 RDF # 75 NB 100 100 Plantains dried all TBD Bananas  Market Basket 0.01 RDF # 75 PB 100 100 Cranberries all 3 Cranberry FDA 0.001 RDF # 76 PB 32 68 Cranberry  babyfood all 3 Cranberry FDA 0.001 RDF # 76 PB 32 68 Cranberry  dried all 3 Cranberry FDA 0.001 RDF # 76 PB 32 68 Cranberry  juice all 3 Cranberries FDA 0.001 RDF # 76 PB 32 68 Flaxseed, oil 0.5 Flax seed FT 0.01 0.0001 B 1 1 Grape all 10 Grapes PDP 0.016 RDF # 77 PB 7 10 Grape juice all 10 Grapes juice PDP 0.010 RDF # 78 PB 7 10 Grape juice  babyfood all 10 Grapes juice PDP 0.010 RDF # 78 PB 7 10 Grape leaves all 10 Grapes PDP 0.016 RDF # 77 PB 7 10 Grape raisins all 10 Grapes PDP 0.016 RDF # 77 PB 7 10 Grape wine and sherry all 10 Grapes PDP 0.016 RDF # 77 PB 7 10 Okra all 4 Okra FT 1.0 RDF # 79 NB/ PB 33 53 Olive all 10 Olive FT 3.85 RDF # 80 PB 13 2 Olive oil all 10 Olive FT 3.85 0.077 B 13 2 Peanut all 0.05 Peanuts FT 0.01 0.0006 B 3 5 Peanuts butter all 0.05 Peanuts FT 0.01 0.0006 B 3 5 Peanut oil all 0.05 Peanuts FT 0.01 0.0006 B 3 5 Pineapple Imports only all TBD Pineapple PDP 0.0052 RDF # 97 NB/ PB 50% imported 100% CT Pineapple  babyfood Imports only all TBD Pineapple PDP 0.0052 RDF # 97 PB 50% imported 100% CT Pineapple dried Imports only all TBD Pineapple PDP 0.0052 RDF # 97 PB 50% imported 100% CT Pineapple juice Imports only all TBD Pineapple PDP 0.0052 RDF # 97 PB 50% imported 100% CT Pineapples juice babyfood Imports only all TBD Pineapple PDP 0.0052 RDF # 97 PB 50% imported 100% CT Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files Commodity DEEM Food Form Reassessed Tolerance, ppm 1 Data Source2 Anticipated Residue ( ppm) or RDF # Blended Classification % CT Chronic/ Cancer Acute Avg Max Pistachio all 0.1 Pistachio FT 0.03 RDF # 83 PB 13 34 Prickly pear cactus, pads Cactus pads ( nopal) 12 not in DEEM Prickly pear cactus, fruit 5 not in DEEM Strawberry all 4 Strawberry PDP 0.0638 RDF # 84 PB 17 27 Strawberry babyfood all 4 Strawberry PDP 0.0638 RDF # 84 PB 17 27 Strawberry juice all 4 Strawberry PDP 0.0638 RDF # 84 PB 17 27 Strawberry juice babyfood all 4 Strawberry PDP 0.0638 RDF # 84 PB 17 27 Sunflower oil 98 Refined 0.5 Sunflower  FT 0.042 0.0004 B 1 1 Sunflower oil babyfood 98 Refined 0.5 Sunflower  FT 0.042 0.0004 B 1 1 Sunflower seeds all7 0.5 Sunflower  FT 0.042 RDF # 85 PB 1 1 Fish Fish, shellfish, mollusc ( Oysters) 2 Tolerance

1. See Carbaryl Product and Residue Chemistry Chapters for the Reregistration Eligibility Decision. DP Barcode: D238151. 2. PDP = USDA Pesticide Data Program; FDA = FDA Surveillance Program Data; FT = field trial data; P = processing. 3. Reported in the QUA as " Other Crops"

Table 1b: Summary of Market Basket Survey Data Commodity DEEM Food Form Market Basket Survey Commodity Used RDF # % CT Likely Max Citrus Fruit Citrus citron All food forms Orange RDF # 101 2 Grapefruit All food forms except juice RDF # 102 11 Kumquats All food forms RDF # 101 2 Lemons All food forms except juice RDF # 103 3 Limes All food forms except juice RDF # 101 2 Oranges All food forms except juice RDF # 104 4 Tangelos All food forms RDF # 101 2 Tangerine All food forms except juice RDF # 101 2 Pome Fruit Apples All food forms except juice and apples, dried Apple RDF # 107 35 18 Dried RDF # 108 35 Pear All food forms RDF # 117 5 Quinces All food forms RDF # 119 2 Loquat All food forms RDF # 119 2 Crabapples All food forms RDF # 124 2 Stone Fruits Apricot All food forms Peach RDF # 109 2 Nectarines All food forms RDF # 115 13 Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files Commodity DEEM Food Form Market Basket Survey Commodity Used RDF # % CT Likely Max 29 Peaches All food forms RDF # 116 12 Plums ( damsons) All food forms RDF # 118 8 Brassica Vegetables Broccoli All food forms Broccoli RDF # 110 6 Cauliflower All food forms RDF # 111 2 Leafy Vegetables Lettuce  head 11 Uncooked Lettuce RDF # 114 4 Lettuce  leaf 11 Uncooked RDF # 113 2 Fruiting Vegetables Eggplant 13 Pepper  Bell 12 Pepper  NonBell 14 Tomato All food forms Tomato RDF # 120 10 Miscellaneous Crops Bananas All food forms Bananas RDF # 105 100 Plantains All food forms RDF # 105 100 Grapes All food forms except juice Grapes RDF # 112 10 Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files 30 Table 2. Residue Distribution Files ( All RDFs shown were used in the analysis. RDF #' s may not be in sequential order.)

Garden Beets ( roots) Carrot PDP 1994  1996 1888 samples/ 0 detects 1/ 2 LOD = 0.0116 ppm RDF # 1 ' Garden Beets ( roots) ( Carrots PDP) ' 26% CT TOTALZ= 74 26, 0.0116 Sugarbeet ( roots) Blended Field trial data Information from 12/ 2/ 93 AR memo ( S. Hummel, D193129, 12/ 3/ 93) 3% CT Average Residue = 0.01 ppm Acute AR = 0.0003 Carrots  PDP 1994  1996 1888 samples/ 0 detects 1/ 2 LOD = 0.0116 ppm RDF # 2 Carrots PDP 1994 96 6% CT Totalz= 94 Totalnz= 6 0.0116 0.0116 0.0116 0.0116 0.0116 0.0116 Horseradish, Parsnip, Salsify Carrots  PDP 1994  1996 1888 samples/ 0 detects 1/ 2 LOD = 0.0116 ppm RDF # 3 Chic, Horse, Parsnip, Salsify ( Carrots PDP) 1994 96 2% CT Totalz= 98 Totalnz= 2 0.0116 0.0116 Chronic AR = 0.024 ppm Chronic AR = 0.01 ppm Chronic AR = 0.0116 ppm Chronic AR = 0.0116 ppm Potatoes  PDP 1994 1995 1401 samples/ 0 detects 1/ 2 LOD = 0.0119 ppm RDF # 4 Potatoes PDP 1994 95 3% CT Totalz= 97 Totalnz= 3 0.0119 0.0119 0.0119 For dried potatoes ( blended)  acute AR = 0.00036 Radishes Carrot PDP 1994  1996 1888 samples/ 0 detects 1/ 2 LOD = 0.0116 ppm RDF # 5 ' Radishes ( Carrots PDP) ' 2% CT TOTALZ= 98 TOTALNZ= 2 0.0116 0.0116 Turnips, rutabagas Carrot PDP 1994  1996 1888 samples/ 0 detects 1/ 2 LOD = 0.0116 ppm RDF # 6 ' Turnips ( roots) ' 2% CT TOTALZ= 98 TOTALNZ= 2 0.0116 0.0116 Sweet Potato  PDP 1559 samples/ 3 detects 1996 1998 1/ 2 LOD = 0.011 ppm RDF # 7 ' Sweet potatoes  PDP  96 98 ' 38 % CT TOTALZ= 967 TOTALNZ= 3 589, 0.0059 0.67 0.01 0.29 Chronic AR = 0.0119 ppm Chronic AR = 0.0116 ppm Chronic AR = 0.0116 ppm Chronic AR = 0.0065 ppm Garden Beet Tops Field Trial Data 24 Samples RDF # 8 ' Garden beet tops ' 26% CT TOTALZ= 68 TOTALNZ= 24 3.96 4.27 4.49 14.48 18.28 21.18 8.45 8.46 9.84 25.47 28.36 42.23 3.19 3.9 3.91 2.41 2.71 4.65 1.63 1.77 1.9 8.64 9.2 10 Radish Tops, salsify tops ( Garden beet tops) Field trial data. 24 samples RDF # 9 Radish tops ( Garden beet tops  FT) 2% CT Totalz= 1176 Totalnz= 24 3.96 4.27 4.49 14.48 18.28 21.18 8.45 8.46 9.84 25.47 28.36 42.23 3.19 3.9 3.91 2.41 2.71 4.65 1.63 1.77 1.9 8.64 9.2 10 Celery PDP 1994 176 samples/ 0 detects 1/ 2 LOD = 0.0152 ppm RDF # 11 Celery  PDP 1994 4% CT Totalz= 96 Totalnz= 4 0.0152 0.0152 0.0152 0.0152 Spinach  PDP data Translated to Dandelions, Parsley, turnip tops, kale, mustards, rape, endive, and swiss chard 1995 1997 1639 samples/ 10 detects 1/ 2 LOD = 0.006 ppm RDF # 12 Spinach PDP 2% CT Totalz= 1606 Totalnz= 10 23, 0.008 0.01 0.01 0.01 0.01 0.068 0.11 0.02 0.02 0.077 0.039 Chronic AR = 10.14 ppm Chronic AR = 10.14 ppm Chronic AR = 0.0152 ppm Chronic AR = 0.0082 ppm Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files 31 Canned Spinach  PDP 1997 1998 863 samples/ no detects 1/ 2 LOD = 0.006 ppm RDF # 13 Canned Spinach 2% CT Totalz= 98 Totalnz= 2 0.006 0.006 Head Lettuce  PDP 1994 691 samples/ no detects 1/ 2 LOD = 0.0169 ppm RDF # 14 Lettuce  Head 4% CT = Totalz= 96 Totalnz= 4 0.0169 0.0169 0.0169 0.0169 Leaf Lettuce  FDA 1992 1998 241 samples/ no detects 1/ 2 LOD = 0.001 ppm RDF # 15 Leaf Lettuce 2% CT Totalz= 98 Totalnz= 2 0.001 0.001 Broccoli  PDP 1994 679 samples/ 1 detect 1/ 2 LOD = 0.0125 ppm RDF # 17 Broccoli  PDP 1994 6% CT Totalz= 638 Totalnz= 1 40, 0.013 0.007 Chronic AR = 0.006 ppm Chronic AR = 0.0169 ppm Chronic AR = 0.001 ppm Chronic AR = 0.013 ppm Brussels sprouts ( Cabbage  FDA 1992  1998) 246 samples/ 0 detects 1/ 2 LOD = 0.001 ppm RDF # 18 ' Brussels sprout ( Cabbage  FDA 92 98) ' 38% CT TOTALZ= 62 TOTALFREQ = 1 38, 0.001 Cabbage  FDA 1992  1998 246 samples/ 0 detects 1/ 2 LOD = 0.001 ppm RDF # 19 ' Cabbage  FDA 92 98 ' 5% CT TOTALZ= 95 TotalFreq = 1 5, 0.001 Cauliflower ( Broccoli  PDP 1994) 679 samples/ 1 detect 1/ 2 LOD = 0.0125 ppm RDF # 20 Cauliflower ( Broccoli  PDP 1994) 3% CT Totalz= 659 Totalnz= 1 19, 0.013 0.007 Collards ( Spinach PDP) 1995 1997 1639 samples/ 10 detects 1/ 2 LOD = 0.006 ppm RDF # 21 ' Collards ( Spinach PDP) ' 11% CT TOTALZ= 1459 TOTALNZ= 10 170, 0.008 0.01 0.01 0.01 0.01 0.068 0.11 0.02 0.02 0.077 0.039 Chronic AR = 0.001 ppm Chronic AR = 0.001 ppm Chronic AR = 0.013 ppm Chronic AR = 0.0082 ppm Kohlrabi ( Cabbage  FDA 1992  1998) 246 samples/ 0 detects 1/ 2 LOD = 0.001 ppm RDF # 23 ' Kohlrabi ( Cabbage  FDA 92 98) ' 2% CT TOTALZ= 98 TOTALFREQ= 1 2, 0.001 Dried Beans  Blended Soybean PDP 749 samples/ 0 detects 1% CT 1/ 2 LOD = 0.0015 ppm Average = 0.0015 ppm Acute AR = 0.00015 Fresh Succulent Beans PDP 1994 1995 1177 samples/ 44 detects 14% CT  4% detects 1/ 2 LOD = 0.01 ppm RDF # 24 Fresh Beans 14% CT Totalz= 1012 Totalnz= 44 121, 0.0138 1.6 0.067 0.45 0.9 0.096 0.064 0.11 0.23 0.37 0.011 0.26 0.086 0.046 0.15 0.06 0.06 0.011 0.04 0.007 0.15 0.007 0.1 0.18 0.93 0.15 0.12 0.26 0.082 0.2 0.57 0.25 0.025 0.037 0.31 0.29 0.29 0.13 0.15 1.4 0.85 0.21 0.02 0.02 0.15 Processed Succulent Beans  PDP 1996 1998 1588 samples/ 161 detects 14% CT  10 % detects 1/ 2 LOD = 0.006 ppm RDF # 25 Processed Beans 14% CT Totalz= 1366 Totalnz= 161 61, 0.006 See Appendix A for residues Chronic AR = 0.001 ppm Chronic AR = 0.0015 ppm Chronic AR = 0.023 ppm Chronic AR = 0.012 ppm Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files 32 Lima Beans ( Processed Succulent Beans  PDP 1996 1998) 1588 samples/ 161 detects 8% CT  10 % detects 1/ 2 LOD = 0.006 ppm RDF # 26 Lima Beans 8% CT Totalz= 1427 Totalnz= 161 See Appendix L for residues Peas  Green Beans PDP 1994 1995 1177 samples/ 44 detects 3% detected 1/ 2 LOD = 0.01 ppm RDF # 27 Peas  Fresh  Green Beans PDP 3% DETECTED TOTALZ= 1422 TOTALNZ= 44 1.6 0.067 0.45 0.9 0.096 0.064 0.11 0.23 0.37 0.011 0.26 0.086 0.046 0.15 0.06 0.06 0.011 0.04 0.007 0.15 0.007 0.1 0.18 0.93 0.15 0.12 0.26 0.082 0.2 0.57 0.25 0.025 0.037 0.31 0.29 0.29 0.13 0.15 1.4 0.85 0.21 0.02 0.02 0.15 Processed Peas  PDP 1994 1996 1458 samples/ 19 detects 1/ 2 LOD = 0.011 ppm RDF # 28 Processed Peas 2% CT Totalz= 1429 Totalnz= 19 11, 0.011 0.13 0.43 0.086 0.12 0.06 0.01 0.028 0.042 0.06 0.14 0.067 0.0802 0.043 0.37 0.12 0.13 0.05 0.11 0.12 Dried Peas ( Blended) 749 samples/ 0 detects 1% CT 1/ 2 LOD = 0.0015 ppm Average = 0.0015 Acute AR = 0.00015 Chronic AR = 0.012 ppm Chronic AR = 0.023 ppm Chronic AR = 0.012 ppm Chronic AR = 0.0015 ppm Soybean ( Blended) PDP data 749 samples/ 0 detects 1% CT 1/ 2 LOD = 0.0015 ppm Acute AR = 0.000015 Eggplant  Tomato PDP 1996 1998 1613 samples/ 4 detects 1/ 2 LOD = 0.0043 ppm 13% CT RDF # 29 ' Eggplant ( tomato PDP) ' 13% CT TOTALZ= 1403 TOTALNZ= 4 206, 0.0043 0.008 0.004 0.017 0.007 Non bell Pepper  Tomato PDP 1996 1998 1613 samples/ 4 detects ( 0.2% detects) 1/ 2 LOD = 0.0043 ppm RDF # 30 ' Non bell peppers ( Tomato PDP) ' 14% detects TOTALZ= 1387 TOTALNZ= 4 222, 0.0043 0.008 0.004 0.017 0.007 Bell Pepper   Tomato PDP 1996 1998 1613 samples/ 4 detects ( 0.2% detects) 1/ 2 LOD = 0.0043 ppm RDF # 31 ' Bell pepper ( Tomato PDP) l ' 12% CT TOTALZ= 1419 TOTALNZ= 4 190, 0.0043 0.008 0.004 0.017 0.007 Chronic AR = 0.0015 ppm Chronic AR = 0.0044 ppm Chronic AR = 0.0044 ppm Chronic AR = 0.0044 ppm ProcessedTomatoes  PDP 1996 1998 1613 samples/ 4 detects ( 0.2% detects) 1/ 2 LOD = 0.0043 ppm RDF # 32 Tomatoes  PDP 9% CT  0.2% detects Totalz= 1468 Totalnz= 4 141, 0.0043 0.008 0.004 0.017 0.007 Fresh Tomatoes  PDP 1996 1998 1613 samples/ 4 detects ( 0.2% detects) 1/ 2 LOD = 0.0043 ppm RDF # 33 Tomatoes  PDP 10% CT  0.2% detects Totalz= 1451 Totalnz= 4 158, 0.0043 0.008 0.004 0.017 0.007 Cucumber  PDP 2000 737 samples/ 13 detects 1/ 2 LOD = 0.009 ppm RDF # 34 ' Cucumber  PDP ' 22% CT  3% detects TOTALZ= 575 TOTALNZ= 13 149, 0.009 0.013 0.013 0.013 0.013 0.028 0.032 0.035 0.035 0.035 0.057 0.08 0.11 0.23 Melons ( Cantaloupe  PDP 1998) 408 samples/ 2 detects ( 0.5% detects) 1/ 2 LOD = 0.005 ppm RDF # 35 Cantaloupe  PDP 2% CT  0.5% detects Totalz= 400 Totalnz= 2 6, 0.005 0.01 0.01 Chronic AR = 0.0044 ppm Chronic AR = 0.0044 ppm Chronic AR = 0.0033 ppm Chronic AR = 0.0056 ppm Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files 33 Cantaloupe  PDP 1998 408 samples/ 2 detects ( 0.5% detects) 1/ 2 LOD = 0.005 ppm RDF # 36 Cantaloupe  PDP 13% CT  0.5% detects Totalz= 354 Totalnz= 2 52, 0.005 0.01 0.01 Honey dew ( Cantaloupe  PDP) 1998 408 samples/ 2 detects ( 0.5% detects) 1/ 2 LOD = 0.005 ppm RDF # 37 Cantaloupe  PDP 36% CT  0.5% detects Totalz= 261 Totalnz= 2 145, 0.005 0.01 0.01 Watermelon  FDA 1992 1998 330 samples/ 4 detects 1/ 2 LOD = 0.001 ppm RDF # 38 Watermelon  FDA 12% CT  1% detects Totalz= 290 Totalnz= 4 36, 0.001 0.06 0.1 0.04 0.094 Pumpkin ( Winter Squash  PDP 1997  98) 970 samples/ 1 detect 1/ 2 LOD = 0.005 ppm RDF # 39 Pumpkin ( Winter Squash  PDP) 24 % CT  0.1% detects Totalz= 737 Totalnz= 1 232, 0.006 0.013 Chronic AR = 0.0056 ppm Chronic AR = 0.0056 ppm Chronic AR = 0.0019 ppm Chronic AR = 0.006 ppm Winter Squash  PDP 1997 1998 970 samples/ 1 detect 1/ 2 LOD = 0.005 ppm RDF # 40 Winter Squash  PDP 24 % CT  0.1% detects Totalz= 737 Totalnz= 1 232, 0.006 0.013 Summer Squash  Cucumber PDP 2000 737 samples/ 13 detects 1/ 2 LOD = 0.009 ppm RDF# 41 ' Summer Squash  ( Cucumber PDP) ' 24% CT  2% detect TOTALZ= 560 TOTALNZ= 13 164, 0.009 0.013 0.013 0.013 0.013 0.028 0.032 0.035 0.035 0.035 0.057 0.08 0.11 0.23 Citrus citron, Lime, Tangelos, Tangerine, ( Orange  Market Basket 399 samples/ 11 detects RDF # 101 Number of samples = 399 Other Citrus 2% CT Totalz= 388 Totalnz= 11 0.0032 0.0017 0.015 0.0032 0.0017 0.0047 0.022 0.032 0.043 0.0052 0.013 Grapefruit juice ( Orange juice PDP data 1997 1998) 1392 samples/ 30 detects 2% detects  11% CT 1/ 2 LOD = 0.006 ppm RDF # 43 Grapefruit juice ( Orange juice PDP) 2% detects  11% CT Totalz= 1239 Totalnz= 30 123, 0.006 21, 0.01 7, 0.013 0.031 0.017 Chronic AR = 0.006 ppm Chronic AR = 0.0033 ppm Chronic AR = 0.013 ppm Chronic AR = 0.006 ppm Lemon juice ( Orange juice PDP data 1997 1998) 1392 samples/ 30 detects 2% detects  3% CT 1/ 2 LOD = 0.006 ppm RDF # 44 Lemon juice ( Orange juice PDP) 2% detects  3% CT Totalz= 1350 Totalnz= 30 12, 0.006 21, 0.01 7, 0.013 0.031 0.017 Orange Orange  Market Basket 399 samples/ 11 detects Replaces RDF # 104 Number of samples = 399 Orange  Market Basket Survey 4% CT  Totalz= 383 Totalnz= 11 4, 0.0005 0.0032 0.0017 0.015 0.0032 0.0017 0.0047 0.022 0.032 0.043 0.0052 0.013 Lime juice, tangerine juice ( Orange juice PDP data 1997 1998) 1392 samples/ 30 detects 2% detects  2% CT 1/ 2 LOD = 0.006 ppm RDF # 46 Lime juice ( Orange juice PDP) 2% detects  2% CT Totalz= 1362 Totalnz= 30 21, 0.01 7, 0.013 0.031 0.017 Orange juice PDP data 1997 1998) 1392 samples/ 30 detects 2% detects  4% CT 1/ 2 LOD = 0.006 ppm RDF # 47 Orange juice PDP 2% detects  4% CT Totalz= 1336 Totalnz= 30 26, 0.006 21, 0.01 7, 0.013 0.031 0.017 Chronic AR = 0.006 ppm Chronic AR = 0.013 ppm Chronic AR = 0.006 ppm Chronic AR = 0.006 ppm Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files 34 Apple  Single serving PDP  1999 387 samples/ 37 detects 1/ 2 LOD = 0.006 ppm RDF # 48 Apple Single Serving 35% crop treated TOTALZ= 252 TOTALNZ= 37 98, 0.003 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.02 0.022 0.023 0.027 0.033 0.037 0.04 0.045 0.053 0.054 0.054 0.062 0.063 0.065 0.076 0.092 0.11 0.11 0.12 0.14 0.16 0.17 0.17 0.22 0.23 0.28 0.31 0.33 0.42 Apples, Dried ( Blended) Apple  Single serving PDP  1999 387 samples/ 37 detects RDF # 98 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.02 0.022 0.023 0.027 0.033 0.037 0.04 0.045 0.053 0.054 0.054 0.062 0.063 0.065 0.076 0.092 0.11 0.11 0.12 0.14 0.16 0.17 0.17 0.22 0.23 0.28 0.31 0.33 0.42 Apple Juice PDP 1996 1998 1554 samples/ 454 detects 29% detects  35% CT 1/ 2 LOD = 0.006 ppm RDF # 50 Apple juice  PDP 35% CT  29% detects Totalz= 1010 Totalnz= 454 90, 0.006 see Appendix B for residue values Pear PDP decomposition 1997 1998 1420 samples/ 60 detects 4% detects  5% CT 1/ 2 LOD = 0.0065 ppm n= 13 Decomp. values were 0.000026 to 12 RDF # 51 Pear  PDP Totalz= 28500 Totalnz= 1000 500, 0.0065 see App. C for residue values Chronic AR = 0.03 ppm Chronic AR = 0.03 ppm Chronic AR = 0.01 ppm Chronic AR = 0.0098 ppm Partially blended Pear  PDP 1997 1998 1420 samples/ 60 detects 4% detects  5% CT 1/ 2 LOD = 0.0065 ppm RDF # 52 Pear  PDP Totalz= 1349 Totalnz= 60 11, 0.0065 0.24 0.007 0.058 0.12 0.007 0.007 0.017 0.007 0.007 0.007 0.3 0.007 0.007 0.14 0.013 0.042 0.01 0.017 0.05 0.036 0.007 0.01 0.1 0.013 0.007 0.01 0.053 0.007 0.007 0.007 0.007 0.061 0.81 0.01 0.11 0.035 0.07 0.076 0.042 0.013 0.007 0.007 0.052 0.45 0.013 0.013 0.042 0.41 0.49 0.12 0.013 0.01 0.19 0.14 0.14 0.013 0.033 0.01 0.01 0.089 Quince, Loquat ( Pear PDP) decomposition 1997 1998 1420 samples/ 60 detects 4% detects  2% CT 1/ 2 LOD = 0.0065 ppm n= 13 Decomp. values were 0.000026 to 12 RDF # 53 Quince  PDP Totalz= 73500 Totalnz= 1000 500, 0.0065 see App. C for residue values Crabapple  Apple  Single serving PDP  1999 387 samples/ 37 detects 1/ 2 LOD = 0.006 ppm RDF # 54 Crabapple  Apple Single Serving 2% crop treated TOTALZ= 1813 TOTALNZ= 37 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.02 0.022 0.023 0.027 0.033 0.037 0.04 0.045 0.053 0.054 0.054 0.062 0.063 0.065 0.076 0.092 0.11 0.11 0.12 0.14 0.16 0.17 0.17 0.22 0.23 0.28 0.31 0.33 0.42 Apricot  Peaches Single Serving PDP 2000 534 samples/ 79 detects RDF # 56 ' Apricot  ( single serving PDP) ' 2 % CT TOTALZ= 523 TOTALNZ= 79 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.011 0.022 0.025 0.026 0.03 0.031 0.031 0.041 0.042 0.046 0.049 0.051 0.052 0.054 0.057 0.06 0.065 0.071 0.073 0.083 0.087 0.094 0.1 0.11 0.11 0.12 0.13 0.14 0.14 0.15 0.15 0.15 0.15 0.15 0.16 0.16 0.18 0.2 0.21 0.24 0.25 0.29 0.34 0.37 0.41 0.49 0.5 0.51 0.54 0.56 0.58 0.59 0.76 0.94 0.94 1.2 1.5 2.7 Chronic AR = 0.0098 ppm Chronic AR = 0.0098 ppm Chronic AR = 0.03 ppm Chronic AR = 0.07 ppm Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files 35 Cherries PDP 2000  2001 561 samples/ 275 detects RDF # 57 ' Cherries PDP ' 47% detects Totalz= 286 Totalnz= 275 see Appendix D for residue values Nectarines  Peaches Single Serving PDP 2000 534 samples/ 79 detects 13% CT RDF # 59 Nectarines ( Peaches single serving PDP) ' 13% CT TOTALZ= 465 TOTALNZ= 79 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.011 0.022 0.025 0.026 0.03 0.031 0.031 0.041 0.042 0.046 0.049 0.051 0.052 0.054 0.057 0.06 0.065 0.071 0.073 0.083 0.087 0.094 0.1 0.11 0.11 0.12 0.13 0.14 0.14 0.15 0.15 0.15 0.15 0.15 0.16 0.16 0.18 0.2 0.21 0.24 0.25 0.29 0.34 0.37 0.41 0.49 0.5 0.51 0.54 0.56 0.58 0.59 0.76 0.94 0.94 1.2 1.5 2.7 Peaches Single Serving PDP 2000 534 samples/ 79 detects 18% CT  15% detected RDF # 61 Peaches  Single Serving PDP 18% CT  15% detected Totalz= 438 Totalnz= 79 17,0.006 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.011 0.022 0.025 0.026 0.03 0.031 0.031 0.041 0.042 0.046 0.049 0.051 0.052 0.054 0.057 0.06 0.065 0.071 0.073 0.083 0.087 0.094 0.1 0.11 0.11 0.12 0.13 0.14 0.14 0.15 0.15 0.15 0.15 0.15 0.16 0.16 0.18 0.2 0.21 0.24 0.25 0.29 0.34 0.37 0.41 0.49 0.5 0.51 0.54 0.56 0.58 0.59 0.76 0.94 0.94 1.2 1.5 2.7 Peach, Canned  PDP 1997 739 samples/ 80 detects RDF # 106 ' Peaches  canned PDP97 ' 18% CT Totalz= 606 Totalnz= 80 53, 0.006 0.484 0.4 0.31 0.3 0.22 0.2 0.19 0.19 0.19 0.19 0.18 0.16 0.16 0.16 0.14 0.14 0.13 0.12 0.12 0.12 0.11 0.096 0.095 0.086 0.084 0.084 0.084 0.084 0.081 0.081 0.08 0.063 0.063 0.057 0.055 0.055 0.051 0.048 0.042 0.035 0.035 0.035 0.035 0.035 0.035 0.035 0.033 0.033 0.033 0.033 0.033 0.027 0.027 0.022 0.02 0.017 0.017 0.017 0.017 0.017 0.017 0.017 0.017 0.017 0.017 0.017 0.013 0.013 0.013 0.013 0.013 0.013 0.013 0.01 0.01 0.01 0.01 0.01 0.01 0.01 Chronic AR = 0.062 ppm Chronic AR = 0.07 ppm Chronic AR = 0.07 ppm Chronic AR = 0.07 ppm Plums FDA FDA 1992 98 51 samples/ 2 detects 4% detects  9 % CT 1/ 2 LOD = 0.001 ppm RDF # 62 Plums  FDA 9% CT Totalz= 46 Totalnz= 2 3, 0.001 0.002 0.002 Blackberries ( Raspberry FDA 1992 98) 247 samples/ 51 detects 30% Detects  44 % CT 1/ 2 LOD = 0.001 ppm RDF # 63 Blackberry ( Raspberry FDA) 30% CT Totalz= 173 Totalnz= 51 23, 0.001 3.79 1.52 1.18 0.019 0.04 0.436 2.78 0.298 3.43 0.032 0.028 0.005 0.016 1.13 0.021 0.19 0.02 0.005 0.005 0.005 0.005 0.005 0.005 0.005 0.005 0.03 0.13 0.005 0.045 0.16 0.13 0.08 0.005 0.034 1.07 0.007 0.063 0.16 0.88 0.005 0.026 0.005 0.35 0.06 0.83 0.005 0.06 3.2 0.23 0.005 0.12 Blueberry  FDA 1992 1998 212 samples/ 23 detects 11 % detects  44% CT 1/ 2 LOD = 0.001 ppm RDF # 64 Blueberry FDA 44% CT  11% detects Totalz= 119 Totalnz= 23 70, 0.001 0.342 0.245 1.06 0.146 0.112 0.206 0.234 0.005 0.19 4.38 0.119 0.005 0.005 0.52 0.23 2.05 0.08 9.7 0.005 0.02 0.054 0.15 0.012 Boysenberry, Dewberry, Loganberry, Youngberry ( Raspberry FDA 1992 98) 247 samples/ 51 detects 21 % Detects  2 % CT 1/ 2 LOD = 0.001 ppm RDF # 65 Boysenberry ( Raspberry FDA) 2% CT Totalz= 2499 Totalnz= 51 3.79 1.52 1.18 0.019 0.04 0.436 2.78 0.298 3.43 0.032 0.028 0.005 0.016 1.13 0.021 0.19 0.02 0.005 0.005 0.005 0.005 0.005 0.005 0.005 0.005 0.03 0.13 0.005 0.045 0.16 0.13 0.08 0.005 0.034 1.07 0.007 0.063 0.16 0.88 0.005 0.026 0.005 0.35 0.06 0.83 0.005 0.06 3.2 0.23 0.005 0.12 Chronic AR = 0.07 ppm Chronic AR = 0.09 ppm Chronic AR = 0.09 ppm Chronic AR = 0.09 ppm Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files 36 Currant, Elderberries, Gooseberries, Huckleberries, ( Blueberry  FDA) 1992 1998 153 samples/ 15 detects 11 % detects  2% CT 1/ 2 LOD = 0.001 ppm RDF # 66 Currant ( Blueberry FDA) 2% CT Totalz= 4655 Totalnz= 23 72, 0.001 0.342 0.245 1.06 0.146 0.112 0.206 0.234 0.005 0.19 4.38 0.119 0.005 0.005 0.52 0.23 2.05 0.08 9.7 0.005 0.02 0.054 0.15 0.012 Raspberries  FDA Raspberry FDA 1992 98) 247 samples/ 51 detects 21 % Detects  7% CT 1/ 2 LOD = 0.001 ppm RDF # 67 Raspberry FDA 7% CT  21% detected Totalz= 196 Totalnz= 51 3.79 1.52 1.18 0.019 0.04 0.436 2.78 0.298 3.43 0.032 0.028 0.005 0.016 1.13 0.021 0.19 0.02 0.005 0.005 0.005 0.005 0.005 0.005 0.005 0.005 0.03 0.13 0.005 0.045 0.16 0.13 0.08 0.005 0.034 1.07 0.007 0.063 0.16 0.88 0.005 0.026 0.005 0.35 0.06 0.83 0.005 0.06 3.2 0.23 0.005 0.12 Almonds  FT 15 samples RDF # 68 Almonds  FT 1% CT Totalz= 1485 Totalnz= 15 0.0614 0.0704 0.0786 0.0822 0.0826 0.0932 0.0304 0.0358 0.0380 0.0704 0.0800 0.0840 0.01 0.0300 0.0384 Chestnuts ( Almonds  FT) 15 samples RDF # 69 Chestnuts ( Almonds  FT) 2% CT Totalz= 735 Totalnz= 15 0.0614 0.0704 0.0786 0.0822 0.0826 0.0932 0.0304 0.0358 0.0380 0.0704 0.0800 0.0840 0.01 0.0300 0.0384 Chronic AR = 0.09 ppm Chronic AR = 0.09 ppm Chronic AR = 0.059 ppm Chronic AR = 0.059 ppm Filberts ( Pecan  FT) 18 samples RDF # 70 Filberts ( Pecan  FT) 12% CT Totalz= 132 Totalnz= 18 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.044 0.053 0.053 0.025 0.026 0.045 0.01 0.023 0.027 Pecan  FT 18 samples RDF # 71 Pecan  FT 24% CT Totalz= 57 Totalnz= 18 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.044 0.053 0.053 0.025 0.026 0.045 0.01 0.023 0.027 Walnut  FT 15 samples 2% CT RDF # 72 Walnut  FT 2% CT Totalz= 735 Totalnz= 15 0.044 0.064 0.153 0.037 0.043 0.052 0.507 0.811 0.999 0.266 0.389 0.65 0.01 0.01 0.01 Corn, Fresh  PDP 1994 1996 1306 samples/ 0 detects 1% CT 1/ 2 LOD = 0.0085 RDF # 73 Fresh Corn 1% CT Totalz= 99 Totalnz= 1 0.0085 Chronic AR = 0.022 ppm Chronic AR = 0.022 ppm Chronic AR = 0.27 ppm Chronic AR = 0.0085 ppm Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files 37 Corn grain  FT Blended 0 detects 1/ 2 LOD = 0.01 1% CT Acute AR = 0.0001 Millet, Sorghum, Wheat  Blended ( Wheat grain PDP) 1563 samples/ 6 detects 1% CT 1557 @ 1/ 2 LOD = 0.0015 0.011 0.004 0.01 0.013 0.005 0.005 Average residue = 0.0015 ppm Acute AR = 0.000015 Rice PDP 2001 Blended 1% CT 614 samples/ 14 detects Average Residue = 0.003 Acute AR = 0.0003 Asparagus  FDA 1992 98 381 samples/ 6 detects 45% CT 1/ 2 LOD = 0.001 ppm RDF # 74 Asparagus  FDA 45% CT Totalz= 210 Totalnz= 6 165, 0.001 0.087 0.504 0.005 0.180 0.069 0.005 Chronic AR = 0.01 ppm Chronic AR = 0.0015 ppm Chronic AR = 0.003 ppm Chronic AR = 0.0032 ppm Banana/ Plantains ( Bananas  Market Basket Survey data) 400 samples/ 5 detects RDF # 105 Number of samples = 400 Bananas/ Plantains 100% CT Totalz= 0 Totalnz= 5 395, 0.0005 0.0019 0.0013 0.0011 0.0020 0.0016 Cranberries  FDA 1992  98 111 samples/ 3 detects 1/ 2 LOD = 0.001 ppm RDF # 76 Cranberries  FDA 68% CT Totalz= 36 Totalnz= 3 72, 0.001 0.002 0.002 0.002 Flax seed Blended Field Trial 10 samples No detects < 0.02 ppm 1% CT Average Residues = 1/ 2 LOD = 0.01 ppm Acute AR = 0.0001 Grapes  PDP 1994 96 1884 samples/ 65 detects 12% CT 1/ 2 LOD = 0.01 ppm RDF # 77 Grapes PDP 12% CT Totalz= 1658 Totalnz= 65 161, 0.01 0.94 0.01 0.011 0.011 0.011 0.011 0.013 0.017 0.017 0.017 0.017 0.02 0.02 0.02 0.02 0.025 0.025 0.025 0.025 0.036 0.042 0.042 0.042 0.047 0.053 0.057 0.061 0.063 0.063 0.067 0.068 0.068 0.071 0.079 0.086 0.088 0.11 0.11 0.12 0.12 0.12 0.13 0.13 0.14 0.15 0.18 0.19 0.19 0.22 0.23 0.23 0.24 0.25 0.29 0.29 0.34 0.38 0.42 0.43 0.48 0.5 0.52 0.54 0.62 Chronic AR = 0.01 ppm Chronic AR = 0.001 ppm Chronic AR = 0.01 ppm Chronic AR = 0.016 ppm Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files 38 Grape juice PDP 1998 665 samples/ 245 detects 37% Detects  12 % CT RDF # 78 Grape juice PDP 37% detects ( 12% CT) Totalz= 420 Totalnz= 245 See Appendix E for residues Okra Field Trials 10 samples RDF # 79 Okra  FT 94% CT Totalz= 1 Totalnz= 10 2.5 2.99 0.152 0.155 0.399 0.546 0.105 0.32 1.17 1 .65 Olives Field Trials 12 samples RDF # 80 Olives  FT 2% CT Totalz= 588 Totalnz= 12 4.44 5.56 7.49 2.08 2.22 3.95 2.77 3.79 9.83 0.83 1.18 2.11 Olive oil ( Olives) Blended Field Trials 12 samples 2% CT 4.44 5.56 7.49 2.08 2.22 3.95 2.77 3.79 9.83 0.83 1.18 2.11 Average residue = 3.85 Acute AR = 0.077 Chronic AR = 0.01 ppm Chronic AR = 1.0 ppm Chronic AR = 3.85 ppm Chronic AR = 3.85 ppm Peanuts Blended Field Trial 24 samples/ no detects LOD = < 0.02 6% CT Average Residue = 1/ 2 LOD = 0.01 Acute AR = 0.0006 ppm Pineapple  Imports only PDP PDP 2000 2001 1097 samples/ 11 detects RDF # 97 Pineapples 50% imported, 100% CT Totalz= 668 Totalnz= 11 657, 0.005 0.013 0.013 0.013 0.017 0.017 0.017 0.017 0.033 0.036 0.043 0.06 Pistachios Field Trials 12 samples RDF # 83 Pistachios 38% CT Totalz= 20 Totalnz= 12 0.026 0.026 0.03 0.01 0.01 0.01 0.073 0.089 0.099 0.01 0.01 0.01 Strawberry  PDP 2000 518 samples/ 89 detects 1/ 2 LOD = 0.005 RDF # 84 Strawberry  PDP 27% CT Totalz= 378 Totalnz= 89 51, 0.005 0.013 0.013 0.013 0.013 0.013 0.013 0.013 0.013 0.013 0.017 0.017 0.017 0.017 0.017 0.017 0.017 0.017 0.017 0.017 0.017 0.017 0.017 0.017 0.017 0.033 0.035 0.037 0.037 0.043 0.044 0.047 0.05 0.056 0.059 0.062 0.069 0.079 0.084 0.092 0.093 0.1 0.13 0.14 0.14 0.14 0.16 0.17 0.17 0.2 0.21 0.23 0.23 0.23 0.24 0.26 0.26 0.27 0.27 0.29 0.34 0.37 0.38 0.46 0.51 0.51 0.53 0.55 0.56 0.64 0.68 0.74 0.77 0.81 0.96 0.97 0.98 1 1.1 1.2 1.4 1.6 1.6 1.8 1.8 1.8 2.1 2.7 4 4.4 Chronic AR = 0.01 ppm Chronic AR = 0.0052 ppm Chronic AR = 0.03 ppm Chronic AR = 0.0638 ppm Attachment 1: Anticipated Residues Summary Table and Residue Distribution Files 39 Sunflower oil Blended Field Trial data 15 samples 1% CT Residues 0.01 0.029 0.036 0.01 0.01 0.01 0.01 0.01 0.01 0.065 0.079 0.090 0.047 0.077 0.129 Average residue = 0.04 Acute AR = 0.0004 Sunflower seeds Field Trial data 15 samples 1% CT RDF # 85 Sunflower  FT 1% CT Totalz= 1485 Totalnz= 15 0.01 0.029 0.036 0.01 0.01 0.01 0.01 0.01 0.01 0.065 0.079 0.090 0.047 0.077 0.129 Milk translate to ruminant meat and fat Feeding study % CT based on alfalfa, feed grains, and forages % CT of 1%

RDF # 86 Milk 1% CT Totalz= 99 Totalnz= 1 0.0299 Ruminant Liver Feeding study % CT based on alfalfa, feed grains, and forages % CT of 1%

RDF # 87 Ruminant Liver 1% CT Totalz= 99 Totalnz= 1 0.79 Chronic AR = 0.04 ppm Chronic AR = 0.04 ppm Chronic AR = 0.0003 ppm Chronic AR = 0.0063 Ruminant Kidney Feeding study % CT based on alfalfa, feed grains, and forages % CT of 1%

RDF # 88 Ruminant Kidney 1% CT Totalz= 99 Totalnz= 1 2.1 Swine Meat Feeding study % CT based on feed grains, and forages % CT of 1%

RDF # 89 Swine Meat 1% CT Totalz= 99 Totalnz= 1 0.036 Swine Fat Feeding study % CT based on feed grains, and forages % CT of 1%

RDF # 90 Swine Fat 1% CT Totalz= 99 Totalnz= 1 0.0192 Swine Liver Feeding study % CT based on feed grains, and forages % CT of 1%

RDF # 91 Swine Liver 1% CT Totalz= 99 Totalnz= 0.102 Chronic AR = 0.0179 Chronic AR = 0.000348 Chronic AR = 0.000096 Chronic AR = 0.000792 Swine Kidney Feeding study % CT based on feed grains, and forages % CT of 1%


[Federal Register Volume 86, Number 29 (Tuesday, February 16, 2021)]
[Notices]
[Pages 9510-9512]
[FR Doc No: 2021-03023]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2030]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Application for Food
and Drug Administration Approval To Market a New Drug

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by March 18, 2021.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0001. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Application for FDA Approval To Market a New Drug; OMB Control No.
0910-0001--Revision

    This information collection supports FDA regulations. Under section
505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 355(a)), a new drug may not be commercially marketed in the
United States unless an approval of an application filed with FDA under
section 505(b) or (j) of the FD&C Act is effective with respect to such
drug. We have issued regulations in part 314 (21 CFR part 314) to
govern procedures and requirements for applications submitted in
accordance with section 505. The regulations in subpart A (Sec. Sec.
314.1 through 314.3) set forth general provisions, while regulations in
subparts B and C (Sec. Sec.  314.50 through 314.99) set forth content
and format requirements for new drug applications (NDAs) and
abbreviated new drug applications (ANDAs) respectively. The regulations
include requirements for the submission of specific data elements along
with patent information, pediatric use information, supplements and
amendments, proposed labeling, and specific postmarketing reports.
Respondents to the information collection are sponsors of these
applications.
    To assist respondents to the information collection we have
developed the following forms:
     Form FDA 0356h (and instructions): Application to Market a
New or Abbreviated New Drug or Biologic for Human Use;
     Form FDA 2252 (and instructions): Transmittal of Annual
Reports for Drugs and Biologics For Human Use (Sec.  314.81);
     Form FDA 2253 (and instructions): Transmittal of
Advertisements and Promotional Labeling For Drugs and Biologics For
Human Use; and
     Forms FDA 3331/3331a: Field Alert Report and Instruction
     Forms FDA 3542 and 3542a and Instructions: Patent
Information Submitted Upon and After Approval of an NDA Supplement;
Patent Information Submitted With the Filing of an NDA, Amendment, or
Supplement
     New Draft Form FDA 3898 and Instruction: Drug Master File
    Individuals requesting printed forms are instructed to contact the
FDA Forms Manager by email at<EMAIL_ADDRESS>Certain fees may
be applicable.
    Regulations in subpart D (Sec. Sec.  314.100 through 314.170)
explain Agency actions on applications and set forth timeframes for FDA
review. We are revising the information collection to include
provisions established through our Agency user fee programs, most
recently authorized under the FDA Reauthorization Act of 2017. These
provisions pertain to review transparency, communications with FDA,
dispute resolution, drug safety enhancements, and the allocation of
Agency resources to align with these program objectives as agreed to
with our stakeholders and set forth in our ``Performance Goals for
Fiscal Years 2018-2022'' Commitment Letters, which are available from
our website at https://www.fda.gov along with more information about
FDA user fee programs.
    Information collection pertaining to hearing and other
administrative proceedings covered in 21 CFR subpart E are approved
under OMB control no. 0910-0191. Unless otherwise noted, information
collection pertaining to postmarket safety reporting and associated
recordkeeping is approved under OMB control nos. 0910-0230, 0910-0291,
and 0910-0645.
    Included among the miscellaneous provisions in subpart G
(Sec. Sec.  314.410 to 314.445), Sec.  314.420 covers information to
include in drug master files (DMFs). To assist respondents to this
information collection we have prepared templates and resources
available from our website at www.fda.gov/drugs/forms-submission-requirements/drug-master-files-dmfs. As noted above, we have developed
new Form FDA 3898 and accompanying instructions on submitting DMFs in
accordance with the applicable regulations. In accordance with Sec.
314.445, we also develop Agency guidance documents to assist
respondents in complying with provisions in part 314. These guidance
documents are issued consistent with our good guidance practice
regulations at Sec.  10.115. To search available FDA guidance
documents, visit our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Finally, applications
submitted in accordance with subpart H (Sec. Sec.  314.500 through
314.560) pertain to accelerated approval of new drugs for serious or
life-threatening illness, and submissions in subpart I (Sec. Sec.
314.600 through 314.650) pertain to approval of new drugs when human
efficacy studies are not ethical or feasible. The regulations provide
for the submission of specific data elements along with promotional
material.
    We use the information collection to approve drugs shown to be safe
and effective and to implement effective public health monitoring
systems. We also use product approval and related patent and
exclusivity information to publish the ``Approved Drug Products with
Therapeutic Equivalence Evaluations'' list (the Orange Book). More
information regarding the Orange Book is available from our website at
https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book.
    In the Federal Register of November 16, 2020 (85 FR 73057), we
published a 60-day notice requesting public

comment on the proposed collection of information. No comments were
received and we have therefore made no adjustments to our estimate,
which is as follows:

                                   Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
         21 CFR section              Number of     responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses      (in hours)
----------------------------------------------------------------------------------------------------------------
                                                    Subpart B
----------------------------------------------------------------------------------------------------------------
314.50(a)-(l)--Content and                   121            1.15             139           1,921         267,019
 format of a 505(b)(1) or
 505(b)(2) application..........
314.50(i)(1)--patent
 certifications:
    Form FDA 3542...............             281           2.875             808              10           8,080
    Form FDA 3542a..............             310           2.084             646              15           9,690
314.50(i)(6) amended patent                   17               1              17               2              34
 certifications.................
314.52(a), (b), and (e)--NDAs--               15               3              45              15             675
 notice of noninfringement of
 patent certification...........
314.52(c)--Noninfringement of                 22               3              66        0.33 (20              22
 patent certification notice                                                            minutes)
 content........................
314.53(f)(1)--Correction of                   24               1              24              10             240
 patent information errors by
 persons other than the NDA
 holder.........................
314.53(f)(2)--Correction of                   28             1.4              39               1              39
 patent information errors by
 the NDA holder.................
314.60--Amendments to unapproved             256            8.23           2,106              80         168,480
 NDA, supplement or resubmission
314.60(f)--patent certifications               6               1               6               2              12
 for unapproved applications....
314.65--Withdrawal of unapproved              14            1.21              17               2              34
 applications...................
314.70 and 314.71--Supplements               492            6.57           3,232             150         484,800
 and other changes to approved
 application....................
314.72--Changes of ownership of               67            1.45              97               2             194
 NDAs...........................
314.81--Other postmarketing                  484            20.3           9,834               8          78,672
 reports 314.81(b)(1) [3331 and
 3331a field alert reports and
 followups].....................
314.81(b)(2)[2252]--Annual                   626             4.9           3,066              40         122,640
 reports........................
314.81(b)(2)[2253]--Promotional              331           141.3          46,782               2          93,564
 labeling.......................
----------------------------------------------------------------------------------------------------------------
                                                    Subpart C
----------------------------------------------------------------------------------------------------------------
314.94(a)and(d)--ANDA content...             229             4.3             987             480         473,760
314.94(a)(12)(viii) amended                  153               1             153               2             306
 patent certifications before
 approval of ANDA...............
314.95(c)--Non-infringement of               400               3           1,200        0.33 (20             400
 patents (ANDAs)................                                                        minutes)
314.96(a)(1)--Amendments to                  451            36.2          16,311              80       1,304,880
 unapproved ANDAs...............
314.96(c) amendment for                        1               1               1             300             300
 pharmaceutical equivalent to a
 listed drug other than RLD.....
314.96(d)--patent certification              100               1             100               2             200
 requirements...................
314.97--Supplements and other                361            22.8           8,237              80         658,960
 changes to ANDAs...............
314.97(b) Supplements to ANDA                  1               1               1             300             300
 for pharmaceutical equivalent
 to a listed drug other than RLD
314.99(a)--ANDA Applicants:                   77             2.3             177               2             354
 Withdrawal of unapproved ANDAs.
314.99(a)--ANDA Transfer of                  135            1.24             167               2             334
 ownership......................
----------------------------------------------------------------------------------------------------------------
                                                    Subpart D
----------------------------------------------------------------------------------------------------------------
314.101(a)--NDA or ANDA filing                 1               1               1         0.5 (30             0.5
 over protest...................                                                        minutes)
314.107(e)--notification of                  247               2             494         0.5 (30             247
 court actions or written                                                               minutes)
 consent to approval............
----------------------------------------------------------------------------------------------------------------
                                              Subparts G, H, and I
----------------------------------------------------------------------------------------------------------------
314.420--drug master files [FDA               36            27.2             981              61          59,841
 3938]--original amendments.....
DMFs--technical, administrative,           2,946            11.4          33,590               8         268,720
 REMS)..........................
DMFs--annual reports............           2,946            3.33           9,834               4          39,336
314.550--Promotional material                 55            11.6             640             120          76,800
 and subpart H applications.....
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............     4,118,933.5
----------------------------------------------------------------------------------------------------------------

    Our estimated burden for the information collection reflects a
decrease. We attribute this adjustment to improved operational
efficiencies with regard to Agency data systems and digital submission
processes.

    Dated: February 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03023 Filed 2-12-21; 8:45 am]
BILLING CODE 4164-01-P