UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES May 12, 2006 MEMORANDUM SUBJECT: Aldicarb. List A Reregistration Case No. 0140/ Chemical ID No. 098301. Revised Anticipated Residues and Dietary Exposure Analyses for the HED Human Health Risk Assessment. DP Barcode No. D328808.

FROM: Felecia Fort, Chemist Reregistration Branch 1 Health Effects Division ( 7509C)

THROUGH: Sheila Piper, Chemist Sherrie Kinard, Chemist Dietary Exposure Science Advisory Council ( DESAC)

and Whang Phang, Ph. D., Branch Senior Scientist Reregistration Branch 1 Health Effects Division ( 7509C)

TO: Sherrie Kinard, Chemical Review Manager Special Review and Reregistration Division ( 7508W)

Background/ Action Requested A dietary assessment was completed for aldicarb on June 20, 2005 ( F. Fort, D299873). The assessment has been revised to incorporate comments submitted by the registrant, Bayer CropSciences during the Phase 1 " Error Correction" comment period. A detailed description of these comments can be found in the memorandum, " Aldicarb. List A Reregistration Case No. 0140/ Chemical ID No. 098301. HED's Response to Bayer CropScience " Error Only" Comments DP Barcode No. D320377."

In order to complete the Agency's human health risk assessment for aldicarb, HED has been requested to prepare refined ( Tier 3/ 4) dietary exposure and risk analyses which incorporate both existing uses as well as proposed label amendments for potatoes and citrus, and a proposed import tolerance for aldicarb residues in bananas. Page 2 of 203 Anticipated residues incorporate available field trial residue data, pesticide monitoring data from both the United States Department of Agriculture ( USDA) and the Food and Drug Administration ( FDA), and market basket survey data submitted by the registrant and the Carbamate Task Force ( CTF). In addition, estimates of percent crop treated (% CT) generated by EPA's Biologic and Economic Analysis Division ( BEAD) are used to refine the assessment. Finally, results of processing and cooking studies submitted in support of registration and reregistration are incorporated.

Risk estimates were generated for acute ( single day) dietary exposures using the most recent version of the Dietary Exposure Evaluation Model ( DEEM FCID   , Version 2.03) and toxicological doses and endpoints selected by HED for aldicarb risk assessments. Results based on the rat red blood cell cholinesterase depression endpoint ( RBC ChEI) reflect standard Agency policy for defining hazard inputs for risk assessment purposes. Results based on rat brain ChEI and human RBC ChEI endpoints are provided for characterization purposes.

Executive Summary The aldicarb acute dietary exposure assessments were highly refined ( i. e., Tier 3/ 4), incorporating monitoring data from the USDA Pesticide Data Program ( PDP, potatoes) and the Carbamate Task Force Market Basket Survey ( oranges). These two data sets were used to assess exposure from all potato and sweet potato food forms, as well as all citrus commodities ( orange, grapefruit, lemon and lime). For all other commodities, field trial data were used in the assessment, but residues were either very low or nondetectable ( soybeans, cottonseed, peanuts, dry beans and coffee). Sugarbeet and sugarcane were excluded from the assessments, since aldicarb residues would not be expected in the processed commodities as consumed; the existing tolerance for sorghum was used in the assessment, but did not contribute to estimated dietary exposure due to the low % CT, the low tolerance, and the low consumption.

Percent crop treated information was incorporated for both fresh and processed potatoes, oranges and grapefruit, and for all other commodities. In addition, extensive processing/ cooking data, generally indicating reduction of residues through boiling and juicing, were incorporated into the assessment.

This memorandum describes the endpoints and doses for acute dietary exposure and risk assessment; consumption and residue data used, including use information and processing factors; and the detailed residue inputs and DEEM   outputs. The general approach to calculation of anticipated residues ( ARs) and the process for incorporating the aldicarb residue and monitoring data into the acute dietary exposure analysis was discussed by HED's Chemistry Science Advisory Council ( ChemSAC) on 5/ 9/ 01; the dietary exposure assessments were also subject to peer review in HED's Dietary Exposure Science Advisory Council ( DE SAC).

Acute Dietary Exposure Acute dietary exposure assessments were conducted for the general US population and population subgroups including all infants (< 1 year old), children 1 2, children 3 5, children 6 12, youth 13 19, adults 20 49, females 13 49, and adults 50+ years old. The analysis which included existing aldicarb registrations indicates estimated acute dietary exposure Page 3 of 203 and risk exceed HED's level of concern [ i. e., > 100 % of the acute population adjusted dose ( aPAD)] for the general US population and relevant population subgroups at the 99.9th % ile of exposure ( Table 1). Estimated acute dietary exposure and risk exceed HED's level of concern [ i. e., > 100 % aPAD] for children 1 2 years and children 3 5 years old. The estimated dietary exposure and risk for these two population subgroups at the 99.9th percentile exposure using the rat RBC ChEI endpoint was 0.000797 mg/ kg/ day, or 159% aPAD and 0.000643 mg/ kg/ day or 129% aPAD, respectively. For the general US population, estimated dietary exposure was 0.000358 mg/ kg/ day, or 72% aPAD. Estimated exposure and risk were below HED's level of concern ( i. e., < 100 % aPAD) at the 99.8th percentile for both children 1 2 years old and children 3 5 years old. If the PAD is based on the rat brain ChEI or human RBC ChEI endpoint, risks estimates are above HED's level of concern for children 1 2 years old ( 106% ( brain) and 122% ( human), respectively).

Because estimated dietary exposure was above HED's level of concern, an analysis was conducted to determine the foods or food forms which contribute the most to the exposure estimates. For all population subgroups, residues in potatoes were the most significant source of dietary exposure. For all infants, residues in sweet potato were also significant contributors.

Sensitivity analyses were conducted to determine if assumptions for nondetectable residues overestimated exposures. These analyses consisted of ( 1) assuming aldicarb per se residues were 0 ppm; and ( 2) assuming nondetect residues in citrus monitoring samples were true zeroes. The assumption of zero residues for aldicarb per se had a greater impact on the estimated exposure than the assumption of zero residue values for citrus nondetects. However, the sensitivity analyses did not significantly reduce the estimated exposure and risk for any of the population subgroups. These analyses indicate that actual detected residues from monitoring data were the source of the exposure and risk, and not assumed residues for nondetects ( Table 10b). For the general US population, assuming aldicarb residues of 0 ppm and zero residues for nondetects in citrus, the estimated exposure was reduced to 70 % of the aPAD; for children 1 2 years old, the estimated exposure was reduced to 154 % of the aPAD.

Since residues in citrus and potatoes were identified as significant contributors to estimated dietary exposure, analyses were conducted in which citrus and potato commodities were separately omitted from the exposure assessment ( Table 10b). When citrus commodities were excluded, estimated exposure for children 1 2 years old was reduced from 159% to 151% of the aPAD; exposures for infants < 1 year old from 123% to119 % of the aPAD, while exposures for the general US population and all other population subgroups ranged from 54 90% of the aPAD. When potato commodities were excluded, the highest estimated exposure was for children 1 2, at 0.000199 mg/ kg/ day, or 40% of the aPAD; estimated exposures for all other population subgroups ranged from 5 to 32% of the aPAD, all based on rat RBC ChEI. Detailed results are shown in Table 10b.

Proposed amended label requests would allow the establishment of a citrus crop group tolerance; a shorter pre harvest interval ( PHI, from 150 to 120 days) on potatoes grown in the Pacific Northwest; use on potatoes in six Midwestern states; and an import tolerance for residues in bananas. Acute dietary exposure analyses were conducted to determine the potential increased incremental exposure associated with each of these proposed registration actions, even though exposures estimated for the existing uses already exceed HED's level of concern. These additional assessments indicate there would be little or no increased dietary exposure and risk associated with the establishment of a citrus Page 4 of 203 crop group tolerance or a proposed import tolerance in bananas. However, increased dietary exposure would be incurred if the two label amendments for potatoes were approved. Inclusion of both potato label amendments resulted in an estimated risk of 216% of the aPAD for children 1 2 years old. Based on individual assessments for the two label amendments, the proposed shorter PHI results in a greater incremental increase in the estimated exposure than the use on potatoes in six additional Midwestern states. Exposure estimates for the proposed registration actions are shown in detail in Table 11.

These above results are based on the rat RBC ChEI toxicological endpoint. The comparative risk estimates based on rat brain ChEI and human RBC ChEI are shown in the summary tables.

Chronic Dietary Exposure A chronic assessment was not conducted because the toxicity database for aldicarb indicates that the magnitude of ChEI does not increase with continued exposure, due to the reversibility of ChEI ( generally within 8 to 24 hours). The longer term exposures could be considered as a series of acute exposures.

Drinking Water Acute dietary exposure and risk from food alone was above HED's level of concern ( i. e., > 100 % aPAD), so a drinking water only assessment was conducted. If all of the allowable exposure occurred through drinking water, HED would not have concerns for acute exposure to aldicarb residues in surface water. Acute water exposure and risk estimates for infants, the most highly exposed population subgroup, range from 1% aPAD [ potato] to 15% aPAD [ cotton] at the 95th % ile of exposure. Acute water exposure and risk estimates for the general US population and all other population subgroups ranged from < 1% aPAD to 5% aPAD ( see Table 14).

Seven regional ground water monitoring residue levels were used to derive an acute dietary exposure estimate for water alone ( the eighth region had a residue value of 0 ppb, and was excluded from the aggregate assessment). The data indicate that acute exposure from ground water sources of drinking water is also of concern, with acute aggregate risks ranging from 20% aPAD to 945% aPAD ( see Table 15).

Drinking water exposure and risk estimates calculated based on ground water monitoring overestimate risks for all but those who obtain their drinking water from wells in vulnerable aldicarb use areas. However, since acute food only exposures exceed the aPAD, HED is concerned about any additional exposure ( to all subpopulations) through drinking water, regardless of the source. Page 5 of 203 Table 1. Aldicarb Acute Dietary Exposure and Risk ( 99.9th % ile)   Existing Registrations Population Exposure ( mg/ kg/ day) Rat ( RBC ChEI) % PAD Rat ( Brain ChEI) % PAD Human ( RBC ChEI) % PAD U. S. Pop 0.000358 72 48 55 All Infants 0.000463 93 62 71 Children 1 2 years 0.000797 159 106 123 Children 3 5 years 0.000643 129 86 99 Children 6 12 years 0.000457 91 61 70 Youth 13 19 0.000312 62 42 48 Adults 20 49 yrs: 0.000298 60 40 46 Adults 50+ 0.000320 64 43 49 Females13 49 0.000282 56 38 43 Population Adjusted Dose ( PAD) = 0.0005 mg/ kg/ day Rat ( RBC CheI) 0.00075 mg/ kg/ day Rat ( Brain CheI) 0.00065 mg/ kg/ day Human ( RBC CheI)

Table 1b. Aldicarb Acute Dietary Exposure and Risk ( 99.9th % ile)   ( Aldicarb = 0; citrus nondetects = 0)

Population Exposure ( mg/ kg/ day) Rat ( RBC ChEI) % PAD Rat ( Brain ChEI) % PAD Human ( RBC ChEI) % PAD U. S. Pop 0.000349 70 46 54 All Infants 0.000443 89 59 68 Children 1 2 years 0.000773 154 103 119 Children 3 5 years 0.000623 125 83 96 Children 6 12 years 0.000443 89 59 68 Youth 13 19 0.000304 61 41 46 Adults 20 49 yrs: 0.000290 58 39 45 Adults 50+ 0.000314 63 42 48 Females13 49 0.000274 55 37 42 Population Adjusted Dose ( PAD) = 0.0005 mg/ kg/ day Rat ( RBC CheI) 0.00075 mg/ kg/ day Rat ( Brain CheI) 0.00065 mg/ kg/ day Human ( RBC CheI) Page 6 of 203 Uncertainties in the Aldicarb Dietary Exposure Assessments Estimated dietary exposure in these preliminary assessments is almost entirely due to potatoes and citrus. Potato exposure estimates are based on potato monitoring data generated by the USDA PDP in a 1997 special survey, and citrus exposure is based on orange monitoring data submitted by the Carbamate Task Force. The potato and orange monitoring studies were used both directly for these commodities, as well as by translation to sweet potatoes and other citrus, such as lemon, lime, etc. These monitoring data were considered most appropriate for aldicarb acute dietary exposure analyses since residues were measured in individual potato tubers and oranges, thereby eliminating the need for mathematical " decomposition" of composite monitoring sample residues. In addition, the PDP and CTF data sets were largely relied upon because residues were determined closest to the point of consumption ( i. e., " dinner plate" residues), and because the limits of detection ( LODs) in these two data sets were lower than those achieved in any other studies.

In the 1997 PDP special survey, aldicarb and its metabolites were analyzed in 342 composite potato samples collected from states where aldicarb can be applied ( FL, ID, OR and WA). Residues were detected in 20 composite samples, and individual potato tubers ( 10 per composite) from 16 of the composites with detects were analyzed. The highest combined residue in a composite sample was 0.17 ppm, which is below the reassessed tolerance of 0.2 ppm. The highest residue in an individual tuber was approximately 0.4 ppm, or twice the tolerance. In the CTF market basket survey, aldicarb and metabolite residues were measured in 399 oranges collected from grocery stores; residues were detected in 16 of the oranges sampled. The maximum orange residue of 0.03 ppm is 10 times lower than the reassessed tolerance of 0.3 ppm. In both the PDP and CTF studies, detected residues were the sulfone and sulfoxide metabolites, but aldicarb per se was not detected.

There are some uncertainties associated with the potato and orange monitoring data:

  For both potatoes and citrus, only the fresh market commodity was analyzed for aldicarb residues, but the data were used to assess exposure from processed commodities. The % CT is clearly greater for both processed potatoes and oranges than for fresh potatoes and oranges. The underlying assumption is that the typical application rates for fresh and processed commodities are similar.

  The potato monitoring data from PDP were part of a special survey, and were not specifically generated for risk assessment purposes. Of the 342 composite samples analyzed, there were detectable residues in 20 samples, and individual potato tuber residues were determined in 16 of the 20 composites. Since individual tuber residues were determined in only the composites with detectable residues, and not in the 322 composites with residues of less than or equal to the LOD, the individual tuber residue data may be skewed. There was no attempt to compensate for this artifact of study design in the current dietary exposure assessment; for example, no assumptions were made regarding the distribution of individual tuber residues in the four composite samples with detectable residues that were not further analyzed. In addition, there was no assumption regarding the potential distribution of residues in the remaining 322 composite samples that had no detectable residues.

  The highest residue found in individual potato tubers from the PDP special survey was approximately 0.4 ppm, yet one FDA monitoring sample from 1997 indicated residues in potatoes were as high as 1.4 ppm. In addition, previously submitted 6( a) 2 data have shown that aldicarb residues as high as 1.2 ppm have been found in canned potatoes. Although the FDA and 6( a) 2 data were not used quantitatively in the acute dietary exposure analysis, they raise concerns regarding potential exposures much higher than those which already indicate a Page 7 of 203 risk concern. [ FDA surveillance monitoring resulted in only one detect of aldicarb residues in potatoes in 1998, and none in 1999].

  Translation of potato data to sweet potatoes may not be appropriate, since aldicarb use areas and growing regions for the two types of potatoes are not the same. However, use rates for both types of potatoes are similar, and therefore translation of potato monitoring data should be more representative of likely exposures than field trial data for sweet potatoes.

  Orange monitoring data were translated to all other citrus; this approach is considered appropriate since the use pattern is the same, and since field trial data support the establishment of a citrus crop group tolerance. However, residue profiles in individual citrus fruits may differ.

  HED generally assumes that nondetectable residues in treated samples are ½ the LOD. However, for monitoring data in which aldicarb and metabolite residues were determined individually, nondetect residues of aldicarb per se in potatoes and oranges, and all nondetect residues in citrus commodities, were assumed to be 0, rather than ½ LOD. This assumption did not underestimate exposure, since the sensitivity analyses showed that exposure and risk were largely due to detected residues in potato and citrus monitoring samples.

  Aldicarb residues were detected by PDP in one sample each of green beans ( 1994) and cantaloupe ( 1998), commodities for which there is no registered use; there have been documented poisoning incidents associated with purported misuse on watermelons ( 1978, 1985 and 1987) and cucumbers ( 1988), but these PDP monitoring detections are not considered to indicate a consistent pattern of violative residues, and have not been included in the aldicarb dietary exposure analyses.

Toxicological Information The HED determined that the rat subchronic neurotoxicity study [ MRID 43829602] and the rat acute neurotoxicity study ( MRID 45068601; Moser) be used as co critical studies for endpoint selection. Aldicarb induced inhibition of ChE activity is rapidly reversible ( less than 24 hours). Therefore, chronic exposure to aldicarb is considered to be a series of acute exposures, and a separate chronic assessment is not necessary. A summary of the doses and endpoints relevant to dietary exposure assessment are shown below.

Aldicarb is classified as not likely to be carcinogenic to humans, based on the lack of evidence of carcinogenicity in studies in rats and mice and the absence of a mutagenicity concern. Therefore, a dietary exposure assessment for cancer risk assessment is not required. Page 8 of 203 Table 2. Aldicarb Toxicology Endpoint Selection.

Exposure Scenario Dose Used in Risk Assessment, UF1 Hazard Based FQPA SF and Endpoint for Risk Assessment Study and Toxicological Effects DIETARY EXPOSURES Acute Dietary: General US Population [ MRID Nos. 43829602, 45068601, 43442302, 43442305, & 42373001] BMDL10 = 0.02 mg/ kg UF = 20 Acute RfD = 0.001 mg/ kg/ day FQPA SF = 2X aPAD= acute RfD FQPA SF = 0.0005 mg/ kg/ day Rat acute/ subchronic neurotoxicity ( adult) RBC ChEI human study [ reduction of interspecies factor to 2X]

Chronic Dietary: General US Population [ MRID No. 43829602, 45068601, 43442302, 43442305, & 42373001] BMDL10 = 0.02 mg/ kg UF = 20 Chronic RfD = 0.001 mg/ kg/ day FQPA SF = 2X cPAD = chronic RfD FQPA SF = 0.0005 mg/ kg/ day Rat acute/ subchronic neurotoxicity ( adult) RBC ChEI human study [ reduction of interspecies factor to 2X]

Cancer Aldicarb is classified as not likely to be carcinogenic to humans, based on the lack of evidence of carcinogenicity in studies in rats and mice and the absence of a mutagenicity concern. Therefore, a dietary exposure assessment for cancer risk assessment is not required.

Use Information A Quantitative Usage Analysis ( QUA) was completed by BEAD/ OPP ( Attachment 1, J. Faulkner, 12/ 23/ 99). Subsequently, HED requested additional information related to use on both fresh and processed citrus and potatoes, and a revised QUA was generated for these commodities ( Attachment 2, J. Faulkner, 5/ 12/ 00).

In terms of pounds of active ingredient ( ai) applied, the most significant use site for aldicarb is cotton, with 2 to 3 million lbs ai applied on an annual basis. Other significant use sites ( in decreasing amounts of ai applied) are peanuts, potatoes, sugar beets and oranges.

For all crops having registered uses, both a weighted average and estimated maximum % CT were generated. In acute analyses the adjustment for estimated maximum % CT is incorporated in the residue distribution files ( RDFs) by adding zero residue values corresponding to the percent of the crop not treated. For commodities considered to be blended ( e. g., sugars and oil), the adjustment for % CT is incorporated into the acute AR ( point estimate).

Usage estimates for potatoes were based on data from 1996 through 1998, since the use on potatoes was reinstated in 9/ 95 ( refer to the Residue Data section of this document for additional information). In conjunction with the proposed use on bananas, the registrant provided estimates of additional % CT on both fresh and processed potatoes that would likely result from two proposed label amendments to i) shorten the PHI to 120 days in the Pacific Northwest ( PNW); and ii) allow use on Page 9 of 203 potatoes grown in six Midwestern states ( MI, MN, ND, SD, WY and CO). The registrant's estimated proportional changes [ found in MRID No. 44847405] in use on fresh and processed potatoes were applied to the BEAD estimates of % CT for potatoes. In addition, BEAD generated fresh and processed % CT estimates for orange and grapefruit. The % CT estimates for both fresh and processed potatoes and citrus are shown in Table 3. These estimates have been used to construct residue distributions for use in the acute analysis.

Table 3. Aldicarb Usage Estimates for Fresh/ Processed Potatoes and Citrus.

Fresh Commodity Usage Estimate (% CT) Processed Commodity Usage Estimate (% CT) Commodity Weighted Average Estimated Maximum Weighted Average Estimated Maximum Potato, 1 Current 4 5 17 24 Current+ PHI 7 9 26 36 Current+ MW 6 7 21 28 Current+ PHI+ MW 8 10 29 40 Orange 7 13 11 23 Grapefruit 16 25 17 33 1 Current = existing use areas, FL and the Pacific NW; PHI = including a proposed label amendment allowing a shorter PHI in the Pacific NW; MW = including the proposed use on potatoes in six Midwestern states.

Insufficient information is available to determine reliable % CT estimates for coffee; although aldicarb is registered for use on coffee in Puerto Rico, the BEAD QUA indicates 94% of aldicarb usage on coffee occurs in Brazil. An upper bound assessment for coffee % CT was calculated by HED, assuming that 100% of Brazilian coffee is treated with aldicarb, and based on an average of 20% of US coffee imports originating in Brazil [ Agricultural Statistics 1997, ( 1993 1995 import statistics)]. There are no % CT data for the proposed use on bananas, but the registrant estimates ( at most) a 45% market share, which has been used in the dietary exposure estimates.

For crops where no usage is reported ( e. g., grain sorghum or soybean), or for which < 1 % CT is estimated, HED typically defaults to 1 % CT in dietary exposure analyses. Commodities from these crops may be excluded from analyses conducted to identify significant contributors to dietary exposure.

Consumption Data DEEM FCID   Program and Consumption Information Acute dietary exposure assessments were conducted for aldicarb using DEEM FCID   , Version 2.03 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. For acute exposure assessment, consumption data are are retained as individual consumption events. Based on analysis of the 1994 96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the Page 10 of 203 general U. S. population, all infants (< 1 year old), children 1 2, children 3 5, children 6 12, youth 13 19, adults 20 49, females 13 49, and adults 50+ years old.

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

Residue Data Existing and reassessed tolerances for aldicarb residues in raw agricultural commodities ( RACs) are expressed in terms of the combined residues of aldicarb and its cholinesterase inhibiting metabolites aldicarb sulfoxide [ 2 methyl 2( methylsulfinyl) propionaldehyde O( methyl carbamoyl) oxime] and aldicarb sulfone [ 2 methyl 2( methylsulfonyl) propionaldehyde O( methyl carbamoyl) oxime] ( 40 CFR § 180.269, § 185.150 ( a), and § 186.150). Reassessed plant commodity tolerances range from 0.02 ppm ( sugarcane) to 0.3 ppm ( citrus). In conjunction with the review of all available residue chemistry data, HED has determined that tolerances for aldicarb residues in poultry and livestock commodities are not needed; therefore, the current dietary risk estimates exclude existing tolerances for residues in milk and the meat, meat by products, and fat of cattle, hogs, horses, goats and sheep.

The residue chemistry database for aldicarb is largely complete ( C. Swartz, Residue and Product Chemistry Chapters of the HED RED; DP Barcode D266396, 6/ 2/ 2000); additional studies have been required to determine appropriate tolerances for residues in grain sorghum forage, cottonseed and cotton gin by products ( gin trash). Several proposed label amendments for potatoes and a petition for use on bananas are supported by adequate residue data. In addition, the registrant's proposal to establish a citrus crop group tolerance is supported by adequate data. Aldicarb is generally applied early in the growing season, and residues tend to be low or nondetectable in harvested RACs, with the exception of potatoes, sweet potatoes and citrus commodities. In field trials for these commodities, aldicarb per se is typically at or just above the LOD; however, residues of aldicarb sulfoxide and/ or aldicarb sulfone are detected more often and at higher levels than that of aldicarb. Aldicarb sulfoxide residues are found more frequently than the sulfone, and tend to be higher than sulfone residues when both are present. In monitoring data, aldicarb per se is rarely detected. Aldicarb sulfoxide is considered to be as potent as the parent in terms of toxicity, while the sulfone is less potent.

In the past, monitoring data have shown that individual or combined aldicarb residues higher than the tolerance may occur in single potato ( and sweet potato) tubers. Due to concerns for acute dietary risk associated with these higher residues, the registrant voluntarily canceled use on potatoes in 1990, and subsequently generated extensive field trial data, including both composite and single tuber residue measurements for aldicarb and its metabolites in potatoes. These data showed that residues in composite samples would not exceed the reassessed tolerance of 0.2 ppm provided positive displacement application ( PDA) equipment is used during application of the pesticide. In addition, Page 11 of 203 acute dietary exposure associated with residues in individual potatoes was considered below the Agency's level of concern. The use on potatoes was reinstated in 9/ 95, and all current labels specify use of PDA equipment for treatment of potatoes, citrus and sweet potatoes.

In general, residue data submitted in support of registration and reregistration were generated using an analytical method, similar to the enforcement method, which converts all residues to aldicarb sulfone. For the more recent field trial data and for market basket and single tuber analyses, residue values for aldicarb per se and each of its metabolites were generated individually; the total residue was then calculated as the sulfone using the following formula, which accounts for the difference in molecular weights of the parent and two metabolites:

Total residue ( as sulfone) = aldicarb sulfone + ( aldicarb x 1.17) + ( aldicarb sulfoxide x 1.08)

In order to incorporate nondetectable residues into the exposure assessment, HED used the current policy [ refer to ChemSAC memo dated 5/ 19/ 98 and HED SOP 99.6] of assigning residue values of ½ LOD to these samples. If the residues were determined as the sulfone, then the ½ LOD for the total residue determined as the sulfone was used in the analysis. When the parent and metabolites were determined individually, using a ½ LOD of 0.005 for aldicarb and each of its metabolites, for example, the combined ½ LOD is as follows:

Total ½ LOD residue ( ppm) = 0.005 + ( 0.005 x 1.17) + ( 0.005 x 1.08) = 0.01625 ppm As noted in the policy document, HED typically conducts sensitivity analyses to determine if the exposure estimate is due in large part to the assumption of ½ LOD values for nondetectable residues. These sensitivity analyses generally consist of first evaluating risk assuming ½ LOD for nondetect residues, and then evaluating risk when these residues are assumed to be true zeroes. In citrus commodities, an additional type of sensitivity analysis assumed true zero residues for aldicarb per se. This analysis was conducted since no parent residues were identified in an acceptable lemon metabolism study; aldicarb per se was not detected in any fresh market monitoring data for oranges, although there was one detectable residue of aldicarb per se in orange juice monitoring data ( see below). Sensitivity analyses conducted for the aldicarb dietary exposure analysis are described in more detail below ( see " Description of Analyses Performed"). Attachment 3 provides a detailed discussion of use patterns, available field trial and monitoring data, and use of the data to calculate anticipated residues and generate residue distribution files for the acute dietary exposure assessments.

Monitoring Data Extensive monitoring data for aldicarb and its sulfoxide and sulfone metabolites have been generated in numerous commodities through the USDA PDP and the FDA Surveillance Monitoring Program. The PDP data are generally preferred over FDA data for use in dietary exposure and risk analyses. The USDA PDP was specifically designed for risk assessment; analysts prepare samples in a manner similar to typical consumer practices, such as washing, coring/ pitting, and/ or peeling. The PDP samples are 5 lb composites collected at large scale distribution centers, just prior to sale in grocery stores, and are more likely to reflect " dinner plate" residues. The FDA samples are generally 20 lb composites collected for tolerance enforcement purposes, and are not typically washed or peeled prior to analysis; in addition, FDA samples are collected in the channels of commerce, and often represent " farm gate" residues.

Overviews of the PDP ( 1994 1998) and FDA data ( 1992 1998) for aldicarb are shown in Tables 4 and 5, respectively. Specific information regarding use of these data in the dietary exposure analyses, including generation of residue distribution files ( acute analysis), is provided in Attachment 3. As Page 12 of 203 noted in Table 4, aldicarb residues were detected by PDP in green beans and cantaloupe ( 1 sample each), commodities for which there is no registered use; these detections are not considered to indicate a consistent pattern of violative residues, and have not been included in aldicarb dietary exposure analyses. In 1997, PDP conducted a special survey for aldicarb in potatoes, in order to provide a comparison between a composite residue value and the distribution of residues within that sample on a single serving basis. While not specifically designed for risk assessment purposes, the special survey provided the best data for evaluation of dietary exposure to aldicarb residues in potatoes. The results of the study, as well as the incorporation of the residues into the dietary exposure assessments, are discussed in detail in Attachment 3. Page 13 of 203 Table 4. Summary of USDA's Pesticide Data Program Monitoring for Aldicarb and Metabolites ( Composite Samples Only) 1994 1998.

Analytical Limit of Detection ( LOD) Range ( ppm)

Commodity1 Years Monitored # Sampled2/

(# Detects) 3 Aldicarb Aldicarb Sulfone Aldicarb Sulfoxide Wtd. Ave ½ LOD4 Apple 1994 1996 1,476/ 0 0.004 0.04 0.008 0.06 0.008 0.1 0.036756 Apple Juice 1996 1998 1,249/ 0 0.004 0.021 0.007 0.075 0.007 0.076 0.030687 Banana 1994 1995 1,012/ 0 0.004 0.04 0.008 0.06 0.008 0.1 0.034017 Broccoli 1994 567/ 0 0.004 0.04 0.008 0.06 0.008 0.1 0.037013 Celery 1994 119/ 0 0.004 0.032 0.008 0.06 0.008 0.1 0.036825 Carrot 1994 1996 1,470/ 0 0.004 0.04 0.008 0.06 0.008 0.1 0.032301 Sweet Corn 1994 1996 1,198/ 0 0.004 0.032 0.008 0.06 0.008 0.1 0.029146 Green Bean 1994 1998 2,159/ 1 0.004 0.04 0.007 0.075 0.007 0.1 0.031477 Grape 1994 1996 1,490/ 0 0.004 0.04 0.008 0.06 0.008 0.1 0.028654 Grape Juice 1998 500/ 0 0.004 0.021 0.007 0.075 0.007 0.076 0.027591 Lettuce 1994 489/ 0 0.004 0.032 0.008 0.06 0.008 0.1 0.038489 Orange 1994 1996 1,776/ 4 0.004 0.036 0.008 0.06 0.008 0.1 0.036451 Orange Juice 1997 1998 1,392/ 1 0.008 0.021 0.01 0.041 0.01 0.036 0.032106 Peach 1994 1997 1,782/ 0 0.004 0.04 0.008 0.06 0.008 0.1 0.036491 Sweet Pea 1994 1996 1,173/ 0 0.004 0.036 0.007 0.06 0.007 0.1 0.035113 Potato 1994 1995 1,124/ 0 0.004 0.032 0.008 0.06 0.008 0.1 0.027527 Potato Special Survey 1997 342/ 20 ( 6%) 0.005 0.005 0.004 0.007585 Spinach 1995 1998 2491/ 0 0.007 0.04 0.009 0.06 0.009 0.1 0.034889 Sweet Potato 1996 1998 1,220/ 6 0.004 0.021 0.007 0.075 0.007 0.076 0.026279 Tomato 1996 1998 1,613/ 0 0.004 0.021 0.007 0.041 0.007 0.036 0.028099 Pear 1997 1998 1,150/ 0 0.004 0.021 0.007 0.075 0.007 0.076 0.033889 Cantaloupe 1998 310/ 1 0.004 0.021 0.007 0.041 0.007 0.036 0.026110 Strawberry 1998 657/ 0 0.008 0.02 0.01 0.022 0.01 0.027 0.027176 Squash 1997 1998 1,061/ 0 0.004 0.021 0.007 0.075 0.007 0.076 0.030295 Milk 1996 1998 1,392/ 0 0.003 0.005 0.004 0.009 0.004 0.012 0.009941 1. The commodities monitored were fresh with the following exceptions: Sweet corn, sweet peas and green beans ( canned and frozen); spinach ( canned and fresh); strawberries and winter squash ( fresh and frozen).

2 The number sampled reported herein refers to the number of samples for which aldicarb and both metabolites were measured. There were samples analyzed in the TX laboratory that only included measurements for the sulfoxide, and these were excluded from the # sampled.

3 Green Bean: 1 detect; sulfone = 0.013 ppm; sulfoxide = 0.076 ppm ( total residue = 0.097420 ppm)

Orange: 4 detects of sulfoxide: 0.025; 0.015; 0.017; and 0.017 ppm ( total residue = 0.043275; 0.028040; 0.028040; and 0.025880 ppm)

Orange Juice: 1 detect; aldicarb = 0.035 ppm ( total residue = 0.080890 ppm)

Cantaloupe: 1 detect; sulfoxide = 0.017ppm ( total residue = 0.028040)

Potato ( 1997) 9 detects, sulfone = 0.008 0.051 ppm; 20 detects, sulfoxide = 0.007 0.15 ppm [ single tuber summary, see Attachment 3]

Sweet Potato: 6 detects; sulfone and sulfoxide ( 3 samples, total residue = 0.040040 0.182280, sulfoxide only ( 3 samples, total residue = 0.025880 0.146240) [ Details are provided in Attachment 3]

4 The weighted average ½ LOD was calculated based on the total ½ LOD residue in each laboratory, and using the number of samples analyzed in each laboratory. Page 14 of 203 Monitoring data generated by the FDA Surveillance Monitoring Program are shown in Table 5. Although monitoring data were generated for numerous commodities, only the commodities of interest, i. e. commodities for which there are registered uses, are summarized in the table. Aldicarb and its metabolites are completely recovered using multiresidue methods typically used by FDA in its monitoring program. As shown in Table 5, residues were generally not detected in the monitored commodities.

Most of the detections in potato samples occurred in 1996 and 1997, after use on potatoes was reinstated. In 1996, a total of 33 potato samples had aldicarb residues ranging from trace amounts ( i. e., < 0.01 ppm) to 0.96 ppm; in most cases, confirmatory analyses identified a significant portion of the residue as the sulfoxide metabolite. The average total aldicarb residue in 1996 potato detects from FDA monitoring was 0.27 ppm. In 1997, fewer residues were detected in potatoes; the average sulfoxide residue across 21 samples was 0.18 ppm, with a maximum of 1.22 ppm ( total aldicarb residues were 1.38 ppm). In 1998, there was only one aldicarb detect in potatoes, at 0.08 ppm There were no aldicarb detects in monitored crops/ commodities in 1999.

Table 5. FDA Surveillance Monitoring Data for Aldicarb ( Registered Uses Only) 1992  1998.

Commodity # Sampled/# Detects (%) Min./ Max. Residue ( ppm) Residue Detected Orange 261/ 0 Lime 7/ 0 Grapefruit 60/ 1 ( 1.7) 0.06 Sulfoxide Lemon 22/ 0 Citrus juice 10/ 0 Potato 858/ 56 ( 6.5) Trace/ 1.352 Aldicarb + sulfoxide Potato/ Sauce 6/ 3 ( 50) Trace/ 0.073 Sulfoxide Sweet potato 101/ 0 Sugar beet 22/ 0 Coffee Beans 2/ 0 Wheat, whole grain 5/ 0 Wheat, flour 2/ 0 Peanut, in shell 7/ 0 Peanut, shelled 2/ 0 The FDA data have been presented largely for risk characterization purposes, since available field trial residue data, market basket data and PDP monitoring data are more appropriate for risk assessment. Page 15 of 203 Processing Factors Processing factors ( PFs) for aldicarb in juices, dried potatoes, cooked potato food forms, dry beans, soybean oil, peanut oil, cottonseed oil, sugarcane, and sugar beet have been generated in processing/ cooking studies submitted in support of reregistration. The studies were considered to be acceptable and appropriate for use in risk assessment and tolerance reassessment. The processing/ cooking studies indicate a general reduction of residues; since residues are systemic, the reduction in residues is not related to removal of certain inedible commodity fractions, e. g., peel. Detailed results of the studies are discussed in Attachment 3. Application of the aldicarb processing factors to specific food forms in DEEM   ( using Adjustment Factor 1) is described in Table 6.

Table 6. Summary of Aldicarb Processing Factors ( PFs) Used in the Dietary Exposure Analyses.

Commodity/ Processed Food Form PF1 Application of PF to Relevant Food Forms in DEEM   Orange/ juice 0.58 0.58 Orange juice Tangerine juice Grapefruit/ juice 0.14 Grapefruit juice Lime/ juice 0.46 0.46 Lime juice Lemon juice Potatoes/ dry 0.3 Cooked, boiled, canned, canned: boiled, frozen: cooked 0.62 Potatoes/ white peeled  fried, frozen: fried Potatoes/ white peel only  fried Potatoes/ white whole  fried Sweet potatoes: Fried Potatoes/ fried 0.19 Potatoes/ dry  fried 0.5 Potatoes/ white peeled  boiled, canned: cooked; canned: boiled; frozen: cooked Potatoes/ white whole  boiled Sweet potato  boiled, canned: cooked, canned: boiled Potatoes/ boiled, cooked 0.15 Potatoes/ white dry  boiled, canned: boiled Beans, dry 0.05 Baked, boiled, fried, canned: cooked; canned: boiled; cooked: NFS Peanut/ oil NA NA Soybean/ oil NA NA Cottonseed/ oil NA NA Sugarcane/ sugar beet NA NA 1 Processing factors were entered into the DEEM   software as Adjustment Factor 1. When no processing factors were available, the DEEM   default factors were used.

Residue Inputs for the DEEM   Analyses Page 16 of 203 The detailed residue inputs to the acute dietary exposure analyses are shown in Tables 7 and 8.

Acute Dietary Exposure Commodity Classification In accordance with HED SOP 99.6, commodities included in the aldicarb acute dietary exposure analysis are classified as non blended ( NB, e. g., a single potato or orange), partially blended ( PB, e. g., orange juice or canned potatoes), or blended ( B, e. g., cottonseed oil). The type of data which may be used in an acute assessment, and the way in which the data are incorporated into residue distribution files ( RDFs) or ARs, varies depending on the commodity classification. For example, fresh oranges are considered to be non blended; therefore, residues in single oranges are incorporated into a distribution of residues. If there are no " single serving" monitoring data available, composite sample measurements may be used if they have been " decomposited" to generate single unit residue values. Alternatively, the composite distribution may be used directly if there are few samples with detectable residues, and if detected residues are very low or close to the LOD. For partially blended commodities such as canned potatoes, a distribution of composite residue values is used. For blended commodities, a single point estimate residue value is generated. Citrus and potato commodities and food forms included in the aldicarb acute dietary exposure analysis were also designated as fresh or processed, to allow for appropriate adjustments to the residue files based on the % CT estimates. The fresh/ processed designation and classification for commodities included in the aldicarb dietary exposure analyses are shown in Tables 7 and 8.

Residue Distribution Files and Anticipated Residues There are multiple residue data sources for orange, grapefruit, potato and sweet potato; therefore, RDFs were prepared from each data source to generate a " menu" of RDFs for acute dietary exposure analyses. In evaluating the available residue data for risk assessment, HED noted that due to the very low PAD, the dietary risk assessment may be sensitive to assumed concentrations for nondetectable residues. [ In order to evaluate the extent to which the ½ LOD assumption affects dietary risk estimates for aldicarb, dietary exposure was assessed for citrus, potatoes and sweet potatoes individually using all of the available data sources, and then the most appropriate data source for each commodity was used in an assessment which included all commodities. The results of these individual commodity analyses have not been included in this document.]

For field trial data sources, RDFs were generated by assuming all the samples analyzed constituted the estimated maximum % CT, and an appropriate number of zero residue values was added based on the percent of crop not treated. For field trial ( FT) data, the number of zero residue values was calculated as follows:

# Zeroes = # FT results x [( 100% CT)/% CT]

The field trial RDF then consists of the individual detected residues and the calculated number of zeroes. To calculate an acute AR for blended commodities or food forms from field trial data, the following equation was used:

Acute AR = [ sum of FT residue values/# residues] x Max. % CT/ 100 Page 17 of 203 For monitoring data, the following parameters were used to construct the RDFs:

# Sampled = # samples reported analyzed # Detects = # samples reported to have detectable residues % Detects = [(# Detects/# Sampled) x 100] Max CT = estimated maximum % CT # Zeros ( TOTALZ) = the number of samples assumed to have zero residue values, derived from the % crop not treated and # Sampled: TOTALZ = [ 1( Est. Max % CT/ 100)] x # Sampled. ½ LOD = ½ the weighted average LOD from monitoring data. # ½ LOD = the number of samples assumed to have residues at ½ LOD ( i. e., treated, but with no detectable residues): # ½ LOD = [( Max CT  % Detects)/ 100)] x # Sampled The RDF then consists of the detected residues, the residues assumed to be present at ½ LOD, and the number of samples assumed to have zero residue values.

In order to calculate the acute AR for blended commodities or food forms from monitoring data, the following equation was used:

AR = [ Sum of detected residues + # Samples @ ½ LOD x ( ½ LOD)]/# Sampled Description of Analyses Performed Acute dietary exposure analyses were conducted based on the existing registered uses for aldicarb.

Acute For the acute analysis, the most refined exposure assessment resulted from the use of data from the CTF for citrus commodities, and the 1997 PDP special survey data for potatoes. The CTF data set consisted of residue data for aldicarb and its metabolites in 399 single oranges taken very close to the point of consumption ( grocery shelves), and using a combined ½ LOD residue value lower than that of any other data set. The 1997 potato data generated by PDP provide composite and " single serving" residue data for potatoes; these data represent residues closer to the point of consumption than those of any other data set for potatoes, and were also collected with considerably lower LOD's ( and therefore ½ LOD). There were a total of 342 composite potato samples analyzed, 20 of which had detectable aldicarb residues; individual tubers in 16 of the 20 composite samples were analyzed. Due to the use of the lower ½ LOD values in the two data sets, the resulting analyses are less likely to be sensitive to the ½ LOD assumption for nondetectable residues.

The following acute analyses were conducted for risk assessment and risk characterization:

Initial Analysis ( Attachment 5): Analysis 1: Acute exposure analyses based on existing uses; Page 18 of 203 Sensitivity Analyses ( Attachments 6 and 7): Analysis 2: Acute exposure analysis assuming aldicarb per se residues of 0 ppm in citrus and potatoes; Analysis 3: Acute exposure analysis assuming aldicarb per se = 0, and assuming ½ LOD residues in citrus monitoring samples were true zeroes;

Incorporation of Proposed Registration Actions ( Attachments 8, 9, 10, 11, 12 and 13): Analysis 4: Analysis 3, and including the proposed citrus crop group tolerance; Analysis 5: Analysis 3, and including the proposed shorter PHI for potatoes; Analysis 6: Analysis 3, and including the proposed use on potatoes in six Midwestern states; Analysis 7: Analysis 3, and including the proposed shorter PHI for potatoes and the proposed use on potatoes in six Midwestern states; Analysis 8: Analysis 3, and including a proposed import tolerance for bananas. Analysis 9: Analysis 3, and including all proposed label amendments.

Additional Assessments for Risk Characterization Purposes ( Attachments 14 and 15):

Analysis 10: Analysis 3, Excluding Citrus Commodities. Analysis 11: Analysis 3, Excluding Potato Commodities.

Results Acute Dietary Exposure and Risk Estimates Page 19 of 203 The acute dietary exposure assessment which included the existing aldicarb registrations indicates that estimated dietary exposure exceeds HED's level of concern ( i. e., > 100 % aPAD) for the general US population and relevant population subgroups. The highest exposure estimate was for children 1 2 years old; the 99.9th percentile dietary exposure estimate was 0.000797 mg/ kg/ day, or 469 % aPAD. For the general US population, estimated dietary exposure was 211 % aPAD ( 0.000358 mg/ kg/ day). Estimated exposure and risk were below HED's level of concern ( i. e., < 100 % aPAD) at the 99.5th percentile for children 1 2 years old, and at the 99.7th percentile of exposure for the general US population and all remaining population subgroups. Refer to Table 9 for a complete listing of the results of the acute dietary exposure assessment; the DEEM   input and output files are included in the attachments.

Because estimated dietary exposure was above HED's level of concern, an analysis was conducted to determine the foods or food forms which contribute the most to the exposure estimates. For all population subgroups, residues in potatoes were the most significant source of dietary exposure. For all infants, residues in sweet potato were also significant contributors.

Sensitivity analyses were conducted to determine if assumptions for nondetectable residues overestimated exposures. These analyses consisted of ( 1) assuming aldicarb per se residues were 0 ppm; and ( 2) assuming nondetect residues in citrus monitoring samples were true zeroes. The assumption of zero residues for aldicarb per se had a greater impact on the estimated exposure than the assumption of zero residue values for citrus nondetects. However, the sensitivity analyses did not significantly reduce the estimated exposure and risk for any of the population subgroups. These analyses indicate that actual detected residues from monitoring data were the source of the exposure and risk, and not assumed residues for nondetects ( Table 10a). For the general US population, assuming aldicarb residues of 0 ppm and zero residues for nondetects in citrus, the estimated exposure was reduced to 205 % aPAD; for children 1 2 years old, the estimated exposure was reduced to 454 % aPAD.

Since residues in citrus and potatoes were identified as significant contributors to estimated dietary exposure, analyses were conducted in which citrus and potato commodities were separately omitted from the exposure assessment ( Table 10b). When citrus commodities were excluded, estimated exposure for children 1 2 years old was 444 % of the aPAD; exposures for infants < 1 year old were 254 % of the aPAD, while exposures for the general US population and all other population subgroups ranged from 159 351% of the aPAD. When potato commodities were excluded, the highest estimated exposure was for children 1 2, at 0.000199 mg/ kg/ day, or 117% of the aPAD; estimated exposures for all other population subgroups ranged from 15 to 96% of the aPAD. Detailed results are shown in Table 10b.

Proposed Label Amendments The registrant for technical aldicarb, Aventis CropScience, has proposed a number of registration actions; HED has been requested to estimate dietary exposure and risk associated with these proposals, even though exposure and risk based on existing uses already exceed HED's level of concern. Proposed registrations actions include: establishment of a citrus crop group tolerance; a shorter PHI for potatoes in the Pacific Northwest ( PNW); use on potatoes in six Midwestern states; and a proposed import tolerance for residues in bananas. The results of DEEM   analyses conducted for the proposed registration actions are shown in Table 11, and the input and output files are included in the attachments. Page 20 of 203 The proposed citrus crop group tolerance did not result in increased estimated dietary exposure, assuming the residue profile in other citrus commodities ( kumquats, citrus citron, tangerines and tangelos) would be similar to that observed in oranges, and assuming an estimated maximum of 7 % CT ( translated from limes).

The proposed shorter PHI on potatoes in the PNW resulted in a greater incremental increase in estimated acute dietary exposure than adding use in six Midwestern states. For example, for children 1 2, the shorter PHI results in an estimated exposure of 607 % aPAD, while use in the six new states corresponds to 529 % aPAD.

The proposed use on bananas resulted in a small increase in estimated dietary exposure. However, HED considers this to be an overestimate of exposure, since the results of field trials supporting the proposed use showed that residues were not detected in whole bananas, pulp and banana processed fractions ( such as chips and puree). The exposure assessment for the proposed use assumed residues of the combined ½ LOD in bananas and a 45% market share.

The acute dietary exposure assessment which incorporated all of the proposed registration actions resulted in estimated exposures above HED's level of concern for the general US population and all relevant population subgroups. The most highly exposed population subgroup was children 1 2, at 636 % aPAD; estimated dietary exposure for the general US population corresponds to 293 % aPAD. Page 21 of 203 Table 7. Summary of Orange, Grapefruit, and Potato Residue Inputs for Aldicarb Acute Dietary Exposure Analyses.

[ Analysis 1: Acute Exposure Based on Existing Uses]

Commodity Name1 Food Form ( FF) 2 Classification3 F/ P4 % CT ( A/ M) 5 Data Source6 Acute RDF ( RDF #) 7 Oranges Juice Uncooked PB F Cooked ( NFS) PB F 7/ 13 CTF  single oranges 16 Det.+ 36LOD+ 347Z ( 16)

Canned ( NFS) PB P Frozen ( NFS) PB P 11/ 23 CTF  single oranges 16 Det.+ 76LOD+ 307Z ( 17)

Oranges  Juice Conc. All 7 food forms PB P 11/ 23 CTF  single oranges 16 Det.+ 76LOD+ 307Z ( 17)

Uncooked PB F Cooked ( NFS) PB F Boiled PB F 7/ 13 CTF  single oranges 16 Det.+ 36LOD+ 347Z ( 16)

Canned ( NFS) PB P Oranges  Peel Frozen ( NFS) PB P 11/ 23 CTF  single oranges 16 Det.+ 76LOD+ 307Z ( 17)

Uncooked NB F Cooked ( NFS) NB F 7/ 13 CTF  single oranges 16 Det.+ 36LOD+ 347Z ( 16)

Oranges  Peeled Fruit Canned ( NFS) PB P 11/ 23 CTF  single oranges 16 Det.+ 76LOD+ 307Z ( 17)

Uncooked PB F Boiled PB F 16/ 25 CTF  single oranges 16 Det.+ 37LOD+ 160Z ( 27)

Canned ( NFS) PB P Grapefruit  Juice Frozen PB P 17/ 33 CTF  single oranges 16 Det.+ 37LOD+ 109Z ( 28)

Grapefruit  Juice Conc. Frozen ( NFS) PB P 17/ 33 CTF  single oranges 16 Det.+ 37LOD+ 109Z ( 28)

Grapefruit  Peel Peel PB F 16/ 25 CTF  single oranges 16 Det.+ 37LOD+ 160Z ( 27)

Uncooked NB F Cooked ( NFS) NB F Boiled NB F 16/ 25 CTF  single oranges 16 Det.+ 37LOD+ 160Z ( 27)

Grapefruit  Peeled Fruit Canned ( NFS) PB P 17/ 33 CTF  single oranges 16 Det.+ 37LOD+ 109Z ( 28)

Cooked ( NFS) B P Baked B P Potatoes/ white dry Boiled B P 17/ 24 PDP Special Survey ( composites) 0.002503 Page 22 of 203 Table 7. Summary of Orange, Grapefruit, and Potato Residue Inputs for Aldicarb Acute Dietary Exposure Analyses.

[ Analysis 1: Acute Exposure Based on Existing Uses]

Commodity Name1 Food Form ( FF) 2 Classification3 F/ P4 % CT ( A/ M) 5 Data Source6 Acute RDF ( RDF #) 7 Fried B P Canned ( NFS) B P Canned: Boiled B P Frozen: Cooked B P Cooked ( NFS) NB F Uncooked NB F Baked NB F Boiled NB F Fried NB F 4/ 5 PDP Special Survey ( single units) 160 Det.+ 3040Z ( 46)

Canned: Cooked PB P Canned: Boiled PB P Frozen: Cooked PB P Frozen: Baked PB P Potatoes/ white peeled Frozen: Fried PB P 17/ 24 PDP Special Survey ( composites) 342 Det.+ 1083Z ( 47)

Baked NB F Potatoes/ white peel only Fried NB F 4/ 5 PDP Special Survey ( single units) 160 Det.+ 3040Z ( 46)

Potatoes/ white unspec. Canned ( NFS) PB P 17/ 24 PDP Special Survey ( composites) 342 Det.+ 1083Z ( 47)

Uncooked NB F Cooked ( NFS) NB F Baked NB F Boiled NB F Fried NB F 4/ 5 PDP Special Survey ( single units) 160 Det.+ 3040Z ( 46)

Potatoes/ white whole Canned ( NFS) PB P 17/ 24 PDP Special Survey ( composites) 342 Det.+ 1083Z ( 47)

1 The reassessed tolerances are: 0.3 ppm in orange and grapefruit; and 0.2 ppm in potatoes.

2 Food forms shown in the table are taken directly from the DEEM software.

3 Refer to HED SOP99.6. NB = Not Blended; PB = Partially Blended; B = Blended.

4 F = Fresh commodity; P = Processed commodity.

5 BEAD estimated percent crop treated; M = estimated Maximum ( for acute exposure).

6 CTF = Carbamate Task Force.

7 RDF = Residue Distribution File. Det. = detect; LOD = residues at ½ LOD; Z = zeroes. Numbered RDFs are shown in detail in Attachment 4. For dried potatoes, a point estimate AR was used. Page 23 of 203 Table 8. Residue Inputs for Aldicarb Acute Dietary Exposure Analyses ( Except Orange, Grapefruit and Potato).

[ Analysis 1: Acute Exposure Based on Existing Uses]

% CT2 Commodity/

Reassessed Tol. 1 Ave. Max. Data Source3 Commodity Classification4 Food Forms5 Acute RDF6 ( RDF #) Acute AR7 Beans ( dry)/ 0.1 1 2 FT B Baked, boiled, fried, canned: cooked;

canned: boiled; cooked: NFS N/ A 0.000200 Coffee Beans/ 0.1 20 20 FT/ PS B Boiled; cooked: NFS N/ A 0.002 Cottonseed/ 0.1 27 33 FT/ PS B Cottonseed meal N/ A 0.016995 B Cottonseed oil N/ A 0.000495 Lemon/ 0.3 1 3 CTF PB Peeled fruit: uncooked; cooked;

canned, NFS; Peel: uncooked, baked,

boiled, canned, frozen; Juice: canned,

frozen Juice concentrate: frozen, cooked,

baked, boiled, canned 16 Det.+ 37LOD+ 1,725Z ( 34) N/ A Limes/ 0.3 4 7 CTF PB Peeled fruit; Peel: baked, boiled;

Juice: uncooked, canned, frozen;

Juice concentrate: cooked, frozen 16 Det.+ 37LOD+ 709Z ( 33) N/ A Peanuts 30 47 FT B Peanuts, hulled; Peanuts  butter; N/ A 0.002585 Peanuts, oil N/ A 0.000705 Pecans/ 0.5 4 8 FT PB Unbaked, baked, boiled 22 Detects + 253Z ( 1) N/ A Sorghum, grain/ 0.2 0 ( 1) 0 ( 1) FT B Boiled N/ A 0.002 Soybeans/ 0.02 0 ( 1) 0 ( 1) FT B Soybean flour ( defatted, full fat);

mature seeds, dry; protein isolate;

sprouted seeds) N/ A 0.0001 B soybean oil N/ A 0.00005 Sugarcane/ 0.02 0 ( 1) 0 ( 1) FT B Sugar cane, refined;

sugarcane molasses N/ A N/ A Sugar beets/ 0.05 9 11 FT B Sugar beet, refined; sugar beet/ molasses N/ A N/ A Sweet potato/ 0.1 15 37 PDP potato singles NB Cooked, baked, boiled, fried 160 Det.+ 272Z ( 55) N/ A PDP potato Composites PB Canned ( NFS, cooked, boiled) 342 Det.+ 582Z ( 56) N/ A 1 The relevant commodities are shown along with the reassessed tolerances from the 6/ 2/ 00 Residue Chemistry Chapter.

2 BEAD estimated percent crop treated; Max. = estimated Maximum ( for acute exposure).

3 FT = Field Trials; PS = Processing Study; CTF = Carbamate Task Force; PDP = USDA Pesticide Data Program ( monitoring data).

4 Refer to HED SOP99.6. NB = Not Blended; PB = Partially Blended; B = Blended.

5 Food forms shown in the table are taken directly from the DEEM software.

6 RDF = Residue Distribution File. Det. = detect; LOD = residues at ½ LOD; Z = zeroes. Numbered RDFs are shown in detail in Attachment 4.

7 For blended commodities, a point estimate was used for the acute analysis, with the % CT incorporated into the AR ( i. e., Adj. Factor 2 was set to 1). Page 24 of 203 Table 9. Aldicarb Acute Dietary Exposure and Risk, Based on Existing Registrations. 1 [ Analysis 1] ( 99.9th Percentile Exposure and Risk)

Rat ( RBC)* Rat ( Brain) Human Population Exposure % PAD Exposure % PAD Exposure % PAD U. S. Pop 0.000358 71.63 0.000358 47.75 0.000358 55.10 All Infants 0.000463 92.52 0.000463 61.68 0.000463 71.17 Children 1 2 years 0.000797 159.45 0.000797 106.30 0.000797 122.65 Children 3 5 years 0.000643 128.52 0.000643 85.68 0.000643 98.86 Children 6 12 years 0.000457 91.38 0.000457 60.92 0.000457 70.29 Youth 13 19 0.000312 62.48 0.000312 41.65 0.000312 48.06 Adults 20 49 yrs: 0.000298 59.56 0.000298 39.71 0.000298 45.82 Adults 50+ 0.000320 64.06 0.000320 42.71 0.000320 49.28 Females13 49 0.000282 56.40 0.000282 37.60 0.000282 43.38 PAD 0.0005 mg/ kg/ day 0.00075 mg/ kg/ day 0.00065 mg/ kg/ day Table 10a. Aldicarb Acute Dietary Exposure, Sensitivity Analyses. 1( 99.9th Percentile Exposure and Risk) Aldicarb = 0 Rat ( RBC)* Rat ( Brain) Human Population Exposure % PAD Exposure % PAD Exposure % PAD U. S. Pop 0.000349 69.71 0.000349 46.47 0.000349 53.62 All Infants 0.000443 88.64 0.000443 59.09 0.000443 68.18 Children 1 2 years 0.000773 154.66 0.000773 103.11 0.000773 118.97 Children 3 5 years 0.000623 124.70 0.000623 83.13 0.000623 95.92 Children 6 12 years 0.000443 88.58 0.000443 59.06 0.000443 68.14 Youth 13 19 0.000304 60.85 0.000304 40.56 0.000304 46.81 Adults 20 49 yrs: 0.000290 58.01 0.000290 38.67 0.000290 44.62 Adults 50+ 0.000314 62.89 0.000314 41.93 0.000314 48.38 Females13 49 0.000274 54.85 0.000274 36.57 0.000274 42.20 PAD 0.0005 mg/ kg/ day 0.00075 mg/ kg/ day 0.00065 mg/ kg/ day Page 25 of 203 Table 10b. Aldicarb Sensitivity Analysis No citrus No potatoes Population Exposure Rat ( RBC ChEI) Rat( Brain ChEI) Human ( RBC ChEI) Exposure Rat ( RBC ChEI) Rat( Brain ChEI) Human ( RBC ChEI) U. S. Pop 0.000337 67 45 52 0.000063 13 8.4 9.7 All Infants 0.000433 87 58 67 0.000025 5.0 3.4 3.9 Children 1 2 years 0.000755 151 101 116 0.000199 40 26 31 Children 3 5 years 0.000597 119 80 92 0.000162 32 22 25 Children 6 12 years 0.000452 90 60 70 0.000101 20 13 16 Youth 13 19 0.000300 60 40 46 0.000067 13 9.0 10 Adults 20 49 yrs: 0.000283 57 38 44 0.000050 10 6.7 7.7 Adults 50+ 0.000307 61 41 47 0.000052 10 6.9 7.9 Females13 49 0.000270 54 36 42 0.000055 11 7.3 8.4 Population Adjusted Dose ( PAD) = 0.0005 mg/ kg/ day Rat ( RBC CheI) 0.00075 mg/ kg/ day Rat ( Brain CheI) 0.00065 mg/ kg/ day Human ( RBC CheI) Page 26 of 203 Table 11. Estimated Acute Dietary Risk Associated With Proposed Registration Actions. 1 % aPAD at the 99.9th Percentile of Exposure2 Population Citrus Crop Group Tolerance [ Analysis 4] Shorter PHI on PNW Potatoes [ Analysis 5] Use on Potatoes in 6 MW States [ Analysis 6] Potato Shorter PHI+ Use in 6 MW States [ Analysis 7] Import Tolerance on Bananas [ Analysis 8] All Proposed Label Amendments [ Analysis 9]

Rat RBC US Population 70 94 82 99 70 99 All Infants (< 1yr) 91 122 106 130 94 134 Children 1 2 yrs 153 206 180 216 154 216 Children 3 5 yrs 123 169 148 178 123 177 Children 6  12 yrs 91 120 105 127 89 131 Youth 13 19 yrs 60 87 74 93 63 92 Adults 20 49 yrs 59 78 69 83 58 84 Adults 50+ yrs 61 81 73 84 62 85 Females 13 49 yrs 56 75 65 79 56 79 Rat Brain US Population 46 63 55 66 47 66 All Infants (< 1yr) 61 81 71 86 63 89 Children 1 2 yrs 102 137 120 144 103 144 Children 3 5 yrs 82 113 99 119 82 118 Children 6  12 yrs 61 80 70 85 59 88 Youth 13 19 yrs 40 58 49 62 42 61 Adults 20 49 yrs 39 52 46 55 39 56 Adults 50+ yrs 41 54 48 56 42 56 Females 13 49 yrs 37 50 44 52 38 53 Human RBC US Population 53 72 63 76 54 77 All Infants (< 1yr) 70 94 82 100 70 103 Children 1 2 yrs 118 159 138 166 118 166 Children 3 5 yrs 94 130 114 137 94 136 Children 6  12 yrs 70 93 81 98 70 101 Youth 13 19 yrs 46 67 57 71 46 71 Adults 20 49 yrs 45 60 53 64 45 64 Adults 50+ yrs 47 62 56 65 41 65 Females 13 49 yrs 43 57 50 60 43 61 1 Proposed registration actions include: 1) Establishment of a citrus crop group tolerance; 2) reduction of the PHI on potatoes in the Pacific Northwest ( PNW) from 150 to 120 days; 3) Proposed use on potatoes grown in six Midwestern states ( 6 MW); and 4) A proposed import tolerance for residues in bananas. 2 Acute exposure is expressed in mg/ kg/ day, and as a percentage of the acute population adjusted dose ( aPAD), which is 0.00017 mg/ kg/ day. Page 27 of 203 Drinking Water A drinking water assessment was provided by the Environmental Fate and Effects Division ( Jonathon Angier, Ph. D, 5/ 10/ 05, D316754).

Surface water monitoring data for aldicarb were too limited to be used quantitatively in the drinking water exposure assessment, so EFED used Tier II modeling to generate estimated environmental concentrations ( EECs) in surface water. Specifically, the Pesticide Root Zone Model and Exposure Analysis Model System ( PRZM/ EXAMS) Index Reservoir was used to generate surface water EECs for drinking water. The model is used by OPP to estimate pesticide concentrations that may be in surface water due to pesticide use and runoff. The PRZM/ EXAMS estimates of potential pesticide levels in surface water incorporate pesticide specific properties, simulation of multiple years to reflect climatic variations, and modeling on a crop specific basis.

A Tier II EEC for a particular crop or use is based on a single site that represents a high exposure scenario for the crop or use. Weather and agricultural practices are simulated at the site for 36 years to estimate the probability of exceeding a given concentration ( maximum concentration or average concentration) in a single year. Maximum EECs are calculated so that there is a 10% probability that the maximum concentration in a given year will exceed the EEC at the site; this can also be expressed as an expectation that water concentrations will exceed EECs once every 10 years.

In the dietary assessment, a distribution of estimates of possible concentrations in drinking water were used. Approximately 11000 values were generated based on maximum aldicarb use patterns in/ on Florida citrus, Idaho potatoes, and Mississippi cotton. The values were adjusted for percent crop area ( PCA) using a factor of 0.87 for Florida citrus and Idaho potato scenarios and a factor of 0.20 for Mississippi cotton. These values represent the complete daily 36 year PRZMEXAMS output distribution and are considered somewhat conservative, but are within the range of aldicarb detects in targeted surface water monitoring data.. 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. The range of the concentrations are shown in Table 12.

Table 12. Range of Surface Water Concentrations Used In the Dietary Exposure Assessment Crop/ Location Acute Concentration ( ppb)

Mississippi Cotton 0  38.6 Idaho Potato 0  5.8 Florida Citrus 0  13.1 Ground water monitoring for aldicarb and metabolite residues has been extensive over the last two Page 28 of 203 decades. Over 43000 individual samples were collected and analyzed during this time. Monitoring data sources include the registrant, Bayer ( formerly Aventis CropScience, formerly RPAC), STORET, the U. S. Geological Survey ( USGS), state and local governments, and university researchers. [ The STOrage and RETrieval ( STORET) system is a database maintained by EPA which contains information on water monitoring data including where and when the sample was taken, and the name of the organization that sponsored the monitoring.] The ground water monitoring data are discussed in detail and summarized in the EFED RED chapter.

Although the ground water data are extensive, they are not ideal for direct use in probabilistic exposure models for a variety of reasons. In most areas where there has been ground water contamination from aldicarb, steps have been taken to mitigate exposures, either through filtering or through use of alternative sources of drinking water. Ground water sampling has also varied in frequency and scope over the years, generally declining during the last 10 to 12 years. Some of the monitoring data do not reflect current use areas and rates, and do not reflect present conditions. [ Current label restrictions prohibit aldicarb application in areas where there have been historical concerns for ground water contamination ( i. e., Del Norte and Humboldt counties in CA, Curry County in OR, and Nassau and Suffolk Counties in NY). The registrant does not market aldicarb for use in Northeastern states. However, regions presenting soil/ stratigraphic/ hydrologic attributes similar to these historical problem areas should be considered potentially vulnerable to groundwater contamination]. Overall, the extent of ground water contamination today may be less than in the past, but it is also not well characterized. For the purpose of the drinking water assessment, ground water concentrations have been presented on a regional basis. Eight distinct regions were selected based on broad similarity in aldicarb usage, crop type or soil conditions. The monitoring data from each region were examined, and a single maximum sample result was chosen to represent ground water concentrations within the entire region; for each region, the sample chosen was detected the within the last 5 to 10 years ( i. e., higher residue values that may have resulted from historical use of aldicarb in vulnerable areas were excluded). The aldicarb water residue values chosen for the drinking water assessment are considered to be somewhat conservative, because they reflect exposures to people who are most highly exposed in each region. The population potentially exposed at these levels consists of individuals who obtain drinking water from private wells in areas with vulnerable soils, or that may be contaminated from past agricultural applications of aldicarb. A summary of the suggested ground water concentrations for use in the drinking water exposure assessment has been taken directly from the EFED RED chapter, and is presented in Table 13.

Table 13. Aldicarb Ground Water Concentrations for Use in the Drinking Water Assessment.

Region1 Location and Year of Detection Aldicarb Concentration ( ppb) Data Source Rationale for Selection A ID; Caribou Co., 1992 2.1 State of ID Max. conc. since 1990 B CA; Solano Co., 1997 6.4 State of CA Max. conc. since 1997; most recent detect in region.

C WY; Washakie Co., 1992 9.7 Registrant Max. conc. since 1992; second most recent detect in region D N/ A 0.0 N/ A No aldicarb detections reported from this region. Page 29 of 203 Table 13. Aldicarb Ground Water Concentrations for Use in the Drinking Water Assessment.

Region1 Location and Year of Detection Aldicarb Concentration ( ppb) Data Source Rationale for Selection E WI; Langlade Co., 1992 23.0 Registrant Max. conc. since 1992. Very little data available after 1994; however, 2 detects above 10 ppb in 1997.

F RI; Newport Co., 1994 24.0 State of RI Max. conc. since 1994; fourth most recent detection in region.

G AL, Baldwin Co., 1990 20.0 Registrant Max. conc. since 1990. No data available after 1993.

H FL, Madison Co., 1996 9.3 State of FL Max. conc. since 1996; ninth most recent detection in region.

1 Regions are described as follows: Region A = Pacific Northwest ( ID/ OR/ WA); Region B = CA; Region C = Central Plains and Western ( MT, WY, NV, UT, CO, KS, NE, ND, SD, MN, IA, MO); Region D = Southwest and Central Plains ( AZ, NM, TX, OK); Region E = Midwest and Central Plains ( WI, IL, IN, MI, OH, WV, PA, NJ, DE, MD); Region F = New England ( NY, VT, NH, MA, CT, RI, ME); Region G = Southeast ( AR, LA, MS, AL, GA, TN, KY, SC, NC, VA, DC); Region H = FL.

Typical acute aggregate exposure and risk assessments include the estimated acute ( food only) exposure and acute surface water ( modeled) and ground water EECs ( calculated from monitoring data). For aldicarb, estimated dietary ( food only) exposure to aldicarb for all population subgroups exceeds the level of concern for acute dietary exposure. When acute food exposure alone exceeds the level of concern, HED does not typically aggregate modeled EECs, but states that any additional exposure through drinking water would be of concern. However, as a tool for the risk managers, a " water only" dietary assessment was done assuming no exposure from food to get an estimate of contribution of drinking water to the dietary exposure and risk. For surface water, a distribution of concentrations derived from PRZM EXAMS modeling was used in the assessment. For ground water, a point estimate derived from monitoring data was used.

If there were no acute dietary food exposure, and all of the allowable exposure occurred through surface water sources ( i. e., assuming the aPAD ( rat RBC) of 0.0005 mg/ kg/ day is completely allotted to exposure to residues in water), HED would not have concerns for total aldicarb residues. Drinking water exposures determined based on surface water sources ranged from < 1% to 15% aPAD at the 95th percentile of exposure.

Seven regional ground water monitoring residue levels were used to derive an acute dietary exposure estimate for water alone ( the eighth region had a residue value of 0 ppb, and was excluded from the aggregate assessment). The data indicate that acute exposure from ground water sources of drinking water is also of concern, with acute aggregate risks ranging from 20% aPAD to 945% aPAD.

A drinking water assessment was also conducted for ground water sources of drinking water, since extensive monitoring data are available. Drinking water exposure and risk estimates for the general population, all infants, children 1 2., and females 13 49 years are shown in Table 14. The data indicate Page 30 of 203 that acute exposure from ground water sources of drinking water is also of concern, with drinking water exposure and risk estimates ranging from 20% aPAD ( youth 13 19 yrs old, Region A) to 945% aPAD ( infants, Region F).

The drinking water exposure and risk estimates calculated based on ground water monitoring values overestimate risks for all but those who obtain their drinking water from wells in vulnerable aldicarb use areas. However, since food only exposures exceed the aPAD, HED is concerned about any additional exposure through drinking water, regardless of the source.

Table. 14. Aldicarb Acute Water Exposure and Risk for Select Population Subgroups at the 95th % ile of Exposure [ Based on Surface Water Concentrations from Modeling] U. S. Population All infants Children 1 2 years Females 13 49 Regions Exposure % PAD Exposure % PAD Exposure % PAD Exposure % PAD Rat  RBC Cotton 0.000025 5.0 0.000078 15 0.000037 7.4 0.000024 5 Potato 0.000006 1.2 0.000015 3.1 0000008 1.6 0.000005 1.1 Citrus 0.000002 0.46 0.000006 1.3 0.000003 0.66 0.000002 0.43 Rat   Brain Cotton 0.000025 3.4 0.000078 10 0.000037 5.0 0.000024 3.2 Potato 0.000006 0.77 0.000015 2.1 0000008 1.1 0.000005 0.72 Citrus 0.000002 0.31 0.000006 0.83 0.000003 0.44 0.000002 0.29 Human  RBC Cotton 0.000025 3.9 0.000078 12 0.000037 5.7 0.000024 3.6 Potato 0.000006 0.89 0.000015 2.4 0000008 1.3 0.000005 0.83 Citrus 0.000002 0.35 0.000006 0.96 0.000003 0.51 0.000002 0.33 1. EDWCs were based on the following scenarios: Mississippi Cotton; Idaho Potato; Florida Citrus 2. Generated using the DEEM FCID model  Version 2.03 3. Acute Aggregate Risk = % of the aPAD= [( Total Exposure/ aPAD mg/ kg/ day) x 100] Table. 15. Aldicarb Acute Water Exposure and Risk for Select Population Subgroups at the 95th % ile of Exposure.

[ Based on Ground Water Concentrations from Monitoring]

Gen Population All Infants (< 1 Year) Children ( 1  2 Years) Females 13 49 Years Region1 Aldicarb Conc.

in Ground Water ( ppb) Water Exp.

( mg/ kg/ day) 2 % aPAD3 Water Exp.

( mg/ kg/ day) 2 % aPAD3 Water Exp.

( mg/ kg/ day) 2 % aPAD3 Water Exp.

( mg/ kg/ day) 2 % aPAD3 Rat  RBC A 2.1 0.000110 22 0.000414 83 0.000172 34 0.000102 20 B 6.4 0.000334 67 0.001261 252 0.000525 105 0.000312 62 C 9.7 0.000507 101 0.001910 382 0.000795 159 0.000472 94 E 23.0 0.001201 240 0.004530 906 0.001885 377 0.001119 224 F 24.0 0.001254 251 0.004727 945 0.001967 393 0.001168 234 G 20.0 0.001045 139 0.003939 525 0.001639 219 0.000973 130 H 9.3 0.000486 97 0.001832 366 0.000762 152 0.000453 91 Rat  Brain A 2.1 0.000110 15 0.000414 55 0.000172 23 0.000102 14 B 6.4 0.000334 45 0.001261 168 0.000525 70 0.000312 42 C 9.7 0.000507 68 0.001910 255 0.000795 106 0.000472 63 E 23.0 0.001201 160 0.004530 604 0.001885 251 0.001119 149 F 24.0 0.001254 166 0.004727 626 0.001967 261 0.001168 155 G 20.0 0.001045 139 0.003939 525 0.001639 219 0.000973 130 H 9.3 0.000486 65 0.001832 244 0.000762 102 0.000453 60 Human RBC A 2.1 0.000110 17 0.000414 64 0.000172 26 0.000102 16 Table. 15. Aldicarb Acute Water Exposure and Risk for Select Population Subgroups at the 95th % ile of Exposure.

[ Based on Ground Water Concentrations from Monitoring]

Gen Population All Infants (< 1 Year) Children ( 1  2 Years) Females 13 49 Years Region1 Aldicarb Conc.

in Ground Water ( ppb) Water Exp.

( mg/ kg/ day) 2 % aPAD3 Water Exp.

( mg/ kg/ day) 2 % aPAD3 Water Exp.

( mg/ kg/ day) 2 % aPAD3 Water Exp.

( mg/ kg/ day) 2 % aPAD3 B 6.4 0.000334 51 0.001261 194 0.000525 81 0.000312 48 C 9.7 0.000507 78 0.001910 294 0.000795 122 0.000472 73 E 23.0 0.001201 185 0.004530 697 0.001885 290 0.001119 172 F 24.0 0.001254 191 0.004727 722 0.001967 300 0.001168 178 G 20.0 0.001045 161 0.003939 606 0.001639 252 0.000973 150 H 9.3 0.000486 65 0.001832 244 0.000762 102 0.000453 60 1 Regions are described as follows: Region A = Pacific Northwest ( ID/ OR/ WA); Region B = CA; Region C = Central Plains and Western ( MT, WY, NV, UT, CO, KS, NE, ND, SD,

MN, IA, MO); Region E = Midwest and Central Plains ( WI, IL, IN, MI, OH, WV, PA, NJ, DE, MD); Region F = New England ( NY, VT, NH, MA, CT, RI, ME); Region G =

Southeast ( AR, LA, MS, AL, GA, TN, KY, SC, NC, VA, DC); Region H = FL. [ There were no detections in Region D, Southwest and Central Plains ( AZ, NM, TX, OK)].

2. Generated using the DEEM FCID model  Version 2.03 3 Acute Aggregate Risk = % of the aPAD= [( Total Exposure/ aPAD mg/ kg/ day) x 100] Page 33 of 203 In summary, acute dietary food only exposure exceeds HED's level of concern; ground water monitoring data indicate that potential exposures through drinking water in high aldicarb use areas are also above HED's level of concern. For surface and ground water drinking water obtained from public and community water systems, the potential effect of water treatment processes on aldicarb residues has not been considered; however, monitoring data indicate that these types of drinking water sources are not likely to be contaminated with aldicarb residues.

Attachments:

Attachment 1: Percent Crop Treated Estimates for the Aldicarb Dietary Exposure and Risk Assessment. Attachment 2: Additional Fresh/ Processed Aldicarb Usage Estimates for Citrus and Potatoes. Attachment 3: Aldicarb Residue Data and Anticipated Residues for the DEEM   Analysis. Attachment 4: Summary of Aldicarb Residue Distribution Files ( RDFs) for Acute Dietary Exposure Analysis. Attachment 5: Analysis 1  DEEM   Input/ Output Files for Acute Dietary Exposure ( Based on Existing Registrations). Attachment 6: Analysis 2  Residue Inputs and DEEM   Files for Acute Exposure Assessment, Assuming Aldicarb per se = 0 ppm. Attachment 7: Analysis 3  Residue Inputs and DEEM   Files for Acute Exposure Assessment, Assuming Aldicarb per se = 0 ppm and Assuming Citrus Nondetects = 0 ppm. Attachment 8: Analysis 4  Residue Inputs and DEEM   Files for Acute Exposure Assessment, Including the Proposed Citrus Crop Group Tolerance. Attachment 9: Analysis 5  Residue Inputs and DEEM   Files for Acute Exposure Assessment, Including the Proposed Shorter PHI for Potatoes in the PNW. Attachment 10: Analysis 6  Residue Inputs and DEEM   Files for Acute Exposure Assessment, Including the Proposed Use on Potatoes in 6 Midwestern States. Attachment 11: Analysis 7  Residue Inputs and DEEM   Files for Acute Exposure Assessment, Including the Shorter PHI for Potatoes in the PNW and Use on Potatoes in 6 Midwestern States. Attachment 12: Analysis 8  Residue Inputs and DEEM   Files for Acute Exposure Assessment, Including the Proposed Import Tolerance on Bananas. Attachment 13: Analysis 9  Residue Inputs and DEEM   Files for Acute Exposure Assessment, Including All Proposed Label Amendments. Attachment 14: Analysis 10  Residue Inputs and DEEM   Files for Acute Exposure Assessment, Assuming Aldicarb per se = 0 ppm and Excluding Citrus Commodities. Attachment 15: Analysis 11  Residue Inputs and DEEM   Files for Acute Exposure Assessment, Assuming Aldicarb per se = 0 ppm and Assuming Citrus Nondetects = 0 ppm, Excluding Potato and Sweet Potato Commodities. Attachment 1: Percent Crop Treated Estimates for the Aldicarb Dietary Exposure and Risk Assessment.

ALDICARB Case #: 140 AI #: 98301 Analyst: John Faulkner Data years: 1988 98 QUA date: December 23, 1999 aldicar9. wpd EPA's QUANTITATIVE USAGE ANALYSIS Acres Treated ( 000) % of Crop Treated LB AI Applied ( 000) Average Application Rate States of Most Usage Site Acres Grown ( 000) Wtd Avg Est Max Wtd Avg Est Max Wtd Avg Est Max lb ai/

acre/ yr # appl / yr lb ai/

A/ appl (% of total lb ai used on this site)

Citrus, Other * 55 2 4 4% 7% 7 12 3.5 1.1 3.3 FL 100%

Grapefruit 167 20 33 12% 20% 77 113 3.8 1.3 3.0 FL TX 100%

Lemons 62 0 2 1% 3% 2 5 3.8   CA 86%

Oranges 888 40 90 5% 10% 150 299 3.8 1.2 3.0 FL 90%

Pecans 469 18 39 4% 8% 55 134 3.1 1.2 2.5 GA MS TX AL 87%

Potatoes 1,433 150 289 10% 20% 400 703 2.7 1.0 2.7 WA FL MI OR 85%

Sweet Potatoes, Yams 82 13 30 15% 37% 17 41 1.4 1.0 1.4 NC TX AL 87%

Beans/ Peas, Dry 2,190 25 39 1% 2% 24 67 1.0 1.1 0.9 WA ID MI 84%

Beans/ Peas, Green 709 2 5 0% 1% 2 6 1.3 1.0 1.3 WA ID 90%

Sorghum 11,140 10 34 0% 0% 5 18 0.5 1.0 0.4 TX MO AR 82%

Alfalfa 23,701 1 12 0% 0% 1 12 1.3 1.0 1.3 CA MT 90%

Peanuts 1,582 480 749 30% 47% 540 931 1.1 1.1 1.0 GA AL NC VA 87%

Soybeans 63,141 76 136 0% 0% 52 93 0.7 1.0 0.7 SC IL VA AL WA TN 82%

Sunflower 2,789 1 2 0% 0%

Cotton 12,967 3,500 4,330 27% 33% 2,600 3,271 0.6 1.0 0.6 GA TX CA NC MS AR 68%

Sugar Beets 1,425 130 160 9% 11% 238 387 1.8 1.1 1.7 ID NE WY CO MT 81% Attachment 1: Percent Crop Treated Estimates for the Aldicarb Dietary Exposure and Risk Assessment.

Acres Treated ( 000) % of Crop Treated LB AI Applied ( 000) Average Application Rate States of Most Usage Site Acres Grown ( 000) Wtd Avg Est Max Wtd Avg Est Max Wtd Avg Est Max lb ai/

acre/ yr # appl / yr lb ai/

A/ appl (% of total lb ai used on this site)

Sugarcane 926 0* 0* 0* 0* 0* 0*

Coffee 400    550  1.4   Brazil 94%

Tobacco 716 50 81 7% 11% 80 157 1.6 1.0 1.6 NC VA 92%

Total 4,918 5,477 4,800 5,525 COLUMN HEADINGS Wtd Avg = Weighted average the most recent years and more reliable data are weighted more heavily.

Est Max = Estimated maximum, which is estimated from available data.

Average application rates are calculated from the weighted averages.

NOTES ON TABLE DATA Calculations of the above numbers may not appear to agree because they are displayed as rounded to the nearest 1000 for acres treated or lb. a. i. ( Therefore 0 = < 500)

to the nearest whole percentage point for % of crop treated. ( Therefore 0% = < 0.5%)

0* = Available EPA sources indicate that no usage is observed in the reported data for this site, which implies that there is little or no usage.

A dash () indicates that information on this site is NOT available in EPA sources or is insufficient.

* Citrus, Other includes kumquats, limes, tangelos, and tangerines.

SOURCES: EPA data ( 1988 98), USDA ( 1990 97), and National Center for Food and Agricultural Policy ( 1992 data) Attachment 2. Additional Fresh/ Processed Aldicarb Usage Estimates for Citrus and Potatoes.

Acres ( 000)

Treated % of Crop Treated Lb ai ( 000)

Applied Average Application Rates Site Acres ( 000) Grown Wtd Avg Est Max Wtd Avg Est Max Wtd Avg Est Max lb ai/ A/ yr # appl/ year lb ai/

A/ appl States/ Regions Potatoes, fresh Florida 14 * 12 12 83% 83% FL Pacific Northwest ( PNW) 138 * 15 22 11% 16% ID OR WA PNW with shorter PHI proj 138 * 30 45 22% 32% ID OR WA Midwest ( MW) proj 105 * 9 9 9% 9% MI MN ND SD WY CO US Current ( FL + PNW) 626 27 34 4% 5% FL ID OR WA with shorter PHI in PNW proj 626 42 56 7% 9% FL ID OR WA US Current + MW ( FL PNW MW) proj 626 36 43 6% 7% FL ID OR WA MW with shorter PHI in PNW proj 626 51 65 8% 10% FL ID OR WA MW Potatoes, processed Florida 30 * 21 21 72% 72% FL Pacific Northwest ( PNW) 455 * 107 157 23% 34% ID OR WA PNW with shorter PHI proj 455 * 167 247 37% 54% ID OR WA Midwest ( MW) proj 240 * 27 27 11% 11% MI MN ND SD WY CO US Current ( FL + PNW) 736 128 178 17% 24% FL ID OR WA with shorter PHI in PNW proj 736 189 268 26% 36% FL ID OR WA US Current + MW ( FL PNW MW) proj 736 155 205 21% 28% FL ID OR WA MW with shorter PHI in PNW proj 736 216 295 29% 40% FL ID OR WA MW Potatoes, fresh and processed Florida 44 * 33 33 75% 75% FL Pacific Northwest ( PNW) 593 * 122 179 21% 30% ID OR WA PNW with shorter PHI proj 593 * 198 291 33% 49% ID OR WA Midwest ( MW) proj 345 * 36 36 10% 10% MI MN ND SD WY CO US Current ( FL + PNW) 1,362 155 212 11% 16% 400 700 2.6 1.1 2.3 FL ID OR WA with shorter PHI in PNW proj 1,362 231 324 17% 24% FL ID OR WA Attachment 2. Additional Fresh/ Processed Aldicarb Usage Estimates for Citrus and Potatoes.

Acres ( 000)

Treated % of Crop Treated Lb ai ( 000)

Applied Average Application Rates Site Acres ( 000) Grown Wtd Avg Est Max Wtd Avg Est Max Wtd Avg Est Max lb ai/ A/ yr # appl/ year lb ai/

A/ appl States/ Regions US Current + MW ( FL PNW MW) proj 1,362 191 248 14% 18% FL ID OR WA MW with shorter PHI in PNW proj 1,362 267 360 20% 26% FL ID OR WA MW Grapefruit Fresh 165 26 41 16% 25% 122 191 4.7 1.3 3.5 34 FL Processed 38 6 13 17% 33% 20 38 3.0 1.1 2.7 7 FL TX Total 203 33 54 16% 26% 142 229 4.3 1.3 3.4 42 FL TX Oranges Fresh 408 27 51 7% 13% 97 182 3.6 1.2 3.0 32 FL Processed 518 59 120 11% 23% 185 377 3.1 1.1 2.9 64 FL TX Total 926 86 171 9% 18% 283 559 3.3 1.1 3.0 96 FL TX COLUMN HEADINGS * Acres grown applies to the entire US unless indicated with an asterisk (*) where it applies only to the region specified.

Wtd Avg = Weighted average the most recent years and more reliable data are weighted more heavily.

Est Max = Estimated maximum, which is estimated from available data.

Average application rates are calculated from the weighted averages.

NOTES ON TABLE DATA Calculations of the above numbers may not appear to agree because they are displayed as rounded to the nearest 1000 for acres treated or lb. a. i. ( Therefore 0 = < 500)

to the nearest whole percentage point for % of crop treated. ( Therefore 0% = < 0.5%)

proj = projected. Numbers in italics and indicated with " proj" are projected or include projected amounts.

SOURCES: EPA data ( 1988 98), USDA ( 1990 98), and National Center for Food and Agricultural Policy ( 1992 data)

WEFA Group forecasts ( 1997 data) Attachment 3: Aldicarb Residue Data and Anticipated Residues for the DEEM   Analysis.

Page 38 of 203 Summary of Residue Data Supporting Anticipated Residue Estimates and Acute RDFs:

Crop/ Commodity MRID Nos.

Pecans 140487, 102123 Peanuts 102013 Cottonseed 102061, 42436606 Dry Beans 135031 Soybeans 135031, 40884601 Sugarcane 101923 Sugarbeet 35368, 35369, 101966 Coffee 096131, 016252 Orange 36313, 42016901, 42004401, 43110601, 140001, 102114 Grapefruit 148971, 102129, 42016901 Lime 102129 Lemon 102129 Potato 42827804, 42827802, 43299002, 43385001, 44244701, 44196701, 44209001, 44341801 Sweet Potato 101923, 42722301 Banana 44847402, 44847403, 45181802 Attachment 3: Aldicarb Residue Data and Anticipated Residues for the DEEM   Analysis.

Page 39 of 203 Pecans Use Pattern and % CT Estimates Aldicarb is applied post emergence, soil incorporated, to producing pecan trees; either a single application is made at bud break, or split applications are permitted at bud break and mid summer. For single applications, the maximum seasonal rate is 5 lb ai/ A in FL, 7.1 lb ai/ A in AZ, and 10.1 ai/ A in other states. For split applications, the first application may be made at bud break, at 5 lb ai/ A, followed by a 3 lb ai/ A application in mid summer; alternatively, a single application of 3 lb ai/ A may be made mid summer. Labels specify a seasonal maximum of 10.1 lb ai/ A. Under certain Special Local Need ( SLN) registrations, shank or injection split applications may be made at bud break at 2.6 lb ai/ A, followed by a mid summer application of 1.2 lb ai/ A, for a total seasonal application 3.8 lb ai/ A. Label specified pre harvest intervals ( PHI's) range from 105 to 120 days, although some labels do not specify a PHI. Applications made in CA exclude Del Norte and Humboldt counties. Usage estimates provided by BEAD indicate an estimated maximum of 8 % CT for the acute analysis for pecans.

Residue Data [ MRID Nos. 140487 and 102123]

Residue data submitted under MRID Nos. 140487 and 102123 are identical. In field trials conducted in 1975 1976, pecans grown in GA, AL, SC and MS were treated with single applications of 2  38.4 lb ai/ A, or with two split applications of 5 lb ai/ A. Total aldicarb residues were measured in kernels and shells, and the residues in whole nuts calculated to determine the appropriate tolerance. The method limit of detection was 0.01 ppm, with nondetectable residues assigned a residue value of ½ LOD, or 0.005 ppm. For the purpose of risk assessment, HED is most concerned with residues in pecan kernels ( i. e., nuts) reflecting the maximum label rate ( i. e., 5 10 lb ai/ A). However, the quantitative usage analysis prepared by BEAD/ OPP indicates that the average application rate for pecans is 3.1 lb ai/ A, with approximately one application made per year. Most of the usage on pecans occurs in GA, MS, TX and AL. Since field trial data reflect worst case farmgate residues, and since the usage data indicate the maximum label rate is not typically used, the entire range of available field trial residue data, reflecting all application rates up to the maximum 1X label rate, have been incorporated into the acute residue distribution file ( RDF, for acute analysis), as shown in Table 1. Attachment 3: Aldicarb Residue Data and Anticipated Residues for the DEEM   Analysis.

Page 40 of 203 Table 1. Pecan Field Trial Summary for Risk Assessment.

Trial Location Appl. Rate ( lb ai/ A) PHI ( Days) Total Residue, ppm 2 180 197 0.02; 0.005 GA 4 180 197 0.04; 0.02 AL; SC 5 171 268 0.05; 0.08; 0.005 GA; MS 6 180 197 0.07; 0.01; 0.06; 0.005 GA 8 180 197 0.03; 0.09 GA; AL; SC 10 180 268 0.11; 0.10; 0.01; 0.27; 0.03; 0.05; 0.12; 0.005 GA 5+ 5 ( split) 106 0.17 Average Pecan Residue 0.0614 ppm The pecan RDF is included in a complete listing of RDFs for the aldicarb dietary exposure analysis, Attachment 4. The acute RDF are shown below.

PECANS Acute ( RDF)

RDF1 Pecans PB 22 Detects + 253 zeroes Ave. Residue = 0.0614 Peanuts Use Pattern and % CT Estimates Aldicarb labels allow application to peanuts via soil incorporation ( in furrow or banded) at planting at 3 lb ai/ A; alternatively, split applications may be made at planting at 1.5 lb ai/ A, with a 1.5 lb ai/ A application made at or just prior to peg initiation but no later than 40 days after emergence and prior to last cultivation. The maximum seasonal rate is 3 lb ai/ A, with a PHI of 90 days. Use is limited to AL, FL, GA, NC, and VA.

Usage estimates provided by BEAD indicate an estimated maximum of 47 % CT for peanuts. Since peanuts are considered to be blended, the acute dietary exposure assessment incorporated a residue point estimate for aldicarb in peanuts. The estimated maximum of 47% CT is incorporated into the acute point estimate.

Residue Data [ MRID No 102013]

Field trial data for peanuts were submitted under MRID No. 102013 in support of registration. In field trials conducted in AL, FL, GA, NC, OK, TX and VA, peanuts were treated at rates of 2, 4 or 6 lb ai/ A, either pre plant, at plant or at pegging, and harvested 118 168 days later. In addition, several trials were conducted in which peanuts were treated with split applications of 2 + 2, 4 + 4, 4 + 2, or 6 + 2 lb ai/ A, with the first application at plant and the second application at pegging, with PHI's of 38 137 days. Total aldicarb residues were measured in green nuts, whole nuts, dry nuts, and, in some cases, the kernel, or edible portion. Residues were generally low or nondetectable, with a method sensitivity ( LOD) of 0.01 ppm for whole nuts, dry nut and green nut, and 0.002 ppm for kernels; the resulting ½ LOD values assigned to nondetectable residues were 0.005 ppm and 0.001 ppm, respectively. Only one field trial conducted in VA used the label rate of 3 lb ai/ A, but nuts were harvested at PHI's less Attachment 3: Aldicarb Residue Data and Anticipated Residues for the DEEM   Analysis.

Page 41 of 203 then 90 days, and residues in only the green nuts were measured. Residues in peanut oil processed from peanuts bearing detectable residues were < 0.003 ppm; residues in oil are therefore estimated at ½ LOD or 0.0015 ppm. The acute anticipated residues in peanut oil are derived from ½ LOD, as shown in Table 2. Since residues in peanut kernel samples are most useful for risk assessment, only the kernel results ( i. e., excluding whole dry nuts and green nuts) are summarized in Table 2. Since none of the results in kernels reflect the label maximum of 3 lb ai/ A, all the residue values from the 2 and 4 lb ai/ A applications were used. This approach is considered to be an upper bound estimate of aldicarb residues in peanuts, since usage data indicate a lower application rate of approximately 1 lb ai/ A is typically used.

Table 2. Peanut Field Trial Summary for Risk Assessment.

Trial Location Appl. Rate ( lb ai/ A) PHI ( Days) Total Kernel Residue, ppm 2 ( at plant) 144 0.001, 0.001 AL 4 ( at plant) 144 0.001, 0.012 2 ( preplant) 121 0.002, 0.001 GA 4 ( preplant) 121 0.002, 0.003 2 ( at plant) 131 0.006, 0.009 NC 4 ( at plant) 131 0.016, 0.017 TX 2 ( at plant) 114 0.005, 0.005 2 ( at plant) 156 0.007, 0.004 VA 4 ( at plant) 156 0.003, 0.004 Average residue in peanuts ( kernels) 0.0055 ppm Acute AR = 0.0055 x 47% = 0.002585 ppm Acute oil AR = 0.0015 x 47% = 0.000705 ppm Cottonseed Use Pattern and % CT Estimates Aldicarb products may be applied to cotton either at planting or post emergence; rates range from 0.75 lb ai/ A ( 5% G formulation) to 4.1 lb ai/ A ( 10% G and 15% G formulations, rate for AZ/ Far West). The registrant's proposed label revisions include a maximum seasonal use rate of 3.2 lb ai/ A, which is the current use rate for at plant + post emergence applications allowed on EPA Reg. No. 264 426. Current and proposed labels specify a 90 day pre harvest interval ( PHI).

Usage estimates provided by BEAD indicate an estimated maximum of 33 % CT and a weighted average of 27 % CT for cotton; use in GA, TX, CA, NC, MS and AR accounts for 68% of aldicarb use on cotton. Since cottonseed and its associated food forms ( cottonseed meal and oil) are considered to be blended, the acute dietary exposure assessments incorporate a residue point estimate for aldicarb in cottonseed. The estimated maximum of 33% CT is incorporated into the acute point estimate. Residue Data [ MRID Nos. 102061 and 42436606]

Available field trial data are limited; the studies were conducted prior to 1975, and do not adequately Attachment 3: Aldicarb Residue Data and Anticipated Residues for the DEEM   Analysis.

Page 42 of 203 reflect current use patterns. Residue data to support use on cotton were submitted under MRID No. 102061, a literature study generated by USDA [ J. Ag. Food Chem. 21( 3): 379 386, 1973]. Seedling cotton grown in 3 different locations, in both dry and irrigated fields, was treated with a single application of granular 10% G at 1.5 lb ai/ A, and harvested 90 days later. Residues in treated cotton ranged from 0.0 ppm ( i. e., nondetectable) to 0.21 ppm, and appeared to be lower in the irrigated cotton.

Limited field trials were submitted under MRID No. 42436606 [ 1992 re format of a 1973 study]. Residues in cotton treated once at plant, once at plant with an additional sidedress application, or once at sidedress only, at rates ranging from 0.5 to 3 lb ai/ A. The results of a cottonseed processing study discussed in the Aldicarb Registration Standard indicate residues in cottonseed oil processed from seed bearing measurable aldicarb residues are < 0.003 ppm, and therefore the anticipated residue in oil is ½ LOD, or 0.0015 ppm. These data are summarized in Table 3.

Table 3. Cottonseed Field Trial Summary for Risk Assessment.

Trial Location Appl. Rate ( lb ai/ A) PHI ( Days) Total Cottonseed Residue, ppm NC 1 ( at plant) " Normal Harvest" 0.12 2 ( at plant) " Normal Harvest" 0.11 SC 1+ 2+ 2 ( at plant + sidedress) " Normal Harvest" 0.10 0.5( at plant) 0.005 MS 1 ( at plant) " Normal Harvest" 0.01 AR 2 ( at plant) " Normal Harvest" 0.03 2 ( at plant) 0.005 TX 1+ 3 ( at plant + sidedress) " Normal Harvest" 0.04, 0.08 2 ( sidedress) 0.03, 0.03 AZ 4 ( sidedress) " Normal Harvest" 0.05, 0.06 Average residue in cottonseed 0.0515 ppm Acute AR = 0.0515 x 33% = 0.016995 ppm Acute oil AR = 0.0015 x 33% = 0.000495 ppm Dry Beans Use Pattern and % CT Estimates Aldicarb applications to dry beans are made at planting at either 1.1 ( CA only) or 2.1 lb ai/ A; a postemergence ( up to bloom) application at 2.1 lb ai/ A may be made in ID, OR and WA. A maximum of 1 application per season is permitted, with a PHI of 80 days for the post emergence application, and a PHI of 90 days for at planting applications.

Usage estimates provided by BEAD indicate an estimated maximum of 2 % CT and a weighted average Attachment 3: Aldicarb Residue Data and Anticipated Residues for the DEEM   Analysis.

Page 43 of 203 of 1 % CT for dry beans, with up to 84% of usage on dry beans occurring in WA, ID and MI. Since dry beans and associated food forms ( e. g., baked, boiled, etc.) are considered to be blended, the acute dietary exposure assessments incorporate a residue point estimate for aldicarb in dry beans. The estimated maximum of 2 % CT is incorporated into the acute point estimate.

Residue Data [ MRID No. 135031]

Field trials were conducted in CA, CO, ID, MI, NE, NY, NC and WA, with application rates ranging from 0.25 3 lb ai/ A. Only residues in mature dry seed from field trials conducted at up to 2 lb ai/ A are included in the summary table ( Table 3), shown below. Residues were very low or nondetectable ( i. e., residues were assumed to be ½ LOD, or 0.01 ppm) in dry seed harvested from 87 147 days following application.

Table 3. Dry Bean Field Trial Summary for Risk Assessment.

Trial Location Appl. Rate ( lb ai/ A) PHI ( Days) Total Dry Bean Residue, ppm 0.25 0.01, 0.01 0.5 0.01, 0.01 CA ( small white)

1.0 129 0.01, 0.01 0.75 0.04, 0.03 * From pods which split during shipping CA ( blackeye)

1.5 107 0.11, 0.10 * From pods which split during shipping CA ( pink) 2 103 0.01, 0.01 0.5 0.01, 0.01 CA ( lima)

1.0 147 0.01, 0.01 0.5 0.01, 0.01 CA ( blackeye)

1.0 147 0.01, 0.01 CO ( pinto) 1.5 106 0.01, 0.01 ID ( white) 1.5 121 0.01, 0.01 ID ( wax) 1.5 113 0.01, 0.01 MI ( white) 1.5 140 0.01, 0.01 0.5 0.01, 0.01 NE ( great north.)

1.0 112 0.01, 0.01 NC ( blackeye) 1.0 87 0.01, 0.01 0.75 0.01, 0.01 WA ( pinto)

1.5 106 0.01, 0.01 Average residue in dry beans 0.01 ppm [ excludes CA trial w/ split pods beans]

Acute AR = 0.01 x 2% = 0.0002 ppm The registrant conducted a cooking study in which dry beans ( blackeye, red kidney and field peas) bearing detectable aldicarb residues of 0.10 to 0.49 ppm were cooked for 1, 2 or 3 hours at 100 C. Residues in blackeye peas were 0.49 ppm prior to cooking, and were 0.02 or 0.03 ppm after cooking, resulting in an average cooking factor of 0.05X. This cooking factor is included as adjustment factor 1 in the DEEM   analysis. HED notes that dietary exposure to aldicarb residues in dry beans is not expected since all residues were nondetectable; therefore, a sensitivity analysis could exclude dry beans. Attachment 3: Aldicarb Residue Data and Anticipated Residues for the DEEM   Analysis.

Page 44 of 203 Soybean Use Pattern and % CT Estimates Soybeans may be treated with one at plant application of aldicarb at rates ranging from 1.1 to 3 lb ai/ A, depending on the geographic location. Labels specify a PHI of 90 days. Usage estimates provided by BEAD indicate no significant aldicarb usage on soybeans, i. e., 0 % CT for both the estimated maximum and weighted average. HED typically defaults to 1% CT when estimates are < 1%; however, in additional sensitivity analyses, soybeans should be excluded. Since soybeans and associated food forms are considered to be blended, the acute dietary exposure assessments incorporate a residue point estimate for aldicarb in soybeans. The estimate of 1 % CT is incorporated into the acute point estimate.

Residue Data [ MRID Nos. 135031; 40884601]

In field trials conducted in AL, AR, IN, NC, OK, SC, TX and VA, soybeans were treated with one atplant application of aldicarb at rates ranging from 0.7 3.0 lb ai/ A, with PHI's ranging from 126 194 days after application. The LOQ was 0.02 ppm, and therefore nondetectable residues were reported as 0.01 ppm.

Results of the field trials are shown in Table 4.

Table 4. Soybean Field Trial Summary for Risk Assessment.

Trial Location Appl. Rate ( lb ai/ A) PHI ( Days) Total Soybean Residue, ppm 3 0.01, 0.01 AL 2 160 0.01, 0.01 2 194 0.01, 0.01 3 160 0.01, 0.01 AR 3 161 0.01, 0.01 1.5 0.01, 0.01 IN 3 126 0.01, 0.01 1.5 0.01, 0.01 NC 3 160 0.01, 0.01 1.5 0.01, 0.01 OK 3.5 150 0.01, 0.01 1.5 0.01, 0.01 3 0.01, 0.01 3 160 0.01, 0.01 1.5 0.01, 0.01 SC 3 169 0.01, 0.01 1.5 0.01, 0.01 TX 3 134 0.01, 0.01 1 0.01, 0.01 VA 1 147 0.01, 0.01 Attachment 3: Aldicarb Residue Data and Anticipated Residues for the DEEM   Analysis.

Page 45 of 203 Table 4. Soybean Field Trial Summary for Risk Assessment.

Trial Location Appl. Rate ( lb ai/ A) PHI ( Days) Total Soybean Residue, ppm 1.5 0.01, 0.01 3 164 0.01, 0.01 1.5 0.01, 0.01 3 127 0.01, 0.01 0.7 0.01, 0.01 1.4 166 0.01, 0.01 Average residue in soybeans 0.01 ppm Acute soybean AR = 0.01 x 1% = 0.0001 ppm Acute soybean oil AR = 0.005 ppm x 1% = 0.00005 ppm Although soybean processing data were included in MRID No. 135031, these data were considered unacceptable since there were no detectable aldicarb residues in soybeans processed into meal and oil. Additional soybean processing data were submitted under MRID No. 40884601. Following treatment at 12 lb ai/ A ( 4X the maximum label rate), residues in dried soybeans were 0.03 ppm. Residues in soybean meal were 0.05 and 0.04 ppm, while residues in both samples of refined oil were < 0.01 ppm. For the purpose of dietary exposure assessment, the anticipated residue in refined oil is ½ the LOD for the processing study, or 0.005 ppm. For the acute analysis, incorporation of the % CT into the point estimate results in an AR of 0.00005 ppm.. HED notes that since residues in soybean and soybean oil were nondetectable ( and since BEAD estimates 0 % CT), a sensitivity analysis could be conducted excluding soybeans and associated food forms.

Grain Sorghum Aldicarb products may be applied to grain sorghum soil incorporated at planting, at a rate of 1.1 lb ai/ A. Only one application is permitted per season, with a PHI of 90 days. Usage estimates provided by BEAD indicate no significant aldicarb usage on grain sorghum, i. e., 0 % CT for both the estimated maximum and weighted average. HED typically defaults to 1% CT when estimates are < 1%; however, in additional sensitivity analyses, sorghum should be excluded. The sorghum AR is based on the tolerance of 0.2 ppm, and the maximum % CT, or 1%. For the acute analysis, the AR is 0.002 ppm.

Sugarcane [ MRID No. 101923] Attachment 3: Aldicarb Residue Data and Anticipated Residues for the DEEM   Analysis.

Page 46 of 203 Sugarcane grown in LA may be treated with aldicarb once per season, either at planting or at ratoon growth, at 3 lb ai/ A. The label PHI is 120 days. Usage estimates provided by BEAD indicate no significant aldicarb usage on sugarcane, i. e., 0 % CT for both the estimated maximum and weighted average. Residue data to support the use on sugarcane were submitted under MRID No. 101923. Sugarcane stalk residues were in the < 0.01  0.02 range following treatment at 2 or 4 lb ai/ A. Cane stalks with residues < 0.011 were processed into bagasse, dilute juice, clarified juice, syrup, raw sugar and molasses, in which residues were all < 0.011 ppm. In addition, fortified dilute juice ( 0.24 ppm) was processed into clarified juice, syrup and raw sugar. Residues in clarified juice were 0.1 ppm, while residues in syrup and raw sugar were 0.21 and < 0.011 ppm, respectively. Given that there is no significant usage estimated on sugarcane, residues in stalks were generally nondetectable even at 1.3X, and since aldicarb residues in raw sugar are not expected, HED concludes that sugarcane ( refined sugar and molasses) should be excluded from dietary exposure analyses for aldicarb.

Sugar beet Use Pattern and % CT Estimates Aldicarb may be applied to sugar beet soil incorporated at planting ( or 1 week before planting) at 2.1  5 lb ai/ A. Alternatively, an at plant application may be made, followed by an additional application 40 60 days after the initial application; the application rates specified are 2.1  3 lb ai/ A. Finally, a single post emergence application can be made at 2.1  4 lb ai/ A, 30 60 days after planting. Registered labels specify a PHI of 90 days, or 120 days if sugar beet tops are to be fed to livestock. Usage estimates provided by BEAD/ OPP indicate an estimated maximum of 11 % CT and a weighted average of 9 % CT for sugar beet. [ Since sugar beet food forms are considered to be blended, the acute dietary exposure assessments incorporate a residue point estimate for aldicarb in sugar beet].

Residue Data [ MRID Nos. 35368; 35369; 101966]

Sugar beet tops field trial data submitted under MRID No. 35368 have not been presented, since they are a livestock feed item, and since secondary residues in livestock commodities are not expected to occur.

Field trials described in MRID No. 35369 ( 1970) were conducted in CO, and included applications at 2 or 4 lb ai/ A, with harvest occurring 160 and 176 days later, respectively. Residues in roots were < 0.01 ppm, [ 0.005 ppm] in duplicate root samples from each trial. A range of application rates and timing was incorporated in field trials submitted under MRID No. 101966. In field trials conducted in CA, UT, ID, MI, ND, CO, NC, OH, NM and WA, single or multiple applications were made at rates ranging from 1 30 lb ai/ A, with harvest occurring from 18 238 days after treatment. Very few trials were conducted with either a 120 or 90 day PHI. These trials are summarized below, in Table 5:

Table 5. Sugar beet Field Trial Summary for Risk Assessment.

Trial Location Appl. Rate ( lb ai/ A) PHI ( Days) Total Sugar beet Residue, ppm CA 3 ( at plant) 90 0.02 UT 2 ( preplant) 90 0.005, 0.005 Attachment 3: Aldicarb Residue Data and Anticipated Residues for the DEEM   Analysis.

Page 47 of 203 Table 5. Sugar beet Field Trial Summary for Risk Assessment.

Trial Location Appl. Rate ( lb ai/ A) PHI ( Days) Total Sugar beet Residue, ppm 120 0.005, 0.005 90 0.02, 0.04 4 ( preplant)

120 0.01, 0.005 90 0.005 2 ( preplant)

120 0.005 90 0.01 ID 4 ( preplant)

120 0.01 MI 5 ( at plant) 114 0.03 1.5+ 1 ( at plant+ post emergence) 113 0.01 ND 4 ( at plant) 103 0.01 104 0.005 WA 1+ 1 ( at plant + over foliage) 110 0.005 Average residue in sugar beet 0.0114 ppm Acute sugar beet AR = 0.0114 x 11% = 0.0013 ppm In conjunction with the field trials summarized above, a processing study was conducted in which roots bearing detectable residues were processed into diffusion juice, thin juice, thick juice, dry pulp, and wet pulp. Although there were detectable residues in the diffusion juice, these residues were found to be unstable following treatment with lime water, which simulates commercial processing. Residues in thin juice and thick juice were generally either 0.005 ppm, or < 0.005 ppm. Based on these data, the registrant concluded that there would be no detectable aldicarb residues in beet sugar and molasses processed from treated sugar beet roots. HED concurs with this conclusion; therefore, these commodities should be excluded from dietary exposure analyses conducted for aldicarb.

Coffee Use Pattern and % CT Estimates Coffee grown in Puerto Rico may be treated with up to 2 applications per season, totaling 4.4 lb ai/ A ( 0.11 oz/ tree). Applications are made to the soil along both driplines, and coffee can be harvested 90 days later. Tolerances were originally proposed in 1977 for uses outside the US, primarily in Latin America, Africa and Asia. Labels submitted in support of PP# 7F1953 permitted two applications at 6.7 13.4 lb ai/ A ( 1.5 3 g ai/ tree), with harvest occurring at least 90 days after the second treatment; HED has no data regarding the use patterns for aldicarb on coffee grown outside the US. The estimated upper bound % CT for coffee is 20 %.

Residue Data [ MRID No. 096131; 016252]

Residue data submitted under MRID No. 096131 indicate residues in mature green coffee beans are at or below the limit of detection (< 0.02 ppm) following application at the purported label rates. In conjunction with the aldicarb Registration Standard, a coffee bean processing study was required to support aldicarb use on coffee. Data submitted under MRID No. 016252 were deemed acceptable. Attachment 3: Aldicarb Residue Data and Anticipated Residues for the DEEM   Analysis.

Page 48 of 203 Coffee was treated at 4X the maximum label rate, resulting in detectable residues of 0.11 ppm in green coffee beans. Aldicarb residues were < 0.02 ( i. e., nondetectable) in roasted beans, spent grounds and instant coffee processed from the treated beans. Based on the low residues expected in mature beans, and on the processing study conducted in coffee, the anticipated residue for aldicarb in coffee is 0.01 ppm, or ½ LOD for coffee. Application of the % CT estimate to the AR results in an acute AR of 0.002 ppm. Since residues were not detected in coffee as consumed, a sensitivity analysis excluding coffee could be conducted.

Citrus Fruits ( Orange, Grapefruit, Lemon, Lime)

Aldicarb is currently registered for use on orange, grapefruit, lemon and lime, and these crops and their associated commodities have been considered in the dietary exposure analysis. However, a petition to establish a citrus crop group tolerance would allow use on additional citrus crops such as tangerine, kumquat, citron, etc. The existing use and the proposed uses are considered separately.

Use Pattern Aldicarb can be applied to citrus as a band or in furrow treatment along the driplines on both sides of the tree row just prior to or during spring flush of foliage growth. The maximum seasonal and single application rate is 5 lb ai/ A, with a 30 day PHI specified for lemons only. BEAD/ OPP provided usage estimates for both fresh and processed oranges and grapefruit, as previously described. Usage data suggest that most citrus crops are treated once per season ( in accordance with the label), but that the typical rate is somewhat less than the maximum of 5 lb ai/ A. Orange and grapefruit % CT data have been discussed in detail under " usage information;" lemon and lime usage data are discussed below.

Orange Residue Data There are several sources of residue data available to complete dietary exposure analyses for oranges, and, by translation, other citrus commodities. These include:

( i) Field trial data submitted in support of reregistration, including composite sample analyses for total aldicarb residues as the sulfone;

( ii) An in orchard variability study in which aldicarb and metabolite residues were measured in single oranges following treatment at the label rate;

( iii) A " market basket" study in which single oranges were analyzed for total aldicarb residues using the enforcement method, considered to be more like a farm gate monitoring study;

( iv) USDA Pesticide Data Program composite monitoring data for aldicarb and metabolite residues in oranges and orange juice;

( v) A juice processing study resulting in a reduction factor for aldicarb and metabolites;

( vi) The Carbamate Task Force Carbamate Market Basket Survey, in which aldicarb and metabolite residues in single oranges were analyzed; and Attachment 3: Aldicarb Residue Data and Anticipated Residues for the DEEM   Analysis.

Page 49 of 203 ( vii) FDA Surveillance Monitoring Data included a total of 261 composite samples analyzed during 1992 through 1998, in which there were no aldicarb residues detected.

Depending on the data set, 2 types of sensitivity analyses are possible. First, since aldicarb per se was not detected in any of the samples from certain data sets, these residues may be assumed to be true zeroes ( rather than ½ LOD); this approach is supported by the results of the lemon metabolism study. Second, in monitoring data, all nondetectable residues may be assumed to be zero residue values. These two types of analyses can therefore be used to determine if the dietary exposure estimates are sensitive to assumed values for nondetectable residues.

Based on the orange food forms included in DEEM   and the availability of fresh and processed % CT data, relevant RDFs consist of fresh non blended ( NB) and partially blended ( PB) food forms and processed PB food forms.

Field Trial Data [ MRID Nos. 36313; 42016901; 42004401; 43110601]

Orange field trial data submitted under MRID No. 36313 included several different application rates ranging from 2.5 to 10 lb ai/ A, but only the 5 lb ai/ A residue results have been summarized. Following a single application of 5 lb ai/ A in FL, CA and AZ, composite samples consisting of 12 25 fruits were harvested at PHIs ranging from 30 to 244 days. Total aldicarb residues were measured ( as the sulfone) in both peel and pulp. Results of the study are shown in Table 6.

Table 6. Orange Field Trial Summary ( 5 lb ai/ A Application).

Trial Location Sample Type PHI ( Days) Total Pulp Residue, ppm Total Peel Residue, ppm Green fruit 30 0.07, 0.06 0.34, 0.38 Mature fruit 62 0.03, 0.03 0.12, 0.08 Fruit 124 0.05, 0.04 0.04, 0.04 Mature fruit 31, 63 0.05, 0.05, 0.04, 0.05 0.18, 0.17, 0.16, 0.12 FL Whole fruit 93 127 0.07, 0.07, 0.09, 0.09, 0.07, 0.09, 0.04, 0.04, 0.03, 0.03 CA Mature fruit 178 0.02, 0.02, 0.02, 0.03, 0.04, 0.05 0.02, 0.03, 0.04, 0.06, 0.06, 0.07 CA Mature fruit 193 0.02, 0.02, 0.02, 0.02, 0.02, 0.02 0.04, 0.04, 0.04, 0.04, 0.04, 0.04 Green and Ripe fruit 158 188 0.005, 0.005, 0.005, 0.005 0.01, 0.01, 0.01, 0.01 Green and Ripe fruit 249 0.005, 0.005, 0.005, 0.005 0.01, 0.01, 0.01, 0.01 AZ Ripe fruit 280 0.005, 0.005 0.01, 0.01 Total # of Pulp Residues = 32 Ave Pulp Residue= 0.0256 ppm When field trial data are used to generate residue distribution files, the partially blended and nonblended RDFs are essentially the same; since composite field trial data generally represent upper bound estimates of residues, they are not decomposited to yield single unit residues. The following acute RDFs were generated using the field trial data: Attachment 3: Aldicarb Residue Data and Anticipated Residues for the DEEM   Analysis.

Page 50 of 203 ORANGE, FT Acute ( RDF)

RDF2 Orange, NB= PB Fresh 32 detects + 214 Zeroes Ave. Residue = 0.0256 [% CT = 13]

RDF3 Orange, PB Proc. 32 Detects + 107 Zeroes Ave. Residue = 0.0256 [% CT = 23] Attachment 3: Aldicarb Residue Data and Anticipated Residues for the DEEM   Analysis.

Page 51 of 203 An in orchard variability study was submitted under MRID Nos. 420169 01 and 420044 01, in which oranges were treated at 5 lb ai/ A as an incorporated band under the driplines of the trees, and fruit was harvested 60 days later. A total of 100 individual oranges from each of three trials was analyzed for aldicarb and each of its metabolites. In the first trial, there were no detections ( i. e., < 0.01, or 0.005 ppm assumed ) of aldicarb per se or the sulfone metabolite; detections of the sulfoxide ranged from < 0.01 ( 0.005) to 0.04 ppm. In the second trial, there was one detection of aldicarb per se at 0.005 ppm, with no other detections of aldicarb or the sulfoxide and sulfone metabolites; because aldicarb was detected at ½ LOD, the total residue for all 100 samples was 0.01625 ppm ( the combined ½ LOD for the method). In the third trial, there were no detections ( i. e., < 0.01, or 0.005 ppm assumed ) of aldicarb per se, and detections of the sulfone ranged from 0.005 to 0.02 ppm; aldicarb sulfoxide detects ranged from 0.005 to 0.15 ppm. The combined residue in the third trial ranged from 0.01625 to 0.17785 ppm. The overall average residue ( parent plus metabolites) for all three trials is 0.026524 ppm. The individual residue values are captured in the acute RDFs shown in attachment 4. All oranges are assumed to have been treated, and the acute RDFs are constructed using the 300 measured residue values and then a number of zero residues values were added to account for the percent of the crop not treated. Since aldicarb per se residues were detected ( below the LOD), there was no sensitivity analysis for zero residues of aldicarb.

ORANGE, FT Acute ( RDF)

RDF4 Orange, NB= PB Fresh 300 detects + 2007 zeroes Residue Range = 0.01625 to 0.17785 Ave. Residue = 0.026254 [% CT = 13]

RDF5 Orange, PB Proc. 300 detects + 1004 zeroes Range = < 0.005  0.12 Ave. Residue = 0.026254 [% CT = 23]

A " market basket survey" for aldicarb residues in oranges was submitted under MRID No. 431106 01 ( 1993). Oranges were sampled from March to May from orange groves known to have been treated with aldicarb, with the additional criteria that mature fruit were present on trees at the time of treatment, and that the oranges were intended for fresh market. This study is considered to be more like a farmgate monitoring study than a traditional market basket survey; a majority of the aldicarb usage on oranges is in FL, and the data were intended to be extrapolated to the remaining US production for fresh market.

Harvest was timed as close as possible to the harvest date, and only bearing trees were selected. A total of 50 trees were selected randomly from the treated locations, and then eight oranges were selected from each tree; once the selected oranges were placed in a sample bag, one orange was selected at random for analysis. A total of 869 individual oranges were analyzed. Since the enforcement method was used, combined residues were determined as the sulfone. Residues ranged from 0.005 ppm ( i. e., < 0.01, therefore ½ LOD used) to 0.12 ppm, with an average of 0.008648 ppm. The individual residue values are shown in Attachment 4. [ Even though these data were based on fresh market residues, there are no data reflecting residues in oranges intended for processing; therefore, the fresh market residue data were also used to construct a processed orange RDF for this data set]. The following acute RDFs were generated: Attachment 3: Aldicarb Residue Data and Anticipated Residues for the DEEM   Analysis.

Page 52 of 203 ORANGE Acute ( RDF)

RDF6 Orange, NB= PB Fresh 869 detects + 5,815 Zeroes Residue Range = < 0.005  0.12 Ave. Residue = 0.008648 [% CT = 13]

RDF7 Orange, PB Proc. 869 detects + 2,909 Zeroes Residue Range = < 0.005  0.12 Ave. Residue = 0.008648 [% CT = 23]

Orange Processing Data [ MRID Nos. 140001; 102114]

Residues in oranges were 0.08/ 0.06 and 0.65/ 0.52 ppm in fresh fruit; following simulated commercial processing, residues in juice were 0.07/ 0.05 and 0.17/ 0.18 ppm, indicating an average reduction factor of 0.58X, to be used in the DEEM   analysis as Adjustment Factor 1. [ Note that this factor may only be applied when fresh orange residue data are the residue source data for orange juice].

PDP Monitoring Data Oranges Aldicarb residues in oranges were monitored by USDA's PDP during 1994 1996; a total of 1,776 samples were analyzed for aldicarb and each of its metabolites, with 4 detects of aldicarb sulfoxide. Detected sulfoxide residues were 0.015, 0.017, 0.017 and 0.025 ppm, with corresponding total aldicarb residues of 0.02588, 0.02804, 0.02804, and 0.04328 ppm. The PDP combined weighted average ½ LOD value for aldicarb in oranges is 0.036451 ppm. The relatively high ½ LOD is due to the high LOD value achieved for aldicarb sulfoxide in some PDP laboratories. Assuming residues of 0 ppm for aldicarb per se, the weighted average ½ LOD is 0.025848 ppm. Generally, the low number of detects and relatively low levels of the detected sulfoxide residues would permit use of the monitoring data directly for both partially blended and nonblended food forms ( i. e., the detects would not be decomposited). However, this approach is not appropriate for aldicarb, since there are single unit residue data available for nonblended food forms. Therefore, the acute RDFs constructed from the PDP orange data are as follows:

ORANGE, PDP Acute ( RDF)

RDF8 Orange PB Fresh 4 Detects+ 227@ 1/ 2 LOD+ 1,545 Zeroes Sum of Detects = 0.125235 ½ LOD = 0.036451 ( wtd. ave.) [% CT = 13]

RDF9 Orange PB Proc. 4 Detects+ 405@ 1/ 2 LOD+ 1,367 Zeroes Sum of Detects = 0.125235 ½ LOD = 0.036451 ( wtd. ave.) [% CT = 23] Attachment 3: Aldicarb Residue Data and Anticipated Residues for the DEEM   Analysis.

Page 53 of 203 In order to conduct sensitivity analyses, RDFs identical to RDF8 and RDF9 were prepared, assuming aldicarb per se residues of 0 ppm [ see below, RDFs 10 and 11]. The combined ½ LOD of 0.025848 ppm was used, with detected residues of 0.03450, 0.02336, 0.02336 and 0.02120 ppm; the sum of the detected residues, assuming zero residues of aldicarb, is 0.10242 ppm. In addition, RDF12 was prepared assuming zero residues for aldicarb per se, and assuming that 1,772 samples with nondetectable residues were zeroes; RDF12 applies to both fresh and processed commodities.

ORANGE, PDP Acute ( RDF)

RDF10 Orange PB Fresh 4 Detects+ 227@ 1/ 2 LOD+ 1,545 Zeroes Sum of Detects = 0.10242 ½ LOD = 0.025848 ( wtd. ave.) [% CT = 13]

RDF11 Orange PB Proc. 4 Detects+ 405@ 1/ 2 LOD+ 1,367 Zeroes Sum of Detects = 0.10242 ½ LOD = 0.025848 ( wtd. ave.)

RDF12 [ Sens.] Orange PB F/ P 4 Detects + 1772 Zeroes Sum of Detects = 0.10242 [% CT = 23]

Orange Juice Aldicarb residues in orange juice were monitored by USDA's PDP during 1997 1998; a total of 1,392 samples were analyzed for aldicarb and each of its metabolites, with 1 detect of aldicarb per se at 0.035 ppm ( for a total combined residue 0.080890 ppm). The weighted ½ LOD for orange juice is 0.032106 ppm. As with fresh oranges, the relatively high ½ LOD is due to the high LOD value for aldicarb sulfoxide. An analysis in which aldicarb per se residues are assumed to be zero could not be conducted using this data set, since the parent was the only residue detected in one sample. The following acute RDFs, including one for the sensitivity analysis, were prepared for juice:

OJ, PDP Acute ( RDF)

RDF13 Orange Juice PB Fresh 1 Detect+ 180@ ½ LOD+ 1,211 Zeroes Detect= 0.08089 ½ LOD = 0.032106 ( Wtd. Ave.) [% CT = 13]

RDF14 Orange Juice PB Proc. 1 Detect + 319@ ½ LOD+ 1,072 Zeroes Detect= 0.08089 ½ LOD = 0.032106 ( Wtd. Ave.) [% CT = 23]

RDF15 [ Sens.] Orange Juice, PB F/ P 1 detect + 1,391 Zeroes Detect= 0.08089 Note that in the DEEM   analysis, any of the RDFs generated for fresh oranges may be used for juice, Attachment 3: Aldicarb Residue Data and Anticipated Residues for the DEEM   Analysis.

Page 54 of 203 with the juice processing factor of 0.58X applied via Adjustment Factor 1.

Carbamate Market Basket Survey Preliminary data from a carbamate market basket survey conducted by the Carbamate Task Force ( CTF) included results for oranges tested for residues of aldicarb and it metabolites. These data are currently undergoing review in HED, and are presented herein for the purpose of conducting a preliminary risk assessment for aldicarb. A total of 399 single oranges were analyzed for residues of aldicarb and its two metabolites; the LOD for the analytical method, 0.001 ppm, is considerably lower than in other studies submitted in conjunction with reregistration. Nondetectable combined residues ( i. e., ½ LOD) were therefore much lower, at 0.001625 ppm. A total of 16 of 399 samples ( 4%) had detectable combined residues, ranging from 0.0014738 to 0.029065 ppm. As in other studies, aldicarb per se was not detected, but there were 16 detections of the sulfoxide, and 8 of those samples also had detectable sulfone residues. The sum of the detected combined residues is 0.129892 ppm; assuming zero residues of aldicarb per se, detected combined residues ranged from 0.000888 to 0.028480 ppm, with a sum of 0.120532 ppm. The following RDFs were prepared using the data, and are presented in detail in Attachment 4.

ORANGE, CTF Acute ( RDF)

RDF16 Orange NB= PB, fresh 16 detects+ 36@ ½ LOD+ 347 zeroes Sum of detects= 0.129892 ½ LOD= 0.001625 [% CT = 13]

RDF17 Orange PB, Proc. 16 detects+ 76@ ½ LOD+ 307 zeroes Sum of detects= 0.129892 ½ LOD= 0.001625 [% CT = 23]

In order to conduct sensitivity analyses, RDFs 18 and 19, identical to RDF16 and RDF17, were prepared, assuming aldicarb per se residues of 0 ppm. The combined ½ LOD of 0.00104 was used, and detected residues included only the sulfoxide and sulfone. In addition, RDF20 was prepared assuming all nondetectable residues were zeroes ( applies to both fresh and processed commodities). The acute RDFs are as follows:

ORANGE, CTF Acute ( RDF)

RDF18 Orange NB= PB, fresh 16 detects+ 36@ ½ LOD+ 347 zeroes Sum of Detects = 0.120532 ½ LOD = 0.00104 [% CT = 13]

RDF19 Orange PB, Proc. 16 detects+ 76@ ½ LOD+ 307 zeroes Sum of Detects = 0.120532 ½ LOD = 0.00104 [% CT = 23]

RDF20 [ Sens.] NB, PB Fresh/ Proc. 16 detects+ 383 zeroes Sum of Detects = 0.120532 Attachment 3: Aldicarb Residue Data and Anticipated Residues for the DEEM   Analysis.

Page 55 of 203 Grapefruit [ MRID Nos. 148971; 102129; 42016901]

Residue data to support aldicarb use on grapefruit are not as extensive as orange residue data. Field trial data were submitted under MRID Nos. 148971 and 102129. In addition, an in orchard variability study, similar to the study conducted on oranges, was submitted under MRID No. 42016901. Finally, a grapefruit processing study, also submitted under MRID No. 102129, demonstrates a reduction in residues in grapefruit juice. These data can be used to generate RDFs and ARs for grapefruit. In addition, translation of orange monitoring data is permitted ( refer to HED SOP 99.3).

Field Trial Data In field trials conducted in TX, FL and CA ( MRID Nos. 102129 and 148971), grapefruit were treated at either 5 or 10 lb ai/ A. Grapefruit were harvested at PHIs ranging from 105 to 300 days following application. Table 7 indicates total aldicarb residues ( determined as the sulfone) in grapefruit; no information is available regarding the method sensitivity.

Table 7. Grapefruit Field Trial Summary ( MRID No. 148971).