Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Pyridaben,

[Federal Register: September 23, 2005 (Volume 70, Number 184)]

[Rules and Regulations]

[Page 55761-55770]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr23se05-16]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0267; FRL-7738-6]

Pyridaben; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes tolerances for residues of pyridaben in or on hop, dried cones; papaya; star apple; sapote, black; mango; sapodilla; sapote, mamey; canistel, fruit, stone, group 12; strawberry; and tomato. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). EPA is also deleting certain pyridaben tolerances that are no longer needed as result of this action.

DATES: This regulation is effective September 23, 2005. Objections and requests for hearings must be received on or before November 22, 2005.

ADDRESSES: To submit a written objection or hearing request follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. EPA has established a docket for this action under docket identification (ID) number OPP-2005-0267. All documents in the docket are listed in the EDOCKET index at http://www.epa.gov/edocket.

Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in EDOCKET or in hard copy at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305- 5805.

FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-6463; e-mail address: madden.barbara@epa.gov.

SUPPLEMENTARY INFORMATION:

1. General Information

   1. Does this Action Apply to Me?

      You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

      Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

      Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.

      Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.

      Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.

      This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

   2. How Can I Access Electronic Copies of this Document and Other Related Information?

      In addition to using EDOCKET (http://www.epa.gov/edocket/), you may

      access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180

      is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

      To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/ .

2. Background and Statutory Findings

   In the Federal Register of July 3, 2003 (68 FR 39942) (FRL-7315-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (0E6068, 1E6226, 1E6303, 2E6457, and 2E6460) from IR-4, 681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390. The

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   petitions requested that 40 CFR 180.494 be amended by establishing tolerances for residues of pyridaben, 2-tert-butyl-5-(4-tert- butylbenzylthio)-4-chloropyridazin-3(2H)-one in or on the following raw agricultural commodities: Strawberry at 2.5 parts per million (ppm) (PP 0E6068); hop, dried cones at 10.0 ppm (PP 1E6226); tomato at 0.2 ppm (PP 1E6303); fruit, stone, group at 2.5 ppm (PP 2E6457); papaya, black sapote, canistel, mamey sapote, mango, sapodilla, and star apple at 0.1 ppm (PP 2E6460). The tomato petition was subsequently amended to propose a tolerance at 0.15 ppm. Registration for tomato will be limited to greenhouse grown tomato based on the available residue data. The petitioner also proposed that established tolerances for nectarine, peach, plum, and prune at 2.5 ppm be deleted since they will be superceded by the tolerance for fruit, stone, group 12 at 2.5 ppm. That notice included a summary of the petition prepared by BASF Corporation, the registrant. The Agency received one comment expressing support for this action.

   EPA is also deleting the apricot, sweet cherry and tart cherry tolerances in Sec. 180.494(a) since they expired on June 30, 2004, and will also be superceded by the tolerance for fruit, stone, group 12.

   Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .''

   EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL- 5754-7) at http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm .

3. Aggregate Risk Assessment and Determination of Safety

   Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for a tolerance for residues of pyridaben, 2-tert- butyl-5-(4-tert-butylbenzylthio)-4-chloropyridazin-3(2H)-one in or on hop, dried cones at 10.0 ppm; papaya at 0.10 ppm; star apple at 0.10 ppm; sapote, black at 0.10 ppm; mango at 0.10 ppm; sapodilla at 0.10 ppm; sapote, mamey at 0.10 ppm; canistel at 0.10 ppm; fruit, stone, group 12 at 2.5 ppm; strawberry at 2.5 ppm; and tomato at 0.15 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

   1. Toxicological Profile

      EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by pyridaben are discussed in Table 1 of this unit as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

      Table 1.--Subchronic, Chronic, and Other Toxicity

      Guideline No.

      Study Type

      Results

      870.3100

      90-Day oral toxicity--rats NOAEL in males: = 4.94 mg/kg/day and NOAEL in females: 2.64 mg/kg/day LOAEL = 11.55 mg/kg/day based on decreased body weight (bwt) gain, food consumption, food efficiency and altered clinical pathology parameters in males and a LOAEL of 5.53 mg/kg/day based on decreased body weight gain and food efficiency in females

      870.3100

      90-Day oral toxicity mice NOAEL = males: 4.07 and females: 4.92 mg/kg/ day LOAEL = males: 13.02 and females: 14.65 mg/ kg/day based on decreased body weight gain

      870.3150

      90-Day oral toxicity-- NOAEL = 1.0 mg/kg/day nonrodents

      LOAEL = 4.0 mg/kg/day based on increased incidence of clinical signs and decreased body weight gain in both sexes

      870.3150

      90-Day oral toxicity-- NOAEL = 15 mg/kg/day

      870.3800

      Reproduction and fertility Parental/Systemic NOAEL = males: 2.20 and effects

      females: 2.41 mg/kg/day Parental/Systemic LOAEL = males: 6.31 and females: 7.82 mg/kg/day based on decreased body weight, body weight gains, and food efficiency Offspring NOAEL = 2.2 mg/kg/day Offspring LOAEL = 6.3 mg/kg/day based on decreased pup body weight and body weight gain Reproductive NOAEL = males: 6.31 and females: 7.82 mg/kg/day (HDT). No reproductive toxicity was observed at any dose Reproductive LOAEL = males: > 6.31 and > 7.82 mg/kg bwt/day (HDT)

      870.4100

      Chronic toxicity-dogs NOAEL = Not established LOAEL = 0.5 mg/kg/day based on increased clinical signs of toxicity in both sexes and decreased body weight gain in females

      870.4100

      Chronic toxicity--dogs NOAEL = Not established LOAEL = 1.0 mg/kg/day based on increased clinical signs of toxicity in both sexes and decreased body weight gain in females

      870.4200

      Carcinogenicity--rats NOAEL = males: 1.13 and females: 1.46 mg/kg/ day LOAEL = males: 5 and females: 6.52 mg/kg/ day based on decreased body weight and body weight gain observed in males and females, and decreased alanine transferase in males There was no evidence of carcinogenicity

      870.4300

      Carcinogenicity--mice NOAEL = 2.78 mg/kg/day (males and females) LOAEL = males: 8.88 and females: 9.74 mg/kg/ day) based on decreased body weight gain, decreased food efficiency and changes in organ weights and histopathology (males) No evidence of carcinogenicity

      870.5100

      Gene mutation - Salmonella Negative

      870.5300

      Gene mutation in Chinese Negative hamster cultured V-79

      870.5380

      Mutagenic- structural Negative chromosome aberration -in vitro cytogenetics - Chinese hamster

      870.5385

      Mutagenic - structural Negative chromosome aberration - micronucleus - mouse

      870.5500

      Mutagenic- DNA damage/ Negative repair- E. Coli

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      870.6200

      Acute oral neurotoxicity - NOAEL = 44 mg/kg (both sexes) rat

      LOAEL = 80 mg/kg/day based on increased incident of piloerection, hypoactivity, tremors, partially closed eyes, and decreases in body weight gain and food consumption No neuropathological effects were observed

      870.6200

      Subchronic neurotoxicity NOAEL = males: 8.5 and females: 9.3 mg/kg/ screening battery

      day LOAEL = males: 28.8 and females: 31.1 mg/kg/ day based on decreased body weight, body weight gain, food consumption and food efficiency in both sexes No neuropathological effects were observed

      870.7485

      Metabolism and

      Rapidly metabolized. Gastrointestinal tract pharmacokinetics

      was the major site for distribution, and elimination. Highest residues were found in liver, pancreas, spleen, kidney, lymph node and fat. Parent compound was metabolized to 20 - 30 metabolites and were resolved in urine and feces

   2. Toxicological Endpoints

      For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns.

      The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at http://www.epa.gov/pesticides/health/human.htm.

      A summary of the toxicological endpoints for pyridaben used for human risk assessment is shown in Table 2 of this unit:

      Table 2.-- Summary of Toxicological Dose and Endpoints for Pyridaben for Use in Human Risk Assessment

      Dose Used in Risk Assessment,

      Special FQPA SF and Exposure/Scenario

      Interspecies and Level of Concern for Study and Toxicological Intraspecies and any Risk Assessment

      Effects Traditional UF

      Acute dietary (all populations)

      NOAEL = 44 mg/kg/day Special FQPA SF = 1X Acute Neurotoxicity-Rat UF = 100............... Acute Population

      LOAEL = 80 mg/kg/day Acute Reference Dose Adjusted Dose (aPAD) = based on an increased (RfD) = 0.44 mg/kg/day. acute RfD/Special FQPA incidence of SF = 0.44 mg/kg/day. piloerection, hypoactivity, tremors and partially closed eyes, decreased body weight gain and food consumption

      Chronic dietary (all populations) LOAEL = 0.5 mg/kg/day Special FQPA SF = 1X Chronic Feeding-Dog UF = 100............... cPAD = chronic RfD/ LOAEL = 0.5 mg/kg/day Chronic RfD = 0.005 mg/ Special FQPA SF = .005 based on an increased kg/day.

      mg/kg/day.

      incidence of ptyalism, emesis and soft stools, and decreased body weight gain in females. EPA determined that this LOAEL could be used in risk assessment without an additional safety factor because the effects seen were minimal

      Cancer (oral, dermal, inhalation) Pyridaben has been classified as a Group E chemical (i.e. evidence of non- carcinogenicity for humans) based on the lack of evidence of carcinogenicity in male and female rats as well as in male and female mice

   3. Exposure Assessment

      1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.494) for the residues of pyridaben, in or on a variety of raw agricultural commodities including nectarine, peach, plum, and prune at 2.5 ppm. Tolerances have also been established for milk and fat, meat, and meat byproducts for cattle, goat, hog, horse, and sheep. Risk assessments were conducted by EPA to assess dietary exposures from pyridaben in food as follows:

         i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. The Dietary Exposure Evaluation Model (DEEM\TM\) analysis evaluated the individual food consumption as reported by respondents in the United States Department of Agriculture (USDA) 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each

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         commodity. The following assumptions were made for the acute exposure assessments: A Tier 3, acute dietary-exposure assessment (probabilistic) was conducted for pyridaben. The probabilistic assessment was based upon residue distribution files or anticipated- residue estimates derived from crop field trial data for most commodities; processing factors from processing studies were utilized for most processed commodities; and percent crop-treated estimates and projected market-share estimates were utilized for most crops.

         ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 nationwide CSFII, and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: A Tier 2, partially-refined, chronic dietary-exposure assessment was conducted for pyridaben. Anticipated-residue estimates were utilized to account for the residues of concern for risk assessment derived from proposed and established tolerance levels; and percent crop-treated estimates and projected market-share estimates were utilized for most crops.

         iii. Cancer. Pyridaben has been classified as not likely to be carcinogenic to humans. Therefore, a quantitative exposure assessment was not conducted to assess cancer risk.

         iv. Anticipated residue and percent crop treated (PCT) information. Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must pursuant to section 408(f)(1) require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. For the present action, EPA will issue such Data Call-Ins for information relating to anticipated residues as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Such Data Call-Ins will be required to be submitted no later than 5 years from the date of issuance of this tolerance.

         Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT.

         The Agency used PCT information as follows:

         4% almonds, 20% apples, 34% apricots, 25% cherries, 10% cranberry, 35% grapefruit, 10% grapes, 4% lemons, 8% oranges, 8% peaches, 22% pears, 8% plums and prunes, 15% nectarines, 1% pistachios, 25% strawberry, 25% tangerines, 8% tomatoes, and 35% for meat and milk. The following PCT data were used in the chronic dietary exposure analysis: 2.5% almonds, 10% apples, 34% apricots, 2.5% cherries, 10% cranberry, 15% grapefruit, 5% grapes, 2.5% lemons, 5% oranges, 5% peaches, 15% pears, 5% plums and prunes, 19% strawberry, 15% tangerines, and 4% tomatoes.

         EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available federal, state, and private market survey data for that use, averaging by year, averaging across all years, and rounding up to the nearest multiple of five except for those situations in which the average PCT is less than one. In those cases The lack of evidence for abnormalities in the development of the fetal nervous system including the prenatal developmental toxicity studies in either rats (oral gavage up to 1,000 mg/kg/day) or rabbits (oral greater than 15 mg/kg/day and dermal up to 450 mg/kg/day) and the 2-generation reproduction study in rats (up to 6.31 mg/kg/day).

         The levels at which effects occurred in the acute and subchronic neurotoxicity studies were the highest doses tested where significant toxicity, other than neurotoxic signs were noted. Transient piloerection and hypoactivity were noted in the mid dose males (100 mg/ kg/day) and piloerection, hypoactivity, tremors and partially closed eyes were observed in animals in the 200 mg/kg bwt group (highest dose tested) in the acute neurotoxicity study in rats. There was also transient (only 1 week), poorly coordinated righting reflex in highest dose tested (28.8 mg/kg/day) in males only in the subchronic neurotoxicity study. No neuropathology was noted in either study.

         Inhibition of plasma (butyryl and acetyl) cholinesterase activity at the highest dose tested (27.68 mg/kg/day, females) in the standard 90-day rat feeding study, this was not seen in the reversibility phase of the study. Pyridaben may have some flexibility and charge characteristics which would allow it to interact with the cholinesterase receptor in some tissues, but this response is not indicative of a neurotoxic mode of action.

         Only transient (appearing at only week 8, but not at weeks 4 or 13), poorly coordinated righting reflex in high dose males (28.8 mg/kg bwt/day) was observed in the absence of neurotoxicity in the subchronic neurotoxicity study.

         No other study of any duration showed evidence of neurotoxic effects (clinical signs, organ weights, histopathology) and the studies were tested high enough to elicit frank toxicity (other than neurotoxicity).

         The 2-generation reproduction study in rats included developmental and neurotoxicity assessments. The observations included a comprehensive evaluation of clinical signs, onset and completion of pinna (ear) unfolding, hair growth, tooth eruption, eye opening, auditory and visual function assessed using the startle response and examination of pupil closure along with assessment of the visual placement response. No effects were noted up to and including the highest dose tested (6.31 mg/kg/day). No effects were noted on reproductive parameters. The observed effects in the 2-generation reproduction study were minimal in nature involving only body weight and food consumption.

      3. Conclusion. There is a complete toxicity data base for pyridaben and exposure data are complete. There is no quantitative or qualitative evidence of increased susceptibility of rat and rabbit fetuses to in utero exposure to pyridaben in developmental studies. There is no quantitative or qualitative

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         evidence of increased susceptibility to pyridaben following prenatal/ postnatal exposure in a 2-generation reproduction study incorporating neurotoxicity measurements. There is no concern for developmental neurotoxicity resulting from exposure to pyridaben. Since there was no observed evidence of potential developmental neurotoxicity in short- and long-term toxicity studies in rats, mice, and dogs, a DNT study is not required.

         The dietary exposure scenarios includes metabolites and/or degradates of concern and the dietary food exposure assessment is refined for acute food exposure and partially refined for chronic food exposure. Although refined, the assessments are based on reliable data and will not underestimate exposure/risk. The dietary drinking water assessment (Tier 2 estimates) utilizes values generated by models and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations. There are no residential uses of pyridaben.

         Based on these data, the Agency has reduced the FQPA Safety Factor to 1X and a developmental neurotoxicity study will not be required.

   5. Aggregate Risks and Determination of Safety

      The Agency currently has two ways to estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses. First, a screening assessment can be used, in which the Agency calculates drinking water levels of comparison (DWLOCs) which are used as a point of comparison against EECs. The DWLOC values are not regulatory standards for drinking water, but are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water (e.g., allowable chronic water exposure (mg/kg/day) = cPAD - (average food + residential exposure)). This allowable exposure through drinking water is used to calculate a DWLOC.

      A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by EPA's Office of Water are used to calculate DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short-term, intermediate-term, chronic, and cancer.

      When EECs for surface water and ground water are less than the calculated DWLOCs, EPA concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. When new uses are added EPA reassesses the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.

      More recently the Agency has used another approach to estimate aggregate exposure through food, residential and drinking water pathways. In this approach, modeled surface water and ground water EECs are directly incorporated into the dietary exposure analysis, along with food. This provides a more realistic estimate of exposure because actual body weights and water consumption from the CSFII are used. The combined food and water exposures are then added to estimated exposure from residential sources to calculate aggregate risks. The resulting exposure and risk estimates are still considered to be high end, due to the assumptions used in developing drinking water modeling inputs.

      There are no existing or proposed uses for pyridaben that would result in residential non-dietary exposure, therefore aggregate acute and chronic risks are based solely on exposure from food and water, which are as follows:

      1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to pyridaben will occupy 3% of the aPAD for the U.S. population, 2% of the aPAD for females 13 years and older, 4% of the aPAD for all infants