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

[Federal Register: October 27, 2004 (Volume 69, Number 207)]

[Rules and Regulations]

[Page 62602-62615]

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

[DOCID:fr27oc04-16]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0331; FRL-7683-5]

Deltamethrin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a tolerance for combined residues of deltamethrin, isomers trans-deltamethrin and [alpha]-R-deltamethrin in or on almond hulls; apples, wet pomace; artichoke, globe; barley, bran; cattle, fat; cattle, meat; cattle, meat byproducts; corn, field, forage; corn, field, refined oil; corn, field, stover; corn, pop, stover; corn, sweet, forage; corn, sweet, kernel + cob with husks removed; corn, sweet, stover; egg; fruit, pome, group 11; goat, fat; goat, meat; goat, meat byproducts; grain, aspirated fractions; grain, cereal, group 15, except sweet corn; hog, fat; horse, fat; horse, meat; horse, meat byproducts; lychee (import tolerance); milk, fat (reflecting 0.02 ppm in whole milk); nut, tree, group 14; onion, dry bulb; onion, green; poultry, fat; poultry, meat; poultry, meat byproducts; radish tops; rapeseed; rice, hulls; rye, bran; sheep, fat; sheep, meat; sheep, meat byproducts; sorghum, grain forage; sorghum, grain stover; soybean, seed; soybean, hulls; starfruit (import tolerance); sunflower seeds; vegetable, cucurbit, group 9; vegetable, fruiting, group 8; vegetable, root, except sugar beet, subgroup IB; vegetable, tuberous and corm, subgroup; IC; wheat, bran. Bayer Crop Science LP, formerly Aventis CropScience, requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective October 27, 2004. Objections and requests for hearings must be received on or before December 27, 2004.

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 -2004-0331. 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: George LaRocca, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone number: (703) 305-6100; e-mail address: larocca.george@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;

      [[Page 62603]]

      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 November 7, 2001 (66 FR 56298) (FRL- 6808-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 1E6232) (PP 0F6080) by Bayer Crop Science LP, formerly Aventis CropScience, P.O. Box 12014, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.435 be amended by establishing a tolerance for residues of the insecticide deltamethrin, in or on almond hulls; apples, wet pomace; artichokes; brassica, head and stem crop subgroup 5A, excluding cabbage; bulb vegetables ; cabbage (w/wrapper leaves); cabbage (w/o wrapper leaves); carambola (star fruit); corn, field grain; corn, forage (field); corn, fodder/stover (field); corn, refined oil; corn, flour; corn, meal; corn, milled by products; cucurbit vegetables; eggs; fruiting vegetables; leafy vegetables; lichi fruit; milk, fat (reflecting 0.02 ppm in whole milk); mustard greens; pome fruit; poultry, fat; poultry, mbyp; poultry, meat; prunes; rapeseed (including canola and crambe); root vegetable, except sugarbeet (subgroup 1B): roots; ruminant fat; ruminant mbyp; ruminant meat; sorghum, forage; sorghum, fodder/stover; sorghum, grain; soybeans; stone fruit; sunflower seeds; tree nuts; tuberous and corm vegetables subgroup 1C, excluding artichokes; wheat gluten (post harvest); wheat, grain (post harvest); wheat, grain dust (post harvest) at 1.2, 1.2, 0.5, 0.50, 1.5, 1.5, 0.15, 0.2, 0.06, 0.7, 7.0, 0.6, 0.18, 0.12, 0.18, 0.06, 0.02, 0.25, 4.5, 0.2, 0.1, 4.5, 0.2, 0.05, 0.02, 0.02, 2.4, 0.12, 0.15, 0.04, 0.02, 0.02, 0.5, 2.0, 0.5, 0.05, 0.6, 0.05, 4.0, 0.1, 0.04, 1.4, 2.0, and 2.7 parts per million (ppm) respectively . The registrant originally filed petition PP 1E6232 with the Agency, proposing the establishment of regulations for residues of deltamethrin, an insecticide, in or on various food commodities. The petition (PP 1E6232) requested the establishment of proposed tolerances for deltamethrin in/on almond hull, three crop subgroups and rapeseed, and import tolerances for two tropical fruits, as petitioned through the Minor Crop Pest Management program (IR-4). Petition (PP 1E6232) was superceded, at the request of the registrant, by petition (PP 0F6080), including additional tolerances for the above listed crops, and the proposed commodities described in the previous petition (PP 1E6232). The Notice of Filing of November 7, 2001 ( 66 FR 56298) (FRL-6808-5) identified an inclusive summary of both petitions prepared by Bayer Crop Science LP formerly Aventis CropScience, the registrant. There were no comments received in response to the notice of filing.

   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).

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 combined residues of deltamethrin, isomers trans-deltamethrin and [alpha]-R-deltamethrin in or on the commodities listed in Unit II. 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 deltamethrin is discussed in Tables 1 and 2 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.

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

      Guideline No.

      Study Type

      Results

      870.3100

      90-day oral toxicity-- NOAEL = 1.0 and 10 milligrams/kilogram/day rodents

      (mg/kg/day) for males and females respectively LOAEL = 2.5 mg/kg/day for males based on decreased body weight for males, females was not established.

      870.3150

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

      LOAEL = 2.5 mg/kg/day based on central nervous system effects diarrhea, vomiting and decreased body weight gain for males and females.

      870.3200

      21/28-Day dermal toxicity NOAEL > 1,000 mg/kg/day for males and rat

      females (limit dose) Dermal NOAEL was not established. Signs of local irritation seen at all doses.

      870.3250

      90-Day dermal toxicity NA

      870.3465

      21-Day inhalation toxicity NOAEL = 3.0 mg/kg/day males and females. rat

      LOAEL = 9.6 mg/kg/day based on decreased weight gain, nervous system stimulation and skin irritation for males and females

      870.3700

      Prenatal developmental-- Maternal NOAEL = 3.3 mg/kg/day rodents

      Maternal LOAEL = 7.0 mg/kg/day based on decreased body weights and body weight gains and clinical signs of toxicity Developmental NOAEL = greater than 11.0 mg/ kg/day Developmental LOAEL = none observed

      870.3700

      Prenatal developmental-- Maternal NOAEL >= 10 mg/kg/day mouse

      Maternal LOAEL = not observed Developmental NOAEL = 0.1 mg/kg/day Developmental LOAEL = 1.0 mg/kg/day based on decreased fetal weight, and delayed ossification of the sternebrae and paws

      870.3800

      Reproduction and fertility Parental/Systemic NOAEL = 5.4 and 6.1 mg/kg/ effects

      day for males and females respectively. Parental/Systemic LOAEL = 21.2 and 23.5 mg/ kg/day for males and females respectively. Based on increased mortality and clinical signs, decreased body weights, body weight gains, and absolute food consumption, and gross pathological findings in both sexes. Reproductive NOAEL = 21.2 mg/kg/day for males and females. Reproductive LOAEL = [not established] Offspring NOAEL = 5.8 and 6.7 mg/kg/day for males and females respectively. Offspring LOAEL = 24.9 and 27.2 mg/kg/day for males and females respectiveley. Based on increased mortality and clinical signs, decreased body weights, body weight gains, and absolute food consumption, and gross pathological findings in both sexes.

      870.4100

      Chronic toxicity--rodents Same as Chronic Toxicity/Carcinogenicity- rat see below (870.4300)

      870.4100

      Chronic toxicity--dogs NOAEL = 1.0 mg/kg/day males and females. LOAEL = 10.0 mg/kg/day males and females. Based on reduced body weight gain, chewing and scratching of extremities, and liquid feces.

      870.4200

      Carcinogenicity--rats No evidence of carcinogenicity Same as chronic toxicity/carcinogenicity- rat see below (870.4300).

      870.4300

      Carcinogenicity--mice NOAEL = 2,000 mg/kg/day (HDT) LOAEL = not established No evidence of carcinogenicity, HDT assumed to be adequate to characterize the carcinogenic potential based on a 12-week toxicity study in mice showing death and body weight differences (13% decrease) at 3,000 ppm.

      870.4300

      Chronic/Carcinogenicity- NOAEL = >50 ppm (HDT) for males and rat

      females. LOAEL was not determined No evidence of carcinogenicity

      870.5100

      Bacterial reverse mutation There was no evidence of an induced test-S. typhimurium

      mutagenic effect up to cytotoxic concentrations >=38 micro grams/mL -S9; 150 [mu]g/mL +S9). Levels >=75 micrograms/ mL were insoluble.

      [[Page 62605]]

      870.5375

      In vitro mammalian

      There was no evidence of an induced chromosome aberration mutagenic effect up to cytotoxic test- Chinese hamster concentrations (>=38 micrograms/mL -S9; ovary (CHO) cells

      150 micrograms/mL +S9). Levels >=75 micrograms/mL were insoluble.

      870.5550

      Other Genotoxicity

      There was no evidence of DNA repair/damage Bacterial DNA damage/

      up to the limit dose ( (5,000 micrograms/ repair-E. coli.

      well +/-S9). Compound precipitation seen at >=200 micrograms/well.

      870.5550

      Other Genotoxicity

      There was no evidence that unscheduled DNA Unscheduled DNA synthesis synthesis was induced up to insoluble in primary rat

      concentrations (>=130 micrograms/mL). hepatocytes.

      870.6200

      Acute neurotoxicity

      NOAEL = 5 mg/kg/day screening battery rats LOAEL = 15 mg/kg/day based on salivation, soiled fur, impaired motility, no reaction to approach or touch response in the functional observation battery (FOB)

      870.6200

      Subchronic neurotoxicity NOAEL = 14 and 16 mg/kg/day for males and screening battery

      females respectively. LOAEL = 54 and 58 mg/kg/day for males and females respectivley.. Based on mortality, clinical signs, FOB findings, and decreased body weights, body weight gains, and food consumption.

      870.6300

      Developmental

      NA neurotoxicity

      870.7485

      Metabolism and

      The test material was relatively well pharmacokinetics - rats absorbed. Excretion was almost complete within 48 hours. Approximately 36-59% of the dose was found in feces and an approximately equal amount in urine. Absorbed deltamethrin was cleaved by hydrolysis at the ester site followed by rapid sulfate and glucuronide conjugation.

      870.7600

      Dermal penetration

      NA

      Special studies

      There were no special studies

      Table 2.--Non-guideline Toxicity Studies and Literature.

      Study Type

      Results

      Citation

      Acute Motor Function Oral-male rat Vehicle: Corn oil

      Crofton et al., (1995) ED50 5.1 mg/kg............................. LOAEL 3.0 mg/kg (based on reduced motor function). NOAEL 1.0 mg/kg............................ Vehicle: Methylcellulose................... ED50 >1,000 mg/kg.......................... LOAEL 300 mg/kg (based on reduced motor function). NOAEL 100 mg/kg............................

      Acute Motor Function Oral- male rat Vehicle: Corn oil

      Crofton and Reiter, (1984) LOAEL 2.0 mg/kg (based on reduced motor function). NOAEL Not established......................

      Acute Locomotor Activity Oral- male rat Vehicle: Corn oil

      Gilbert et al., (1990) LOAEL 3.0 mg/kg (based on reduced locomotor activity). NOAEL 1.0 mg/kg............................

      Acute Acoustic Startle Response (ASR) Vehicle: Corn oil

      Sheets et al., (1994) Oral-rats

      21-day old rats:........................... LOAEL 1 mg/kg.............................. NOAEL Not established...................... Adults:.................................... LOAEL 2 mg/kg.............................. NOAEL Not established...................... At the ED50 (4 mg/kg), the brain concentration of deltamethrin was [ap]2- fold higher in weanlings than in adults.

      [[Page 62606]]

      Acute Behavioral Tests Oral - Mice Vehicle: 20% Fat Emulsion at 0.7 mg/kg Eriksson and Fredriksson, (only dose tested)

      (1991) 17- day old mice........................... No significant changes..................... 4-month old mice........................... Significant changes in locomotion, rearing and activity and a significant decrease in 3HQNB binding sites in the cerebral cortex..

      Prenatal developmental--rodents

      Maternal NOAEL = 1.0 mg/kg/day

      Non-guideline Maternal LOAEL = 7.0 mg/kg/day based on slightly reduced body weights. Developmental NOAEL = 1.0 mg/kg/day........ Developmental LOAEL = 10 mg/kg/day based on delayed ossification of the sternebrae.

      Prenatal developmental--nonrodents Maternal NOAEL = 100 mg/kg/day

      Non-guideline Maternal LOAEL = not established........... Developmental NOAEL = 25 mg/kg/day......... Developmental LOAEL = 100 mg/kg/day based on increases in the incidences of delayed ossification and skeletal variations.

      Prenatal developmental--nonrodents Maternal NOAEL = 10 mg/kg/day

      Non-guideline Maternal LOAEL = 32 mg/kg/day based on decreased bodyweight gain between GD 6 and 21.. Developmental NOAEL = >32 mg/kg/day........ Developmental LOAEL = not established......

   2. Toxicological Endpoints

      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. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.

      Three other types of safety or uncertainty factors may be used: ``Traditional uncertainty factors;'' the ``special FQPA safety factor;'' and the ``default FQPA safety factor.'' By the term ``traditional uncertainty factor,'' EPA is referring to those additional uncertainty factors used prior to FQPA passage to account for database deficiencies. These traditional uncertainty factors have been incorporated by the FQPA into the additional safety factor for the protection of infants and children. The term ``special FQPA safety factor'' refers to those safety factors that are deemed necessary for the protection of infants and children primarily as a result of the FQPA. The ``default FQPA safety factor'' is the additional 10X safety factor that is mandated by the statute unless it is decided that there are reliable data to choose a different additional factor (potentially a traditional uncertainty factor or a special FQPA safety factor).

      For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by an UF of 100 to account for interspecies and intraspecies differences and any traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). Where a special FQPA safety factor or the default FQPA safety factor is used, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of safety factor.

      For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

      The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk). An example of how such a probability risk is expressed would be to describe the risk as one in one hundred thousand (1 X 10-\5\), one in a million (1 X 10-\6\), or one in ten million (1 X 10-\7\). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a ``point of departure'' is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOEcancer= point of departure/exposures) is calculated.

      A summary of the toxicological endpoints for deltamethrin used for human risk assessment is shown in Table 3 of this unit:

      [[Page 62607]]

      Table 3.--Summary of Toxicological Dose and Endpoints for Deltamethrin for Use in Human Risk Assessment

      Dose Used in Risk Assessment, Interspecies and Special FQPA SF and Level of Study and Toxicological Exposure Scenario

      Intraspecies and any Concern for Risk Assessment

      Effects Traditional UF

      Acute Dietary (General Population and Females 13-49 years of

      NOAEL = 1.0 mg/kg/day

      Special FQPA SF = 3X Neurotoxicity-Motor Activity age)

      UF = 100 aPAD = acute RfD/ Special

      (Crofton et al., 1995) Acute RfD = 0.01 mg/kg/day FQPA SF = 0.0033 mg/kg/day LOAEL = 3.0 mg/kg/day based on reduced motor activity

      Chronic Dietary (All populations)

      NOAEL= 1.0 mg/kg/day

      Special FQPA SF = 3X

      Chronic Dog Study UF = 100 cPAD = chronic RfD/Special LOAEL = 10 mg/kg/day based Chronic RfD = 0.01 mg/kg/day FQPA SF = 0.0033 mg/kg/day

      on clinical signs and reduced body weight gain

      Incidental Oral Short and Intermediate Term

      NOAEL = 1.0 mg/kg/day

      LOC for MOE = 300 Same as chronic dietary UF = 100

      Dermal All Durations

      Not required: No systemic toxicity via the dermal route was seen at the limit dose; there was no evidence of cumulative toxicity; and physical and dermal properties indicate low dermal absorption.

      Inhalation All Durations (Residential)

      NOAEL = 1.0 mg/kg/day

      LOC for MOE = 300 Same as chronic dietary. UF = 100= 100%)

      (Residential)

      Cancer (oral, dermal, inhalation)

      Classification: Not likely to be a human carcinogen.

   3. Exposure Assessment

      1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.435) for the combined residues of deltamethrin, isomers trans-deltamethrin and [alpha]-R-deltamethrin, in or on a variety of raw agricultural commodities, including additional meat, milk, poultry and egg tolerances. Risk assessments were conducted by EPA to assess dietary exposures from combined residues of deltamethrin, isomers trans-deltamethrin and [alpha]-R-deltamethrin, and tralomethrin in food as follows:

         i. Acute exposure. Acute dietary 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 one-day or single exposure.

         In conducting the acute dietary risk 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 Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: The acute dietary exposure analysis was a refined probabilistic one. The analysis was refined through the use of projected market share estimates from Agency analysis and anticipated residues (ARs) based on field trial values. At the 99.9th percentile of exposure, the risk estimate for the general U.S. population is 39% of the acute population adjusted dose (aPAD). The most highly exposed population subgroup is All Infants, which utilizes 65% of the aPAD.

         ii. Chronic exposure. In conducting the chronic dietary risk 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 Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: Chronic exposure analysis was refined through the use of projected market share estimates from Agency analysis and the anticipated residues (ARs) are based on field trial values. The U.S. population and all population subgroups have exposure and risk estimates that are below the Agency's level of concern. The general U.S. population utilizes 3.0% of the chronic PAD (cPAD). The most highly exposed subgroup, Children 1-2 years, utilizes 7.6% of the cPAD.

         iii. Cancer. Deltamethrin is classified by the Agency as not likely to be carcinogenic in humans.

         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 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.

         Section 408(b)(2)(F) of the 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

         [[Page 62608]]

         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 %CT as required by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to submit data on %CT.

         The Agency used PCT information as follows:

         For existing uses of deltamethrin and tralomethrin, the Agency used estimates of PCT for the acute and chronic exposure assessments which were determined using Doanes Market Survey Data (1996-2001). The following deltamethrin PCT data estimates were used for both the acute and chronic dietary exposure assessments: Cotton (14), tomato (19). The following tralomethrin PCT data estimates were used for both the acute and chronic dietary exposure assessments: Broccoli (6.0), lettuce, head (15), lettuce, leaf (22), and soybean (1.0). Tralomethrin is also registered for use on cotton and sunflower. For cotton, the deltamethrin PCT value is higher; therefore, the deltamethrin value was used in the assessment. There is a proposed use for deltamethrin on sunflower, and the projected market share value is higher than the PCT value for tralomethrin. As a result, the projected market share value for deltamethrin was used in the assessment. Since deltamethrin and tralomethrin are essentially the same chemical, it was assumed that both pesticides would not be used on the same crop.

         The Agency believes that the three conditions listed in Unit III.C.1.iv. have been met. With respect to Condition 1, PCT estimates are derived from market survey data, which are reliable and have a valid basis.

         The Agency used maximum PCT for both acute and chronic dietary exposure estimates. A maximum PCT is unlikely to underestimate exposure to an individual because of the fact that an individual is unlikely to be exposed to more than the maximum PCT either on an acute basis or over a lifetime. For acute assessments, the Agency incorporates PCT information by creating a residue distribution file which includes the measured residue values from field trials, and zero residue values added to account for the percent of crop not treated. This approach is used only for non-blended or partially blended commodities as defined under EPA SOP99.6. For blended commodities, a single-point estimate is created from the residue value multiplied by the upper bound PCT. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation.

         For the new uses, the Agency used PCT estimates for both the acute and chronic exposure assessments based on market share projections as follows: Almond (28 %); apple (38 %); canola (1.0 %); cantaloupe (11 %); carrot (22 %); corn (5.0 %); cucumber (10 %); garlic (1.0 %); onion (2.0 %); pear (23 %); pepper (12 %); potato (7.0 %); soybean (1.0 %); squash (2.0 %); sunflower (9.0 %); and walnut (5.0%). The following methods were used to estimate market share for the new uses: The Agency reviewed the proposed new uses for deltamethrin, identified practicable alternatives based on the primary target pest for each use site, and estimated a likely upper-bound for the percent crop treated. The Agency has determined that the alternatives are viable based on the best available EPA data, and assumes they will control the insect pests identified on the proposed label. The Agency believes that the projected market share estimates are upper-bound estimates because it summed the current market share of all chemicals that are currently being used to control the target pest on a particular crop. By doing so, the Agency has made the assumption that deltamethrin will replace all other insecticides that are currently being used on that crop to control the primary target pest that deltamethrin will be used to control. Furthermore, the Agency has made the assumption that deltamethrin will replace all competing insecticides on all of the crops for which projected market share data were used. In addition, the Agency has made the assumption that for many of the crops in the dietary analysis, 100% of the crop would be treated. For the stored grains, the PCT estimates are derived from usage data for chlorpyriphos-methyl, historically the most widely used insecticide for control of insect pests in stored grains. The estimates are as follows: Wheat, oats, and barley (avg: 8.0 %, max: 9.0 %); field corn and pop corn (avg: 3.0 %, max: 6.0 %); sweet corn (avg: 2.1 %, max: 3.5 %); sorghum (avg: 3.2 %, max: 3.7 %); and rice (avg: 2.9 %, max: 3.1 %). For all other new uses, it was assumed that 100% of the crop would be treated.

         The Agency believes that the three conditions previously discussed have been met regarding PCT estimates for the new deltamethrin registrations. With respect to Condition 1, EPA finds that the PCT information described in Unit II.C.1.iv. for deltamethrin on almonds, apples, canola, cantaloupe, carrots, corn, cucumbers, garlic, onions, pears, peppers, potatoes, soybeans, squash, sunflowers, walnuts, and stored cereal grains is derived from market survey data, which are reliable and have a valid basis. For almonds, apples, canola, cantaloupe, carrots, corn, cucumbers, garlic, onions, pears, peppers, potatoes, soybeans, squash, sunflowers, and walnuts, the PCT estimates are based on current market share data for all alternative insecticides used to control the primary target pest, and the generous assumption that deltamethrin will replace all of the competing insecticides used to control that target pest. For stored grains, the estimate is derived from usage data for chlorpyrifos-methyl, historically the most widely used insecticide for control of insect pests in stored grains. These estimates should not underestimate actual usage of deltamethrin on the new crops/sites.

         As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which deltamethrin may be applied in a particular area.

      2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for deltamethrin in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of deltamethrin.

         [[Page 62609]]

         The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The SCI-GROW model is used to predict pesticide concentrations in shallow groundwater. For a screening-level assessment for surface water EPA will use FIRST, a tier 1 model, before using PRZM/EXAMS, a tier 2 model. The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high end runoff scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an index reservoir environment, the PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.

         None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a screen for sorting out pesticides for which it is unlikely that drinking water concentrations would exceed human health levels of concern.

         Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs), which are the model estimates of a pesticide's concentration in water. EECs derived from these models are used to quantify drinking water exposure and risk as a %RfD or %PAD. Instead drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to deltamethrin they are further discussed in the aggregate risk sections in Unit III.E.

         Based on FIRST and SCI-GROW models, the EECs of deltamethrin for acute exposures are estimated to be 0.20 parts per billion (ppb) for surface water and 0.006 ppb for ground water. The EECs for chronic exposures are estimated to be 0.067 ppb for surface water and 0.006 ppb for ground water.

      3. From non-dietary exposure. The term ``residential exposure'' is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

         Deltamethrin is currently registered for use on lawns, turf, golf courses, sod farms, ornamental gardens, perimeter treatment, indoor broadcast, spot, and crack and crevice surface treatment, and pet collars. The end use products are formulated as ready-to-use sprays, granular, dust, wettable powders and liquids to be applied by commercial applicators and/or homeowners depending on the product. These uses include a wide range of application methods including hose- end sprayers, push-type spreader, shaker can, aerosol can, low/high pressure hand wands, injection, airless sprayers, injection syringe, and paint brush/roller used to treat indoors and outdoors.

         No dermal endpoint was selected because no systemic toxicity via the dermal route was seen at the limit dose and therefore a dermal risk assessment for handlers was not required. All inhalation MOEs for residential handlers exposure ranged from 3,300 to 1,800,000 and therefore did not exceed the Agency's level of concern.

         Based on the use pattern of residential products, duration of postapplication exposure is expected to be short term. As indicated previously no dermal endpoint was selected and therefore no risk from dermal exposure is expected. The Agency concluded that use of an indoor fogger would result in the worst case scenario for assessing postapplication inhalation exposure. The postapplication inhalation MOEs following use of a fogger were greater than the targeted MOE and therefore the risks were not of concern. Fogger postapplication risks are protective of inhalation risks from other indoor products. Furthermore the vapor pressure of deltamethrin is very low (1.5 x 10-\8\ mm Hg at 25[deg]) and therefore postapplication inhalation exposure is expected to be minimal for indoor uses.

         The following postapplication incidental oral scenarios following application to lawns and indoor surfaces (carpet versus hardwood or vinyl floors) were assessed:

         i. Short-term oral hand-to-mouth exposure to toddlers and children from indoor use ;

         ii. Short-term oral object to mouth exposure to toddlers and children from ingestion of pesticide treated turf; and

         iii. Short-term oral exposure to toddlers and children following soil ingestion. Since the FQPA safety factor for the protection of children and infants was reduced to 3X, a target MOE value of 300 has been identified for residential assessments. MOE values greater than 300 are not considered to be of concern to the Agency. MOE estimates are based on the NOAEL dose level of 1 mg/kg/day established for short-term oral risk assessment.

         Table 4.--Summary of Short-term Residential Postapplication MOEs.

         Exposure Scenario

         Oral Dose (mg/kg/day

         Oral MOE

         Hand-to-Mouth (Indoor Use)

         0.0028

         340

         Object-to-Mouth (Turf)

         0.00049

         2,000

         Soil Ingestion (Turf)

         0.0000065

         150,000

         Note: Episodic incidental ingestion of granules and paint chips was also assessed and was not considered to be of concern to the Agency.

      4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.''

         Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to deltamethrin and any other substances and deltamethrin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that deltamethrin has a common mechanism of toxicity with other substances. For information

         [[Page 62610]]

         regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's OPP concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's web site at http://www.epa.gov/pesticides/cumulative/.

   4. Safety Factor for Infants and Children

      1. In general. Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate.

      2. Prenatal and postnatal sensitivity. The toxicology data base for deltamethrin for an FQPA assessment includes developmental toxicity studies in rats, rabbits and mice, a two-generation reproduction toxicity study in rats, acute and subchronic neurotoxicity studies in rats, and studies from the open literature indicating increased susceptibility and neurotoxicity.

         Signs of neurotoxicity were seen in guideline acute and subchronic neurotoxicity studies in rats, including salivation, soiled fur, impaired mobility, no reaction to approach and no reaction to touch response observed in the functional observation battery (FOB) in the acute study, and mortality, clinical signs of toxicity, FOB findings, and decreased body weights, body weight gains, and food consumption in the subchronic study. In addition, similar signs of neurotoxicity were observed in several literature studies conducted in rats and mice.

         Acceptable developmental toxicity studies in rats and rabbits indicated no evidence of developmental toxicity. In 3 non-guideline multi-species developmental toxicity studies, there is concern for developmental effects that occurred in either the absence of or in the presence of mild maternal toxicity in three species (mice, rats and rabbits). In mice, an increase in delayed ossification in the fetuses was seen in the absence of maternal toxicity at the highest dose tested. In rats, increased delayed ossification was seen in the presence of decreased body weight in the dams. In rabbits, increased fetal death and decreased fetal body weight were seen in the absenceof maternal toxicity at the highest dose tested.

         There is qualitative evidence of increased susceptibility only at the highest dose tested in the two-generation toxicity study in rats. Effects were seen in the adults of the F1 generation. These effects were not seen in the P generation or in the F1 rats when they were pups. These effects included increased death, clinical findings (i.e. impaired righting reflexes, hyperactivity, splayed limbs, vocalization, and excessive salivation) and cerebral congestion and/or blood clots at the highest dose tested. Evidence for age-related sensitivity was seen in a published literature study in which the brain concentration of deltamethrin in weanling rats was higher than in adult rats.

         Based on clinical signs indicative of neurotoxicity observed in adult animals, concern for the effects seen in the two-generation reproduction study and structural-activity relationship concerns, a developmental neurotoxicity study (DNT) has been required for deltamethrin. The study protocol indicates that the proposed lowest dose in the study is 1 mg/kg/day, which is equivalent to the NOAELs currently selected for dietary and non-dietary risk assessment.

      3. Conclusion. The hazard-based FQPA Safety Factor has been reduced to 3x for all population subgroups including those comprised of infants and children.

         Previously, the Agency determined that the overall FQPA Safety Factor should be retained at 10x due to the lack of an acceptable pre- natal toxicity study in rabbits; the lack of the required developmental neurotoxicity (DNT) study; an overall degree of concern for the qualitative and quantitative evidence of increased susceptibility observed in mice; and residual uncertainties for pre/post-natal toxicity. The default 10x factor encompassed the database uncertainty factor and the Special FQPA Safety Factor.

         The Agency has since received and reviewed an acceptable pre-natal developmental toxicity study in rabbits which does not show evidence (quantitative or qualitative) of increased susceptibility. A dose analysis indicated no need for a database uncertainty factor for the lack of a DNT since this study is not expected to lower the doses currently used for the overall risk assessment. Therefore, there is no need for a database uncertainty factor. However, the Special FQPA Safety Factor is needed since there is still a concern for the qualitative evidence of increased susceptibility observed in mice. A Special FQPA Safety Factor of 3X (as opposed to a 10X) was determined to be adequate based on the following weight-of-evidence considerations.

         i. The endpoint of concern for risk assessment is already based on the most sensitive endpoint (i.e., clinical signs indicative of neurotoxicity),

         ii. In the acute and subchronic neurotoxicity studies, no damage to the neurological system (e.g., neuropathology or alterations in brain weight) was seen, and there was no evidence of malformations or variations of the central nervous system of the fetuses in the pre- natal studies or to offspring in the post-natal study,

         iii. The generally accepted mechanism of action for pyrethroids, sodium channel disruption, has not been traditionally associated with developmental neuropathology, and

         iv. A dose that was four-fold higher than the dose used for risk assessment was required to cause the two-fold difference in brain concentration of deltamethrin in weanling rats.

         The NOAEL of 1.0 mg/kg/day currently used for overall risk assessment is protected by a safety factor of 3X which yields an extrapolated dose of 0.3 mg/kg/day. This dose is an order of magnitude lower than the dose that caused the two-fold decrease in brain concentrations of deltamethrin in the weanling rats. Therefore, a half- log reduction (3X) in the Special FQPA Safety Factor is considered to be sufficiently protective of the concerns for the qualitative susceptibility seen in mice.

   5. Aggregate Risks and Determination of Safety

      To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against EECs. DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a

      [[Page 62611]]

      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 the EPA's Office of Water are used to calculate DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female and youth 13-19), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. 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, OPP concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP 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. If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.

      1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to deltamethrin will occupy 39% of the aPAD for the U.S. population, 28% of the aPAD for females 13 to 49, 65% of the aPAD for All Infants (