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

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Federal Register: May 30, 2003 (Volume 68, Number 104)Rules and RegulationsPage 32390-32400From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr30my03-20

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

OPP-2003-0133; FRL-7306-8Clothianidin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes tolerances for residues of clothianidin in or on canola, corn, and milk. In addition, tolerances are established for indirect or inadvertent residues of clothianidin in or on nongrass animal feed; cereal grain forage, fodder and straw; grass forage, fodder and hay; and soybean forage and hay. Bayer Corporation 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 May 30, 2003. Objections and requests for hearings, identified by docket ID number OPP-2003-0133, must be received on or before July 29, 2003.

ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Daniel Kenny, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone number: (703) 305-7546; e-mail address: kenny.dan@epa.gov. SUPPLEMENTARY INFORMATION:

I. General Information

A. 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:

[sbull] Crop Production (NAICS 111)

[sbull] Animal Production (NAICS 112)

[sbull] Food Manufacturing (NAICS 311)

[sbull] Pesticide Manufacturing (NAICS 32532)

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.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0133. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., 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.

2. Electronic access. 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 http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html , a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select ``search,'' then key in the appropriate docket ID number.

II. Background and Statutory Findings

In the Federal Register of November 14, 2001 (66 FR 57079) (FRL- 6809-7), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 1F6315) by Bayer Corporation, 8400 Hawthorn Road, Kansas City, MO 64120. That notice included a summary of the petition prepared by Bayer Corporation, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on canola, seed at 0.01 parts per million (ppm); corn, field, grain at 0.01 ppm; corn, pop, grain at 0.01 ppm; corn, sweet, kernel plus cob with husk removed at 0.01 ppm; corn, field, forage at 0.10 ppm; corn, sweet, forage at 0.10 ppm; corn, field, stover at 0.10 ppm; corn, sweet, stover at 0.10 ppm; corn, pop, stover at 0.10 ppm; and milk at 0.01 ppm. Following the review of all the data, tolerances are also required on the following rotational crops, which are used only for livestock feeds. These tolerances do not impact the dietary risk

[Page 32391]assessment since these residues are significantly lower than those in feed items from the crops which are treated directly with clothianidin and/or thiamethoxam. Tolerances are established on animal feed, nongrass at 0.02 ppm; grain, cereal, forage, fodder and straw at 0.02 ppm; grass, forage, fodder and hay at 0.02 ppm; soybean, forage at 0.02 ppm; and soybean, hay at 0.02 ppm.

Section 408(b)(2)(A)(i) of the 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 the 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 the 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 the 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).

III. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D) of the 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 the FFDCA, for tolerances for residues of clothianidin on canola, seed at 0.01 ppm; corn, field, grain at 0.01 ppm; corn, pop, grain at 0.01 ppm; corn, sweet, kernel plus cob with husk removed at 0.01 ppm; corn, field, forage at 0.10 ppm; corn, sweet, forage at 0.10 ppm; corn, field, stover at 0.10 ppm; corn, sweet, stover at 0.10 ppm; corn, pop, stover at 0.10 ppm; and milk at 0.01 ppm, animal feed, nongrass at 0.02 ppm; grain, cereal, forage, fodder and straw at 0.02 ppm; grass, forage, fodder and hay at 0.02 ppm; soybean, forage at 0.02 ppm; and soybean, hay at 0.02 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

A. 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 clothianidin 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

NOAEL: 27.9/34.0 toxicity rodents milligrams/ (rats)

kilogram/day (mg/ kg/day) (male/ female) LOAEL: 202.0/254.2 mg/kg/day (male/ female: decreased body weight (bwt) and bwt gain)

870.3150

90-Day oral

NOAEL: 19.3/42.1 mg/ toxicity in

kg/day (male/ nonrodents (dogs) female) LOAEL: 40.9/61.8 mg/ kg/day (thinness, decreased bwt, bwt gain and anemia (one male); decreased white blood cells, albumin, and total protein (female)

870.3200

21/28-Day dermal NOAEL: 1,000 mg/kg/ toxicity (rats) day (highest dose tested) LOAEL: > 1,000 mg/ kg/day

870.3700

Prenatal

Maternal NOAEL: 10 developmental in mg/kg/day rodents (rats) Maternal LOAEL: 40 mg/kg/day (decreased bwt gain and food consumption) Developmental NOAEL: 125 mg/kg/ day Developmental LOAEL: cannot be established

870.3700

Prenatal

Maternal NOAEL: 25 developmental in mg/kg/day nonrodents

Maternal LOAEL: 75 (rabbit)

mg/kg/day (increased incidences of clinical signs (scant feces and orange urine), mortalities, decreased food consumption, early delivery, abortion, and decreased bwt gain) Developmental NOAEL: 25 mg/kg/ day Developmental LOAEL: 75 mg/kg/ day (premature deliveries, decreased gravid uterine weights, an increased litter incidence of a missing lobe of the lung and decreased litter average for ossified sternal centra per fetus)

[Page 32392]

870.3800

Reproduction and Parental systemic fertility effects NOAEL: 31.2/36.8 (rat)

mg/kg/day (male/ female) Parental systemic LOAEL: 163.4/188.8 mg/kg/day (male/ female) (decreased bwt, bwt gain and absolute and relative thymus weights) Offspring systemic NOAEL: 9.8/11.5 mg/ kg/day (male/ female) Offspring systemic LOAEL: 31.2/36.8 mg/kg/day (male/ female: decreased bwt gains and delayed sexual maturation (male); decreased absolute thymus weights in F1 pups of both sexes and an increase in stillbirths in both generations) Reproductive NOAEL: 31.2/188.8 mg/kg/ day (male/female) Reproductive LOAEL: 163.4/not established mg/kg/ day (male/female: decreased sperm motility, and increased number of sperm with detached heads in both generations)

870.4100

Chronic toxicity NOAEL: 46.4/40.1 mg/ dogs

kg/day (male/ female) LOAEL: Not established/52.9 mg/kg/day (male/ female: clinical evidence of anemia in females). Note: dose-related decreases in ALT activity observed in mid- and high- dose males and females

870.4200

Carcinogenicity NOAEL: 171.4/65.1 mice

mg/kg/day (male/ female) LOAEL: 254.1/215.9 mg/kg/day (male/ female: decreased bwt and bwt gain; decreased food consumption and food efficiency in males at the LOAEL). No evidence of carcinogenicity

870.4300

Chronic feeding/ NOAEL: 82.0/32.5 mg/ Carcinogenicity kg/day (male/ rat

female) LOAEL: 156.5/97.8 mg/kg/day (male/ female, decreased bwt and food consumption and altered hepatocellular eosinophilic focus of the liver in both sexes; ovary interstitial gland hyperplasia and increased lymphohistiocytic infiltrate in females; and slightly increased incidences of pelvic mineralization and transitional cell hyperplasia in the kidney, mottled livers of males. No evidence of carcinogenicity

870.5100

Gene Mutation Small, but bacterial reverse significant mutation assay increase in Parent

frequency of histidine revertants in TA1535 strain treated at 1,500 and 5,000 [mu]g/ plate +/-S9; still present but weaker in its absence. The positive response was only reproducible at 5,000 [mu]g/plate +/-S9. Clothianidin considered mutagenic under conditions of this test

870.5100

Gene Mutation No mutagenic bacterial reverse activity in mutation assay bacteria Parent

(Salmonella typhimurium and Escherichia coli) under conditions of this assay

870.5100

Gene Mutation No mutagenic bacterial reverse activity in mutation assay bacteria Parent

(Salmonella typhimurium) under conditions of this assay

870.5100

Gene Mutation Only TA 1535 bacterial reverse tested. No mutation assay mutagenic activity Parent

in bacteria (Salmonella typhimurium) under conditions of this assay

870.5100

Gene Mutation No mutagenic bacterial reverse activity in mutation assay bacteria BN0335E2

(Salmonella metabolite

typhimurium) under conditions of this assay

870.5100

Gene Mutation No mutagenic bacterial reverse activity in mutation assay bacteria TZMU metabolite (Salmonella typhimurium) under conditions of this assay

870.5100

Gene Mutation No mutagenic bacterial reverse activity in mutation assay bacteria methyl guanidine (Salmonella intermediate

typhimurium) under conditions of this assay

870.5100

Gene Mutation No mutagenic bacterial reverse activity in mutation assay bacteria TZNG metabolite (Salmonella typhimurium) under conditions of this assay

870.5100

Gene Mutation No mutagenic bacterial reverse activity in mutation assay bacteria TMG metabolite (Salmonella typhimurium) under conditions of this assay

[Page 32393]

870.5100

Gene Mutation No mutagenic bacterial reverse activity in mutation assay bacteria BN0230M

(Salmonella metabolite

typhimurium) under conditions of this assay

870.5100

Gene Mutation No mutagenic bacterial reverse activity in mutation assay bacteria MAI metabolite (Salmonella typhimurium) under conditions of this assay

870.5100

Gene Mutation No mutagenic bacterial reverse activity in mutation assay N- bacteria Methylnitroguanid (Salmonella in intermediate typhimurium) under conditions of this assay

870.5100

Gene Mutation - No mutagenic bacterial reverse activity in mutation assay TI bacteria 435-Triazan

(Salmonella intermediate

typhimurium) under conditions of this assay

870.5100

Gene Mutation - No mutagenic bacterial reverse activity in mutation assay TI bacteria 435-CCMT- Adduct (Salmonella typhimurium) under conditions of this assay

870.5300

Gene Mutation - in Increases in mutant vitro mammalian frequency with and cell gene

without S9 at dose mutation test levels that were (L5178Y TK +/- cytotoxic. The mouse lymphoma observed response cells) Parent was primarily due to small colony formation, indicating clastogenic activity

870.5300

Gene Mutation - in No increase in vitro mammalian mutant frequency cell gene

under the mutation test conditions of the (V79-HPRT Assay) study Parent

870.5395

Cytogenetics - Clothianidin is mammalian

considered to be erythrocyte

neither micronucleus test clastogenic nor Parent

aneugenic under these test conditions

870.5375

Cytogenetics - in Significant vitro mammalian increases in chromosome

frequency of cells aberration test with structural (CHL Cells)

aberrations. Parent

Predominant types were chromatid breaks and exchanges. There was, however, no clear indication of a dose-related response in either the presence or absence of S9 activation

870.5500

Other Effects - No potential for DNA Repair Test DNA damage under in Bacillus

these conditions subtillis Parent

870.5550

Other Effects - No evidence (or a (UDS) in

dose related Mammalian Cells positive response) in Culture Parent that UDS was induced

870.6200

Acute

NOAEL: Not neurotoxicity established screening battery LOAEL: 100 mg/kg (rat)

(FOB: decreased arousal and decreased motor and locomotor activity)

870.6200

Subchronic

NOAEL: 60.0/71.0 mg/ neurotoxicity kg/day (male/ screening battery female) (rat)

LOAEL: 177.0/200.1 mg/kg/day (male/ female: Slightly decreased food consumption, bwt and bwt gains)

870.6300

Developmental Maternal NOAEL: neurotoxicity 42.9 mg/kg/day (rat)

Maternal LOAEL: 142 mg/kg/day (decreased bwt, bwt gains, and food consumption) Offspring NOAEL: 12.9 mg/kg/day Offspring LOAEL: 42.9 mg/kg/day (decreased bwt and bwt gains)

870.7485

Metabolism and Overall recovery: pharmacokinetics 95-100%. Readily (rat)

absorbed and excreted within 96 hours following a single 2.5 mg/kg bwt or repeated oral dose of 25 mg/ kg bwt, but at a dose of 250 mg/kg, absorption became biphasic and was saturated

[Page 32394]

870.7485

Metabolism and Of the administered pharmacokinetics radioactivity, (mouse)

98.7-99.2% was recovered. Readily absorbed and excreted within 168 hours following a single oral dose of 5 mg/ kg bwt

870.7600

Dermal Penetration Dermal absorption - monkey

as the sum of urinary and fecal excretion and Cage/ Pan/Chair Wash, Debris was 0.24 (+ 0.11) as percent of dose. Adjustment of the direct absorption determination was not necessary because recovery from the dermal dose was 90%. A value of 1% dermal absorption was considered appropriate for use in risk assessment. This estimation takes into account any variability that would have likely occurred with testing several dose levels

Special study: NOAEL: 25 mg/kg/day Neurotoxicity and (male/female) pharmacology LOAEL: 50 mg/kg bw mouse

mg/kg/day (transient signs of decreased spontaneous motor activity, tremors, and deep respirations)

B. Toxicological Endpoints

The dose at which 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 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. EPA has concluded that the toxicology database for clothianidin is not complete. Due to evidence of effects on the immune system and that juvenile rats appear to be more susceptible to these effects, EPA has determined that testing should be conducted to assess immune system function in adults and in young animals following developmental exposures. Therefore, a 10X database UF is to be applied to all dietary exposure endpoints for the lack of a developmental immunotoxicity study.

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 the appropriate UF (RfD = NOAEL/UF). Where an additional safety factors (SF) is retained due to concerns unique to the FQPA, 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 FQPA SF.

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 is expressed as 1 x 10-\6\ or one in a million). 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 clothianidin used for human risk assessment is shown in Table 2 of this unit:

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

Dose Used in Risk Special FQPA SF2and Study and Toxicological Exposure Scenario

Assessment, UF1LOC for Risk Assessment

Effects

Acute Dietary

Developmental NOAEL = FQPA SF = 1

Developmental rabbit (Females 13-50 years of age)......... 25

aPAD = acute RfD /FQPA study UF = 10001............. SF= 0.025 mg/kg.

Developmental LOAEL = Acute RfD = 0.025 mg/kg

75 mg/kg/day based on an increased litter incidence of a missing lobe of the lung

Acute Dietary

NOAEL = 25

FQPA SF = 1 aPAD = Special Neurotoxicity/ (General population)................. UF = 10001............. acute RfD / FQPA SF Pharmacology Study in Acute RfD = 0.025 mg/kg = 0.025 mg/kg.......... Mice and Rats LOAEL = 50 mg/kg based on transient signs of decreased spontaneous motor activity, tremors and deep respirations

[Page 32395]

Chronic Dietary

Offspring NOAEL= 9.8 FQPA SF = 1 cPAD = 2-Generation (All populations).................... UF = 10001............. chronic RfD / FQPA SF Reproduction Study Chronic RfD = 0.0098 mg/ = 0.0098 mg/kg/day..... Offspring LOAEL = 31.2 kg/day.

mg/kg/day based on decreased mean bwt gain and delayed sexual maturation, decreased absolute thymus weights in F1 pups and an increase in stillbirths in both generations

Cancer (oral, dermal, inhalation) Classification: Not likely

1 An additional 10X database uncertainty factor for lack of a developmental immunotoxicity study. 2 The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Currently there are no tolerances established for clothianidin alone on any commodity. However, clothianidin is a major metabolite of thiamethoxam, and tolerances for the combined residues of thiamethoxam and its metabolite clothianidin have been established under 40 CFR part 180.565 for both plant and livestock commodities. Tolerances for thiamethoxam range from 0.02 ppm to 1.5 ppm. Risk assessments were conducted by EPA to assess dietary exposures from clothianidin 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 1-day or single exposure. The Dietary Exposure Evaluation Model (DEEM[reg]) 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 commodity. The following assumptions were made for the acute exposure assessments: The acute analysis was a conservative, Tier I assessment which was based on tolerance level residues and the assumption of 100% crop treated. Although the only proposed uses for clothianidin are on canola and corn, clothianidin is a major metabolite of thiamethoxam which has many registered uses and several pending uses. As a result, residues of clothianidin which would theoretically result from the metabolism of thiamethoxam were included in the analysis. In crop field trials and in animal feeding studies, the quantities of both clothianidin and thiamethoxam were measured. The ratio of clothianidin to thiamethoxam in each commodity was multiplied by the respective thiamethoxam tolerance level to arrive at the theoretical maximum clothianidin residue level which would be present. These maximum clothianidin residues were used in the acute analysis. For the commodities which have both thiamethoxam tolerances and proposed clothianidin tolerances (i.e., sweet corn, field corn, pop corn, canola, and milk), the proposed clothianidin tolerances were added to the residues which result from use of thiamethoxam.

As this is a Tier I assessment, dietary exposure and risk at the 95th percentile of exposure are reported. The general U.S. population and all population subgroups have exposure and risk estimates which are below EPA's LOC (i.e., the aPADs are all below 100%). The most highly exposed population subgroup is children 1 to 2 years of age, which utilizes 16% of the aPAD.

ii. Chronic exposure. In conducting this chronic dietary risk assessment, the DEEM[reg] analysis evaluated the individual food consumption 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: The chronic analysis was a conservative, Tier I assessment which was based on tolerance level residues and the assumption of 100% crop treated. As stated previously, although the only proposed uses for clothianidin are on canola and corn, clothianidin is a major metabolite of thiamethoxam which has many registered uses and several pending uses. As a result, residues of clothianidin which would theoretically result from the metabolism of thiamethoxam were included in the analysis. In crop field trials and in animal feeding studies, the quantities of both clothianidin and thiamethoxam were measured. The ratio of clothianidin to thiamethoxam in each commodity was multiplied by the respective thiamethoxam tolerance level to arrive at the theoretical maximum clothianidin residue level which would be present. These maximum clothianidin residues were used in the chronic analysis. For the commodities which have both thiamethoxam tolerances and proposed clothianidin tolerances (i.e., sweet corn, field corn, pop corn, canola, and milk), the proposed clothianidin tolerances were added to the residues which result from use of thiamethoxam.

The general U.S. population and all population subgroups have exposure and risk estimates which are below EPA's LOC (i.e., the chronic population adjusted doses (cPADs) are all below 100%). The most highly exposed population subgroup is children 1 to 2 years of age, which utilizes 18% of the cPAD.

iii. Cancer. EPA has determined that clothianidin is not likely to be a human carcinogen and EPA, therefore, does not expect it to pose a cancer risk. As a result, a quantitive cancer dietary exposure analysis was not performed.

2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for clothianidin 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 clothianidin.

The Agency uses the First 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.

[Page 32396]The screening concentration in ground water (SCI-GROW) model is used to predict pesticide concentrations in shallow ground water. For a screening-level assessment for surface water EPA will use FIRST (a Tier I model) before using PRZM/EXAMS (a Tier II 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 coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever 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) from these models 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 clothianidin, they are further discussed in the aggregate risk sections.

Based on the FIRST and SCI-GROW models, the EECs of clothianidin for acute exposures are estimated to be 3.97 parts per billion (ppb) for surface water and 1.46 ppb for ground water. The EECs for chronic exposures are estimated to be 2.14 ppb for surface water and 1.46 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). Clothianidin is not registered for use on any sites that would result in residential exposure. Clothianidin is a major metabolite of the insecticide thiamethoxam in plants and animals. Since there are also no residential uses of thiamethoxam, possible residential exposure to clothianidin due to thiamethoxam uses is not expected.

4. Cumulative exposure to substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of the 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.''

EPA does not have, at this time, available data to determine whether clothianidin has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, clothianidin 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 clothianidin has a common mechanism of toxicity with other substances. For information 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 final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

1. In general. Section 408 of the 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 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.

2. Prenatal and postnatal sensitivity. No quantitative or qualitative susceptibility was observed in either of the developmental rat or rabbit studies. Quantitative susceptibility was observed in both the reproduction and developmental neurotoxicity studies; however, the degree of concern for these studies is low because the observed effects are well characterized and there are clear NOAELs/LOAELs in each case. In addition, the endpoint of concern is the one that is being used for short-, intermediate- and long-term dietary and non-dietary exposure risk assessments. There are no residual uncertainties. Therefore, there are no to low concerns with regard to prenatal and/or postnatal toxicity.

3. Conclusion. The toxicology database for clothianidin is not complete for FQPA purposes. A complete complement of acceptable developmental, reproduction, developmental neurotoxicity, mammalian neurotoxicity and special neurotoxicity studies are available; however, due to evidence of decreased absolute and adjusted organ weights of the thymus and spleen in multiple studies in the clothianidin data base, and since juvenile rats in the 2-generation reproduction study appear to be more susceptible to these effects, EPA has determined that testing should be conducted to assess immune system function in adults and in young animals following developmental exposures. As noted previously, a 10X database UF was applied because of the lack of this study.

The FQPA factor is removed because there are no to low concerns and no residual uncertainties with regard to prenatal and/or postnatal toxicity. As stated above, no quantitative or qualitative susceptibility was observed in either of the development rat or rabbit studies, and the observed effects are well characterized and there are clear NOAELs/LOAELs in the reproduction and developmental neurotoxicity studies. In addition, the acute and chronic dietary food exposure assessment utilizes existing and proposed tolerance level residues and 100% crop treated information for all commodities. By using these screening-level assessments, acute and chronic exposures/risks will not be underestimated. Furthermore, the dietary drinking water assessment (Tier I estimates) uses values generated by model and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations. Finally, there are no residential uses for either clothianidin or thiamethoxam.

E. 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 the model estimates of a pesticide's concentration

[Page 32397]in water (EECs). DWLOC values are not regulatory standards for drinking 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 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). 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, 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. If new uses are added in the future, EPA 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 clothianidin will occupy 7.3% of the aPAD for the U.S. population, 5.4% of the aPAD for females 13 years and older, 11% of the aPAD for all infants (less than 1 year old) and 16% of the aPAD for children 1 to 2 years old. In addition, there is potential for acute dietary exposure to clothianidin in drinking water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in Table 3 of this unit:

Table 3.--Aggregate Risk Assessment for Acute Exposure to Clothianidin

Surface Ground Population Subgroup

aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC kg)

  (Food) (ppb)

  (ppb)

  (ppb)

General U.S. population

0.025

7.3

3.97

1.46

810

All infants (2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603-0061.

2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it ``Tolerance Petition Fees.''

EPA is authorized to waive any fee requirement ``when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by docket ID number OPP-2003-0133, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or

[Page 32399]ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

VII. Statutory and Executive Order Reviews

This final rule establishes a tolerance under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ``meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' ``Policies that have federalism implications'' is defined in the Executive Order to include regulations that have ``substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any ``tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ``meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' ``Policies that have tribal implications'' is defined in the Executive Order to include regulations that have ``substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

VIII. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: May 19, 2003. James Jones, Director, Office of Pesticide Programs.

0 Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0 1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346(a) and 371.

0 2. Section 180.586 is added to read as follows:

Sec. 180.586 Clothianidin; tolerances for residues.

  (a) General. Tolerances are established for residues of the insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3- methyl-2-nitroguanidine, in or on the following raw agricultural commodities:

Commodity

Parts per million

Canola, seed.........................................

0.01 Corn, field, forage..................................

0.10 Corn, field, grain...................................

0.01 Corn, field, stover..................................

0.10 Corn, pop, grain.....................................

0.01 Corn, pop, stover....................................

0.10 Corn, sweet, forage..................................

0.10 Corn, sweet, kernel plus cob with husk removed.......

0.01 Corn, sweet, stover..................................

0.10 Milk.................................................

0.01

[Page 32400]

  (b) Section 18 emergency exemptions. [Reserved]

  (c) Tolerances with regional registrations. [Reserved]

  (d) Indirect and inadvertant residues. Tolerances are established for the indirect or inadvertent residues of the insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2- nitroguanidine, in or on the following raw agricultural commodities when present therein as a result of the application of clothianidin to crops listed in paragraph (a) of this section:

Commodity

Parts per million

Animal feed, nongrass................................

0.02 Grain, cereal, forage, fodder and straw..............

0.02 Grass, forage, fodder and hay........................

0.02 Soybean, forage......................................

0.02 Soybean, hay.........................................

0.02

FR Doc. 03-13564 Filed 5-29-03; 8:45 amBILLING CODE 6560-50-S

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