[Federal Register Volume 70, Number 31 (Wednesday, February 16, 2005)]
[Rules and Regulations]
[Pages 7886-7894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2984]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0406; FRL-7690-2]


Clothianidin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

[[Page 7887]]


ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
clothianidin in or on pome fruit. Arvesta Corporation requested this 
tolerance 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 February 16, 2005. Objections and 
requests for hearings must be received on or before April 18, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2004-0406. 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: 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:[email protected].

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:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. 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 on 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/.

II. Background and Statutory Findings

    In the Federal Register of December 31, 2003 (68 FR 75504) (FRL-
7334-2), 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 
1F6342) by Arvesta Corporation, 100 First St., Suite 1700, San 
Francisco, CA 94105. The petition requested that 40 CFR 180.586 be 
amended by establishing a tolerance for residues of the insecticide 
clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-
nitroguanidine, in or on pome fruit at 1.0 parts per million (ppm). 
That notice included a summary of the petition prepared by Arvesta 
Corporation, 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).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for a tolerance for residues of clothianidin on 
pome fruit at 1.0 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 as 
well as the no observed adverse effect level (NOAEL) and the lowest 
observed adverse effect level (LOAEL) from the toxicity studies 
reviewed are discussed in the Federal Register of May 30, 2003 (68 FR 
32390) (FRL-7306-8).

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

[[Page 7888]]

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 clothianidin used for 
human risk assessment is shown in Table 1 of this unit:

     Table 1.--Summary of Toxicological Dose and Endpoints for Clothianidin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,
          Exposure/Scenario                Interspecies and     Special FQPA SF and LOC  Study and Toxicological
                                         Intraspecies and any     for Risk Assessment            Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary                          Developmental NOAEL =    FQPA SF = 1              Developmental rabbit
(Females 13-50 years of age).........   25 mg/kg/day            aPAD = acute RfD / FQPA   study
                                       UF = 1000..............   SF.                     Developmental LOAEL =
                                       Acute RfD = 0.025 mg/kg  = 0.025 mg/kg..........   75 mg/kg/day based on
                                                                                          an increased litter
                                                                                          incidence of a missing
                                                                                          lobe of the lung.
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Acute dietary                          NOAEL = 25 mg/kg/day     FQPA SF = 1              Special Neurotoxicity/
(General population).................  UF = 1000..............  aPAD = acute RfD / FQPA   Pharmacology Study in
                                       Acute RfD = 0.025 mg/kg   SF.                      Mice and Rats
                                                                = 0.025 mg/kg..........  LOAEL = 50 mg/kg based
                                                                                          on transient signs of
                                                                                          decreased spontaneous
                                                                                          motor activity,
                                                                                          tremors and deep
                                                                                          respirations.
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Chronic dietary                        Offspring NOAEL = 9.8    FQPA SF = 1              2-Generation
(All populations)....................   mg/kg/day               cPAD = chronic RfD /      reproduction study
                                       UF = 1000..............   FQPA SF.                Offspring LOAEL = 31.2
                                       Chronic RfD = 0.0098 mg/ = 0.0098 mg/kg/day.....   mg/kg/day based on
                                        kg/day.                                           decreased mean body
                                                                                          weight gain and
                                                                                          delayed sexual
                                                                                          maturation, decreased
                                                                                          absolute thymus
                                                                                          weights in F1 pups and
                                                                                          an increase in
                                                                                          stillbirths in both
                                                                                          generations.
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Incidental Oral                        NOAEL = 9.8 mg/kg/day    Residential LOC for MOE  2-Generation
(All Durations)......................                            = 1000                   Reproduction Study
                                                                                         Offspring LOAEL = 31.2
                                                                                          mg/kg/day based on
                                                                                          decreased mean body
                                                                                          weight gain and
                                                                                          delayed sexual
                                                                                          maturation, decreased
                                                                                          absolute thymus
                                                                                          weights in F1 pups and
                                                                                          an increase in
                                                                                          stillbirths in both
                                                                                          generations.
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[[Page 7889]]

 
Dermal                                 Oral study NOAEL= 9.8    Residential LOC for MOE  2-Generation
(All Durations)......................   mg/kg/day (dermal        = 1000                   Reproduction Study
                                        absorption rate = 1%)                            Offspring LOAEL = 31.2
                                                                                          mg/kg/day based on
                                                                                          decreased mean body
                                                                                          weight gain and
                                                                                          delayed sexual
                                                                                          maturation, decreased
                                                                                          absolute thymus
                                                                                          weights in F1 pups and
                                                                                          an increase in
                                                                                          stillbirths in both
                                                                                          generations.
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Inhalation                             Oral study               Residential LOC for MOE  2-Generation
(All durations)......................  NOAEL = 9.8 mg/kg/day     = 1000                   Reproduction Study
                                        (inhalation absorption                           Offspring LOAEL = 31.2
                                        rate = 100%).                                     mg/kg/day based on
                                                                                          decreased mean body
                                                                                          weight 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 to be carcinogenic to humans
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.586) for the residues of clothianidin, in or on 
a variety of raw agricultural commodities. Tolerances for clothianidin 
are established on canola, field corn, pop corn, sweet corn, and milk. 
Since clothianidin is a major metabolite of thiamethoxam, which has 
many registered uses and several pending uses, residues of clothianidin 
that would theoretically result from the metabolism of thiamethoxam are 
included in the analysis. 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. In conducting the acute dietary risk assessment EPA 
used the Dietary Exposure Evaluation Model software with the Food 
Commodity Intake Database (DEEM-FCID\T\), which incorporates food 
consumption data 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 is a conservative assessment that was based on tolerance level 
residues and the assumption of 100% crop treated (PCT) for established 
and proposed clothianidin uses. For the commodities that have both 
thiamethoxam tolerances and established or proposed clothianidin 
tolerances (i.e., sweet corn, field corn, pop corn, canola, milk, and 
pome fruit), the proposed clothianidin tolerances are added to the 
residues that could result from use of thiamethoxam. The assumptions 
made for the acute exposure assessments for thiamethoxam are discussed 
in the Federal Register of January 5, 2005 (70 FR 708) (FRL-7689-7). 
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 infants 
less than 1 year old, which utilizes 80% of the aPAD.
    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment EPA used the DEEM-FCID\TM\, which incorporates food 
consumption data as reported by respondents in the USDA 1994-1996 and 
1998 Nationwide CSFII, and accumulated exposure to the chemical for 
each commodity. The following assumptions were made for the chronic 
exposure assessments: The chronic analysis is a relatively conservative 
assessment that was based on tolerance level residues and the 
assumption of 100% CT for established and proposed clothianidin uses, 
with the exception of anticipated residues (AR) for apples and pears. 
For the commodities that have both thiamethoxam tolerances and 
established or proposed clothianidin tolerances (i.e., sweet corn, 
field corn, pop corn, canola, and milk), the proposed clothianidin 
tolerances are added to the residues that could result from use of 
thiamethoxam. For apples and pears, the highest average field trial 
(HAFT) levels from the residue field trials were added to the residues 
that could result from use of thiamethoxam. The assumptions made for 
the chronic exposure assessments for thiamethoxam are discussed in the 
Federal Register of January 5, 2005 (70 FR 708) (FRL-7689-7). The 
general U.S. population and all population subgroups have exposure and 
risk estimates which are below EPA's LOC (i.e., the cPADs are all below 
100%). The most highly exposed population subgroup is children 1 to 2 
years of age, which utilizes 15% of the cPAD.
    iii. Cancer. EPA has determined that clothianidin is not likely to 
be a human carcinogen. As a result, a quantitative cancer dietary 
exposure analysis was not performed.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of 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. As 
required by section 408(b)(2)(E) of FFDCA, EPA will issue a data call-
in for information relating to anticipated residues to be submitted no 
later than 5 years from the date of issuance of this tolerance.

[[Page 7890]]

    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 FQPA Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index 
reservoir. 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 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. Both FIRST and PRZM/EXAMS incorporate 
an index reservoir environment, and both models include 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 
LOC.
    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 clothianidin they are 
further discussed in the aggregate risk sections in Unit III.E.
    Based on the FIRST and SCI-GROW models, the EECs of clothianidin 
for acute exposures are estimated to be 7.29 parts per billion (ppb) 
for surface water and 5.84 ppb for ground water. The EECs for chronic 
exposures are estimated to be 1.35 ppb for surface water and 5.84 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 
currently registered for use on the following residential non-dietary 
sites: Turfgrasses. The risk assessment was conducted using the 
following residential exposure assumptions: Due to the use patterns on 
turfgrasses, a number of residential or recreational post-application 
exposures are possible. In a residential setting, a ``homeowner'' may 
be exposed during application of the material to his or her lawn. 
Further, the ``homeowner'' may also experience post-application dermal 
exposure. Toddlers may be exposed via ``hand-to-mouth'' oral exposures 
and/or dermal exposures. ``Aggregated'' exposures are presented for 
toddlers (i.e., hand-to-mouth turf plus hand-to-mouth soil plus dermal 
post-application). EPA considers hand-to-mouth ingestion of granules to 
be episodic in nature, that is, a ``one-time'' event. Therefore the 
exposure from ingestion of granules is not combined with believed 
multiple exposures from ``mouthing'' of turf or soil or from post-
application dermal exposure. The estimated exposures and risks are 
presented below in Table 2 of this unit:

Table 2.--Summary of Residential Post-Application Exposures and Risks to
                              Clothianidin
------------------------------------------------------------------------
                                                  Exposure
                                                 (Dose)/mg
                   Activity                     a.i./kg bw/      MOE
                                                    day
------------------------------------------------------------------------
Toddler oral hand to mouth from contacting           0.0059        1,700
 treated turf
-------------------------------------------------------------
Toddler incidental oral ingestion of treated        0.00002      490,000
 soil
-------------------------------------------------------------
Adult dermal post-application turf contact          0.00108        9,100
-------------------------------------------------------------
Adult combined dermal exposure = application +   0.000026 +        8,900
 post-application                                   0.00108
-------------------------------------------------------------
Toddler dermal post-application turf contact        0.00155        6,300
-------------------------------------------------------------
Toddler combined oral (except granules) and         0.00747        1,300
 dermal exposures (treated turf + treated soil
 + dermal)
-------------------------------------------------------------
Adult golfer post-application turf contact         0.000075      130,000
-------------------------------------------------------------
Child golfer post-application turf contact         0.000128       77,000
------------------------------------------------------------------------

    A MOE of 1,000 is adequate to protect adults and children from 
residential non-dietary post-application exposures to clothianidin. The 
estimated MOE's are based upon conservative assumptions and are greater 
than 1,000. Therefore, the estimated risks from residential non-dietary 
post-application exposures do not exceed EPA's LOC.
    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.''
    EPA does not have, at this time, available data to determine 
whether clothianidin has a common mechanism of toxicity with other 
substances. Unlike

[[Page 7891]]

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 clothianidin and any other 
substances and 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 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/.

D. 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. 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 (i.e., a 
developmental immunitoxicity study).
    In the absence of the developmental immunotoxicity study, EPA 
determined that there is insufficient data to justify selection of an 
additional safety factor for the protection of infants and children 
lower than the default value of 10X for both single and repeated dose 
exposure scenarios. Therefore, an additional FQPA safety factor of 10X, 
in the form of a data base uncertainty factor (UFDB), will be applied 
to both single and repeated dose exposure scenarios (i.e., acute and 
chronic RfDs, short- and intermediate-term incidental oral exposures, 
and short-, intermediate-, and long-term dermal and inhalation exposure 
resulting from residential uses of clothianidin) to account for the 
lack of the developmental immunotoxicity study with clothianidin.

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 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 the 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 18% of the aPAD for the U.S. population, 12% 
of the aPAD for females 13 years and older, 80% of the aPAD for infants 
less than one year old, and 60% 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 and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the aPAD, as shown in Table 3 of 
this unit:

[[Page 7892]]



                     Table 3.--Aggregate Risk Assessment for Acute Exposure to Clothianidin
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population/Subgroup                aPAD(mg/kg)    %/aPAD/     Water EEC/   Water EEC/  Acute DWLOC
                                                                 (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. Population                                0.025           18         7.29         5.84          710
--------------------------------------------------------------
All infants (less than one year old)                   0.025           80         7.29         5.84           48
--------------------------------------------------------------
Children 1-2 years old                                 0.025           60         7.29         5.84           92
--------------------------------------------------------------
Females 13-49 years old                                0.025           12         7.29         5.84          640
--------------------------------------------------------------
Adults 50+ years old                                   0.025           14         7.29         5.84        1,500
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
clothianidin from food will utilize 6% of the cPAD for the U.S. 
population, 13% of the cPAD for infants less than one year old, and 15% 
of the cPAD for children 1-2 years old. There are also registered uses 
on turfgrasses for clothianidin that may result in chronic residential 
exposure. Combined residential exposure estimates range from an MOE of 
1,300 for combined oral and dermal exposure to toddlers (treated turf + 
treated soil + dermal) to 8,900 for dermal exposure to adults 
(application + post-application) adults. In addition, there is 
potential for chronic dietary exposure to clothianidin in drinking 
water. After calculating DWLOCs and comparing them to the EECs for 
surface and ground water, EPA does not expect the aggregate exposure to 
exceed 100% of the cPAD, as shown in Table 4 of this unit:

              Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Clothianidin
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population/Subgroup                cPAD/mg/kg/     %/cPAD     Water EEC/   Water EEC/    Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                       0.0098            6         1.35         5.84          320
--------------------------------------------------------------
All infants (less than one year old)                  0.0098           13         1.35         5.84           85
--------------------------------------------------------------
Children 1-2 years old                                0.0098           15         1.35         5.84           83
--------------------------------------------------------------
Females 13-49 years old                               0.0098            5         1.35         5.84          280
--------------------------------------------------------------
Adults 50+ years old                                  0.0098            5         1.35         5.84          330
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Clothianidin is currently registered for use that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term 
exposures for clothianidin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 5,900 for the general U.S. 
population; 1,100 for children 1-2 years old; and 6,200 for females 13 
to 49 years old. These aggregate MOEs do not exceed the Agency's LOC 
for aggregate exposure to food and residential uses. In addition, 
short-term DWLOCs were calculated and compared to the EECs for chronic 
exposure of clothianidin in ground and surface water. After calculating 
DWLOCs and comparing them to the EECs for surface and ground water, EPA 
does not expect short-term aggregate exposure to exceed the Agency's 
LOC, as shown in Table 5 of this unit:

                   Table 5.--Aggregate Risk Assessment for Short-Term Exposure to Clothianidin
----------------------------------------------------------------------------------------------------------------
                                                 Aggregate/                  Surface      Ground/
              Population/Subgroup                MOE/(Food +   Aggregate/   Water EEC/   Water EEC/   Short-Term
                                                Residential)      LOC         (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. Population                                5,900        1,000         1.35         5.84          280
--------------------------------------------------------------
Children 1-2 years old                                 1,100        1,000         1.35         5.84          8.7
--------------------------------------------------------------
Females 13-49 years old                                6,200        1,000         1.35         5.84          250
----------------------------------------------------------------------------------------------------------------

    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).

[[Page 7893]]

    Clothianidin is currently registered for use(s) that could result 
in intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic food and water and 
intermediate-term exposures for clothianidin.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that food and 
residential exposures aggregated result in aggregate MOEs of 5,900 for 
the general U.S. population: 1,100 for children 1-2 years old; and 
6,200 for females 13 to 49 years old. These aggregate MOEs do not 
exceed the Agency's LOC for aggregate exposure to food and residential 
uses. In addition, intermediate-term DWLOCs were calculated and 
compared to the EECs for chronic exposure of clothianidin in ground 
water and surface water. After calculating DWLOCs and comparing them to 
the EECs for surface water and ground water, EPA does not expect 
intermediate-term aggregate exposure to exceed the Agency's LOC, as 
shown in Table 6 of this unit:

               Table 6.--Aggregate Risk Assessment for Intermediate-Term Exposure to Clothianidin
----------------------------------------------------------------------------------------------------------------
                                               Aggregate/                  Surface      Ground/    Intermediate-
             Population/Subgroup               MOE/(Food +   Aggregate/   Water EEC/   Water EEC/    Term DWLOC
                                              Residential)      LOC         (ppb)        (ppb)         (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. Population                              5,900         1000         1.35         5.84           280
------------------------------------------------------------
Children 1-2 years old                               1,100        1,000         1.35         5.84           8.7
------------------------------------------------------------
Females 13-49 years old                              6,200        1,000         1.35         5.84           250
----------------------------------------------------------------------------------------------------------------

    5. Aggregate cancer risk for U.S. population. Clothianidin has been 
classified as a ``not likely human carcinogen.'' Therefore, it is not 
expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to clothianidin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/mass 
spectroscopy/mass spectroscopy LC/MS/MS analysis) is available to 
enforce the tolerance expression. The method may be requested from: 
Chief, Analytical Chemistry Branch, Environmental Science Center, 701 
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; 
e-mail address: [email protected].

B. International Residue Limits

    No Codex, Canadian, or Mexican maximum residue levels (MRLs) have 
been established for residues of clothianidin.

V. Conclusion

    Therefore, the tolerance is established for residues of 
clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-
nitroguanidine, in or on pome fruit at 1.0 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by FQPA, any person may 
file an objection to any aspect of this regulation and may also request 
a hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. Although the procedures in those regulations require 
some modification to reflect the amendments made to FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA provides essentially the same process for persons to 
``object'' to a regulation for an exemption from the requirement of a 
tolerance issued by EPA under new section 408(d) of FFDCA, as was 
provided in the old sections 408 and 409 of FFDCA. However, the period 
for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2004-0406 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before April 18, 
2005.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW., 
Washington, DC 20005. 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 (202) 564-6255.
    2. 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 ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2004-0406, 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

[[Page 7894]]

location of the PIRIB described in ADDRESSES. You may also send an 
electronic copy of your request via e-mail to: [email protected]. 
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 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 
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 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 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: February 7, 2005.
Losi Rossi,
Director, Registration Division, 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), 346a and 371.

0
2. Section 180.586 is amended by alphabetically adding the commodity 
``Pome fruit'' to the table in paragraph (a) to read as follows:


Sec.  180.586  Clothianidin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
 Pome fruit..........................................                1.0
------------------------------------------------------------------------

* * * * *

[FR Doc. 05-2984 Filed 2-15-05; 8:45 am]
BILLING CODE 6560-50-S