[Federal Register Volume 73, Number 25 (Wednesday, February 6, 2008)]
[Rules and Regulations]
[Pages 6851-6856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-1784]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0280; FRL-8346-9]


Clothianidin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
clothianidin in or on sugar beet roots, tops and molasses. Bayer 
CropScience requested this tolerance under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective February 6, 2008. Objections and 
requests for hearings must be received on or before April 7, 2008, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2007-0280. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (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 in the electronic docket at http://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Kable Bo Davis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number:

[[Page 6852]]

(703) 306-0415; e-mail address: <a href="/cdn-cgi/l/email-protection#3e5a5f48574d10555f5c525b7e5b4e5f10595148"><span class="__cf_email__" data-cfemail="c7a3a6b1aeb4e9aca6a5aba287a2b7a6e9a0a8b1">[email protected]</span></a>.

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 those 
engaged in the following activities:
    <bullet> Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
    <bullet> Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
    <bullet> Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
    <bullet> Pesticide manufacturing (NAICS code 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 to 
provide 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?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to 
any aspect of this regulation and may also request a hearing on those 
objections. You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in 40 CFR part 
178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2007-0280 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 as required by 40 CFR part 178 on or 
before April 7, 2008.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2007-0280, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of April 30, 2007 (72 FR 21263) (FRL-8124-
5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
6F7159) by Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle 
Park, NC 27709. 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 beet, sugar, root at 0.02 parts per million 
(ppm); beet, sugar, tops at 0.04 ppm; and beet, sugar, molasses at 0.06 
ppm. That notice referenced a summary of the petition prepared by Bayer 
CropScience, the registrant, which is available to the public in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.
    Upon completing review of the current clothianidin database, the 
Agency concluded that the appropriate tolerance levels for clothianidin 
residues in or on pending crops should be established as follows: Beet, 
sugar, roots at 0.02 ppm, beet, sugar, molasses at 0.05 ppm and beet, 
sugar, dried pulp at 0.03 ppm. The Agency no longer considers sugar 
beet tops to be a significant livestock feedstuff; therefore, a 
separate tolerance for tops is not required.

III. Aggregate Risk Assessment and Determination of Safety

    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....'' These provisions were added to FFDCA by the Food Quality 
Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), 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 for the petitioned-for tolerance 
for residues of clothianidin on beet, sugar, roots at 0.02 ppm, beet, 
sugar, molasses at 0.05 ppm and beet, sugar, dried pulp at 0.03. 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

[[Page 6853]]

concerning the variability of the sensitivities of major identifiable 
subgroups of consumers, including infants and children. Specific 
information on the studies received and the nature of the adverse 
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 can be found at http://www.regulations.gov. The risk assessment is available in the docket 
established by this action, which is described under ADDRESSES, and is 
identified as EPA-HQ-OPP-2007-0280 in that docket.
    Clothianidin does not appear to exhibit toxicity towards a 
consistent specific target organ. Decreases in body weight and body 
weight gain were observed in rats, dogs, and mice. In single-dose 
studies, mice (acute toxicity category II) appear more sensitive than 
rats (category IV). Clinical signs of neurotoxicity were exhibited in 
both mice (decreased motor activity, tremors, and deep respirations at 
50 milligram/kilogram (mg/kg)) and rats (transient signs of decreased 
arousal, motor activity, and locomotor activity at 100 mg/kg) in acute 
neurotoxicity studies following exposure by gavage; however, no 
indications of neurotoxicity were observed following dietary exposure 
in the subchronic neurotoxicity study in rats. In a developmental 
neurotoxicity study in rats, decreased body weights, body weight gains, 
motor activity, and acoustic startle response amplitude (females) were 
seen in offspring at doses lower than those resulting in maternal 
toxicity. Although the NOAELs were similar for the subchronic and 
chronic feeding studies in the rat, a greater spectrum of effects was 
observed in the chronic study (decreased body weight, body weight gain, 
and food consumption plus additional observations in the liver, ovary, 
and kidney) versus the subchronic study (effects only on body weight 
and food consumption). In the rat, administration via the oral route 
appears to be more toxic than via the dermal route. In longer term 
studies, dogs exhibited clinical signs of anemia. The only observed 
effects in mice following chronic dietary administration were increases 
in vocalization and decreases in body weight and body weight gain. 
Clothianidin has been classified as not likely to be carcinogenic to 
humans.
    There was no evidence of increased quantitative or qualitative 
susceptibility of rat or rabbit offspring in developmental studies; 
however, increased quantitative susceptibility of rat pups was seen in 
both the reproduction and developmental neurotoxicity studies. The 
degree of concern for both of these studies is low because the observed 
effects are well characterized, and there are clear NOAELs and LOAELs. 
The NOAEL for the effects of concern identified in the reproduction 
study (decreased mean body weight gain and absolute thymus weights in 
pups, delayed sexual maturation, and an increase in still births) is 
the basis for the endpoint selected for the chronic dietary and short-
term, intermediate-term and long-term non-dietary risk assessments.
    In adult rats, a guideline immunotoxicity study shows no 
clothianidin-mediated immunotoxicity at doses lower than those 
resulting in generalized signs of toxicity (e.g., decreases in body 
weight); however, it cannot be concluded that a similar lack of effects 
will occur in offspring. Based on evidence of decreased absolute and 
adjusted organ weights of the thymus and spleen in multiple studies in 
the clothianidin data base and on evidence of increased quantitative 
susceptibility of juvenile rats, compared to adults, in the 2-
generation reproduction study to these effects, a developmental 
immunotoxicity (DIT) study has been required.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the highest dose at which the NOAEL in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the LOAEL is sometimes used for risk 
assessment. Uncertainty/safety factors (UFs) are used in conjunction 
with the LOC to take into account 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. Safety is assessed for acute and chronic risks by 
comparing aggregate exposure to the pesticide to the acute population 
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The 
aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. 
Short-term, intermediate-term, and long-term risks are evaluated by 
comparing aggregate exposure to the LOC to ensure that the margin of 
exposure (MOE) called for by the product of all applicable UFs is not 
exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for clothianidin used for 
human risk assessment can be found at http://www.regulations.gov in 
document ``Clothianidin: Human Health Risk Assessment for Proposed Use 
on Sugar Beet'' at pages 18-20 in docket ID number EPA-HQ-OPP-2007-
0280.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to clothianidin, EPA considered exposure under the petitioned-
for tolerances as well as all existing clothianidin tolerances in (40 
CFR 180.586). EPA assessed dietary exposures from clothianidin in food 
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    In estimating acute dietary exposure, EPA used food consumption 
information from the U.S. Department of Agriculture (USDA) 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII). The acute assessment is based on maximum residues of 
clothianidin observed in clothianidin and thiamethoxam field trials and 
assumes 100 percent crop treated (%CT).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. The chronic assessment is based on average residues 
from clothianidin and thiamethoxam field trials and assumes 100% CT.
    iii. Cancer. Because clothianidin is not expected to pose a cancer 
risk, a quantitative dietary exposure assessment for the purposes of 
assessing cancer risk was not conducted.
    iv. Anticipated residue and percent crop treated (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 residues that have been 
measured in food. If EPA relies on such information, EPA must pursuant 
to FFDCA section 408(f)(1) require that

[[Page 6854]]

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. For the present action, EPA will issue such 
data call-ins as are required by FFDCA section 408(b)(2)(E) and 
authorized under FFDCA section 408(f)(1). Data will be required to be 
submitted no later than 5 years from the date of issuance of this 
tolerance.
    The Agency used PCT information as follows:
    The acute assessment is based on maximum residues of clothianidin 
observed in clothianidin field trials and assumes 100% crop treated. 
The chronic assessment is based on average residues from clothianidin 
field trials and also assumes 100% CT.
    The Agency believes that the three conditions listed in Unit III. 
have been met. With respect to Condition 1, PCT estimates are derived 
from Federal and private market survey data, which are reliable and 
have a valid basis. The Agency is reasonably certain that the 
percentage of the food treated is not likely to be an underestimation. 
As to Conditions 2 and 3, regional consumption information and 
consumption information for significant subpopulations is taken into 
account through EPA's computer-based model for evaluating the exposure 
of significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which clothianidin 
may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring 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 environmental 
fate characteristics of clothianidin. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated environmental concentrations (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.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 7.29 ppb was used to 
access the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 5.84 ppb was used to 
access the contribution to drinking 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 the following residential 
non-dietary sites: Turfgrass. EPA assessed residential exposure using 
the following assumptions: The following exposure scenarios were 
assessed for residential post-application risks: Toddlers playing on 
treated turf, adults performing yard work on treated turf, and adults 
and youths playing golf on treated turf.
    Additional information on residential exposure assumptions can be 
found at www.regulations.gov (Docket ID EPA-HQ-OPP-2007-0280, pages 26 
through 27).
    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.''
    Clothianidin is a member of the neonicotinoid class of pesticides 
and is a metabolite of another neonicotinoid, thiamethoxam. Structural 
similarities or common effects do not constitute a common mechanism of 
toxicity. Evidence is needed to establish that the chemicals operate by 
the same, or essentially the same sequence of major biochemical events 
(EPA, 2002). Although clothianidin and thiamethoxam bind selectively to 
insect nicotinic acetylcholine receptors (nAChR), the specific binding 
site(s)/receptor(s) for clothianidin, thiamethoxam, and the other 
neonicotinoids are unknown at this time. Additionally, the commonality 
of the binding activity itself is uncertain, as preliminary evidence 
suggests that clothianidin operates by direct competitive inhibition, 
while thiamethoxam is a non-competitive inhibitor. Furthermore, even if 
future research shows that neonicotinoids share a common binding 
activity to a specific site on insect nicotinic acetylcholine 
receptors, there is not necessarily a relationship between this 
pesticidal action and a mechanism of toxicity in mammals. Structural 
variations between the insect and mammalian nAChRs produce quantitative 
differences in the binding affinity of the neonicotinoids towards these 
receptors, which, in turn, confers the notably greater selective 
toxicity of this class towards insects, including aphids and 
leafhoppers, compared to mammals. While the insecticidal action of the 
neonicotinoids is neurotoxic, the most sensitive regulatory endpoint 
for clothianidin is based on unrelated effects in mammals, including 
changes in body and thymus weights, delays in sexual maturation, and 
still births. Additionally, the most sensitive toxicological effect in 
mammals differs across the neonicotinoids (e.g., testicular tubular 
atrophy with thiamethoxam; mineralized particles in thyroid colloid 
with imidaclopid). Thus, there is currently no evidence to indicate 
that neonicotinoids share common mechanisms of toxicity, and EPA is not 
following a cumulative risk approach based on a common mechanism of 
toxicity for the neonicotinoids. 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 concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism released by EPA's Office of Pesticide Programs on 
EPA's website at http://www.epa.gov/pesticides/cumulative/.
    Note that because clothianidin is a major metabolite of 
thiamethoxam, EPA has combined exposure to clothianidin resulting both 
from thiamethoxam use and from use of clothianidin as an active 
ingredient and has compared this aggregate exposure estimate to 
relevant endpoints for clothianidin. EPA has taken the further 
conservative step of assuming that, in instances where both 
thiamethoxam and clothianidin are

[[Page 6855]]

registered for use on a crop, both pesticides will, in fact, be used on 
that crop.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional (``10X'') 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 database on toxicity and 
exposure unless EPA determines based on reliable data that a different 
margin of safety will be safe for infants and children. This additional 
margin of safety is commonly referred to as the FQPA safety factor. 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 FQPA 
safety factor value based on the use of traditional UFs and/or special 
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. In the developmental 
neurotoxicity study, toxicity in the offspring was observed at a lower 
dose level than the dose that caused toxicity in the maternal animals. 
Maternal effects included decreased body weights, body weight gains, 
and food consumption. Effects seen in the offspring included decreased 
body weights, body weight gains, motor activity, and acoustic startle 
response in the females. However, EPA determined that the degree of 
concern for the developmental neurotoxicity study is low and there are 
no residual uncertainties for prenatal and/or postnatal toxicity due to 
the results of the developmental neurotoxicity study because the 
observed effects are well characterized and there are clear NOAELs/
LOAELs.
    In the 2-generation reproduction study, offspring toxicity 
(decreased body weight gains, delayed sexual maturation in males, 
decreased absolute thymus weights in F1 pups of both sexes, and an 
increase in stillbirths in both generations) was seen at a lower dose 
than the dose that caused parental toxicity. Based on evidence of 
decreased absolute and adjusted organ weights of the thymus and spleen 
in multiple studies in the clothianidin data base and on evidence of 
increased quantitative susceptibility of juvenile rats, compared to 
adults, in the 2-generation reproduction study to these effects. EPA 
has required that testing be conducted to assess immune system function 
in adults and in young animals following exposure during the period of 
organogenesis. No quantitative or qualitative susceptibility was 
observed in either of the developmental rat or rabbit studies. In the 
rat, no developmental toxicity was observed at the highest dose tested, 
although this dose level induced decreases in body weight gain and food 
consumption in the dams. In the rabbit, premature deliveries, decreased 
gravid uterine weights, an increase in litter incidence of a missing 
lobe of the lung, and a decrease in the litter average for ossified 
sternal centra per fetus were noted at a dose level in which maternal 
death, a decrease in food consumption, and clinical signs (scant feces 
and orange urine) were observed. Since the developmental effects 
observed in the rabbit study were seen in the presence of maternal 
toxicity, they are not considered to be qualitatively more severe than 
the maternal effects.
    3. Conclusion. The exposure data for clothianidin are complete or 
are estimated based on data that reasonably accounts for potential 
exposures. The acute dietary exposure assessment is based on maximum 
residues of clothianidin observed in clothianidin and thiamethoxam 
field trials and assumes 100% CT. The chronic assessment is based on 
average residues from clothianidin and thiamethoxam field trials and 
also assumes 100% CT. For water, the highest acute estimate from 
conservative models was used for both the acute and the chronic dietary 
exposure analyses. By using these conservative assessments, acute and 
chronic exposures/risks will not be underestimated. The residential 
exposure assessment utilizes residential standard operation procedures 
(SOPs) to assess post-application exposure to children as well as 
incidental oral ingestion by toddlers. The residential SOPs are based 
on reasonable worst-case assumptions and will not likely underestimate 
exposure/risk. These assessments are unlikely to underestimate the 
potential exposure to 74,800 infants and children resulting from the 
use of clothianidin.
    The toxicology data base for clothianidin, however, 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 database, and because 
juvenile rats in the two-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. Given the levels at 
which this testing should be conducted it could result in selection of 
a more protective (i.e., lower) regulatory endpoint.
    Due to the uncertainty with regard to potential effects on immune 
system function in young animals, EPA cannot conclude that there are 
reliable data supporting selection of a children's safety factor 
different from the presumptive 10X factor. Therefore, the 10X FQPA 
children's safety factor will be retained. This safety factor will be 
in the form of a database uncertainty factor to account for the lack of 
the testing with regard to immune system function with clothianidin.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-term, intermediate-term, 
and long-term risks are evaluated by comparing aggregate exposure to 
the LOC to ensure that the MOE called for by the product of all 
applicable UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to clothianidin will occupy 45% of the aPAD for the population group 
(children 1-2 years old) receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
clothianidin from food and water will utilize 16% of the cPAD for the 
population group (children 1-2 years old). Based on the use pattern, 
chronic residential exposure to residues of clothianidin is not 
expected.
    3. Short-term / Intermediate-term risk. Short-term aggregate and 
intermediate-term aggregate exposures take into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
    Clothianidin is currently registered for use(s) 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.
    EPA has determined that, for clothianidin, the toxicological 
effects

[[Page 6856]]

are the same across oral, dermal, and inhalation routes of exposure and 
has selected the same endpoint and dose for short-term and 
intermediate-term exposure scenarios. Therefore, the exposures are 
simply summed (combined/aggregated) for use in risk calculations. 
Short- and intermediate aggregate risk estimates range from an MOE of 
1,100 for toddlers (food + water + treated turf + treated soil + 
dermal) to 22,000 for youth golfers (food + water + post-application 
treated turf). The short-term and intermediate-term aggregate risks 
associated with the registered and proposed uses of clothianidin do not 
exceed the Agency's LOC for the general U.S. population or any 
population subgroup.
    4. Aggregate cancer risk for U.S. population. Clothianidin has been 
classified as a ``not likely human carcinogen.'' It is not expected to 
pose a cancer risk.
    5. 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, or to infants and children from aggregate 
exposure to clothianidin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate liquid chromotography/mass spectrometry/mass spectrometry 
(LC/MS/MS) methods are available for both collecting data and enforcing 
tolerances for clothianidin residues in plant (Bayer Methods 00552 and 
109240-1) and animal (Bayer Method 00624) commodities. The validated 
limit of quantitation (LOQ) for clothianidin in plant commodities is 
0.010 ppm, except for wheat straw (0.020 ppm), and the validated LOQs 
are 0.010 ppm in milk and 0.020 ppm in animal tissues. All three of 
these methods have been reviewed by EPA's Analytical Chemistry 
Laboratory (ACL), approved for tolerance enforcement, and forwarded to 
FDA for inclusion in PAM Volume II.

B. International Residue Limits

    There are no established or proposed Canadian, Mexican, or Codex 
maximum residue limits (MRLs) for clothianidin residues on sugar beet 
commodities.

V. Conclusion

    Therefore, the tolerance is established for residues of (E)-1-(2-
chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on 
beet, sugar, roots at 0.02 ppm, beet, sugar, molasses at 0.05 ppm and 
beet, sugar, dried pulp at 0.03.

VI. 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, 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) or Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997). 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., 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).
    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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000) do not apply to this rule. In addition, This 
rule does not 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).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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: January 22, 2008.
Lois 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 following 
commodities to the table in paragraph (a) to read as follows:


Sec.  180.586  Clothianidin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Beet, sugar, dried pulp..............................               0.03
Beet, sugar, molasses................................               0.05
Beet, sugar, roots...................................               0.02
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-1784 Filed 2-5-08; 8:45 am]
BILLING CODE 6560-50-S


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