Document ID: EPA-HQ-OPP-2011-0860-0005
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Clothianidin
Posted Date: 2013-03-29T04:00Z

[Federal Register Volume 78, Number 61 (Friday, March 29, 2013)]
[Rules and Regulations]
[Pages 19130-19136]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07093]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0860; FRL-9378-6]

Clothianidin; Pesticide Tolerances

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 tea, dried and increases the tolerance level for 
pepper to support a shorter pre-harvest interval (PHI). These 
tolerances were requested by Interregional Research Project Number 4 
(IR-4) and Valent U.S.A. Corporation, respectively, under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 29, 2013. Objections and 
requests for hearings must be received on or before May 28, 2013, 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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2011-0860, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; email address: jackson.sidney@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).

[[Page 19131]]

     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2011-0860 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
May 28, 2013. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    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 (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2011-0860, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of December 8, 2011 (76 FR 76674) (FRL-
9328-8) and September 28, 2012 (77 FR 59578) (FRL-9364-6), EPA issued a 
document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), 
announcing the filing of pesticide petitions ((PP) 1E7923 and 2F8008) 
by IR-4, IR-4 Headquarters, 500 College Road East, Suite 201 W, 
Princeton, NJ 08540 and Valent U.S.A. Corporation, P.O. Box 8025, 
Walnut Creek, CA 94596, respectively. The petitions requested that 40 
CFR 180.586 be amended by establishing tolerances for residues of the 
insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-
methyl-2-nitroguanidine, in or on fruit, citrus, group 10-10; citrus, 
dried pulp; pistachio; strawberry and tea, fresh at 0.60, 1.0, 0.01, 
1.50 and 70 parts per million (ppm), respectively, 1E7923; and 
vegetable, fruiting group 8-10, except pepper/eggplant, subgroup 8-10B; 
and pepper/eggplant subgroup 8-10B at 0.20, and 0.7 ppm, respectively, 
2F8008. In addition, PP 2F8008 requested that 40 CFR 180.586(a) be 
amended by deleting the tolerance for residues of clothianidin in or on 
the vegetable, fruiting group 8 at 0.2 ppm, upon approval of 
vegetables, fruiting, group 8-10, except pepper/eggplant subgroup 8-10B 
at 0.2 ppm; and replacing the tolerance for residues of clothianidin in 
or on fruit, pome at 1.0 ppm with fruit, pome group 11-10 at 1.0 ppm 
due to EPA expansion of the crop group. The above-mentioned Federal 
Register documents referenced a summary of the petition prepared by 
Valent U.S.A. Corporation, P.O. Box 8025, Walnut Creek, CA 94596, the 
registrant, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing. 
EPA's response to this comment is discussed in Unit IV.C.
    At this time, EPA is only establishing tolerances for tea, dried 
and is increasing the tolerance level for pepper to support PHI for an 
existing registration. In addition, EPA is re-defining the crop group 
tolerance expression ``vegetable, fruiting, group 8'' as ``vegetable, 
fruiting, group 8, except pepper.'' EPA is not prepared to establish 
tolerances for the remaining petitioned-for clothianidin tolerances 
until the potential ecological and environmental risks can be assessed. 
EPA will make a final determination on the other petitioned-for 
tolerances at a later date. The reasons for these changes are explained 
in Unit IV.D.

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. * * 
*''
    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 clothianidin including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with clothianidin follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
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.
    EPA considered the toxicity of clothianidin as well as several 
metabolites and degradates in conducting this risk assessment. EPA 
assumed that clothianidin's metabolites/degradates that are similar in 
structure to clothianidin are toxicologically equivalent to 
clothianidin with respect to the endpoints being used for risk 
assessment.
    The available data indicate that there are no consistent target 
organs in mammals; however, some effects noted in the liver, 
hematopoietic system and kidney are similar to effects from other 
neonicotinoid insecticides. In

[[Page 19132]]

subchronic oral studies, the dog seemed to be more sensitive to 
clothianidin than the rat. In addition to decreases in body weight and 
body weight gains observed in both animals, dogs also displayed 
decreased white blood cells, albumin and total protein, as well as some 
anemia. Long-term dietary administration of clothianidin did not result 
in a wider spectrum of effects in the dog; in contrast, the chronic 
feeding studies in rats showed additional effects in the liver, ovaries 
and kidneys. In the mouse chronic oral study, increases in vocalization 
and decreases in body weight and body weight gain were noted.
    Based on the lack of significant tumor increases in two adequate 
rodent carcinogenicity studies, EPA has classified clothianidin as 
``not likely to be carcinogenic to humans.'' A bone marrow micronucleus 
assay in mice showed that clothianidin is neither clastogenic nor 
aneugenic up to a toxic oral dose. Additionally, a study on the livers 
of Wistar male mice showed no induction of unscheduled DNA synthesis up 
to the limit dose; therefore, mutagenicity is not of concern.
    Clinical signs of neurotoxicity were exhibited in both rats 
(decreased arousal, motor activity and locomotor activity) and mice 
(decreased spontaneous motor activity, tremors and deep respirations) 
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.
    There was no evidence of increased quantitative or qualitative 
susceptibility of rat or rabbit fetuses following in utero exposure to 
clothianidin in developmental studies; however, increased quantitative 
susceptibility of rat pups was seen in both the reproduction and 
developmental neurotoxicity studies. In the rat reproduction study, 
offspring toxicity (decreased body weight gains and absolute thymus 
weights in pups, delayed sexual maturation and an increase in 
stillbirths) was observed in the absence of maternal effects. In the 
developmental neurotoxicity study in rats, offspring effects (decreased 
body weights, body weight gains, motor activity and acoustic startle 
response amplitude) were noted at doses lower than those resulting in 
maternal toxicity.
    Decreased absolute and relative thymus and spleen weights were 
observed in multiple studies; these studies showed possible evidence of 
effects on the immune system. In addition, juvenile rats in the rat 
reproduction study appeared to be more susceptible to these effects. 
However, a guideline immunotoxicity study showed no evidence of 
clothianidin-mediated immunotoxicity in adult rats and a developmental 
immunotoxicity study demonstrated no increased susceptibility for 
offspring with regard to immunotoxicity.
    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 in document: ``Clothianidin--Aggregate Human Health 
Risk Assessment of New Uses on Strawberry, Pistachio, and Citrus; New 
Tolerance for Tea; and Revised PHI and Tolerance for Pepper and 
Eggplant (Crop Subgroup 8-10B),'' dated September 27, 2012 at page 32, 
and additional information on pome fruit can be found in document: 
``Clothianidin--Human Health Risk Assessment for Requested Foliar Uses 
on Rice, Seed Treatment on Leafy Vegetables, Increased Application Rate 
for Vegetables, and Expanded Uses on Fruiting Vegetables and Pome 
Fruit,'' dated February 1, 2012, in docket ID number EPA-HQ-OPP-2011-
0860.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. 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/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for clothianidin used for 
human risk assessment is discussed in Unit II of the final rule 
published in the Federal Register of August 29, 2012 (77 FR 52246) 
(FRL-9360-4).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to clothianidin, EPA considered exposure for all of 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.
    Such effects were identified for clothianidin. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA) 2003-2008 National Health and 
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As 
to residue levels in food, EPA used maximum field trial values, 
empirical processing factors and assumed 100 percent crop treated (PCT) 
for all commodities. Clothianidin is a major metabolite of 
thiamethoxam, and there are a number of crops for which uses of both 
clothianidin and thiamethoxam have been registered. The labels for the 
various end-use products containing these active ingredients prohibit 
the application of both active ingredients to the same crop during a 
growing cycle. Due to that restriction and the assumption of 100 PCT, a 
single value reflecting the greatest clothianidin residue from either 
active ingredient has been used for crops listed for use with both 
active ingredients (versus combined estimates from clothianidin and 
thiamethoxam). Generally, this assessment uses the established or 
recommended clothianidin tolerance for crops having tolerances for both 
compounds (the exception being low-growing berry, subgroup 13-07G, 
which is based on observed clothianidin residues in thiamethoxam 
strawberry field trials). For foods with thiamethoxam tolerances but 
without clothianidin tolerances, maximum residues of clothianidin 
observed in thiamethoxam field trials have been used in these 
assessments. Foods falling

[[Page 19133]]

into this category include meats, meat by-products, artichoke, tropical 
fruits, coffee, hop, mint, and rice.
    In relying on maximum field trial residues of clothianidin, EPA has 
adjusted the field trial values upward to account for metabolites of 
concern for leafy and root and tuber vegetables and for ruminants and 
poultry. Details on these adjustments are provided in document: 
``Clothianidin--Human Health Risk Assessment for Requested Foliar Uses 
on Rice, Seed Treatment on Leafy Vegetables, Increased Application Rate 
for Vegetables, and Expanded Uses on Fruiting Vegetables and Pome 
Fruit,'' dated February 1, 2012, in docket ID number EPA-HQ-OPP-2011-
0860.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA assessed chronic 
dietary exposure using the same residue information and assumptions 
regarding metabolites/degradates as in the acute exposure analysis.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that clothianidin does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue information. EPA used anticipated residue 
(maximum field trial residues) in the dietary assessment for 
clothianidin.
    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 require 
pursuant to FFDCA section 408(f)(1) 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. 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 these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for clothianidin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
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.
    The Agency modeled estimated drinking water concentrations (EDWC) 
of clothianidin in surface and groundwater using the Tier 1 Rice Model, 
the Food Quality Protection Act (FQPA) Index Reservoir Screening Tool 
(FIRST), and the Screening Concentrations in Groundwater model (SCI-
GROW). The Tier 1 Rice Model produced the greatest value of any of the 
models used to predict EDWCs for acute and chronic exposures. The Tier 
1 Rice Model EDWC of 72 parts per billion (ppb) was entered directly 
into the dietary exposure model.
    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 uses that 
could result in residential exposures: Turf, ornamental plants, and/or 
indoor use to control bed bugs. EPA assessed residential exposure using 
the following assumptions: Exposures may occur during application of 
products containing clothianidin (handler exposure) as well as 
following application (post-application exposure) and are expected to 
be of short-term (1-30 days) duration.
    Adults were assessed for potential short-term dermal and inhalation 
handler exposure from applying clothianidin to residential turf/home 
lawns and for short-term post-application dermal exposure from contact 
with treated residential and recreational turf home lawns and golf 
courses. There is also potential for post-application dermal and 
inhalation exposure for adults and children resulting from use of 
clothianidin on residential turf, ornamentals (i.e., trees), and indoor 
surfaces, as well as, potential for incidental oral post-application 
exposure for children.
    Although there is potential for adult exposure resulting from both 
applying the product and post-application activities, the Agency did 
not combine exposure estimates from adult handler and post-application 
activities because of the conservative assumptions and inputs within 
each exposure scenario. The children's combined exposure includes only 
the hand-to-mouth exposure for the incidental oral exposure component. 
To include exposure from object-to-mouth and soil ingestion in addition 
to hand-to-mouth would overestimate incidental oral exposures for 
purposes of estimating combined residential exposure. Further, because 
the level of concern for dermal exposures (MOEs less than 100) and 
inhalation exposure (MOEs less than 1,000) are different, a total 
aggregate risk index (ARI) approach was used instead of the MOE 
approach. ARIs of greater than 1 indicate risks are not of concern.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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. 
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 noncompetitive inhibitor. Furthermore, even if 
future research shows that neonicotinoids share a common binding 
activity to a specific site on insect nAChRs, 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,

[[Page 19134]]

and stillbirths. Additionally, the most sensitive toxicological effect 
in mammals differs across the neonicotinoids (such as testicular 
tubular atrophy with thiamethoxam, and 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 OPP on EPA's Web site at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) 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 (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There is no residual concern 
for increased qualitative or quantitative susceptibility in the rat or 
rabbit developmental toxicity studies. Since there is evidence of 
increased quantitative susceptibility of the young following exposure 
to clothianidin in the rat reproduction study and the DNT study, EPA 
performed a degree of concern analysis to:
    i. Determine the level of concern for the effects observed when 
considered in the context of all available toxicity data; and,
    ii. Identify any residual uncertainties after establishing toxicity 
endpoints and traditional uncertainty factors to be used in the 
clothianidin risk assessment.
    Considering the overall toxicity profile and the endpoints and 
doses selected for the clothianidin risk assessment, EPA characterized 
the degree of concern for the effects observed in the clothianidin 2-
generation reproduction and DNT studies as low, noting that there are 
clear NOAELs for the offspring effects and regulatory doses were 
selected to be protective of these effects. No other residual 
uncertainties were identified with respect to susceptibility.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X in assessing risks from dermal and oral 
exposure pathways. However, EPA does not have reliable data to support 
reduction of the FQPA SF in assessing risks from the inhalation 
exposure pathway and thus is retaining the 10X FQPA SF for these 
assessments. That decision is based on the following findings:
    i. The toxicity database for clothianidin is complete with the 
exception of a required 28-day inhalation study.
    ii. There are no residual concerns regarding potential prenatal and 
postnatal toxicity in the young. A rat developmental neurotoxicity 
study is available and shows evidence of increased quantitative 
susceptibility of offspring. However, EPA considers the degree of 
concern for the developmental neurotoxicity study to be low for 
prenatal and postnatal toxicity because the NOAEL and LOAEL were well 
characterized, and the doses and endpoints selected for risk assessment 
are protective of the observed susceptibility. While the rat multi-
generation reproduction study showed evidence of increased quantitative 
susceptibility of offspring compared to adults, the degree of concern 
is low because the study NOAEL has been selected as the POD for risk 
assessment purposes for relevant exposure routes and durations. In 
addition, the potential immunotoxic effects observed in the study have 
been further characterized with the submission of a developmental 
immunotoxicity study that showed no evidence of susceptibility. As a 
result, there are no concerns or residual uncertainties for pre- and 
postnatal toxicity after establishing toxicity endpoints and 
traditional UFs to be used in the risk assessment for clothianidin.
    iii. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on assumptions that were judged to be highly conservative and health-
protective for all durations and population subgroups, including 
maximum field trial residues, adjustment factors from metabolism data, 
empirical processing factors, and 100 PCT for all commodities. The 
exposure databases (dietary food, drinking water, and residential) are 
complete. The risk assessment for each potential exposure scenario 
includes all metabolites and/or degradates of concern and does not 
underestimate potential exposure and risk for infants or children. 
Additionally, EPA made conservative (protective) assumptions in the 
ground water and surface water modeling used to assess exposure to 
clothianidin in drinking water. EPA used similarly conservative 
assumptions to assess post-application exposure of children as well as 
incidental oral exposure of toddlers. These assessments will not 
underestimate the exposure and risks posed by clothianidin.
    In conclusion, there are reliable data showing that, with the 
exception of scenarios involving inhalation exposure, the risk to 
infants and children can be safely assessed without an additional 10X 
safety factor. However, in the absence of the required inhalation 
toxicity study, EPA is retaining the 10X FQPA factor as a database 
uncertainty factor for assessing inhalation exposure and risk only, for 
both adults and children.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute Population adjusted dose (aPAD) and chronic PAD (cPAD). For 
linear cancer risks, EPA calculates the lifetime probability of 
acquiring cancer given the estimated aggregate exposure. Short-, 
intermediate-, and chronic-term risks are evaluated by comparing the 
estimated aggregate food, water, and residential exposure to the 
appropriate PODs to ensure that an adequate MOE exists.
    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 28% of the aPAD for children 1-2 years old, 
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
clothianidin from food and water will utilize 28% of the cPAD for 
children 1-2 years old the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
clothianidin is not expected;

[[Page 19135]]

therefore, the chronic aggregate risk estimates are equivalent to the 
dietary risk estimates and are below EPA's level of concern.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    For purposes of performing an aggregate assessment, the EPA 
selected the worst-case adult and children exposure scenarios. The 
treatment of tree trunks using a manually-pressurized handwand presents 
the worst-case exposure estimate for adults, while the bed bug scenario 
presents the worst-case exposure estimates for children 1 to <2 yrs 
old.
    For short- and intermediate-term ``worst-case'' aggregate exposure 
estimates, the ARI for adults is 6.5 and for children 1 to <2 years 
old, the ARI is estimated at 1.2. ARI estimated values greater than 1.0 
indicate risks are not of concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, clothianidin was classified as ``not likely to be carcinogenic 
to humans,'' and is not expected to pose a cancer risk to humans.
    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 enforcement methodologies, based on solvent extraction and 
Liquid chromatography--mass spectrometry/mass spectrometry (LC-MS/MS) 
separation, identification, and quantification, are available for plant 
(Morse Method Meth 164--modified, RM-39C-1, or Bayer Method 
00552) and livestock (Bayer Method 00624) matrices. The (LOQ) for 
clothianidin in plant commodities is 0.01 ppm, except for wheat straw 
(0.02 ppm), and the validated LOQs are 0.01 ppm in milk and 0.02 ppm in 
animal tissues. Clothianidin and its major metabolites are not 
adequately recovered using any of the United States Food and Drug 
Administration (FDA) multiresidue methods.
    The methods may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has established MRLs for clothianidin in or on tea, fresh 
at 0.7 ppm and fruiting vegetables other than cucurbits at 0.050 ppm. 
The residue field trial submitted to support the U.S. tolerances 
results in higher clothianidin residues than the maximum residue levels 
established by Codex and therefore, the U.S. tolerances cannot be 
harmonized with the Codex MRLs.

C. Response to Comments

    EPA received one comment on the notice of filing for petition, 
1E7923, in which the commenter requested that EPA deny IR-4's petition 
to establish a tolerance for residues of clothianidin on food crops 
because it is toxic to humans.
    When new or amended tolerances are requested for the presence of 
the residues of a pesticide and its toxicologically significant 
metabolite(s) in food or feed, the Agency, as is required by section 
408 of the FFDCA, estimates the risk of the potential exposure to these 
residues by performing an aggregate risk assessment. As discussed in 
Unit III, EPA's assessment for clothianidin concludes that there is a 
reasonable certainty that no harm will result from exposure to 
clothianidin residues of interest. Therefore, the tolerances 
established by this action are found to be acceptable. The commenter 
submitted no evidence or argument that addresses this statutory 
finding.

D. Revisions to Petitioned-For Tolerances

    In this action EPA is only establishing tolerances for tea, dried 
and pepper and will make a final determination on the remaining 
petitioned for tolerances at a later date. Though EPA is able to make 
the required safety finding under FFDCA and the human health risk 
assessments support all of the petitioned-for uses, what must still be 
considered for the additional uses to be registered in the United 
States are potential ecological and environmental risks associated with 
clothianidin. Therefore, at this time EPA is only prepared to establish 
a tolerance on dried tea (without a U.S. registration; i.e., an 
``import tolerance'') and to increase the tolerance on pepper to 
support a shorter pre-harvest interval (PHI).
    EPA is still in the process of assessing the potential ecological 
concerns identified with the additional exposures expected from the 
registration of the proposed pome fruit group 11-10, pepper/eggplant 
subgroup 8-10B, citrus fruit group 10-10, pistachio, and strawberry 
uses. However, in order to support an effort to establish tolerances 
for residues of pesticides on tea, to ensure a safe supply of tea for 
the U.S. consumer, EPA has determined it will move forward with 
establishing the tolerance for clothianidin on tea prior to finalizing 
the decision on the remaining petitioned for uses. Additionally, there 
is an existing tolerance for residues of clothianidin on fruiting 
vegetable group 8 at 0.20 ppm and residue field trial data were 
submitted for pepper to support a lower PHI which results in a 
recommended higher tolerance. Though EPA is not prepared to allow the 
expansion of the Fruiting Vegetable Group 8 at this time to include the 
additional commodities in Pepper/eggplant Subgroup 8-10B, shortening 
the PHI on pepper is not expected to result in any additional 
environmental exposure. Therefore, the EPA has determined that it will 
establish a higher tolerance for clothianidin on pepper in this action 
and a final determination on the petition for the pepper/eggplant 
subgroup 8-10B tolerance will be made at a later date.
    As to the tolerance levels, the proposed tea, fresh tolerance at 50 
ppm will be established on tea, dried at 70 ppm. The commodity listing 
is changed from tea, fresh to tea, dried to reflect the commodity from 
which residue data were collected and to reflect the principal tea 
commodity that is in the channels of trade. The value of the tolerance 
is changed based on the

[[Page 19136]]

output from the Organisation for Economic Cooperation and Development 
(OECD) calculation procedures. EPA is also establishing the separate 
tolerance on pepper at 0.80 ppm which is different than the requested 
tolerance at 0.7 ppm for pepper/eggplant subgroup 8-10B. EPA based the 
0.80 tolerance level on the non-bell-pepper residue data and OECD 
Calculation Procedures.
    Finally, to account for the establishment of a ``separate'' pepper 
tolerance, EPA re-defined the existing crop group tolerance expression 
``vegetable, fruiting, group 8'' as ``vegetable, fruiting, group 8, 
except pepper''.

V. Conclusion

    Therefore, tolerances are established for residues of clothianidin, 
(E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in 
or on tea, dried at 70 ppm, pepper at 0.80 ppm, and vegetable, 
fruiting, group 8, except pepper at 0.20 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
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 final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``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 FFDCA section 408(d), such as the tolerances 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 FFDCA section 408(n)(4). 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 9, 2000) do not apply to this final rule. In addition, 
this final 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) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: March 15, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    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 in paragraph (a)(1) by revising the 
commodity ``vegetable, fruiting, group 8'', by alphabetically adding 
the commodities ``pepper'' and ``tea, dried'', and by adding footnote 1 
to the table to read as follows:

Sec.  180.586  Clothianidin; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Pepper.....................................................         0.80
 
                                * * * * *
Tea, dried \1\.............................................           70
 
                                * * * * *
Vegetable, fruiting, group 8, except pepper................         0.20
 
                                * * * * *
------------------------------------------------------------------------
\1\ No U.S. registrations.

* * * * *
[FR Doc. 2013-07093 Filed 3-28-13; 8:45 am]
BILLING CODE 6560-50-P