Document ID: EPA-HQ-OPP-2008-0945-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Clothianidin
Posted Date: 2009-12-09T05:00Z

[Federal Register: December 9, 2009 (Volume 74, Number 235)]
[Rules and Regulations]               
[Page 65021-65029]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09de09-7]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0945; FRL-8793-6]

 
Clothianidin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY:  This regulation establishes tolerances for residues of 
clothianidin in or on multiple commodities which are identified and 
discussed later in this document. This regulation additionally 
increases established tolerances in or on cotton, gin byproducts; 
cotton, undelinted seed and potato, granules/flakes and deletes 
tolerances in or on several commodities that will be superseded by this 
action. Valent U.S.A. Corporation, Bayer CropScience and Interregional 
Research Project Number 4 (IR-4) requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 9, 2009. Objections and 
requests for hearings must be received on or before February 8, 2010, 
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-2008-0945. All documents in the 
docket are listed in the docket index available at http://
www.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: Laura Nollen, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7390; e-mail address: nollen.laura@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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 electronically available documents 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 e-CFR cite 
at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2008-0945 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 February 8, 2010.
    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-2008-0945, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     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 Facility'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 September 5, 2008 (73 FR 51817) (FRL-
8380-4), 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 
8F7395) by Valent U.S.A. Corporation, P.O. Box 8025, Walnut Creek, CA 
94596. The petition 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 almond, hull at 1.5 parts per million (ppm); cotton, seed at 0.25 
ppm; cotton, gin trash at 4.5 ppm; cotton, meal at 0.25 ppm; cotton, 
hull at 0.25 ppm; cotton, refined oil at 0.01 ppm; soybean, seed at 
0.03 ppm; soybean, hull at 0.35 ppm; soybean, meal at 0.07 ppm; 
soybean, oil at 0.01 ppm; tomato, paste at 0.08 ppm; tomato, puree at 
0.07 ppm; nut, tree, group 14 at 0.01 ppm;

[[Page 65022]]

vegetable, cucurbit, group 9 at 0.05 ppm; and vegetable, fruiting, 
group 8 at 0.25 ppm. The petition additionally requested to establish 
tolerances for residues of clothianidin and its metabolite TMG, N-(2-
chlorothiazol-5-ylmethyl)-N'-methylguanidine, in or on vegetable, 
leafy, brassica, group 5 at 3.0 ppm; and vegetable, leafy, except 
brassica, group 4 at 3.5 ppm. That notice referenced a summary of the 
petition prepared by Valent U.S.A. Corporation, the registrant, which 
is available to the public in the docket, http://www.regulations.gov. 
This petition was assigned Docket No. OPP-2008-0646. There were no 
comments received in response to the notice of filing.
    In the Federal Register of December 3, 2008 (73 FR 73640) (FRL-
8390-4), 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 
8F7413) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Dr., 
Research Triangle Park, NC 27709. The petition 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 and its metabolite TMG, N-(2-chloro-5-
thiazolylmethyl)-N-'-methylguanidine, in or on vegetable, root, except 
sugar beet, subgroup 1B at 0.6 ppm; vegetable, tuberous and corm, 
subgroup 1C at 0.2 ppm; vegetable, bulb, group 3 at 0.2 ppm; vegetable, 
leafy greens, except brassica, subgroup 4A at 1.1 ppm; and vegetable, 
brassica, leafy, group 5 at 0.35 ppm. The petition additionally 
requested to establish tolerances for residues of clothianidin in or on 
vegetable, fruiting, group 8 at 0.01 ppm; vegetable, cucurbit, group 9 
at 0.01 ppm; grain, cereal, except rice, group 15 at 0.01 ppm, wheat, 
forage at 0.35 ppm, wheat, hay at 0.07 ppm and wheat, straw at 0.04 
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. This petition was assigned Docket 
No. OPP-2008-0771. There were no comments received in response to the 
notice of filing.
    In the Federal Register of April 13, 2009 (74 FR 16866) (FRL-8396-
6), 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 
8E7460) by Interregional Research Project Number 4 (IR-4), 500 College 
Rd. East, Suite 201 W., Princeton, NJ 08540. The petition 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 berry, low growing, 
subgroup 13-07H, except strawberry at 0.01 ppm; peach at 0.70 ppm; and 
vegetable, tuberous and corm, subgroup 1C at 0.05 ppm. That notice 
referenced a summary of the petition prepared on behalf of IR-4 by 
Valent U.S.A. Corporation, the registrant, which is available to the 
public in the docket, http://www.regulations.gov. This petition was 
assigned Docket No. OPP-2008-0945. There were no comments received in 
response to the notice of filing.
    In the Federal Register of April 13, 2009 (74 FR 16866) (FRL-8396-
6), 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 
8F7416) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Dr., 
Research Triangle Park, NC 27709. The petition requested that 40 CFR 
180.586 be amended by increasing the tolerance for residues of the 
insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-
methyl-2-nitroguanidine and its metabolite TMG, N-(2-chloro-5-
thiazolylmethyl)-N-'-methylguanidine, in or on potato from 0.05 ppm to 
0.6 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. This petition was assigned 
Docket No. OPP-2008-0771. There were no comments received in response 
to the notice of filing.
    In the Federal Register of May 6, 2009 (74 FR 20947) (FRL-8412-7), 
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 9F7530) 
by Valent U.S.A. Corporation, P.O. Box 8025, Walnut Creek, CA 94596. 
The petition 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 fig 
at 0.05 ppm and pomegranate at 0.2 ppm. That notice referenced a 
summary of the petition prepared by Valent, U.S.A. Corporation, the 
registrant, which is available to the public in the docket, http://
www.regulations.gov. This petition was assigned Docket No. OPP-2009-
0262. There were no comments received in response to the notice of 
filing.
    Bayer CropScience requested tolerances for residues of clothianidin 
to support seed treatment uses, whereas Valent U.S.A. Corporation and 
IR-4 requested tolerances to support foliar applications. Typically, 
foliar applications will result in higher residues than seed treatment 
uses. In cases where both use patterns were requested for the use of 
clothianidin on the same commodity, tolerance levels are being 
established at the higher level proposed; however, based upon review of 
the data supporting the petitions, EPA has revised the proposed foliar 
application tolerance levels for leafy vegetable, except brassica, crop 
group 4; brassica leafy vegetable, crop group 5; fruiting vegetable, 
crop group 8; and cucurbit vegetable, crop group 9. The Agency is also 
revising tolerances for several other proposed individual and group 
commodities.
    EPA has determined that the proposed tolerance in or on bulb onion 
group 3 should be established on bulb onion, group 3-07. The Agency has 
also determined that tolerances are not required for several 
petitioned-for commodities. EPA is establishing tolerances on several 
commodities that were not proposed and is deleting several existing 
tolerances. Finally, the Agency is amending an established tolerance on 
potato granules/flakes that was not proposed. The reasons for these 
changes are explained in Unit IV.C.

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 section 408(b)(2)(D) of FFDCA, and the factors 
specified in 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 for the petitioned-for

[[Page 65023]]

tolerances for residues of clothianidin on almond hulls at 1.5 ppm; 
low-growing berry, subgroup 13-07H, except strawberry at 0.01 ppm; 
cotton, gin byproducts at 4.5 ppm; cotton undelinted seed at 0.20 ppm; 
fig at 0.05; cereal grain, forage, fodder and straw, group 16, except 
rice, forage at 0.35 ppm; cereal grain, forage, fodder and straw, group 
16, except rice, hay at 0.07 ppm; cereal grain, forage, fodder and 
straw, group 16, except rice, stover at 0.1 ppm; cereal grain, forage, 
fodder and straw, group 16, except rice, straw at 0.05 ppm; cereal 
grain, group 15, except rice at 0.01 ppm; tree nut, group 14 at 0.01 
ppm; peach at 0.80 ppm; pomegranate at 0.20 ppm; potato chips at 0.6 
ppm; potato, granules/flakes at 1.5 ppm; soybean seed at 0.02 ppm; 
leafy brassica vegetable, group 5 at 1.9 ppm; bulb vegetable, group 3-
07 at 0.45 ppm; cucurbit vegetable, group 9 at 0.06 ppm; fruiting 
vegetable, group 8 at 0.20 ppm; leafy vegetable except brassica, group 
4 at 3.0 ppm; root vegetable except sugar beet, subgroup 1B at 0.8 ppm; 
and tuberous and corm vegetable, subgroup 1C at 0.3 ppm. EPA's 
assessment of exposures and risks associated with establishing 
tolerances 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.
    EPA considered the toxicity of clothianidin as well as several 
metabolites and degradates in conducting this risk assessment. 
Metabolites/degradates of concern in plants include parent and TMG for 
leafy and root and tuber vegetables; parent-only for other crops; and 
parent, TZNG and MNG for rotational crops. For livestock commodities, 
the metabolites/degradates of concern include: Parent and TZU, TZG, 
TZNG and ATMG-pyruvate for ruminants; and parent and TZU, TZG, TZNG, 
and ATG-acetate for poultry. Acute toxicity and genotoxicity data are 
available for several metabolites/degradates of clothianidin. Given 
that the points of departure (POD) used for risk assessment are well 
below the lethal dose LD50 levels observed in the acute 
toxicology studies and that clothianidin and its metabolites/degradates 
of toxicological concern are similar in structure, EPA is assuming that 
these compounds are toxicologically equivalent to clothianidin with 
respect to the endpoints being used for risk assessment.
    Clothianidin and its metabolites and degradates have relatively low 
acute toxicity via oral, dermal and inhalation routes of exposure; 
however, acute oral administration of clothianidin in mice and the TMG 
metabolite in rats showed evidence of increased relative toxicity. 
There is no evidence of dermal sensitization or eye irritation with the 
exception of the clothianidin-triazan intermediate, which is a dermal 
sensitizer. 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 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 the document ``Clothianidin: Human Health Risk 
Assessment for Proposed Uses on Berries (Group 13-07H), Brassica 
Vegetables (Group 5), Cotton, Cucurbit Vegetables (Group 9), Fig, 
Fruiting Vegetables (Group 8), Leafy Green Vegetables (Group 4A), 
Peach, Pomegranate, Soybean, Tree Nuts (Group 14), and Tuberous and 
Corm Vegetables (Group 1C),'' pages 46-54 in docket ID number EPA-HQ-
OPP-2008-0945.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological POD is identified as the basis for 
derivation of reference values for risk assessment. The POD may be 
defined as the highest dose at which no adverse effects are observed 
(the NOAEL) in the toxicology study identified as appropriate for use 
in risk assessment. However, if a NOAEL cannot be determined, the 
lowest dose at which adverse effects of concern are identified (the 
LOAEL) or a Benchmark Dose (BMD) approach is sometimes used for risk 
assessment. Uncertainty/safety factors (UFs) are used in conjunction 
with the POD to take into account uncertainties inherent in the

[[Page 65024]]

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 dietary 
risks by comparing aggregate food and water 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 
POD by all applicable UFs. Aggregate short-, intermediate-, and 
chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the level of concern (LOC).
    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 
greater than that 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 can be found at http://www.regulations.gov in the 
document ``Clothianidin: Human Health Risk Assessment for Proposed Uses 
on Berries (Group 13-07H), Brassica Vegetables (Group 5), Cotton, 
Cucurbit Vegetables (Group 9), Fig, Fruiting Vegetables (Group 8), 
Leafy Green Vegetables (Group 4A), Peach, Pomegranate, Soybean, Tree 
Nuts (Group 14), and Tuberous and Corm Vegetables (Group 1C),'' page 23 
in docket ID number EPA-HQ-OPP-2008-0945.

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). As to residue levels in food, EPA used tolerance-level 
residues, 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 
from 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. These include meats, meat by-products, artichoke, tropical 
fruits, coffee, hop, mint, rice, and strawberry. The metabolism of 
clothianidin is complex, with a few major (> 10% of the total 
radioactive residues) and numerous minor metabolites. Metabolites/
degradates of concern in plants include clothianidin and TMG for leafy, 
root and tuber vegetables; parent-only for other crops; and parent, 
TZNG and MNG for rotational crops. For livestock commodities, the 
metabolites of concern include: parent and TZU, TZG, TZNG, and ATMG-
pyruvate for ruminants; and parent and TZU, TZG, TZNG, and ATG-acetate 
for poultry. For leafy vegetables the EPA required analysis for 
residues of TMG along with parent in field trial samples. Residues of 
TMG were shown to occur in leafy vegetables at levels approximately 
tenfold below those of clothianidin. EPA has not included these 
metabolites in the tolerance expression for plant or animal commodities 
because the metabolites are only found in certain commodities, 
including the metabolites would create tolerance harmonization issues 
with Canada, and monitoring residues of clothianidin based on parent 
only would be representative of total clothianidin residues and thus 
adequate for enforcement. Because the metabolites are not included in 
the tolerance expressions, an adjustment factor of 1.1 has been 
incorporated into the assessment for leafy vegetables to account for 
the presence of the metabolite TMG, and an adjustment factor of 1.5 has 
been incorporated for livestock-derived commodities (milk) to account 
for the presence of metabolites TZU, TZG, TZNG, ATMG-pyruvate and ATG-
acetate. The 1.1 adjustment factor is based on field trial data showing 
TMG does not exceed 10% of the parent compound residue level in leafy 
vegetables and the 1.5 factor was based on metabolism data.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. 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 lack of evidence of carcinogenicity in 
two adequate rodent carcinogenicity studies, EPA has classified 
clothianidin as ``not likely to be carcinogenic to humans.'' Therefore, 
a quantitative exposure assessment to evaluate cancer risk is 
unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for clothianidin. Tolerance level residues and/or 100 PCT were assumed 
for all food commodities.
    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.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of clothianidin for 
surface water are estimated to be 7.29 parts per billion (ppb) for 
acute exposures and 1.35 ppb for chronic exposures. For ground water, 
the EDWC is estimated to be 5.88 ppb.

[[Page 65025]]

    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. The water concentration value 
of 7.29 ppb was used to assess the contribution to drinking water for 
the acute dietary assessment. For chronic dietary risk assessment, the 
water concentration of value 5.88 ppb was used.
    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 turf. Residential 
handler exposure is not expected from the currently registered or 
proposed uses of clothianidin since these products are to be applied by 
commercial applicators. Adult short- and intermediate-term 
postapplication exposures were assessed for dermal exposures from 
commercial applications (via granular push-type spreaders), dermal 
post-application contact and golfer postapplication contact. For 
toddlers, short- and intermediate-term postapplication incidental oral 
(hand-to-mouth and soil ingestion) and dermal risks were assessed for 
exposure to treated turf.
    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/.

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 Food Quality 
Protection Act (FQPA) safety factor (SF). In applying this provision, 
EPA either retains the default value of 10X, or uses a different 
additional SF when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. The toxicology data for 
clothianidin provide no indication of increased quantitative or 
qualitative susceptibility, as compared to adults, of rat and rabbit 
fetuses to in utero exposure in developmental studies. However, 
increased quantitative susceptibility was observed in both the 
developmental neurotoxicity and rat multi-generation reproduction 
studies. In the developmental neurotoxicity study, offspring toxicity 
(decreased body weight gains, motor activity and acoustic startle 
response) was seen at a lower dose than that which caused maternal 
toxicity. In the 2-generation rat 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 dose 
lower than that which caused parental toxicity.
    3. Conclusion. In the final rule published in the Federal Register 
of February 6, 2008 (73 FR 6851) (FRL-8346-9), EPA had previously 
determined that the FQPA SF for clothianidin should be retained at 10X 
because EPA had required the submission of a developmental 
immunotoxicity study to address the combination of evidence of 
decreased absolute and adjusted organ weights of the thymus and spleen 
in multiple studies in the clothianidin data base, and evidence showing 
that juvenile rats in the 2-generation reproduction study appear to be 
more susceptible to these potential immunotoxic effects. In the absence 
of a developmental immunotoxicity study EPA concluded that there was 
sufficient uncertainty regarding immunotoxic effects in the young that 
the 10X FQPA factor should be retained as a database uncertainty 
factor. Since that determination, EPA has received and reviewed an 
acceptable/guideline developmental immunotoxicity study, which 
demonstrated no treatment-related effects. Taking the results of this 
study into account as well as the rest of the data on clothianidin, EPA 
has determined that reliable data show the safety of infants and 
children would be adequately protected if the FQPA SF for clothianidin 
were reduced to 1X. That decision is based on the following findings:
    i. The toxicity database for clothianidin is complete. As noted, 
the prior data gap concerning developmental immunotoxicity has been 
addressed by the submission of an acceptable developmental 
immunotoxicity study.

[[Page 65026]]

    ii. 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; therefore, there are no residual concerns regarding 
effects in the young.
    iii. 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 and 
LOAEL have been selected 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 prenatal and postnatal toxicity after 
establishing toxicity endpoints and traditional UFs to be used in the 
risk assessment for clothianidin.
    iv. 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 
tolerance-level residues, adjustment factors from metabolite data, 
empirical processing factors, and 100 PCT for all commodities. 
Additionally, EPA made conservative (protective) assumptions in the 
ground and surface water modeling used to assess exposure to 
clothianidin in drinking water. EPA used similarly conservative 
assumptions to assess postapplication exposure of children and adults 
as well as incidental oral exposure of toddlers. These assessments will 
not underestimate the exposure and risks posed by clothianidin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. Using the exposure assumptions discussed in this unit 
for acute exposure, the acute dietary exposure from food and water to 
clothianidin will occupy 23% of the aPAD for children 1 to 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 19% of the cPAD for 
children 1 to 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.
    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).
    Clothianidin is currently registered for use on turf that could 
result in short- and intermediate-term residential exposure and the 
Agency has determined that it is appropriate to aggregate chronic 
exposure through food and water with short- and intermediate-term 
residential exposures to clothianidin. Using the exposure assumptions 
described in this unit for short- and intermediate-term exposures, EPA 
has concluded the combined short- and intermediate-term food, water, 
and residential exposures aggregated result in aggregate MOEs of 
greater than 380 for all population subgroups. As the aggregate MOEs 
are greater than 100 (the LOC) for all population subgroups, including 
infants and children, short- and intermediate-term aggregate exposures 
to clothianidin are not of concern to EPA.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in mice and rats at doses that were judged 
to be adequate to assess the carcinogenic potential, 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 liquid chromatography/mass spectrometry/mass spectrometry 
(LC/MS/MS) enforcement methodology is available to enforce the 
tolerance expression for both plant and animal commodities and has been 
forwarded to the Food and Drug Administration for inclusion in the 
Pesticide Analytical Manual (PAM), Volume II. 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: residuemethods@epa.gov.

B. International Residue Limits

    In order to harmonize with Canadian maximum residue limits (MRLs) 
on potato tubers at 0.3 ppm; potato chips at 0.6 ppm and potato 
granules/flakes at 1.5 ppm, EPA has recommended the following 
tolerances: Vegetable, tuberous and corm, subgroup 1C (which includes 
potato) at 0.3 ppm; potato, chips at 0.6 ppm; and potato granules/
flakes at 1.5 ppm. Additionally, Canada is currently reviewing a 
petition to establish a tolerance in or on the stone fruit (including 
peaches) crop group at 0.8 ppm. A tolerance on peach at 0.80 ppm is 
being recommended by EPA to harmonize with Canada's recommended stone 
fruit MRL. There are currently no Canadian MRLs established for 
residues of clothianidin in or on other commodities associated with 
these petitions. There are currently no Codex or Mexican MRLs 
established for residues of clothianidin in or on commodities 
associated with these petitions.

C. Revisions to Petitioned-For Tolerances

    EPA has revised the proposed tolerance levels for foliar 
applications of clothianidin on the following commodities: Leafy 
vegetable, crop group 4 from 3.5 ppm to 3.0 ppm; brassica vegetable, 
crop group 5 from 3.0 ppm to 1.9 ppm; fruiting vegetable, crop group 8 
from 0.25 to 0.20 ppm; and cucurbit vegetable, crop group 9 from 0.05 
to 0.06 ppm. EPA has also revised the proposed tolerance levels in or 
on

[[Page 65027]]

soybean, seed from 0.03 ppm to 0.02 ppm; root vegetable, except sugar 
beet, subgroup 1B from 0.60 ppm to 0.8 ppm; bulb vegetable group 3-07 
from 0.2 ppm to 0.45 ppm; and wheat, straw from 0.04 ppm to 0.05 ppm; 
and has revised the proposed tolerance amendment for cotton, undelinted 
seed (the preferred commodity definition for cotton, seed) from 0.25 to 
0.20. EPA revised the tolerance levels based on analysis of the residue 
field trial data using the Agency's Tolerance Spreadsheet in accordance 
with the Agency's Guidance for Setting Pesticide Tolerances Based on 
Field Trial Data.
    The Agency has also revised tolerances in order to harmonize U.S. 
MRLs with currently established or pending Canadian MRLs for peach from 
0.7 ppm to 0.80 ppm; and for tuberous and corm vegetable, group 1C 
(based on the a seed piece treatment which results in the highest 
residue) from 0.2 ppm to 0.3 ppm. Additionally, the Agency has 
established a tolerance in or on potato, chips at 0.6 ppm; and has 
increased a currently-established tolerance in or on potato, granules/
flakes from 0.08 to 1.5 ppm to harmonize with Canadian MRLs on the 
commodities.
    EPA has also determined that individual tolerances are not 
necessary for several petitioned-for commodities. A request to increase 
an existing potato tolerance from 0.05 ppm to 0.6 ppm is not necessary 
because potato is superseded by inclusion in the tuberous and corm 
subgroup 1C; thus, the existing potato tolerance is being deleted. A 
proposed tolerance on vegetable, leafy greens, except brassica, 
subgroup 4A at 1.1 ppm is not necessary, as the subgroup tolerance is 
superseded by inclusion in the leafy vegetable except brassica, group 
4. Separate tolerances in or on soybean, hulls; soybean, meal; and 
soybean, oil are not required because adequate soybean processing data 
indicate that quantifiable residues are unlikely to occur in soybean 
processed fractions; thus, only a soybean seed tolerance is being 
established. Separate tolerances in or on cotton, meal; cotton, hulls; 
and cotton, refined oil are not required because residues were reduced 
in these commodities; therefore, the existing cotton, undelinted seed 
(the preferred commodity term for cotton, seed) and cotton, gin 
byproducts (the preferred commodity term for cotton, gin trash) 
tolerances are being amended to reflect increased tolerances of 0.20 
and 4.5 ppm, respectively. Finally, adequate processing data indicate 
that separate tolerances in or on tomato, paste at 0.08 ppm and tomato, 
puree at 0.07 ppm are not necessary; therefore, only a fruiting 
vegetable group 8 (including tomato) tolerance is required.
    EPA has reviewed the available wheat, corn and sorghum data and has 
determined that sufficient data are available to establish the 
following group tolerances: Grain, cereal, forage, fodder and straw, 
group 16, except rice, forage at 0.35 ppm; grain, cereal, forage, 
fodder and straw, group 16, except rice, hay at 0.07 ppm; grain, 
cereal, forage, fodder and straw, group 16, except rice, stover at 0.1 
ppm; grain, cereal, forage, fodder and straw, group 16, except rice, 
straw at 0.05 ppm. The registrant petitioned for a crop group tolerance 
on the Cereal Grains Group (Crop Group 15) but only petitioned for 
individual tolerances in or on wheat, forage (at 0.35 ppm); wheat, hay 
(at 0.07 ppm); and wheat, straw (at 0.04); and not tolerances on the 
crop group covering Forage, Fodder, and Straw of the Cereal Grains 
(Crop Group 16). However, EPA has determined that tolerances for group 
16 are appropriate because the petitioned-for wheat feed item 
tolerances when considered in conjunction with the existing feed item 
tolerances for corn and sorghum satisfied the requirements for 
establishment of Crop Group 16 tolerances. The Crop Group 16 tolerances 
are being limited like the Crop Group 15 tolerance to exclude rice. 
Additionally, the following established tolerances are being deleted 
because they are superseded by inclusion in group 16: corn, field, 
forage at 0.10 ppm; corn, field, stover at 0.10 ppm; corn, pop, stover 
at 0.10 ppm; corn, sweet, forage at 0.10 ppm; corn, sweet, stover at 
0.10; sorghum, forage and stover at 0.01 ppm; and grain, cereal, 
forage, fodder and straw, group 16 at 0.02 ppm (a tolerance resulting 
from indirect/inadvertent residues of clothianidin). Finally, 
tolerances of clothianidin in or on corn, field grain at 0.01 ppm; 
corn, pop, grain at 0.01 ppm; corn, sweet, kernel plus cob with husk 
removed at 0.01 ppm; and sorghum, grain at 0.01 ppm are being deleted 
because they are being superseded by inclusion in the grain, cereal, 
group 15.
    Additionally, a final rule published in the Federal Register of 
December 7, 2007 (72 FR 69150) (FRL-8343-1) that amended the existing 
bulb vegetable group 3 by adding several commodities; the updated group 
was renamed the bulb vegetable group 3-07. This rule, as well as the 
earlier May 23, 2007 proposed rule (72 FR 28920) (FRL-8126-1) stated 
that, for existing petitions for which a Notice of Filing had been 
published, the Agency would attempt to conform these petitions to the 
rule. Therefore, consistent with this rule, EPA has assessed for and is 
establishing a tolerance for group 3-07 instead of the proposed bulb 
vegetable group 3.
    Finally, EPA has revised the tolerance expression to clarify (1) 
that, as provided in FFDCA section 408(a)(3), the tolerance covers 
metabolites and degradates of clothianidin not specifically mentioned; 
and (2) that compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression.

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 almond, hulls at 1.5 ppm; berry, low-growing, subgroup 13-07H, 
except strawberry at 0.01 ppm; fig at 0.05; grain, cereal, forage, 
fodder and straw, group 16, except rice, forage at 0.35 ppm; grain, 
cereal, forage, fodder and straw, group 16, except rice, hay at 0.07 
ppm; grain, cereal, forage, fodder and straw, group 16, except rice, 
stover at 0.1 ppm; grain, cereal, forage, fodder and straw, group 16, 
except rice, straw at 0.05 ppm; grain, cereal, group 15, except rice at 
0.01 ppm; nut, tree, group 14 at 0.01 ppm; peach at 0.80 ppm; 
pomegranate at 0.20 ppm; potato, chips at 0.6 ppm; soybean, seed at 
0.02 ppm; vegetable, brassica, leafy, group 5 at 1.9 ppm; vegetable, 
bulb, group 3-07 at 0.45 ppm; vegetable, cucurbit, group 9 at 0.06 ppm; 
vegetable, fruiting, group 8 at 0.20 ppm; vegetable, leafy, except 
brassica, group 4 at 3.0 ppm; vegetable, root, except sugar beet, 
subgroup 1B at 0.8 ppm; and vegetable, tuberous and corm, subgroup 1C 
at 0.3 ppm. Additionally, tolerances are amended for residues of 
clothianidin in or on cotton, gin byproducts from 0.01 ppm to 4.5 ppm; 
cotton, undelinted seed from 0.01 ppm to 0.20 ppm; and potato, 
granules/flakes from 0.08 to 1.5 ppm. This regulation deletes a 
tolerance in or on potato at 0.05 ppm; corn, field, forage at 0.10 ppm; 
corn, field, grain at 0.01 ppm; corn, field, stover at 0.10 ppm; corn, 
pop, grain at 0.01 ppm; corn, pop, stover at 0.10 ppm; corn, sweet, 
forage at 0.10 ppm; corn, sweet, kernel plus cob with husk removed at 
0.01 ppm; corn, sweet, stover at 0.10 ppm; and sorghum, forage, grain, 
stover at 0.01 ppm. Finally, this regulation deletes a tolerance for 
indirect/inadvertent residues of clothianidin in or on grain, cereal, 
forage, fodder and straw, group 16 at 0.02 ppm. Also, the introductory 
text in 40 CFR 180.586(a), (b) and (d), which includes the tolerance 
expression, are revised.

[[Page 65028]]

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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 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 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 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) (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: November 27, 2009.
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 revised to read as follows:

Sec.  180.586  Clothianidin; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide clothianidin, including its metabolites and degradates. 
Compliance with the tolerance levels specified below is to be 
determined by measuring only clothianidin, (E)-1-(2-chloro-1,3-thiazol-
5-ylmethyl)-3-methyl-2-nitroguanidine, in or on the following raw 
agricultural commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Almond, hulls........................................                1.5
Beet, sugar, dried pulp..............................               0.03
Beet, sugar, molasses................................               0.05
Beet, sugar, roots...................................               0.02
Berry, low-growing, subgroup 13-07H, except                         0.01
 strawberry..........................................
Canola, seed.........................................               0.01
Cotton, gin byproducts...............................                4.5
Cotton, undelinted seed..............................               0.20
Fig..................................................               0.05
Fruit, pome..........................................                1.0
Grain, cereal, forage, fodder and straw, group 16,                  0.35
 except rice, forage.................................
Grain, cereal, forage, fodder and straw, group 16,                  0.07
 except rice, hay....................................
Grain, cereal, forage, fodder and straw, group 16,                   0.1
 except rice, stover.................................
Grain, cereal, forage, fodder and straw, group 16,                  0.05
 except rice, straw..................................
Grain, cereal, group 15, except rice.................               0.01
Grape................................................               0.60
Milk.................................................               0.01
Nut, tree, group 14..................................               0.01
Peach................................................               0.80
Pomegranate..........................................               0.20
Potato, chips........................................                0.6
Potato, granules/flakes..............................                1.5
Soybean, seed........................................               0.02
Vegetable, brassica, leafy, group 5..................                1.9
Vegetable, bulb, group 3-07..........................               0.45
Vegetable, cucurbit, group 9.........................               0.06
Vegetable, fruiting, group 8.........................               0.20
Vegetable, leafy, except brassica, group 4...........                3.0
Vegetable, root, except sugar beet, subgroup 1B......                0.8
Vegetable, tuberous and corm, subgroup 1C............                0.3
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for the residues of the insecticide clothianidin, including 
its metabolites and degradates in connection with use of the pesticide 
under section 18 emergency exemptions granted by EPA. Compliance with 
the tolerance levels specified below is to be determined by measuring 
only clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-
nitroguanidine. These tolerances will expire and are revoked on the 
dates specified in the following table:

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date
------------------------------------------------------------------------
Beet, sugar, roots............................         0.02     12/31/09

[[Page 65029]]

Beet, sugar, tops.............................         0.02     12/31/09
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect and inadvertant residues. Tolerances are established 
for the indirect or inadvertent residues of the insecticide 
clothianidin, including its metabolites and degradates. Compliance with 
the tolerance levels specified below is to be determined by measuring 
only clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-
nitroguanidine, in or on the following raw agricultural commodities 
when present therein as a result of the application of clothianidin to 
crops listed in paragraph (a) of this section:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Animal feed, nongrass, group 18......................               0.02
Grass, forage, fodder and hay, group 17..............               0.02
Soybean, forage......................................               0.02
Soybean, hay.........................................               0.02
------------------------------------------------------------------------

[FR Doc. E9-29339 Filed 12-9-09; 8:45 am]

BILLING CODE 6560-50-S