[Federal Register: December 9, 2009 (Volume 74, Number 235)]
[Rules and Regulations]
[Page 65021-65029]
[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tolerances in or on several commodities that will be superseded by this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:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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<PHONE_NUMBER>.

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;

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

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

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.

    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.

    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:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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

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.

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

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


[Federal Register Volume 76, Number 158 (Tuesday, August 16, 2011)]
[Notices]
[Page 50748]
[FR Doc No: 2011-20800]

-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4009-DR; Docket ID FEMA-2011-0001]

Minnesota; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Minnesota (FEMA-4009-DR), dated July 28, 2011, and
related determinations.

DATES: Effective Date: August 10, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Minnesota is hereby amended to include the following
area among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of July 28, 2011.

    Kanabec County for Public Assistance.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-20800 Filed 8-15-11; 8:45 am]
BILLING CODE 9111-23-P