

[Federal Register: December 13, 2006 (Volume 71, Number 239)]
[Rules and Regulations]               
[Page 74795-74802]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13de06-9]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0902; FRL-8105-5]

 
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 sorghum (grain, forage, and stover) and cotton 
(undelinted and gin byproducts). Bayer CropScience requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act of 1996 (FQPA). In addition, 
this establishes time-limited tolerances for residues of clothianidin, 
in or on beet, sugar, roots, and beet, sugar, tops. This action is in 
response to EPA's granting of an emergency exemption under section 18 
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
authorizing use of the pesticide on sugar beet seeds. This regulation 
establishes a maximum permissible level for residues of clothianidin in 
these food commodities. The tolerances for sugar beet commodities 
expire and are revoked on December 31, 2009. This regulation 
establishes tolerances for residues of clothianidin in or on grapes, 
potatoes, and potatoes, granules/flakes. Arvesta Corporation requested 
these tolerances under the FFDCA, as amended by the Food Quality 
Protection Act of 1996 (FQPA).

DATES: This regulation is effective December 13, 2006. Objections and 
requests for hearings must be received on or before February 12, 2007, 
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-2006-0902. All documents in the 
docket are listed in the index for the docket. 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

[[Page 74796]]

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 
Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is 
open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The Docket telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Kable Bo Davis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 306-0415; e-mail address: Davis.Kable@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:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
 To access the OPPTS Harmonized Guidelines 

referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm



C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. 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-2006-0902. in the 
subject line on the first page of your submission. All requests must be 
in writing, and must be mailed or delivered to the Hearing Clerk on or 
before February 12, 2007.
    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 your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0902., 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 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of December 8, 2004 (69 FR 71036) (FRL-
7687-4), 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 
4F6869) by Arvesta Corporation, 15401 Weston PKWY Suite 150, Cary, 
North Carolina 27513. 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 grapes at 0.5 parts per million (ppm), raisins 
at 1.0 ppm, and potatoes at 0.1 ppm. That notice included a summary of 
the petition prepared by Arvesta Corporation, the registrant. There 
were no comments received in response to the notice of filing.
    In the Federal Register of June 16, 2004 (69 FR 33635) (FRL-7350-
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 
3F6792) by Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle 
Park, North Carolina 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, in or on sorghum, grain at 0.01 ppm, sorghum, forage at 
0.01 ppm, and sorghum, stover at 0.01 ppm. That notice included a 
summary of the petition prepared by Bayer CropScience, the registrant. 
There were no comments received in response to the notice of filing.
    In the Federal Register of December 14, 2005 (70 FR 74003) (FRL-
7747-4), 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 
5F6908) by, Bayer CropScience, 2 T.W. Alexander Drive Research Triangle 
Park, North Carolina 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, in or on cotton, undelinted at 0.01 ppm, and cotton, 
gin byproducts at 0.01 ppm. That notice included a summary of the 
petition prepared by Bayer CropScience, the registrant. There were no 
comments received in response to the notice of filing.
    Upon completing review of the current clothianidin database, the

[[Page 74797]]

Agency concluded that the appropriate tolerance levels for clothianidin 
residues in or on pending crops should be established as follows: 
Sorghum, grain at 0.01 ppm, sorghum, forage at 0.01 ppm, sorghum, 
stover at 0.01 ppm, cotton, undelinted seed at 0.01 ppm, cotton, gin 
byproducts at 0.01 ppm, grape at 0.60 ppm, potato at 0.05 ppm, and 
potato, granules/flakes at 0.08 ppm. In addition, the proposed 
tolerance for raisins was withdrawn because based on available 
processing data, a tolerance for this commodity is not needed.
    EPA is also establishing time-limited tolerances for combined 
residues of the insecticide, clothianidin, in or on beet, sugar, roots, 
and beet, sugar, tops at 0.02 ppm. These tolerances expire and are 
revoked on December 31, 2009. The beet tolerances are being established 
in response to a regional crisis exemption request on behalf of 
Colorado, North Dakota, and Wyoming under FIFRA section 18 for the 
emergency use of clothianidin as a seed treatment on sugar beet seeds 
to control the beet leafhopper, which is a vector of the beet curly top 
virus in certain sugar beet growing regions throughout the western 
United States.
    As part of its assessment of this emergency exemption request, EPA 
assessed the potential risks presented by residues of clothianidin in 
or on beet, sugar, roots, and beet, sugar, tops. In doing so, EPA 
considered the safety standard in section 408(b)(2) of the FFDCA, and 
EPA decided that the necessary tolerances under section 408(l)(6) of 
the FFDCA would be consistent with the safety standard and with FIFRA 
section 18. Consistent with the need to move quickly on the emergency 
exemption in order to address the urgent non-routine situation and to 
ensure that the resulting food is safe and lawful, EPA is issuing the 
tolerances without notice and opportunity for public comment as 
provided in section 408(l)(6) of the FFDCA. Although these tolerances 
expire and are revoked on December 31, 2009, under section 408(l)(5) of 
the FFDCA, residues of the pesticide not in excess of the amount 
specified in the tolerances remaining in or on beet, sugar, roots, and 
beet, sugar, tops after that date will not be unlawful, provided the 
pesticide is applied in a manner that was lawful under FIFRA, and the 
residues do not exceed a level that was authorized by this tolerance at 
the time of that application. EPA will take action to revoke these 
tolerances earlier if any experience with, scientific data on, or other 
relevant information on this pesticide indicate that the residues are 
not safe.
    Because the tolerances are being approved under emergency 
conditions, EPA has not made any decisions about whether clothianidin 
meets EPA's registration requirements for use on beet, sugar, roots, 
and beet, sugar, tops or whether permanent tolerances for this use 
would be appropriate. Under these circumstances, EPA does not believe 
that these tolerances serve as a basis for registration of clothianidin 
by a State for special local needs under FIFRA section 24(c). Nor do 
these tolerances serve as the basis for any States other than Oregon, 
Colorado, North Dakota, and Wyoming to use this pesticide on this crop 
under section 18 of FIFRA without following all provisions of EPA's 
regulations implementing FIFRA section 18 as identified in 40 CFR part 
166. For additional information regarding the emergency exemption for 
clothianidin, contact the Agency's Registration Division at the address 
provided under FOR FURTHER INFORMATION CONTACT.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.


III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for tolerances for residues of clothianidin (E)-1-
(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on 
grapes at 0.60 ppm, potatoes at 0.05 ppm, potatoes, granules/flakes at 
0.08 ppm, sorghum, grain at 0.01 ppm, sorghum, forage at 0.01 ppm, 
sorghum, stover at 0.01 ppm, cotton, undelinted at 0.01 ppm, and 
cotton, gin byproducts at 0.01 ppm, and beet, sugar, roots at 0.02 ppm, 
and beet, sugar, tops at 0.02 ppm. EPA's assessment of exposures and 
risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the toxic effects caused by clothianidin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.epa.gov/EPA-PEST/2003/May/Day-30/p13564.htm
.


B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which the NOAEL are observed from the 
toxicology study identified as appropriate for use in risk assessment 
is used to estimate the toxicological level of concern (LOC). However, 
the LOAEL of concern are identified is sometimes used for risk 
assessment if no NOAEL was achieved in the toxicology study selected. 
An uncertainty factor (UF) is applied to reflect uncertainties inherent 
in the extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases. More information 
can be found on the general principles EPA uses in risk 
characterization at http://www.epa.gov/pesticides/health/human.htm.


[[Page 74798]]

    A summary of the toxicological endpoints for clothianidin used for 
human risk assessment can be found at http://www.regulations.gov (pages 18-20) 

in Docket ID EPA-HQ-OPP-2006-0902. To locate this information on the 
regulations.gov website follow these steps:
    1. Select ``Advanced Search'', then ``Docket Search''
    2. In ``Keyword'' field type the chemical name or insert the 
applicable ``Docket ID number.'' (example: EPA-HQ-OPP-2005-9999).
    3. Click the ``Submit'' button.
    Follow the instructions on the regulations.gov website to view the 
index for the docket and access available documents.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.586) for the residues of clothianidin, in or on 
a variety of raw agricultural commodities. Tolerances have also been 
established for residues of clothianidin in milk. Risk assessments were 
conducted by EPA to assess 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 one-day or single exposure.
     In conducting the acute dietary exposure assessment EPA used the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCID\TM\), which incorporates food consumption 
data as reported by respondents in the United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII), and accumulated exposure to the 
chemical for each commodity. The following assumptions were made for 
the acute exposure assessments: The acute dietary exposure assessment 
is based on maximum residues of clothianidin observed in clothianidin 
and thiamethoxam field trials and assumed 100 percent crop treated 
(%CT).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM-FCID\TM\, which incorporates food 
consumption data as reported by respondents in the USDA 1994-1996 and 
1998 Nationwide CSFII, and accumulated exposure to the chemical for 
each commodity. The following assumptions were made for the chronic 
exposure assessments: The chronic assessment is based on average 
residues from clothianidin field trials and also assumes 100% CT.
    iii. Cancer. Because clothianidin has been classified as a ``not 
likely human carcinogen'', a cancer risk assessment is not required.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must pursuant 
to section 408(f)(1) require that data be provided 5 years after the 
tolerance is established, modified, or left in effect, demonstrating 
that the levels in food are not above the levels anticipated. Following 
the initial data submission, EPA is authorized to require similar data 
on a time frame it deems appropriate. For the present action, EPA will 
issue such data call-ins for information relating to anticipated 
residues as are required by FFDCA section 408(b)(2)(E) and authorized 
under FFDCA section 408(f)(1). Such data call-ins will be required to 
be submitted no later than 5 years from the date of issuance of this 
tolerance.
    The Agency used PCT information as follows:
    The acute assessment is based on maximum residues of clothianidin 
observed in clothianidin field trials and assumes 100% CT. The chronic 
assessment is based on average residues from clothianidin field trials 
and also assumes 100% CT.
    The Agency believes that the three conditions listed have been met. 
With respect to Condition 1, PCT estimates are derived from Federal and 
private market survey data, which are reliable and have a valid basis. 
The Agency is reasonably certain that the percentage of the food 
treated is not likely to be an underestimation. As to Conditions 2 and 
3, regional consumption information and consumption information for 
significant subpopulations is taken into account through EPA's 
computer-based model for evaluating the exposure of significant 
subpopulations including several regional groups. Use of this 
consumption information in EPA's risk assessment process ensures that 
EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which clothianidin 
may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for clothianidin in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of clothianidin. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.

    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated environmental concentrations (EECs) of clothianidin for acute 
exposures are 7.29 parts per billion (ppb) for surface water and 5.84 
ppb for ground water. The EECs for chronic exposures are 1.35 ppb for 
surface water and 5.84 ppb for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
     Clothianidin is currently registered for use on the following 
residential non-dietary sites: Turfgrass. The risk assessment was 
conducted using the following residential exposure assumptions: The 
following exposure scenarios were assessed for residential post-
application risks: toddlers playing on treated turf, adults performing 
yard work on treated turf, and adults and youths playing golf on 
treated turf. Additional information on residential exposure 
assumptions can be found at http://www.regulations.gov (Docket ID EPA-HQ-OPP-

2006-0902, pages 27 through 29).
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the 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

[[Page 74799]]

common effects do not constitute a common mechanism of toxicity. 
Evidence is needed to establish that the chemicals operate by the same, 
or essentially the same sequence of major biochemical events (EPA, 
2002). Although clothianidin and thiamethoxam bind selectively to 
insect nicotinic acetylcholine receptors (nAChR), the specific binding 
site(s)/receptor(s) for clothianidin, thiamethoxam, and the other 
neonicotinoids are unknown at this time. Additionally, the commonality 
of the binding activity itself is uncertain, as preliminary evidence 
suggests that clothianidin operates by direct competitive inhibition, 
while thiamethoxam is a non-competitive inhibitor. Furthermore, even if 
future research shows that neonicotinoids share a common binding 
activity to a specific site on insect nicotinic acetylcholine 
receptors, there is not necessarily a relationship between this 
pesticidal action and a mechanism of toxicity in mammals. Structural 
variations between the insect and mammalian nAChRs produce quantitative 
differences in the binding affinity of the neonicotinoids towards these 
receptors, which, in turn, confers the notably greater selective 
toxicity of this class towards insects, including aphids and 
leafhoppers, compared to mammals. While the insecticidal action of the 
neonicotinoids is neurotoxic, the most sensitive regulatory endpoint 
for clothianidin is based on unrelated effects in mammals, including 
changes in body and thymus weights, delays in sexual maturation, and 
still births. Additionally, the most sensitive toxicological effect in 
mammals differs across the neonicotinoids (e.g., testicular tubular 
atrophy with thiamethoxam; mineralized particles in thyroid colloid 
with imidaclopid). Thus, there is currently no evidence to indicate 
that neonicotinoids share common mechanisms of toxicity, and EPA is not 
following a cumulative risk approach based on a common mechanism of 
toxicity for the neonicotinoids. For information regarding EPA's 
efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
the policy statements concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism released by EPA's Office of Pesticide Programs on 
EPA's website at http://www.epa.gov/pesticides/cumulative/.

     Note that because clothianidin is a major metabolite of 
thiamethoxam, EPA has combined exposure to clothianidin resulting both 
from thiamethoxam use and from use of clothianidin as an active 
ingredient and has compared this aggregate exposure estimate to 
relevant endpoints for clothianidin. EPA has taken the further 
conservative step of assuming that, in instances where both 
thiamethoxam and clothianidin are registered for use on a crop, both 
pesticides will, in fact, be used on that crop.

D. Safety Factor for Infants and Children

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

[[Page 74800]]

infants and children resulting from the use of clothianidin.
     The toxicology data base for clothianidin, however, is not 
complete for FQPA purposes. A complete complement of acceptable 
developmental, reproduction, developmental neurotoxicity, mammalian 
neurotoxicity and special neurotoxicity studies are available; however, 
due to evidence of decreased absolute and adjusted organ weights of the 
thymus and spleen in multiple studies in the clothianidin data base, 
and because juvenile rats in the two-generation reproduction study 
appear to be more susceptible to these effects, EPA has determined that 
testing should be conducted to assess immune system function in adults 
and in young animals following developmental exposures. Given the 
levels at which this testing should be conducted it could result in 
selection of a more protective (i.e., lower) regulatory endpoint.
    Due to the uncertainty with regard to potential effects on immune 
system function in young animals, EPA cannot conclude that there are 
reliable data supporting selection of a children's safety factor 
different from the presumptive 10X factor. Therefore, the 10X FQPA 
children's safety factor will be retained. This safety factor will be 
in the form of a database uncertainty factor to account for the lack of 
the testing with regard to immune system function with clothianidin.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
clothianidin will occupy 11% of the acute population adjusted dose 
(aPAD) for the U.S. population, 8% of the aPAD for females 13-49 years, 
31% of the aPAD for all infants (< 1 year old), and 45% of the aPAD for 
children 1-2 years old. The acute aggregate risks associated with the 
registered and proposed uses of clothianidin do not exceed the Agency's 
level of concern for the general U.S. population or any population 
subgroup.
    2. Chronic risk. For the chronic exposure assessments the residues 
of concern are clothianidin. Using the exposure assumptions described 
in this unit for chronic exposure, EPA has concluded that exposure to 
clothianidin from food and water will utilize 5% of the chronic 
population adjusted dose (cPAD) for the U.S. population, 13% of the 
cPAD for all infants (<  1 year old), and 16% of the cPAD for children 
1-2 years old. Based on the use pattern, chronic residential exposure 
to residues of clothianidin is not expected. The long-term aggregate 
risks associated with clothianidin exposure resulting from the 
registered and proposed uses of clothianidin and from the registered 
uses of thiamethoxam do not exceed the Agency's level of concern for 
the general U.S. population or any population subgroup.
    3. Short-term/Intermediate-term risk. Short-term aggregate and 
intermediate-term aggregate exposures takes into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
    Clothianidin is currently registered for use that could result in 
short-term and intermediate-term residential exposure and the Agency 
has determined that it is appropriate to aggregate chronic food and 
water and short-term exposures for clothianidin.
    EPA has determined that, for clothianidin, the toxicological 
effects are the same across oral, dermal, and inhalation routes of 
exposure and has selected the same endpoint and dose for short-term and 
intermediate-term exposure scenarios. Therefore, the exposures are 
simply summed (combined/aggregated) for use in risk calculations. 
Short-term and intermediate aggregate risk estimates range from an MOE 
of 1,100 for toddlers (food + water + treated turf + treated soil + 
dermal) to 22,000 for youth golfers (food + water + post-application 
treated turf). The short-term and intermediate-term aggregate risks 
associated with the registered and proposed uses of clothianidin do not 
exceed the Agency's level of concern for the general U.S. population or 
any population subgroup.
    4. Aggregate cancer risk for U.S. population. Clothianidin has been 
classified as a ``not likely human carcinogen.'' It is not expected to 
pose a cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to clothianidin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate LC/MS/MS methods are available for both collecting data 
and enforcing tolerances for clothianidin residues in plant (Bayer 
Methods 00552 and 109240-1) and animal (Bayer Method 00624) 
commodities. The validated limit of quantitation (LOQ) for clothianidin 
in plant commodities is 0.010 ppm, except for wheat straw (0.020 ppm), 
and the validated LOQs are 0.010 ppm in milk and 0.020 ppm in animal 
tissues. All three of these methods have been approved for tolerance 
enforcement, and forwarded to FDA for inclusion in PAM Volume II.
    In addition, Arvesta has submitted another LC/MS/MS method (Morse 
Method Meth-164) for enforcing tolerances and collecting data 
on residues of clothianidin and TMG in grape and potato commodities. 
This newer method is similar to Method 00552 and involves extraction of 
residues with acetonitrile/water, cleanup using solid phase extraction 
(SPE) cartridges, and the separate analysis of clothianidin and N-(2-
chloro-5-thiazolymethyl)-N'-methylguanidine (TMG) by LC/MS/MS. The 
validated LOQ for each analyte is 0.020 ppm in all grape and potato 
matrices, except for potato chips and raisins (with LOQs of 0.040 ppm). 
The method was adequately validated in conjunction with the field 
trials and processing studies and has undergone a successful 
independent laboratory validation (ILV) trial.

B. International Residue Limits

    Canadian maximum residue limits (MRLs) have been established for 
residues of clothianidin at 0.01 milligram/kilogram (mg/kg) in milk, 
corn and canola. As of February 2006, there are no Canadian, Mexican, 
or Codex MRLs or tolerances for cotton, sorghum, grapes, or potatoes.

C. Response to Comments

    There were no comments received in response to the notice of 
filing.

V. Conclusion

    Therefore, the tolerances are established for residues of 
clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-
nitroguanidine, in or on grapes at 0.60 ppm, potatoes at 0.05 ppm, 
potatoes, granules/flakes at 0.08 ppm, sorghum (grain, forage, and 
stover) at 0.01 ppm, and cotton (undelinted and gin byproducts) at 0.01 
ppm. Time-limited tolerances are also established for residues of 
clothianidin in or on beet, sugar, roots, and beet, sugar, tops at 0.02 
ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735,

[[Page 74801]]

October 4, 1993). Because this rule has been exempted from review under 
Executive Order 12866 due to its lack of significance, this rule is not 
subject to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of FFDCA or are established under section 
408(1)(6), such as the tolerances in this final rule, do not require 
the issuance of a proposed rule, the requirements of the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, 
the Agency has determined that this action will not have a substantial 
direct effect on States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: december 1, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.586 is amended by alphabetically adding commodities to 
the table in paragraph (a) to read as follows, and by revising 
paragraph (b) as follows:


Sec.  180.586  Clothianidin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Cotton, gin byproducts.........................                     0.01
Cotton, undelinted seed........................                     0.01
                                * * * * *
Grape..........................................                     0.60
                                * * * * *
Potato.........................................                     0.05
Potato, granules/flakes........................                     0.08
Sorghum, forage, grain, stover.................                     0.01
------------------------------------------------------------------------

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for the residues of the insecticide clothianidin, (E)-1-(2-
chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in connection 
with use of the pesticide under section 18 emergency exemptions granted 
by EPA. These tolerances will expire and are revoked on the dates 
specified in the following table:

----------------------------------------------------------------------------------------------------------------
                Commodity                          Parts per million              Expiration/revocation date
----------------------------------------------------------------------------------------------------------------
Beet, sugar, roots......................                                0.02                   December 31, 2009
Beet, sugar, tops.......................                                0.02                   December 31, 2009
----------------------------------------------------------------------------------------------------------------


[[Page 74802]]

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[FR Doc. E6-20898 Filed 12-12-06; 8:45 am]

BILLING CODE 6560-50-S
