Document ID: EPA-HQ-OPP-2008-0814-0007
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Thiamethoxam
Posted Date: 2009-09-30T04:00Z

[Federal Register: September 30, 2009 (Volume 74, Number 188)]
[Rules and Regulations]               
[Page 50137-50145]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30se09-7]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0814; FRL-8436-5]

 
Thiamethoxam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of thiamethoxam (3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-
nitro-4H-1,3,5-oxadiazin-4-imine) and its metabolite CGA-322704, [N-(2-
chloro-thiazol-5-ylmethyl)-N'-methyl-N'-nitro-guanidine, calculated as 
the stoichiometric equivalent of thiamethoxam, in or on: avocado; 
berry, low growing, subgroup 13-07G, except cranberry; black sapote; 
bushberry subgroup 13-07B, except lingonberry and blueberry, lowbush; 
caneberry subgroup 13-07A; canistel; fruit, small, vine climbing, 
subgroup 13-07F, except fuzzy kiwifruit; mamey sapote; mango; papaya; 
rice, grain; sapodilla; star apple; and vegetable, root, subgroup 1A. 
Interregional Research Project Number 4 (IR-4) and Syngenta Crop 
Protection, Inc., requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA). In addition, this regulation amends 
existing tolerances for combined residues of thiamethoxam and its 
metabolite CGA-322704 in or on: cattle, meat byproducts; goat, meat 
byproducts; horse, meat byproducts; and sheep, meat byproducts. 
Syngenta Crop Protection, Inc., requested these amended tolerances 
under FFDCA.

DATES: This regulation is effective September 30, 2009. Objections and 
requests for hearings must be received on or before November 30, 2009, 
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-2008-0814. 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: Julie Chao, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8735; e-mail address: chao.julie@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at

[[Page 50138]]

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-2008-0814 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 November 30, 2009.
    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-2008-0814, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Registers of April 13, 2009 (74 FR 16866) (FRL-8396-
6) and August 19, 2009 (74 FR 41898) (FRL-8426-7), EPA issued notices 
pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), 
announcing the filing of pesticide petitions PP 8E7411 and PP 8F7449 by 
Interregional Research Project Number 4 (IR-4), 500 College Road East, 
Suite 201 W., Princeton, NJ 08540, and Syngenta Crop Protection, Inc., 
P.O. Box 18300, Greensboro, NC 27419-8300, respectively. The petitions 
requested that 40 CFR 180.565 be amended by establishing tolerances for 
combined residues of the insecticide thiamethoxam (3-[(2-chloro-5-
thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-oxadiazin-4-
imine) and its metabolite CGA-322704 [N-(2-chloro-thiazol-5-ylmethyl)-
N'-methyl-N'-nitro-guanidine], in or on the following commodities:
    PP 8E7411: Avocado at 0.2 parts per million (ppm); canistel at 0.2 
ppm; mango at 0.2 ppm; papaya at 0.2 ppm; sapodilla at 0.2 ppm; sapote, 
black at 0.2 ppm; sapote, mamey at 0.2 ppm; star apple at 0.2 ppm; 
vegetable, root, subgroup 1A at 0.04 ppm.
    In addition, PP 8E7411 proposed to revise the tolerance expression 
for the Berry Crop Group 13 to become the Berry and Small Fruit Crop 
Group 13, per the Pesticide Tolerance Crop Grouping Program published 
in the Federal Register of December 7, 2007 (72 FR 69150) (FRL-8343-1). 
The proposed new tolerance expressions for the Berry and Small Fruit 
Crop Group 13 for the tolerances in 40 CFR.565 for combined residues of 
the insecticide thiamethoxam and its metabolite CGA-322704 are as 
follows, in or on: Bushberry subgroup 13-07B at 0.20 ppm; caneberry 
subgroup 13-07A at 0.35 ppm; fruit, small, vine climbing subgroup 13-
07F, except fuzzy kiwifruit at 0.20 ppm; low growing berry subgroup 13-
07G, except cranberry at 0.30 ppm. The existing tolerance on cranberry 
at 0.02 ppm is retained.
    PP 8E7411 also requested that the following tolerances be deleted: 
Bushberry subgroup 13B at 0.20 ppm; caneberry subgroup 13A at 0.35 ppm; 
grape at 0.20 ppm; Juneberry at 0.20 ppm; lingonberry at 0.20 ppm; 
salal at 0.20 ppm; strawberry at 0.30 ppm; and vegetable, root, except 
sugar beet, subgroup 1B at 0.02 ppm.
    PP 8F7449: Rice, bran at 0.02 ppm; rice, grain at 0.02 ppm; rice, 
hulls at 0.1 ppm; rice, polished at 0.02 ppm; rice, straw at 0.02 ppm.
    In addition, PP 8F7449 requested that 40 CFR 180.565 be amended by 
increasing tolerances for combined residues of the insecticide 
thiamethoxam and its metabolite CGA-322704 in or on the following: 
Cattle, meat byproducts from 0.02 ppm to 0.04 ppm; goat, meat 
byproducts from 0.02 ppm to 0.04 ppm; horse, meat byproducts from 0.02 
ppm to 0.04 ppm; sheep, meat byproducts from 0.02 ppm to 0.04 ppm; 
vegetable, root, except sugarbeet, subgroup 1B from 0.02 ppm to 0.05 
ppm.
    The notices referenced summaries of the petitions prepared by 
Syngenta Crop Protection, Inc., and Interregional Research Project 
Number (IR-4), the registrants, which are available to the public in 
the docket EPA-HQ-OPP-2008-0814, http://www.regulations.gov. There were 
no comments received in response to the notices of filing.
    Based upon review of the data supporting the petition, EPA has 
determined that the proposed tolerances for avocado; canistel; mango; 
papaya; sapodilla; sapote, black; sapote, mamey; star apple; and 
vegetable, root, subgroup 1A need to be raised. In addition, EPA has 
determined that no tolerances are needed for rice, bran; rice, hulls; 
rice, polished; and rice, straw. Finally, EPA is removing existing 
tolerances that are no longer needed for bushberry subgroup 13B; 
caneberry subgroup 13A; grape; Juneberry; lingonberry; salal; 
strawberry; and vegetable, root, except sugar beet, subgroup 1B. 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 combined residues of thiamethoxam (3-[(2-chloro-5-
thiazolyl)methyl]tetrahydro-5-methyl-N-

[[Page 50139]]

nitro-4H-1,3,5-oxadiazin-4-imine) and its metabolite CGA-322704 [N-(2-
chloro-thiazol-5-ylmethyl)-N'-methyl-N'-nitro-guanidine], calculated as 
the stoichiometric equivalent of thiamethoxam, in or on avocado at 0.40 
ppm; berry, low growing, subgroup 13-07G, except cranberry at 0.30 ppm; 
bushberry subgroup 13-07B, except lingonberry and blueberry, lowbush at 
0.20 ppm; caneberry subgroup 13-07A at 0.35 ppm; canistel at 0.40 ppm; 
fruit, small, vine climbing, subgroup 13-07F, except fuzzy kiwifruit at 
0.20 ppm; mango at 0.40 ppm; papaya at 0.40 ppm; sapodilla at 0.40 ppm; 
sapote, black at 0.40 ppm; sapote, mamey at 0.40 ppm; star apple at 
0.40 ppm; vegetable, root, subgroup 1A at 0.05 ppm; rice, grain at 0.02 
ppm; cattle, meat byproducts at 0.04 ppm; goat, meat byproducts at 0.04 
ppm; horse, meat byproducts at 0.04 ppm; sheep, meat byproducts at 0.04 
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.
    Thiamethoxam shows toxicological effects primarily in the liver, 
kidney, testes, and hematopoietic system. In addition, developmental 
neurological effects were observed in rats. This developmental effect 
is being used to assess risks associated with acute exposures to 
thiamethoxam, and the liver and testicular effects are the bases for 
assessing longer term exposures. Although thiamethoxam causes liver 
tumors in mice, the Agency has classified thiamethoxam as ``not likely 
to be carcinogenic to humans'' based on convincing evidence that a non-
genotoxic mode of action for liver tumors was established in the mouse 
and that the carcinogenic effects are a result of a mode of action 
dependent on sufficient amounts of a hepatotoxic metabolite produced 
persistently. The non-cancer (chronic) assessment is sufficiently 
protective of the key events (perturbation of liver metabolism, 
hepatotoxicity/regenerative proliferation) in the animal mode of action 
for cancer. Refer to the Federal Register of June 22, 2007 (72 FR 
34401) (FRL-8133-6) for more information regarding the cancer 
classification of thiamethoxam.
    Thiamethoxam produces a metabolite known as CGA-322704 (referred to 
in the remainder of this rule as clothianidin). Clothianidin is also 
registered as a pesticide. While some of the toxic effects observed 
following testing with the thiamethoxam and clothianidin are similar, 
the available information indicates that thiamethoxam and clothianidin 
have different toxicological effects in mammals and should be assessed 
separately. A separate risk assessment of clothianidin has been 
completed in conjunction with the registration of clothianidin. The 
most recent assessments, which provide details regarding the toxicology 
of clothianidin, are available in the docket EPA-HQ-OPP- 2008-0814, at 
http:///www.regulations.gov. Refer to the documents 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); and Clothianidin: Human Health Risk 
Assessment for Proposed Seed Treatment Uses on Root and Tuber 
Vegetables (Group 1), Bulb Vegetables (Group 3), Leafy Green Vegetables 
(Group 4A), Brassica Leafy Vegetables (Group 5), Fruiting Vegetables 
(Group 8), Cucurbit Vegetables (Group 9), and Cereal Grains (Group 15, 
except rice).
    Specific information on the studies received and the nature of the 
adverse effects caused by thiamethoxam as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule 
published in the Federal Register of June 22, 2007.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (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 thiamethoxam used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of June 22, 2007.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to thiamethoxam, EPA considered exposure under the petitioned-
for tolerances as well as all existing thiamethoxam tolerances in 40 
CFR 180.565. EPA assessed dietary exposures from thiamethoxam in food 
as follows:
    For both acute and chronic exposure assessments for thiamethoxam, 
EPA combined residues of clothianidin coming from thiamethoxam with 
residues of thiamethoxam per se. As discussed in this unit, 
thiamethoxam's major metabolite is CGA-322704, which is also the 
registered active ingredient clothianidin. Available information 
indicates that thiamethoxam and clothianidin have different 
toxicological effects in mammals and should be assessed separately; 
however, these exposure assessments for this action incorporated the 
total residue of thiamethoxam and clothianidin from use of thiamethoxam 
because the total residue for each commodity for which thiamethoxam has 
a tolerance has not been separated between thiamethoxam

[[Page 50140]]

and its clothianidin metabolite. The combining of these residues, as 
was done in this assessment, results in highly conservative estimates 
of dietary exposure and risk. A separate assessment was done for 
clothianidin. The clothianidin assessment included clothianidin 
residues from use of clothianidin as a pesticide and clothianidin 
residues from use of thiamethoxam on those commodities for which the 
pesticide clothianidin does not have a tolerance. As to these 
commodities, EPA has separated total residues between thiamethoxam and 
clothianidin.
    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 assumed tolerance-level 
residues of thiamethoxam and clothianidin. It was also assumed that 
100% of crops with registered or requested uses of thiamethoxam and 
100% of crops with registered or requested uses of clothianidin are 
treated.
    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 assumed tolerance 
level and/or anticipated residues from thiamethoxam field trials. It 
was also assumed that 100% of crops with registered or requested uses 
of thiamethoxam and 100% of crops with registered or requested uses of 
clothianidin are treated.
    A complete listing of the inputs used in these assessments can be 
found in the following documents: Thiamethoxam Acute and Chronic 
Aggregate Dietary (Food and Drinking Water) Exposure and Risk 
Assessments for the Section 3 Registration on Rice, Sugar Beets, and 
Tropical Fruits; Clothianidin Acute and Chronic Aggregate Dietary (Food 
and Drinking Water) Exposure and Risk Assessments. These documents are 
available in the docket, EPA-HQ-OPP-2008-0814, at http://
www.regulations.gov.
    iii. Cancer. A quantitative cancer exposure assessment is not 
necessary because EPA concluded that thiamethoxam is ``not likely to be 
carcinogenic to humans'' based on convincing evidence that a non-
genotoxic mode of action for liver tumors was established in the mouse, 
and that the carcinogenic effects are a result of a mode of action 
dependent on sufficient amounts of a hepatotoxic metabolite produced 
persistently. The non-cancer (chronic) assessment is sufficiently 
protective of the key events (perturbation of liver metabolism, 
hepatotoxicity/regenerative proliferation) in the animal mode of action 
for cancer and thus a separate exposure assessment pertaining to cancer 
risk is not necessary. Because clothianidin is not expected to pose a 
cancer risk, a quantitative dietary exposure assessment for the 
purposes of assessing cancer risk was not conducted.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use PCT information in the dietary assessments for 
thiamethoxam or clothianidin.
    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to section 408(f)(1) of FFDCA that data be provided 5 years 
after the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such Data Call-Ins 
as are required by section 408(b)(2)(E) of FFDCA and authorized under 
section 408(f)(1) of FFDCA. Data will be required to be submitted no 
later than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. Thiamethoxam is expected 
to be persistent and mobile in terrestrial and aquatic environments. 
These fate properties suggest that thiamethoxam has a potential to move 
into surface water and shallow ground water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for thiamethoxam in drinking water. 
Because the Agency does not have comprehensive monitoring data, the 
Agency used screening level water exposure models in the dietary 
exposure analysis and risk assessment for thiamethoxam in drinking 
water. These simulation models take into account data on the physical, 
chemical, and fate/transport characteristics of thiamethoxam. 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.
    A Tier I screening-level drinking water assessment was conducted 
for the proposed rice seed treatment use. Because the proposed uses on 
rice and cranberries (a registered use) involve flooding, for which 
Pesticide Root Zone Model/Exposure/Analysis Modeling System (PRZM/
EXAMS) is not currently parameterized, these uses were assessed using 
the modified Tier I Rice Model and the Provisional Cranberry Model. The 
estimated drinking water concentrations (EDWCs) are based on 
thiamethoxam concentrations in tail water from rice paddies and 
cranberry bogs that drain into adjacent surface water bodies. Exposure 
estimates were refined with a default percent cropped area factor of 
87%. The Tier I Rice Model is expected to generate conservative EDWCs 
that exceed peak measured concentrations of pesticides in water bodies 
well downstream of rice paddies by less than one order of magnitude to 
multiple orders of magnitude. Exposure in ground water due to leaching 
was assessed with the Screening Concentration in Groundwater (SCI-GROW) 
models.
    Based on the Tier I Rice Model and SCI-GROW models, the EDWCs of 
thiamethoxam for acute exposures are 131.77 parts per billion (ppb) for 
tail water and 2.93 ppb for ground water. The EDWCs for chronic 
exposures for non-cancer assessments are 11.31 ppb for tail water and 
2.93 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. The most conservative EDWCs in 
both the acute and chronic exposure scenarios were for tail water, and 
represent worst case scenarios. Therefore, for the acute dietary risk 
assessments for thiamethoxam, the upper-bound EDWC value of 131.77 ppb 
was used to assess the contribution to drinking water. For the chronic 
dietary risk assessments for thiamethoxam, the upper-bound EDWC value 
of 11.31 ppb was used to assess the contribution to drinking water.
    The registrant has conducted small-scale prospective ground water 
studies in several locations in the United States to investigate the 
mobility of thiamethoxam in a vulnerable hydrogeological setting. A 
review of those data show that generally, residues of thiamethoxam, as 
well as CGA-322704, are below the limit of quantification (0.05 ppb). 
When quantifiable residues are found, they are sporadic and at low 
levels. The maximum observed residue levels from any monitoring well 
were 1.0 ppb for

[[Page 50141]]

thiamethoxam and 0.73 ppb for CGA-322704. These values are well below 
the modeled estimates summarized in this unit, indicating that the 
modeled estimates are, in fact, protective of what actual exposures are 
likely to be.
    Clothianidin is not a significant degradate of thiamethoxam in 
surface-or ground water sources of drinking water and, therefore, was 
not included in the EDWCs used in the thiamethoxam dietary assessments. 
For the clothianidin assessments, the acute EDWC value of 7.29 ppb for 
clothianidin was incorporated into the acute dietary assessment and the 
chronic EDWC value of 5.88 ppb for clothianidin was incorporated into 
the chronic dietary assessment.
    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).
    Thiamethoxam is currently registered for the following uses that 
could result in residential exposures: Turfgrass on golf courses, 
residential lawns, commercial grounds, parks, playgrounds, athletic 
fields, landscapes, interiorscapes, and sod farms; indoor crack and 
crevice or spot treatments to control insects in residential settings. 
EPA assessed residential exposure using the following assumptions:
    Thiamethoxam is registered for use on turfgrass (on golf courses, 
residential lawns, commercial grounds, parks, playgrounds, athletic 
fields, landscapes, interiorscapes and sod farms) and for indoor use to 
control insects in residential settings. Thiamethoxam is applied by 
commercial applicators only. Therefore, exposures resulting to 
homeowners from applying thiamethoxam were not assessed. However, 
entering areas previously treated with thiamethoxam could lead to 
exposures for adults and children. As a result, risk assessments have 
been completed for postapplication scenarios.
    Short-term exposures (1 to 30 days of continuous exposure) may 
occur as a result of activities on treated turf. Short-term and 
intermediate-term exposures (30 to 90 days of continuous exposure) may 
occur as a result of entering indoor areas previously treated with a 
thiamethoxam indoor crack and crevice product. The difference between 
short- and intermediate-term aggregate risk is the frequency of hand-
to-mouth events for children. For short-term exposure there are 20 
events per hour and for intermediate-term exposure there are 9.5 events 
per hour. The doses and end-points for short- and intermediate-term 
aggregate risk are the same.
    EPA combined all non-dietary sources of post application exposure 
to obtain an estimate of potential combined exposure. These scenarios 
consisted of adult and toddler dermal postapplication exposure and oral 
(hand-to-mouth) exposures for toddlers. Since postapplication scenarios 
for turf occur outdoors, the potential for inhalation exposure is 
negligible and therefore does not require an inhalation exposure 
assessment. Since thiamethoxam has a very low vapor pressure (6.6 x 
10-9 @ 25[deg]C), inhalation exposure is also expected to be 
negligible as a result of indoor crack and crevice use. Therefore, a 
quantitative postapplication inhalation exposure assessment was not 
performed.
    Thiamethoxam use on turf or as an indoor crack and crevice or spot 
treatment does not result in significant residues of clothianidin. In 
addition, clothianidin residential and aggregate risks are not of 
concern. For further details, refer to the documents 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); and Clothianidin: Human Health Risk 
Assessment for Proposed Seed Treatment Uses on Root and Tuber 
Vegetables (Group 1), Bulb Vegetables (Group 3), Leafy Green Vegetables 
(Group 4A), Brassica Leafy Vegetables (Group 5), Fruiting Vegetables 
(Group 8), Cucurbit Vegetables (Group 9), and Cereal Grains (Group 15, 
except rice), available in the docket, EPA-HQ-OPP-2008-0814, at http://
/www.regulations.gov.
    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.''
    Thiamethoxam is a member of the neonicotinoid class of pesticides 
and produces, as a metabolite, another neonicotinoid, clothianidin. 
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 thiamethoxam is based on unrelated 
effects in mammals, including effects on the liver, kidney, testes, and 
hematopoietic system. 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 imidacloprid).
    Thus, EPA has not found thiamethoxam or clothianidin to share a 
common mechanism of toxicity with any other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
thiamethoxam and clothianidin do not have a common mechanism of 
toxicity with other substances. 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 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

[[Page 50142]]

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) safey 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. In the developmental 
studies, there is no evidence of increased quantitative or qualitative 
susceptibility of rat or rabbit fetuses to in utero exposure to 
thiamethoxam. The developmental NOAELs are either higher than or equal 
to the maternal NOAELs. The toxicological effects in fetuses do not 
appear to be any more severe than those in the dams or does. In the rat 
developmental neurotoxicity study, there was no quantitative evidence 
of increased susceptibility.
    There is evidence of increased quantitative susceptibility for male 
pups in two 2-generation reproductive studies. In one study, there are 
no toxicological effects in the dams whereas for the pups, reduced 
bodyweights are observed at the highest dose level, starting on day 14 
of lactation. This contributes to an overall decrease in bodyweight 
gain during the entire lactation period. Additionally, reproductive 
effects in males appear in the F1 generation in the form of increased 
incidence and severity of testicular tubular atrophy. These data are 
considered to be evidence of increased quantitative susceptibility for 
male pups (increased incidence of testicular tubular atrophy at 1.8 
milligrams/kilogram/day (mg/kg/day) when compared to the parents 
(hyaline changes in renal tubules at 61 mg/kg/day; NOAEL is 1.8 mg/kg/
day).
    In a more recent 2-generation reproduction study, the most 
sensitive effect was sperm abnormalities at 3 mg/kg/day (the NOAEL is 
1.2 mg/kg/day) in the F1 males. This study also indicates increased 
susceptibility for the offspring for this effect.
    Although there is evidence of increased quantitative susceptibility 
for male pups in both reproductive studies, NOAELs and LOAELs were 
established in these studies and the Agency selected the NOAEL for 
testicular effects in F1 pups as the basis for risk assessment. The 
Agency has confidence that the NOAEL selected for risk assessment is 
protective of the most sensitive effect (testicular effects) for the 
most sensitive subgroup (pups) observed in the toxicological database.
    3. Conclusion.In the final rule published in the Federal Register 
of January 5, 2005 (70 FR 708) (FRL-7689-7), EPA had previously 
determined that the FQPA SF should be retained at 10X for thiamethoxam, 
based on the following factors: Effects on endocrine organs observed 
across species; significant decrease in alanine amino transferase 
levels in companion animal studies and in dog studies; the mode of 
action of this chemical in insects (interferes with the nicotinic 
acetylcholine receptors of the insect's nervous system); the transient 
clinical signs of neurotoxicity in several studies across species; and 
the suggestive evidence of increased quantitative susceptibility in the 
rat reproduction study.
    Since that determination, EPA has received and reviewed a 
developmental neurotoxicity (DNT) study in rats, and an additional 
reproduction study in rats. Taking the results of these studies into 
account, as well as the rest of the data on thiamethoxam, EPA has 
determined that reliable data show the safety of infants and children 
would be adequately protected if the FQPA SF for thiamethoxam were 
reduced to 1X. That decision is based on the following findings:
    i. The toxicity database for thiamethoxam is largely complete, 
including acceptable/guideline developmental toxicity, 2-generation 
reproduction, and DNT studies designed to detect adverse effects on the 
developing organism, which could result from the mechanism that may 
have produced the decreased alanine amino transferase levels. The 
registrant must now submit, as a condition of registration, an 
immunotoxicity study. This study is now required under 40 CFR part 158. 
The available data for thiamethoxam show the potential for immunotoxic 
effects, which are described in more detail below.
    ii. In the subchronic dog study, leukopenia (decreased white blood 
cells) was observed in females only, at the highest dose tested (HDT) 
of 50 mg/kg/day; the NOAEL for this effect was 34 mg/kg/day. The 
overall study NOAEL was 9.3 mg/kg/day in females (8.2 mg/kg/day in 
males) based on hematology and other clinical chemistry findings at the 
LOAEL of 34 mg/kg/day (32 mg/kg/day in males).
    iii. In the subchronic mouse study, decreased spleen weights were 
observed in females at 626 mg/kg/day; the NOAEL for this effect was the 
next lowest dose of 231 mg/kg/day. The overall study NOAEL was 1.4 mg/
kg/day (males) based on increased hepatocyte hypertrophy observed at 
the LOAEL of 14.3 mg/kg/day. The decreased absolute spleen weights were 
considered to be treatment related, but were not statistically 
significant at 626 mg/kg/day or at the HDT of 1,163 mg/kg/day. Since 
spleen weights were not decreased relative to body weights, the 
absolute decreases may have been related to the decreases in body 
weight gain observed at higher doses.
    iv. Overall, the Agency has a low concern for the potential for 
immunotoxicity related to these effects for the following reasons:
    a. In general, the Agency does not consider alterations in 
hematology parameters alone to be a significant indication of potential 
immunotoxicity. In the case of thiamethoxam, high-dose females in the 
subchronic dog study had slight microcytic anemia as well as leukopenia 
characterized by reductions in neutrophils, lymphocytes and monocytes; 
the leukopenia was considered to be related to the anemic response to 
exposure. Further, endpoints and doses selected for risk assessment are 
protective of the observed effects on hematology.
    b. Spleen weight decreases, while considered treatment-related, 
were associated with decreases in body weight gain, and were not 
statistically significant. In addition, spleen weight changes occurred 
only at very high doses, more than 70 times higher than the doses 
selected for risk assessment. Therefore, an additional 10X safety 
factor is not warranted for thiamethoxam at this time.
    v. For the reasons discussed in Unit III.D.2., there is low concern 
for an increased susceptibility in the young.
    vi. Although there is evidence of neurotoxicity after acute 
exposure to thiamethoxam at doses of 500 mg/kg/day including drooped 
palpebral closure, decrease in rectal temperature and locomotor 
activity and increase in forelimb grip strength, no evidence of 
neuropathology was observed. These effects occurred at doses at least 
fourteen-fold and 416-fold higher than the doses used for the acute, 
and chronic risk assessments, respectively; thus, there is low concern 
for these effects since it is expected that the doses used for 
regulatory purposes would be protective of the effects noted at much 
higher doses.
    vii. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed using 
tolerance-level and/or anticipated residues that are based on reliable 
field trial data observed in the thiamethoxam field trials. Although 
there is available information indicating that

[[Page 50143]]

thiamethoxam and clothianidin have different toxicological effects in 
mammals and should be assessed separately, the residues of each have 
been combined in these assessments to ensure that the estimated 
exposures of thiamethoxam do not underestimate actual potential 
thiamethoxam exposures. An assumption of 100 PCT was made for all foods 
evaluated in the assessments. For the acute and chronic assessments, 
the EDWCs of 131.77 ppb and 11.3 ppb, respectively, were used to 
estimate exposure via drinking water. Compared to the results from 
small-scale prospective ground water studies where the maximum observed 
residue levels from any monitoring well were 1.0 ppb for thiamethoxam 
and 0.73 ppb for CGA-322704, the modeled estimates are protective of 
what actual exposures are likely to be. Similarly conservative 
Residential SOPs as well as a chemical-specific turf transfer residue 
(TTR) study were used to assess post-application exposure to children 
and incidental oral exposure of toddlers. These assessments will not 
underestimate the exposure and risks posed by thiamethoxam.
    viii. 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 database, 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:
    a. 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.
    b. 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.
    c. 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.
    d. 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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to thiamethoxam will occupy 9.6% of the aPAD for children 1 to 2 years 
old, the population group receiving the greatest exposure. Acute 
dietary exposure from food and water to clothianidin is estimated to 
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 
thiamethoxam from food and water will utilize 42% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure. Chronic exposure to clothianidin from food and water will 
occupy 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 thiamethoxam and clothianidin is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Thiamethoxam is currently registered for uses that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to thiamethoxam. The level of 
concern for margins of exposure (MOEs) is 100 for aggregate short-term 
exposures (i.e., MOEs less than 100 indicate potential risks of 
concern).
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures aggregated result in aggregate MOEs of 370 to 
500 for thiamethoxam and 380 to 2,200 for

[[Page 50144]]

clothianidin, for all exposure scenarios for infants, children, and 
adults.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Thiamethoxam is currently registered for uses that could result in 
intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic exposure to thiamethoxam 
through food and water with intermediate-term exposures for 
thiamethoxam. The level of concern for MOEs is 100 for aggregate 
intermediate-term exposures (i.e., MOEs less than 100 indicate 
potential risks of concern).
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures aggregated 
result in aggregate MOEs of 370 to 540 for thiamethoxam, and 380 to 
2,200 for clothianidin, for all exposure scenarios for infants, 
children, and adults.
    5. Aggregate cancer risk for U.S. population. The Agency has 
classified thiamethoxam as not likely to be a human carcinogen based on 
convincing evidence that a non-genotoxic mode of action for liver 
tumors was established in the mouse and that the carcinogenic effects 
are a result of a mode of action dependent on sufficient amounts of a 
hepatotoxic metabolite produced persistently. Thiamethoxam is not 
expected to pose a cancer risk. Clothianidin has been classified as 
``not likely to be a human carcinogen.'' It is not expected to pose a 
cancer risk.
    6. 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 thiamethoxam or clothianidin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid 
chromatography/ultraviolet (HPLC/UV) or mass spectrometry (MS)) is 
available to enforce the tolerance expression. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.

B. International Residue Limits

    There are no CODEX or Mexican maximum residue limits (MRLs) for 
thiamethoxam. A number of Canadian MRLs exist for this chemical and are 
in accord with U.S. tolerances. The new/revised tolerances established 
by this rule have been derived using the NAFTA Tolerance Harmonization 
Spreadsheet.

C. Revisions to Petitioned-For Tolerances

    Available field trial data support tolerances for combined residues 
of thiamethoxam and CGA-322704 in or on avocado, black sapote, 
canistel, mamey sapote, mango, papaya, sapodilla, and star apple at 
0.40 ppm. Therefore, the proposed tolerances of 0.20 ppm for each of 
these commodities are being raised to 0.40 ppm.
    Available field trial data support tolerances for combined residues 
of thiamethoxam and CGA-322704 in or on vegetable, root, subgroup 1A at 
0.05 ppm. Therefore, the proposed tolerance of 0.04 ppm for this 
subgroup is being raised to 0.05 ppm. In addition, because a group 
tolerance for vegetable, root, subgroup 1A is being established, the 
group tolerance for vegetable, root, except sugar beet, subgroup 1B is 
no longer needed, and is therefore being removed.
    Based on the data submitted for rice bran and polished rice, 
residues were shown not to concentrate in these processed commodities. 
Therefore, EPA has determined that tolerances are not needed for these 
commodities. Rice straw and rice hulls are no longer considered 
significant animal feed items; therefore, the Agency is no longer 
setting tolerances for these commodities.
    New crop group tolerances are being established for caneberry 
subgroup 13-07A; bushberry subgroup 13-07B, except lingonberry and 
blueberry, lowbush; fruit, small, vine climbing, subgroup 13-07F, 
except fuzzy kiwifruit; and berry, low growing, subgroup 13-07G, except 
cranberry. Therefore, the tolerances for caneberry subgroup 13A; 
bushberry subgroup 13-07B; grape; Juneberry; lingonberry; salal; and 
strawberry are no longer needed, and are being removed.
    Previously reviewed data support tolerances for combined residues 
of thiamethoxam and CGA-322704 in or on cattle, goat, horse, and sheep 
meat byproducts at 0.04 ppm. Therefore, the existing tolerances of 0.02 
ppm for each of these commodities are being raised to 0.04 ppm.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
thiamethoxam (3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-
nitro-4H-1,3,5-oxadiazin-4-imine) and its metabolite CGA-322704 [N-(2-
chloro-thiazol-5-ylmethyl)-N'-methyl-N'-nitro-guanidine], calculated as 
the stoichiometric equivalent of thiamethoxam, in or on: avocado at 
0.40 ppm; berry, low growing, subgroup 13-07G, except cranberry at 0.30 
ppm; bushberry subgroup 13-07B, except lingonberry and blueberry, 
lowbush at 0.20 ppm; caneberry subgroup 13-07A at 0.35 ppm; canistel at 
0.40 ppm; fruit, small, vine climbing, subgroup 13-07F, except fuzzy 
kiwifruit at 0.20 ppm; mango at 0.40 ppm; papaya at 0.40 ppm; sapodilla 
at 0.40 ppm; sapote, black at 0.40 ppm; sapote, mamey at 0.40 ppm; star 
apple at 0.40 ppm; vegetable, root, subgroup 1A at 0.05 ppm; rice, 
grain at 0.02 ppm.
    In addition, revised tolerances are established in or on cattle, 
meat byproducts at 0.04 ppm; goat, meat byproducts at 0.04 ppm; horse, 
meat byproducts at 0.04 ppm; sheep, meat byproducts at 0.04 ppm.
    Tolerances are revoked and removed for bushberry subgroup 13B; 
caneberry subgroup 13A; grape; Juneberry; lingonberry; salal; 
strawberry; and vegetable, root, except sugarbeet, subgroup 1B. These 
tolerances are no longer needed, since residues on these commodities 
will be covered by the new crop group tolerances being established.

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

[[Page 50145]]

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: September 22, 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 180.565 is amended by:
    a. Revising the introductory text in paragraph (a).
    b. Removing the entries for bushberry subgroup 13B; caneberry 
subgroup 13A; grape; Juneberry; lingonberry; salal; strawberry; and 
vegetable, root, except sugar beet, subgroup 1B from the table in 
paragraph (a).
    c. Revising the existing entries for cattle, meat byproducts; goat, 
meat byproducts; horse, meat byproducts; and sheep, meat byproducts in 
the table in paragraph (a).
    d. By alphabetically adding entries for avocado; berry, low 
growing, subgroup 13-07G, except cranberry; bushberry subgroup 13-07B, 
except lingonberry and blueberry, lowbush; caneberry subgroup 13-07A; 
canistel; fruit, small, vine climbing, subgroup 13-07F, except fuzzy 
kiwifruit; mango; papaya; rice, grain; sapodilla; sapote, black; 
sapote, mamey; star apple; vegetable, root, subgroup 1A; to the table 
in paragraph (a) to read as follows:

Sec.  180.565  Thiamethoxam; tolerances for residues.

    (a) Tolerances are established for residues of the insecticide 
thiamethoxam, including its metabolites and degradates, in or on the 
following commodities. Compliance with the tolerance levels specified 
below is to be determined by measuring only thiamethoxam (3-[(2-chloro-
5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-oxadiazin-4-
imine) and its metabolite CGA-322704 [N-(2-chloro-thiazol-5-ylmethyl)-
N'-methyl-N'-nitro-guanidine], calculated as the stoichiometric 
equivalent of thiamethoxam, in or on the following commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Avocado..............................................               0.40
                                * * * * *
Berry, low growing, subgroup 13-07G, except cranberry               0.30
                                * * * * *
Bushberry subgroup 13-07B, except lingonberry and                   0.20
 blueberry, lowbush..................................
Caneberry subgroup 13-07A............................               0.35
Canistel.............................................               0.40
                                * * * * *
Cattle, meat byproducts..............................               0.04
                                * * * * *
Fruit, small, vine climbing, subgroup 13-07F, except                0.20
 fuzzy kiwifruit.....................................
                                * * * * *
Goat, meat byproducts................................               0.04
                                * * * * *
Horse, meat byproducts...............................               0.04
                                * * * * *
Mango................................................               0.40
                                * * * * *
Papaya...............................................               0.40
                                * * * * *
Rice, grain..........................................               0.02
                                * * * * *
Sapodilla............................................               0.40
                                * * * * *
Sapote, black........................................               0.40
Sapote, mamey........................................               0.40
Sheep, meat byproducts...............................               0.04
                                * * * * *
Star apple...........................................               0.40
                                * * * * *
Vegetable, root, subgroup 1A.........................               0.05
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E9-23628 Filed 9-29-09; 8:45 am]

BILLING CODE 6560-50-S