Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Rules and Regulations 50137 

APPENDIX A—SUMMARY OF ACCEPTABLE DECISIONS—Continued 

End-use Substitute Decision Further information 

Rigid Polyurethane & 

Polyisocyanurate Laminated 

Boardstock.

HFC–365mfc as a substitute for 

HCFC–141b.

Acceptable ... HFC–365mfc is mildly flammable and has a 100-year 

global warming potential of 794. Observe recommendations in the manufacturer’s MSDS and guidance for 

using this compound, particularly to address its potential 

flammability. Follow safe handling and shipping as prescribed by OSHA and DOT (for example, using personal safety equipment and following requirements for 

shipping hazardous materials at 49 CFR parts 170 

through 173). Its CAS Reg. No. is 405–58–6. 

Formacel® TI as a substitute for 

HCFC–22 and HCFC–142b.

Acceptable ... Observe recommendations in the manufacturer’s MSDS 

and guidance for using these blends. 

Phenolic Insulation Board & 

Bunstock.

HFC–365mfc as a substitute for 

HCFC–141b.

Acceptable ... HFC–365mfc is mildly flammable and has a 100-year 

global warming potential of 794. Observe recommendations in the manufacturer’s MSDS and guidance for 

using this compound, particularly to address its potential 

flammability. Follow safe handling and shipping as prescribed by OSHA and DOT (for example, using personal safety equipment and following requirements for 

shipping hazardous materials at 49 CFR parts 170 

through 173). Its CAS Reg. No. is 405–58–6. 

[FR Doc. E9–23470 Filed 9–29–09; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

thiamethoxam (3-[(2-chloro-5- 

thiazolyl)methyl]tetrahydro-5-methyl-Nnitro-4H-1,3,5-oxadiazin-4-imine) and 

its metabolite CGA-322704, [N-(2- 

chloro-thiazol-5-ylmethyl)-N’-methylN’-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 


sroberts on DSKD5P82C1PROD with RULES
50138 Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Rules and Regulations 

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-Nnitro-4H-1,3,5-oxadiazin-4-imine) and 

its metabolite CGA-322704 [N-(2-chlorothiazol-5-ylmethyl)-N’-methyl-N’-nitroguanidine], 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 CGA322704 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 CGA322704 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-NVerDate Nov<24>2008 14:46 Sep 29, 2009 Jkt 217001 PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 E:\FR\FM\30SER1.SGM 30SER1

sroberts on DSKD5P82C1PROD with RULES
Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Rules and Regulations 50139 

nitro-4H-1,3,5-oxadiazin-4-imine) and 

its metabolite CGA-322704 [N-(2-chlorothiazol-5-ylmethyl)-N’-methyl-N’-nitroguanidine], 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 nongenotoxic 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-observedadverse-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 


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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 nongenotoxic 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 CallIns 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 smallscale 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 CGA322704, 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 


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thiamethoxam and 0.73 ppb for CGA322704. 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 nonoccupational, 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. Shortterm 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 shortand 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 endpoints 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°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 


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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 


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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 smallscale 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 chemicalspecific turf transfer residue (TTR) 

study were used to assess postapplication 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 


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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 intermediateterm 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; email 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-Nnitro-4H-1,3,5-oxadiazin-4-imine) and 

its metabolite CGA-322704 [N-(2-chlorothiazol-5-ylmethyl)-N’-methyl-N’-nitroguanidine], 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 


sroberts on DSKD5P82C1PROD with RULES
Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Rules and Regulations 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. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 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: 

§ 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-Nnitro-4H-1,3,5-oxadiazin-4-imine) and 

its metabolite CGA-322704 [N-(2-chlorothiazol-5-ylmethyl)-N’-methyl-N’-nitroguanidine], calculated as the 

stoichiometric equivalent of 

thiamethoxam, in or on the following 

commodities: 

Commodity Parts per million 

*****

Avocado .......................... 0.40 

Commodity Parts per million 

*****

Berry, low growing, subgroup 13-07G, except 

cranberry ..................... 0.30 

*****

Bushberry subgroup 13- 

07B, except 

lingonberry and blueberry, lowbush ............. 0.20 

Caneberry subgroup 13- 

07A .............................. 0.35 

Canistel ........................... 0.40 

*****

Cattle, meat byproducts 0.04 

*****

Fruit, small, vine climbing, subgroup 13-07F, 

except fuzzy kiwifruit ... 0.20 

*****

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 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 679 

[Docket No. 0910091344–9056–02] 

RIN 0648–XR90 

Fisheries of the Exclusive Economic 

Zone Off Alaska; Pollock in Statistical 

Area 620 of the Gulf of Alaska 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; modification 

of a closure. 

SUMMARY: NMFS is reopening directed 

fishing for pollock in Statistical Area 

620 of the Gulf of Alaska (GOA). This 

action is necessary to fully use the C 

season allowance of the 2009 total 


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