50904 Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Rules and Regulations 

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) (Pub. L. 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: August 9, 2011. 

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 180.617 is amended by 

revising paragraph (a) to read as follows: 

§ 180.617 Metconazole; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of metconazole, 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified below is to 

be determined by measuring only 

metconazole [5-[(4- 

chlorophenyl)methyl]-2,2-dimethyl-1- 

(1H-1,2,4-triazol-1- 

ylmethyl)cyclopentanol] as the sum of 

its cis- and trans-isomers in or on the 

following commodities: 

Commodity Parts per 

million 

Almond, hulls ............................ 4 .0 

Banana 1 ................................... 0 .1 

Barley, grain ............................. 2 .5 

Barley, hay ................................ 7 .0 

Barley, straw ............................. 7 .0 

Beet, sugar, dried pulp ............. 0 .70 

Beet, sugar, molasses .............. 0 .08 

Beet, sugar, roots ..................... 0 .07 

Bushberry subgroup 13–07B .... 0 .40 

Canola seed ............................. 0 .04 

Cattle, meat byproducts ........... 0 .04 

Corn, field, forage ..................... 3 .0 

Corn, field, grain ....................... 0 .02 

Corn, field, stover ..................... 4 .5 

Corn, pop, grain ........................ 0 .02 

Corn, pop, stover ...................... 4 .5 

Corn, sweet, forage .................. 3 .0 

Corn, sweet, kernel plus cob 

with husks removed .............. 0 .01 

Corn, sweet, stover .................. 4 .5 

Cotton, gin byproducts ............. 8 .0 

Cotton, undelinted seed ........... 0 .25 

Egg ........................................... 0 .04 

Fruit, stone, group 12 ............... 0 .20 

Goat, meat byproducts ............. 0 .04 

Grain, aspirated grain fractions 7 .0 

Horse, meat byproducts ........... 0 .04 

Nut, tree, group 14 ................... 0 .04 

Oat, grain .................................. 1 .0 

Oat, hay .................................... 17 

Oat, straw ................................. 6 .0 

Peanut ...................................... 0 .04 

Peanut, refined oil .................... 0 .05 

Pistachio ................................... 0 .04 

Rye, grain ................................. 0 .25 

Rye, straw ................................. 14 

Sheep, meat byproducts .......... 0 .04 

Soybean, forage ....................... 3 .0 

Soybean, hay ............................ 6 .0 

Soybean, hulls .......................... 0 .08 

Soybean, seed .......................... 0 .05 

Vegetable, tuberous and corn, 

subgroup 1C ......................... 0 .04 

Wheat, grain ............................. 0 .15 

Wheat, hay ............................... 16 

Wheat, milled byproducts ......... 0 .20 

Wheat, straw ............................. 18 

1 No U.S. registration as of August 30, 2006. 

* * * * * 

[FR Doc. 2011–20841 Filed 8–16–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0481; FRL–8874–9] 

Thiamethoxam; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of thiamethoxam 

in or on peanut; peanut, hay; peanut, 

meal; alfalfa, forage; alfalfa, hay; and in 

food/feed commodities in food/feed 

handling establishments. Syngenta Crop 

Protection, Inc. requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 17, 2011. Objections and 

requests for hearings must be received 

on or before October 17, 2011, 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: This final rule addresses 

three petitions for tolerances. EPA has 

established a docket under docket 

identification (ID) number EPA–HQ– 

OPP–2011–0481 which contains only 

this final rule and is a summary docket 

used to lead the user to the individual 

docket established for each of the three 

petitions for tolerances addressed in this 

final rule: EPA–HQ–OPP–2010–0041 

(peanut), EPA–HQ–OPP–2010–0324 

(alfalfa), EPA–HQ–OPP–2010–0602 

(food/feed commodities in food/feed 

handling establishments). The user 

should look in the individual dockets to 

view the previous Federal Register 

publications and supporting documents 

for each tolerance petition. 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 


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Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Rules and Regulations 50905 

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 get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site http://ecfr.gpoaccess.gov/cgi/t/text/ 

text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 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–2011–0481 (summary docket) or 

the individual docket for a specific new 

use: EPA–HQ–OPP–2010–0041 

(peanut), EPA–HQ–OPP–2010–0324 

(alfalfa), or EPA–HQ–OPP–2010–0602 

(food/feed commodities in food/feed 

handling establishments) in the subject 

line on the first page of your 

submission. All objections and requests 

for a hearing must be in writing, and 

must be received by the Hearing Clerk 

on or before October 17, 2011. 

Addresses for mail and hand delivery of 

objections and hearing requests are 

provided in 40 CFR 178.25(b). 

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. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2011–0481 (summary 

docket) or the individual docket for a 

specific new use: EPA–HQ–OPP–2010– 

0041 (peanut), EPA–HQ–OPP–2010– 

0324 (alfalfa), –HQ–OPP–2010–0602 

(food/feed commodities in food/feed 

handling establishments) by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

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. Summary of Petitioned-For 

Tolerance 

This final rule addresses three 

petitions for tolerances. 

1. Peanut. In the Federal Register of 

March 24, 2010 (75 FR 14154) (FRL– 

8815–6), EPA issued a notice pursuant 

to section 408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 9F7657) by 

Syngenta Crop Protection, Inc., P.O. Box 

18300, Greensboro, NC 27419. The 

petition requested that 40 CFR 180.565 

be amended by establishing tolerances 

for 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, N-(2-chloro-thiazol-5- 

ylmethyl)-N′-methyl-N′-nitro-guanidine, 

in or on peanut at 0.05 parts per million 

(ppm) and peanut hay at 0.25 ppm. That 

notice referenced a summary of the 

petition prepared by Syngenta Crop 

Protection, Inc., the registrant, which is 

available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

determined that a tolerance must also be 

established for peanut meal at 0.15 ppm. 

The reasons for this change are 

explained in Unit IV.D. 

2. Alfalfa. In the Federal Register of 

June 8, 2010 (75 FR 32463) (FRL–8827– 

5), EPA issued a notice pursuant to 

section 408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 0F7707) by 

Syngenta Crop Protection, Inc., P.O. Box 

18300, Greensboro, NC 27419. The 

petition requested that 40 CFR 180.565 

be amended by establishing tolerances 

for 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, N-(2-chloro-thiazol-5- 

ylmethyl)-N′-methyl-N′-nitro-guanidine, 

in or on alfalfa, forage at 0.05 ppm and 

alfalfa, hay at 0.12 ppm. That notice 

referenced a summary of the petition 

prepared by Syngenta Crop Protection, 

Inc., the registrant, which is available in 

the docket, http://www.regulations.gov. 

One comment was received from a 

private citizen who opposes any 

pesticide that leaves a residue on food. 

The Agency has received this same 

comment from this commenter on 

numerous previous occasions and 

rejects it for reasons previously stated. 

70 FR 1349, 1354 (January 7, 2005). 

3. Food/feed commodities in food/ 

feed handling establishments. In the 

Federal Register of June 22, 2011 (76 FR 

36479) (FRL–8878–1), EPA issued a 

notice pursuant to section 408(d)(3) of 

FFDCA, 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 0F7734) by Syngenta Crop 

Protection, Inc., P.O. Box 18300, 

Greensboro, NC 27419. The petition 

requested that 40 CFR 180.565 be 

amended by establishing tolerances for 

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, N-(2-chloro-thiazol-5- 

ylmethyl)-N′-methyl-N′-nitro-guanidine, 

in or on food commodities and feed 


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50906 Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Rules and Regulations 

commodities (other than those covered 

by a higher tolerance as a result of use 

on growing crops) in food/feed handling 

establishments at 0.01 ppm. That notice 

referenced a summary of the petition 

prepared by Syngenta Crop Protection, 

Inc., the registrant, which is available in 

the docket, http://www.regulations.gov. 

One comment was received from a 

private citizen who opposes any 

pesticide that leaves a residue on food. 

The Agency has received this same 

comment from this commenter on 

numerous previous occasions and 

rejects it for reasons previously stated. 

70 FR 1349, 1354 (January 7, 2005). 

Based upon review of the data 

supporting the petition, EPA has 

determined that the tolerance for food 

commodities and feed commodities 

(other than those covered by a higher 

tolerance as a result of use on growing 

crops) in food/feed handling 

establishments be raised to 0.02 ppm. 

The reasons for this change are 

explained in Unit IV.D. 

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 thiamethoxam 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with thiamethoxam 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–2008–0945, 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 Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). 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 

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. 


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Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Rules and Regulations 50907 

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 

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. 

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. 

Such effects were identified for 

thiamethoxam. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States 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 as a Seed Treatment for 

Alfalfa and Peanuts, and for Use in Food 

Handling Establishments,’’ available in 

the dockets EPA–HQ–OPP–2009–0041, 

EPA–HQ–OPP–2010–0324, and EPA– 

HQ–OPP–2010–0602, at http:// 

www.regulations.gov; and ‘‘Clothianidin 

Acute and Chronic Aggregate Dietary 

(Food and Drinking Water) Exposure 

and Risk Assessments,’’ available in the 

docket EPA–HQ–OPP–2008–0771, at 

http://www.regulations.gov. 

iii. Cancer. 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. 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 FFDCA section 408(f)(1) 

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 FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). 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. 

For surface water, the estimated 

drinking water concentrations (EDWCs) 

are based on thiamethoxam 

concentrations in water from rice 

paddies and cranberry bogs that drains 

into adjacent surface water bodies (often 

referred to as ‘‘tail water’’). Because the 

uses on rice and cranberries 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. 

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. 

For ground water, the EDWCs are 

based on thiamethoxam concentrations 

resulting from use on dry bulb onions. 

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 (i.e. surface water) and 4.66 ppb 

for ground water. The EDWCs for 

chronic exposures for non-cancer 

assessments are 11.31 ppb for tail water 

and 4.66 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 rice tail water, and represent 

worst case scenarios. Therefore, for the 

acute dietary risk assessments for 


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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 

clothianidin, 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 

thiamethoxam and 0.73 ppb for 

clothianidin. 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. 

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 as a Seed Treatment for 

Alfalfa and Peanuts, and for Use in Food 

Handling Establishments,’’ available in 

the dockets EPA–HQ–OPP–2009–0041, 

EPA–HQ–OPP–2010–0324, and EPA– 

HQ–OPP–2010–0602, at http:// 

www.regulations.gov; and ‘‘Clothianidin 

Acute and Chronic Aggregate Dietary 

(Food and Drinking Water) Exposure 

and Risk Assessments,’’ available in the 

docket EPA–HQ–OPP– 2008–0771, at 

http://www.regulations.gov. 

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 × 10¥9 Pa @ 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. 

A complete listing of the inputs used 

in these assessments can be found in the 

following documents: ‘‘Thiamethoxam: 

Occupational and Residential Exposure/ 

Risk Assessment for Proposed Section 3 

Registration for Seed Treatment Use on 

Peanut and Alfalfa’’ available in the 

dockets EPA–HQ–OPP–2010–0041 and 

EPA–HQ–OPP–2010–0324 at http:// 

www.regulations.gov; and 

‘‘Thiamethoxam: Occupational and 

Residential Exposure/Risk Assessment 

for Proposed Section 3 Registration for 

Use in Food/Feed Handling 

Establishments’’ available in the docket 

EPA–HQ–OPP–2010–0602 at http:// 

www.regulations.gov. 

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– 

2008–0945, at http:// 

www.regulations.gov. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

trac/science/trac6a05.pdf. 

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, 


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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 Web site at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor 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 DNT 

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. i. 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 city 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 

were reduced to 1X (June 23, 2010, 75 

FR 35653; FRL–8830–4); (June 22, 2007, 

72 FR 34401). That decision is based on 

the following findings: 

a. 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. 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). 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 


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decreases in body weight gain observed 

at higher doses. 

Overall, the Agency has a low concern 

for the potential for immunotoxicity 

related to these effects for the following 

reasons: 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. 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. 

b. For the reasons discussed in Unit 

III.D.2., there is low concern for an 

increased susceptibility in the young. 

c. 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. 

In the DNT study, there was no 

evidence of neurotoxicity in the dams 

exposed up to 298.7 mg/kg/day; a dose 

that was associated with decreases in 

body weight gain and food 

consumption. In pups exposed to 298.7 

mg/kg/day, there were significant 

reductions in absolute brain weight and 

size (i.e., length and width of the 

cerebellum was less in males on day 12, 

and there were significant decreases in 

Level 3–5 measurements in males and 

in Level 4–5 measurements in females 

on day 63). However, there is low 

concern for this increased qualitative 

susceptibility observed in the DNT 

study because the doses and endpoints 

selected for risk assessment are 

protective of the effects in the offspring. 

As noted previously, the Agency 

selected the NOAEL for testicular effects 

in F1 pups based on two reproductive 

toxicity studies for risk assessment to be 

protective of all sensitive 

subpopulations. 

d. 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 

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 clothianidin, the modeled estimates 

are protective of what actual exposures 

are likely to be. Similarly conservative 

residential standards of procedures, as 

well as a chemical specific 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. 

ii. 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 DNT 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 DNT 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 DNT 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 

(February 11, 2011, 76 FR 7712) (FRL– 

8858–3). 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 DNT study. 

b. A rat DNT study is available and 

shows evidence of increased 

quantitative susceptibility of offspring. 

However, EPA considers the degree of 

concern for the DNT 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 DNT 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 water and 

surface water modeling used to assess 

exposure to clothianidin in drinking 

water. EPA used similarly conservative 

assumptions to assess post-application 

exposure of children and adults as well 

as incidental oral exposure of toddlers. 

These assessments will not 


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underestimate the exposure and risks 

posed by clothianidin. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer 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 appropriate 

PODs to ensure that an adequate MOE 

exists. 

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 9.5% of the 

aPAD for all infants (<1 year), 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 43% 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 

utilize 19% of the cPAD for children 1 

to 2 years old, the population group 

receiving the greatest exposure. 

Based on the explanation in Unit 

III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of 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. Using the 

exposure assumptions described in this 

unit for short-term exposures, EPA has 

concluded the combined short-term 

food, water, and residential exposures 

for thiamethoxam result in aggregate 

MOEs of: 370 for the general U.S. 

population; 490 for all infants (<1 year); 

440 for children 1 to 2 years; 450 for 

children 3–5 years; 370 for children 6– 

12 years; 380 for youth 13–19 years, 

adults 20–49 years, adults 50+ years, 

and females 13–49 years. Because EPA’s 

level of concern for thiamethoxam is a 

MOE of 100 or below, these MOEs are 

not 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 for clothianidin 

result in aggregate MOEs of: 1,700 for 

the general U.S. population; 480 for all 

infants (<1 year); 380 for children 1 to 

2 years; 500 for children 3–5 years; 

1,400 for children 6–12 years; 2,200 for 

youth 13–19 years, adults 20–49 years, 

and females 13–49 years; 2,100 for 

adults 50+ years. Because EPA’s level of 

concern for clothianidin is a MOE of 

100 or below, these MOEs are not of 

concern. 

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 through food and water with 

intermediate-term residential exposures 

to thiamethoxam. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures result 

in aggregate MOEs of 370 for the general 

U.S. population; 540 for all infants (<1 

year); 470 for children 1 to 2 years; 490 

for children 3–5 years; 370 for children 

6–12 years; 380 for youth 13–19 years, 

adults 20–49 years, adults 50+ years, 

and females 13–49 years. Because EPA’s 

level of concern for thiamethoxam is a 

MOE of 100 or below, these MOEs are 

not of concern. 

Using the exposure assumptions 

described in this unit for intermediate 

exposures, EPA has concluded the 

combined intermediate food, water, and 

residential exposures for clothianidin 

result in aggregate MOEs of 1,700 for the 

general U.S. population; 480 for all 

infants (<1 year); 380 for children 1 to 

2 years; 500 for children 3–5 years; 

1,400 for children 6–12 years; 2,200 for 

youth 13–19 years, adults 20–49 years, 

and females 13–49 years; 2,100 for 

adults 50+ years. Because EPA’s level of 

concern for clothianidin is a MOE of 

100 or below, these MOEs are not of 

concern. 

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. Therefore, thiamethoxam 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. 

For further details, refer to the 

document ‘‘Thiamethoxam—Human 

Health Risk Assessment for New Seed 

Treatment Uses on Alfalfa and Peanuts, 

and Use in Food Handling 

Establishments’’ in the dockets EPA– 

HQ–2010–0041, EPA–HQ–OPP–2010– 

0324, EPA–HQ–OPP–2010–0602, at 

http://www.regulations.gov and 

‘‘Thiamethoxam. Petition to Establish a 

Permanent Tolerance for Residues of the 

Insecticide Resulting from Food/Feed 

Use as a Seed Treatment on Bulb 

Onions. Response to Data Gaps from 

Conditional Registration of Various 

Food/Feed Crops (as Specified in HED 

Memo D281702; M. Doherty; 17 April 

2007). Summary of Analytical 

Chemistry and Residue Data,’’ available 

in the docket EPA–HQ–OPP–2009– 

0737, at http://www.regulations.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 


Emcdonald on DSK2BSOYB1PROD with RULES
50912 Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Rules and Regulations 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established a MRL 

for thiamethoxam. 

C. Response to Comments 

Comments were received in dockets 

EPA–HQ–OPP–2010–0324 and EPA– 

HQ–OPP–2010–0602 from a private 

citizen who opposes any pesticide that 

leaves a residue on food. The Agency 

has received these same comments from 

this commenter on numerous previous 

occasions and rejects them for reasons 

previously stated. 70 FR 1349, 1354 

(January 7, 2005). 

D. Revisions to Petitioned-For 

Tolerances 

EPA made two revisions to the 

tolerances as proposed: The addition of 

a tolerance for peanut meal and an 

increase in the proposed tolerance for 

food commodities and feed 

commodities (other than those covered 

by a higher tolerance as a result of use 

on growing crops) in food/feed handling 

establishments. 

In addition to the two requested raw 

agricultural commodity tolerances for 

peanut and peanut hay, EPA considered 

the residues on processed peanut 

commodities. The processed 

commodities associated with the 

proposed use on peanuts are peanut 

meal and refined oil. Two peanut field 

trials were conducted in the U.S. during 

the 1999 growing season in which 

peanut seeds treated at an exaggerated 

(roughly 6–6.5X) rate were grown for 

processing into peanut meal and refined 

oil. Thiamethoxam residues were not 

detected in the nutmeat nor processed 

fractions of peanuts grown from peanut 

seeds treated at the 6–6.5X rate. 

Residues were not detected in any of the 

peanut oil samples upon processing. 

Residues were observed in the nutmeat 

and meal of peanuts, grown from peanut 

seeds treated at roughly a 2X rate, from 

both field trials. The theoretical 

concentration factor for peanut meal 

(EPA Residue Chemistry Test Guideline 

860.1520, Table 3) is 2.2X. The 

empirical concentration factors for 

thiamethoxam in meal (range 2.0–3.1X, 

average 2.6X) conform well to the 

theoretical value. A tolerance is not 

required in peanut oil. However, based 

on the highest average field trial 

combined residues of 0.05 ppm (0.09 

ppm at a 2X rate) in peanut nutmeat, 

and the theoretical concentration factor 

for peanut meal of 2.2X, EPA is setting 

a tolerance of 0.15 ppm in peanut meal. 

The submitted data for thiamethoxam 

use in food handling areas are 

acceptable and support the proposed 

use (spot, void, and crack and crevice 

treatment) in food handling 

establishments. An adequate variety of 

food commodities were exposed to 

thiamethoxam, in two different types of 

food handling establishments, at 1X the 

maximum proposed rate. Maximum 

thiamethoxam and clothianidin residues 

were each <0.01 ppm in food 

commodities exposed to 1X treatment in 

food handling areas (with the vast 

majority of samples containing nondetectable residues). The registrants 

proposed tolerance had failed to add 

these two sources together. EPA is 

setting a tolerance of 0.02 ppm in food 

commodities and feed commodities 

(other than those covered by a higher 

tolerance as a result of use on growing 

crops) in food/feed handling 

establishments based on the presence of 

detectable residues of thiamethoxam 

added to detectable residues of the 

metabolite clothianidin in various 

samples. 

V. Conclusion 

Therefore, tolerances are established 

for residues of thiamethoxam, 3-[(2- 

chloro-5-thiazolyl)methyl]tetrahydro-5- 

methyl-N-nitro-4H-1,3,5-oxadiazin-4- 

imine and its metabolite, N-(2-chlorothiazol-5-ylmethyl)-N′-methyl-N′-nitroguanidine, in or on peanut at 0.05 ppm; 

peanut hay at 0.25 ppm; peanut meal at 

0.15 ppm; alfalfa, forage at 0.05 ppm; 

alfalfa, hay at 0.12 ppm; and food 

commodities and feed commodities 

(other than those covered by a higher 

tolerance as a result of use on growing 

crops) in food/feed handling 

establishments at 0.02 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 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 


Emcdonald on DSK2BSOYB1PROD with RULES
Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Rules and Regulations 50913 

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: August 5, 2011. 

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 

alphabetically adding the following 

commodities to the table in paragraph 

(a) to read as follows: 

§ 180.565 Thiamethoxam; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

Alfalfa, forage ........................... 0.05 

Alfalfa, hay ................................ 0.12 

* * * * * * * 

Food commodities and feed 

commodities (other than 

those covered by a higher 

tolerance as a result of use 

on growing crops) in food/ 

feed handling establishments 0.02 

* * * * * * * 

Peanut ...................................... 0.05 

Peanut, hay .............................. 0.25 

Peanut, meal ............................ 0.15 

* * * * * * * 

* * * * * 

[FR Doc. 2011–20839 Filed 8–16–11; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 65 

[Docket ID FEMA–2011–0002; Internal 

Agency Docket No. FEMA–B–1211] 

Changes in Flood Elevation 

Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Interim rule. 

SUMMARY: This interim rule lists 

communities where modification of the 

Base (1% annual-chance) Flood 

Elevations (BFEs) is appropriate because 

of new scientific or technical data. New 

flood insurance premium rates will be 

calculated from the modified BFEs for 

new buildings and their contents. 

DATES: These modified BFEs are 

currently in effect on the dates listed in 

the table below and revise the Flood 

Insurance Rate Maps (FIRMs) in effect 

prior to this determination for the listed 

communities. 

From the date of the second 

publication of these changes in a 

newspaper of local circulation, any 

person has ninety (90) days in which to 

request through the community that the 

Deputy Federal Insurance and 

Mitigation Administrator reconsider the 

changes. The modified BFEs may be 

changed during the 90-day period. 

ADDRESSES: The modified BFEs for each 

community are available for inspection 

at the office of the Chief Executive 

Officer of each community. The 

respective addresses are listed in the 

table below. 

FOR FURTHER INFORMATION CONTACT: Luis 

Rodriguez, Chief, Engineering 

Management Branch, Federal Insurance 

and Mitigation Administration, Federal 

Emergency Management Agency, 500 C 

Street, SW., Washington, DC 20472, 

(202) 646–4064, or (e-mail) 

luis.rodriguez1@dhs.gov. 

SUPPLEMENTARY INFORMATION: The 

modified BFEs are not listed for each 

community in this interim rule. 

However, the address of the Chief 

Executive Officer of the community 

where the modified BFE determinations 

are available for inspection is provided. 

Any request for reconsideration must 

be based on knowledge of changed 

conditions or new scientific or technical 

data. 

The modifications are made pursuant 

to section 201 of the Flood Disaster 

Protection Act of 1973, 42 U.S.C. 4105, 

and are in accordance with the National 

Flood Insurance Act of 1968, 42 U.S.C. 

4001 et seq., and with 44 CFR part 65. 

For rating purposes, the currently 

effective community number is shown 

and must be used for all new policies 

and renewals. 

The modified BFEs are the basis for 

the floodplain management measures 

that the community is required either to 

adopt or to show evidence of being 

already in effect in order to qualify or 

to remain qualified for participation in 

the National Flood Insurance Program 

(NFIP). 

These modified BFEs, together with 

the floodplain management criteria 

required by 44 CFR 60.3, are the 

minimum that are required. They 

should not be construed to mean that 

the community must change any 

existing ordinances that are more 

stringent in their floodplain 

management requirements. The 

community may at any time enact 

stricter requirements of its own or 

pursuant to policies established by other 

Federal, State, or regional entities. The 

changes in BFEs are in accordance with 

44 CFR 65.4. 

National Environmental Policy Act. 

This interim rule is categorically 

excluded from the requirements of 44 

CFR part 10, Environmental 

Consideration. An environmental 

impact assessment has not been 

prepared. 

Regulatory Flexibility Act. As flood 

elevation determinations are not within 

the scope of the Regulatory Flexibility 

Act, 5 U.S.C. 601–612, a regulatory 

flexibility analysis is not required. 

Regulatory Classification. This 

interim rule is not a significant 

regulatory action under the criteria of 

section 3(f) of Executive Order 12866 of 

September 30, 1993, Regulatory 

Planning and Review, 58 FR 51735. 

Executive Order 13132, Federalism. 

This interim rule involves no policies 

that have federalism implications under 

Executive Order 13132, Federalism. 

Executive Order 12988, Civil Justice 

Reform. This interim rule meets the 

applicable standards of Executive Order 

12988. 

List of Subjects in 44 CFR Part 65 

Flood insurance, Floodplains, 

Reporting and recordkeeping 

requirements. 

Accordingly, 44 CFR part 65 is 

amended to read as follows: 

PART 65—[AMENDED] 

■ 1. The authority citation for part 65 

continues to read as follows: 


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